BTC CANDESARTAN HCT 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

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:

2022-12-02

Patient Information leaflet

BTC Candesartan HCT
1
BTC CANDESARTAN HCT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BTC CANDESARTAN HCT?
BTC Candesartan HCT contains the active ingredient candesartan
cilexetil and hydrochlorothiazide. BTC Candesartan HCT is
used to treat high blood pressure.
For more information, see Section 1. Why am I using BTC Candesartan
HCT?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BTC CANDESARTAN HCT?
Do not use if you have ever had an allergic reaction to BTC
Candesartan HCT or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
BTC Candesartan HCT?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BTC Candesartan HCT and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE BTC CANDESARTAN HCT?
•
The standard dose for this medicine is one tablet once daily.
•
Swallow the tablet whole with a full glass of water.
More instructions can be found in Section 4. How do I use BTC
Candesartan HCT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BTC CANDESARTAN HCT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
BTC Candesartan HCT.
•
Tell your doctor if you have excessive vomiting or diarrhoea while
taking BTC Candesartan HCT.
•
Tell your doctor if you plan to have an examination such as an x-ray
or a scan requiring injection of
iodinated contract (dye) that you are taking BTC Candesartan HCT.
•
If you have had skin cancer or if you develop a suspicious skin lesion
during treatment with BTC
Candesartan HCT, tell your doctor or pharmacist.
THINGS YOU
SHOULD NOT DO
•
Do not

Summary of Product characteristics

221202-BTC Candesartan.HCT-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
BTC CANDESARTAN HCT
TABLETS (CANDESARTAN
CILEXETIL/HYDROCHLOROTHIAZIDE)
1
NAME OF THE MEDICINE
Candesartan cilexetil/ Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BTC
Candesartan
HCT
16
mg/12.5
mg
contains
candesartan
cilexetil
16
mg
and
hydrochlorothiazide 12.5 mg.
BTC
Candesartan
HCT
32
mg/12.5
mg
contains
candesartan
cilexetil
32
mg
and
hydrochlorothiazide 12.5 mg.
BTC
Candesartan
HCT
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
BTC Candesartan HCT 16 mg/12.5 mg tablets are apricot, mottled, oval
biconvex tablets,
scored on both sides.
BTC Candesartan HCT 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.
BTC Candesartan HCT 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 BTC Candesartan HCT must be determined by careful
titration of the dose of each
of the individual components.
METHOD OF ADMINISTRATION
The recommended dose of BTC Candesartan HCT is one tablet once daily,
taken with or
without food. BTC Candesartan HCT tablets should not be divided.
BTC Candesartan HCT 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.
221202-BTC Candesartan.HCT-pi
Page 2 of 20
BTC Candesartan HCT 32 mg/12.5 mg or 32 mg/25 mg may be administered
in patients whose
blood pressure is n