TRAMADEX OD 300

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

TRAMADOL HYDROCHLORIDE

Διαθέσιμο από:

DEXCEL PHARMA TECHNOLOGIES LTD

Φαρμακολογική κατηγορία (ATC):

N02AX02

Φαρμακοτεχνική μορφή:

TABLETS PROLONGED RELEASE

Σύνθεση:

TRAMADOL HYDROCHLORIDE 300 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

DEXCEL LTD, ISRAEL

Θεραπευτική ομάδα:

TRAMADOL

Θεραπευτική περιοχή:

TRAMADOL

Θεραπευτικές ενδείξεις:

Treatment of moderate to severe pain.

Ημερομηνία της άδειας:

2023-08-31

Αρχείο Π.Χ.Π.

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: prolonged-release tablets: Each tablet contains 100
mg of tramadol
hydrochloride.
Tramadex OD 200: prolonged-release tablet: Each tablet contains 200 mg
of tramadol
hydrochloride.
Tramadex OD 300: prolonged-release tablet: Each tablet contains 300 mg
of 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.
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death [see section 4.5].
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
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 intensity of the pain and the
sensitivity of the individual
patient. The lowest effective dose for analgesia should generally be
selected. The total daily
dose of 400 mg of tramadol should not be exceeded, except in special
circumstances.
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