देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
PFIZER (MALAYSIA) SDN. BHD.
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
30 mcg/mL
DAIICHI SANKYO EUROPE GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ OLMETEC PLUS ® TABLET Olmesartan Medoxomil and Hydrochlorothiazide (20 mg/12.5 mg, 40 mg/12.5 mg) WHAT IS IN THIS LEAFLET 1. What Olmetec Plus is used for 2. How Olmetec Plus works 3. Before you use Olmetec Plus 4. How to use Olmetec Plus 5. While you are using it 6. Side effects 7. Storage and Disposal of Olmetec Plus 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT OLMETEC PLUS IS USED FOR Olmetec Plus is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan medoxomil or hydrochlorothiazide alone. HOW OLMETEC PLUS WORKS Olmetec Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide. - Olmesartan medoxomil belongs to a group of medicines called angiotensin II-receptor antagonists. It lowers blood pressure by relaxing the blood vessels. - Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (“water tablets”). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. BEFORE YOU USE OLMETEC PLUS - _When you must not use it_ Do not take Olmetec Plus if you: - are allergic to olmesartan medoxomil or hydrochlorothiazide or sulphonamides, or any of the other ingredients of Olmetec Plus - are in the second and third trimesters of pregnancy - have severe kidney problems - suffer from low potassium, low sodium, high calcium or high uric acid levels in the blood - have severe liver problems or have problems with drainage of the bile from the gallbladder or liver (biliary obstruction and cholestasis) _Pregnancy and lactation_ Do not take Olmetec Plus if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Olmetec Plus 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 Olmetec Plus, tell your doctor if you: - have diarrhea, पूरा दस्तावेज़ पढ़ें
1 OLMETEC PLUS (Olmesartan medoxomil and hydrochlorothiazide combination) 1. NAME OF THE MEDICINAL PRODUCT Olmetec Plus 20 mg/12.5 mg film-coated tablets Olmetec Plus 40 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olmetec Plus 20 mg/12.5 mg film-coated tablet: Each film-coated tablet contains 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide. Olmetec Plus 40 mg/12.5 mg film-coated tablet: Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide. Excipients: Olmetec Plus tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Olmetec Plus 20 mg/12.5 mg film-coated tablet: Reddish-yellow, round, film-coated tablet with C22 debossed on one side. Olmetec Plus 40 mg/12.5 mg film-coated tablet: Reddish-yellow, oval, film-coated tablet with C23 debossed on one side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmetec Plus fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or hydrochlorothiazide alone. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS_ Olmetec Plus is used in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or hydrochlorothiazide alone. Olmetec Plus is administered once daily, with or without food. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered, taking into account that the antihypertensive effect of olmesartan medoxomil is maximal by about 8 weeks after initiating therapy (see section 5.1). Dose titration of the individual components is recommended: 2 Olmetec Plus 20 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by the optimal monotherapy olmesartan medoxomil 20 mg alone. Olmetec Plus 40 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil पूरा दस्तावेज़ पढ़ें