MABRON CAPSULES 50MG

País: Malàisia

Idioma: anglès

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

ingredients actius:

TRAMADOL HYDROCHLORIDE

Disponible des:

KOMEDIC SDN BHD

Designació comuna internacional (DCI):

TRAMADOL HYDROCHLORIDE

Unidades en paquete:

500 Capsule Capsules; 100 Capsule Capsules

Fabricat per:

MEDOCHEMIE LTD

Fitxa tècnica

1
PACKAGE INSERT – MABRON
1.
NAME OF THE MEDICINAL PRODUCT
MABRON 50mg, capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Yellow/ dark green, size number 4, hard gelatin capsule.
For oral administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Severe acute to chronic pain
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be adjusted to the intensity of the pain. Unless
otherwise prescribed, Tramadol HCL should be
taken as follows - independent of meals:
Single dose for adults and adolescents over 14 years of age: 1 capsule
to be taken with little liquid. This is usually
sufficient to relieve the pain. If however, pain relief is
unsatisfactory a further Tramadol HCL capsule may be taken
after about 30 -60 minutes.
In general the daily dose should not exceed 400 mg Tramadol HCL.
_Adults and adolescents (12 years and older) _
MABRON is not approved for use in patients below 12 years old_ _
_ _
_ _
_Paediatric population _
The safety and efficacy of MABRON has not been studied in the
paediatric population. Therefore, use of MABRON
is not recommended in patients under 12 years of age.
In impaired renal or hepatic function it may be necessary to adjust
the dose.
_ _
Method of administration
The capsules are to be taken whole, not divided or chewed, with
sufficient liquid, with or without food
Duration of administration
Tramadol should under no circumstances be administered for longer than
absolutely necessary. If long-term pain
treatment with tramadol is necessary in view of the nature and
severity of the illness, then careful and regular
monitoring should be carried out (if necessary with breaks in
treatment) to establish whether and to what extent
further treatment is necessary.
4.3.
CONTRAINDICATIONS
MABRON is contraindicated:

in hypersensitivity to the active substance or any of the excipients
listed in section 6.1

in acute intoxication with a