Teltartan telmisartan 80mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
20-10-2017
Active ingredient:
telmisartan, Quantity: 80 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Telmisartan
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: magnesium stearate; mannitol; povidone; meglumine; sodium hydroxide; sodium stearylfumarate
Administration route:
Oral
Units in package:
28
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
TELTARTAN is indicated for:,Treatment of hypertension,Prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage (see CLINICAL TRIALS)
Product summary:
Visual Identification: White to off-white color, oval shape, biconvex, uncoated tablets debossed with L204 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-05-19
Patient Information leaflet
1
TELTARTAN TABLETS
_Telmisartan _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Teltartan.
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 or
doctor 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 IS USED
FOR
Teltartan is used to:
•
treat high blood pressure (also called
hypertension)
•
prevent cardiovascular
complications, including death due
to cardiovascular causes, in patients
older than 55 years of age with
coronary artery disease, peripheral
vascular disease, previous stroke,
previous transient ischaemic attack
(TIA) or high risk diabetes with
evidence of end organ damage
TREATMENT OF
HYPERTENSION
Teltartan 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 normal, 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 WORKS _
Teltartan contains telmisartan.
Telmisartan belongs to
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – TELTARTAN
(TELMISARTAN) TABLET
1
NAME OF THE MEDICINE
Telmisartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TELTARTAN contains the active ingredient telmisartan. Tablets
containing 40 mg and 80 mg of
telmisartan are available.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TELTARTAN is available as tablets for oral administration.
TELTARTAN tablets are white to off-white, biconvex, oval-shaped,
uncoatedtablets.
TELTARTAN 40 mg tablets have one face marked with L203 and plain on
the other side.
TELTARTAN 80 mg tablets have one face marked with L204 and plain on
the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TELTARTAN is indicated for:
•
Treatment of hypertension
•
Prevention of cardiovascular morbidity and mortality in patients 55
years or older with
coronary artery disease, peripheral artery disease, previous stroke,
transient ischaemic
attack or high risk diabetes with evidence of end organ damage (see
Section 5.1
PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS)
4.2
D
OSE AND METHOD OF ADMINISTRATION
TREATMENT OF HYPERTENSION:
_Adults_: The recommended dose is 40 mg once daily. In cases where the
target blood pressure is
not achieved, telmisartan dose can be increased to 80 mg once daily.
Telmisartan may be used
in combination with thiazide-type diuretics such as
hydrochlorothiazide
which has
been
shown
to have an additive blood pressure lowering effect with telmisartan.
When considering raising
the dose, it must be borne in mind that, while reduction in blood
pressure is achieved after the first
dose, the maximum antihypertensive effect is generally attained four
to eight weeks after the start
of treatment.
PREVENTION OF CARDIOVASCULAR MORBIDITY AND MORTALITY:
The recommended dose is 80 mg once daily. It is not known whether
doses lower than 80 mg of
telmisartan are effective in preventing cardiovascular morbidity and
mortality.
2
When initiating telmisartan therapy for the prevention of
cardiovascular morbidi
Read the complete document
