Candesartan Sandoz 8mg Tablet

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

CANDESARTAN CILEXETIL

Verfügbar ab:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Internationale Bezeichnung):

CANDESARTAN CILEXETIL

Einheiten im Paket:

90 Tablets; 30 Tablets; 60 Tablets

Hergestellt von:

LEK PHARMACEUTICALS D.D.

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP) _
CANDESARTAN SANDOZ TABLET
Candesartan cilexetil (8mg, 16mg and 32mg)
1
WHAT IS IN THIS LEAFLET:
1.
What Candesartan Sandoz is used
for
2.
How Candesartan Sandoz works
3.
Before you use
Candesartan Sandoz
4.
How to use Candesartan Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Candesartan Sandoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CANDESARTAN SANDOZ
IS USED FOR
Candesartan Sandoz 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.
HOW CANDESARTAN SANDOZ
WORKS
Candesartan Sandoz 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.
BEFORE YOU USE
CANDESARTAN SANDOZ
Do not take Candesartan Sandoz 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. Candesartan Sandoz may
cause serious harm or even death to
your baby if used during pregnancy.
-
_When you must not use it _
•
If you are breast-feeding
•
If you are allergic to any of the
ingredients in Candesartan
Sandoz.
•
Important: You should not take
Candesartan Sandoz if you have
had problems in the past when
taking medicines containing
candesartan cilexetil.
Take special care with Candesartan
Sandoz.
-
_Before you start to use it _
Please talk to your doctor or pharmacist
before taking this medicine:
•
If you have any heart, liver or
kidney problems.
•
If you suffer from lactose
intolerance.
•
If you are vomiting or have
diarrhoea.
-
_Taking other medicines _
Please inform your doctor or pharmacist

Fachinformation

1
1.
NAME OF THE MEDICINAL PRODUCT
Candesartan Sandoz 8 mg tablet
Candesartan Sandoz 16 mg tablet
Candesartan Sandoz 32 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CANDESARTAN SANDOZ 8 MG TABLET
Each tablet contains 8 mg of candesartan cilexetil.
Each tablet contains 69.57 mg of lactose monohydrate.
CANDESARTAN SANDOZ 16 MG TABLET
Each tablet contains 16 mg of candesartan cilexetil.
Each tablet contains 139.14 mg of lactose monohydrate.
CANDESARTAN SANDOZ 32 MG TABLET
Each tablet contains 32 mg of candesartan cilexetil.
Each tablet contains 278.27 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
CANDESARTAN SANDOZ 8 MG TABLET
8 mg tablets: pink, mottled, round biconvex tablet, debossed with 8 on
one side and scored on the other side.
CANDESARTAN SANDOZ 16 MG TABLET
16 mg tablets: pink, mottled, round biconvex tablet, debossed with 16
on one side and scored on the other
side.
CANDESARTAN SANDOZ 32 MG TABLET
32 mg tablets: pink, mottled, round biconvex tablet, debossed with 32
on one side and scored on the other
side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 inhibitors are not tolerated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage for Hypertension
Recommended Initial Dose and Usual Maintenance Dose: 8 mg once daily.
The dose may be increased to 16 mg once daily. If blood pressure is
not sufficiently controlled after 4
weeks of treatment with 16 mg once daily, the dose may be further
increased to a maximum of 32 mg once
daily. 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.
_Eld