Kaparlon-S

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

ENALAPRIL MALEATE

Fáanlegur frá:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

ATC númer:

C09AA02

INN (Alþjóðlegt nafn):

ENALAPRIL MALEATE 5 mg

Lyfjaform:

TABLET

Samsetning:

ENALAPRIL MALEATE 5 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Leyfisstaða:

Withdrawn

Leyfisdagur:

2006-11-22

Upplýsingar fylgiseðill

 
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 

ƒ  Tablets 5mg/tab 
Each tablet contains 5mg of the active ingredient Enalapril
Maleate 

ƒ  Tablets 20mg/tab 
Each tablet contains 20mg of the active ingredient Enalapril
Maleate 

1.5 
DESCRIPTION OF PACKAGING 

ƒ  Tablets 5mg/tab 
Carton Box, which contains an aluminium PVC/PVDC foil blister
(blister 3 x 10), of 30 
white tablets. 

ƒ  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

Vara einkenni

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