Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Azilsartan medoxomil
Takeda Pharma A/S
C09CA09
azilsartan medoxomil
Agents acting on the renin-angiotensin system
Hypertension
Edarbi is indicated for the treatment of essential hypertension in adults.
Revision: 10
Authorised
2011-12-07
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER_ _ EDARBI 20 MG TABLETS EDARBI 40 MG TABLETS EDARBI 80 MG TABLETS azilsartan medoxomil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Edarbi is and what it is used for 2. What you need to know before you take Edarbi 3. How to take Edarbi 4. Possible side effects 5. How to store Edarbi 6. Contents of the pack and other information 1. WHAT EDARBI IS AND WHAT IT IS USED FOR Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of medicines called angiotensin II receptor antagonists (AIIRAs). Angiotensin II is a substance which occurs naturally in the body and which causes the blood vessels to tighten, therefore increasing your blood pressure. Edarbi blocks this effect so that the blood vessels relax, which helps lower your blood pressure. This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age). A reduction in your blood pressure will be measureable within 2 weeks of initiation of treatment and the full effect of your dose will be observed by 4 weeks. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDARBI DO NOT TAKE EDARBI IF YOU - are ALLERGIC to azilsartan medoxomil or any of the other ingredients of this medicine (listed in section 6). - are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid this medicine in early pregnancy - see pregnancy section). - have diabetes or impaired kidney function and you are treated with a blood pressure Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Edarbi 20 mg tablets Edarbi 40 mg tablets Edarbi 80 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Edarbi 20 mg tablets Each tablet contains 20 mg of azilsartan medoxomil (as potassium). Edarbi 40 mg tablets Each tablet contains 40 mg of azilsartan medoxomil (as potassium). Edarbi 80 mg tablets Each tablet contains 80 mg of azilsartan medoxomil (as potassium). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Edarbi 20 mg tablets White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other. Edarbi 40 mg tablets White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other. Edarbi 80 mg tablets White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Edarbi is indicated for the treatment of essential hypertension in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose in adults is 40 mg once daily. The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose. Near-maximal antihypertensive effect is evident at 2 weeks, with maximal effects attained by 4 weeks. If blood pressure is not adequately controlled with Edarbi alone, additional blood pressure reduction can be achieved when this treatment is coadministered with other antihypertensive medicinal products, 3 including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel blockers (see sections 4.3, 4.4, 4.5 and 5.1). _ _ _Special populations _ _Elderly (65 years and over) _ No initial dose adjustment with Edarbi is necessary in elderly patients (see section 5.2), although consideration can be given to 20 mg as a starting dose in the very elderly (≥ 75 years), who may be at risk of hypotension. _ Pročitajte cijeli dokument