TELMISARTAN HCTZ AN 80/25 telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide,telmisartan

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Hydrochlorothiazide,Telmisartan

Authorization status:

Registered

Patient Information leaflet

_Telmisartan HCTZ AN tablets – Consumer Medicine Information _
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_Telmisartan HCTZ AN CMI v2.0 _
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_Page 1 _
TELMISARTAN HCTZ AN
TABLETS
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_TELMISARTAN AND HYDROCHLOROTHIAZIDE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
TELMISARTAN HCTZ AN.
It does not contain all available information. It
does not take the place of talking to your doctor or
pharmacist.
This leaflet was last updated on the date at the end
of this leaflet. More recent information may be
available.
The latest Consumer Medicine Information is
available from your pharmacist, doctor, or from
www.medicines.org.au and may contain important
information about the medicine and its use of
which you should be aware.
All medicines have benefits and risks. Your doctor
has weighed the risks of you taking this medicine
against the benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET
WITH THE MEDICINE.
You may need to read it again.
WHAT TELMISARTAN HCTZ AN
IS USED FOR
TELMISARTAN HCTZ AN is used to lower high
blood pressure (hypertension).
Everyone has blood pressure. This pressure helps
your blood move around your body. Your blood
pressure may be different at different times of the
day, depending on how busy or worried you are.
You have hypertension (high blood pressure) when
your blood pressure stays higher than is needed,
even when you are calm or relaxed. There are
usually no signs of hypertension. The only way of
knowing that you have hypertension is to have your
blood pressure checked on a regular basis.
If high blood pressure is not treated, it can lead to
serious health problems, including stroke, heart
disease and kidney failure.
_HOW TELMISARTAN HCTZ AN WORKS _
_ _
TELMISARTAN HCTZ AN contains telmisartan
and hydrochlorothiazide in one single tablet. These
two active ingredients help to reduce blood
pressure in different ways:

Telmisartan belongs to a group of
medicines called angiotensin II rec

Summary of Product characteristics

Telmisartan HCTZ AN PI v3.0
Page 1
TELMISARTAN HCTZ AN
TABLETS
(TELMISARTAN AND HYDROCHLOROTHIAZIDE)
NAME OF THE MEDICINE
TELMISARTAN HCTZ AN contains the active ingredients telmisartan and
hydrochlorothiazide.
TELMISARTAN HCTZ AN is available in three tablet strengths:

TELMISARTAN HCTZ AN 40/12.5 containing telmisartan 40
mg/hydrochlorothiazide 12.5 mg,

TELMISARTAN HCTZ AN
80/12.5 containing telmisartan 80 mg/hydrochlorothiazide 12.5 mg, and

TELMISARTAN HCTZ AN
80/25 containing telmisartan 80 mg/hydrochlorothiazide 25 mg.
Telmisartan and hydrochlorothiazide have the following structural
formula:
TELMISARTAN
HYDROCHLOROTHIAZIDE
DESCRIPTION
Telmisartan is a specific angiotensin II receptor (type AT
1
) antagonist.
The chemical name for
telmisartan
is
4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1_H_-benzimidazol]-1’-yl)-methyl]-[1,1’-biphenyl]-2-
carboxylic acid (IUPAC nomenclature). The molecular formula is C
33
H
30
N
4
O
2
and the molecular
weight is 514.6. The CAS number is 144701-48-4.
Telmisartan is an off-white to yellowish crystalline powder. It is
practically insoluble in water, very
slightly soluble in ethanol, slightly soluble in methanol and soluble
in a mixture of chloroform and
methanol (1:1).
Hydrochlorothiazide
is
a
benzothiadiazine
(thiazide)
diuretic.
The
chemical
name
for
hydrochlorothiazide
is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
The molecular formula is C
7
H
8
ClN
3
O
4
S
2
and the molecular weight is 297.73. The CAS number is
58-93-5.
Hydrochlorothiazide is a white, or practically white, odourless
crystalline powder. It is very slightly
soluble in water, and freely soluble in sodium hydroxide solution.
TELMISARTAN HCTZ AN tablets contain a combination of 40 mg of
telmisartan and 12.5 mg of
hydrochlorothiazide or 80 mg of telmisartan and 12.5 mg or 25 mg of
hydrochlorothiazide. The
excipients in each tablet are povidone (K25), lactose, magnesium
stearate, meglumine, sodium
Telmisartan HCTZ AN PI v3.0
Page 2
hydroxide, sodium stearyl fumar