Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENALAPRILMALEAAT 40 mg/stuk SAMENSTELLING overeenkomend met ; ENALAPRIL 30,6 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
C09AA02
ENALAPRILMALEAAT 40 mg/stuk SAMENSTELLING overeenkomend met ; ENALAPRIL 30,6 mg/stuk
Tablet
IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; TALK (E 553 B),
Oraal gebruik
Enalapril
Hulpstoffen: IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMWATERSTOFCARBONAAT (E 500 (II)); TALK (E 553 B);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENALAPRILMALEAAT 30 MG, TABLETTEN ENALAPRILMALEAAT 40 MG, TABLETTEN enalaprilmaleaat 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 [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT ENALAPRIL MALEATE IS AND WHAT IT IS USED FOR ENALAPRIL MALEATE IS USED to reduce high blood pressure (hypertension) for insufficient pumping power of the heart with symptoms of disease (symptomatic heart failure) for insufficient pumping power of the heart (heart failure) before symptoms occur, to prevent the occurrence of these symptoms (such as breathlessness, swollen ankles and feet, and fatigue after slight exertion such as walking). Enalapril maleate belongs to the ACE inhibitor (angiotensin conversion inhibitors) group of medicines. Enalapril blocks the formation of a blood pressure-increasing substance by the body. As a result, the pressure falls and/or the action of the heart improves. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL MALEATE DO NOT TAKE ENALAPRIL MALEATE: if you are allergic to: - enalapril or any of the other ingredients of this medicine (listed in section 6) - other ACE-inhibitors. if you had sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), breathing d Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enalaprilmaleaat 30 mg, tabletten Enalaprilmaleaat 40 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg enalapril maleate. Each tablet contains 40 mg enalapril maleate. Excipient with known effect: Each tablet contains 167.9 mg lactose (as lactose monohydrate). Excipient with known effect: Each tablet contains 223.8 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. [Nationally completed name] 30 mg tablet is an oblong, convex, orange tablet with two breaking notches, both sides scored with markings ‘EN 30’. The tablet can be divided into three equal doses. [Nationally completed name] 40 mg tablet is an oblong, convex, orange tablet with three breaking notches, both sides scored with markings ‘EN 40’. The tablet can be divided into four 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) 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The absorption of enalapril maleate is not affected by food. 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). Enalapril maleate 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 experien Les hele dokumentet