Each film coated tablet contains Tramadol Hydrochloride BP 37.5 mg & Paracetamol BP 325 mg.
For the symptomatic treatment of moderate to severe pain, such as post surgical pain, acute and chronic low back pain, osteoarthritic pain, dental pain, muscle pain etc.
Hypersensitivity to Tramadol Hydrochloride, paracetamol or to any of the excipients of the medicinal product. Acute intoxication with alcohol, hypnotic drugs, centrally acting analgesics, opioids or psychotropic drugs. Should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal or with severe hepatic impairment, epilepsy which is not controlled by treatment.
Dosage & Administration
For the management of pain, the recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. Novodol is not recommended in patients under 18 years of age.
The most commonly reported undesirable effects during the clinical trials performed with the Tramadol Hydrochloride/Paracetamol combination were nausea, dizziness and somnolence.
Should be used with caution in opioid dependent patients or in patients with cranial trauma, in patients prone to convulsive disorder, biliary tract disorders, in a state of shock, in an altered state of consciousness for unknown reasons, with problems affecting the respiratory center or the respiratory function, or with an increased intracranial pressure. Paracetamol in overdosage may cause hepatic toxicity in some patients. At therapeutic doses, Tramadol Hydrochloride has the potential to cause withdrawal symptoms. Rarely, cases of dependence and abuse have been reported.
Pregnancy and Lactation Since it is a fixed combination of active ingredients including Tramadol Hydrochloride, it should not be used during pregnancy & lactation.
Use with great caution in patients taking monoamine oxidase inhibitors. Concomitant use of tramadol with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome. Should not be used concomitantly with alcohol consumption. Use in patients with liver disease is not recommended. Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, should not be used concomitantly with other acetaminophen-containing products.
Novodol Tablet: Each box containing 5x10 tablets in blister strips.