Страна: Мальта
Язык: английский
Источник: Medicines Authority
HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C09DA01
HYDROCHLOROTHIAZIDE 25 mg LOSARTAN POTASSIUM 100 mg
FILM-COATED TABLET
HYDROCHLOROTHIAZIDE 25 mg LOSARTAN POTASSIUM 100 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2013-08-07
Package leaflet: Information for the user LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO 50 MG/12.5 MG FILM-COATED TABLETS LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO 100 MG/12.5 MG FILM-COATED TABLETS LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO 100 MG/25 MG FILM-COATED TABLETS losartan potassium and 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 Losartan/Hydrochlorothiazide Aurobindo is and what it is used for 2. What you need to know before you take Losartan/Hydrochlorothiazide Aurobindo 3. How to take Losartan/Hydrochlorothiazide Aurobindo 4. Possible side effects 5. How to store Losartan/Hydrochlorothiazide Aurobindo 6. Contents of the pack and other information 1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO IS AND WHAT IT IS USED FOR Losartan/Hydrochlorothiazide Aurobindo is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. Losartan/Hydrochlorothiazide Aurobindo is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE AUROBIN Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide Aurobindo 50 mg/12.5 mg film-coated tablets Losartan/Hydrochlorothiazide Aurobindo 100 mg/12.5 mg film-coated tablets Losartan/Hydrochlorothiazide Aurobindo 100 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Losartan/Hydrochlorothiazide Aurobindo 50 mg/12.5 mg _ Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients. Excipient with known effect : Each tablet contains 111 mg lactose monohydrate. _Losartan/Hydrochlorothiazide Aurobindo 100 mg/12.5 mg _ Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients. Excipient with known effect : Each tablet contains 222 mg lactose monohydrate. _Losartan/Hydrochlorothiazide Aurobindo 100 mg/25 mg _ Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients. Excipient with known effect : Each tablet contains 222 mg lactose monohydrate. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. _Losartan/Hydrochlorothiazide Aurobindo 50 mg/12.5 mg _ Yellow coloured, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘48’ on the other side. The size is 11.5 mm X 6.5 mm. _Losartan/Hydrochlorothiazide Aurobindo 100 mg/12.5 mg _ White, Oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘F’ on one side and ‘74’ on the other side. The size is 17.1 mm X 7.3 mm. _Losartan/Hydrochlorothiazide Aurobindo 100 mg/25 mg _ Yellow coloured, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘49’ on the other side. The size is 17.1 mm X 7.3 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losartan/Hydrochlorothiazide Aurobindo is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losa Прочитать полный документ