Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Irbesartan; HYDROCHLOROTHIAZIDE
SYNERRV SDN BHD
Irbesartan; HYDROCHLOROTHIAZIDE
28 Tablets
Macleods Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ IRBEMAC H 300/12.5 TABLETS IRBEMAC H 300/25 TABLETS Irbesartan/ Hydrochlorothiazide Tablet (300mg/12.5mg, 300mg/25mg) Page 1 of 3 WHAT IS IN THIS LEAFLET? 1) What IRBEMAC H is used for 2) How IRBEMAC H works 3) Before you use IRBEMAC H 4) How to use IRBEMAC H 5) While you are using IRBEMAC H 6) Side effects 7) Storage and Disposal of IRBEMAC H 8) Product Description 9) Manufacturer and Product Registration Holder 10) Date of Revision 1. WHAT IRBEMAC H IS USED FOR: IRBEMAC H is used to treat high blood pressure ( _essential hypertension_ ), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. 2. HOW IRBEMAC H WORKS: Irbesartan tablets belong 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. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure 3. BEFORE YOU USE IRBEMAC H: _- When you must not use it _ • are allergic to irbesartan or hydrochlorothiazide, or any of the other ingredients of this medicine, or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further clarification). • are more than 3 months pregnant. (It is also better to avoid IRBEMAC H tablets in early pregnancy • have severe liver or kidney problems. • have difficulty in producing urine. • have a condition which is associated with persistently high calcium or low potassium levels in your blood. • have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren _- Before you start to use it _ Talk to your doctor before u Lue koko asiakirja
MACLEODS PHARMACEUTICALS LTD. FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY IRBEMAC H 300/12.5 TABLET ( Irbesartan 300mg & Hydrochlorothiazide 12.5mg) IRBEMAC H 300/25 TABLET ( Irbesartan 300mg & Hydrochlorothiazide 25mg) COMPOSITION: Each film coated tablet contains: Irbesartan Ph.Eur 300 mg Hydrochlorothiazide Ph.Eur 12.5 mg Each film coated tablet contains: Irbesartan Ph.Eur 300 mg Hydrochlorothiazide Ph.Eur 25 mg DESCRIPTION: 300/12.5 mg: Peach coloured, oval, film coated tablets debossed with “ML 33” on one side and plain on other side. 300/25 mg: Pink coloured, oval, film coated tablets debossed with “ML 32” on one side and plain on other side. PHARMACOKINETICS Concomitant administration of Hydrochlorothiazide and Irbesartan has no effect on the pharmacokinetics of either medicinal product. Irbesartan and hydrochlorothiazide are orally active agents and do not require biotransformation for their activity. Following oral administration of irbesartan/hydrochlorothiazide, the absolute oral bioavailability is 60-80 % and 50-80 % for irbesartan and hydrochlorothiazide, respectively. Food does not affect the bioavailability of irbesartan/hydrochlorothiazide. Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide. Plasma protein binding of irbesartan is approximately 96 %, with negligible binding to cellular blood components. The volume of distribution for irbesartan is 53-93 litres. MACLEODS PHARMACEUTICALS LTD. Hydrochlorothiazide is 68 % protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg. Irbesartan exhibits linear and dose proportional pharmacokinetics .The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively. The terminal elimination half-life of irbesartan is 11-15 hours. Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen. Limited accumulation of irbesartan (< 20 %) is obser Lue koko asiakirja