tramadol + paracetamol


Korea Pharma


SB Pharma
Concise Prescribing Info
Paracetamol 325 mg, tramadol HCl 37.5 mg
Symptomatic treatment of moderate to severe pain.
Dosage/Direction for Use
Adult & childn >12 yr Initially 2 tab. Max 8 tab w/ interval of not <6 hr.
May be taken with or without food.
Hypersensitivity. Acute intoxication w/ alcohol, hypnotics, centrally-acting analgesics, opioids or psychotropics. Concomitant w/ MAOIs or w/in 2 wk after withdrawal. Severe hepatic impairment. Uncontrolled epilepsy.
Special Precautions
Severe renal insufficiency (CrCl <10 mL/min), hepatic impairment, resp insufficiency. Concomitant w/ opioid agonists-antagonists. Opioid-dependent patients, cranial trauma, convulsive disorder, biliary tract disorder, in state of shock, altered state of consciousness for unknown reason, problems affecting resp center or function, increased intracranial pressure. Avoid use of tramadol during light planes of anaesth. Moderate renal insufficiency. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <12 yr. Elderly >75 yr.
Adverse Reactions
Dizziness, somnolence, headache, trembling, confusion, mood changes, sleep disorders.
Drug Interactions
Concomitant use is contraindicated w/ non-selective MAOIs, selective-A & B MAOIs; not recommend w/ alcohol, carbamazepine & other enzyme inducers, opioid agonists-antagonists; needs consideration w/ selective serotonin re-uptake inhibitors, triptans, other opioid derivatives & anxiolytics, barbiturates, benzodiazepines, hypnotics, sedative antidepressants & antihistamines, neuroleptics, centrally-acting antihypertensives, TCAs, thalidomide, baclofen, warfarin-like compd, ketoconazole, erythromycin, bupropion, ondansetron.
MIMS Class
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Hycephen FC tab
10 × 10's;2 × 10's
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