Medokinal Film-Coated Tablet
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
SUMMARY OF THE PRODUCT CHARACTERISTICS Formatiert: Schriftart: 14 Pt., Nicht Kapitälchen, Großbuchstaben, Unterschneidung ab 16 Pt. 1 NAME OF THE MEDICINAL PRODUCT Formatiert: Überschrift 1, Zentriert Formatiert: Schriftart: Quinapril Zentiva 5 mg film-coated tablet Formatiert: Standard Quinapril Zentiva 10 mg film-coated tablet Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Quinapril Zentiva 20 mg film-coated tablet Großbuchstaben Quinapril Zentiva 40 mg film-coated tablet Formatiert: Überschrift 2;2 SmPC, Einzug: Links: 0 cm, Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerierungs formatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: 2 QUALITATIVE AND QUANTITATIVE COMPOS ITION Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Quinapril Zentiva 5 mg film-coated tablets: Großbuchstaben Each film-coated tablet contains 5 mg quinapril (as quinapril hydrochloride). Formatiert: Überschrift 2;2 SmPC, Einzug: Links: 0 cm, Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerierungs Quinapril Zentiva 10 mg film-coated tablets: formatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Each film-coated tablet contains 10 mg quinapril (as quinapril hydrochloride). Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm
Quinapril Zentiva 20 mg film-coated tablets: Each film-coated tablet contains 20 mg quinapril (as quinapril hydrochloride).
Quinapril Zentiva 40 mg film-coated tablets: Each film-coated tablet contains 40 mg quinapril (as quinapril hydrochloride).
Excipient with known effect: sodium. Each tablet contains less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1. Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Großbuchstaben Formatiert: Überschrift 2;2 SmPC, Einzug: Links: 0 cm, 3 PHARMACEUTICAL FORM Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerierungs formatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Film-coated tablet Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm
Quinapril Zentiva 5 mg is an oval, biconvex, red-brown film-coated tablet, scored on both Formatiert: Standard sides and imprinted with "I" on one side. Size 4.5 x 8.7 mm. Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. Quinapril Zentiva 10 mg is an oval, biconvex, red-brown film-coated tablet, scored on both Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Großbuchstaben sides and imprinted with "L" on one side. Size 5.8 x 11.3 mm. Formatiert: Überschrift 2;2 SmPC, Einzug: Links: 0 cm, Quinapril Zentiva 20 mg is a round, biconvex, red-brown film-coated tablet, scored on both Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerierungs sides and imprinted with "I" on one side. Diameter 7 mm. formatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Quinapril Zentiva 40 mg is an oval, biconvex, red-brown film-coated tablet, scored on both Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm sides and imprinted with "I" on one side. Size 6.5 x 12.7 mm. Formatiert: Schriftart: Formatiert: Standard, Links, Nicht vom nächsten Absatz The tablet can be divided into equal doses. trennen
Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 4 CLINICAL PARTICULARS Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine 4 Aufzählungen oder Nummerierungen 4.1 Therapeutic indications Formatiert: Schriftart: Nicht Kursiv 4.1 Formatiert: Schriftart: Nicht Kursiv Essential hHypertension. Formatiert: Schriftart: Nicht Kursiv Congestive heart failure. Formatiert: Schriftart: Nicht Kursiv Formatiert: Schriftart: Nicht Kursiv
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
4.2 Posology and method of administration Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt.
For different dosage regimens, appropriate strengths of Quinapril Zentiva are available.
If a satisfactory response has not been achieved within 3 months, a change of therapy should be considered.
Posology
Adults
Essential Hypertension
Monotherapy: The recommended initial dose is 10 mg once daily in hypertension. Depending upon clinical response, patient’s dosage may be titrated (by doubling the dose allowing 3-4 weeks for dosage adjustment) to a maintenance dosage of 20 to 40 mg/day given as a single dose or divided into 2 doses. Long term control is maintained in most patients with a single daily dosage regimen. The usual maximum maintenance dose is 40 mg/day.
Concomitant diuretic: Symptomatic hypotension may occur following initiation of therapy with quinapril. This is more likely in patients who are being treated currently with diuretics. Caution is therefore recommended, since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2-3 days before beginning therapy with quinapril. In order to determine if excess hypotension will occur, an initial dosage of 2.5 mg of Quinapril Zentiva is recommended in patients who are being treated with a diuretic. After this, the dosage of Quinapril Zentiva Tablets should be titrated (allowing adequate time for dosage adjustment) to the optimal response (see section 4.5).
Congestive heart failure In order to closely monitor patients for symptomatic hypotension, a single 2.5 mg initial dosage is recommended. After this, patients should be titrated (allowing 2-3 weeks for dosage adjustment) to an effective dose: (up to 40 mg/day) given in 1-2 doses, with concomitant diuretic and/or cardiac glycoside therapy. Patients are usually maintained effectively on doses of 10-20 mg/day given in 1-2 doses with concomitant therapy. The maximum dose of 40 mg/day should not be exceeded.
Patients who are considered to be at higher risk should have treatment initiated in hospital (see section 4.4).
Elderly (>65 years) Formatiert: Nicht vom nächsten Absatz trennen As renal function tends to be reduced with age, this should also be taken into consideration in elderly patients. An initial dosage in essential hypertension of 2.5 mg is recommended followed by titration to the optimal response.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Renal impairment: The initial dose of quinapril should be reduced in patients with impaired renal function as the plasma concentration of quinaprilat increases with reduced creatinine clearance. The following doses are recommended:
Creatinine clearance (ml/min) Maximum recommended initial daily dose Formatierte Tabelle (mg) > 60 10 30-60 5 10-30 2.5 < 10 Insufficient experience
There is currently no information available about patients with creatinine clearance below 10 ml/min. Dialysis has no appreciable effect on the elimination of quinaprilat. If a satisfactory response has not been achieved within 3 months, a change of therapy should be considered.
Paediatric population Efficacy and safety of use in children and adolescents has not been established. Use in children and adolescents is therefore not recommended.
Method of administration For oral use.
4.3 Contraindications Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. - Hypersensitivity to quinapril, to any of the excipients listed in section 6.1 or any other Formatiert: Rechtschreibung und Grammatik nicht prüfen ACE inhibitor. Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt - Concomitant use of Quinapril Zentiva with aliskiren-containing products is + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,59 cm + Einzug bei: 1,59 cm, Vom nächsten Absatz contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 trennen, Diesen Absatz nicht zusammenhalten, Keine ml/min/1.73 m2) (see sections 4.5 and 5.1). Silbentrennung, Tabstopps: Nicht an 1,59 cm - Quinapril Zentiva is contraindicated in the second and third trimester of pregnancy (see Formatiert: Rechtschreibung und Grammatik nicht prüfen, sections 4.4 and 4.6). Nicht Hochgestellt/ Tiefgestellt - Quinapril Zentiva is contraindicated in patients with a history of angioedema related to Formatiert: Rechtschreibung und Grammatik nicht prüfen previous treatment with ACE inhibitors. Formatiert: Schriftart: 12 Pt., Nicht Kursiv, Rechtschreibung - Quinapril Zentiva is contraindicated in patients with hereditary/idiopathic angioneurotic und Grammatik nicht prüfen oedema. Formatiert: Rechtschreibung und Grammatik nicht prüfen - Concomitant use with sacubitril/valsartan therapy. Quinapril Zentiva must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see sections 4.4 and 4.5). Formatiert: Einzug: Links: 0 cm 4.4 S pecial warnings and precautions for use Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. Formatiert: Nicht vom nächsten Absatz trennen Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE- inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Symptomatic hypotension Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients. In hypertensive patients receiving quinapril, hypotension is more likely to occur if the patient has been volume-depleted e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting, or has severe renin-dependent hypertension (see sections 4.5 and 4.8). In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed. This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment. In patients at increased risk of symptomatic hypotension, initiation of therapy and dose adjustment should be closely monitored. Similar considerations apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses, which can be given without difficulty once the blood pressure has increased after volume expansion.
Patients who may be considered to be at higher risk and should have treatment initiated in hospital include: patients who are on high dose loop diuretics (e.g. > 80 mg furosemide) or on multiple diuretic therapy, have hypovolaemia, hyponatraemia (serum sodium < 130 mg Eq/l) or systolic blood pressure < 90 mm Hg, are on high dose vasodilator therapy, have a serum creatinine > 150 µmol/l or are aged 70 years or over.
Aortic and mitral valve stenosis / hypertrophic cardiomyopathy As with other ACE inhibitors, quinapril should be given with caution to patients with mitral valve stenosis and obstruction in the outflow of the left ventricle such as aortic stenosis or hypertrophic cardiomyopathy. In haemodynamically relevant cases quinapril should not be administered.
Renal function impairment In cases of renal impairment (creatinine clearance <60 ml/min), the quinapril dosage should be adjusted according to the patient’s creatinine clearance (see section 4.2) and then as a function of the patient’s response to treatment. Routine monitoring of potassium and creatinine is part of normal medical practice for these patients.
In some patients with bilateral renal artery stenosis or with a stenosis of the artery to a solitary kidney, who have been treated with ACE inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen. This is especially likely in patients with renal insufficiency. If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency. In these patients, treatment should be started under close medical supervision with low doses and careful dose titration. Since treatment with diuretics may be a contributory factor to the above,
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 they should be discontinued and renal function should be monitored during the first weeks of quinapril therapy.
Some hypertensive patients with no apparent pre-existing renal disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when quinapril has been given concomitantly with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or quinapril may be required.
There is no experience in patients with severe renal impairment (creatinine clearance < 10 ml/min) and in patients on dialysis. Treatment is therefore not recommended in these patients.
Kidney Transplantation There is no experience regarding the administration of quinapril in patients with a recent kidney transplantation. Treatment with quinapril is therefore not recommended.
Anaphylactoid reactions
Haemodialysis pPatients Anaphylactoid reactions have been reported in patients dialysed with high flux membranes and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or different class of antihypertensive agent.
Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis Rarely, patients receiving ACE inhibitors during low-density lipoproteins (LDL) apheresis with dextran sulphate have experienced life-treatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Desensitisation Some patients receiving ACE inhibitors during desensitisation treatment (e.g. hymenoptera venom) have experienced sustained anaphylactoid reactions. In the same patients, these reactions have been avoided when ACE inhibitors were temporarily withheld but they have reappeared upon inadvertent re-administration of the medicinal product.
Hypersensitivity/aAngioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including quinapril. Symptoms may appear long after initiation of treatment, at any time during therapy. In such cases, quinapril should be discontinued promptly and appropriate treatment and monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patients. Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient.
Very rarely, fatalities have been reported due to angioedema associated with laryngeal oedema or tongue oedema. Patients with involvement of the tongue, glottis or larynx, are likely to experience airway obstruction, especially those with a history of airway surgery. In such cases emergency therapy should be administered promptly. This may include the
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 administration of adrenaline and/or the maintenance of a patent airway. The patient should be under close medical supervision until complete and sustained resolution of symptoms has occurred.
Caution should be exercised in those known to be hypersensitive to other ACE inhibitors, and particularly those with obstructive airways disease. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see section 4.3).
Angiotensin converting enzyme inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
The cConcomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated due to the as this increaseds the risk of angioedema (see sections 4.3 and 4.5). Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of quinapril. Treatment with quinapril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see sections 4.3 and 4.5).
Concomitant use of ACE inhibitors with racecadotril, mTOR inhibitors (e.g. sirolimus, Formatiert: Schriftart: Nicht Kursiv everolimus, temsirolimus) Formatiert: Schriftart: Nicht Kursiv Formatiert: Schriftart: Nicht Kursiv Neprilysin (NEP) inhibitors (e.g. racecadotril): Formatiert: Schriftart: Kursiv Patients taking concomitant nNeprilysin (NEP) inhibitors (e.g. racecadotril) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5).
Hepatic failure Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up
Neutropenia/ aAgranulocytosis Neutropenia/ Agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. Neutropenia and agranulocytosis are reversible after discontinuation of the ACE inhibitor. Quinapril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy. If quinapril is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
Ethnic differences ACE inhibitors cause a higher rate of angioedema in black patients. As with other ACE inhibitors, quinapril may be less effective in lowering blood pressure in black patients than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Cough Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Surgery/aAnaesthesia In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, quinapril may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkalaemia Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including quinapril. Patients at risk for the development of hyperkalaemia include those with renal insufficiency, diabetes mellitus, or those using concomitant potassium- sparing diuretics, potassium supplements or potassium-containing salt substitutes, or those patients taking other medicinal products associated with increases in serum potassium (e.g. heparin, co-trimoxazole also known as trimethoprim/sulfamethoxazole ). If concomitant use of the above-mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Diabetic patients In diabetic patients ACE inhibitors may enhance insulin sensitivity and have been associated with hypoglycaemia in patients treated with oral antidiabetic agents or insulin. Glycaemic control should be closely monitored during the first month of treatment with an ACE inhibitor (see section 4.5).
Lithium Formatiert: Nicht vom nächsten Absatz trennen The combination of lithium and quinapril is generally not recommended (see section 4.5).
Pregnancy and lactation ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitors is considered essential, patients planning pregnancy should be changed to alternative anti- hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Primary hyperaldosteronism Patients with primary hyperaldosteronism generally do not respond to antihypertensive agents acting via the rennin-angiotensin-system. Therefore, treatment with ACE inhibitors is not recommended in these patients.
Warning about excipients Formatiert: Schriftart: Kursiv This medicine contains less than 1 mmol sodium (23 mg) per tablet; that is to say essentially “sodium-free”.
4.5 Interaction with other medicinal products and other forms of interaction Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 4.5 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine Sacubitril/valsartan: Aufzählungen oder Nummerierungen The cConcomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this Formatiert: Nicht vom nächsten Absatz trennen
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 increases the risk of angioedema (see sections 4.3 and 4.4). ). Treatment with quinapril must not be started until 36 hours after taking the last dose of sacubitril/valsartan. Sacubitril/valsartan must not be started until 36 hours after the last dose of Quinapril Zzentiva..
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Tetracycline and other medicinal products that interact with magnesium salts: Because of the presence of magnesium salts in the formulation, quinapril has been shown in healthy volunteers to reduce the absorption of tetracycline in concomitant administration by 28-37%. It is recommended that concomitant administration with tetracycline be avoided.
Concomitant diuretic therapy : Patients treated with diuretics may occasionally experience an excessive reduction of blood pressure after initiation of therapy with quinapril. This hypotensive effect may be effectively minimised by either discontinuing the diuretic or increasing the salt intake prior to the initial dose of quinapril. If discontinuation of the diuretic is not possible, medical supervision should be provided for up to two hours following administration of the initial dose (see sections 4.2 and 4.4).
Agents increasing serum potassium - potassium sparing diuretics, potassium supplements or potassium-containing salt substitutes : Qquinapril is an angiotensin-converting enzyme inhibitor capable of lowering aldosterone levels, which in turn can result in a mild elevation in serum potassium. Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some patients treated with quinapril.ACE inhibitors attenuate diuretic-induced potassium loss. Potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, the combination of quinapril with the above-mentioned drugs is not recommended. If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium (see section 4.4), especially in patients with impaired renal function, since by decreasing aldosterone production, quinapril often causes an increase in serum potassium.
Surgery/anaesthesia : Although no data are available to indicate there is an interaction between quinapril and anaesthetic agents that produces hypotension, caution should be exercised when patients undergo major surgery or anaesthesia since angiotensin converting enzyme inhibitors have been shown to block angiotensin II formation secondary to compensatory rennin release. This may lead to hypotension which can be corrected by volume expansion.
Lithium : Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy due to the sodium-losing effect of these agents. These medicinal products should be co-administered with caution and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, it may increase the risk of lithium toxicity.
Non-steroidal anti-inflammatory medicinal products including acetylsalicylic acid ≥3g/day: In some patients, the administration of a non-steroidal anti-inflammatory agent may reduce the antihypertensive effect of ACE inhibitors. Furthermore, it has been described that NSAID’s and ACE inhibitors exert an additive effect on the increase in serum potassium, whereas renal function may decrease. These effects are in principle reversible and occur especially in patients with compromised renal function.
Allopurinol, cytostatic and immunosuppressive agents, systemic corticosteroids or procainamide:
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Concomitant administration with ACE inhibitors may lead to an increased risk for leucopenia.
Alcohol, barbiturates or narcotics: Formatiert: Nicht vom nächsten Absatz trennen Potentiation of orthostatic hypotension may occur.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Other anti-hypertensive agents: ß-blockers, methyldopa and diuretics may enhance the hypotensive effects of quinapril, and should only be used under careful supervision. Concomitant propranolol did not affect the pharmacokinetics of quinapril in a single dose study.
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Sympathomimetics Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Antacids: May decrease the bioavailability of quinapril tablets.
Antidiabetic medicinal products (oral hypoglycaemic agents and insulin): Formatiert: Nicht vom nächsten Absatz trennen Concomitant administration of ACE inhibitors and anti-diabetic medicines (insulin, oral hypoglycaemic agents) may cause an increased blood glucose lowering effect with the risk of hypoglycaemia. This phenomenon may be more likely to occur during the first weeks of combined treatment and in patients with renal impairment. Dosage adjustments of the antidiabetic medicinal products may be required.
Trimethoprim: A severe hyperkalaemia has been reported during concomitant treatment of ACE-inhibitors with trimethoprim.
Racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and vildagliptin Concomitant use of ACE inhibitors with racecadotril, Patients taking concomitant mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and vildagliptintherapy may lead to anbe Formatiert: Nicht Hervorheben at increased risk for
Neprilysin (NEP) inhibitors Formatiert: Abstand Nach: 0 Pt., Zeilenabstand: einfach : An increased risk of angioedema has been reported with concomitant use of ACE inhibitors and NEP inhibitors (such as racecadotril) (see section 4.4).
Co-trimoxazole (trimethoprim/sulfamethoxazole) Patients taking concomitant co-trimoxazole (trimethoprim/sulfamethoxazole) may be at
Cyclosporine Hyperkalaemia may occur during concomitant use of ACE inhibitors with cyclosporine. Monitoring of serum potassium is recommended.
Heparin Hyperkalaemia may occur during concomitant use of ACE inhibitors with heparin. Monitoring of serum potassium is recommended.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
4.6 Fertility, pregnancy and lactation Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 4.6 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine Pregnancy Aufzählungen oder Nummerierungen The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4).The use of ACE inhibitors is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitors therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started. ACE inhibitors therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).
Breast-feeding Limited pharmacokinetic data demonstrate very low concentrations in breast milk (see section 5.2). Although these concentrations seem to be clinically irrelevant the use of quinapril in breastfeeding is not recommended for preterm infants and for the first few weeks after delivery, because of hypothetical risk of cardiovascular and renal effects and because there is not enough clinical experience. In case of an older infant the use of quinapril in breast-feeding mother may be considered if this treatment is necessary for the mother and the child is observed for any adverse effect.
4.7 Effects on ability to drive and use machines Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 4.7 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine Quinapril Zentiva has no or negligible influence on the ability to drive and use machines. Aufzählungen oder Nummerierungen When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur.
4.8 Undesirable effects Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 4.8 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine The following undesirable effects have been observed during treatment with quinapril and Aufzählungen oder Nummerierungen other ACE inhibitors with the following frequencies: Common (>1/100), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.
Psychiatric disorders: Uncommon: Sleep disorders, nervousness Rare: Depression, confusion.
Nervous system disorders:
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Common: Dizziness, Uncommon: Paraesthesia, somnolence. Rare: Disturbance of balance, neuropathy.
Eye disorders: Rare: Blurred vision, amblyopia
Ear and labyrinth disorders: Rare: Tinnitus.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Cardiac disorders: Uncommon: Palpitations, chest pain, angina pectoris Rare: Tachycardia, syncope, myocardial infarction, transient ischaemic attacks, cerebral haemorrhage.
Vascular disorders: Common: Hypotension. Uncommon: Postural hypotension
Blood and lymphatic disorders: Uncommon: Neutropenia Rare: Agranulocytosis
Respiratory, thoracic and mediastinal disorders: Common: Cough. Uncommon: Sinusitis, pharyngitis, upper respiratory tract infection Rare: Bronchospasm, dyspnoea, bronchitis, rhinitis, worsening of asthma,. Very rare: Allergic alveolitis, anaphylactoid reaction
Gastrointestinal disorders: Common: Nausea, vomiting, diarrhoea. Uncommon: Dyspepsia, abdominal pain, flatulence and dry mouth or throat. Rare: Altered taste, constipation, pancreatitis, glossitis, ileus. Very rare: Intestinal angioedema
Hepato-biliary disorders: Rare: Hepatic function disturbance Very rare: Cholestatic icterus, hepatitis
Skin and subcutaneous tissue disorders: Uncommon: Pruritus, rash, exfoliative dermatitis, increased perspiration, exanthema, urticaria Rare: Erythema multiforme, Stevens Johnson syndrome, epidermic necrolysis, psoriasis-like efflorescences, alopecia, pemphigus, photosensibility.
Musculoskeletal, connective tissue and bone disorders: Rare: Arthralgia, myalgia, back pain
Renal and urinary disorders: Uncommon: Proteinuria (sometimes with concurrent deterioration of kidney function) Rare: Impairment of kidney function, hyperkalaemia. Very rare: Kidney failure
Reproductive system and breast disorders: Uncommon : Impotence
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 General disorders: Common: Headache, fatigue Uncommon: Asthenia, vertigo, angioedema (swelling of the extremities, swelling of face, lips, tongue, pharynx, glottis and/or larynx.
Rare cases of agranulocytosis have been reported, and also a syndrome including fever, serositis, vasculitis, myalgia, arthralgia/arthritis, positive ANA-titre, ESR-elevation, eosinophilia, and leukocytosis. Gynaecomastia and vasculitis have been reported with other ACE-inhibitors and it cannot be excluded that these unwanted effects are group specific.
Drug/Laboratory: Increases (> 1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 3% and 4% respectively of the patients on monotherapy. Such increases are more likely to occur in patients receiving concomitant diuretic therapy than those on monotherapy with Quinapril Zentiva. These observed increases will often reverse on continued therapy.
Slight decreases in haemoglobin and haematocrit values have been reported for other ACE- inhibitors. It cannot be excluded that these observations are group specific.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V <[To be completed nationally]>
4.9 Overdose Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 4.9 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine Symptoms Aufzählungen oder Nummerierungen Symptoms of overdosage are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure.
Management Measures to prevent absorption (e.g. gastric lavage, administration of adsorbents and sodium sulphate within 30 minutes after intake) and hasten elimination should be applied if ingestion is recent. Haemodialysis and peritoneal dialysis have little effect on the elimination of quinapril and quinaprilat. If hypotension occurs, the patient should be placed in the shock position and salt and volume supplementation should be given rapidly. Treatment with angiotensin II should be considered. Bradycardia or extensive vagal reactions should be treated by administering atropine. The use of a pacemaker may be considered. Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Großbuchstaben 5 PHARMACOLOGICAL PROPERTIES Formatiert: Überschrift 2;2 SmPC, Einzug: Links: 0 cm, Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerierungs 5 formatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: 5.1 Pharmacodynamic properties Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + 5.1 Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm Pharmacotherapeutic group: ACE inhibitors, ATC code: C09AA06 Formatiert: Schriftart: Quinapril Zentiva contains the hydrochloride salt of quinapril. The substance has three chiral Formatiert: Standard, Links centres and is a pure stereoisomer. Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine Aufzählungen oder Nummerierungen
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Quinapril is a prodrug, which is hydrolysed to the active metabolite quinaprilat, a potent long- acting inhibitor of angiotensin converting enzyme (ACE) in plasma and tissue. ACE catalyses the conversion of angiotensin I to angiotensin II, which is a potent vasoconstrictor. Inhibition of ACE results in decreased concentrations of angiotensin II and reduced aldosterone secretion; bradykinin metabolism is probably also inhibited. In clinical studies quinapril has been found to be lipid neutral and has no negative effect on glucose metabolism. Quinapril reduces the total peripheral and renal arterial resistance. In general there are no clinically relevant changes in renal blood flow or glomerular filtration rate. Quinaprilat results in a reduction of prone, sitting and standing blood pressure. The peak effect is achieved after 2-4 hours at recommended doses. Achievement of maximum blood pressure lowering effect may require 2-4 weeks of therapy in some patients. A decrease in left ventricular hypertrophy was observed with quinapril in experimental models of hypertension in animals. Morbidity/mortality data is lacking.
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE- inhibitor with an angiotensin II receptor blocker. ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy. These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers. ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy. ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Concomitant treatment with thiazide diuretics increases the blood pressure lowering effect of quinapril.
5.2 Pharmacokinetic properties Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 5.2 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine The bioavailability of the active metabolite, quinaprilat, is 30-40% of the given oral dose of Aufzählungen oder Nummerierungen quinapril. Peak plasma concentrations are reached after approximately 2 hours. The absorption of quinapril is not affected by concurrent food intake, but an extremely high fat content in the food may reduce uptake. Approximately 97% of the active substance is bound to plasma proteins. With repeat dosing quinaprilat has a half life of 3 hours. Steady state is
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 reached in 2-3 days. Quinaprilat is mainly excreted unchanged by the kidneys. The clearance is 220 ml/min. Dialysis does not noticeably affect the elimination of quinapril. In patients with renal impairment, quinapril has not been detected in the dialysate and for the metabolite quinaprilat approximately 2.5% of the dose has been detected after peritoneal dialysis and 5.4% after haemodialysis. Prolonged half life and increased concentration of quinaprilat in plasma occurs in patients with renal impairment (see 4.2 Posology and method of administration). In patients with severe hepatic impairment a reduced concentration of quinaprilat is seen due to reduced hydrolysis of quinapril. After a single oral dose of 20 mg of quinapril in six breast-feeding women M/P for quinapril was 0.12. Quinapril was not detected in milk after 4 hours after the dose. Quinalaprilat milk levels were undetectable (<5 µg/L) at all time points. It is estimated that a breastfed infant would receive about 1.6% of the maternal weight-adjusted dosage of quinapril.
5.3 Preclinical safety data Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 5.3 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine Preclinical data reveal no special hazard for humans based on conventional studies of safety Aufzählungen oder Nummerierungen pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Reproductive toxicity studies suggest that quinapril has no negative effects on fertility and reproductive performance in rats, and is not teratogenic. ACE inhibitors, as a class, have been shown to be foetotoxic (causing injury and/or death to the foetus) when given in the second or third trimester.
6 PHARMACEUTICAL PARTICULARS Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, 6 Großbuchstaben 6.1 List of excipients Formatiert: Überschrift 2;2 SmPC, Block, Einzug: Links: 0 cm, Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerier 6.1 ungsformatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Tablet core Ausrichtung: Links + Ausgerichtet an: 0 cm + Tabstopp nach: Heavy magnesium carbonate 0 cm + Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm Calcium hydrogen phosphate, anhydrous Formatiert: Schriftart: Pregelatinised starch (maize) Formatiert: Standard Croscarmellose sodium Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. Magnesium stearate Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt., Keine Aufzählungen oder Nummerierungen Film coating Hypromellose Hydroxypropylcellulose Titanium dioxide (E171) Macrogol 400 Red iron oxide (E 172)
6.2 Incompatibilities Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt.
Not applicable.
6.3 S helf-life Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt.
2 years.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
6.4 S pecial precautions for storage Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt.
Do not store above 25˚C.
6.5 Nature and content of container Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt.
Blister (A1/A1/ Polyamide/PVC) containing 10, 14, 28, 30, 50, 56, 98, 100 and 500 (5 x 100) tablets. Tablet container (polypropylene) containing 250 tablets. Not all pack sizes may be marketed.
6.6 S pecial precautions for disposal Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt.
No special requirements.
7 MARKETING AUTHORISATION HOLDER Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Großbuchstaben Formatiert: Überschrift 2;2 SmPC, Block, Einzug: Links: 0 Zentiva Italia S.r.l. cm, Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerier Viale Bodio, 37/b20158 Milano ungsformatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm
8 MARKETING AUTHORISATION NUMBER(S ) Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, 8 Großbuchstaben Quinapril Zentiva 5 mg film-coated tablets Formatiert: Überschrift 2;2 SmPC, Block, Einzug: Links: 0 cm, Hängend: 1 cm, Abstand Vor: 0 Pt., Mit Gliederung + 10 tablets in blister AIC n. 037301013 Ebene: 1 + Nummerierungsformatvorlage: 1, 2, 3, … + 14 tablets in blister AIC n. 037301025 Beginnen bei: 1 + Ausrichtung: Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Einzug bei: 0 cm, Tabstopps: Nicht 28 tablets in blister AIC n. 037301037 an 0 cm 30 tablets in blister AIC n. 037301049 Formatiert: Schriftart: 50 tablets in blister AIC n. 037301052 Formatiert: Standard, Abstand Vor: 0 Pt. 56 tablets in blister AIC n. 037301076 98 tablets in blister AIC n. 037301088 Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 100 tablets in blister AIC n. 037301090 250 tablets in bottle AIC n. 037301102 500 (5 x 100) tablets in blister AIC n. 037301064 Formatiert: Vom nächsten Absatz trennen
10 tablets in blister AIC n. 037301114 14 tablets in blister AIC n. 037301126 28 tablets in blister AIC n. 037301138 30 tablets in blister AIC n. 037301140 50 tablets in blister AIC n. 037301153 56 tablets in blister AIC n. 037301165 98 tablets in blister AIC n. 037301177 100 tablets in blister AIC n. 037301189 250 tablets in bottle AIC n. 037301203 500 (5 x 100) tablets in blister AIC n. 037301191 Formatiert: Vom nächsten Absatz trennen
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
Quinapril Zentiva 20 mg film-coated tablets Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 10 tablets in blister AIC n. 037301215 14 tablets in blister AIC n. 037301227 28 tablets in blister AIC n. 037301239 30 tablets in blister AIC n. 037301241 50 tablets in blister AIC n. 037301254 56 tablets in blister AIC n. 037301266 98 tablets in blister AIC n. 037301278 100 tablets in blister AIC n. 037301280 250 tablets in bottle AIC n. 037301304 500 (5 x 100) tablets in blister AIC n. 037301292 Formatiert: Vom nächsten Absatz trennen Quinapril Zentiva 40 mg film-coated tablets Formatiert: Abstand Vor: 0 Pt., Nach: 0 Pt. 10 tablets in blister AIC n. 037301316 14 tablets in blister AIC n. 037301328 28 tablets in blister AIC n. 037301330 30 tablets in blister AIC n. 037301342 50 tablets in blister AIC n. 037301355 56 tablets in blister AIC n. 037301367 98 tablets in blister AIC n. 037301379 100 tablets in blister AIC n. 037301381 250 tablets in bottle AIC n. 037301405 Formatiert: Englisch (USA) 500 (5 x 100) tablets in blister AIC n. 037301393 Formatiert: Vom nächsten Absatz trennen
9 DATE OF FIRS T AUTHORISATION/RENEWAL OF THE AUTHORISATION Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Großbuchstaben Formatiert: Überschrift 2;2 SmPC, Block, Einzug: Links: 0 Date of first authorization: 07/05/2007 – Renewal of the authorization: October 2008 cm, Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerier ungsformatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm DATE OF REVISION OF THE TEXT: 10 Formatiert: Schriftart: 12 Pt., Nicht Kapitälchen, Großbuchstaben Formatiert: Überschrift 2;2 SmPC, Block, Einzug: Links: 0 cm, Hängend: 1 cm, Mit Gliederung + Ebene: 1 + Nummerier ungsformatvorlage: 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Links + Ausgerichtet an: 0 cm + Tabstopp nach: 0 cm + Einzug bei: 0 cm, Tabstopps: Nicht an 0 cm
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer cartons for blisters - outer carton for tablet containers Formatiert
1. NAME OF THE MEDICINAL PRODUCT
Quinapril Zentiva 5 mg film-coated tablets Quinapril Zentiva 10 mg film-coated tablets Quinapril Zentiva 20 mg film-coated tablets Quinapril Zentiva 40 mg film-coated tablets Formatiert: Englisch (Großbritannien), Hervorheben Formatiert: Kopfzeile, Einzug: Links: 0 cm, Erste Zeile: 0 cm, Trennen 2. S TATEMENT OF ACTIVE S UBSTANCE(S )
Each film-coated tablet contains: 5, 10, 20 and 40 mg of quinapril in the form of quinapril hydrochloride
3. LIST OF EXCIPIENTS
Contains sodium. See the package leaflet for further information.
//
4. PHARMACEUTICAL FORM AND CONTENTS
Film-coated tablets
10 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 98 tablets 100 tablets 250 tablets 500 (5 x 100) tablets Formatiert: Schriftart: 12 Pt.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 11
5. METHOD AND ROUTE(S ) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
6 S PECIAL WARNING THAT THE MEDICINAL PRODUCT MUS T BE Formatiert S TORED OUT OF THE S IGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER S PECIAL WARNING(S ), IF NECESS ARY
Consumption of alcoholic beverages is contraindicated.
8. EXPIRY DATE
EXPIRY DATE The expiry date shown refers to the product in its original packaging, correctly stored.
9. S PECIAL S TORAGE CONDITIONS Formatiert: Einzug: Links: 0 cm Do not store above 25°C.
10. S PECIAL PRECAUTIONS FOR DISPOS AL OF UNUS ED MEDICINAL PRODUCTS OR WAS TE MATERIALS DERIVED FROM S UCH MEDICINAL PRODUCTS , IF APPROPRIATE.
See Blue Box
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Zentiva Italia S.r.l. Formatiert: Italienisch (Italien) Viale L. Bodio, 37/b Formatiert: Einzug: Links: 0 cm 20158 Milan Italy
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
12. MARKETING AUTHORIS ATION NUMBER(S ) Formatiert
Quinapril Zentiva 5 mg film-coated tablets 10 tablets in blister pack MA no. 037301013 14 tablets in blister pack MA no. 037301025 28 tablets in blister pack MA no. 037301037 30 tablets in blister pack MA no. 037301049 50 tablets in blister pack MA no. 037301052 56 tablets in blister pack MA no. 037301076 98 tablets in blister pack MA no. 037301088 100 tablets in blister pack MA no. 037301090 250 tablets in bottle MA no. 037301102 500 (5 x 100) tablets in blister pack MA no. 037301064 Quinapril Zentiva 10 mg film-coated tablets 10 tablets in blister pack MA no. 037301114 14 tablets in blister pack MA no. 037301126 28 tablets in blister pack MA no. 037301138 30 tablets in blister pack MA no. 037301140 50 tablets in blister pack MA no. 037301153 56 tablets in blister pack MA no. 037301165 98 tablets in blister pack MA no. 037301177 100 tablets in blister pack MA no. 037301189 250 tablets in bottle MA no. 037301203 500 (5 x 100) tablets in blister pack MA no. 037301191 Quinapril Zentiva 20 mg film-coated tablets 10 tablets in blister pack MA no. 037301215 14 tablets in blister pack MA no. 037301227 28 tablets in blister pack MA no. 037301239 30 tablets in blister pack MA no. 037301241 50 tablets in blister pack MA no. 037301254 56 tablets in blister pack MA no. 037301266 98 tablets in blister pack MA no. 037301278 100 tablets in blister pack MA no. 037301280 250 tablets in bottle MA no. 037301304 500 (5 x 100) tablets in blister pack MA no. 037301292 Quinapril Zentiva 40 mg film-coated tablets 10 tablets in blister pack MA no. 037301316 14 tablets in blister pack MA no. 037301328 28 tablets in blister pack MA no. 037301330 30 tablets in blister pack MA no. 037301342 50 tablets in blister pack MA no. 037301355 56 tablets in blister pack MA no. 037301367 98 tablets in blister pack MA no. 037301379 100 tablets in blister pack MA no. 037301381 250 tablets in bottle MA no. 037301405 500 (5 x 100) tablets in blister pack MA no. 037301393
13. BATCH NUMBER
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
Batch no. Formatiert: Schriftfarbe: Schwarz
14. GENERAL CLAS S IFICATION FOR S UPPLY
Medicinal product subject to medical prescription.
15. INS TRUCTIONS ON USE Formatiert
Not applicable
16. INFORMATION IN BRAILLE Formatiert: Nicht vom nächsten Absatz trennen Formatiert: Nicht vom nächsten Absatz trennen Quinapril Zentiva 5 mg film-coated tablets Quinapril Zentiva 10 mg film-coated tablets Quinapril Zentiva 20 mg film-coated tablets Quinapril Zentiva 40 mg film-coated tablets Formatiert: Hervorheben
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: SN: NN:
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
(Information to appear on the outer label)
Generic medicinal product; Formatiert: Abstand Nach: 0 Pt. Price € Optically-read adhesive label/ Pack dispensed by the NHS Medicinal product subject to medical prescription Formatiert: Abstand Nach: 0 Pt. Dispose of responsibly after use. Use the containers provided for the differentiated collection of unused medicinal products.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR S TRIPS Formatiert: Schriftfarbe: Schwarz
BLISTER
1. NAME OF THE MEDICINAL PRODUCT
Quinapril Zentiva 5 mg film-coated tablets Quinapril Zentiva 10 mg film-coated tablets Quinapril Zentiva 20 mg film-coated tablets Quinapril Zentiva 40 mg film-coated tablets Formatiert: Hervorheben
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Zentiva Italia S.r.l. Formatiert: Schriftart: 12 Pt., Italienisch (Italien) Formatiert: Italienisch (Italien)
3. EXPIRY DATE
Expiry date Formatiert: Schriftart: 12 Pt.
4. BATCH NUMBER Formatiert: Schriftfarbe: Schwarz Batch no. Formatiert: Schriftart: 12 Pt.
Formatiert: Einzug: Links: 0 cm, Erste Zeile: 0 cm Formatiert: Schriftart: Nicht Fett 5. OTHER
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
MINIMUM PARTICULARS TO APPEAR ON S MALL IMMEDIATE PACKAGING Formatiert UNITS
BOTTLE
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S ) OF ADMINISTRATION
Quinapril Zentiva 5 mg film-coated tablets Quinapril Zentiva 10 mg film-coated tablets Quinapril Zentiva 20 mg film-coated tablets Quinapril Zentiva 40 mg film-coated tablets Formatiert: Hervorheben
2. METHOD OF ADMINISTRATION
Oral use. Formatiert: Schriftart: 12 Pt. Read the package leaflet before use.
3. EXPIRY DATE Formatiert: Schriftart: 12 Pt. Expiry date
4. BATCH NUMBER Formatiert: Schriftart: 12 Pt. Batch no.
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
250 tablets Formatiert: Schriftart: 12 Pt.
6. OTHER
Zentiva Italia S.r.l. Formatiert: Schriftart: 12 Pt., Italienisch (Italien)
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Quinapril Zentiva 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets
Generic medicinal product
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. Formatiert: Rechtschreibung und Grammatik nicht prüfen - If you have any further questions, ask your doctor or pharmacist. Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Keine - This medicine has been prescribed for you only. Do not pass it on to others. It may harm Silbentrennung, Tabstopps: Nicht an 0,95 cm + 1,59 cm them, even if their signs of willness are the same as yours. Formatiert: Schriftart: Nicht Fett, Nicht unterstrichen, - If you get any side effects, talk to your doctor or pharmacist. This includes any possible Rechtschreibung und Grammatik nicht prüfen side Formatiert: Rechtschreibung und Grammatik nicht prüfen Formatiert: Schriftart: Nicht Fett, Nicht unterstrichen, Rechtschreibung und Grammatik nicht prüfen What is in this leaflet: 1. What Quinapril Zentiva is and what it is used for Formatiert: Rechtschreibung und Grammatik nicht prüfen 2. What you need to know before you use Quinapril Zentiva Formatiert: Schriftart: Nicht Fett, Nicht unterstrichen 3. How to use Quinapril Zentiva Formatiert: Nicht unterstrichen 4. Possible side effects Formatiert: Einzug: Links: 0 cm, Tabstopps: Nicht an 0,95 cm 5. How to store Quinapril Zentiva Formatiert: Einzug: Links: 0 cm, Tabstopps: 0,95 cm, 6. Contents of the pack and other information Listentabstopp + Nicht an 1,59 cm
1. What Quinapril Zentiva is and what it is used for Formatiert: Rechtschreibung und Grammatik nicht prüfen Formatiert: Block, Einzug: Links: 0 cm, Hängend: 1,01 cm, Quinapril Zentiva belongs to a group of medicines called ACE-inhibitors. It contains Rechts: -0 cm, Trennen, Tabstopps: Nicht an 1 cm + 1,64 cm quinapril, which inhibits the production of certain substances present in the body that cause a Formatiert: Schriftart: Fett, Rechtschreibung und Grammatik rise in blood pressure. Treatment with Quinapril Zentiva causes the blood vessels to dilate and nicht prüfen consequently lowers blood pressure. Formatiert: Einzug: Links: 0 cm Quinapril Zentiva is used to treat high blood pressure and congestive heart failure.
2. What you need to know before you use Quinapril Zentiva Formatiert: Rechtschreibung und Grammatik nicht prüfen Formatiert: Block, Einzug: Links: 0 cm, Hängend: 1,01 cm, Do not use Quinapril Zentiva: Rechts: -0 cm, Trennen, Tabstopps: Nicht an 1 cm + 1,64 cm - If you are allergic to quinapril or other ACE-inhibitors or any of the other ingredients of Formatiert: Schriftart: Fett, Rechtschreibung und Grammatik Quinapril Zentiva. nicht prüfen - If you have diabetes or impaired kidney function and you are treated with a blood Formatiert: Einzug: Links: 0 cm pressure lowering medicine containing aliskiren. Formatiert: Rechtschreibung und Grammatik nicht prüfen - If you suffer from hereditary or idiopathic angioneurotic oedema. Formatiert: Standard, Einzug: Links: 0 cm, Hängend: 1 cm, - If in the past you have had episodes of angio-oedema (swelling of the legs, arms, face, Aufgezählt + Ebene: 1 + Ausgerichtet an: 0,63 cm + mucosae or tongue) related to treatment with ACE-inhibitors. Tabstopp nach: 1,59 cm + Einzug bei: 1,59 cm, Tabstopps: - If you are more than three months pregnant (it is also recommended to avoid using Nicht an 1,59 cm Quinapril Zentiva during early pregnancy – see the paragraph on Pregnancy).
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 - If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased. Formatiert: Rechtschreibung und Grammatik nicht prüfen
Warning and precautions - Please tell your doctor about any health problems you may have or have had in Formatiert: Schriftart: Nicht Fett, Rechtschreibung und the past, particularly impaired renal function (including kidney transplant), dialysis, Grammatik nicht prüfen blood disorders, diabetes, liver problems, other types of heart disease (for example heart Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: valve defects) and allergies. It is particularly important to tell your doctor if you have 1,59 cm + Einzug bei: 1,59 cm, Tabstopps: Nicht an 1,59 cm ever had allergic reactions that have caused swelling, for example of your face, tongue Formatiert: Rechtschreibung und Grammatik nicht prüfen and/or throat (reactions to food and/or wasp or bee stings). - Please tell your doctor if you experience excessive vomiting or diarrhoea, you are taking potent diuretics, potassium supplements, potassium-saving medications, culinary salt substitutes containing potassium or if you are on a low-sodium diet, as all of these may influence the effect of the medicinal product. - Severe allergic reactions may occur when Quinapril Zentiva is administered during treatment for hypersensitivity to bee or wasp stings (hyposensitisation) or during LDL apheresis. You should therefore tell your doctor if you are taking any of these treatments. Formatiert: Einzug: Erste Zeile: 0 cm - Before any surgical procedure or anaesthesia (including for dental treatment) Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt your doctor/dentist should be informed you are under treatment with Quinapril Zentiva , + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,59 cm + Einzug bei: 1,59 cm, Tabstopps: Nicht an 1,59 cm as there is a risk of an excessive drop in blood pressure during anaesthesia. - It is important to remember that patients with primary hyperaldosteronism Formatiert: Einzug: Links: 0 cm, Abstand Nach: 0 Pt., (known also as Conn’s syndrome) – an adrenal gland disorder in which there is Zeilenabstand: einfach excessive production of the hormone aldosterone – usually do not respond to ACE- Formatiert: Rechtschreibung und Grammatik nicht prüfen inhibitors. Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,59 cm + Einzug bei: 1,59 cm, Keine Silbentrennung, Talk to your doctor or pharmacist before taking Quinapril Zentiva: Tabstopps: Nicht an 1,59 cm - • Iif you are taking any of the following medicines, the risk of angioedema (rapid Formatiert: Rechtschreibung und Grammatik nicht prüfen swelling under the skin in area such as the throat) is increased: Formatiert: Block, Aufgezählt + Ebene: 2 + Ausgerichtet an: - Racecadotril, a medicine used to treat diarrhoea, and other medicines 1,9 cm + Tabstopp nach: 2,54 cm + Einzug bei: 2,54 cm, belonging to the class of neprilysin (NEP) inhibitors; Keine Silbentrennung - Medicines used to prevent organ transplant rejection and for cancer (e.g., Formatiert: Aufgezählt + Ebene: 2 + Ausgerichtet an: 1,9 cm + Tabstopp nach: 2,54 cm + Einzug bei: 2,54 cm, Keine temsirolimus - sirolimus, everolimus and other medicines belonging to the Silbentrennung class of mTOR inhibitors) (used to avoid rejection of transplanted organs); - Vildagliptin, a medicine used to treat diabetes; Formatiert: Rechtschreibung und Grammatik nicht prüfen - racecadotril and other medicines belonging to the class of neprilydin (NEP) Formatiert: Rechtschreibung und Grammatik nicht prüfen Formatiert: Schriftart: Englisch (Großbritannien), inhibitors; Rechtschreibung und Grammatik nicht prüfen
Formatiert: Zeilenabstand: einfach, Aufgezählt + Ebene: 2 + - •Iif you are taking any of the following medicines used to treat high blood pressure: Ausgerichtet an: 1,9 cm + Tabstopp nach: 2,54 cm + Einzug - - an angiotensin II receptor blocker (ARBs) (also known as sartans - for bei: 2,54 cm, Keine Silbentrennung example valsartan, telmisartan, irbesartan), in particular if you have diabetes- Formatiert: Abstand Nach: 0 Pt., Zeilenabstand: einfach related kidney problems; Formatiert: Rechtschreibung und Grammatik nicht prüfen - - aliskiren. Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,59 cm + Einzug bei: 1,59 cm, Keine Silbentrennung, Your doctor may check your kidney function, blood pressure, and the amount of electrolytes Tabstopps: Nicht an 1,59 cm (e.g. potassium) in your blood at regular intervals. Formatiert: Rechtschreibung und Grammatik nicht prüfen
Formatiert: Aufgezählt + Ebene: 2 + Ausgerichtet an: 1,9 See also information under the heading “Do not use Quinapril Zentiva” cm + Tabstopp nach: 2,54 cm + Einzug bei: 2,54 cm, Keine Silbentrennung Formatiert: Einzug: Links: 0 cm
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Quinapril Zentiva is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe damage to your baby if taken in this period (see the paragraph on Pregnancy).
Formatiert: Einzug: Links: 0 cm, Hängend: 2,95 cm, Nicht Tell your doctor or pharmacist if you are taking, have recently taken or might take any other vom nächsten Absatz trennen medicines. Formatiert: Einzug: Links: 0 cm
This applies in particular if you are also taking: - Medicines which are most often used to avoid rejection of transplanted organs Formatiert: Rechtschreibung und Grammatik nicht prüfen (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt mTOR inhibitors). See section “Warnings and precautions”. + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,59 cm + Einzug bei: 1,59 cm, Keine Silbentrennung, - Sacubitril/valsartan – a medicine used for treating a type of long-term (chronic) heart Tabstopps: Nicht an 0,5 cm + 1,5 cm + 1,59 cm failure in adults (see also information under the headings “Do not take Quinapril Zentiva and Warning and precautions”); Formatiert: Schriftart: Nicht Fett, Rechtschreibung und - Medicines as racecadotril used against diarrhea (medicines belonging to the class of n Grammatik nicht prüfen - An angiotensin II receptor blocker (ARB) or aliskiren (see also information under the Formatiert: Rechtschreibung und Grammatik nicht prüfen - Antibiotics belonging to the tetracycline family because Quinapril Zentiva contains Formatiert: Schriftart: Nicht Fett, Rechtschreibung und magnesium, which delays their absorption. Consequently, tetracycline should not be Grammatik nicht prüfen taken whilst taking Quinapril Zentiva. Formatiert: Rechtschreibung und Grammatik nicht prüfen - Medicines containing lithium because they may only be taken at the same time as Formatiert: Rechtschreibung und Grammatik nicht prüfen Quinapril Zentiva if the concentration of lithium in the blood is carefully monitored by Formatiert: Rechtschreibung und Grammatik nicht prüfen your doctor. - Potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene or amiloride) and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots)Potassium-saving medicines, potassium supplements or salt substitutes containing potassium, diuretics (water tablets, in particular those so called potassium sparing), treatments for gout (allopurinol), medicines for controlling diabetes (oral glycaemia- lowering agents such as vildagliptin or insulin) and other drugs which can increase potassium in your body (such as heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole). - Quinapril Zentiva may reduce the excretion of potassium from the body and Formatiert: Rechtschreibung und Grammatik nicht prüfen consequently mineral salts containing potassium or medicines that increase the level of potassium may only be taken under doctor’s orders. It is also important for your doctor to know if you are taking anti-hypertension medications, antiacids, anaesthetics, cytostatics or immunosuppressants, systemic corticosteroids, procainamide, trimethoprim, anti-inflammatory analgesics or medications for depression or mental disorders.
It is important to know that consumption of alcohol, barbiturates or narcotics may cause a rise in orthostatic hypotension.
Quinapril Zentiva with food and drink Formatiert: Einzug: Links: 0 cm, Erste Zeile: 0 cm Quinapril Zentiva must not be taken with alcoholic beverages. Formatiert: Einzug: Links: 0 cm
Pregnancy and breast-feeding Formatiert: Einzug: Links: 0 cm
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy Formatiert: Einzug: Links: 0 cm ACE-inhibitor treatment must not be started during pregnancy. Quinapril Zentiva is contraindicated during the second and third trimesters of pregnancy.
You must tell your doctor if you think you may be pregnant (or if it is possible that you may Formatiert: Einzug: Links: 0 cm become pregnant). Your doctor will probably recommend you stop taking Quinapril Zentiva before becoming pregnant or as soon as you know you are pregnant and will recommend you take another medicine instead of Quinapril Zentiva. Quinapril Zentiva is not recommended at the beginning of a pregnancy and you must not take it if you are more than three months pregnant, as it may cause severe damage to your baby if taken after the third month of pregnancy.
In the event of exposure to quinapril after the third month of pregnancy, an ultrasound scan of the kidneys and head are recommended.
Newborns whose mothers have taken quinapril must be kept under close observation.
Breast-feeding Formatiert: Einzug: Links: 0 cm Please tell your doctor if you are breast-feeding or are about to start breast-feeding. Breast-feeding newborns (in the first few weeks after birth) and particularly premature babies is not recommended whilst taking Quinapril Zentiva. In the case of older babies, your doctor will advise you about the risks and benefits of taking Quinapril Zentiva whilst breast-feeding, compared to other treatments.
Driving and using machines Treatment with Quinapril Zentiva may cause dizziness or tiredness in some patients. These effects may influence your ability to drive or use machines. Please observe your personal reaction.
Quinapril Zentiva contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
3. How to use Quinapril Zentiva
Always take this medicine exactly as your doctor has told you. Check with your doctor or Formatiert: Einzug: Links: 0 cm, Erste Zeile: 0 cm, Keine pharmacist if you are not sure. Silbentrennung, Tabstopps: 0,5 cm, Links + 1 cm, Links + Nicht an 0,95 cm
Formatiert: Schriftart: Nicht Fett, Nicht unterstrichen Formatiert: Einzug: Links: 0 cm Essential hypertension Formatiert: Schriftart: Nicht Fett Monotherapy: Depending on clinical response, the dosage may be adjusted, as indicated by Formatiert: Standard, Keine Silbentrennung, Tabstopps: 0,5 cm, Links + 1 cm, Links your doctor, up to a maintenance dose of between 20 and 40 mg/day, taken as 1 or 2 separate administrations.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 The usual maximum maintenance dose is 40 mg/day.
Concomitant diuretic therapy: You may develop symptomatic hypotension after starting Formatiert: Einzug: Links: 0 cm treatment with quinapril. This is much more likely to happen in patients treated with diuretics. If possible, the diuretic should be suspended 2-3 days before the start of treatment with quinapril. The starting dose is 2.5 mg of Quinapril Zentiva in patients who have been treated with diuretics. The dose of Quinapril Zentiva tablets should subsequently be adjusted, according to your doctor’s orders, to achieve optimal response.
Congestive heart failure The initial individual dose is 2.5 mg. In patients under treatment with diuretic and/or cardiac glycoside, the dose must subsequently be adjusted, according to doctor’s orders, to an efficacious dose: the efficacious dose is usually between 10 and 20 mg/day, taken as 1 or 2 administrations. The maximum daily dose of 40 mg must not be exceeded.
Patients considered to be at high risk should start treatment in hospital conditions.
Elderly patients (>65) Treatment in elderly patients should take into account that renal function tends to worsen with age. A starting dose of 2.5 mg, subsequently adjusted to achieve optimal response is recommended.
Renal function impairment: Formatiert: Nicht unterstrichen The starting dose of quinapril must be reduced in patients with impaired renal function. This Formatiert: Standard, Einzug: Links: 0 cm, Keine must also be taken into consideration for elderly patients, as renal function tends to worsen Absatzkontrolle with age. The recommended posology is as follows: Formatiert: Einzug: Links: 0 cm
Creatinine clearance Recommended maximum daily Formatierte Tabelle (ml/min) starting dose (mg) > 60 10 30-60 5 10-30 2.5 < 10 Inadequate evidence
Children and adolescents Formatiert: Nicht unterstrichen : Use in children and adolescents is not recommended. Formatiert: Einzug: Links: 0 cm, Keine Absatzkontrolle Formatiert: Schriftart: Nicht Fett Please contact your doctor or pharmacist if you think that the effect of Quinapril Zentiva is Formatiert: Einzug: Links: 0 cm too strong or too weak. Formatiert: Einzug: Links: 0 cm, Erste Zeile: 0 cm
If you take more Quinapril Zentiva than you should Formatiert: Schriftart: Nicht Fett If you accidentally take too many tablets or if a child swallows some tablets, contact a doctor Formatiert: Einzug: Erste Zeile: 0 cm or hospital. Formatiert: Einzug: Links: 0 cm Overdose may cause a drop in blood pressure, with dizziness and fainting. Formatiert: Schriftart: Nicht Fett If you forget to take Quinapril Zentiva Formatiert: Einzug: Erste Zeile: 0 cm Take the next dose as prescribed. Formatiert: Einzug: Links: 0 cm Do not take a double dose to make up for a forgotten dose. Formatiert: Einzug: Erste Zeile: 0 cm
If you stop taking Quinapril Zentiva
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Do not stop taking your tablets, even if you are feeling well, unless your doctors tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
Like all medicines, this medicine cause side effects, although not everybody gets them. Formatiert: Einzug: Links: 0 cm
Common: less than 1 in 10 patients, but more than 1 in 100 patients Formatiert: Nicht vom nächsten Absatz trennen Uncommon: less than 1 in 100 patients, but more than 1 in 1,000 patients Rare: less than 1 in 1,000 patients, but more than 1 in 10,000 patients Very rare: less than one in 10,000 patients, including isolated reports
Psychiatric disorders: Formatiert: Einzug: Links: 0 cm Uncommon: Sleeping disorders, irritability. Formatierte Tabelle Rare: Depression, mental confusion. Formatiert: Einzug: Links: 0 cm Nervous system disorders: Common: Dizziness. Formatierte Tabelle Uncommon: Paraesthesia (numbness or pins and needles), drowsiness. Rare: Balance disorders, neuropathy (altered sensitivity due to nerve defects). Formatiert: Einzug: Links: 0 cm Eye disorders: Rare: Blurred vision, amblyopia (reduction in visual acuity). Formatierte Tabelle Formatiert: Einzug: Links: 0 cm Ear and labyrinth disorders: Rare: Tinnitus (sounds in the ear). Formatierte Tabelle
Cardiac disorders: Formatiert: Einzug: Links: 0 cm Uncommon: Palpitations, chest pain, angina pectoris (cardiac spasms). Formatierte Tabelle Rare: Tachycardia, syncope (fainting), myocardial infarction, transient ischaemic attack (TIA), brain haemorrhage.
Vascular disorders: Formatiert: Einzug: Links: 0 cm Common: Hypotension. Formatierte Tabelle Uncommon: Postural hypotension.
Formatiert: Einzug: Links: 0 cm Blood and lymphatic system disorders: Formatierte Tabelle Uncommon: Neutropoenia. Formatiert: Einzug: Links: 0 cm Rare: Agranulocytosis. Formatiert: Englisch (Großbritannien) Rare: Agranulocytosis. Formatiert: Kopfzeile, Keine Absatzkontrolle, Leerraum zwischen asiatischem und westlichem Text nicht anpassen, Leerraum zwischen asiatischem Text und Zahlen nicht Respiratory, thoracic and mediastinal disorders: anpassen Common: Coughing. Formatierte Tabelle Uncommon: Sinusitis,Cough. laryngitis, upper airway infections. Formatierte Tabelle Rare: Bronchospasm, dyspnoea (difficulty breathing), bronchitis, Formatiert: Standard, Block, Absatzkontrolle, Abstand rhinitis, asthma exacerbations. zwischen asiatischem und westlichem Text anpassen, Abstand Very rare: Allergic alveolitis, anaphylactic reactions. zwischen asiatischem Text und Zahlen anpassen
Formatiert: Einzug: Links: 0 cm
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
Formatiert: Einzug: Links: 0 cm
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 Gastrointestinal disorders: Common: Nausea, vomiting, diarrhoea. Formatierte Tabelle Uncommon: Dyspepsia (benign gastric disorder), abdominal pain, flatulence and Formatiert: Einzug: Links: 0 cm dry mouth and throat. Rare: Taste alterations, pancreatitis, glossitis, inflammation of the ileum. Formatiert: Einzug: Links: 0 cm Very rare: Intestinal angio-oedema. Formatiert: Einzug: Links: 0 cm Formatiert: Einzug: Links: 0 cm Hepatobiliary disorders: Rare: Hepatic function alterations. Formatierte Tabelle Very rare: Cholestatic jaundice, hepatitis. Formatiert: Einzug: Links: 0 cm Skin and subcutaneous tissue disorders: Uncommon: Itchiness, rash, exfoliative dermatitis, increased perspiration, Formatierte Tabelle exanthema, hives. Very rare: Polymorphous erythema (skin and mucosal lesions), Stevens Johnson syndrome (bullous lesions), epidermal necrolysis, psoriasis-like marks, hair loss, pemphigus (a group of autoimmune diseases that affect the skin and mucosae), photosensitivity.
Musculoskeletal and connective tissue disorders: Formatiert: Einzug: Links: 0 cm Rare: Joint and muscle pain, backache. Formatierte Tabelle Formatiert: Einzug: Links: 0 cm Renal and urinary disorders: Uncommon: Proteinuria (loss of proteins in the urine, sometimes associated with renal function impairment). Formatiert: Links, Einzug: Links: 0 cm Uncommon: Proteinuria (loss of proteins in the urine, sometimes associated Formatierte Tabelle with renal function impairment). Rare: Renal function impairment, hyperpotassaemia. Very rare: Kidney failure. Formatiert: Einzug: Links: 0 cm Reproductive system and breast disorders: Uncommon: Impotence. Formatierte Tabelle Formatiert: Einzug: Links: 0 cm General disorders: Common: Headache, tiredness. Formatierte Tabelle Uncommon: Asthenia (condition of great fatigue), vertigo, angio-oedema (with swelling of the limbs, face, lips, tongue, pharynx, glottis and/or larynx).
Laboratory parameters: increases (>1.25 times the upper limit of normal) have been reported Formatiert: Einzug: Links: 0 cm, Vom nächsten Absatz in blood creatinine and nitrogen of 3% and 4% respectively, in patients under monotherapy. It trennen, Diesen Absatz nicht zusammenhalten is far more likely that these increases will occur in patients on concomitant treatment with diuretics than in patients under Quinapril Zentiva monotherapy. The increases observed often normalise without interrupting treatment.
Reporting of side effects Formatiert: Einzug: Links: 0 cm If you get any side effects, talk to your doctor or pharmacist. This includes any possible side Formatiert: Absatz-Standardschriftart effects not listed in this leaflet. You can also report side effects directly via the national
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01 reporting system listed in Appendix V<[To be completed nationally]>. By reporting side effects you can help provide more information on the safety of this medicine.
Formatiert: Schriftart: Fett, Rechtschreibung und Grammatik nicht prüfen, Nicht Doppelt durchgestrichen Formatiert: Block, Einzug: Links: 0 cm, Rechts: -0 cm, Nummerierte Liste + Ebene: 1 + Nummerierungsformatvorlage : 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Links + Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,64 cm + Einzug bei: 1,64 cm, Tabstopps: Nicht an 1,64 cm
IT/H/250/001-004/IB/011 Formatiert: Rechts, Einzug: Links: 2,3 cm PSUSA ACEI_2019_01
Formatiert: Einzug: Links: 0 cm Do not store QUINAPRIL ZENTIVA above 25°C.
Keep this medicine out of the sight and reach of children.
Attention: Do not use Quinapril Zentiva after the expiry date which is stated on the pack. Formatiert: Einzug: Links: 0 cm
For environmental and safety reasons, unused or expired medicines should be returned to the Formatiert: Einzug: Links: 0 cm pharmacy for disposal.
6.4. Contents of the pack and other information Formatiert: Rechtschreibung und Grammatik nicht prüfen Formatiert: Block, Einzug: Links: 0 cm, Rechts: -0 cm, What Quinapril Zentiva contains Nummerierte Liste + Ebene: 1 + Nummerierungsformatvorlage : 1, 2, 3, … + Beginnen bei: 1 + Ausrichtung: Links + - - The active substance is 5 mg, 10 mg, 20 mg or 40 mg of quinapril (in the form of Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,64 cm + hydrochloride salt). Einzug bei: 1,64 cm, Trennen, Tabstopps: Nicht an 0,63 cm + - - The other ingredients are: 1,64 cm Core of the tablet: heavy magnesium carbonate, anhydrous dibasic calcium phosphate, Formatiert: Einzug: Links: 0 cm pregelatinised corn starch, croscarmellose sodium, magnesium stearate. Formatiert: Rechtschreibung und Grammatik nicht prüfen Coating film: hypromellose, hydroxy propyl cellulose, macrogol 400, titanium dioxide Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: (E171) and red ferrous oxide (E172). 1,59 cm + Einzug bei: 1,59 cm, Tabstopps: Nicht an 1,59 cm
Formatiert: Rechtschreibung und Grammatik nicht prüfen What Quinapril Zentiva looks like and contents of the pack Formatiert: Einzug: Links: 1 cm, Erste Zeile: 0 cm Quinapril Zentiva 5 mg is an oval, biconvex, red-brown film-coated tablet, scored on both sides and imprinted with "I" on one side. Size 4.5 x 8.7 mm. Formatiert: Rechtschreibung und Grammatik nicht prüfen Quinapril Zentiva 10 mg is an oval, biconvex, red-brown film-coated tablet, scored on both Formatiert: Einzug: Links: 0 cm sides and imprinted with "L" on one side. Size 5.8 x 11.3 mm. Quinapril Zentiva 20 mg is a round, biconvex, red-brown film-coated tablet, scored on both sides and imprinted with "I" on one side. Diameter 7 mm. Quinapril Zentiva 40 mg is an oval, biconvex, red-brown film-coated tablet, scored on both sides and imprinted with "I" on one side. Size 6.5 x 12.7 mm.
All the tablets can be divided into equal doses. Formatiert: Block, Einzug: Links: 0 cm
Pack sizes: Blister: 10, 14, 28, 30, 50, 56, 98, 100 and 500 tablets Tablet container: 250 tablets in bottle
Not all pack sizes may be marketed. Formatiert: Schriftart: Nicht Fett Marketing authorisation holder and Manufacturer Formatiert: Block, Einzug: Links: 0 cm, Keine Marketing authorisation holder Silbentrennung, Tabstopps: 1 cm, Links Zentiva Italia S.r.l., Viale Bodio 37/b - 20158 Milan Formatiert: Einzug: Links: 0 cm, Tabstopps: 1 cm, Links + Nicht an 0,95 cm Manufacturer Formatiert: Nicht Doppelt durchgestrichen Actavis hf - Reykjavikurvegur, 78 - IS-220 Hafnarfjördur (Iceland) Formatiert: Absatz-Standardschriftart Formatiert: Schriftart: Nicht Fett This leaflet was last revised in: Formatiert: Block, Einzug: Erste Zeile: 0 cm, Tabstopps: 1 cm, Links