Korandil 20 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ENALAPRIL MALEATE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 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:

Authorised

Authorization date:

2006-11-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KORANDIL 5 MG TABLETS
KORANDIL 20 MG TABLETS
Enalapril maleate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Korandil is and what it is used for
2.
What you need to know before you take Korandil
3.
How to take Korandil
4.
Possible side effects
5.
How to store Korandil
6.
Contents of the pack and other information
1.
WHAT KORANDIL IS AND WHAT IT IS USED FOR
Korandil contains an active substance called enalapril maleate. This
belongs to the
group of medicines called ACE inhibitors (angiotensin converting
enzyme inhibitors).
Korandil is used:
-
to treat high blood pressure (hypertension).
-
to treat heart failure (weakening of heart function). It can lower the
need to go to
hospital and can help some patients live longer.
-
to prevent the signs of heart failure. The signs include: shortness of
breath, tiredness
after light physical activity such as walking, or swelling of the
ankles and feet.
This medicine works by widening your blood vessels. This lowers your
blood pressure.
The medicine usually starts to work within an hour and the effect
lasts for at least 24
hours. Some people will require several weeks of treatment until the
best effect on your
blood pressure is seen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KORANDIL
DO NOT TAKE KORANDIL
-
if you are allergic to enalapril maleate or any of the other
ingredients of this medicine
(listed in section 6).
-
if you have ever had an allergic reaction to a type of medici

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Korandil 5 mg tablets
Korandil 20 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Korandil 5 mg tablets: Each tablet contains 5 mg of enalapril maleate.
Korandil 20 mg tablets: Each tablet contains 20 mg of enalapril
maleate.
Excipient(s) with known effect
Korandil 5 mg tablets: This product contains 190.5 mg lactose.
Korandil 20 mg tablets: This product contains 174.5 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Korandil 5 mg tablets: White, scored, normal convex, barrel shaped
tablets with
Remedica’s logo on one side.
Korandil 20 mg tablets: Peach, mottled, normal convex, barrel shaped
tablets scored on
one side with Remedica’s logo on the other side.
The tablet can be divided into equal doses.
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%)
(see
section
5.1
'Pharmacodynamic properties').
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The absorption of Korandil Tablets is not affected by food.
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The dose should be individualised according to patient profile (see
section 4.4) and
blood pressure response.
_Paediatric Population _
There is limited clinical trial experience of the use of enalapril
maleate in hypertensive
paediatric patients (see sections 4.4, 5.1 and 5.2).
_Hypertension _
The initial dose is 5 to maximally 20 mg, depending on the degree of
hypertension and
the condition of the patient (see below). Korandil 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
ex