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The maximum dose of 8 tablets of Tramadol hydrochloride/Paracetamol should not be exceeded in adults and adolescents 12 years and older. In order to avoid inadvertent overdose, patients should be advised not to exceed the recommended dose and not to use any other Paracetamol (including over-the-counter) or Tramadol hydrochloride containing products concurrently without the advice of a physician.
In severe renal impairment (creatinine clearance <10 mL/min), Tramadol hydrochloride/Paracetamol is not recommended.
In patients with severe hepatic impairment, Tramadol hydrochloride/Paracetamol should not be used. The hazards of Paracetamol overdose are greater in patients with non-cirrhotic alcoholic liver disease. In moderate cases, prolongation of dosage interval should be carefully considered.
In severe respiratory impairment, Tramadol hydrochloride/Paracetamol is not recommended.
Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, Tramadol cannot suppress morphine withdrawal symptoms.
Convulsions have been reported in Tramadol-treated patients susceptible to seizures or taking other medications that lower the seizure threshold, especially selective serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics, centrally acting analgesics or local anaesthesia. Epileptic patients controlled by a treatment or patients susceptible to seizures should be treated with Tramadol hydrochloride/Paracetamol only if there are compelling circumstances. Convulsions have been reported in patients receiving Tramadol at the recommended dose levels. The risk may be increased when doses of Tramadol exceed the recommended upper dose limit.
