Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OLMESARTAN MEDOXOMIL
Ascend Laboratories Sdn Bhd
OLMESARTAN MEDOXOMIL
3 x 10 Tablets; 6 X 10 Tablets
Alkem Laboratories Limited
MEPRESIN 20 (OLMESARTAN MEDOXOMIL 20MG TABLET) MEPRESIN 40 (OLMESARTAN MEDOXOMIL 40MG TABLET) Olmesartan Medoxomil 20mg/40mg Tablet 1 _Consumer Medication Information Leaflet (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What MEPRESIN is used for 2. How MEPRESIN works 3. Before you use MEPRESIN 4. How to use MEPRESIN 5. While you are using it 6. Side effects 7. Storage and Disposal of MEPRESIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MEPRESIN IS USED FOR Olmesartan Medoxomil is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition. HOW MEPRESIN_ _WORKS Olmesartan Medoxomil belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Olmesartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. BEFORE YOU USE MEPRESIN_ _ - _When you must not use it_ Do not take MEPRESIN if you: • are allergic to olmesartan medoxomil or to any of the other ingredients of MEPRESIN. • are in the second and third trimesters of pregnancy. • suffer from problems with drainage of the bile from the gallbladder (biliary obstruction). • have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. _Pregnancy and lactation _ Do not take MEPRESIN if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take MEPRESIN if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Before you take MEPRESIN, tell your doctor.if you: • have diarrhoea, vomiting, or you are on a treatment with high doses of diuretics or on a low salt diet • are taking medicinal products that affect the renin-angiotensin-aldosterone system • have kidney proble Lestu allt skjalið
COMPOSITION MEPRESIN 20: Each film coated tablet contains: Olmesartan Medoxomil Ph.Eur .......... 20 mg MEPRESIN 40: Each film coated tablet contains: Olmesartan Medoxomil Ph.Eur .......... 40 mg PRODUCT DESCRIPTION MEPRESIN 20: White to off white coloured, 8.60 mm ± 0.3 mm round shape film coated tablets debossed with OLM on side & 20 on other side. MEPRESIN 40: White to off white coloured, 15.10 ± 0.3 mm x 7.10 mm ± 0.3 mm oval shape film coated tablets debossed with OLM on one side & 40 on other side. PHARMACODYNAMICS Pharmacotherapeutic group: Angiotensin II antagonists Mechanism of action / Pharmacodynamic effects Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor (type AT1) 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 I and II concentrations, and some decrease in plasma aldosterone concentrations. Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a significant role in the pathophysiology of hypertension via the type 1 (AT1) receptor. PHARMACOKINETICS _Absorption and distribution_ Olmesartan medoxomil is a prodrug. It is rapidly converted to the pharmacologically active metabolite, olmesartan, by esterases in the gut mucosa and in portal blood during absorption from the gastrointestinal tract. No intact olmesartan medoxomil or intact side chain medoxomil moiety have been detected in plasma or excreta. The mean absolute bioavailability of olmesartan from a tablet formulation was 25.6%. The mean peak plasma concentration (C ) of olmesartan is reached within about 2 hours after oral dosing with olmesartan max medoxomil, and olmesartan plasma concentrations increase approximately linearly with increasing single oral doses up to about 80 mg.Food had minimal effect on the bioavailability of o Lestu allt skjalið