ADESAN HCT 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:

Alphapharm Pty Ltd

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

7, 30

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, mottled, round, biconvex tablets debossed with CH above the break line and 3 below the break line on one side and M on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-01-09

Patient Information leaflet

ADESAN HCT
_Candesartan cilexetil / hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers to some
common questions people ask about
ADESAN HCT. It does not contain
all the information that is known
about ADESAN HCT.
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
ADESAN HCT 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 THIS
MEDICINE.
You may need to read it again.
WHAT ADESAN HCT IS
USED FOR
ADESAN HCT 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 ADESAN
HCT 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 ADESAN
HCT is addictive.
BEFORE TAKING
ADESAN HCT
_WHEN YOU MUST NOT TAKE IT_
DO NOT USE ADESAN HCT IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
candesartan cilexetil, or
hydrochlorothiazide
•
any of the ingredients listed at the
end of this 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
•
swelling of the face, lip

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ADESAN HCT
_Candesartan cilexetil/Hydrochlorothiazide tablet_
_ _
1
NAME OF THE MEDICINE
Candesartan cilexetil and hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients in ADESAN HCT are candesartan cilexetil and
hydrochlorothiazide.
Candesartan is an angiotensin II receptor antagonist.
Hydrochlorothiazide is a sulfonamide derived drug.
Each tablet contains the following active ingredients:
Adesan
HCT
16/12.5
mg
Tablet:
:
16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide
Adesan
HCT
32/12.5
mg
Tablet:
:
32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide
Adesan HCT 32/25 mg Tablet:
:
32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide
Excipients with known effect: Sugars (as lactose). For the full list
of excipients, see Section 6.1 LIST
OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
16/12.5 mg Tablet: : Peach coloured, mottled, round, biconvex tablet
debossed with “M” on one side
and “CH2” on the other.
32/12.5 mg Tablet: : Yellow coloured, mottled, round, biconvex tablets
debossed with “CH” above the
break line and “3” below the break line on one side of the tablet
and “M” on
the other side.
32/25 mg Tablet: : Peach coloured, mottled, round, biconvex tablets
debossed with “CH” above the
break line and “4” below the break line on one side of the tablet
and “M” on
the other 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 ADESAN HCT must be determined by careful titration of the
dose of each of the
individual components.
Adesan HCT – PRODUCT INFORMATION
2
The recommended dose of ADESAN HCT is 1 tablet once daily, ADESAN HCT
may be taken with
or without food. ADESAN HCT tablets should not be divided.
ADESAN HCT 16/12.5 may be administered in patients whose blood
pressure is not optimally
controlled with hydrochlorothiazide alone or