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Summary of Product Characteristics 1. Name Of SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Invented name] 5 mg / 5 mg capsules, hard [Invented name] 5 mg / 10 mg capsules, hard [Invented name] 10 mg / 5 mg capsules, hard [Invented name] 10 mg / 10 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Invented name] 5 mg / 5 mg: Each capsule, hard contains 5 mg ramipril and 5 mg amlodipine (as amlodipine besilate). [Invented name] 5 mg / 10 mg: Each capsule, hard contains 5 mg ramipril and 10 mg amlodipine (as amlodipine besilate). [Invented name] 10 mg / 5 mg: Each capsule, hard contains 10 mg ramipril and 5 mg amlodipine (as amlodipine besilate). [Invented name] 10 mg / 10 mg: Each capsule, hard contains 10 mg ramipril and 10 mg amlodipine (as amlodipine besilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard [Invented name] 5 mg / 5 mg: Hard gelatin, light blue capsules, content is white or almost white powder or slightly compacted agglomerates; size of capsules – No. 3 [Invented name] 5 mg / 10 mg - Hard gelatin capsules with white body and blue cap, content is white or almost white powder or slightly compacted agglomerates; size of capsules – No.1 [Invented name] 10 mg / 5 mg - Hard gelatin, white capsules, content is white or almost white powder or slightly compacted agglomerates; size of capsules – No.1 [Invented name] 10 mg / 10 mg - Hard gelatin, blue capsules, content is white or almost white powder or slightly compacted agglomerates; size of capsules – No. 1 4. CLINICAL PARTICULARS 4.1 Therapeutic indications [Invented name] is indicated for treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same dose level as in the combination, but as separate medicinal products. 4.2 Posology and method of administration Posology Adults 1 Recommended daily dose is one capsule of the given strength. The fixed dose combination is not suitable for initial therapy. If it is necessary to adjust posology, dose of [Invented name] may be changed or individual titration of components of free combination may be considered. Diuretic-treated patients Caution is therefore recommended since these patients may be volume and/or salt depleted. Renal function and serum potassium should be monitored (see sections 4.3, 4.4, 4.5 and 5.1). Special populations Patients with hepatic impairment In patients with hepatic impairment, treatment with ramipril must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg ramipril. [Invented name] is recommended only for patients who were switched to 5 mg ramipril as optimal maintenance dose during dose titration of ramipril. In case of hepatic impairment elimination of amlodipine may be elongated. Exact dosage recommendations concerning amlodipine have not been established, but the drug should therefore be administered with special caution in these patients (see section 4.4). Renal impairment: In order to find optimal initial and maintenance dose in patients with renal impairment, patients’ dose should be adjusted individually by separate titration of doses of ramipril and amlodipine components (regarding details see SmPCs of monocomponent medicinal products). [Invented name] is recommended only for patients who were switched to 5 mg ramipril as optimal maintenance dose during dose titration of ramipril. Daily dose of ramipril in patients with renal impairment should be based on creatinine clearance: - if creatinine clearance is ≥ 60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 10 mg; - if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg; - if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; - in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed. Amlodipine is not dialyzable. Therefore it should be used with caution in dialyzable patients (see section 4.4). Renal function and serum potassium should be monitored during treatment with [Invented name]. In case of deterioration of renal function, administration of [Invented name] should be stopped, and its components should be given in adequately adjusted doses. Elderly Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects. In very old and frail patients [Invented name] is not recommended. In elderly normal dosage regimens of amlodipine can be used, but caution is recommended during dose titration (see section 5.2). Paediatric population Currently available data for ramipril and amlodipine components are described in sections 4.8, 5.1, 5.2 and 5.3 but no specific recommendation on posology can be made. Method of administration [Invented name] is for oral use. 2 [Invented name] may be taken once daily, at the same time of day with or without food. The capsules should not be chewed or crushed. 4.3 Contraindications Linked to [Invented name] - Hypersensitivity to the active substances, dihydropyridines, ACE inhibitors or to any of the excipients listed in section 6.1 Linked to ramipril: - History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs) - Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) - Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Ramipril must not be used in patients with hypotensive or haemodynamically unstable states - The concomitant use of [Invented name] 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. Ramipril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see also sections 4.4 and 4.5). Linked to amlodipine: - Severe hypotension - Shock (including cardiogenic shock) - Left ventricular outflow obstruction (e.g. large degree of aortic stenosis) - Haemodynamically unstable heart failure after acute myocardial infarction. 4.4 Special warnings and precautions for use Linked to ramipril: Special populations Pregnancy: ACE inhibitors such as ramipril should not be initiated during pregnancy. Unless continued ACE inhibitor 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 (see sections 4.3 and 4.6). Patients at particular risk of hypotension - Patients with strongly activated renin-angiotensin-aldosterone system Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase. Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in: - patients with severe hypertension - patients with decompensated congestive heart failure - patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve) 3 - patients with unilateral renal artery stenosis with a second functional kidney - patients in whom fluid or salt depletion exists or may develop (including patients with diuretics) - patients with liver cirrhosis and/or ascites - patients undergoing major surgery or during anaesthesia with agents that produce hypotension. Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload). - Transient or persistent heart failure post MI - Patients at risk of cardiac or cerebral ischemia in case of acute hypotension The initial phase of treatment requires special medical supervision. Elderly patients See section 4.2. Surgery It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery. Monitoring of renal function Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. Particularly careful monitoring is required in patients with renal impairment (see section 4.2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant. Hypersensitivity/angioedema Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8). In case of angioedema, ramipril must be discontinued. Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged
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