TELTARTAN HCT 80/25 mg telmisartan 80 mg & hydrochlorothiazide 25 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
29-10-2021
Summary of Product characteristics
(SPC)
26-03-2021
Public Assessment Report
(PAR)
20-10-2017
Active ingredient:
hydrochlorothiazide, Quantity: 25 mg; telmisartan, Quantity: 80 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Hydrochlorothiazide,Telmisartan
Pharmaceutical form:
Tablet, multilayer
Composition:
Excipient Ingredients: meglumine; magnesium stearate; sodium stearylfumarate; povidone; mannitol; purified water; sodium hydroxide; lactose monohydrate; Colour
Administration route:
Oral
Units in package:
28
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Teltartan HCT is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.
Product summary:
Visual Identification: Oblong 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
TELTARTAN HCT TABLETS
_ _
_TELMISARTAN AND HYDROCHLOROTHIAZIDE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TELTARTAN HCT.
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 TELTARTAN HCT
IS USED FOR
TELTARTAN HCT 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 TELTARTAN HCT WORKS _
_ _
TELTARTAN HCT 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 antagonists. Angiotensin II
is a substance in the body which
causes blood vessels to narrow,
thus increasing blood pressure.
Telmisartan works by blo
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – TELTARTAN HCT
(TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Telmisartan and hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TELTARTAN HCT is available in three tablet strengths:
•
TELTARTAN HCT 40/12.5 mg containing telmisartan 40
mg/hydrochlorothiazide 12.5 mg
•
TELTARTAN HCT
80/12.5 mg containing telmisartan 80 mg/hydrochlorothiazide 12.5 mg
•
TELTARTAN HCT
80/25 mg containing telmisartan 80 mg/hydrochlorothiazide 25 mg
EXCIPIENTS WITH KNOWN EFFECT
The tablets also contains sugars as lactose monohydrate. For full list
of excipients, see section 6.1 LIST
OF EXCIPIENTS
3
PHARMACEUTICAL FORM
TELTARTAN HCT
40/12.5 mg
and
80/12.5 mg
tablets
are
pink mottled
and
white to off-white
biconvex, oval shaped, two layer tablets. The white to off-white layer
may contain pink specks. The
pink mottled face of TELTARTAN HCT 40/12.5 mg tablets are marked with
L199. The pink mottled face
of TELTARTAN HCT 80/12.5 mg tablets are marked with L200.
TELTARTAN HCT 80/25 mg tablets are yellow mottled and white to
off-white biconvex, oval shaped,
two layer tablets. The white to off-white layer may contain yellow
specks. The yellow face of
TELTARTAN HCT 80/25 mg tablets are marked with L201.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TELTARTAN HCT is indicated for the treatment of hypertension.
Treatment should not be initiated
with these combinations.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_Adults_: The recommended dose is one tablet once daily.
2
The dose of telmisartan can be increased before switching to TELTARTAN
HCT. Direct change from
monotherapy to the fixed combinations may be considered.
TELTARTAN HCT 40/12.5 mg may be administered in patients whose blood
pressure is not adequately
controlled by telmisartan 40 mg or hydrochlorothiazide.
TELTARTAN HCT 80/12.5 mg may be administered in patients whose blood
pressure is not adequately
controlled by telmisartan
80 mg or by TELTARTAN HCT 40/12.5 mg.
TELTARTAN HCT 80/25 mg may be administered in p
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