CANDESARTAN/HCT SANDOZ 16mg/12.5mg candesartan cilexetil/hydrochlorothiazide 16 mg/12.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

candesartan cilexetil, Quantity: 16 mg; hydrochlorothiazide, Quantity: 12.5 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

Product summary:

Visual Identification: apricot, mottled, oval biconvex tablets, scored on both sides; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-01-05

Patient Information leaflet

CANDESARTAN/ HCT SANDOZ
®
1
CANDESARTAN/ HCT
SANDOZ
®
_Candesartan cilexetil and hydrochlorothiazide tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Candesartan/HCT
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 risk of you taking
Candesartan/HCT Sandoz against the
benefits it is expected to 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/HCT
SANDOZ IS USED
FOR
This medicine is used to treat high
blood pressure.
It contains the active ingredients
candesartan cilexetil and
hydrochlorothiazide.
Candesartan cilexetil belongs to a
group of medicines called
angiotensin II - receptor antagonists
(or blocker). It works by causing
relaxation of blood vessels.
Hydrochlorothiazide belongs to a
group of medicines called diuretics.
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY
Your doctor may have prescribed it
for another reason.
They may differ from the
information contained in this leaflet.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CANDESARTAN/HCT
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
candesartan cilexetil and
hydrochlorothiazide, the active
ingredients, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description
•
any other similar medicines (such
as Irbesartan), angiotensin II
receptor antagonist
•
any sulphur drugs
(sulphonamides) such as some
anti

Summary of Product characteristics

210826-Candesartan.HCT-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
CANDESARTAN/HCT SANDOZ
®
TABLETS (CANDESARTAN
CILEXETIL/HYDROCHLOROTHIAZIDE)
1
NAME OF THE MEDICINE
Candesartan cilexetil/ Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Candesartan/HCT
Sandoz
16
mg/12.5
mg
contains
candesartan
cilexetil
16
mg
and
hydrochlorothiazide 12.5 mg.
Candesartan/HCT
Sandoz
32
mg/12.5
mg
contains
candesartan
cilexetil
32
mg
and
hydrochlorothiazide 12.5 mg.
Candesartan/HCT
Sandoz
32
mg/25
mg
contains
candesartan
cilexetil
32
mg
and
hydrochlorothiazide 25 mg.
Candesartan cilexetil is a white to off white powder and is
practically insoluble in water.
Excipients with known effect: Sugars as Lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Candesartan/HCT Sandoz 16 mg/12.5 mg tablets are apricot, mottled,
oval biconvex tablets,
scored on both sides.
Candesartan/HCT Sandoz 32 mg/12.5 mg tablets are light brown, mottled,
oblong, biconvex
tablets, debossed with 32 on one side and with score line on both
sides.
Candesartan/HCT Sandoz 32 mg/25 mg tablets are reddish brown, mottled,
oblong, biconvex
tablets, debossed with H 32 on one side and with score line on both
sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The treatment of hypertension. Treatment should not be initiated with
this fixed dose
combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The dose of Candesartan/HCT Sandoz must be determined by careful
titration of the dose of
each of the individual components.
METHOD OF ADMINISTRATION
The recommended dose of Candesartan/HCT Sandoz is one tablet once
daily, taken with or
without food. Candesartan/HCT Sandoz tablets should not be divided.
210826-Candesartan.HCT-pi
Page 2 of 20
Candesartan/HCT Sandoz 16 mg/12.5 mg may be administered in patients
whose blood
pressure is not optimally controlled with hydrochlorothiazide alone or
with candesartan 16 mg
monotherapy.
Candesartan/HCT Sandoz 32 mg/12.5 mg or 32 mg/25 mg may be
administered in pat