Durotram XR Tablet 100mg

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Tramadol hydrochloride

Beschikbaar vanaf:

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

ATC-code:

N02AX02

Dosering:

100.00mg

farmaceutische vorm:

TABLET, EXTENDED RELEASE

Samenstelling:

Tramadol hydrochloride 100.00mg

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

Laboratoires Confab Inc.

Autorisatie-status:

ACTIVE

Autorisatie datum:

2010-09-17

Bijsluiter

TRAMADOL 
HYDROCHLORIDE 

DUROTRAM
®
 XR  

100 MG, 200 MG OR (MALAYSIA ONLY) 300 MG 
EXTENDED RELEASE TABLETS

PRODUCT INFORMATION 

COMPOSITION 
DUROTRAM
®
 XR contains tramadol hydrochloride as the active ingredient in the
form of extended release tablets. 
DUROTRAM® XR tablets contain the following excipients: Contramid®
(Hydroxypropyl distarch phosphate (E 1442)), polyvinyl 
acetate, povidone, sodium lauryl sulfate, xanthan gum, vegetable
oil-hydrogenated, magnesium stearate, silica colloidal 
anhydrous, Opacode monogramming ink S-1-17823 black.  

INDICATIONS 
Relief of moderate to severe pain. 

DOSAGE AND ADMINISTRATION 
GENERAL ADVICE 
DUROTRAM
®
 XR tablets must be swallowed whole with liquid and not broken,
chewed, dissolved or crushed. 
DUROTRAM
®
 XR can be taken with or without food. DUROTRAM
®
 XR dosage should be individualised according to patient 
need using the lowest effective dose. The maximum recommended dose of
400 mg once daily should not be exceeded. 
Before using DUROTRAM
®
 XR for longer than three months, re-assessment of the patient
should be undertaken in order to 
determine whether ongoing treatment is required. If long-term
tramadol treatment is required, careful and regular monitoring 
should be undertaken to establish whether, and to what extent,
ongoing treatment with the medicine is necessary. 
Alternative tablet strengths of DUROTRAM
®
 XR are available. Where necessary, appropriate tablet strengths
should be used 
to achieve the required dose.  
ADULTS  
The starting dose is one 100 mg extended release tablet once
daily. The usual dose is one 200 mg extended release tablet 
once daily, to be taken preferably in the evening.  
If this does not provide sufficient pain relief, the dosage can
be increased in 100 mg dose increments to a maximum of 400 mg 
once daily.  
In general, the lowest effective analgesic dose should be chosen. 
DUROTRAM
®
 XR should not be used for�

Productkenmerken

TRAMADOL
HYDROCHLORIDE
DUROTRAM
® XR
100 MG, 200 MG OR (MALAYSIA ONLY) 300 MG
EXTENDED RELEASE TABLETS
PRODUCT INFORMATION
COMPOSITION
DUROTRAM
®
XR contains tramadol hydrochloride as the active ingredient in the
form of extended release tablets.
DUROTRAM® XR tablets contain the following excipients: Contramid®
(Hydroxypropyl distarch phosphate (E 1442)), polyvinyl
acetate, povidone, sodium lauryl sulfate, xanthan gum, vegetable
oil-hydrogenated, magnesium stearate, silica colloidal
anhydrous, Opacode monogramming ink S-1-17823 black.
INDICATIONS
Relief of moderate to severe pain.
DOSAGE AND ADMINISTRATION
GENERAL ADVICE
DUROTRAM
®
XR tablets must be swallowed whole with liquid and not broken, chewed,
dissolved or crushed.
DUROTRAM
®
XR can be taken with or without food. DUROTRAM
®
XR dosage should be individualised according to patient
need using the lowest effective dose. The maximum recommended dose of
400 mg once daily should not be exceeded.
Before using DUROTRAM
®
XR for longer than three months, re-assessment of the patient should
be undertaken in order to
determine whether ongoing treatment is required. If long-term tramadol
treatment is required, careful and regular monitoring
should be undertaken to establish whether, and to what extent, ongoing
treatment with the medicine is necessary.
Alternative tablet strengths of DUROTRAM
®
XR are available. Where necessary, appropriate tablet strengths should
be used
to achieve the required dose.
ADULTS
The starting dose is one 100 mg extended release tablet once daily.
The usual dose is one 200 mg extended release tablet
once daily, to be taken preferably in the evening.
If this does not provide sufficient pain relief, the dosage can be
increased in 100 mg dose increments to a maximum of 400 mg
once daily.
In general, the lowest effective analgesic dose should be chosen.
DUROTRAM
®
XR should not be used for a period longer than absolutely necessary.
If continued pain treatment is necessary
due to the nature and severity of the illness, careful regular
s