Not to be given in patients w/ history of anaphylactoid reactions to codeine & other opioids. Not to be used in opioid-dependent patients. Increased risk of seizure w/ doses above the recommended range. Risk of convulsions may be increased in patients w/ epilepsy, those w/ history of seizures, or those w/ a recognized risk for seizure. Patients at risk for resp depression; w/ increased ICP or head injury. Chronic heavy alcohol abusers may be at increased risk of liver toxicity. W/drawal symptoms may occur in abrupt discontinuation. Use w/ caution & in reduced doses in patients receiving CNS depressants eg, alcohol, opioids, anaesth agents, phenothiazines, tranquilizers or sedative hypnotics. Not to be coadministered w/ other tramadol- or paracetamol-containing products. Concomitant use w/ SSRI, TCA, other tricyclic compd (eg, cyclobenzaprine, promethazine), or opioids; MAOIs, neuroleptics, or other drugs that reduce seizure threshold. May impair mental & physical abilities required for the performance of potentially hazardous tasks eg, driving a car or operating machinery. Not recommended in severe hepatic impairment. Safe use in pregnancy has not been established. Not recommended during lactation. Not recommended in childn <12 yr.