Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Perindopril erbumine
Accord-UK Ltd
C09AA04
Perindopril erbumine
8mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5060149312964
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL 2 MG TABLETS PERINDOPRIL 4 MG TABLETS PERINDOPRIL 8 MG TABLETS Perindopril tert-butylamine 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,pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. . WHAT IS IN THIS LEAFLET: 1. What Perindopril Tablets are and what they are used for 2. What you need to know before you take Perindopril Tablets 3. How to take Perindopril Tablets 4. Possible side effects 5. How to store Perindopril Tablets 6. Contents of the pack and other information 1. WHAT PERINDOPRIL TABLETS ARE AND WHAT THEY ARE 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. Perindopril 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 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 TABLETS DO NOT TAKE PERINDOPRIL TABLETS if you are allergic (hypersensitive) to perindopril or any of the other ingredients of Perindopril Tablets (see Further Information, section 6) or to any other ACE inhibitor. if you have had sym Read the complete document
OBJECT 1 PERINDOPRIL 8 MG TABLETS Summary of Product Characteristics Updated 15-Nov-2016 | Accord Healthcare Limited 1. Name of the medicinal product Perindopril 8 mg Tablets. 2. Qualitative and quantitative composition Each tablet contains perindopril tert-butylamine 8 mg equivalent to 6.676 mg perindopril. Excipient(s) with known effect: Lactose anhydrous. Each tablet contains 170.40 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. White capsule shaped, biconvex tablets, engraved “P” Bisect “8”on one side and plain on the other side. The tablets can be divided into equal halves. 4. Clinical particulars 4.1 Therapeutic indications Hypertension Treatment of hypertension Heart Failure Treatment of symptomatic heart failure Stable coronary artery disease Reduction of risk of cardiac events in patients with a history of myocardial infraction and/or revascularisation. Perindopril can be used alone or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). 4.2 Posology and method of administration Posology 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 section 4.4 and blood pressure response. Hypertension Perindopril can be used alone or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). The recommended starting dose is 4 mg given once daily in the morning. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A starting dose of 2 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. The dose may be increased to 8 mg once daily after one month of treatment. Symptomatic hypotension may occur following initiation Read the complete document