TERRY WHITE CHEMISTS METOPROLOL metoprolol tartrate 100mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
06-09-2019
Summary of Product characteristics
(SPC)
06-09-2019
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
metoprolol tartrate
Available from:
Apotex Pty Ltd
INN (International Name):
Metoprolol tartrate
Authorization status:
Registered
Patient Information leaflet
TERRY WHITE CHEMISTS
METOPROLOL TABLETS
_Contains the active ingredient metoprolol tartrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has 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 THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Metoprolol tablets.
It contains the active ingredient
metoprolol.
It is used:
•
to treat high blood pressure, also
called hypertension
•
to prevent a type of chest pain,
also called angina
•
after a heart attack
•
to prevent migraine headaches.
Metoprolol belongs to a group of
medicines called beta-blockers. It
works by affecting the body's
response to some nerve impulses,
especially in the heart.
As a result, it decreases the heart's
need for blood and oxygen and
reduces the amount of work that the
heart must do. It also widens the
blood vessels in the rest of the body.
Metoprolol can be used alone or in
combination with other medicines to
treat your condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Metoprolol is only available with a
doctor's prescription.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
Metoprolol is not recommended for
use in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
sudden losses of consciousness
•
asthma, wheezing, difficulty
breathing or other severe lung
problems
•
a
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Summary of Product characteristics
1
AUSTRALIAN PI -TERRY WHITE CHEMISTS METOPROLOL
(METOPROLOL TARTRATE) TABLETS
1
NAME OF THE MEDICINE
Metoprolol tartrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains either 50 mg or 100 mg of metoprolol tartrate as
the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
50 MG TABLET:
Pink, round, biconvex film-coated tablets with notch break line on one
side and ‘50’ debossed
on other side.
100 MG TABLET:
White to off-white, round, biconvex film-coated tablets with notch
break line on one side and
‘100’ debossed on other side.
4
CLINICAL PARTICULARS
4.1
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.
•
Suspected or definite myocardial infarction.
•
Migraine prophylaxis.
4.2
DOSE AND METHOD OF ADMINISTRATION
The maximum daily dose should not exceed 400 mg.
Although twice daily dosage is optimal, in those patients whose
maintenance dosage is 150
mg daily or less, it may be administered as a single dose.
It is advisable to individualise the dosage.
The film coated tablets should be swallowed whole.
HYPERTENSION
Mild: 50 or 100 mg, given once daily, for one week
Moderate to severe: 50 or 100 mg, given twice daily for one week
Maintenance: 50 or 100 mg, given once or twice daily.
2
Some patients may respond to 50 mg once daily. However, a large number
of patients will
respond to 100 mg, given once daily as initial and maintenance
therapy. Response is rarely
improved by increasing the dose beyond 200 mg daily.
ANGINA PECTORIS
50 mg to 100 mg, given two or three times daily
MYOCARDIAL INFARCTION
The recommended dosage can be reduced depending on the haemodynamic
status of the
patient.
Initially
Therapy should commence with 50 mg twice daily and be continued for 48
hours.
Maintenance
Generally
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