Atacand

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Candesartan cilexetil 4mg;  ;  

Available from:

AstraZeneca Limited

INN (International Name):

Candesartan cilexetil 4 mg

Dosage:

4 mg

Pharmaceutical form:

Tablet

Composition:

Active: Candesartan cilexetil 4mg     Excipient: Carmellose calcium Hyprolose Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Purified water

Units in package:

Blister pack, PVC/PCDC-Al, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Procos SpA

Therapeutic indications:

Treatment of hypertension

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PCDC-Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PCDC-Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1996-12-03

Patient Information leaflet

Atacand

CMI 050220
Copyright
1(5)
ATACAND
®
CANDESARTAN CILEXETIL 4 MG, 8 MG 16 MG AND 32 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
ATACAND. It does not contain
all the information that is known about ATACAND.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking ATACAND
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 ATACAND IS USED FOR
ATACAND is a type of medicine called an angiotensin II receptor
inhibitor (or antagonist).
ATACAND is used for treating high blood pressure, also called
hypertension.
ATACAND is also used to treat heart failure - increase survival,
reduce hospitalisation and improve
symptoms. 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. ATACAND 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 sto

Summary of Product characteristics

Atacand Data Sheet 050220
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
A
TACAND
®
4
mg Tablets
A
TACAND
®
8
mg Tablets
A
TACAND
®
16
mg Tablets
A
TACAND
®
32
mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains candesartan cilexetil 4 mg, 8 mg, 16 mg or 32 mg.
Excipient with known effect:
4 mg: Each tablet contains 93.4 mg lactose monohydrate.
8 mg: Each tablet contains 89.4 mg lactose monohydrate.
16 mg: Each tablet contains 81.4 mg lactose monohydrate.
32 mg: Each tablet contains 162.8 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
A
TACAND
4 mg are round (diameter 7 mm), white tablets with a score and marked
A/CF on one side and 004 on the other side.
A
TACAND
8 mg are round (diameter 7 mm), light pink tablets with a score and
marked
A/CG on one side and marked 008 on the other side.
A
TACAND
16 mg are round (diameter 7 mm), pink tablets with a score and marked
A/CH on one side and marked 016 on the other side.
A
TACAND
32 mg are round (diameter 9.5 mm), pink tablets with a score and
marked
A/CL on one side and 032 on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension.
Treatment of patients with heart failure and left ventricular systolic
dysfunction.
Treatment with A
TACAND
reduces mortality, reduces hospitalisation due to heart failure
and improves symptoms.
Atacand Data Sheet 050220
Copyright
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN HYPERTENSION
The recommended initial and maintenance dose of A
TACAND
is 8 mg once daily. The
dose may be increased to 16 mg once daily. In patients who require
further blood
pressure reduction, the dose may be increased to 32 mg once daily.
Therapy should be adjusted according to blood pressure response. The
maximal
antihypertensive effect is attained within 4 weeks after initiation of
treatment.
In patients with less than optimal blood pressure reduction on A
TACAND
, combination
with a thiazide diuretic is recommended.
Use in the elderly
No initial dos