Abridged Prescribing Information:

Composition:  TRD-CONTIN™ 50 & 100: Each white, oblong, scored, film coated tablet of CONTINUS™ contains Tramadol Hydrochloride BP 50 mg & BP 100 mg in the CONTINUS™ controlled release system.

Clinical Pharmacology: Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, at least two complementary mechanisms appear applicable binding of parent drug and its M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.

Indication: Moderate to moderately severe pain.

Dosage & Administration: The following guidelines apply, unless the doctor has prescribed TRD-CONTIN™ 50 & 100 (Tramadol hydrochloride tablets) adults and adolescents from the age of 12 years: Tramadol Hydrochloride 50 mg – 100 mg (one TRD-CONTIN™ 50 mg CONTINUS™ controlled release tablet to one TRD-CONTIN™ 100 mg CONTINUS™ controlled release tablet) twice daily, increased if necessary to 150 mg – 200 mg (three TRD-CONTIN™ CONTINUS™ controlled release 50 mg tablets to two TRD-CONTIN™ 100 mg CONTINUS™ controlled release tablets) twice daily, preferably in the morning and evening. In general, the lowest pain-relieving dose should be selected. Daily doses of 400 mg Tramadol should not be exceeded, unless there are special medical reasons for doing so. The interval between doses must be more than eight hours.

Children: TRD-CONTIN™ (Tramadol Hydrochloride) tablets are not intended for use in children below the age of 12 years. Geriatric patients: In general it is not necessary to adjust the dose in elderly patients (up to 75 years) with no signs of severe liver or kidney disease. In old patients (above 75 years) excretion may be prolonged. Consequently, the dosage interval may have to be prolonged, depending on the individual patient.

Contraindications: Hypersensitivity to tramadol; acute central nervous system intoxications due to alcohol, opioids or psychotropic; opioid-dependent patients; children and nursing mothers.

Side Effects: Dizziness, nausea, constipation, headache, vomiting, pruritus, sweating and dry mouth may occur after tramadol administration. Palpitation and postural hypotension has been observed in rare cases. Convulsions have been reported with the use of tramadol especially in those taking higher doses of the product and / or tricyclic antidepressants, selective serotonin reuptake inhibitor antidepressants or MAO inhibitors, with a higher risk in epileptic patients.

Use in pregnancy and lactation: The safety of tramadol in pregnancy has not been established (Pregnancy-Category C). Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, tramadol should be used in pregnancy only if the potential benefit justifies the risk to the fetus. Tramadol hydrochloride should not be administrated during breast feeding as tramadol and its metabolites have been detected in breast milk.

Drug interaction: In general, physician need not be concerned about drugs interacting with tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with tramadol. Concomitant administration of carbamazepine with tramadol causes a significant increase in tramadol metabolism and it requires to increase the dose of tramadol.

Overdose: After taking very high doses, reduced level of consciousness up to coma (deep unconsciousness), generalized epileptic fits, fall in blood pressure, fast heart-beat, pinpoint or wide pupils, and difficulty in breathing up to stoppage of breathing may occur. In such cases, a doctor should be called immediately.

Storage: Store at or below 30°C, in a dry place, protected from light. Presentation: TRD-CONTIN™ 50: Box of 50 tables. TRD-CONTIN™ 100: Box of 50 tables.