Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Medicines Authority
Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland
C09AA04
PERINDOPRIL ARGININE 10 mg
FILM-COATED TABLET
PERINDOPRIL ARGININE 10 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2024-01-17
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL ARGININE CLONMEL 2.5 MG FILM-COATED TABLETS PERINDOPRIL ARGININE CLONMEL 5 MG FILM-COATED TABLETS PERINDOPRIL ARGININE CLONMEL 10 MG FILM-COATED TABLETS perindopril arginine 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 Perindopril Arginine Clonmel is and what it is used for 2. What you need to know before you take Perindopril Arginine Clonmel 3. How to take Perindopril Arginine Clonmel 4. Possible side effects 5. How to store Perindopril Arginine Clonmel 6. Contents of the pack and other information 1. WHAT PERINDOPRIL ARGININE CLONMEL IS AND WHAT IT IS USED FOR Perindopril Arginine Clonmel is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Perindopril Arginine Clonmel is used ‒ to treat HIGH BLOOD PRESSURE (hypertension). ‒ to treat HEART FAILURE (a condition where the heart is unable to pump enough blood to meet the body’s needs) (only Perindopril Arginine Clonmel 2.5 mg and 5 mg). ‒ to reduce the risk of cardiac events, such as heart attack, in patients with STABLE CORONARY ARTERY DISEASE (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE CLONMEL DO NOT TAKE PERINDOPRIL ARGININE Կարդացեք ամբողջական փաստաթուղթը
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Perindopril Arginine Clonmel 2.5 mg film-coated tablets Perindopril Arginine Clonmel 5 mg film-coated tablets Perindopril Arginine Clonmel 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril Arginine Clonmel 2.5 mg: Each film-coated tablet contains 2.5 mg perindopril arginine equivalent to 1.6975 mg perindopril. Perindopril Arginine Clonmel 5 mg: Each film-coated tablet contains 5 mg perindopril arginine equivalent to 3.395 mg perindopril. Perindopril Arginine Clonmel 10 mg: Each film-coated tablet contains 10 mg perindopril arginine equivalent to 6.790 mg perindopril. Excipient with known effect Perindopril Arginine Clonmel 2.5 mg: Each film-coated tablet contains 58.19 mg lactose (as monohydrate). Perindopril Arginine Clonmel 5 mg: Each film-coated tablet contains 116.38 mg lactose (as monohydrate). Perindopril Arginine Clonmel 10 mg: Each film-coated tablet contains 232.75 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Perindopril Arginine Clonmel 2.5 mg: White to off-white, rounded, convex film-coated tablet of diameter 5.0 ± 0.25 mm. Perindopril Arginine Clonmel 5 mg: Light-green, oval, biconvex film-coated tablet with length 10.0 ± 0.50 mm and width 4.75 ± 0.24 mm with both-sided score line. The tablet can be divided into equal doses. Perindopril Arginine Clonmel 10 mg: Green to marble green, rounded, biconvex film-coated tablet of diameter 9.0 ± 0.45 mm with one-sided debossing “10”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of hypertension. Heart failure (only Perindopril Arginine Clonmel 2.5 mg and 5 mg) Treatment of symptomatic heart failure. Stable coronary artery disease Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation. Page 2 of 17 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be individualised Կարդացեք ամբողջական փաստաթուղթը