Actapin 10 mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AMLODIPINE BESILATE

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

AMLODIPINE BESILATE

Unit dalam pakej:

3x10 Tablets; 10x10 Tablets

Dikeluarkan oleh:

PT Actavis Indonesia

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
ACTAPIN TABLET
Amlodipine (5mg, 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Actapin is used for
2.
How Actapin works
3.
Before you use Actapin
4.
How to take Actapin
5.
While you are using Actapin
6.
Side Effects
7.
Storage
and
Disposal
of
Actapin
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ACTAPIN IS USED FOR
Actapin
is
used
to
treat
high
blood
pressure
(hypertension)
and angina pectoris.
HOW ACTAPIN WORKS
Actapin
contains
the
active
substance
amlodipine
which
belongs to a group of medicines
called calcium antagonists.
In
patients
with
high
blood
pressure,
Actapin
works
by
relaxing blood vessels, so that
blood
passes
through
them
easily.
In patients with angina, Actapin
works
by
improving
blood
supply
to
the
heart
muscle
which
then
receives
more
oxygen
and
as
a
result
chest
pain is prevented. Actapin does
not provide immediate relief of
chest pain from angina.
BEFORE YOU USE ACTAPIN
_-When you must not take it_
Do not use Actapin if:
-
you
are
allergic
(hypersensitive) to amlodipine,
or any of the other ingredients
of
Actapin
or
to
any
other
calcium antagonists. This may
be itching, reddening of the skin
or difficulty in breathing.
-
you
have
severe
low
blood
pressure (hypotension).
_-Before you start to take it _
You should inform your doctor
if you have or have had any of
the following conditions:
- Recent heart attack
- Heart failure
-
Severe
increase
in
blood
pressure (hypertensive crisis)
- Liver disease
_-Taking other medicines _
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines
including
medicines
obtained without a prescription.
Actapin
may
affect
or
be
affected
by
other
medicines,
such as:
-
ketoconazole,
itraconazole
(anti-fungal medicines)
-
ritonavir
(so
called
protease
inhibitors used to treat HIV)
- rifampicin (antibiotics)
-
hypericum
perforatum
(St
John’s wort)
- diltiazem (heart medicines)
Actapin may lower your blood
pressure even more if you are

Ciri produk

DESCRIPTION
Actapin 5 mg Tablet : White, round, at, 8 mm tablets with
score on one side and code “AB5” on the other side
Actapin 10 mg Tablet : White, round, at, 10 mm tablets with
score on one side and code “AB10” on the other side
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Dihydropyridine derivative with long half-life. Eases
cardiac work and lowers peripheral resistance. No effect on
supraventricular arrhythmias.
_Mechanism of action:_
Inhibits calcium ion in flux in cardiac muscle cells and
vascular smooth muscle.
_Pharmacodynamic e ffects:_
Vasodilatation with reduction of peripheral vessel resistance
reduces afterload and lowers raised blood pressure. As the
heart rate is unaffected, reduction of cardiac works reduces
cardiac energy consumption and oxygen need. This, and
dilatation of the coronary vessels, explains the effect of
amlodipine in angina pectoris.
In patients with hypertension, a once daily dose gives a
clinically significant reduction of both supine and standing
blood pressure over 24 hours. Due to slow initial effect,
there is little danger of acute hypotension.
Taken daily by patients with angina pectoris, amlodipine
increases total exercise capacity, and increases the time
to an anginal attack and to 1 mm ST segment depression.
Frequency of anginal attacks and use of nitroglycerine are
reduced.
Amlodipine has not been shown to cause metabolic side
effects or changes in plasma lipids. It may be used by
patients with asthma, diabetes and gout. In cardiac failure
patients with NYHA classes II-IV, amlodipine has not been
shown to cause clinical deterioration as measured by
exercise tolerance, left ventricular ejection fraction and
clinical symptomatology. In patients with NYHA classes
III-IV, treated with digitalis, diuretics and ACE inhibitors,
amlodipine has not been shown to lead to an increased risk
of mortality or morbidity, but it associated with increased
incidence of pulmonary oedema.
PHARMACOKINETIC PROPERTIES
_Absorption:_
Peak plasma concentration is reached after 6