Land: Malta
Taal: Engels
Bron: Medicines Authority
PERINDOPRIL TERT, BUTYLAMINE SALT
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C09AA04
PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg
TABLET
PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2009-05-04
dimensions: pharmacode: date sent: TECHNICAL APPROVAL min pt size: awstudio@actavis.co.uk print proof no: origination date: originated by: revision date: supplier: technically app. date*: * Please note the technical approval is provided by the supplier and is valid on the date indicated. Any technical changes made by the supplier after approval are not the responsibility of the Artwork Studio. Non Printing Colours colours/plates revised by: approved for print/date 1. 2. 3. 4. 5. 6. black 2 9pt 170x600 07.12.2012 07.12.2012 07.12.2012 K. Mutafchieva 14.01.2013 K. Mutafchieva Glenmark Pharmaceuticals Item Number: AAAE6616 Perindopril, All Strengths, PIL, Malta READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Keep this leaflet. You may need to read it again. • If you have any further questions, consult your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects becomes serious, or if you notice any side effects not listed in this leaf- let, please tell your doctor or pharmacist. In this leaflet: 1. What Percarnil is and what is it used for. 2. What you should know before you take Percarnil. 3. How to take Percarnil. 4. Possible side effects. 5. How to store Percarnil. 6. Further information. 1. WHAT PERCARNIL IS AND WHAT IT IS USED FOR PERINDOPRIL belongs to a group of medicines called ACE inhibitors. These work by widening the blood vessels. This makes it easier for your heart to pump blood through the body. Percarnil 2 mg or 4 mg tablets are used to: • treat high blood pressure (hypertension) • treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs) • 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 Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Percarnil 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril 2 mg: Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent to 1.669 mg perindopril Excipient: 31.39 mg of lactose monohydrate _ _ Perindopril 4 mg: Each tablet contains 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril Excipient: 62.78 mg of lactose monohydrate Perindopril 8 mg: Each tablet contains 8 mg perindopril tert-butylamine salt, equivalent to 6.676 mg perindopril Excipient: 125.56 mg of lactose monohydrate _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 2 mg: White, round, biconvex tablet, smooth on both sides. 4mg: White, oblong tablet, with a break-line on both sides, ‘PP’ engraved on one side and ‘4’ on the other. The tablet can be divided into equal halves. 8mg: White, circular, biconvex tablet with ‘PP’ debossed on one side and ‘8’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Treatment of hypertension Heart failure (applicable to Percarnil 2mg & 4mg tablets only): 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that Perindopril is taken once daily in the morning before a meal. The dose should be individualised according to the patient profile (see 4.4 “Special warnings and precautions for use”) and blood pressure response. Page 1 of 14 Hypertension Perindopril may be used in monotherapy or in combination with other classes of antihypertensive therapy. The recommended starting dose is 4 mg given once daily in the morning. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renov Lees het volledige document