CANDESAN COMBI 32/25 candesartan cilexetil 32 mg & hydrochlorothiazide 25 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

candesartan cilexetil, Quantity: 32 mg; hydrochlorothiazide, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

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: Light pink oval biconvex uncoated mottled tablets debossed with 'L3' & '04' on either side of break line on one side & break line on one 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:

2013-03-27

Patient Information leaflet

CANDESAN COMBI – Consumer Medicine Information
Page 1 of 5
Candesan Combi
_(16mg/12.5mg, 32mg/12.5mg & 32mg/25mg tablets) _
_contains the active ingredients candesartan cilexetil and
hydrochlorothiazide _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CANDESAN COMBI.
It does not contain all of 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 CANDESAN
COMBI against the benefits they
expect it will have 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 CANDESAN COMBI IS
USED FOR
CANDESAN COMBI is used to treat
high blood pressure, also called
hypertension.
CANDESAN COMBI contains two
medicines, candesartan cilexetil and
hydrochlorothiazide. In
combination, they lower your blood
pressure more than using either one
on its own.
Candesartan cilexetil belongs to a
group of medicines known as
angiotensin-II receptor antagonists.
It works by relaxing the blood
vessels.
Hydrochlorothiazide is type of
medicine called a diuretic. It works
by reducing the amount of excess
fluid in the body.
Your doctor will have explained
why you are being treated with
Candesartan/hydrochlorothiazide
tablets and told you what dose to
take.
Your doctor may have prescribed
CANDESAN COMBI for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CANDESAN
COMBI HAS BEEN PRESCRIBED FOR
YOU.
CANDESAN COMBI is available only
with a doctor's prescription.
There is no evidence that
CANDESAN COMBI is addictive
BEFORE YOU TAKE CANDESAN
COMBI
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE CANDESAN COMBI IF
YOU ARE ALLERGIC TO:
•
medicines containing
candesartan cilexetil or
hydrochlorothiazide
•
other angiotensin II receptor
antagonists (or blocker)
•
any sulphur drugs
(sulphonamides) such as some
antibiotics or some medicines

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – CANDESAN COMBI
(CANDESARTAN CILEXETIL & HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Candesartan cilexetil & hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CANDESAN COMBI tablets come in three strengths and contain 16 mg of
candesartan cilexetil and
12.5 mg of hydrochlorothiazide, 32 mg of candesartan cilexetil and
12.5 mg of hydrochlorothiazide
or 32 mg of 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
_CANDESAN COMBI 16/12.5_
Candesartan cilexetil 16 mg and hydrochlorothiazide 12.5 mg
uncoated tablet; Light pink, oval biconvex uncoated tablet with
‘L3’ & ‘02’ on either side of break
line on one side and a break line on the other side
_CANDESAN COMBI 32/12.5_
Candesartan cilexetil 32 mg and hydrochlorothiazide 12.5 mg
uncoated tablet; Light yellow, oval biconvex uncoated tablet with
‘L3’ & ‘04’ on either side of break
line on one side and a break line on the other side.
_CANDESAN COMBI 32/25_
Candesartan cilexetil 32 mg and hydrochlorothiazide 25 mg
uncoated tablet; Light pink, oval biconvex uncoated tablet with
‘L3’ & ‘04’ on either side of break
line on one side and a break line on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of hypertension. Treatment should not be initiated with this
fixed dose combination.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dose of candesartan with hydrochlorothiazide combination tablets
must be determined by careful
titration of the dose of each of the individual components.
The recommended dose is 1 tablet once daily. The tablets may be taken
with or without food. The
tablets should not be divided.
CANDESAN COMBI 16/12.5 may be administered in patients whose blood
pressure is not optimally
controlled with hydrochlorothiazide alone or candesartan cilexetil 16
mg monotherapy.
CANDESAN COMBI 32/12.5 or 32/25