Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Enalapril maleate
Phoenix Healthcare Distribution Ltd
C09AA02
Enalapril maleate
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
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 These tablets contain enalapril maleate. Enalapril belongs to a group of medicines known as ‘ACE inhibitors’, which work by widening your blood vessels. They are used to treat: • High blood pressure. • Heart failure (symptoms of which include tiredness after light exercise, breathlessness and swelling of your ankles and legs). They are also used to prevent heart failure and heart attacks in people who have heart problems but have no symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL TABLETS DO NOT TAKE ENALAPRIL TABLETS: • if you are allergic to enalapril or any of the other ingredients of this medicine (listed in section 6) • if you have ever had an allergic reaction to a type of medicine similar to this medicine called an ACE inhibitor • if you have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited • if you are more than 3 months pregnant. (It is also better to avoid Enalapril in early pregnancy - see pregnancy section) • if you have diabetes or impaired kidney function and you are tre Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Enalapril Maleate 20mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg Enalapril maleate. Excipient: each tablet contains 110.933 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White to off-white round flat bevelled edged tablets marked with “20” on one side and break line on the other. 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 Food does not interfere with the absorption of enalapril. The dose should be individualized 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 is 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. Heart Διαβάστε το πλήρες έγγραφο