Mabron Retard 150mg Tablets

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

KOMEDIC SDN BHD

INN (International Name):

TRAMADOL HYDROCHLORIDE

Units in package:

30Tablet Tablets; 60Tablet Tablets

Manufactured by:

MEDOCHEMIE LTD

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

PACKAGE INSERT – MABRON RETARD
1.
NAME OF THE MEDICINAL PRODUCT
MABRON Retard 100 mg prolonged-release tablets
MABRON Retard 150 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 100 mg tramadol hydrochloride.
One prolonged-release tablet contains 150 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
MABRON Retard 100 mg prolonged-release tablets are off white, round
biconvex tablets, 9.1 mm diameter.
MABRON Retard 150 mg prolonged-release tablets are off white, capsule
shaped tablets, 14.3 mm long.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be adjusted to the severity of the pain and the
individual clinical response of the patient. For
doses not practicable with this medicinal product, other strengths of
this medicinal product are available.
Unless otherwise prescribed, MABRON Retard prolonged-release tablets
should be given as follows:
_Adults and adolescents (12 years and older) _
MABRON Retard is not approved for use in patients below 12 years old
The usual initial dose is 100mg twice daily, morning and evening.
Dependent upon the needs of the patient, subsequent doses may be
administered earlier than 12 hours, but must
not be administered earlier than 8 hours after the previous dose.
UNDER NO CIRCUMSTANCES SHOULD MORE THAN TWO
DOSES BE TAKEN IN ANY ONE 24 HOUR PERIOD.
If the pain relief is insufficient, the dose may be increased to
150mg, twice daily or 200mg, twice daily.
MABRON Retard prolonged-release tablets should be swallowed
completely, without breaking or chewing,
independent of meals, with sufficient liquid.
The smallest effective analgesic dose should always be used. Daily
doses of 400 mg of active substance should not
be exceeded, except in special clinical circumstances.
Under no circumstances should MABRON retard be used for longer than
absolute