Posology : מינונים

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 patients (up to 75 years of age) without clinically relevant hepatic or renal impairment is normally not necessary. In patients over 75 years, the elimination half-life of tramadol may be prolonged. Use in these patients is not recommended.
Renal impairment, dialysis and hepatic impairment:
In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements.
Tramadex OD is not recommended for patients with severe hepatic impairment or with severe renal impairment (creatinine clearance <10 ml/min, see section 4.3). Caution is advised in patients with moderate hepatic or moderate renal impairment (creatinine clearance <30 ml/min) (see section 4.4).

Method of administration
The tablets should be swallowed whole, with a sufficient quantity of liquid and not divided crushed or chewed. The tablets can be taken with or without food.