Betaloc CR 23.75

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metoprolol succinate 23.75mg;  

Available from:

AstraZeneca Limited

INN (International Name):

Metoprolol succinate 23.75 mg

Dosage:

23.75 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Metoprolol succinate 23.75mg   Excipient: Ethylcellulose Hydrated silica Hyprolose Hypromellose Liquid paraffin Macrogol 6000 Microcrystalline cellulose Sodium stearyl fumarate Titanium dioxide

Units in package:

Blister pack, PVC PVdC memory pack, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Ipca Laboratories Limited

Therapeutic indications:

· Hypertension. To reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sudden death), and morbidity. · Angina pectoris. · Symptomatic mild to severe chronic heart failure as an adjunct to other heart failure therapy to: increase survival, reduce hospitalisation, improve left ventricular function, improve New York Heart Association (NYHA) functional class and improve Quality of Life. · Cardiac arrhythmias, especially supraventricular tachycardia, reduction of ventricular rate in atrial fibrillation and ventricular extrasystoles. · Maintenance treatment after myocardial infarction · Hyperthyroidism. · Functional heart disorder with palpitations. · Migraine prophylaxis. · Paediatric hypertension

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC PVdC memory pack - 30 tablets - 36 months unopened stored at or below 30°C - Bottle, plastic, HDPE, tamperproof screw cap -   - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1999-12-07

Patient Information leaflet

Betaloc® CR CMI 280320
Copyright
1(7)
BETALOC
®
CR
METOPROLOL SUCCINATE, 23.75 MG, 47.5 MG, 95 MG, 190 MG CONTROLLED
RELEASE TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
BETALOC CR. It does not
contain all the information that is known about BETALOC CR.
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 CR 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 CR IS USED FOR
BETALOC CR 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 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.
BETALOC CR is a controlled release tablet that releases its drug
content in a time controlled manner.
Controlled release tablets ensure a more even effect over 24 hours.
BETALOC CR tablets are used for:

lowering high blood pressure, also called hypertension, to reduce the
risk of complications due to
high blood pressure such as stroke, heart attack or early death.

preventing angina (heart or chest pain brought on by stress or
exercise in patients with coronary
heart disease).

treating or preventing heart attacks, or to reduce your risk of heart
complications following a heart
attack.

treating heart failure (symptomatic mild to severe chronic heart
failure in addition to other heart
failure medicine), to help increase survival, reduce hospitalisation,
improve symptoms, and quality
of life.

treating disturbances of heart rate in patients with heart disease,
especially rapid heart beat.

Summary of Product characteristics

Betaloc CR Data Sheet 120421
Copyright
1
NEW ZEALAND DATA SHEET
1.
NAME OF MEDICINE
B
ETALOC
®
CR 23.75 mg Modified release tablet
B
ETALOC
®
CR 47.5 mg Modified release tablet
B
ETALOC
®
CR 95 mg Modified release tablet
B
ETALOC
®
CR 190 mg Modified release tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains metoprolol succinate 23.75 mg,
47.5 mg, 95 mg or 190
mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablets of metoprolol succinate, (will be referred to
as controlled release
tablets in the following text).
CR tablets 23.75 mg – A controlled-release preparation in which the
active substance
metoprolol succinate, is embedded as coated beads in a disintegrating
tablet. A white to off-
white, oval, biconvex, film-coated tablet scored on both sides and
engraved A/ on one side.
Size: 5.5 x 10.5 mm. The tablet can be divided into equal doses.
Average mass 0.17g.
Each tablet contains 23.75 mg metoprolol succinate, bioequivalent to
25 mg metoprolol
tartrate.
CR
tablets 47.5
mg -
A
controlled-release
preparation
in
which
the
active
substance
metoprolol succinate is embedded as coated beads in a disintegrating
tablet. A white to off-
white, circular, biconvex, film-coated tablet with a score on one side
and engraving A/m
O
on
the other side. The score line is only to facilitate breaking for ease
of swallowing and not to
divide into equal doses. Diameter 9 mm. Average mass 0.22 g. Each
tablet contains 47.5
mg metoprolol succinate, bioequivalent to 50 mg metoprolol tartrate.
CR tablets 95 mg - A controlled-release preparation in which the
active substance metoprolol
succinate is embedded as coated beads in a disintegrating tablet. A
white to off-white,
circular, biconvex, film-coated tablet with a score on one side and
engraving A/m
S
on the
other side. The score line is only to facilitate breaking for ease of
swallowing and not to
divide into equal doses. Diameter 10 mm. Average mass 0.37 g. Each
tablet contains 95
mg metoprolol