APO-CANDESARTAN candesartan cilexetil 8 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
10-09-2021
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
candesartan cilexetil, Quantity: 8 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Candesartan cilexetil
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: macrogol 8000; lactose monohydrate; carmellose calcium; magnesium stearate; maize starch; hyprolose; iron oxide red
Administration route:
Oral
Units in package:
7, 28, 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 292 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:
2013-07-02
Patient Information leaflet
APO-CANDESARTAN TABLETS
1
APO-CANDESARTAN
TABLETS
_Candesartan cilexetil _
_CONSUMER MEDICINE INFORMATION _
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about candesartan. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Candesartan. It contains the active
ingredient candesartan cilexetil.
It is used to treat:
•
high blood pressure, also called
hypertension.
•
heart failure - increase survival,
reduce hospitalisation and
improve symptoms. It is used in
combination with other medicines
to treat your condition.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_HOW IT WORKS _
Candesartan is a type of medicine
called an angiotensin II receptor
inhibitor (or antagonist).
HYPERTENSION:
All people have blood pressure. This
pressure helps to push blood all
around your body. Your blood
pressure changes during the day,
d
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION-
APO-CANDESARTAN TABLETS (CANDESARTAN)
1
NAME OF THE MEDICINE
Candesartan cilexetil
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each candesartan tablet contains candesartan cilexetil as the active
ingredient. In addition,
each candesartan tablet contains the following inactive ingredients:
lactose, carmellose
calcium, maize starch, macrogol 8000, hydroxypropylcellulose,
magnesium stearate and
Pigment Blend PB-24880 Pink (ARTG 108327) which contains iron oxide
red and lactose. The
tablets are gluten free.
4 MG TABLETS
Light pink, mottled, round biconvex uncoated tablet with ‘291’ on
one side and a scoreline on
the other side.
8 MG TABLETS
Light pink, mottled, round biconvex uncoated tablet with ‘292’ on
one side and a scoreline on
the other side.
16 MG TABLETS
Light pink, mottled, round biconvex uncoated tablet with ‘L293’ on
one side and a scoreline on
the other side.
32 MG TABLETS
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
APO- Candesartan is indicated for the treatment of:
•
Hypertension.
•
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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Candesartan 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, combi
Read the complete document
