Uses

Indicated for the short-term management of acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate. Intended for use for five days or less.

Do not use if

Contraindicated in children under 12 years and post-operative management in patients under 18 years after tonsillectomy/adenoidectomy. Also contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, or known hypersensitivity to tramadol or paracetamol. Avoid with MAO inhibitors.

Side effects

Common side effects include nausea, vomiting, constipation, dizziness, somnolence, and headache. Serious risks include life-threatening respiratory depression, serotonin syndrome, seizures, and opioid addiction or misuse.

Warnings

Risk of opioid addiction, abuse, and misuse. Life-threatening respiratory depression can occur, especially in opioid-naive patients. Risk of neonatal opioid withdrawal syndrome if used during pregnancy. Hepatotoxicity risk from paracetamol overdose. Use with caution in patients with head injury, seizure disorders, or CNS depression.

How it works

Tramadol is a centrally acting opioid agonist and inhibitor of norepinephrine and serotonin reuptake, providing analgesia through multiple mechanisms. Paracetamol inhibits prostaglandin synthesis centrally, complementing the analgesic effect. The combination provides additive analgesia at lower individual doses.

Storage

Store at room temperature between 15°C and 30°C. Protect from moisture and light. Keep out of reach of children. Store in a secure location to prevent misuse.