Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Enalapril maleate
Actavis UK Ltd
C09AA02
Enalapril maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
Enalapril Maleate 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). THIS LEAFLET CONTAINS 1. What Enalapril is and what it is used for 2. What you need to know before you take Enalapril 3. How to take Enalapril 4. Possible side effects 5. How to store Enalapril 6. Contents of the pack and other information 1. WHAT ENALAPRIL IS AND WHAT IT IS USED FOR Enalapril belongs to a group of medicines known as angiotensin-converting enzyme inhibitors ('ACE inhibitors'). It works by causing your blood vessels to relax, making it easier for your heart to pump blood around your body. Enalapril can be used to treat: ● high blood pressure (hypertension) ● heart failure, where the heart has difficulty pumping blood around the body Enalapril can also: ● slow down the development of the symptoms of heart failure, which include shortness of breath, swelling of the ankles and feet, and tiredness after only light activity ● slow down the progress of heart failure ● reduce the need for hospitalisation in patients with heart failure or unstable angina ● reduce the risk of heart attacks occurring in patients with unstable angina If you are not sure why you have been prescribed Enalapril, please ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL DO NOT TAKE ENALAPRIL: ● If you are allergic (hypersensitive) to enalapril, other ACE inhibitors (such as captopril, lisinopril or ramapril), or any of the other ingredients of Enalapril Tablets (see section 6). The symptoms of an allergic reaction may include itching, rash, swel Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Enalapril maleate10 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Enalapril 10mg: Each tablet contains 10mg of Enalapril maleate Excipient with known effect: Each tablet contains 98.30mg of lactose monohydrate (see section 4.4). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Enalapril 10mg: White, circular, biplanar, uncoated tablets with “10” embossed on one face and score line on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. The diameter of the tablet is 7.0 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of Hypertension • Treatment of Symptomatic Heart Failure • Prevention of Symptomatic Heart Failure in patients with Asymptomatic Left Ventricular Dysfunction (ejection fraction 35%) (See Section 5.1.) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The absorption of Enalapril tablets is not affected by food. The dose should be individualised according to patient profile (see section 4.4) and blood pressure response. Hypertension The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Enalapril tablets are given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril. A starting dose of 5 mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued fo Baca dokumen lengkap