TELMISARTAN HCT GH 80/25mg telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

telmisartan, Quantity: 80 mg; hydrochlorothiazide, Quantity: 25 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Hydrochlorothiazide,Telmisartan

Pharmaceutical form:

Tablet, multilayer

Composition:

Excipient Ingredients: mannitol; povidone; magnesium stearate; purified water; sodium hydroxide; sodium stearylfumarate; meglumine; lactose monohydrate; Colour

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TELMISARTAN HCT GH is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

Product summary:

Visual Identification: Oblong shaped biconvex, bilayered, uncoated tablets with one white/off white color layer and one yellow colour mottled layer debossed with L201; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-08

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
TELMISARTAN HCT GH
(TELMISARTAN AND HYDROCHLOROTHIAZIDE) MULTILAYER TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Telmisartan HCT GH.
It does not contain all available
information. It does not take the
place of talking to your doctor or
pharmacist.
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 TAKING THIS MEDICINE,
ASK 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, and
may contain important
information about the medicine
and its use of which you should
be aware.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT TELMISARTAN HCT
GH IS USED FOR
Telmisartan HCT GH 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 HCT GH _
_WORKS _
_ _
Telmisartan HCT GH 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 receptor
blockers. Angiotensin II is a
substance in the body which
causes blood vessels to
narrow, thus increasing blood
pressure. Telmisartan

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – TELMISARTAN HCT GH
(TELMISARTAN AND HYDROCHLOROTHIAZIDE) MULTILAYER TABLET
1
NAME OF THE MEDICINE
Telmisartan and hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telmisartan HCT GH is available in three tablet strengths:
•
Telmisartan HCT GH 40/12.5 mg containing telmisartan 40
mg/hydrochlorothiazide 12.5 mg;
•
Telmisartan HCT GH 80/12.5 mg containing telmisartan 80
mg/hydrochlorothiazide 12.5 mg; and
•
Telmisartan HCT GH 80/25 mg containing telmisartan 80
mg/hydrochlorothiazide 25 mg.
List of excipients with known effects: sugars as lactose, and
mannitol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Telmisartan HCT GH 40/12.5 mg tablets are oblong biconvex bilayered
uncoated tablets with one
white/off white color layer and one pink colour mottled layer debossed
with L199.
Telmisartan HCT GH 80/12.5mg tablets are oblong biconvex bilayered
uncoated tablets with one
white/off white color layer and one pink colour mottled layer debossed
with L200.
Telmisartan HCT GH 80/25 mg tablets are oblong shaped biconvex,
bilayered, uncoated tablets with one
white/off white color layer and one yellow colour mottled layer
debossed with L201.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Telmisartan HCT GH is indicated for the treatment of hypertension.
Treatment should not be initiated
with these combinations.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose is one tablet once daily.
The dose of telmisartan can be increased before switching to
Telmisartan HCT GH. Direct change from
monotherapy to the fixed combinations may be considered.
Telmisartan HCT GH 40/12.5 mg may be administered in patients whose
blood pressure is not
adequately controlled by Telmisartan GH 40 mg or hydrochlorothiazide.
Telmisartan HCT GH v7
Page 2 of 26
(telmisartan and hydrochlorothiazide) multilayer tablet
Telmisartan HCT GH 80/12.5 mg may be administered in patients whose
blood pressure is not
adequately controlled by Telmisart