Telmisartan GH 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)
27-11-2017
Active ingredient:
telmisartan, Quantity: 80 mg
Available from:
Generic Health Pty Ltd
INN (International Name):
Telmisartan
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: sodium hydroxide; mannitol; magnesium stearate; sodium stearylfumarate; povidone; meglumine
Administration route:
Oral
Units in package:
28
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
TELMISARTAN GH 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:
Registered
Authorization date:
2014-05-19
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
TELMISARTAN GH
(TELMISARTAN) TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Telmisartan 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.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT TELMISARTAN GH IS
USED FOR
Telmisartan GH 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 _
Telmisartan 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
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 TELMISARTAN GH WORKS _
Telmisartan GH contains
telmisartan. 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 blocking
the effect of angiotensin II.
When the effect of
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – TELMISARTAN GH
(TELMISARTAN) TABLETS
1
NAME OF THE MEDICINE
Telmisartan.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telmisartan GH is available as tablets for oral administration.
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
Telmisartan GH tablets are white to off-white, biconvex, oval-shaped
tablets. Tablets containing 40 mg
and 80 mg of telmisartan are available. Telmisartan GH 40 mg tablets
have one face marked with L203
and plain on the other side. Telmisartan GH 80 mg tablets have one
face marked with L204 and plain
on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Telmisartan GH 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
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.
Telmisartan GH v5.0
Page 2 of 20
(telmisartan
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