ATACAND PLUS 32/12.5 candesartan cilexetil & hydrochlorothiazide 32 mg/12.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 12.5 mg; candesartan cilexetil, Quantity: 32 mg

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: carmellose calcium; iron oxide yellow; lactose monohydrate; hyprolose; macrogol 8000; magnesium stearate; maize starch

Administration route:

Oral

Units in package:

7 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

Product summary:

Visual Identification: Yellow, oval biconvex tablets with a score and engraved A/CJ on one side and a pressure sensitive bisect on the reverse side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-09-23

Patient Information leaflet

ATACAND
® PLUS
_Candesartan cilexetil and hydrochlorothiazide tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
ATACAND PLUS. It does not
contain all the information that is
known about ATACAND PLUS.
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 PLUS 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 PLUS
IS FOR
ATACAND PLUS is used to treat
high blood pressure.
Candesartan cilexetil is a type of
medicine called an angiotensin II
receptor antagonist (or blocker). It
mainly works by causing relaxation
of blood vessels.
Hydrochlorothiazide is a type of
medicine called a diuretic. It works
by reducing the amount of excess
fluid in the body.
Using these two medicines together
will lower your blood pressure more
than using either one on its own.
Your doctor will have explained why
you are being treated with
ATACAND PLUS and told you what
dose to take.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
There is no evidence that
ATACAND PLUS is addictive.
BEFORE YOU USE
ATACAND PLUS
_WHEN YOU MUST NOT USE IT_
DO NOT USE ATACAND PLUS IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
candesartan cilexetil or
hydrochlorothiazide
•
any of the ingredients listed at the
end of the leaflet
•
any medicine containing an
angiotensin II receptor antagonist
(or blocker)
•
any sulphur drugs
(sulphonamides) such as some
antibiotics or some medicines to
treat diabetes
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing

Summary of Product characteristics

1 of 18
AUSTRALIAN PRODUCT INFORMATION
ATACAND PLUS
® (CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Candesartan cilexetil and hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATACAND PLUS 16/12.5 contains 16 mg candesartan cilexetil and 12.5 mg
of
hydrochlorothiazide.
ATACAND PLUS 32/12.5 contains 32 mg candesartan cilexetil and 12.5 mg
of
hydrochlorothiazide.
ATACAND PLUS 32/25 contains 32 mg candesartan cilexetil and 25 mg of
hydrochlorothiazide.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ATACAND PLUS 16/12.5 tablets are peach, oval biconvex tablets with a
score on both sides and
engraved
CS
A
.
ATACAND PLUS 32/12.5 tablets are yellow, oval, biconvex tablets with a
score and engraved
CJ
A
on one side and a pressure sensitive bisect on the reverse side.
ATACAND PLUS 32/25 tablets are pink, oval, biconvex tablets with a
score and engraved
CD
A
on
one side and a pressure sensitive bisect on the reverse side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of hypertension. Treatment should not be initiated with
these fixed dose
combinations.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose of ATACAND PLUS must be determined by careful titration of
the dose of each of the
individual components.
The recommended dose of ATACAND PLUS is 1 tablet once daily. ATACAND
PLUS may be
taken with or without food. ATACAND PLUS tablets should not be
divided.
2 of 18
ATACAND PLUS 16/12.5 may be administered in patients whose blood
pressure is not optimally
controlled with hydrochlorothiazide alone or ATACAND 16 mg
monotherapy.
ATACAND PLUS 32/12.5 or 32/25 may be administered in patients whose
blood pressure is not
optimally controlled with hydrochlorothiazide alone or ATACAND 32 mg
monotherapy, or at a
lower dose of ATACAND PLUS. Dose titration of candesartan cilexetil is
recommended when
adding on to hydrochlorothiazide monotherapy.
Most of the antihypertensive ef