OSELFLU Gelatin capsule Ref.[50457] Active ingredients: Oseltamivir

Neuropsychiatric events such as convulsions, abnormal and inappropriate behaviour, disturbances in consciousness, hallucinations and delirium have been reported during OSELFLU administration in patients with influenza. In rare cases, the delirium resulted in fatal accidental injury. These events occurred mostly within the first few days of taking OSELFLU. All patients taking OSELFLU should be carefully monitored for these adverse events.

There is no evidence for efficacy of OSELFLU in any illness caused by agents other than influenza virus types A and B.

OSELFLU is not a substitute for influenza vaccination.

Dose adjustment is recommended for patients with creatinine clearance of 10-30 ml/min for the treatment of influenza and the prophylaxis of influenza. No dosing recommendation is available for patients undergoing routine haemodialysis and continuous peritoneal dialysis with end stage renal disease and for patients with creatinine clearance of ≤10 ml/min (see section 4.2).

Paediatric population

The safety and efficacy of OSELFLU in children under 1 year has not been established (see section 4.3), therefore, OSELFLU should not be used in children under 1 year of age.

Information derived from pharmacology and pharmacokinetic studies of OSELFLU indicate that clinically significant medicine interactions are unlikely. There is no mechanistic basis for an interaction with oral contraceptives.

Cimetidine: A non-specific inhibitor of cytochrome P450 isoforms and competitor for renal tubular secretion of basic or cationic medicines, has no effect on plasma levels of OSELFLU or its active metabolite. Clinically important medicine interactions involving competition for renal tubular secretion are unlikely due to the known safety margin for most of these medicines, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways.

Additional information on special populations

Not applicable.

Paediatric population

Not applicable.

Pregnancy

The safety and efficacy of OSELFLU during pregnancy have not been established (see section 4.3).

Breastfeeding

The safety and efficacy of OSELFLU during breastfeeding have not been established (see section 4.3).

Fertility

There is no evidence that OSELFLU has an effect on male or female fertility (see section 5.3).

OSELFLU can cause neuropsychiatric side effects that can influence a patient’s ability to drive and use machines. Patients should be advised to not drive or use machines until they know how OSELFLU affects them (see section 4.8, Post-marketing experience).

a. Summary of the safety profile

Not applicable.

b. Tabulated summary of adverse reactions

c. Description of selected adverse reactions

Not applicable.

Post-marketing experience

Neuropsychiatric events such as convulsions, abnormal and inappropriate behaviour, disturbances in consciousness, hallucinations and delirium have been reported during OSELFLU administration in patients with influenza. In rare cases the delirium resulted in fatal accidental injury. These events occurred mostly within the first few days of taking OSELFLU. Patients, and especially paediatrics and adolescents, taking OSELFLU should be carefully monitored.

Skin and subcutaneous disorders

Rare cases of hypersensitivity reactions such as allergic skin reactions, including dermatitis, rash, eczema, urticaria, and very rare cases of erythema multiforme and Stevens-Johnson syndrome have been reported. Also, allergy, anaphylactic/ anaphylactoid reactions and angioedema have been reported.

Liver and biliary system disorders

Very rare reports of hepatitis and elevated liver enzymes have been reported in patients with influenza-like illness receiving OSELFLU.

d. Paediatric population

Not applicable.

e. Other special population(s)

Not applicable.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.