Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PERINDOPRIL ERBUMINE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
PERINDOPRIL ERBUMINE
30 Tablets; 100 Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ PERINACE TABLET Perindopril erbumine (4mg, 8mg) Page 1 of 5 WHAT IS IN THIS LEAFLET 1. What PERINACE TABLET is used for 2. How PERINACE TABLET works 3. Before you take PERINACE TABLET 4. How to take PERINACE TABLET 5. While you are taking PERINACE TABLET 6. Side effects 7. Storage and Disposal of PERINACE TABLET 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT PERINACE TABLET IS USED FOR Perinace is an angiotensin converting enzyme (ACE) inhibitor. Perinace is used: - to treat arterial hypertension, - to treat heart failure (when the heart is unable to pump enough blood to meet the body’s needs), - 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 PERINACE TABLET WORKS Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. BEFORE YOU TAKE PERINACE TABLET - _When you must not take it _ _ _ DO NOT TAKE PERINACE - if you are allergic (hypersensitive) to perindopril or any of the other ingredients of this medicine, 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 Perinace in early pregnancy – see pregnancy section). - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. - if you are having dialysis Leggi il documento completo
Page 1 of 10 PERINACE TABLET DESCRIPTION & COMPOSITION PERINACE TABLET 4MG An oblong shape, scored, white to off-white tablet Each tablet contains 4 mg of perindopril erbumine. PERINACE TABLET 8MG A white oval biconvex shape tablet, plain on one side and score line on the other side. The tablet can be divided into equal halves. Each tablet contains 8 mg of perindopril erbumine. PHARMACODYNAMICS Pharmacotherapeutic group: ACE inhibitor, plain, ATC code: C09A A04 MECHANISM OF ACTION Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide. Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone. Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system). It is possible that this mechanism contributes to the blood pressure-lowering action of ACE inhibitors and is partially responsible for certain of their side effects (e.g., cough). Perindopril acts through its active metabolite, perindoprilat. The other metabolites show no inhibition of ACE activity in vitro. CLINICAL EFFICACY AND SAFETY Hypertension: Perindopril is active in all grades of hypertension: mild, moderate, severe; a reduction in systolic and diastolic blood pressures in both supine and standing positions is observed. Perindopril reduces peripheral vascular resistance, leading to blood pressure reduction. As a consequence, peripheral blood flow increases, with no effect on heart rate. Renal blood flow increases as a rule, while the glomerular filtration rate (GFR) is usu Leggi il documento completo