देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
ENALAPRIL MALEATE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
C09AA02
ENALAPRIL MALEATE 20 mg
TABLET
ENALAPRIL MALEATE 20 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2006-12-28
©MEDOCHEMIE LTD 1 PATIENT INFORMATION LEAFLET FOR “KALPIREN” TABLETS PLEASE READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. KEEP THIS LEAFLET IN A SAFE PLACE; YOU MAY WANT TO READ IT AGAIN. THIS LEAFLET ONLY CONTAINS A SUMMARY OF THE INFORMATION AVAILABLE ON YOUR MEDICINE. IF YOU ARE NOT SURE ABOUT ANYTHING, OR YOU HAVE ANY QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR PHARMACIST. YOUR DOCTOR HAS PRESCRIBED THIS MEDICINE FOR YOU. DO NOT GIVE IT TO ANYONE ELSE; IT MAY HARM HIM OR HER, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS. This leaflet tells you what “Kalpiren” is and what it is used for. It tells you about important facts to be considered before taking “Kalpiren”, and tells you how to take “Kalpiren”. The leaflet tells you about possible side effects with “Kalpiren” and how to store your medicine. WHAT YOU SHOULD KNOW ABOUT YOUR MEDICINE The name of your medicine is “Kalpiren”. The tablets contain enalapril maleate, which is the active ingredient. Tablets containing 5 mg (white, round, scored tablets), 10 mg (yellow, round, scored tablets) or 20 mg (peach, round, scored tablets) enalapril maleate are available. The tablets also contain lactose, microcrystalline cellulose, starch, sodium croscarmellose, colloidal anhydrous silica, talk and magnesium stearate. Also, the 10 mg tablets (yellow tablets) contains tartrazine lake (E102) as colouring agent and the 20 mg tablets (peach tablets) contains sunset yellow Lake (E110) as colouring agent. The tablets are supplied in aluminium foil – aluminium foil blisters in packs containing 30 tablets (5 mg and 10 mg) or 20 tablets (20 mg). The marketing authorisation holder and manufacturer of “Kalpiren” are: Medochemie Ltd, p.o box 51409, Limassol, CY-3505, Cyprus ©MEDOCHEMIE LTD 2 WHAT “KALPIREN” IS AND WHAT पूरा दस्तावेज़ पढ़ें
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT “Kalpiren” 5mg “Kalpiren” 20mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg or 20mg of enalapril maleate. For excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets for oral administration. 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 “Kalpiren” is not affected by food. The dose should be individualized according to patient profile (see 4.4 Special Warnings and precautions for use) and blood pressure response _Hypertension _ The initial dose is 5 to maximally 20 mg, depending of the degree of hypertension and the condition of the patient (see below). “Kalpiren” is given once daily. In mild hypertension the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renine-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, the diuretic therapy should be discontinued for two to three days before starting “Kalpiren” therapy. Renal पूरा दस्तावेज़ पढ़ें