TELMISARTAN MYLAN telmisartan 80 mg tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

telmisartan, Quantity: 80 mg

Disponibbli minn:

Alphapharm Pty Ltd

INN (Isem Internazzjonali):

Telmisartan

Għamla farmaċewtika:

Tablet, uncoated

Kompożizzjoni:

Excipient Ingredients: meglumine; povidone; sodium hydroxide; magnesium stearate; mannitol

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

56, 98, 28, 7

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

TELMISARTAN MYLAN 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)

Sommarju tal-prodott:

Visual Identification: White to off white, oblong, biconvex tablets debossed with 'TN80' on one side and 'M' on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2014-01-08

Fuljett ta 'informazzjoni

MIZART
1
TELMISARTAN MYLAN
TABLETS
_contains the active ingredient Telmisartan_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TELMISARTAN
MYLAN. 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.
KEEP THIS INFORMATION WITH YOUR
TELMISARTAN MYLAN TABLETS.
You may need to read it again later.
_TO FIND OUT MORE ABOUT _
_TELMISARTAN MYLAN_
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT YOUR
MEDICINE OR IF YOU HAVE ANY TROUBLE
BEFORE, DURING OR AFTER USING
TELMISARTAN MYLAN.
WHAT TELMISARTAN
MYLAN IS USED FOR
TELMISARTAN MYLAN 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 MYLAN is used to
lower high blood pressure (also
called 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
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. You may
feel fine and have no symptoms, but
if high blood pressure is not treated,
it can lead to serious health problems

Karatteristiċi tal-prodott

MIZART
®
_Telmisartan _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
telmisartan
Chemical name
:
4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)-methyl][1,1’-
biphenyl]-2-carboxylic acid (IUPAC nomenclature)
Structural formula
:
Molecular formula
:
C
33
H
30
N
4
O
2
Molecular weight
:
514.6
CAS Registry no.
:
144701-48-4
DESCRIPTION
Telmisartan is a specific angiotensin II receptor (type AT1)
antagonist.
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).
MIZART
®
is available as tablets for oral administration. Tablets containing 40
mg and 80 mg of telmisartan are
available. The excipients are mannitol, sodium hydroxide, meglumine,
povidone and magnesium stearate
PHARMACOLOGY
PHARMACODYNAMICS
Telmisartan displaces angiotensin II with very high affinity from its
binding site at the AT1 receptor subtype,
which is responsible for the known actions of angiotensin II.
Telmisartan does not exhibit any partial agonist
activity at the AT1 receptor. Telmisartan binds selectively with the
AT1 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
AT1
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. Telmisartan does not inhibit
angiotensin converting enzyme (kininase II), the enzyme which also
degrades bradykinin. Therefore it is not
expected to potentiate bradyk