The effective and safe use of Tramadol/Paracetamol has not been established in children below the age of 12 years. If repeated use or long-term treatment with Tramadol/Paracetamol is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible) to assess whether continuation of the treatment is necessary. Tramadol/Paracetamol should under no circumstances be administered for longer than is strictly necessary (see Section 4.4 - Special warnings and precautions for use). The dosing interval should not be less than 6 hours. The lowest effective dose for analgesia should generally be selected.Īn initial dose of two tablets of Tramadol/Paracetamol 37.5 mg / 325 mg or one tablet of Tramadol/Paracetamol 75 mg / 650 mg is recommended.Īdditional doses can be taken as needed, not exceeding 8 tablets of Tramadol/Paracetamol 37.5 mg / 325 mg or 4 tablets of Tramadol/Paracetamol 75 mg / 650 mg (equivalent to 300 mg of tramadol and 2600 mg of paracetamol) per day. The dose should be adjusted, to the intensity of pain and sensitivity of the individual patient. The use of Tramadol/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol. Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol hydrochloride in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).Īdults and adolescents (12 years and older).
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