Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
ENALAPRIL MALEATE
Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece
C09AA02
ENALAPRIL MALEATE 20 mg
TABLET
ENALAPRIL MALEATE 20 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2006-11-22
1 INSTRUCTION LEAFLET 1.1 TRADENAME KAPARLON-S Tablets 5mg/tablet and 20mg/tablet 1.2 COMPOSITION Active Ingredient: Enalapril Maleate Excipients: KAPARLON-S TABL. 5MG: Lactose monohydrate, Sodium bicarbonate, Starch Maize, Magnesium Stearate KAPARLON-S TABL. 20MG: Lactose monohydrate, Sodium bicarbonate, Starch Maize, Magnesium Stearate, Iron Oxide Red, Iron Oxide Yellow 1.3 PHARMACEUTICAL FORM Tablets 1.4 STRENGTH Tablets 5mg/tab Each tablet contains 5mg of the active ingredient Enalapril Maleate Tablets 20mg/tab Each tablet contains 20mg of the active ingredient Enalapril Maleate 1.5 DESCRIPTION OF PACKAGING Tablets 5mg/tab Carton Box, which contains an aluminium PVC/PVDC foil blister (blister 3 x 10), of 30 white tablets. Tablets 20mg/tab Carton Box, which contains an aluminium PVC/PVDC foil blister (blister 1 x 10 or 3 x 10), of 30 or 10 beige tablets. 1.6 PHARMACOTHERAPEUTICAL CATEGORY Antihypertensive 1.7 MARKETING AUTHORIZATION HOLDER ANFARM HELLAS S.A. K. Paleologou & 27, Perikleous str. Halandri 152 32 Athens - GREECE 1.8 MANUFACTURER ANFARM HELLAS S.A. Schimatari Viotias 2. INFORMATION ABOUT THE DRUG YOUR PHYSICIAN HAS PRESCRIBED YOU 2 2.1 GENERAL INFORMATION Enalapril maleate is the maleate salt of enalapril, a derivative of two amino-acids, L-alanine and L-proline. Kaparlon-S belongs to a group of medicines known as “angiotensin converting enzyme (ACE) inhibitors”. These medicines work by widening your blood vessels to make it easier for the heart to pump blood through them to all parts of your body. This helps to reduce high blood pressure. Effective inhibition of ACE activity usually occurs 2 to 4 hours after oral administration of an individual dose of enalapril. Onset of antihypertens Baca dokumen lengkap
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT KAPARLON-S 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of KAPARLON-S contains 5 or 20 mg enalapril maleate. 3. PHARMACEUTICAL FORM Tablets. 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 ENALAPRIL MALEATE is not affected by food. The dose should be individualised 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). ENALAPRIL MALEATE 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 MALEATE. Renal function and serum potassium should be monitored_._ The usual maintenance do Baca dokumen lengkap