CANDESARTAN GH candesartan cilexetil 8 mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

candesartan cilexetil

Διαθέσιμο από:

Lupin Australia Pty Limited

INN (Διεθνής Όνομα):

Candesartan cilexetil

Καθεστώς αδειοδότησης:

Registered

Φύλλο οδηγιών χρήσης

CONSUMER MEDICINE INFORMATION
CANDESARTAN GH
(CANDESARTAN CILEXETIL) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Candesartan GH.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking
Candesartan GH against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to
read it again.
WHAT CANDESARTAN GH
IS USED FOR
Candesartan GH belongs to a
group of medicines known as
angiotensin-II receptor
antagonists.
Candesartan GH is used to
treat:
•
high blood pressure, also
called hypertension;
•
heart failure, usually in
combination with other
medicines.
_HYPERTENSION _
Everyone has blood pressure.
This pressure helps get your
blood all around your body. Your
blood pressure may be different
at different times of the day,
depending on how busy or
worried you are. You have
hypertension (high blood
pressure) which means your
blood pressure stays high, even
when you are calm and relaxed.
Regular blood pressure checks
are the only way of knowing that
you have hypertension. There
are no symptoms of
hypertension and you may feel
fine. If hypertension is not
treated, serious health problems
such as stroke or heart attack
and heart or kidney failure may
occur.
Candesartan GH lowers blood
pressure by dilating (expanding)
small blood vessels from the
heart, letting the blood be
pumped around the body more
easily.
_HEART FAILURE _
Heart failure means that the
heart muscle cannot pump blood
strongly enough to supply all the
blood needed throughout the
body. Heart failure is not the
same as heart attack and does
not mean that the heart stops
working.
Heart failure may start off with
no symptoms, but as the
condition progresses, patients
may feel short of breath or may
get tired easily after light
physical activ

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION – CANDESARTAN GH
(CANDESARTAN CILEXETIL) UNCOATED TABLET
1
NAME OF THE MEDICINE
Candesartan cilexetil.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Candesartan GH tablets come in four strengths and contain 4 mg, 8 mg,
16 mg or 32 mg of candesartan
cilexetil.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CANDESARTAN GH Candesartan cilexetil 4 mg tablet;
Light pink, mottled, round biconvex uncoated tablet with ‘291’ on
one side and a scoreline on the other
side.
CANDESARTAN GH Candesartan cilexetil 8 mg tablet;
Light pink, mottled, round biconvex uncoated tablet with ‘292’ on
one side and a scoreline on the other
side.
CANDESARTAN GH Candesartan cilexetil 16 mg tablet;
Light pink, mottled, round biconvex uncoated tablet with ‘L293’ on
one side and a scoreline on the other
side.
CANDESARTAN GH Candesartan cilexetil 32 mg tablet;
Light pink, mottled, round biconvex uncoated tablet with ‘L294’ on
one side and a scoreline on the other
side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment of patients with heart failure and impaired left ventricular
systolic function (left ventricular
ejection fraction ≤ 40%) as add-on therapy to ACE inhibitors or when
ACE inhibitors are not tolerated.
4.2 DOSE AND METHOD OF ADMINISTRATION
Candesartan GH should be taken once daily with or without food.
Candesartan GH v6.0
Page 2 of 17
(candesartan cilexetil) uncoated tablet
PAEDIATRICS
The safety and efficacy of candesartan have not been established in
children.
HYPERTENSION
The recommended maintenance dose of candesartan is 8 mg or 16 mg once
daily. The maximal
antihypertensive effect is attained within 4 weeks following
initiation of treatment. For those patients
who start on 8 mg and require further blood pressure reduction, a dose
increase to 16 mg is
recommended. An initial dose of 16 mg is also well tolerated. Some
patients may receive an ad