ASARTAN HCT 16/12.5 candesartan cilexetil/hydrochlorothiazide 16 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: 16 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Candesartan cilexetil,Hydrochlorothiazide

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; propylene glycol; iron oxide yellow; lactose monohydrate; carmellose calcium; aluminium magnesium silicate; hyprolose; iron oxide red

Administration route:

Oral

Units in package:

30, 7

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: Pink, uncoated capsule shaped tablets debossed with J and 05 separated by score line on one side and plain with score line on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-12-18

Patient Information leaflet

ASARTAN HCT™ 16/12.5, 32/12.5 & 32/25
CONSUMER MEDICINE INFORMATION
Candesartan cilexetil and hydrochlorothiazide tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
ASARTAN HCT.
It does not contain all the information that is known about ASARTAN
HCT. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking ASARTAN
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 THE MEDICINE.
You may need to read it again.
WHAT ASARTAN HCT IS USED FOR
ASARTAN 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 ASARTAN
HCT and told you what
dose to take.
YOU MUST 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.
ASARTAN HCT is not known to be addictive.
ASARTAN HCT is only available with a doctor’s prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ASARTAN HCT IF YOU HAVE AN ALLERGY TO:

any medicine containing candesartan cilexetil or hydrochlorothiazide;

any of the ingredients listed at the end of the leaflet;

any medicine containing an angiotensin II receptor antagonist (or
blocker); or

any sulphur drugs (sulphonamides) such as some antibiotics or some
medicines to treat
diabetes.
Some of the symptoms of an allergic r

Summary of Product characteristics

Page 1 of 15
PRODUCT IN
FO
R
M
ATI
O
N
ASARTAN HCT
TM
16/12.5, 32/12.5 & 32/25
TABLETS
NAME OF THE MEDICINE
Active ingredient:
candesartan cilexetil and hydrochlorothiazide
Chemical names
Candesartan cilexetil:
(1_RS_)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2′-(1_H_-
tetrazol-5-yl)biphenyl-4-yl]methyl]-1_H_-benzimidazole-7-
carboxylate
Hydrochlorothiazide:
6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulphonamide
1, 1-dioxide
CAS numbers
Candesartan cilexetil:
145040-37-5
Hydrochlorothiazide:
58-93-5
Molecular weights
Candesartan cilexetil:
611
Hydrochlorothiazide:
297.7
Molecular formula
Candesartan cilexetil:
C
33
H
34
N
6
O
6
Hydrochlorothiazide:
C
7
H
8
ClN
3
S
2
O
4
Chemical structures
Candesartan cilexetil:
Hydrochlorothiazide:
Page 2 of 15
DESCRIPTION
Candesartan cilexetil is a white or almost white powder and is
practically insoluble in water,
freely soluble in methylene chloride and slightly soluble in anhydrous
ethanol. The pKa & log P values
of candesartan cilexetil are 3.8 & 0.05 respectively.
Hydrochlorothiazide is
a
sulfonamide derived
drug.
It
is
a
white,
or
almost
white
crystalline
powder and is very slightly soluble in water, soluble in acetone,
sparingly soluble in ethanol (96%).It
dissolves in dilute solutions of alkali hydroxides. The pKa & log P
values of hydrochlorothiazide are
7.9 & -0.268 respectively.
ASARTAN HCT 16/12.5 contains 16 mg candesartan cilexetil and 12.5 mg
of hydrochlorothiazide.
ASARTAN HCT 32/12.5 contains 32 mg candesartan cilexetil and 12.5 mg
of hydrochlorothiazide.
ASARTAN HCT 32/25 contains 32 mg candesartan cilexetil and 25 mg of
hydrochlorothiazide.
ASARTAN HCT 16/12.5, 32/12.5 and 32/25 tablets also contain following
inactive ingredients:
carmellose calcium, hydroxypropylcellulose, iron oxide red, iron oxide
yellow (16/12.5 mg & 32/25 mg
tablets only), lactose, magnesium stearate, aluminium magnesium
silicate and propylene glycol.
PHARMACOLOGY
PHARMACODYNAMICS
Angiotensin II is the primary vasoactive hormone of the
renin-angiotensin-aldosterone s