Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Enalapril maleate
Waymade Healthcare Plc
C09AA02
Enalapril maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ENALAPRIL MALEATE TABLETS 2.5, 5, 10 AND 20MG 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. WHAT IS IN THIS LEAFLET 1. What Enalapril Tablets are and what they are used for 2. What you need to know before you take Enalapril Tablets 3. How to take Enalapril Tablets 4. Possible side effects 5. How to store Enalapril Tablets 6. Contents of the pack and other information 1. WHAT ENALAPRIL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Enalapril Tablets. The active ingredient, enalapril, belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors, which work by widening your blood vessels. This helps reduce blood pressure and also relieves the workload of the heart in patients with heart failure and following a heart attack. Enalapril Tablets are useful in the treatment of: high blood pressure (hypertension). heart failure. This means that your heart is not working as well as it used to in order to pump blood around your body, leading to tiredness after light exercise, breathlessness and swelling of the ankles and legs. heart muscle damage. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL TABLETS DO NOT TAKE ENALAPRIL TABLETS IF you are allergic to enalapril, a similar medicine or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. you are more than 3 months Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Enalapril maleate 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of Enalapril maleate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White circular biplanar uncoated tablets with 10 embossed on one face and score line on the other. 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 The absorption of Enalapril Tablets is not affected by food. The dose should be individualised according to patient profile (see 4.4) and blood pressure response. Hypertension Enalapril can be used alone or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). 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 for 2-3 days prior to initiation of therapy with enalapril. Renal function and serum potassium should be monitored. The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily. Baca dokumen lengkap