Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
enalaprilmaleat
Cross Pharma AB
C09AA02
enalapril
20 mg
Tablett
laktos (vattenfri) Hjälpämne; enalaprilmaleat 20 mg Aktiv substans
Receptbelagt
Enalapril
Avregistrerad
1999-12-29
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER RENITEC 2.5 MG, 5 MG, 10 MG, OR 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 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 Renitec is and what it is used for 2. What you need to know before you take Renitec 3. How to take Renitec 4. Possible side effects 5. How to store Renitec 6. Contents of the pack and other information 1. WHAT RENITEC IS AND WHAT IT IS USED FOR Renitec contains an active substance called enalapril maleate. This belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Renitec 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 RENITEC DO NOT TAKE RENITEC - 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 medicine similar to this medicine call Läs hela dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Renitec 2.5 mg Tablets Renitec 5 mg Tablets Renitec 10 mg Tablets Renitec 20 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Renitec 2.5 mg Each tablet contains 2.5 mg of enalapril maleate. Excipient: each tablet contains 99 mg of lactose monohydrate. Renitec 5 mg Each tablet contains 5 mg of enalapril maleate. FOR TABLETS MANUFACTURED AT THE ORGANON PHARMA (UK) LIMITED, VIANEX S.A, OR FROSST IBERICA S.A FACILITIES: Excipient: each tablet contains 198 mg of lactose monohydrate. FOR TABLETS MANUFACTURED AT THE MSD ITALIA S.P.A FACILITY: Excipient: each tablet contains 196 mg of lactose monohydrate. Renitec 10 mg Each tablet contains 10 mg of enalapril maleate. Excipient: each tablet contains 164 mg of lactose monohydrate. Renitec 20 mg Each tablet contains 20 mg of enalapril maleate. FOR TABLETS MANUFACTURED AT THE ORGANON PHARMA (UK) LIMITED, VIANEX S.A, OR FROSST IBERICA S.A FACILITIES: Excipient: each tablet contains 154 mg of lactose monohydrate. FOR TABLETS MANUFACTURED AT THE MSD ITALIA S.P.A FACILITY: Excipient: each tablet contains 147 mg of lactose monohydrate. Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Strength Appearance Country 2.5 mg White, round shaped tablet, one side marked MSD 14, the other side plain Germany, Ireland, Sweden, United Kingdom 5 mg White, rounded triangle shaped tablet, one side scored*, the other side marked MSD 712 Austria, Finland, France, Germany, Ireland, Portugal, The Netherlands, Spain, Sweden, United Kingdom White, round shaped tablet, one side scored*, the other side marked 712 Italy White, round flat tablet, one side scored*, other side plain Greece 10 mg Rust Red, rounded triangle shaped tablet, one side scored*, the other side marked MSD 713 Austria, Finland, Germany, Ireland, The Netherlands, Sweden, United Kingdom Peach, rounded triangle shaped tablet, one side scored*, the other side marked MSD 714 Austria, Belgium, Finla Läs hela dokumentet