Dolopar

Paracetamol and Tramadol hydrochloride is a medicine which is used in relieving moderate to severe pain. Tramadol/acetaminophen contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen.

♦ Treating short-term (5 days or less) pain in certain patients.
♦ Tramadol/acetaminophen is an analgesic combination. It works in certain areas of the brain and nervous system to decrease pain. The combination may provide better pain relief than either medicine alone.

Tramadol is a centrally acting opioid analgesic which binds to mu-opioid receptors and weakly inhibits the reuptake of norepinephrine and serotonin. Paracetamol, a para-aminophenol derivative, has analgesic, antipyretic and weak anti-inflammatory activity. Used together, tramadol and paracetamol combination has a faster onset of action compared to tramadol alone and longer duration of action compared to paracetamol alone.
Onset: 17 minutes.
Duration: 5 Hours.

Absorption:
Tramadol: Readily absorbed from GI tract; mean absolute bioavailability 75-90%.
Paracetamol: Readily absorbed from GI tract, peak plasma concentrations reached in 10-60 minutes.

Distribution:
Tramadol: Widely distributed, crosses the placenta and distributes into the breast milk; protein binding: 20%.
Paracetamol: Widely distributed; crosses placenta and distributes into breast milk; negligible protein binding.

Metabolism:
Tramadol: Undergoes metabolism by the cytochrome P450 isoenzymes CYP3A4 and CYP2D6; one of the metabolites, O-desmethyltramadol is pharmacologically active.
Paracetamol: Metabolised in liver.

Excretion:
Tramadol: Excreted via urine as metabolites (60%) and unchanged drug (30%); elimination half-life of O-desmethyl tramadol: 7 hours.
Paracetamol: Excreted mainly in urine as metabolites and unchanged drugs (<5%); elimination half life: 1-3 hours.

Do NOT use Tramadol and Paracetamol if:
♦ you are allergic to any ingredient in tramadol/acetaminophen or to any other codeine- or morphine-related medicine (eg, oxycodone, hydrocodone, dihydrocodeine, hydromorphone)
♦ you have severe or persistent diarrhea due to taking an antibiotic
♦ you have suicidal thoughts or actions, or a history of alcohol or other substance abuse or addiction
♦ you are intoxicated with alcohol or certain medicines, including opioids or narcotics (eg, morphine, codeine), or sedatives or sleeping medicines (eg, temazepam, zolpidem)
♦ you have liver problems
♦ you are taking carbamazepine, sodium oxybate (GHB), or any other medicine containing tramadol or acetaminophen

Tramadol hydrochloride and Paracetamol tablets, USP Should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, USP, Paracetamol, USP, any other component of this product or opioids. Tramadol hydrochloride and Paracetamol tablets, USPÂ are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride and Paracetamol tablets, USPÂ may worsen central nervous system and respiratory depression in these patients.

Nausea, vomiting, constipation, diarrhoea, abdominal pain, dry mouth, dyspepsia, flatulence, dizziness, somnolence, headache, confusion, mood changes, nightmares, amnesia, sweating, pruritus.

Disclaimer:To be taken only after consulting with the doctor.

Store between 15 - 30°C (59 - 86°F).