Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fosinopril sodium
Focus Pharmaceuticals Ltd
C09AA09
Fosinopril sodium
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
FOSINOPRIL SODIUM 20MG TABLETS 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, please ask your doctor, pharmacist or nurse ⋅ 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 IS IN THIS LEAFLET 1. WHAT FOSINOPRIL SODIUM TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL SODIUM TABLETS 3. HOW TO TAKE FOSINOPRIL SODIUM TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FOSINOPRIL SODIUM TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FOSINOPRIL SODIUM TABLETS ARE AND WHAT THEY ARE USED FOR Each tablet contains the active ingredient fosinopril sodium which is used to treat high blood pressure (hypertension) and heart failure. Fosinopril Sodium Tablets belong to a group of medicines called ACE inhibitors and make it easier for the heart to pump blood around the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL SODIUM TABLETS DO NOT TAKE FOSINOPRIL SODIUM TABLETS: ⋅ if you are ALLERGIC (hypersensitive) to fosinopril sodium, other ACE inhibitors or any of the other ingredients of this medicine (listed in section 6) ⋅ if you or a member of your family have PREVIOUSLY HAD SWELLING of the legs, arms, face, mucous membranes or tongue and/or throat (angioedema), with or without ACE inhibitor treatment ⋅ if you have NARROWING OF THE BLOOD VESSELS IN one or both KIDNEYS ⋅ if you are in SHOCK due to heart problems (cardiogenic shock) ⋅ if you are more than 3 months PREGNANT (it is also better to avoid fosinopril sodium in early pregnancy - see ‘Pregnancy and breast feeding' section) ⋅ if you have diabetes or impaired kidney functio Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fosinopril Sodium 20mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg of Fosinopril sodium Excipient(s) with known effect: Each tablet contains 108mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, circular, flat, uncoated 8mm tablets marked ‘FL 20’. 4.1. THERAPEUTIC INDICATIONS Hypertension: Fosinopril Sodium 20mg Tablets are indicated in the treatment of hypertension. Fosinopril Sodium 20mg Tablets may be used alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of Fosinopril Sodium 20mg Tablets and diuretics used concomitantly are approximately additive. Heart Failure: Fosinopril Sodium 20mg Tablets are indicated for the treatment of heart failure in combination with a non-potassium sparing diuretic and where appropriate, digitalis (see section 4.3, 4.4, 4.5, and 5.1). In these patients, Fosinopril Sodium 20mg Tablets improve symptoms and exercise tolerance, reduce severity of heart failure and decrease the frequency of hospitalisation for 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). The maintenance dose should be individualised according to patient profile and blood pressure response (see section 4.4). Hypertension Fosinopril sodium may be used as a monotherapy or in combination with other classes of antihypertensive medicinal products (see sections 4.3, 4.4, 4.5 and 5.1). _Hypertensive patients not being treated with diuretics:_ Starting dose The initia Lesen Sie das vollständige Dokument