Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PERINDOPRIL ARGININE
SERVIER MALAYSIA SDN BHD
PERINDOPRIL ARGININE
30tablet Tablets
SERVIER ( IRELAND) INDUSTRIES LTD
_ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 COVERSYL 10 MG ORODISPERSIBLE TABLETS _Perindopril Arginine (10mg) _ WHAT IS IN THIS LEAFLET 1. What Coversyl is used for 2. How Coversyl works 3. Before you use Coversyl 4. How to use Coversyl 5. While you are using Coversyl 6. Side effects 7. Storage and Disposal of Coversyl 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COVERSYL IS USED FOR Coversyl is used: • to treat _high _ _blood _ _pressure_ (hypertension), • 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. HOW COVERSYL WORKS Coversyl 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. BEFORE YOU USE COVERSYL - _When you must not take Coversyl _ DO NOT TAKE COVERSYL • if you are allergic to perindopril, or any of the other ingredients of this medicine (listed in section 8) or to any other ACE inhibitor, • if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema). • if you are more than 3 months pregnant. (It is also better to avoid Coversyl in early pregnancy (see section ‘Pregnancy and breast- feeding’), • if you have diabetes mellitus or kidney problems and you are treated with aliskiren. • if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Coversyl may not be suitable for you, • if you have kidney problems where the blood supply to your kidneys is reduced (rena Olvassa el a teljes dokumentumot
Final _PI _Coversyl_OD_10mg _05.06.2019 1 COVERSYL ® OD 10 mg orodispersible tablets 1. NAME OF THE MEDICINAL PRODUCT Coversyl OD 10 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One orodispersible tablet contains 6.790 mg perindopril corresponding to 10 mg perindopr il arginine. Excipients with known effect: 125.46 mg lactose, 0.4 mg aspartame. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. White, round tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Hypertension Treatment of h ypertension. 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 Posology The dose should be i ndividualised according to the patient profile (see section 4.4) and blood pressure response. Hypertension Coversyl may be used in monotherapy or in combination with other classes of antihypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1) . The recom mended starting dose is 5 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) ma y experience an excessive drop in blood pressure following the initial dose. A starting dose of 2.5 mg is recommended in such patients and the initiation of treatment should take p lace under medical supervision. The dose may be increased to 10 mg once dail y after one month of treatment. Symptomatic hypotension may occur following initiation of therapy with Coversyl ; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. Olvassa el a teljes dokumentumot