Posology: ADULTS AND ADOLESCENTS (12 years and older): The use of Tramadol HCl + Paracetamol (Tramadin Plus) should be restricted to patients whose moderate to severe pain is considered to require a combination of paracetamol and tramadol. The dose should be individually adjusted according to intensity of pain and response of the patient. An initial dose of two tablets of Tramadol HCl + Paracetamol (Tramadin Plus) is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 2600 mg paracetamol and 300 mg tramadol) per day. The dosing interval should not be less than six hours. Tramadol HCl + Paracetamol (Tramadin Plus) should under no circumstances be administered for longer than is strictly necessary. If repeated use or long term treatment with Tramadol HCl + Paracetamol (Tramadin Plus) 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.
Children: The effective and safe use of Tramadol HCl + Paracetamol (Tramadin Plus) has not been established in children below the age of 12 years. Treatment is therefore not recommended in this population.
Elderly patients: 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.
Renal insufficiency: Because of the presence of tramadol, the use of Tramadol HCl + Paracetamol (Tramadin Plus) 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 hemodialysis or by hemofiltration, post dialysis administration to maintain analgesia is not usually required.
Hepatic insufficiency: In patients with severe hepatic impairment Tramadol HCl + Paracetamol (Tramadin Plus) should not be used. In moderate cases prolongation of the dosage interval should be carefully considered.
Method of administration:
Oral use, Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed.
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