CANDESARTAN SANDOZ candesartan cilexetil 16mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

candesartan cilexetil, Quantity: 16 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Candesartan cilexetil

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: magnesium stearate; maize starch; titanium dioxide; carrageenan; iron oxide red; povidone; croscarmellose sodium; lactose monohydrate

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

Product summary:

Visual Identification: Pink, mottled, round, biconvex tablet, debossed with 16 on one side and scored on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-01-05

Patient Information leaflet

CANDESARTAN SANDOZ
®
1
CANDESARTAN SANDOZ
®
_CANDESARTAN CILEXETIL TABLETS _
_Candesartan cilexetil (kan-de-SAR-tan sil-EX-etil) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Candesartan Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CANDESARTAN
SANDOZ IS USED FOR
Candesartan cilexetil belongs to a
group of medicines called
angiotensin II receptor antagonists
(or blocker).
This medicine is used to treat:
•
high blood pressure, also called
hypertension.
•
heart failure. It is used in
combination with other medicines
to treat your condition.
It contains the active ingredient
candesartan cilexetil.
WHEN TAKING THIS MEDICINE FOR
HYPERTENSION, IT WORKS BY
:
Lowering blood pressure by dilating
(expanding) small blood vessels from
the heart, letting the blood be
pumped around the body more easily.
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.
WHEN TAKING THIS MEDICINE FOR
HEART FAILURE, IT WORKS BY:
Widening the blood vessels, so that
the heart does not have to pump as
hard to move the blood around the
body. This also me

Summary of Product characteristics

190415-candesartan-sandoz-pi
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
CANDESARTAN SANDOZ
®
(CANDESARTAN CILEXETIL)
TABLETS
1
NAME OF THE MEDICINE
Candesartan cilexetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Candesartan Sandoz 4 mg tablet contains 4 mg candesartan
cilexetil.
Each Candesartan Sandoz 8 mg tablet contains 8 mg candesartan
cilexetil.
Each Candesartan Sandoz 16 mg tablet contains 16 mg candesartan
cilexetil.
Each Candesartan Sandoz 32 mg tablet contains 32 mg candesartan
cilexetil.
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Candesartan Sandoz 4 mg tablets are white, round biconvex tablets,
debossed with 4 on one
side and scored on the other.
Candesartan Sandoz 8 mg tablets are pink, mottled, round biconvex
tablets, debossed with 8
on one side and scored on the other.
Candesartan Sandoz 16 mg tablets are pink, mottled, round biconvex
tablets, debossed with 16
on one side and scored on the other.
Candesartan Sandoz 32 mg tablets are pink, mottled, round biconvex
tablets, debossed with 32
on one side and scored on the other.
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
angiotensin converting
enzyme (ACE) inhibitors or when ACE inhibitors are not tolerated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Candesartan Sandoz should be taken once daily with or without food.
_Hypertension _
The recommended maintenance dose of Candesartan Sandoz is 8 or 16 mg
once daily. The
maximal antihypertensive effect is attained within four 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