Paracetamol/ Tramadol

Tablet:

• 37.5mg/325 mg
• 50mg/500mg
• 65mg/500mg

Do not co-administer with other tramadol or acetaminophen containing products

Tramadol: Centrally-acting opioid. It is thought to bind to mu opioid receptors and weakly inhibits nor-epinephrine/serotonin reuptake, producing analgesia

Paracetamol/acetaminophen: It inhibits prostaglandin synthesis in CNS and may block peripheral pain impulse generation. For antipyresis, it acts on the hypothalamus

• Somnolence
• Constipation
• Diaphoresis
• Dizziness
• Nausea
• Anorexia
• Diarrhea
• Xerostomia
• Insomnia
• Pruritus
• Prostatic disorder

• Hypersensitivity to components
• Hypersensitivity to opioids
• MAO inhibitor use within 14 days
• Ultra-rapid CYP2D6 metabolizers
• Patients <12 years old
• Patients 12-18 years with respiratory depression risk
• Post-tonsillectomy or adenoidectomy use (patients <18 years)
• Severe respiratory depression
• Acute or severe asthma
• Known or suspected GI obstruction
• Paralytic ileus
• Hepatic impairment
• Acute alcohol intoxication
• Acute drug intoxication
• Suicidal ideation or behaviour
• History of addiction
• Circulatory shock
• Coma
• Impaired consciousness
• Uncorrected electrolyte abnormalities
• Abrupt withdrawal

WARNING

• Hepatotoxicity may occur with acetaminophen doses that exceed 4g/day
• Paracetamol associated with cases of acute liver failure, at times resulting in liver transplant and death
• Risk of opioid addiction, abuse and misuse, which can lead to overdose and death
• Serious, life-threatening or fatal respiratory depression may occur
• Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated
• Concomitant opioid use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death
• Respiratory depression and death have occurred in children who received tramadol post-tonsillectomy and/or adenoidectomy and were ultra-rapid CYP2D6 metabolizers

• Cisapride
• Dronedarone
• Fluconazole
• Isocarboxazid
• Isoniazid
• Levoketoconazole
• Lidocaine topical
• Linezolid
• Methylene blue
• Naltrexone
• Phenelzine
• Pimozide
• Posaconazole
• Prilocaine topical
• Procarbazine
• Quinidine
• Rasagiline
• Safinamide
• Samidorphan
• Selegiline
• Thioridazine
• Tranylcypromine
• Yohimbe