Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
FOSINOPRIL SODIUM
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C09AA09
FOSINOPRIL SODIUM 10 mg
TABLET
FOSINOPRIL SODIUM 10 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2013-01-04
PACKAGE LEAFLET: INFORMATION FOR THE USER FOSINOPRIL AUROBINDO 10 MG TABLETS FOSINOPRIL AUROBINDO 20 MG TABLETS Fosinopril sodium 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT ISIN THIS LEAFLET : 1. What Fosinopril Aurobindo is and what it is used for 2. What you need to know before you take Fosinopril Aurobindo 3. How to take Fosinopril Aurobindo 4. Possible side effects 5. How to store Fosinopril Aurobindo 6. Contents of the pack and other information 1. WHAT FOSINOPRIL SODIUM AUROBINDO IS AND WHAT IT IS USED FOR Fosinopril belongs to a group of medicines known as ACE (angiotensin converting enzyme) - inhibitors. Fosinopril binds to the ACE in the body, thereby inhibiting the formation of angiotensin II, a substance which raises the blood pressure. Angiotensin II also has a vasoconstricting effect which narrows the blood vessels. By inhibiting this substance, there is a decrease in pressure inside the blood vessels and heart function can be improved. Fosinopril Aurobindo is prescribed if you have high blood pressure, or if the heart is not working sufficiently, this is known as "heart failure". 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL SODIUM AUROBINDO DO NOT TAKE FOSINOPRIL AUROBINDO • If you are allergic to fosinopril sodium or any of the other ingredients of this medicine (listed in section 6) or to other angiotensin-converting enzyme (ACE) inhibitors. • If you have ever experienced hypersensitivity reactions in the past, such as skin reactions and sudden fluid accumulation in the skin and muc Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fosinopril Aurobindo 10 mg tablets Fosinopril Aurobindo 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fosinopril Aurobindo 10 mg tablet contains: 10 mg Fosinopril sodium. Excipient with known effect: Each tablet contains 68 mg of lactose. Each Fosinopril Aurobindo 20 mg tablet contains: 20 mg Fosinopril sodium. Excipient with known effect: Each tablet contains 136 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet _ _ _Fosinopril Aurobindo 10 mg tablets:_ White to off-white, flat, capsule-shaped, uncoated tablets, with a scoreline with notched sides on both sides, debossed on one side of the tablet with 'X' and '77 ' on either side of the scoreline, and plain on the other side The tablets can be divided into equal doses. _ _ _Fosinopril Aurobindo 20 mg tablets: _ White to off white, round, biconvex, uncoated tablets with an "X" on one side and "84" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Treatment of symptomatic heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Fosinopril sodium should be administered orally in a single daily dose. As with all other medicinal products taken once daily, it should be taken at approximately the same time each day. The absorption of fosinopril sodium is not affected by food. The usual initial 10 mg dose has not been studied in patients with severe heart failure NYHA IV and in patients over 75 years treated for heart failure (see section 4.4). In patients who are at particular risk of hypotension (since the renine-angiotensin-aldosteron system has been activated, See section 4.4), such as patients with severe cardiac heart failure (NYHA IV), patients over 75 years treated for heart failure, patients with severe renal and /or severe hepatic impairment, and patients treated with diuretics, it is however recommended to initiate the treatment with a reduced (5 mg) dose. The maintainance do Lesen Sie das vollständige Dokument