Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Irbesartan
Milpharm Ltd
C09CA04
Irbesartan
75mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Irbesartan is and what it is used for 2. What you need to know before you take Irbesartan 3. How to take Irbesartan 4. Possible side effects 5. How to store Irbesartan 6. Contents of the pack and other information Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. 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 prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. IRBESARTAN IS USED IN ADULT PATIENTS • to treat high blood pressure (essential hypertension) • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. DO NOT TAKE IRBESARTAN • if you are ALLERGIC to irbesartan or any other ingredients of this medicine (listed in section 6) • if you are more than 3 months pregnant. (It is also better to avoid Irbesartan 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. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Irbesartan AND IF ANY OF THE FOLLOWING APPLY TO YOU: • if you get Lire le document complet
OBJECT 1 IRBESARTAN 75 MG TABLETS Summary of Product Characteristics Updated 27-Jul-2017 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Irbesartan Milpharm 75 mg tablets 2. Qualitative and quantitative composition Each tablet contains 75 mg of irbesartan. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet White to off-white, biconvex oval shaped uncoated tablets debossed with 'H 28' on one side and plain on other side. The size is 10.8 mm X 5.7 mm. 4. Clinical particulars 4.1 Therapeutic indications Irbesartan Milpharm 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 sections 4.3, 4.4, 4.5 and 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 Milpharm 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 Milpharm 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 Milpharm (see sections 4.3, 4.4, 4.5 and 5.1). 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 Milpharm in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (se Lire le document complet