Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
amlodipine, valsartan, hydrochlorothiazide
Novartis Europharm Ltd.
C09DX01
amlodipine, valsartan, hydrochlorothiazide
Angiotensin II antagonists, plain, Angiotensin II antagonists, combinations
Hypertension
Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Revision: 3
Withdrawn
2009-10-15
146 B. PACKAGE LEAFLET Medicinal product no longer authorised 147 PACKAGE LEAFLET: INFORMATION FOR THE USER IMPRIDA HCT 5 MG/160 MG/12.5 MG FILM-COATED TABLETS amlodipine/valsartan/hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Imprida HCT is and what it is used for 2. Before you take Imprida HCT 3. How to take Imprida HCT 4. Possible side effects 5. How to store Imprida HCT 6. Further information 1. WHAT IMPRIDA HCT IS AND WHAT IT IS USED FOR Imprida HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help to control high blood pressure. Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall, which stops the blood vessels from tightening. Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”. Hydrochlorothiazide increases urine output, which also lowers blood pressure. As a result of all three mechanisms, the blood vessels relax and blood pressure is lowered. Imprida HCT is used to treat high blood pressure in adult patients who are already taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances. 2. BEFORE YOU TAKE IMPRIDA H Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) White, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VCL” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Imprida HCT is one tablet per day, to be taken preferably in the morning. Before switching to Imprida HCT patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Imprida HCT should be based on the doses of the individual components of the combination at the time of switching. The maximum recommended dose of Imprida HCT is 10 mg/320 mg/25 mg. Special populations _Renal impairment _ No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2). Due to the hydrochlorothiazide component, Imprida HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m 2 ) (see sections 4.3, 4.4 and 5.2). _Hepatic impairment _ Due to the valsartan component, Imprida HCT is contraindicated in patients with severe hepatic impairment (see section 4.3). In patients with mild to moderate hepatic impairment without cholestasis, the maxim Прочетете целия документ