METOPROLOL AN metoprolol tartrate 50mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
metoprolol tartrate
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Metoprolol tartrate
Authorization status:
Registered
Patient Information leaflet
_Metoprolol AN tablets – Consumer Medicine Information _
_Metoprolol AN CMI v1.0 _
_ _
_Page 1 _
METOPROLOL AN TABLETS
_Metoprolol tartrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about Metoprolol AN. It does not
contain all the information that is
known about Metoprolol AN.
It
does
not
take
the
place
of
talking
to
your
doctor
and
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
will
have
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 METOPROLOL AN
IS USED FOR
Metoprolol AN is used:
to lower high blood pressure,
also called hypertension
to
prevent
a
type
of
chest
pain, also called angina
after a heart attack to prevent
migraine headaches.
HYPERTENSION
Everyone
has
blood
pressure.
This pressure helps to move your
blood
around
your
body.
Your
blood pressure may be different at
various
times
of
the
day,
depending on how busy you are.
You
have
hypertension
(high
blood pressure) when your blood
pressure
stays
higher
than
is
needed, even when you are calm
and
relaxed.
If
high
blood
pressure is not treated it can lead
to
serious
health
problems,
including
stroke,
heart
disease
and kidney failure.
There are usually no symptoms of
hypertension.
The
only
way
of
knowing that you have it 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. Metoprolol AN helps to
lower your blood pressure.
ANGINA
Angina is a pain or uncomfortable
feeling
in
the
chest,
often
spreading to the arms or neck and
sometimes to the shoulders and
back. This may be caused by too
little blood and oxygen getting to
the heart. The pain of angina is
usually brought on by exercise or
stress but it can also happen while
y
Read the complete document
Summary of Product characteristics
_Metoprolol AN tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Metoprolol AN PI v3.0
Page 1
METOPROLOL AN
_ _
_(METOPROLOL TARTRATE TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is metoprolol (as metoprolol tartrate)
CHEMICAL NAME:
di-[(±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-
propanol] L(+)-tartrate
MOLECULAR FORMULA
: (C
15
H
25
NO
3
)
2
.
(C
4
H
6
O
6
)
MOLECULAR WEIGHT:
684.81
CAS NUMBER:
56392-17-7
DESCRIPTION
Metoprolol tartrate is an aryloxypropanolamine derivative. It is a
white, odourless or almost
odourless, crystalline powder with a melting point of 120°C. It is
very soluble in water, soluble
in chloroform, methylene chloride and alcohol, and almost insoluble in
benzene, diethyl ether
and acetone.
Metoprolol AN tablets contain either 50 mg or 100 mg of metoprolol
tartrate. They also contain
lactose,
colloidal
anhydrous
silica,
microcrystalline
cellulose,
croscarmellose
sodium,
pregelatinised maize starch, sodium starch glycollate, magnesium
stearate, hypromellose,
purified talc, macrogol 400 and titanium dioxide. The 50 mg strength
tablets also contain iron
oxide red.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: cardio-selective beta-blocker; ATC Code:
C07A B02.
PHARMACOLOGICAL ACTIONS
Metoprolol (as tartrate), the active substance of Metoprolol AN, is a
relatively cardioselective
beta-blocker, i.e. it acts on beta
1
-receptors mainly located in the heart at lower doses than those
needed to influence the beta
2
-receptors mainly located in the bronchi and peripheral vessels.
_Metoprolol AN tablets Product Information _
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_Amneal Pharma Australia Pty Ltd _
Metoprolol AN PI v3.0
Page 2
Metoprolol has little membrane-stabilising effect nor does it display
partial agonist activity (i.e.
intrinsic sympathomimetic activity = ISA) at doses required to produce
beta-blockade.
The stimulant effect of catecholamines on the heart is reduced or
inhibited by metoprolol. This
leads to a decrease in heart rate, cardiac co
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