Duocetz

Paracetamol 325 mg, tramadol HCl 37.5 mg

Management of moderate to severe pain.

Adult & childn >16 yr 1-2 tab every 4-6 hr for pain relief. Max: 8 tab daily.

Should be taken with food.

Previous hypersensitivity to tramadol, paracetamol or opioids. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.

Not to be given in patients w/ history of anaphylactoid reactions to codeine & other opioids; who are suicidal or addiction-prone. Patients at risk for resp depression; w/ increased ICP or head injury. Not to be co-administered w/ other tramadol or paracetamol-containing products; alcohol. May cause seizures &/or serotonin syndrome in concomitant use w/ serotonergic agents (including SSRIs, SNRIs & triptans) or drugs that significantly reduce metabolic clearance of tramadol. May complicate clinical assessment of patients w/ acute abdominal conditions. W/drawal symptoms may occur in abrupt discontinuation. Opioid abuse & dependence. Concomitant use w/ tranquilizers, hypnotics or other opiates-containing analgesics. May impair mental or physical abilities required in driving a car or operating machinery. Renal impairment. Not recommended in hepatic impairment. Pregnancy; not to be used in pregnant women prior to or during labor. Lactation; not recommended for obstetrical pre-op medication or post-delivery analgesia in nursing mothers. Childn <16 yr. Elderly.

Constipation, nausea, diarrhea, dry mouth, psychiatric disorders, somnolence, anorexia, insomnia, dizziness, sweating, increased pruritus, prostatic disorder.

Concomitant use w/ drugs that may affect serotonergic neurotransmitter systems eg, SSRIs, MAOIs, triptans, linezolid, lithium or St. John's Wort. Potential serotonin syndrome w/ triptans. Alters effect (including elevation of prothrombin times) of warfarin. Tramadol: Metabolic clearance may be reduced w/ inhibitors of CYP2D6 (eg, quinidine, fluoxetine, paroxetine & amitriptyline) & CYP3A4 (eg, ketoconazole & erythromycin). Reduced analgesic effect w/ carbamazepine. Increased conc w/ quinidine. Digoxin toxicity.

Analgesics (Opioid)

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

CM