TELMISARTAN AN telmisartan 40mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
13-05-2016
Summary of Product characteristics
(SPC)
13-05-2016
Public Assessment Report
(PAR)
20-10-2017
Active ingredient:
Telmisartan
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Telmisartan
Patient Information leaflet
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_Telmisartan AN tablets – Consumer Medicine Information _
_Telmisartan AN CMI v2.0 _
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_Page 1 _
TELMISARTAN AN TABLETS
_Telmisartan _
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CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Telmisartan AN.
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 TELMISARTAN AN
IS USED FOR
Telmisartan AN 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 AN 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 t
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Summary of Product characteristics
Telmisartan AN PI v3.0
Page 1
TELMISARTAN AN
TABLETS
(TELMISARTAN)
NAME OF THE MEDICINE
TELMISARTAN AN contains the active ingredient telmisartan. Telmisartan
has the following
structural formula:
DESCRIPTION
Telmisartan is a specific angiotensin II receptor (type AT1)
antagonist. The chemical name for
telmisartan is
4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1_H_-benzimidazol]-1’-yl)-methyl]-[1,1’-biphenyl]-2-
carboxylic acid (IUPAC nomenclature). The molecular formula is C
33
H
30
N
4
O
2
and the molecular
weight is 514.6. The CAS number is 144701-48-4.
Telmisartan is an off-white to yellowish crystalline powder. It is
practically insoluble in water, very
slightly soluble in ethanol, slightly soluble in methanol and soluble
in a mixture of chloroform and
methanol (1:1).
TELMISARTAN AN
is available as tablets for oral administration. Tablets containing 40
mg and
80 mg of telmisartan are available.
The excipients are povidone K25, meglumine, sodium
hydroxide, mannitol, sodium stearyl fumarate and magnesium stearate.
PHARMACOLOGY
PHARMACODYNAMICS
Telmisartan displaces angiotensin II with very high affinity from its
binding site at the AT
1
receptor
subtype, which is responsible for the known actions of angiotensin II.
Telmisartan does not
exhibit any partial agonist activity at the AT
1
receptor. Telmisartan binds selectively with the AT
1
receptor and does not reveal relevant affinity for other receptors nor
does it inhibit human plasma
renin or block ion channels. The clinically relevant effect of AT
1
receptor blockade is to lower
blood pressure by inhibition of angiotensin II mediated
vasoconstriction leading to reduction of
systemic vascular resistance. During administration with telmisartan,
removal of angiotensin II
negative feedback on renin secretion results in increased plasma renin
activity, which in turn
leads to increases in angiotensin II in plasma. Despite these
increases, antihypertensive activity
and
suppressed
aldosterone
levels
indicate
effective
angiotensin
II
receptor
blockade.
T
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