ADESAN candesartan cilexetil 32 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

candesartan cilexetil, Quantity: 32 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Candesartan cilexetil

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: hyprolose; iron oxide red; glyceryl monostearate; magnesium stearate; maize starch; carmellose calcium; lactose monohydrate

Administration route:

Oral

Units in package:

7, 28, 30

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 less than or equal to 40 percent, as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

Product summary:

Visual Identification: A mottled pink, round, biconvex tablet debossed with "MC" above the breakline and "32" below the breakline on one side of the tablet and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-02-20

Patient Information leaflet

ADESAN
®
_candesartan cilexetil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ADESAN.
It does not contain all 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 ADESAN against
the benefits expected 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 ADESAN IS USED
FOR
ADESAN is a type of medicine
called an angiotensin II receptor
antagonist (or blocker).
ADESAN is used to treat high blood
pressure, also called hypertension.
ADESAN is also used to treat heart
failure. It is used in combination with
other medicines to treat your
condition.
HYPERTENSION:
All people have 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.
ADESAN 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 activity such as
walking. Some patients

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ADESAN
_Candesartan cilexetil tablets _
1
NAME OF THE MEDICINE
Candesartan cilexetil
2
&
3
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICAL FORM
Adesan 4 mg:
Contains 4 mg of candesartan cilexetil as the active ingredient.
A white to off white round, biconvex tablet debossed with M on left
side of the
breakline and C on the right side of the breakline on one side of the
tablet and 24
on the other side.
Adesan 8 mg:
Contains 8 mg of candesartan cilexetil as the active ingredient.
A mottled pink, round, biconvex tablet debossed
with
M
on
left
side
of
the
breakline and C on right side of the breakline on one side of the
tablet and 25 on
the other side.
Adesan 16 mg:
Contains 16 mg of candesartan cilexetil as the active ingredient.
A mottled pink, round, biconvex tablet debossed with M on left side of
the breakline
and C on right side of the breakline on one side of the tablet and 31
on the other
side.
Adesan 32 mg:
Contains 32 mg of candesartan cilexetil as the active ingredient.
A mottled pink, round, biconvex tablet debossed with MC above the
breakline and
32 below the break line on one side of the tablet and plain on the
other side.
ADESAN also contains sugars (as lactose).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
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 should be taken once daily with or without food.
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 re