TRACIDOL capsules should be administered every 24 hours. The capsules should be swallowed whole without chewing. The dosage of Tramadol is determined by the severity of the pain and according to the clinical response of the individual patient. This is valid for all pain relief medicinal products. The correct individual dosage is one that relieves the pain for 24 hours without having any side effects or having side effects of a tolerable level. Patients switched from immediate release tramadol preparations should have their total daily dose calculated, and start on the nearest dose in the TRACIDOL range. It is recommended that patients are slowly titrated to higher doses to minimise transient side effects. TRACIDOL should under no circumstances be administered for longer than is strictly necessary. If repeated use or long-term treatment with tramadol is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether continuation of the treatment is necessary.
The daily total dosage must not exceed 400 mg, unless clinical exceptional circumstances require this.
Dosing in special patients groups: Adults and children over 12 years: The usual starting dosage is one capsule of 100-200 mg per day. If this dosage does not relieve the pain, the dosage is to be raised until an effect of pain relief has been attained.
Elderly people: Patients under 75 years of age with normal liver and kidney functions can be given the normal dosage for adults. In patients over 75 years of age the half-life of Tramadol is prolonged. For those patients, an adjustment of the dosage may be required. If the dosage is increased the condition of the patient must be closely monitored.
Patients with renal insufficiency: The elimination of Tramadol may be delayed. Tramadol is not recommended for patients suffering from moderate to severe kidney insufficiency (creatinine clearance <30 ml/min).
Patients with hepatic insufficiency: Tramadol is contra-indicated in patients with severe hepatic insufficiency. In patients with moderate hepatic insufficiency, tramadol is not recommended.
Children under 12 years: Not recommended.
Mode of Administration: Oral administration.