Negara: Afrika Selatan
Bahasa: Inggris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
MSD (PTY) LTD
Tablet
Each tablet contains ENALAPRIL MALEATE 20 mg
1987-07-09
1 PATIENT INFORMATION LEAFLET INFORMATION FOR THE PATIENT ABOUT RENITEC ® READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RENITEC Keep this leaflet. You may need to read it again If you have further questions, please ask your doctor or your pharmacist. RENITEC has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. SCHEDULING STATUS S3 PROPRIETARY NAME AND DOSAGE FORM RENITEC ® 2,5 Tablet (2,5 mg enalapril maleate) RENITEC 5 Tablet (5 mg enalapril maleate) RENITEC 10 Tablet (10 mg enalapril maleate) RENITEC 20 Tablet (20 mg enalapril maleate) WHAT RENITEC CONTAINS RENITEC (enalapril maleate, MSD) is a tablet. RENITEC tablets contain either 2,5 mg; 5 mg; 10 mg or 20 mg of enalapril maleate as the active ingredient. Copyright © 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J, U.S.A. 2 In addition, RENITEC tablets contain the following inactive ingredients: Sodium hydrogen carbonate, maize starch, pregelatinised starch, magnesium stearate, lactose monohydrate. In addition the 10 mg and 20 mg tablet contains iron oxide red (E172) and iron oxide yellow (E172) – 20 mg tablet only. RENITEC tablets contain sugar. WHAT RENITEC IS USED FOR RENITEC is a medication that belongs to the group of medicines called angiotensin converting enzyme inhibitors, (ACE inhibitors). Your doctor has prescribed RENITEC to treat your hypertension (high blood pressure) or heart failure (weakening of heart function). RENITEC is also used for the prevention of symptomatic heart failure in patients with decreased heart function. RENITEC works by widening your blood vessels to make it easier for the heart to pump blood to all parts of your body. BEFORE YOU TAKE RENITEC DO NOT TAKE RENITEC IF YOU: Are allergic to enalapril maleate or any of the other ingredients of RENITEC (see “WHAT RENITEC CONTAINS”) Have previously been treated with a medication in Baca dokumen lengkapnya
1 SCHEDULING STATUS S3 PROPRIETARY NAME AND DOSAGE FORM RENITEC ® 2,5 Tablet RENITEC 5 Tablet RENITEC 10 Tablet RENITEC 20 Tablet COMPOSITION Each RENITEC 2,5 tablet contains 2,5 mg enalapril maleate, MSD. Each RENITEC 5 tablet contains 5 mg enalapril maleate, MSD. Each RENITEC 10 tablet contains 10 mg enalapril maleate, MSD. Each RENITEC 20 tablet contains 20 mg enalapril maleate, MSD. RENITEC tablets contain sugar. EXCIPIENTS: sodium hydrogen carbonate, maize starch, pregelatinised starch, magnesium stearate, lactose monohydrate. In addition the 10 mg and 20 mg tablet contains iron oxide red (E172) and iron oxide yellow (E172) – 20 mg tablet only. PHARMACOLOGICAL CLASSIFICATION A 7.1.3 Vascular medicines - other hypotensives PHARMACOLOGICAL ACTION Enalapril maleate, is the maleate salt of enalapril, a derivative of two amino acids, L-alanine and L-proline. Following oral absorption, enalapril maleate, is hydrolysed to enalaprilat, which is a specific, long-acting, non- sulphydryl angiotensin converting enzyme inhibitor. Copyright © 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J, U.S.A. 2 CLINICAL PHARMACOLOGY Enalapril lowers blood pressure in patients with hypertension and improves the signs and symptoms associated with chronic heart failure. PHARMACODYNAMICS Mechanism of action Angiotensin converting enzyme (ACE) is a peptidyl dipeptidase which catalyzes the conversion of angiotensin I to the pressor substance angiotensin II . After absorption, enalapril is hydrolyzed to enalaprilat, which inhibits ACE. Inhibition of ACE results in decreased plasma angiotensin II , which leads to increased plasma renin activity (due to removal of negative feedback of renin release), and decreased aldosterone secretion. In some patients the development of optimal blood pressure reduction may require several weeks of therapy. Effective inhibition of ACE activity usually occurs 2 to 4 hours after oral administration of an individual dose of enalapril. Onset of antihyper Baca dokumen lengkapnya