Tramicet

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 opioids. Significant resp depression. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally-acting analgesics, opioids or psychotropic drugs. Concurrent or use of MAOIs w/in last 14 days. Childn <18 yr to treat pain after surgery to remove tonsils &/or adenoids; adolescents between 12 & 18 yr w/ obesity or conditions eg, obstructive sleep apnea or severe lung disease; childn <12 yr.

Discontinue use if serotonin syndrome is suspected; at 1st appearance of skin rash or any other sign of hypersensitivity; if severe skin reactions occur. Not to be used in opioid-dependent patients. History of anaphylactoid reactions to codeine. Increased risk of seizure, resp depression, increased ICP or head injury. Adrenal insufficiency; hyponatremia. Increased risk of hepatotoxicity w/ alcohol use. Tolerance, physical & psychological dependence. Avoid abrupt w/drawal. CYP2D6 ultra-rapid metabolisers. May affect sexual function/reproduction in long-term use. Not to be taken concomitantly w/ other paracetamol- or tramadol-containing medicines. Concomitant use w/ CNS depressants including alcohol; SSRIs, TCAs, other tricyclic compds, opioids, MAOIs or other drugs reducing seizure threshold; benzodiazepines. May affect ability to drive & use machines. Not recommended in patients w/ CrCl <10 mL/min & severe hepatic impairment. Not recommended during pregnancy & lactation. Avoid use in adolescents <18 yr. Not recommended in childn <12 yr. Elderly ≥65 yr.

Dizziness, somnolence; nausea. Headache, trembling; confusion, mood changes (anxiety, nervousness, euphoria), sleep disorders; vomiting, constipation, dry mouth, diarrhoea, abdominal pain, dyspepsia, flatulence; sweating, pruritus.

Increased plasma conc w/ CYP3A4 inhibitors eg, macrolides (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), PIs (eg, ritonavir). Decreased plasma conc w/ CYP3A4 inducers eg, rifampin, carbamazepine, phenytoin. Additive CNS depressant effects w/ CNS depressants eg, benzodiazepines & other sedatives/hypnotics, anesth agents, phenothiazines, tranquilizers, opioids or alcohol. Serotonin syndrome w/ serotonergic drugs. Increased risk of seizures & serotonin syndrome w/ MAOIs eg, phenelzine, tranylcypromine, linezolid. High anion gap metabolic acidosis from pyroglutamic acid w/ flucloxacillin. Increased INR w/ warfarin. Inhibition of tramadol metabolism w/ CYP2D6 inhibitors eg, quinidine, fluoxetine, paroxetine, amitriptyline, bupropion.

Analgesics (Opioid)

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

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