ATACAND TABLET 8MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CANDESARTAN CILEXETIL

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

CANDESARTAN CILEXETIL

Unit dalam pakej:

30 Tablet Tablets

Dikeluarkan oleh:

ASTRAZENECA AB

Risalah maklumat

ATACAND
® TABLET
CANDESARTAN CILEXETIL (8 MG & 16 MG)
_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Atacand is used for
2.
How Atacand works
3.
Before you use Atacand
4.
How to use Atacand
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Atacand
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT ATACAND IS USED FOR
Atacand is used for treating high
blood pressure (hypertension) in
adults. It is also taken for treating a
heart condition known as heart
failure in adults where the heart
does not pump your blood around
your body as well as it should.
HOW ATACAND WORKS
Atacand is a type of medicine
called an angiotensin II receptor
antagonist, which by blocking the
effects of the hormone angiotensin
II causes the blood vessels to relax
and widen. This results in a
lowering of your blood pressure,
and makes it easier for your heart
to pump blood to all parts of your
body.
BEFORE YOU USE ATACAND
Do not take Atacand if you are
pregnant, think you might be
pregnant or considering becoming
pregnant. You must tell your
doctor if you think you are (or
might become) pregnant. Atacand
may cause serious harm or even
death to your baby if used during
pregnancy (see heading on
“Pregnancy”).
_ _
-
_When you must not use it _
_ _
•
If you are breast-feeding.
•
If you are allergic to any of the
ingredients in Atacand.
•
If you have diabetes or
impaired kidney function and
you are treated with a blood
pressure medicine containing
aliskiren.
Important: You should not take
Atacand if you have had problems
in the past when taking medicines
containing candesartan cilexetil.
_Use in children _
The safety and efficacy of Atacand
have not been established in
children and adolescents (under 18
years).
-
_Before you start to use it _
Please talk to your doctor or
pharmacist before taking this
medicine:
•
If you are taking other
medicines to help lower your
blood pressure, particularly:
o
diuretics;
o
an ACE

Ciri produk

1
Atacand  8 mg and 16 mg
Candesartan Cilexetil
Tablets
Composition
Each tablet contains 8 mg and 16 mg candesartan cilexetil.
Pharmaceutical form
Atacand 8 mg: A light pink, circular, biconvex tablet, with a score and engraved A/CG on one
side and 008 on the other side.
Atacand 16 mg: A pink, circular, biconvex tablet, with a score and engraved A/CH on one
side and 016 on the other side.
Therapeutic indication
Treatment of hypertension.
Treatment of patients with heart failure and impaired left ventricle systolic function (left
ventricular ejection fraction  40%) as add -on therapy to ACE inhibitors or when ACE
inhibi tors are not tolerated.
Posology and method of administration
Dosage in Hypertension
The recommended initial dose and usual maintenance dose is 8 mg once daily. The dose may
be increased to 16 mg once daily. If blood pressure is not sufficiently control led after 4 weeks
of treatment with 16 mg once daily, the dose may be further increased to a maximum of 32 mg
once daily (see Pharmacodynamic properties). If blood pressure control is not achieved with
this dose, alternative strategies should be considered .
Therapy should be adjusted according to blood pressure response. Most of the
antihypertensive effect is attained within 4 weeks of initiation of treatment.
Use in the elderly
No initial dosage adjustment is necessary in elderly patients.
Use in patie nts with intravascular volume depletion
An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients
with possible volume depletion (see Special warnings and special precautions for use).
Use in impaired renal function
No initial dosage adjustment is necessary in patients with mild to moderate renal impairment
(i.e. creatinine clearance 30-80 ml/min/1.73 m 2 BSA). In patients with severe renal
impairment (i.e. creatinine clearance