Država: Malta
Jezik: engleski
Izvor: Medicines Authority
IRBESARTAN
Accord Healthcare Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
C09CA04
IRBESARTAN 150 mg
FILM-COATED TABLET
IRBESARTAN 150 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2011-08-29
PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN 75 MG FILM-COATED TABLETS IRBESARTAN 150 MG FILM-COATED TABLETS IRBESARTAN 300 MG FILM-COATED TABLETS Irbesartan Read all of this leaflet carefully before you start taking this medicine • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Irbesartan Tablet is and what it is used for 2. Before you take Irbesartan Tablets 3. How to take Irbesartan Tablets 4. Possible side effects 5. How to store Irbesartan Tablets 6. Further information 1. WHAT IRBESARTAN TABLET IS AND WHAT IT IS USED FOR Irbesartan Tablets belong to a group of medicines called angiotensin –II receptor antagonists, plain. Angiotensin –II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Tablets prevents the binding of angiotensin -II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Tablets slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Irbesartan Tablets are used • to treat high blood pressure (essential hypertension) • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory ev Pročitajte cijeli dokument
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irbesartan 75 mg Film-coated Tablets Irbesartan 150 mg Film-coated Tablets Irbesartan 300 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film - coated tablet contains 75 mg Irbesartan. Excipient: 25.36 mg of lactose monohydrate per tablet. For a full list of excipients, see section 6.1. Each film - coated tablet contains 150 mg Irbesartan. Excipient: 50.72 mg of lactose monohydrate per tablet. For a full list of excipients, see section 6.1. Each film - coated tablet contains 300 mg Irbesartan. Excipient: 101.44 mg of lactose monohydrate per tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film– coated tablet White to off white, oval, biconvex, film coated tablet debossed ‘I 75’ on one side and plain on other side. Film– coated tablet White to off white, oval, biconvex, film coated tablet debossed ‘I 150’ on one side and plain on other side. Film– coated tablet White to off white, oval, biconvex, film coated tablet debossed ‘I 300’ on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen. (See section 5.1) Page 2 of 13 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual recommended initial and maintenance dose is 150 mg once daily, with or with out food. Irbesartan Tablets at a dose of Pročitajte cijeli dokument