Adults and Adolescents (12 years and older): The dose should be individually adjusted according to intensity of pain and response of the patient.
An initial dose of 2 tablets is recommended. Additional doses can be taken at the minimum 6 hours intervals, not exceeding 8 tablets per day.
This drug should under no circumstances be administered for longer than is strictly necessary. If repeated use or long term treatment with this drug is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place, to assess whether continuation of the treatment is necessary.
Pediatrics: The effective and safe use of this drug has not been established in children below the age of 12 years. Treatment is therefore not recommended in this population.
Geriatrics: The usual dosages may be used although it should be noted that in volunteers aged over 75 years the elimination half life of tramadol was increased by 17% following oral administration. In patients over 75 years old, it is recommended that the minimum interval between doses should be not less than 6 hours, due to the presence of tramadol, or as prescribed by the physician.
Renal insufficiency: Because of the presence of tramadol, the use of BELCETRA is not recommended in patients with severe renal insufficiency (creatinine clearance < 10 ml/min). In cases of moderate renal insufficiency (creatinine clearance between 10 and 30 ml/min), the dosing should be increased to 12-hourly intervals. As tramadol is removed only very slowly by haemodialysis or by haemofiltration, post dialysis administration to maintain analgesia is not usually required.
Hepatic failure: It is cautiously considered that patients with moderate hepatic failure take this drug at prolonged administration interval.
This drug is contraindicated to patients with moderate hepatic failure.
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