BETALOC metoprolol tartrate 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metoprolol tartrate, Quantity: 100 mg

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate; povidone; magnesium stearate

Administration route:

Oral

Units in package:

60 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 23 NOVEMBER 2004 : Oral therapy - hypertension, angina pectoris prophylaxis, suspected or definite myocardial infarction, migraine prophylaxis.

Product summary:

Visual Identification: A white to off-white, circular, biconvex tablet, scored and engraved A/ME on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

BETALOC
® TABLETS
_Metoprolol tartrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
BETALOC tablets. It does not
contain all the information that is
known about BETALOC.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
BETALOC 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 BETALOC IS
USED FOR
BETALOC belongs to a group of
medicines called beta-blockers.
BETALOC tablets are used to:
•
lower high blood pressure, also
called hypertension
•
prevent angina
•
treat or prevent heart attacks, or
reduce your risk of heart
complications following a heart
attack
•
prevent migraine headaches.
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
therefore reduces the amount of work
the heart has to do. It also widens the
blood vessels in the body, as well as
helping the heart to beat more
regularly.
Your doctor will have explained why
you are being treated with
BETALOC and told you what dose
to take.
BETALOC may be used either alone
or in combination with other
medicines to treat your condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BETALOC
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
BETALOC is not addictive
BEFORE YOU TAKE
BETALOC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE BETALOC TABLETS IF:
•
YOU HAVE ANY ALLERGIES TO
METOPROLOL TARTRATE, THE ACTIVE
INGREDIENT IN BETALOC
TABLETS, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET, OR ANY OTHER BETA-
BLOCKER MEDICINE.
S

Summary of Product characteristics

1 of 16
AUSTRALIAN PRODUCT INFORMATION
BETALOC
®
METOPROLOL TARTRATE
1
NAME OF THE MEDICINE
Metoprolol tartrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETALOC tablets contain 50 mg or 100 mg metoprolol tartrate and the
following inactive
ingredients: lactose monohydrate, cellulose microcrystalline,
colloidal anhydrous silica, sodium
starch glycollate, povidone and magnesium stearate.
BETALOC Injection solution contains 1mg/mL metoprolol tartrate and the
following inactive
ingredients: sodium chloride and water for injections.
3
PHARMACEUTICAL FORM
TABLETS 50 MG
White to off-white, circular, biconvex tablet with a diameter of 8 mm,
scored and marked A/BB on
one side. The score line is only to facilitate breaking for ease of
swallowing and not to divide into
equal doses.
TABLETS 100 MG
White to off-white, circular, biconvex tablet with a diameter of 10
mm, scored and marked A/ME
on one side. The tablet can be divided into equal halves.
INJECTION SOLUTION, 1MG/ML
Clear, colourless liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ORAL THERAPY
-
Hypertension
-
angina pectoris prophylaxis
-
suspected or definite myocardial infarction
-
migraine prophylaxis.
INTRAVENOUS THERAPY
-
disturbances of cardiac rhythm, in particular supraventricular
tachyarrhythmias.
2 of 16
4.2
DOSE AND METHOD OF ADMINISTRATION
ORAL THERAPY
BETALOC (metoprolol tartrate) is recommended for oral therapy in
hypertension, angina pectoris,
suspected or definite myocardial infarction and migraine prophylaxis.
BETALOC 50 mg tablets are scored to facilitate breaking for ease of
swallowing only and not to
divide the tablet into equal doses. BETALOC 100 mg tablets can be
divided into two equal doses.
_HYPERTENSION _
_Initially _
Mild hypertensives:
50 or 100 mg once daily, for one week.
Severe hypertensives:
50 or 100 mg twice daily for one week.
_Maintenance _
50 or 100 mg once or twice daily.
Some patients will respond to 50 mg once daily. However, a large
number patients will respond to
100 mg once daily as initial and maintenance the