AKILEN 80MG FILM-COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

VERAPAMIL HYDROCHLORIDE

Boleh didapati daripada:

KOMEDIC SDN BHD

INN (Nama Antarabangsa):

VERAPAMIL HYDROCHLORIDE

Unit dalam pakej:

500 Tablets

Dikeluarkan oleh:

MEDOCHEMIE LTD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
AKILEN
_Verapamil (as hydrochloride) 40mg, 80mg _
WHAT IS IN THIS LEAFLET
1.
What AKILEN is used for
2.
How it works
3.
Before you use AKILEN
4.
How to use AKILEN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of AKILEN
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT AKILEN IS USED FOR
AKILEN
is
used
to
treat
and/or
prevent:
-
High blood pressure
-
Some types of irregular heart beats
-
Attacks of chest pain
HOW AKILEN WORKS
AKILEN contains verapamil, which
belongs to a group of medicines called
calcium
channel
blockers.
It
allows
greater
blood
flow
by
opening
out
arteries.
BEFORE YOU USE AKILEN
_- When you must not use it _
Do not take AKILEN if you:
-
are
allergic
(hypersensitive)
to
verapamil or any other ingredient
of the tablet
-
are pregnant or planning to become
pregnant
-
are breast-feeding
-
have very low blood pressure
-
have another heart condition that
the one you are taking AKILEN.
Take AKILEN only if the doctor
recommends you so.
_- Before you start to use it _
Talk
to
your
doctor
before
taking
AKILEN if you:
-
have liver problems
-
have kidney problems
-
epilepsy
PREGNANCY AND BREAST-FEEDING
Verapamil should not be administered
during
the
first
trimester
of
the
pregnancy. Please consult your doctor
or
pharmacist
if
you
are
pregnant,
planning
for
pregnancy
or
breast-
feeding before using any medicine.
_- Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
You should also tell your doctor if you
are taking any of the following:
-
medicine to lower blood pressure,
especially
a
type
called
beta-
blockers (these include atenolol,
propranolol and metoprolol)
-
medicine
to
prevent
transplant
rejection called cyclopsorin
-
medicine
used
to
treat
epilepsy
called carbamazepine, phenytoin
or phenobarbitone
-
an
antibiotic,
usually
to
treat
tuberculosis, called rifamp

Ciri produk

1
AKILEN
1.
NAME OF THE MEDICINAL PRODUCT
Akilen 40 mg film-coated tablets
Akilen 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated tablets containing either 40mg or 80mg of verapamil
hydrochloride.
Excipients with known effect:
Lactose
(only
for
Akilen 40mg
film-coated
tablets). Each 40mg film-coated
tablet
contains
40mg
lactose
monohydrate.
Sunset yellow (only for Akilen 80mg film-coated tablets). Each 80mg
film-coated tablet contains 0.197mg sunset
yellow
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Akilen 40mg film-coated tablets: very pale green, round, convex
film-coated tablets, with diameter of core 7.0mm.
Akilen 80mg film-coated tablets: orange, round, biconvex, with
diameter of core 7.0mm.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Prophylaxis and/or treatment of

Angina pectoris, including Prinzmetal's angina (coronary spasm,
vasospastic angina).

Supraventricular tachycardias such as paroxysmal supraventricular
tachycardia, atrial fibrillation/flutter with
rapid ventricular response (except in Wolff-Parkinson-White syndrome,
see section 4.4)

Mild to moderate essential hypertension.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_ANGINA: _
_Adults:_ 120mg is recommended, 80mg can be completely satisfactory in
some patients with angina of effort. Less
than 120mg is not likely to be effective in angina at rest and variant
angina.
_SUPRAVENTRICULAR TACHYCARDIAS:_ 40 – 120mg according to the
severity of the condition
_Children up to 2 years:_ 40mg tablet 2 – 3 times a day
_2 years and above:_ 1 – 3 40mg tablets 2 – 3 times a day,
according to age and effectiveness
_HYPERTENSION: _
_Adults:_ the usual dose range is 80 – 160mg. The dose should be
increased from 80mg at weekly intervals according
to response, either alone or in conjunction with another
antihypertensive therapy. A further reduction in blood
pressure may be obtained by combining verapamil hydrochloride with
other antihypertensive agents e.g