Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrochlorothiazide; Irbesartan
Milpharm Ltd
C09DA04
Hydrochlorothiazide; Irbesartan
12.5mg ; 150mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502
PACKAGE LEAFLET: INFORMATION FOR THE USER 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 sideeffects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Irbesartan and Hydrochlorothiazide is and what it is used for 2. What you need to know before you take Irbesartan and Hydrochlorothiazide 3. How to take Irbesartan and Hydrochlorothiazide 4. Possible side effects 5. How to store Irbesartan and Hydrochlorothiazide 6. Contents of the pack and other information Irbesartan and Hydrochlorothiazide is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that 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. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. The two active ingredients in Irbesartan and Hydrochlorothiazide work together to lower blood pressure further than if either was given alone. IRBESARTAN AND HYDROCHLOROTHIAZIDE IS USED TO TREAT HIGH BLOOD PRESSURE, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. DO NOT TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE • if you are ALLERGIC to irbesartan or any of the other ingredients of this Read the complete document
OBJECT 1 IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM 150 MG/ 12.5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Irbesartan and Hydrochlorothiazide Milpharm 150 mg/ 12.5 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. _Excipientwith known effect:_ Each film-coated tablet contains 131.85 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Peach coloured film-coated biconvex oval shaped tablets, debossed with “H 35” on one side and plain on other side. The size is 14 mm X 7.6 mm. 4. Clinical particulars 4.1 Therapeutic indications Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 Posology and method of administration Posology Irbesartan/ Hydrochlorothiazide can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: • Irbesartan/ Hydrochlorothiazide 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; • Irbesartan/ Hydrochlorothiazide 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan/ Hydrochlorothiazide 150 mg/12.5 mg. • Irbesartan/ Hydrochlorothiazide 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan/ Hydrochlorothiazide 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Irbesartan/ Hydrochlorothiazide may be admini Read the complete document