Medokinal Film-Coated Tablet
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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