Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OLMESARTAN MEDOXOMIL; AMLODIPINE BESILATE
PFIZER (MALAYSIA) SDN. BHD.
OLMESARTAN MEDOXOMIL; AMLODIPINE BESILATE
30tablet Tablets
DAIICHI SANKYO EUROPE GMBH
Pfizer Confidential _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ AZOREN ® FILM COATED TABLETS Olmesartan Medoxomil and Amlodipine (20 mg/5 mg, 40 mg/5 mg, 40 mg/10 mg) 1 WHAT IS IN THIS LEAFLET 1. What Azoren is used for 2. How Azoren works 3. Before you use Azoren 4. How to use Azoren 5. While you are using it 6. Side effects 7. Storage and Disposal of Azoren 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT AZOREN IS USED FOR Azoren is used for the treatment of high blood pressure in patients whose blood pressure is not controlled enough with either olmesartan medoxomil or amlodipine alone. HOW AZOREN WORKS Azoren contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). • Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists” which lower blood pressure by relaxing the blood vessels. • Amlodipine belongs to a group of substances called “calcium channel blockers”. It stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. BEFORE YOU USE AZOREN - _When you must not use it _ Do not take Azoren if you: _ _ • are allergic to olmesartan medoxomil or to amlodipine or dihydropyridines, or any of the other ingredients of Azoren • are in the second or third trimester of pregnancy • have severe liver problems • have bile ducts blockage • have very low blood pressure • are suffering from insufficient blood supply to your tissues (including insufficient blood supply due to heart problems) • if the blood flow from your heart is obstructed (e.g., because of the narrowing of the artery). • suffer from low heart output after a heart attack. • if you have diabetes mellitus or renal impairment and are taking aliskiren containing products _Pregnancy and lactation _ Do not take Azoren if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Azoren if you are breast- feeding as aml Pročitajte cijeli dokument
1 1. NAME OF THE MEDICINAL PRODUCT Azoren 20 mg/5 mg film-coated tablets Azoren 40 mg/5 mg film-coated tablets Azoren 40 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Azoren 20 mg/5 mg film-coated tablets: Each film-coated tablet of Azoren contains 20 mg of Olmesartan medoxomil and 5 mg of Amlodipine (as amlodipine besylate 6.94 mg). Azoren 40 mg/5 mg film-coated tablets: Each film-coated tablet of Azoren contains 40 mg of Olmesartan medoxomil and 5 mg of Amlodipine (as amlodipine besylate 6.94 mg). Azoren 40 mg/10 mg film-coated tablets: Each film-coated tablet of Azoren contains 40 mg of Olmesartan medoxomil and 10 mg of Amlodipine (as amlodipine besylate 13.89 mg). Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Azoren 20 mg/5 mg film-coated tablets: White, round, film-coated tablet with C73 debossed on one side. Azoren 40 mg/5 mg film-coated tablets: Cream, round, film-coated tablet with C75 debossed on one side. Azoren 40 mg/10 mg film-coated tablets: Brownish-red, round, film-coated tablet with C77 debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Azoren is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy (see sections 4.2 and 5.1). Treatment should not be initiated with fixed-dose combination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should not be initiated with this combination. 2 ADULTS The recommended dosage of Azoren is 1 tablet per day. Azoren 20 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil or 5 mg amlodipine alone. Azoren 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by Azoren 20 mg/5 mg. Azoren 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled by Azoren 40 mg/5 mg. A step-wise titration of the dosage of the Pročitajte cijeli dokument