देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C09BA09
FOSINOPRIL SODIUM 20 mg HYDROCHLOROTHIAZIDE 12.5 mg
TABLET
FOSINOPRIL SODIUM 20 mg HYDROCHLOROTHIAZIDE 12.5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2013-11-27
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER FOSINOPRIL + HYDROCHLOROTHIAZIDE AUROBINDO 20 MG + 12.5 MG TABLETS fosinopril sodium + 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 Fosinopril + Hydrochlorothiazide Aurobindo is and what it is used for 2. What you need to know before you take Fosinopril + Hydrochlorothiazide Aurobindo 3. How to take use Fosinopril + Hydrochlorothiazide Aurobindo 4. Possible side effects 5. How to store Fosinopril + Hydrochlorothiazide Aurobindo 6. Contents of the pack and other information 1. WHAT FOSINOPRIL + HYDROCHLOROTHIAZIDE AUROBINDO IS AND WHAT IT IS USED FOR Fosinopril + Hydrochlorothiazide Aurobindo contains two active substances, fosinopril (and hydrochlorothiazide. Fosinopril belongs to a group of medicines known as angiotensin ACE inhibitors. Fosinopril belongs to the group of medicines called antihypertensives (which are used to lower blood pressure) and is an angiotensin converting enzyme inhibitors (ACE inhibitors). Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics and is an antihypertensive (lowers blood pressure). Fosinopril + Hydrochlorothiazide Aurobindo is used in the treatment of high blood pressure when treatment with fosinopril alone is not effective. It may also be used to replace separate tablets containing 20 mg of fosinopril and 12.5 mg of hydrochlorothiazide 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL + HYDROCHLOROTHIAZIDE AUROBINDO DO NOT TAKE FOSINOPRIL + HYDROCHLOROTHI पूरा दस्तावेज़ पढ़ें
Page 1 of 23 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fosinopril + Hydrochlorothiazide Aurobindo 20 mg + 12.5 mg, Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide. Excipient(s) with known effect: Each tablet contains 238,776 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Peach colored, round, biconvex, uncoated tablets debossed with ‘C 85’ on one side and deep score line on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Fosinopril + Hydrochlorothiazide Aurobindo is indicated for the treatment of essential hypertension in patients who have inadequately responded to the treatment with fosinopril as monotherapy. The fixed dose may also replace the combination of 20 mg fosinopril and 12.5 mg hydrochlorothiazide in patients who have been stabilised on the individual active substances given in the same proportions as separate medications. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Dosage has to be individualized (see sections 4.3, 4.4, 4.5 and 5.1). The fixed dose combination is not suitable for initial therapy. Individual dose titration with the components is recommended. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. Adults: The usual dose is one tablet once daily. Special populations: Renal impairment: In patients with renal impairment (creatinine clearance > 30 mL/min and < 80 ml/min) dose adjustment should be carried out with special care and individual dose titration with the monocomponents is recommended, prior to using the fixed combination. Fosinopril + Hydrochlorothiazide Page 2 of 23 Aurobindo is contra-indicated in patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.3 and 4.4). Hepatic impairment: No initial dose adjustment is necessary in pa पूरा दस्तावेज़ पढ़ें