General: Convulsion and delirium-like neuropsychiatric events have been reported during Tamiflu administration in patients with influenza, predominately in children and adolescents. In rare cases, these events resulted in accidental injury. The contribution of Tamiflu to those events is unknown and these have also been reported in patients with influenza who were not taking Tamiflu. Three separate large epidemiological studies confirmed that influenza infected patients receiving Tamiflu are at no higher risk of developing neuropsychiatric events in comparison to influenza infected patients not receiving antivirals (see Postmarketing Experience under Adverse Reactions).
Patients, especially children and adolescents, should be closely monitored for signs of abnormal behaviour.
There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B.
For dose adjustments in patients with renal impairment see Special Dosage Instructions under Dosage & Administration (see also Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
A bottle of 30 g Tamiflu powder for oral suspension contains 25.713 g of sorbitol. One dose of 45 mg oseltamivir administered twice daily delivers 2.6 g of sorbitol. For subjects with hereditary fructose intolerance this is above the recommended daily maximum limit of sorbitol.
Drug Abuse and Dependence: Not applicable.
Renal Impairment: See Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Hepatic Impairment: See Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Ability to Drive and Use Machines: No or negligible influence on the ability to drive and use machines.
Use in Children: See Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Use in Elderly: See Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
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