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Manidipine and Delapril 30-10Mg-Smpc (3.0)

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Manidipine and Delapril 30-10Mg-Smpc (3.0) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ADAPTUS/DELAMAN 30 mg + 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg of delapril hydrochloride and 10 mg of manidipine hydrochloride. Excipients with known effect: 67.60 mg lactose monohydrate/tablet 0.08 mg sunset yellow (E110) Aluminum lake/tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Salmon-pink, round, scored tablet. The tablet can be divided into equal doses 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of essential hypertension. ADAPTUS/DELAMAN fixed dose combination (30 mg /10 mg) is indicated in patients whose blood pressure is not adequately controlled on delapril or manidipine alone (see section 4.3, 4.4, 4.5 and 5.1) 4.2 Posology and method of administration Posology Dosage recommendations for adults The usual posology is one tablet of ADAPTUS/DELAMAN once a day. Individual dose titration with the components (delapril 30 mg and manidipine 10 mg) is recommended. If clinically acceptable, a direct switch from delapril or manidipine monotherapy to the fixed combination may be considered (see section 4.3, 4.4, 4.5 and 5.1). Special care should be exercised when ADAPTUS/DELAMAN is used in elderly patients and patients with renal failure or hepatic insufficiency and dose titration should be performed using the single components delapril and manidipine according to the following approach: Elderly patients: considering the possible impairment of renal function and the slowing down of metabolic processes in elderly patients; dose titration must be approached with caution. After appropriate dose titration with the components, the direct switch to half a tablet of the fixed combination may be considered. Renal impairment: since in the presence of renal failure a reduced excretion of the component delapril occurs, dose adjustments are needed in patients with serum creatinine >3 mg/dl; Hepatic impairment: due to the wide hepatic metabolization of the component manidipine, a dose reduction should be considered in patients with hepatic insufficiency, according to the severity of the concomitant disorder; Pediatricpopulation: SmPC V(6.15.1) 20198-0510 ADAPTUS/DELAMAN is contraindicated in children and adolescents (see section 4.3 and 4.4); Method of administration: For oral use. The tablet should be swallowed whole with sufficient water in the morning after breakfast. 4.3 Contraindications Hypersensitivity to the active substances ‘delapril’ and ‘manidipine’, to any other ACE inhibitors and to other dihydropyridines or to any of the excipients listed in section 6.1. History of angioneurotic oedema associated with previous ACE inhibitor therapy. Hereditary/idiopathic angioneurotic oedema. Severe renal impairment (creatinine clearance 10 ml/min). Dialysis. Kidney transplantation. Severe hepatic impairment. Bilateral renal artery stenosis or unilateral renal stenosis in cases of a solitary kidney. Hemodynamically relevant aortic and mitral valve stenosis/hypertrophic cardiomyopathy. Cardiogenic shock. Untreated congestive heart failure. Unstable angina pectoris or myocardial infarction (during first 4 weeks). Primary hyperaldosteronism. Second and third trimester of pregnancy (see section 4.4 and 4.6). Use in children and adolescents ( 18 years). The concomitant use of ADAPTUS/DELAMAN with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). Concomitant use with sacubitril/valsartan therapy. ACE inhibitors must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see also sections 4.4 and 4.5). 4.4 Special warnings and special precautions for use Symptomatic hypotension: At the beginning of the treatment with ADAPTUS/DELAMAN, patients with increased risk of symptomatic hypotension should be closely monitored for the first two weeks of treatment. The risk of a marked hypotensive response is more probable in some categories of patients, such as those with severe congestive heart failure with or without concomitant renal failure, renovascular hypertension, renal dialysis, intense saline and/or water retention of any aetiology (e.g. intense therapy with loop- diuretics). Sodium depletion and hypovolaemia must be corrected before treatment with ADAPTUS/DELAMAN can be initiated. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident. Blood pressure and laboratory parameters should be carefully monitored, especially in patients with: - sodium depletion or hypovolaemia - severe cardiac decompensation - renal impairment - severe hypertension - or older than 65 years In these patients therapy should preferably be initiated in a hospital setting. In case of hypotension, it is recommended to lay the patient in supine position and, if necessary, to administer saline solution by intravenous infusion. Paediatric population: SmPC V(6.10) 2019-053 2 The product is not to be used in children and adolescents on account of inadequate experience in this patient population. Pregnancy: ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive 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). General: Adaptus/Delaman contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Adaptus/Delaman contains sunset yellow (E110 aluminium lake, which may cause allergic reactions). Patients with renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with renovascular hypertension and pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney are treated with ADAPTUS/DELAMAN. Treatment with diuretics may be a contributory factor. A renal function reduction may occur even with minor changes in serum creatinine also in patients with unilateral renal artery stenosis. In these patients the treatment should be initiated in hospital under close medical supervision, starting with low doses of the single components followed by a careful dose titration. Diuretic treatment should be discontinued and renal function should be monitored during the first weeks of treatment. Angioedema: Some cases of angioedema have been reported with the use of ACE inhibitors, especially after the first administrations. Angioedema may occur during the first weeks of treatment. In rare cases, however, angioedema may occur after long-term use. In these cases, treatment should be immediately discontinued and if necessary, antihypertensive therapy should be continued using a drug belonging to an other therapeutic class. The patient should be kept under strict medical control until the oedema disappears. When the oedema is limited to face and lips, this condition is generally resolved without any treatment, though antihistamines are useful as symptomatic treatment. Angioedema involving the tongue, glottis or larynx can be lethal and therefore it requires the prompt institution of suitable therapies, such as the subcutaneous injection of a 1:1000 adrenaline solution (0.3-0.5 ml). Therefore, patients should be duly informed about the importance to promptly report any sign or symptom resembling angioedema (swelling of face, eyes, lips, tongue, difficult breathing) and they should consult the physician before any further drug administration. Anaphylactic reactions during hymenoptera desensitisation: Rarely patients receiving ACE-inhibitors have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each desensitisation. Anaphylactoid reactions during LDL aphaeresis: Rarely patients receiving ACE inhibitors during low-density lipoprotein (LDL) aphaeresis with dextran sulphate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each aphaeresis. SmPC V(6.10) 2019-053 3 Ethnic differences: ACE-inhibitors more often cause angioedema in black patients than in non-black patients. As with other ACE inhibitors, ADAPTUS/DELAMAN 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. Proteinuria: Proteinuria may occur, particularly in patients with existing renal function impairment. Impaired renal function: in the presence of renal failure, dose adjustments are necessary and renal function must be carefully monitored, even though generally it does not undergo any further worsening. Under treatment with ACE inhibitors, patients with previous congestive heart failure, mono- or bilateral stenosis of the renal artery, renovascular hypertension and intense water or saline depletion, are at higher risk to develop signs of renal impairment (creatinine increase, BUN and serum potassium; proteinuria; alterations
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