CANDESAN candesartan cilexetil 4 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
23-11-2021
Summary of Product characteristics
(SPC)
12-07-2021
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
candesartan cilexetil, Quantity: 4 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Candesartan cilexetil
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: hyprolose; magnesium stearate; carmellose calcium; macrogol 8000; maize starch; lactose monohydrate; iron oxide red
Administration route:
Oral
Units in package:
30 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of hypertension.,Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction <=40percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Product summary:
Visual Identification: Light pink, round, biconvex uncoated mottled tablets debossed with 291 on one side and break line on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-05-02
Patient Information leaflet
Page 1 of 5
CANDESAN – Consumer Medicine Information
CANDESAN
_contains the active ingredient candesartan cilexetil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
CANDESAN.
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 CANDESAN
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 CANDESAN IS USED FOR
CANDESAN belongs to a group of
medicines known as angiotensin-II
receptor antagonists (or blocker).
CANDESAN is used to treat:
•
high blood pressure, also called
hypertension
•
heart failure, usually in
combination with other
medicines to treat your
condition.
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 you are or
how you are feeling. 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
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.
CANDESAN 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, patie
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Summary of Product characteristics
Candesan PI
1
AUSTRALIAN PI
CANDESAN (CANDESARTAN CILEXETIL) TABLETS
1
NAME OF THE MEDICINE
_Candesartan cilexetil_
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CANDESAN tablets come in four strengths and contain 4 mg, 8 mg, 16 mg
or 32 mg of candesartan
cilexetil.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
_CANDESAN Candesartan cilexetil 4 mg tablet; _
Light pink, mottled, round biconvex uncoated tablet with ‘291’ on
one side and a scoreline on the
other side.
_CANDESAN Candesartan cilexetil 8 mg tablet;_
Light pink, mottled, round biconvex uncoated tablet with ‘292’ on
one side and a scoreline on the
other side.
_CANDESAN Candesartan cilexetil 16 mg tablet;_
Light pink, mottled, round biconvex uncoated tablet with ‘L293’ on
one side and a scoreline on the
other side.
_CANDESAN 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
T
HERAPEUTIC 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.
Candesan PI
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
CANDESAN 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.
In patients with less than optimal blood pressure reduction on
candesartan, combination with a
thiazide diuretic is recommended.
_SPECIAL PATIENT
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