CANDESARTAN/HCT SANDOZ 16mg/12.5mg candesartan cilexetil/hydrochlorothiazide 16 mg/12.5 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Sandoz Pty Ltd

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet

Composition:

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

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: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2011-01-05

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