Kalpiren 20mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ENALAPRIL MALEATE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

C09AA02

INN (International Name):

ENALAPRIL MALEATE 20 mg

Pharmaceutical form:

TABLET

Composition:

ENALAPRIL MALEATE 20 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2006-12-28

Patient Information leaflet

 
©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

Summary of Product characteristics

 
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