Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
aliskiren, amlodipine, hydrochlorothiazide
Novartis Europharm Ltd.
C09XA54
aliskiren, amlodipine, hydrochlorothiazide
Cardiovascular system
Hypertension
Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination.
Revision: 1
Withdrawn
2011-11-22
191 B. PACKAGE LEAFLET Legemidlet er ikke lenger godkjent for salg 192 PACKAGE LEAFLET: INFORMATION FOR THE USER Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide 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. WHAT IS IN THIS LEAFLET 1. What Rasitrio is and what it is used for 2. What you need to know before you take Rasitrio 3. How to take Rasitrio 4. Possible side effects 5. How to store Rasitrio 6. Contents of the pack and other information 1. WHAT RASITRIO IS AND WHAT IT IS USED FOR WHAT RASITRIO IS Rasitrio contains three active substances, called aliskiren, amlodipine and hydrochlorothiazide. All of these substances help to control high blood pressure (hypertension). Aliskiren is a substance that belongs to a group of medicines called renin inhibitors. These reduce the amount of angiotensin II the body can make. Angiotensin II causes blood vessels to tighten, which raises blood pressure. Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure. Amlodipine belongs to a group of medicines known as calcium channel blockers, which help to control high blood pressure. Amlodipine causes blood vessels to dilate and relax; this lowers blood pressure. Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases urine output, which also lowers blood pressure. High blood pressure increases the workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels of the bra Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Legemidlet er ikke lenger godkjent for salg 2 1. NAME OF THE MEDICINAL PRODUCT Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Violet white, ovaloid convex film-coated tablet with bevelled edges, with “YIY” debossed on one side and “NVR” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Rasitrio is one tablet per day. Patients receiving aliskiren, amlodipine and hydrochlorothiazide from separate tablets given concurrently at the same time of the day may be switched to a fixed combination tablet of Rasitrio containing the same component doses. The fixed dose combination should only be used after a stable effect on the monocomponents, given concurrently, has been established after dose titration. Dose should be individualised and adjusted according to the patient’s clinical response. Special populations _Elderly patients aged 65 years and over _ There is evidence of an increased risk of adverse events related to hypotension in patients aged 65 years or older treated with Rasitrio. Therefore, particular caution should be exercised when administering Rasitrio in patients aged 65 years or over. The recommended starting dose of aliskiren in this group of patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients._ _ Legemidlet e Прочетете целия документ