Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Irbesartan; Hydrochlorothiazide* Ph. Eur
Pharmaniaga Marketing Sdn Bhd
Irbesartan; Hydrochlorothiazide* Ph. Eur
4 blisters x 7 Tablets
Jubilant Generics Limited
IRBEJUB H _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS 150 MG + 12.5 MG, 300 MG + 12.5 MG, 300 MG + 25 MG 1 WHAT IS IN THIS LEAFLET 1. What Irbejub H is used for 2. How Irbejub H works 3. Before you use Irbejub H 4. How to use Irbejub H 5. While you are using Irbejub H 6. Side effects of Irbejub H 7. Storage and Disposal of Irbejub H 8. Irbejub H Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS IRBEJUB H USED FOR Irbejub H is used to treat high blood pressure when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. HOW IRBEJUB H WORKS Irbejub H 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 increases the amount of water you lose in your urine and so causes a lowering of blood pressure. The two active ingredients in Irbejub H work together to lower blood pressure further than if either was given alone. BEFORE YOU USE IRBEJUB H _ When you must not use it _ Do not take Irbejub H: • if you are allergic (hypersensitive) to irbesartan, or to any of the other ingredients of this medicine. • if you are allergic (hypersensitive) to hydrochlorothiazide, or to any other sulfonamide-derived medicines • if you are more than 3 months pregnant. (It is also better to avoid Irbejub H in early pregnancy – see Pregnancy and Breast-feeding section). • if you have severe liver or kidney problems • if you have difficulty in producing urine • if your doctor det Aqra d-dokument sħiħ
ITEM CODE: 50000003619 SUPERSEDED ITEM CODE: NA PHARMA CODE: 6480 Last modified: 3. January 2023, 11:40 AM FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY ONLY IRBEJUB H IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS 150 MG+12.5 MG, 300 MG+12.5 MG AND 300 MG+25 MG PRODUCT NAME: Irbesartan and Hydrochlorothiazide tablets 150 mg+12.5 mg Irbesartan and Hydrochlorothiazide tablets 300 mg+12.5 mg Irbesartan and Hydrochlorothiazide tablets 300 mg+25 mg NAME AND STRENGTH OF ACTIVE INGREDIENT: EACH FILM-COATED TABLET CONTAINS: Irbesartan Ph. Eur, 150 mg and Hydrochlorothiazide Ph. Eur, 12.5 mg Irbesartan Ph. Eur, 300 mg and Hydrochlorothiazide Ph. Eur, 12.5 mg Irbesartan Ph. Eur, 300 mg and Hydrochlorothiazide Ph. Eur, 25 mg PRODUCT DESCRIPTION: FOR 150 MG+12.5 MG: Peach coloured, biconvex, oval shaped film-coated tablets, debossed with ‘450’ on one side and plain on the other. FOR 300 MG+12.5 MG: Peach coloured, biconvex, oval shaped film-coated tablets, debossed with ‘451’ on one side and plain on the other. FOR 300 MG+25 MG: Dark pink coloured, biconvex, oval shaped film-coated tablets, debossed with ‘452’ on one side and plain on the other. PHARMACODYNAMICS / PHARMACOKINETICS: PHARMACODYNAMICS PHARMACOTHERAPEUTIC GROUP: angiotensin-II antagonists, combinations ATC CODE: C09DA04 Irbesartan and Hydrochlorothiazide tablet is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide. The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in pla Aqra d-dokument sħiħ