APO-TELMISARTAN telmisartan 40mg 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)
27-11-2017
Active ingredient:
telmisartan, Quantity: 40 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Telmisartan
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: sodium hydroxide; mannitol; sodium stearylfumarate; meglumine; magnesium stearate; povidone
Administration route:
Oral
Units in package:
28
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
APO-TELMISARTAN 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 L203 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
APO-TELMISARTAN
TABLETS
_Contains the active ingredient telmisartan_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. 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 this medicine
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 THIS MEDICINE IS
USED FOR
Telmisartan is used to:
•
treat high blood pressure (also
called hypertension)
•
prevent cardiovascular
complications, including death
due to cardiovascular causes, in
patients aged 55 years of age or
older with coronary artery
disease, peripheral vascular
disease, previous stroke, previous
transient ischaemic attack (TIA)
or high-risk diabetes with
evidence of end organ damage
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.
PREVENTION OF CARDIOVASCULAR
COMPLICATIONS, INCLUDING DEATH DUE
TO CARDIOVASCULAR CAUSES
Patients who may be considered at a
high risk of developing
cardiovascular complications, or at a
high risk of death due to
cardiovascular causes, are those aged
55 or more who have problems such
as coronary artery disease (a hear
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO- TELMISARTAN (TELMISARTAN) TABLET
1
NAME OF THE MEDICINE
Telmisartan.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg or 80 mg telmisartan, as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
40 MG TABLET:
White to off-white colour, oval shape, biconvex, uncoated tablets
debossed with L203 on one
side and plain on other side.
80 MG TABLET:
White to off-white colour, oval shape, biconvex, uncoated tablets
debossed with L204 on one
side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Telmisartan 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
DOSE AND METHOD OF ADMINISTRATION
Telmisartan is available as tablets for oral administration.
Telmisartan may be administered with or without food.
DOSAGE
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.
2
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.
When initiating telmisartan therap
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