País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Enalapril maleate; Lercanidipine
KRKA, d.d., Novo mesto
C09BB; C09BB02
Enalapril maleate; Lercanidipine
20/10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; enalapril and lercanidipine
Marketed
2013-08-09
PACKAGE LEAFLET: INFORMATION FOR THE USER ENALAPRIL/LERCANIDIPINE KRKA 20 MG/10 MG FILM-COATED TABLETS enalapril maleate/lercanidipine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Enalapril/Lercanidipine Krka is and what it is used for 2. What you need to know before you take Enalapril/Lercanidipine Krka 3. How to take Enalapril/Lercanidipine Krka 4. Possible side effects 5. How to store Enalapril/Lercanidipine Krka 6. Contents of the pack and other information 1. WHAT ENALAPRIL/LERCANIDIPINE KRKA IS AND WHAT IT IS USED FOR Enalapril/Lercanidipine Krka is a fixed combination of an ACE-inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two medicines that lower blood pressure. Enalapril/Lercanidipine Krka is used for the treatment of high blood pressure (hypertension) in patients whose blood pressure is not adequately controlled by enalapril 20 mg alone. Enalapril/Lercanidipine Krka should not be used for initial treatment of hypertension. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL/LERCANIDIPINE KRKA DO NOT TAKE ENALAPRIL/LERCANIDIPINE KRKA - if you are allergic to enalapril or lercanidipine or any of the other ingredients of this medicine (listed in section 6); - if you have ever had an allergic reaction to a type of medicines similar to those contained in Enalapril/Lercanidipine Krka, i.e. medicines called ACE-inhibitors or calcium channel blockers; - if you have ever developed angioedema (oedema of the face, lips, mouth, tongue or throat) which caused Leia o documento completo
Health Products Regulatory Authority 06 April 2022 CRN00CW2V Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Enalapril/Lercanidipine Krka 20mg/10mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg enalapril maleate (equivalent to 15.29 mg enalapril) and 10 mg lercanidipine hydrochloride (equivalent to 9.44 mg lercanidipine). Excipients with known effect: lactose monohydrate Each film-coated tablet contains 307 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets are yellow, round, slightly biconvex with bevelled edges, tablet diameter 10 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in patients whose blood pressure is not adequately controlled by enalapril 20 mg alone. Fixed combination Enalapril/Lercanidipine Krka 20 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 treatment with enalapril 20 mg alone could either be titrated up to the higher dose of enalapril monotherapy or switched to Enalapril/Lercanidipine Krka 20 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 at least 15 minutes before meals. _Special populations_ _Elderly_ The dose should depend on the patient's renal function (see section 4.4, "Renal impairment"). _Renal impairment_ Enalapril/Lercanidipine Krka 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 (creatinine clearance: 30‑60 ml/min) renal dysfunction. _Hepatic impairment _ E Leia o documento completo