Dolcet

Tramadol HCl 37.5 mg, paracetamol 325 mg

Management of moderate to severe pain.

Adult & childn ≥16 yr 1-2 tab every 4-6 hr. Max: 8 tab daily.

May be taken with or without food.

Hypersensitivity to tramadol, paracetamol or any other opioids. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally-acting analgesics, opioids or psychotropic drugs. Concurrent use w/ MAOIs or w/in the last 14 days. Post-op management in childn <18 yr following tonsillectomy &/ adenoidectomy. Childn <12 yr.

Discontinue use at 1st appearance of skin rash or any other sign of hypersensitivity. Not to be given in patients w/ history of anaphylactic reactions to codeine & other opioids. Increased risk of convulsions in patients w/ epilepsy, history of seizures or those w/ recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal CNS infections). Patients at risk for resp depression; who are CYP2D6 ultra-rapid metabolizers; w/ increased ICP or head injury. Evaluate patients on an ongoing basis for onset of a new sleep apnea or worsening of an existing sleep apnea. Monitor for signs & symptoms of hyponatremia during treatment in patients w/ predisposing factors. Drug dependence & potential for abuse; not to be used in opioid-dependent patients. W/drawal symptoms may occur if discontinued abruptly. Chronic alcohol abusers. Concomitant use w/ SSRIs (antidepressants or anorectics), TCAs, other tricyclic compd (eg, cyclobenzamine, promethazine) or opioids; MAOIs, neuroleptics or other drugs reducing seizure threshold; anesth or alcohol; CNS depressants. May impair ability to drive or operate machinery. Renal impairment. Not recommended in severe hepatic impairment. Pregnancy. Not recommended during lactation. Avoid use in adolescents <18 yr.

Nausea, dizziness, vomiting, headache, somnolence & constipation.

Decreased rate of metabolism w/ inhibitors of CYP2D6 (eg, quinidine, fluoxetine, paroxetine, amitriptyline, bupropion) & CYP3A4 [eg, macrolides (eg, erythromycin), azole antifungal agents (eg, ketoconazole), PIs (eg, ritonavir)]. Increased rate metabolism w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). Additive or synergistic pharmacodynamic effect w/ benzodiazepines & CNS depressants including alcohol; SSRIs, serotonin & SNRIs, TCAs, triptans, 5-HT₃ receptor antagonists, drugs affecting serotonin neurotransmitter system (eg, mirtazapine, trazodone) & some muscle relaxants (eg, cyclobenzaprine, metaxalone); MAOIs (eg, phenelzine, tranylcypromine, linezolid); flucloxacillin. Increased INR w/ warfarin; may produce hypoprothrombinemia w/ warfarin-like compd.

Analgesics (Opioid) / Supportive Care Therapy

N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.

Rx