Regulatory Class: ℞

Formulations: Tramadol hydrochloride 37.5 mg, paracetamol 325 mg

Indications or Uses: Management of moderate to severe pain.

Dosage and Directions for Use: Adult & childn >16 yr Pain relief 1-2 tab every 4-6 hr. Max: 8 tab/day.

Administration: Taken with or without food

Contraindication: Hypersensitivity. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs.

Special Precaution: Increased risk of seizures patients w/ epilepsy, history of seizures or in those w/ recognized risk for seizure; in combination w/ SSRIs, antidepressants or anorectics, Tricyclic antidepressants (TCA's) & other tricyclic compounds eg, cyclobenzapine, promethazine) or opioids, Monoamine oxidase inhibitors (MAOIs), neuroleptics or other drugs that reduce seizure's threshold. Anaphylactoid reactions. Patients w/ risk of resp depression, those receiving CNS depressants, increased intra-cranial pressure or head injury. Chronic heavy alcohol abusers. W/drawal symptoms may occur w/ abrupt discontinuation. Serious skin reactions eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Impaired renal function. Severe hepatic impairment. May impair ability to drive & use machines. Pregnancy & lactation. Childn < 16 yr.

Adverse Reaction: Nausea, dizziness, somnolence.

Interactions: Reduced analgesic effect w/ carbamazepine. Increased INR w/ warfarin-like compd. MAOIs & SSRIs. Tramadol: Increased conc w/ quinidine. Inhibited metabolism w/ CYP2D6 inhibitors eg, fluoxetine, paroxetine & amitriptyline.

Presentation/Packaging: Film coated tablet 10's, 50's.

For more information on this product, please see the product insert