País: Malta
Idioma: anglès
Font: Medicines Authority
ENALAPRIL MALEATE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
C09AA02
ENALAPRIL MALEATE 20 mg
TABLET
ENALAPRIL MALEATE 20 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2006-11-01
mt-pl-korandil-tabs-a3 Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KORANDIL 5 MG TABLETS KORANDIL 20 MG TABLETS Enalapril maleate 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 Korandil is and what it is used for 2. What you need to know before you take Korandil 3. How to take Korandil 4. Possible side effects 5. How to store Korandil 6. Contents of the pack and other information 1. WHAT KORANDIL IS AND WHAT IT IS USED FOR Korandil contains an active substance called enalapril maleate. This belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Korandil is used: - to treat high blood pressure (hypertension). - to treat heart failure (weakening of heart function). It can lower the need to go to hospital and can help some patients live longer. - to prevent the signs of heart failure. The signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet. This medicine works by widening your blood vessels. This lowers your blood pressure. The medicine usually starts to work within an hour and the effect lasts for at least 24 hours. Some people will require several weeks of treatment until the best effect on your blood pressure is seen. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KORANDIL DO NOT TAKE KORANDIL - if you are allergic to enalapril maleate 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 medici Llegiu el document complet
mt-spc-korandil-tabs-v04-r00-a0 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Korandil 5 mg tablets Korandil 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Korandil 5 mg tablets: Each tablet contains 5 mg of enalapril maleate. Korandil 20 mg tablets: Each tablet contains 20 mg of enalapril maleate. Excipient(s) with known effect Korandil 5 mg tablets: This product contains 190.5 mg lactose. Korandil 20 mg tablets: This product contains 174.5 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Korandil 5 mg tablets: White, scored, normal convex, barrel shaped tablets with Remedica’s logo on one side. Korandil 20 mg tablets: Peach, mottled, normal convex, barrel shaped tablets scored on one side with Remedica’s logo on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of Hypertension. • Treatment of Symptomatic Heart Failure. • Prevention of Symptomatic Heart Failure in patients with Asymptomatic Left Ventricular Dysfunction (ejection fraction ≤35%) (see section 5.1 'Pharmacodynamic properties'). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The absorption of Korandil Tablets is not affected by food. mt-spc-korandil-tabs-v04-r00-a0 Page 2 of 19 The dose should be individualised according to patient profile (see section 4.4) and blood pressure response. _Paediatric Population _ There is limited clinical trial experience of the use of enalapril maleate in hypertensive paediatric patients (see sections 4.4, 5.1 and 5.2). _Hypertension _ The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Korandil is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system, (e.g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may ex Llegiu el document complet