Warnings: In adults and adolescents 12 years and older. The maximum dose of 8 tablets of Tramadol Hydrochloride & Paracetamol tablets should not be exceeded. In order to avoid inadvertent overdose, patients should be advised not to exceed the recommended dose and not to use any other paracetamol (including over the counter) or tramadol hydrochloride containing products concurrently without the advice of a physician.
In severe renal insufficiency (creatinine clearance <10 ml/mm), Tramadol Hydrochloride & Paracetamol tablets is not recommended.
In patients with severe hepatic impairment Tramadol Hydrochloride & Paracetamol tablets should not be used. The hazards of paracetamol overdose are greater in patients with non-cirrhotic alcoholic liver disease. In moderate cases prolongation of dosage interval should be carefully considered.
In severe respiratory insufficiency, Tramadol Hydrochloride & Paracetamol tablets is not recommended.
Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.
Convulsions have been reported in tramadol-treated patients susceptible to seizures or taking other medications that lower the seizure threshold, especially selective serotonin re-uptake inhibitors, tricyclic antidepressants, antipsychotics, centrally acting analgesics or local anaesthesia. Epileptic patients controlled by a treatment or patients susceptible to seizures should be treated with Tramadol Hydrochloride & Paracetamol tablets only if there are compelling circumstances. Convulsions have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses of tramadol exceed the recommended upper dose limit.
Concomitant use of opioid agonists-antagonists (nalbuphine, buprenorphine, pentazocine) is not recommended.
Precautions for use: Tramadol Hydrochloride & Paracetamol tablets 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 has the potential to cause withdrawal symptoms.
Rarely, cases of dependence and abuse have been reported.
Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur.
In one study, use of tramadol during general anaesthesia with enflurane and nitrous oxide was reported to enhance intra-operative recall. Until further information is available, use of tramadol during light planes of anaesthesia should be avoided.
Effects on ability to drive and use machines: Tramadol may cause drowsiness or dizziness, which may be enhanced by alcohol or other CNS depressants. If affected, the patient should not drive or operate machinery.
Use in Pregnancy: Since Tramadol Hydrochloride & Paracetamol tablets is a fixed combination of active ingredients including tramadol, it should not be used during pregnancy.
Data regarding paracetamol: Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosages.
Data regarding tramadol: Tramadol should not be used during pregnancy as there is inadequate evidence available to assess the safety of tramadol in pregnant women.
Tramadol administered before or during birth does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant. Long-term treatment during pregnancy may lead to withdrawal symptoms in the newborn after birth, as a consequence of habituation.
Use in Lactation: Since Tramadol Hydrochloride & Paracetamol tablets is a fixed combination of active ingredients including tramadol, it should not be ingested during breast feeding.
Data regarding paracetamol: Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding by women using single ingredient medicinal products containing only paracetamol.
Data regarding tramadol: Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest about 0.1% of the dose given to the mother. Tramadol should not be ingested during breast feeding.