Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Telmisartan; Hydrochlorothiazide
Boehringer Ingelheim Ltd
C09DA07
Telmisartan; Hydrochlorothiazide
40mg ; 12.5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5012816030053
PACKAGE LEAFLET: INFORMATION FOR THE USER MICARDISPLUS ® 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 MicardisPlus is and what it is used for 2. What you need to know before you take MicardisPlus 3. How to take MicardisPlus 4. Possible side effects 5. How to store MicardisPlus 6. Contents of the pack and other information 1. WHAT MICARDISPLUS IS AND WHAT IT IS USED FOR MicardisPlus 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. MICARDISPLUS IS USED TO treat high blood pressure (essential hyper Les hele dokumentet
OBJECT 1 MICARDISPLUS 40 MG/12.5 MG TABLETS Summary of Product Characteristics Updated 30-May-2017 | Boehringer Ingelheim Limited 1. Name of the medicinal product MicardisPlus 40 mg/12.5 mg tablets MicardisPlus 80 mg/12.5 mg tablets 2. Qualitative and quantitative composition MicardisPlus 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. MicardisPlus 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Excipients with known effect Each 40 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 169 mg sorbitol (E420). Each 80 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 338 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. MicardisPlus 40 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 5.2 mm engraved with the company logo and the code 'H4'. MicardisPlus 80 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 6.2 mm engraved with the company logo and the code 'H8'. 4. Clinical particulars 4.1 Therapeutic indications Treatment of essential hypertension. MicardisPlus 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 MicardisPlus 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. • MicardisPlus 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Micardis 40 mg • MicardisPlus 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Micardis 8 Les hele dokumentet