DILATREND TABLET 25MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CARVEDILOL

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

CARVEDILOL

Unit dalam pakej:

30Tablet Tablets; 100Tablet Tablets

Dikeluarkan oleh:

Delpharm Milano s.r.l

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DILATREND
_®_
_ _
Carvedilol (6.25mg, 25mg)
1
WHAT IS IN THIS LEAFLET
1. What Dilatrend is used for
2. How Dilatrend words
3. Before you take Dilatrend
4. How to take Dilatrend
5. While you are using Dilatrend
6. Side effects
7. After using Dilatrend
8. Product Description
9. Manufacturer
1. WHAT DILATREND IS USED FOR
Dilatrend
contains
a
medicine
called carvedilol. This belongs to a
group of medicines called
‘beta-blockers’.
Dilatrend
is
used
to
treat
the
following:
•
Chronic heart failure.
•
High
blood
pressure
(hypertension).
•
Angina
(chest
pain
or
discomfort that happens when
your heart isn’t getting enough
oxygen).
2. HOW DILATREND WORKS
Dilatrend works by making your
blood vessels relax and widen.
•
This helps to lower your
blood pressure.
•
If you have chronic heart failure,
this
makes
it
easier for
your
heart
to
pump
blood
around
your body.
•
If you have angina, this will
help stop the chest pain.
Your
doctor
may
give
you
other
medicines as well as Dilatrend to help
treat your condition
3. BEFORE YOU TAKE DILATREND
_- When you must not use it _
•
You
are
allergic
(hypersensitive) to carvedilol or
any of the other ingredients of
Dilatrend (listed in Section 8:
Product Description).
•
You
have
ever
had wheezing
due
to
asthma
or
other
lung
diseases.
•
You have severe fluid retention
(swelling of your hands, ankles
and feet) which is being treated
by medicines given into one of
your veins (intravenously).
•
You
have problems
with your
liver.
•
You
have problems
with your
heart (for example ‘heart block’
or slow heart beat). Dilatrend is
not
suitable
for
some
people
with
certain
types
of
heart
problem.
•
You
have
very
low blood
pressure.
•
You have a problem with the
acid
levels
in
your
blood
(‘metabolic acidosis’).
•
You have a growth on one of
your
adrenal
glands
(‘phaeochromocytoma’).
If you are not sure, talk to your
doctor or pharmacist before taking
Dilatrend.
_ _
_ _
_- Before you start to use it _
Chec

Ciri produk

KOEPCKE.PUBLISHING
Leaflet Dilatrend (MY) - FOR REG SUBMISSION ONLY
DRAFT (DATE) 24.06.2022 [11:30 uhr] (4)
COLOURS Black linework
DIMENSIONS 210 x 600 mm
MATERIAL NUMBER 90001869/13
FONT SIZE 7,5 pt
PRODUCT CODE DP xxxxxxxx MY-CP
PACK INSERT FOR MALAYSIA
DILATREND
®
Carvedilol
1. DESCRIPTION
1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Alpha (α) and beta (β) adrenergic receptor blocking agents.
ATC code: C07AG02.
1.2 TYPE OF DOSAGE FORM
Tablets.
The tablet(s) can be divided into equal doses.
1.3 ROUTE OF ADMINISTRATION
Oral.
The tablets are to be swallowed with sufficient fluid.
1.4 STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _carvedilol.
_Tablets_
One 6.25 mg tablet contains 6.25 mg carvedilol.
One 25 mg tablet contains 25 mg carvedilol.
The tablets are uncoated, round, and biconvex with a bilateral
scorelines, and either
yellow (6.25 mg) or white to pale yellowish-beige (25 mg). 2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
_Hypertension_
Dilatrend is indicated for the management of essential hypertension.
It can be used alone or in combination with other antihypertensive
agents
(e.g. calcium channel blockers, diuretics).
_Treatment of angina pectoris _
_Dilatrend is indicated for the treatment of angina pectoris._
_Chronic heart failure_
Unless a contraindication exists, carvedilol is indicated for the
treatment of all
patients with stable and symptomatic, mild, moderate and severe
chronic heart
failure of ischemic or non-ischemic etiology in combination with
standard therapy
(including ACE inhibitors and diuretics with or without digitalis).
2.2 DOSAGE AND ADMINISTRATION
_Hypertension_
The recommended dose for initiation of therapy is 12.5 mg once a day
for the first
two days. Thereafter, the recommended dosage is 25 mg once a day. If
necessary,
the dosage may subsequently be increased at intervals of at least two
weeks to the
recommended maximum daily dose of 50 mg, given once or twice daily.
_Coronary heart disease_
The recomm