CANDESARTAN GH candesartan cilexetil 32 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

candesartan cilexetil

Available from:

Generic Health Pty Ltd

INN (International Name):

Candesartan cilexetil

Authorization status:

Registered

Patient Information leaflet

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 is a type of
medicine called an angiotensin-
II receptor antagonist (or
blocker).
Candesartan GH is used to treat
high blood pressure, also called
hypertension;
Candesartan GH is also used to
treat heart failure. It is used
in combination with other
medicines to treat your
condition.
_HYPERTENSION _
Everyone has blood pressure.
This pressure helps to push
blood all around your body. Your
blood pressure changes during
the day, depending on how busy
you are or how you are feeling.
You have hypertension (high
blood pressure) when your
blood pressure stays higher than
is needed, even when you are
calm and relaxed.
Regular blood pressure checks
are the only way of knowing that
you have hypertension. There
are usually 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 sh

Summary of Product characteristics

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 three strengths and contain 4 mg, 16 mg
or 32 mg of candesartan
cilexetil.
List of excipients with known effects: sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Candesartan GH 4 mg tablet: Light pink, mottled, round biconvex
uncoated tablet with ‘291’ on one side
and a scoreline on the other side.
Candesartan GH 16 mg tablet: Light pink, mottled, round biconvex
uncoated tablet with ‘L293’ on one
side and a scoreline on the other side.
Candesartan GH 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.
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 additional
benefit by increasing the dose to 32 mg once daily.
Candesartan GH v7.0
Page 2 of 17
(candesartan cilexetil) uncoated tablet
In patients with less than optimal blood pressure reduction on
candesartan, combination with a thiazide
diuretic is recommended.
Special Patient Populations
_Use in the Elderly _
An initial dose of 8 mg is recommended.
_Hepatic impairment _
Dose titration is recomme