Summary of Product Characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented Name> 10 mg/10 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg enalapril maleate and 10 mg lercanidipine hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet <Invented Name> 10 mg/10 mg film-coated tablets are white to off white, round, biconvex film-coated tablets approximately 9 mm in diameter. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of essential hypertension in patients whose blood pressure is not adequately controlled by lercanidipine 10 mg alone. Fixed combination <Invented Name> 10 mg/10 mg should not be used for initial treatment of hypertension. 4.2 Posology and method of administration Posology Patients whose blood pressure is not adequately controlled by lercanidipine 10 mg alone could either be titrated up to lercanidipine 20 mg monotherapy or switched to fixed combination <Invented Name> 10 mg/10 mg. Individual dose titration with the components can be recommended. When clinically appropriate, direct switch from monotherapy to the fixed combination may be considered. The recommended dose is one tablet once a day. Elderly patients The dose should depend on the patient’s renal function (see ‘renal impairment’). Renal impairment <Invented Name> is contraindicated in patients with severe renal dysfunction (creatinine clearance <30 ml/min) or in patients undergoing haemodialysis (see sections 4.3 and 4.4). Particular caution is needed when initiating treatment in patients with mild to moderate renal dysfunction. Hepatic impairment <Invented Name> is contraindicated in severe hepatic dysfunction. Particular caution is needed when initiating treatment in patients with mild to moderate hepatic dysfunction. Paediatric population The safety and efficacy of this medicinal product has not been established in patients under 18 years of age, therefore its use in this age group is not recommended. Method of administration Tablets should be taken at least 15 minutes before meals, preferably in the morning. This medicinal product should not be administered with grapefruit (see sections 4.3 and 4.5). 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to any ACE-inhibitor or dihydropyridine calcium channel blocker Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Left ventricular outflow obstruction, including aortic stenosis Untreated congestive heart failure Unstable angina pectoris Within one month of a myocardial infarction Severe renal impairment (creatinine clearance <30 ml/min), including patients undergoing haemodialysis Severe hepatic impairment Coadministration with: - strong CYP3A4 inhibitors (see section 4.5) - ciclosporin (see section 4.5) - grapefruit juice (see section 4.5) Concomitant use of aliskiren-containing products, in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1) A history of angioedema caused by previous therapy with an ACE-inhibitor Hereditary or idiopathic angioedema 4.4 Special warnings and precautions for use Symptomatic hypotension Particularly careful monitoring is required with enalapril in: severe hypotension with systolic blood pressure less than 90 mmHg decompensated heart failure Symptomatic hypotension is rarely seen in uncomplicated hypertensive patients. In hypertensive patients receiving enalapril, symptomatic 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 (see section 4.5). 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, hyponatremia or functional renal impairment. In these patients, therapy should be started under medical supervision and the patients should be followed closely whenever the dose of enalapril and/or diuretic is adjusted. 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. 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 usually without difficulty once the blood pressure has increased after volume expansion. In some patients with heart failure who have normal or low blood pressure, additional lowering of systematic blood pressure may occur with enalapril. This effect is anticipated and usually is not a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose and/or discontinuation of the diuretic and/or enalapril may be necessary. Sick-sinus syndrome Particular caution is recommended in the use of lercanidipine in patients with sick-sinus syndrome (without a pacemaker). Left ventricular dysfunction and ischaemic heart disease Although haemodynamic controlled studies revealed no impairment of ventricular function, caution must be exercised when treating patients with left ventricular dysfunction with calcium channel blockers. It has been suggested that patients with ischaemic heart disease show an elevated cardiovascular risk under treatment with some short-acting dihydropyridines. Although lercanidipine is long-acting, caution is advised in these patients. In rare cases, some dihydropyridines can cause precordial pain or angina pectoris. Very rarely, patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed (see section 4.8). Use in renal impairment Particular caution is required with enalapril when initiating treatment in patients with mild to moderate renal impairment. Routine monitoring of serum potassium and creatinine under enalapril treatment is part of the normal medical care of these patients. Reports of renal failure associated with the use of enalapril have been made especially in patients with severe heart failure or underlying renal disease, including renal artery stenosis. If diagnosed promptly and treated appropriately, renal failure under enalapril treatment is usually reversible. In some hypertensives with no pre-existing renal disease, the combination of enalapril with a diuretic can lead to an increase in blood urea and creatinine. Dosage reduction of enalapril and/or discontinuation of the diuretic may be necessary. In these cases, the possibility of an underlying renal artery stenosis should be considered (see section 4.4, Renovascular hypertension). Renovascular hypertension Patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney are particularly at risk of developing hypotension or renal failure under ACE-inhibitor therapy. In these patients, treatment should be initiated under close medical supervision with low doses and cautious titration. Renal function should be assessed at baseline and closely monitored during treatment. Renal transplantation There is no experience in the use of lercanidipine or enalapril in patients who have recently undergone renal transplantation. Therefore treatment of these patients with <Invented Name> is not recommended. Hepatic failure The antihypertensive effect of lercanidipine can be potentiated in patients with hepatic dysfunction. Rarely, a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis (sometimes fatal) has been observed with ACE-inhibitor treatment. The mechanism of this syndrome is unclear. Patients who develop jaundice or a marked rise in liver enzymes with ACE-inhibitors must stop taking the ACE-inhibitor and should be given appropriate treatment. Neutropenia/agranulocytosis Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients on ACE- inhibitors. Neutropenia is rare in patients with normal renal function and without particular risk factors. Enalapril should be used with extreme caution in patients with collagen vascular disease, those under treatment with immunosuppressants, allopurinol, procainamide or if several of these risk factors are present, especially in pre-existing impairment of renal function. Severe infections occurred in some of these patients, that in few cases did not respond to intensive antibiotic treatment. If enalapril is used in such patients, regular monitoring of leucocytes is advised and patients should be instructed to report any signs of infection to their doctor. Hypersensitivity/angioneurotic oedema Angioneurotic oedema with involvement of the face, extremities, lips, tongue, glottis and/or larynx, has been reported in patients treated with ACE-inhibitors, including enalapril. It may occur at any time during treatment. In such cases, enalapril must be stopped immediately. The patient is to be carefully monitored in order to ensure that the symptoms have fully resolved before discharge from the hospital. In cases where the swelling was limited to the face and lips, symptoms generally resolved without treatment. However, antihistamines were useful in relieving the symptoms. Angioneurotic

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