TDL Plus Special Precautions

Seizures: Seizures have been reported in patients receiving Tramadol within the recommended dosage range. Spontaneous post marketing reports indicate that the seizures risk in increased with the doses of Tramadol above the recommended range. Concomitant use of Tramadol increases the seizures risk in patients taking: selective serotonin reuptake inhibitors (SRRI) antidepressants or anorectics, tricyclic antidepressants (TCAs) and other tricyclic compounds (egg., Cyclobenzaprine, promethazine, etc.), or opioids.
Administration of Tramadol may enhance the seizures risk in patients taking MAO inhibitors, neuroleptics or other drugs that reduce the seizure's threshold. Risk of convulsions may also increase the risk of seizures.
Anaphylactoid Reactions: Patients with a history of Anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Tramadol + Paracetamol.
Respiratory Depression: Administer Tramadol + Paracetamol cautiously in patients at risk of respiratory depression. When large doses of Tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Treat such cases as overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use with CNS Depressants: Tramadol + Paracetamol should be used with caution ad in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, Phenothiazines tranquilizers or sedative hypnotics.
Increase Intra-cranial Pressure or Head Trauma: Tramadol + Paracetamol should be used with the caution in patients with increase intra-cranial pressure or head injury.
Use with Alcohol: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use.
Withdrawal: Withdrawal symptoms may occur if Tramadol + Paracetamol is discontinued abruptly. Pain attack, severe anxiety, hallucinations, paresthesia, tinnitus, and unusual CNS symptoms have also been rarely reported with abrupt discontinuation of Tramadol hydrochloride. Clinical experience suggest that the withdrawal symptoms may be received by tapering the medication.
Use with MAO Inhibitors and Serotonin Reuptake Inhibitors Use: Tramadol + Paracetamol with great caution in patients taking monoamine oxidase inhibitors. Concomitant use of Tramadol with the MAO 30mL/min, it is recommended that the dosing interval of Tramadol + Paracetamol be increased, but not exceed 2 tablets every 12 hours.
Use in Hepatic Diseases: The use of Tramadol + Paracetamol in patients with severe hepatic impairment is not recommended.
Serious Skin Reactions: Such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving Paracetamol.
General Precautions: The recommended dose of Tramadol + Paracetamol should not be exceeded.
Tramadol + Paracetamol should not be co-administered with other Tramadol or Paracetamol-containing products.
Effects on Ability to Drive and Use Machines: Tramadol + Paracetamol may impair mental or physical abilities required for the performance of potentially hazardous tasks, such as driving a car operating machinery.