Amlibon 5mg Tablets

Country: Malaysia

Language: English

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

Active ingredient:

AMLODIPINE BESILATE

Available from:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (International Name):

AMLODIPINE BESILATE

Units in package:

30Tablet Tablets; 20Tablet Tablets

Manufactured by:

Sandoz Grup Saglik Urunleri Ilaclari San. Ve Tic. A.S.

Patient Information leaflet

AMLIBON
 TABLETS
Amlodipine besilate (5mg, 10mg)
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What is Amlibon used for
2.
How Amlibon works
3.
Before you take Amlibon
4.
How to take Amlibon
5.
While you are using Amlibon
6.
Side effects
7.
Storage and Disposal of
Amlibon
8.
Product Description
9.
Manufacturer and Product
a.
Registration
Holder
10.
Date of Revision
WHAT AMLIBON IS USED FOR
Amlodipine belongs to a group of
medicines called calcium channel
blockers.
Amlodipine
is used to treat:
•
high blood
pressure (hypertension)
•
a certain type of chest pain
called angina, a rare form of
which is
Prin
z
metal’s
or variant
angina.
HOW AMLIBON WORKS
In patients with high blood pressure,
your medicine works by relaxing
blood vessels, so that blood passes
through them more easily.
In patients with angina, Amlodipine
works by improving blood supply to
the heart muscle, which then receives
more oxygen, and as a result, chest
pain is prevented. Amlodipine does
not provide immediate relief of chest
pain from angina.
BEFORE YOU TAKE AMLIBON
-
_When you must not use it _
DO NOT TAKE AMLIBON
•
if you are allergic (hypersensitive)
to amlodipine, or any of the other
ingredients of your medicine listed
in “ PRODUCT DESCRIPTION
section”, or to any other calcium
antagonists. The symptoms include
itching, reddening of the skin or
difficulty in breathing
•
if you have severe low blood
pressure (hypotension)
•
if you have narrowing of the aortic
heart valve (aortic stenosis) or
cardiogenic shock (a condition
where your heart is unable to
supply enough blood to the body)
•
If you suffer from heart failure
after a heart attack
-
_Before you start to use 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
•
kidney disease
•
you are elderly
PREGNANCY AND BREAST-FEEDING
_Pregnancy _
The safety of amlodipine in human
pregn

Summary of Product characteristics

AMLIBON®
1
1.
NAME OF THE MEDICINAL PRODUCT
AMLIBON 5 MG TABLETS
AMLIBON 10 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlibon 5 mg tablets
Each tablet contains 5 mg amlodipine (as amlodipine besilate).
Amlibon 10 mg tablets
Each tablet contains 10 mg amlodipine (as amlodipine besilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Amlibon 5 mg tablets
A white or almost white, oblong tablet with bevelled edges, score line
on one side and marked with a
"5" on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
When the tablet has been divided, one part should be taken straight
after the other.
Amlibon 10 mg tablets
A white or almost white, oblong tablet with bevelled edges, score line
on one side and marked with a
"10" on the other side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypertension _
Amlodipine is indicated for the first line treatment of hypertension
and can be used as the sole agent to
control blood pressure in the majority of patients. Patients not
adequately controlled on a single
antihypertensive agent may benefit from the addition of amlodipine,
which has been used in combination
with a thiazide diuretic, alpha-blocker, beta adrenoceptor blocking
agent, or an angiotensin-converting
enzyme inhibitor.
_Chronic Stable Angina _
Amlodipine is indicated for the first line treatment of myocardial
ischaemia, whether due to fixed obstruction
(stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or
variant angina) of coronary vasculature.
Amlodipine may be used where the clinical presentation suggests a
possible vasospastic/vasoconstrictive
component but where vasospasm/vasoconstriction has not been confirmed.
Amlodipine may be used alone,
as monotherapy, or in combination with other antianginal drugs in
patients with angina that is refractory to
nitrates and/or beta-blockers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral