Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Enalapril maleate
IVAX Pharmaceuticals UK 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 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 The name of this medicine is Enalapril Maleate 10mg Tablets or Enalapril Maleate 20mg Tablets referred to as Enalapril throughout this leaflet. Enalapril maleate belongs to a group of medicines called ACE (angiotensin converting enzyme) inhibitors which work by widening your blood vessels. This makes it easier for your heart to pump blood through them and helps to reduce high blood pressure (hypertension). If you have heart failure Enalapril will help your heart to work better. Enalapril has been prescribed for you for one of the following: High blood pressure A heart condition sometimes referred to as “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. Enalapril may prevent your heart failure with symptoms, from getting worse. Therefore, it may be less likely that you go to hospital for treatment. Enalapril may help prevent your heart from weakening further if you have early stage heart failure with no symptoms or have had a heart attack (that is, to help prevent you from developing heart failure). Enalapril being taken if you have heart failure (with or Прочитайте повний документ
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 Прочитайте повний документ