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Summary of Product Characteristics The text with yellow background refers only to full set of strengths applied for in RMS. The text with green background refers only to applications in CMS. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented name>, 2.5 mg/5 mg/12.5 mg capsules, hard <Invented name>, 5 mg/5 mg/12.5 mg capsules, hard <Invented name>, 5 mg/5 mg/25 mg capsules, hard <Invented name>, 5 mg/10 mg/25 mg capsules, hard <Invented name>, 10 mg/5 mg/25 mg capsules, hard <Invented name>, 10 mg/10 mg/25 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <Invented name> 2.5 mg/5 mg/12.5 mg capsules, hard: One capsule contains 2.5 mg ramipril, 5 mg amlodipine (as amlodipine besilate), 12.5 mg hydrochlorothiazide. <Invented name> 5 mg/5 mg/12.5 mg capsules, hard: One capsule contains 5 mg ramipril, 5 mg amlodipine (as amlodipine besilate), 12.5 mg hydrochlorothiazide. <Invented name> 5 mg/5 mg/25 mg capsules, hard: One capsule contains 5 mg ramipril, 5 mg amlodipine (as amlodipine besilate), 25 mg hydrochlorothiazide. <Invented name> 5 mg/10 mg/25 mg capsules, hard: One capsule contains 5 mg ramipril, 10 mg amlodipine (as amlodipine besilate), 25 mg hydrochlorothiazide. <Invented name> 10 mg/5 mg/25 mg capsules, hard: One capsule contains 10 mg ramipril, 5 mg amlodipine (as amlodipine besilate), 25 mg hydrochlorothiazide. <Invented name> 10 mg/10 mg/25 mg capsules, hard: One capsule contains 10 mg ramipril, 10 mg amlodipine (as amlodipine besilate), 25 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard <Invented name> 2.5 mg/5 mg/12.5 mg capsules, hard : Capsule with pale pink opaque cap and ivory opaque body <Invented name> 5 mg/5 mg/12.5 mg capsules, hard : Capsule with pink opaque cap and light grey opaque body <Invented name> 5 mg/5 mg/25 mg capsules, hard : Capsule with pink opaque cap and ivory opaque body <Invented name> 5 mg/10 mg/25 mg capsules, hard : Capsule with red-brown opaque cap and grey opaque body. <Invented name> 10 mg/5 mg/25 mg capsules, hard : Capsule with dark pink opaque cap and yellow opaque body. <Invented name> 10 mg/10 mg/25 mg capsules, hard : Capsule with brown opaque cap and caramel opaque body 4. CLINICAL PARTICULARS 4.1 Therapeutic indications <Invented name> is indicated for treatment of hypertension as substitution therapy in adult patients adequately controlled with the individual products given concurrently at the same dose level as in the combination, but as separate tablets (see sections 4.3, 4.4, 4.5 and 5.1). 4.2 Posology and method of administration Posology Recommended daily dose is one capsule of the given strength. <Invented name> can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). Fixed-dose combination is not suitable for initial therapy. Patients in whom ramipril, amlodipine and diuretic are initiated simultaneously can develop symptomatic hypotension. If dose adjustment is necessary that should only be done with the monocomponents and after setting the appropriate doses the switch to the new fix combination is possible. Special populations Diuretic-treated patients In diuretic-treated patients caution is recommended, as in these patients fluid and/or salt depletion may occur. Renal function and serum potassium level should be monitored. Patients with hepatic impairment In patients with hepatic impairment, treatment with <Invented name> must be initiated only under close medical supervision and the only allowed daily dose of <Invented name> is 2.5 mg/5 mg/12.5 mg see section 4.4). <Invented name> should not be used in patients with hepatic impairment because amount of ramipril component exceeds maximum dose allowed in this condition . Patients with 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, amlodipine and hydrochlorothiazide components (regarding details see SmPCs of monocomponent preparations). Daily dose of <Invented name>in patients with renal impairment should be based on creatinine clearance. - If creatinine clearance is ≥ 60 ml/min, the maximal daily dose of <Invented name> is 10 mg/10 mg/25 mg. 2 - If creatinine clearance is between 30-60 ml/min, the maximal daily dose of <Invented name> is 5 mg/10 mg/25 mg. - <Invented name> is contraindicated in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2). - In haemodialysed patients: the maximal daily dose is 5 mg/10 mg/25 mg; the medicinal product should be administered a few hours after haemodialysis is performed. 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 patients Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of <Invented name>, 10 mg/10 mg/25 mg, since available data in this patient population are limited. When switching eligible elderly hypertensive patients (see section 4.1) to <Invented name>, the lowest available dose of the ramipril and amlodipine components should be used Paediatric population <Invented name> is not recommended for use in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy. Method of administration The capsules should be taken orally each day once at the same time of the day with or without food. It must not be chewed or crushed. It should not be taken with grapefruit juice. 4.3 Contraindications - history of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or angiotensin-II receptor antagonists (AIIRAs). - shock (including cardiogenic shock). - 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6). - lactation (see section 4.6) - 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. - severe renal impairment (creatinine clearance < 30 ml/min) - in patients with hypotensive or haemodynamically unstable states. - refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia. - obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis). - combination with angiotensin II receptor antagonists (ARBs) in patients with diabetic nephropathy (see section 4.4 and 4.5) - Concomitant use with sacubitril/valsartan therapy (see sections 4.4 and 4.5) - 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). - Hypersensitivity to amlodipine or other dihydropyridine CCBs (Calcium Channel Blockers), ramipril, or other ACE (Angiotensin Converting Enzyme) inhibitors, hydrochlorothiazide or other thiazide diuretics, sulphonamides or to any of the excipients listed in section 6.1. - Hepatic impairment 4.4 Special warnings and precautions for use The safety and efficacy of amlodipine in hypertensive crisis has not been established. 3 Special populations Pregnant woman ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE/AIIRAs 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/AIIRAs 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 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). 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 up against the risk of volume overload). - - Patients at risk of cardiac or cerebral ischemia in case of acute hypotension. The initial phase of treatment requires special medical supervision. Patients with cardiac failure Patients with heart failure should be treated with caution. In a long-term, placebo
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