ABRIDGED PRESCRIBING INFORMATION

Composition: TRD-PTM is available as a film coated tablet for oral administration containing Tramadol Hydrochloride BP 37.5 mg & Paracetamol BP 325 mg.

Pharmacology: Tramadol is a centrally acting synthetic opioid analgesic. Paracetamol is a non-opiate centrally acting analgesic. Indication: For the short-term management of moderate to severe pain.

Dosage: 1-2 tablets every 4 to 6 hours, as needed for pain relief up to a maximum of 8 tablets per day.

Contraindications: TRD-PTM must not be taken in cases of: Known hypersensitivity to any component of this product or to opioids; Acute intoxication with hypnotics, analgesics, opioids and psychoactive substances.

Warning & Precautions: The recommended dose of TRD-P™ should not be exceeded. Overdose may be injurious to liver. TRD-P™ should not be co-administered with other tramadol or paracetamol containing products.

Side Effects:  The most common reported events were nausea, dizziness and somnolence.

Pregnancy & Lactation: There are no adequate and well-controlled studies in pregnant women. Safe use in pregnancy has not been established. It is not recommended for nursing mothers because its safety in infants and newborn has not been studied.

Use in Children: TRD-P™ tablets are not recommended for use in children.

Drug interactions: Tramadol should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics.

Overdose: The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, paracetamol toxicity or both.

Storage: Store at or below 300C, in a dry place, protected from light. Keep out of reach of children.

Presentation: TRD-PTM  Tablet: Box of 50 tablets (5 x 10’s blister strip).