TRAMADEX OD 100

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TRAMADOL HYDROCHLORIDE

متاح من:

DEXCEL PHARMA TECHNOLOGIES LTD

ATC رمز:

N02AX02

الشكل الصيدلاني:

TABLETS PROLONGED RELEASE

تركيب:

TRAMADOL HYDROCHLORIDE 100 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DEXCEL LTD, ISRAEL

المجموعة العلاجية:

TRAMADOL

المجال العلاجي:

TRAMADOL

الخصائص العلاجية:

Treatment of moderate to severe pain.

تاريخ الترخيص:

2013-08-31

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tramadex OD 100
Tramadex OD 200
Tramadex OD 300
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tramadex OD 100: One prolonged-release tablet contains 100 mg tramadol
hydrochloride.
Tramadex OD 200: One prolonged-release tablet contains 200 mg tramadol
hydrochloride.
Tramadex OD 300: One prolonged-release tablet contains 300 mg tramadol
hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white, plain, bevelled edge, round biconvex tablet.
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 pain and the response
of the individual
patient.
Alternative tablet strengths of Tramadex OD are available. Where
necessary, appropriate
tablet strengths should be used to achieve the required dose.
Tramadex OD_ _should be taken once every 24 hours as follows:
_Adults and adolescents (14 years and over): _
The starting dose is one 100 mg prolonged-release tablet once daily.
The usual dose is one
200 mg prolonged-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 300 mg or to a maximum of 400 mg once daily.
In general, the lowest effective analgesic dose should be chosen. A
daily dose of 400 mg of
tramadol should not be exceeded except in special clinical cases.
Tramadex OD 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
surveillance should be carried out (including periods without
treatment, if necessary) in
order to determine the need for continued treatment.
_Children (under 14): _
Tramadex OD is not recommended for the treatment of children (under 14
years of age).
_ _
_Elderly patients: _
Dose adjustment in elderly