ATACAND PLUS TABLETS 1612.5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

ASTRAZENECA AB

Risalah maklumat

ATACAND PLUS
®
TABLET
_ _
Candesartan cilexetil 16mg
_ _
Hydrochlorothiazide 12.5mg
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What Atacand Plus is used
for
2.
How Atacand Plus works
3.
Before you use Atacand Plus
4.
How to use Atacand Plus
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Atacand Plus
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ATACAND PLUS IS USED FOR
Atacand Plus is used for treating
hypertension (high blood
pressure), where a monotherapy is
not sufficiently effective.
HOW ATACAND PLUS WORKS
Candesartan cilexetil is a type of
medicine called an angiotensin II
receptor antagonist, which by
blocking the effects of the
hormone angiotensin II, causes
relaxation of the blood vessels and
results in a lowering of the blood
pressure.
Hydrochlorothiazide belongs to a
class of drugs called diuretics. Its
effects promote the urinary
excretion of sodium, chloride and
water and results in a lowering of
the blood pressure.
BEFORE YOU USE ATACAND PLUS
Do not take Atacand Plus if you
are pregnant, think you might be
pregnant or considering becoming
pregnant. Atacand Plus may cause
serious harm or even death to your
baby if used during pregnancy (see
Pregnancy section).
_When you must not use it _
•
If you are breast feeding.
•
If you are allergic to any of the
ingredients in Atacand Plus or
to drugs closely related to
hydrochlorothiazide.
•
If you have severe liver
disease.
•
If you have severe kidney
disease.
•
If you have had gout.
•
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 Plus if you have had
problems in the past when taking
medicines containing candesartan
cilexetil or hydrochlorothiazide.
Atacand Plus is not recommended
for children.
_Before you start to use it_
Please talk to your doctor or
pharmacist before taking this
medicine:
•
If you are taki

Ciri produk

ATACAND PLUS
® 16/12.5 MG
_candesartan cilexetil and hydrochlorothiazide _
TABLET
FERTILITY, PREGNANCY AND LACTATION
_Use in pregnancy _
The use of Atacand Plus is contraindicated during pregnancy (see
‘Contraindications’). Patients
receiving Atacand Plus should be made aware of that before
contemplating a possibility of
becoming pregnant so that they can discuss appropriate options with
their treating physician.
When pregnancy is diagnosed, treatment with Atacand Plus must be
stopped immediately and if
appropriate, alternative therapy should be started.
When used in pregnancy, drugs that act directly on the
renin-angiotensin system can cause foetal
and neonatal injury and death. Exposure to angiotensin II receptor
antagonist therapy is known to
induce
human
fetotoxicity
(decreased
renal
function,
oligohydramnios,
skull
ossification
retardation) and neonatal toxicity (renal failure, hypotension,
hyperkalaemia)
(see ‘Preclinical
safety data’)
.
There is limited experience with hydrochlorothiazide during pregnancy,
especially during the first
trimester. Animal studies are insufficient. Hydrochlorothiazide
crosses the placenta. Based on the
pharmacological mechanism of action of hydrochlorothiazide, its use
during pregnancy may
compromise foeto-placental perfusion and may cause foetal and neonatal
effects like icterus,
disturbance of electrolyte balance and thrombocytopenia.
_ _
_Use in lactation_
It is not known whether candesartan is excreted in human milk.
However, candesartan is excreted
in the milk of lactating rats. Hydrochlorothiazide passes int
o mother’s milk.
Because of the potential for adverse effects on the nursing infant,
breast feeding should be
discontinued if the use of Atacand Plus is considered essential (see
‘
Contraindications
’
).
COMPOSITION
One tablet contains 16 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
PHARMACEUTICAL FORM
Tablets.
Atacand Plus 16 mg/12.5 mg are peach, oval, biconvex tablets with a
score on both sides and
engraved A/CS.
THERAPEUTIC INDICATIONS