国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
Telmisartan, hydrochlorothiazide
Actavis Group hf
C09DA07
telmisartan, hydrochlorothiazide
Agents acting on the renin-angiotensin system, Angiotensin II antagonists and diuretics
Essential Hypertension
Treatment of essential hypertension.Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Revision: 17
Authorised
2013-03-13
73 B. PACKAGE LEAFLET 74 PACKAGE LEAFLET: INFORMATION FOR THE USER ACTELSAR HCT 40 MG/12.5 MG TABLETS telmisartan/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. See section 4. WHAT IS IN THIS LEAFLET 1. What Actelsar HCT is and what it is used for 2. What you need to know before you take Actelsar HCT 3. How to take Actelsar HCT 4. Possible side effects 5. How to store Actelsar HCT 6. Contents of the pack and other information 1. WHAT ACTELSAR HCT IS AND WHAT IT IS USED FOR Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure. - Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. - Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure. High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range. ACTELSAR HCT IS USED TO treat high blood pr 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Actelsar HCT 40 mg/12.5 mg tablets Actelsar HCT 80 mg/12.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Actelsar HCT 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. Actelsar HCT 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Actelsar HCT 40 mg/12.5 mg tablets White or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets marked with “TH” on one side. Actelsar HCT 80 mg/12.5 mg tablets White or almost white, 9.0 x 17.0 mm capsule-shaped tablets marked with “TH 12.5” on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Actelsar HCT fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Actelsar HCT should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. - Actelsar HCT 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg - Actelsar HCT 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg Actelsar HCT is also available at the dose strength 80 mg/25 mg 3 _Special populations: _ _Patients with renal impairment _ Periodic monitoring of renal function is advised (see section 4.4). _Patients with hepatic impairment _ In patients with mild to moderate hepatic impairment the po 阅读完整的文件