ETOCAR metoprolol tartrate 50 mg film-coated tablet 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)
26-11-2017
Active ingredient:
metoprolol tartrate, Quantity: 50 mg
Available from:
Ipca Pharma (Australia) Pty Ltd
INN (International Name):
Metoprolol tartrate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; hypromellose; magnesium stearate; iron oxide red; croscarmellose sodium; macrogol 400; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; purified talc; pregelatinised maize starch
Administration route:
Oral
Units in package:
10, 100
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Hypertension: as monotherapy or for use in combination with other antihypertensives.,Angina pectoris: for long-term prophylaxis. Glyceryl trinitrate should be employed if necessary for alleviating acute attacks.,Confirmed or suspected myocardial infarction.,Prevention of migraine.
Product summary:
Visual Identification: Pink, round, biconvex film-coated tablets with notch break line on one side and '50' debossed on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2015-03-25
Patient Information leaflet
Etocar
50 mg & 100 mg CMI v1.1
1
ETOCAR 50 MG & 100 MG
_Metoprolol tartrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about Etocar. It does not contain
all the information that is known
about Etocar.
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 ETOCAR IS FOR
Etocar is
used:
1. to lower high blood pressure,
also called hypertension
2. to prevent a type of chest pain,
also called angina
3. after a heart attack
4. 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. Etocar 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
you are resting.
Etocar helps to prevent angina
from happening. It is not used to
treat a sudden attack.
RE
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Summary of Product characteristics
Etocar 50 mg & 100 mg PI v1.1
1
ETOCAR TABLETS 50 MG & 100 MG
(METOPROLOL TARTRATE 50 MG & 100 MG FILM COATED TABLETS)
NAME OF THE MEDICINE
Active ingredient:
metoprolol tartrate
Chemical name:
Bis [(2_RS_)-11[4-(2-methoxyethyl)phenoxy]-3-[(1-
methylethyl)amino]propan-2-ol](2_R,3R_)-2,3-dihydroxybutanedioate._ _
CAS number:
56392-17-7
Molecular weight:
685
Molecular formula:
C
34
H
56
N
2
O
12
Chemical structure:
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.
Etocar contain either 50 mg or 100 mg of metoprolol tartrate. They
also contain lactose,
silica - colloidal anhydrous, cellulose - microcrystalline,
croscarmellose sodium, starch –
pregelatinised maize, sodium starch glycollate, magnesium stearate,
hypromellose, talc –
purified, 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, the active substance of Etocar, 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.
Etocar 50 mg & 100 mg PI v1.1
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.
Pharmacodynamics(PD)The stimulant effect of catecholamines on the
heart is reduced or
inhibited by metoprolol. This leads to a decrease in heart rate,
cardiac contractility, and
cardiac output.
Metoprolol lowers elevated blood pressure in both the standing and
lying position. It also
reduces the extent of ri
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