Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IRBESARTAN
LOTUS HEALTHCARE MALAYSIA SDN. BHD.
IRBESARTAN
2 x 14's tablet Tablets
GENEPHARM S.A
_Consumer Medication Information Leaflet (RiMUP) _ _____________________________________________________________________________ 1 BESARTIN FILM COATED TABLETS Irbesartan (150mg, 300mg) WHAT IS IN THIS LEAFLET 1. What Besartin are used for 2. How Besartin works 3. Before you use Besartin 4. How to use Besartin 5. While you are using Besartin 6. Side effects 7. Storage & disposal of Besartin 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT BESARTIN ARE USED FOR Besartin contain a medicine called irbesartan. Irbesartan belongs to a group of medicines known as angiotensin-II receptor blocker. Besartin helps to keep your blood pressure under control. Besartin tablets are used in adult patients to: Treat high blood pressure Protect the kidney in patients with high blood pressure and type 2 diabetes with evidence of impaired kidney function (nephropathy in type 2 diabetic patients). HOW BESARTIN WORKS Besartin prevent the binding of angiotensin-II to angiotensin-II receptors, causing the blood vessels to relax and the blood pressure to lower. Besartin slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. BEFORE YOU USE BESARTIN _When you must not take it_ Do not take Besartin tablets if you: allergic (hypersensitive) to irbesartan or any of the other ingredients of Besartin tablets _(see _ _ingredient list) _ pregnant or planning to be pregnant breast feeding If you have one of these conditions, do not take this medicine and inform your doctor. _Before you start to take it _ If you have the following: liver disease kidney disease diabetes any other diseases ….If you have one of these conditions, INFORM YOUR DOCTOR. You doctor will take it into account during your treatment with Besartin tablets. _Taking other medicines _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. HOW TO USE BESARTIN Baca dokumen lengkap
COPYRIGHTS / CONTACT This artwork and its content is copyright of Alvogen ©Alvogen 2012. All rights reserved. Any Anthropoidea digitally or hardcopy redistribution, alternation or reproduction of part or all of the contents in any form is prohibited by other than Alvogen staff for company usage. MAIN CONTACT: David Garcia, Artwork Director david.garcia@Alvogen.com MINIMUM FONT SIZE = 9 IF THE ABOVE MINIMUM FONT SIZE IS NOT ACCEPTABLE FOR THIS ARTWORK (EXCLUDING CODES) PLEASE DO NOT APPROVE. PRINT COLOURS Black Black 80% Black 20% .. SUPPORT COLOURS (NO PRINT) Die cut .. REGULATORY APPROVAL IRBESARTAN MALAYSIA ALL STRENGTHS PIL Die Cut size Created Modified Proof round ART Code 2 Pages - 180x320mm RM 09/05/2023 RM 10/05/2023 02 ARTDB025338P BRAND OR PRODUCT NAME Besartin Film Coated Tablets 150 mg Besartin Film Coated Tablets 300 mg NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Each Besartin film coated tablet 150 mg contains 150 mg of irbesartan. Each Besartin film coated tablet 300 mg contains 300 mg of irbesartan. PRODUCT DESCRIPTION Besartin film coated tablet 150 mg: White to off-white, oblong, biconvex film-coated tablets with score line and ‘G’ embossed on one side and plain on the other. Besartin film coated tablet 300 mg: White to off-white, oblong, biconvex film-coated tablets with score line. PHARMACODYNAMICS Irbesartan is a potent, orally active, selective angiotensin- II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The selective antagonism of the angiotensin- II (AT1) receptors results in increases in plasma-renin levels and angiotensin II levels, and a decrease in plasma aldosterone concentration. Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses. Clinical Efficacy: Hypertension: Irbesartan lowers blood pressure with minimal change in heart rate. The decrease in blood pressure is dose-related for once-daily doses with Baca dokumen lengkap