দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
ENALAPRIL MALEATE
Stada Arzneimittel AG
ENALAPRIL MALEATE
10 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2012-08-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Enapril Stada 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of enalapril maleate. Excipients: Contains Lactose Monohydrate 124.6mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, convex 'snap tab' tablets, scorded on one side, red-brown in colour with individual white spots. The tablet can be divided into equal halves. 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%). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The absorption of Enapril Stada 2.5mg/5mg/10mg/20mg tablets is not affected by food. The dose should be individualized according to patient profile (see 4.4 Special warnings and special precautions for use) 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). Enapril Stada 2.5mg/5mg/10mg/20mg 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 enapril. A starting dose সম্পূর্ণ নথি পড়ুন