Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fosinopril sodium
Viatris UK Healthcare Ltd
C09AA09
Fosinopril sodium
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5016695000756
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOSINOPRIL SODIUM 10 MG TABLETS FOSINOPRIL SODIUM 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 . WHAT IS IN THIS LEAFLET 1. What Fosinopril is and what it is used for 2. What you need to know before you take Fosinopril 3. How to take Fosinopril 4. Possible side effects 5. How to store Fosinopril 6. Contents of the pack and other information. 1. WHAT FOSINOPRIL IS AND WHAT IS IT USED FOR Fosinopril belongs to the class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors that act on the heart and blood vessels. You may have been given Fosinopril to: • lower your blood pressure if it is too high (a condition called hypertension) • help your heart pump blood around your body if you have a condition known as heart failure and are also being treated with diuretics (medicines which help to remove excess fluid from the body). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL DO NOT TAKE FOSINOPRIL: • if you are allergic to fosinopril or any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of face, lips, tongue, hands and feet, or breathing difficulties • if you know you have, or know that someone in your close family has, a condition called angioneurotic oedema where the face, lips, hands or feet swell up, or you have breathing difficulties. If you develop these symptoms during treatment you should stop taking Fosinopril • Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fosinopril Sodium 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg fosinopril sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white capsule shaped tablet with “G” scoreline “G” on one side and “FS” scoreline “20” on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Fosinopril is indicated in adults for the treatment of hypertension. Fosinopril may be used alone as initial therapy or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). The antihypertensive effects of fosinopril and diuretics used concomitantly are approximately additive. Heart Failure Fosinopril is indicated for adults for the treatment of heart failure in combination with a non-potassium sparing diuretic and where appropriate, digitalis. In these patients, fosinopril improves symptoms and exercise tolerance, reduces severity of heart failure and decreases the frequency of hospitalisation for heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hypertensive patients not being treated with diuretics: The dose range is 10 to 40 mg per day administered in a single dose and without regard to meals. The normal starting dose for patients is 10 mg once a day. Dosage may need to be adjusted after approximately 4 weeks according to blood pressure response. No additional blood pressure lowering is achieved with doses greater than 40 mg daily. If blood pressure is not adequately controlled with fosinopril alone, a diuretic can be added. Hypertensive patients being treated with concomitant diuretic therapy: The diuretic should preferably be discontinued for several days prior to beginning therapy with fosinopril to reduce the risk of an excessive hypotensive response. If blood pressure is inadequately controlled a Прочитајте комплетан документ