País: Reino Unido
Língua: inglês
Origem: myHealthbox
irbesartan
Brown & Burk UK Ltd
C09CA04
irbesartan
150mg
Film-coated tablets
Oral use
Pack sizes of 7,10,14,28,56,64,98 filmcoated tablets
POM - Prescription Only Medicine
Brown & Burk UK Ltd
Angiotensin-II antagonists, plain
It is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen
Authorised
2015-05-13
IRBESARTAN 75MG FILM-COATED TABLETS IRBESARTAN 150MG FILM-COATED TABLETS IRBESARTAN 300MG FILM-COATED TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER 150mm 420 mm Phramcode reading direction Front Phramcode reading direction 150mm 420mm 6 mm might become) pregnant. Irbesartan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). CHILDREN AND ADOLESCENTS: This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established. OTHER MEDICINES AND IRBESARTAN Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change your dose and/or to take other precautions if you are taking aliskiren. Irbesartan does not usually interact with other medicines. You may need to have blood checks if you take: • potassium supplements • salt substitutes containing potassium • potassium-sparing medicines (such as certain diuretics) • medicines containing lithium If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced. IRBESARTAN TABLETS WITH FOOD AND DRINK Irbesartan Tablets can be taken with or without food. PREGNANCY AND BREAST-FEEDING Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan. Irbesartan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breast feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan tablets are Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irbesartan 150 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan. Excipient: 45.00 mg of lactose monohydrate per film-coated tablet. Excipient(s) with known effect:lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oval, biconvex, film-coated tablets, engraved with '150' on one face and plain on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan Tablet at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan can be increased to 300 mg, or other antihypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan (see section 4.5). In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabeti Leia o documento completo