Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
Azilsartan medoxomil
Takeda Pharma A/S
C09CA09
azilsartan medoxomil
Agents acting on the renin-angiotensin system
Hypertension
Ipreziv is indicated for the treatment of essential hypertension in adults.
Revision: 4
Withdrawn
2011-12-07
51 B. PACKAGE LEAFLET Medicinal product no longer authorised 52 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ IPREZIV 20 MG TABLETS IPREZIV 40 MG TABLETS IPREZIV 80 MG TABLETS azilsartan medoxomil This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Ipreziv is and what it is used for 2. What do you need to know before you take Ipreziv 3. How to take Ipreziv 4. Possible side effects 5. How to store Ipreziv 6. Contents of the pack and other information 1. WHAT IPREZIV IS AND WHAT IT IS USED FOR Ipreziv 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. Ipreziv 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). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IPREZIV DO NOT TAKE IPREZIV IF YOU - are ALLERGIC (hypersensitive) to azilsartan medoxomil or any of the other ingredients of Ipreziv (see section 6). - are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid Ipreziv in ea Прочитайте повний документ
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Ipreziv 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of azilsartan medoxomil (as potassium). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ipreziv is indicated for the treatment of essential hypertension in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose 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 Ipreziv alone, additional blood pressure reduction can be achieved when Ipreziv is coadministered with other antihypertensive medicinal products, including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel blockers (see sections 4.3, 4.4, 4.5 and 5.1). _ _ Special populations _Older people (65 years and over) _ No initial dose adjustment with Ipreziv 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. Medicinal product no longer authorised 3 _Renal impairment _ Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Ipreziv in these patients (see sections Прочитайте повний документ