Special Warnings: In adults and adolescents 12 years and older. The maximum dose of 8 tablets of Tramadol HCl + Paracetamol (Tramadin Plus) 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 HCl + Paracetamol (Tramadin Plus) is not recommended. - In patients with severe hepatic impairment Tramadol HCl + Paracetamol (Tramadin Plus) 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 HCl + Paracetamol (Tramadin Plus) 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 anesthesia. Epileptic patients controlled by a treatment or patients susceptible to seizures should be treated with Tramadol HCl + Paracetamol (Tramadin Plus) 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.
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