RELENZA

g. 4). Treatment of influenza Treatment should begin as soon as possible, within 48 hours after onset of symptoms for adults, and within 36 hours after onset of symptoms for children. Relenza is for administration to the respiratory tract by oral inhalation only, using the Diskhaler device provided (See section ‘Step-by-step guide to using your Relenza Diskhaler’ in the leaflet for the directions for proper use, including cleaning of the device).

One blister should be utilised for each inhalation. The recommended dose of Relenza for treatment of influenza in adults and children from the age of 5 years is two inhalations (2 x 5 mg) twice daily for five days, providing a total daily inhaled dose of 20 mg.

Prevention of influenza Post-exposure prophylaxis The recommended dose of Relenza for prevention of influenza, following close contact with an individual, is two inhalations (2 x 5 mg) once daily for 10 days. Therapy should begin as soon as possible and within 36 hours of exposure to an infected person.

Seasonal prophylaxis The recommended dose of Relenza for prevention of influenza during a community outbreak is 2 inhalations (2 x 5 mg) once daily for up to 28 days.

Impaired Renal or Hepatic Function:

No dose modification is required. 2).

Elderly patients:

No dose modification is required. 2).

4). The adverse events considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency. Frequencies are defined as very common (≥1/10), common (>1/100, <1/10), uncommon≥ >1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Immune system disorders Uncommon: allergic-type reactions including oropharyngeal oedema Rare: Anaphylactic/Anaphylactoid reactions, facial oedema Nervous systems disorders Uncommon: vasovagal-like reactions have been reported in patients with influenza symptoms, such as fever and dehydration, shortly following inhalation of zanamivir.

Respiratory, thoracic and mediastinal disorders:

Uncommon: bronchospasm, dyspnoea, throat tightness or constriction Skin and subcutaneous tissue disorders: Common: rash Uncommon: urticaria Rare: Severe skin reactions including Erythema Multiforme, Stevens-Johnson syndrome and Toxic epidermal necrolysis Psychiatric and nervous system disorders: Convulsions and psychiatric events such as depressed level of consciousness, abnormal behaviour, hallucinations and delirium have been reported during Relenza administration in patients with influenza.

The symptoms were mainly reported in children and adolescents. Convulsions and psychiatric symptoms have also been reported in patients with influenza not taking Relenza. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

1) who have been treated, it has not been possible to demonstrate the efficacy and safety of Relenza in these groups. Due to limited and inconclusive data, the efficacy of Relenza in the prevention of influenza in the nursing home setting has not been demonstrated.

1). There have been very rare reports of patients being treated with Relenza who have experienced bronchospasm and/or decline in respiratory function which may be acute and/or serious. Some of these patients did not have any previous history of respiratory disease.

Any patients experiencing such reactions should discontinue Relenza and seek medical evaluation immediately. Due to the limited experience, patients with severe asthma require a careful consideration of the risk in relation to the expected benefit, and Relenza should not be administered unless close medical monitoring and appropriate clinical facilities are available in case of bronchoconstriction.

In patients with persistent asthma or severe COPD, management of the underlying disease should be optimised during therapy with Relenza. Should zanamivir be considered appropriate for patients with asthma or chronic obstructive pulmonary disease, the patient should be informed of the potential risk of bronchospasm with Relenza and should have a fast acting bronchodilator available.

2). Zanamivir inhalation powder must not be made into an extemporaneous solution for administration by nebulisation or mechanical ventilation. There have been reports of hospitalised patients with influenza who received a solution made with zanamivir inhalation powder administered by nebulisation or mechanical ventilation, including a fatal case where it was reported that the lactose in this formulation obstructed the proper functioning of the equipment.

2). This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Relenza is not a substitute for influenza vaccination and the use of Relenza must not affect the evaluation of individuals for annual vaccination.

The protection against influenza only lasts as long as Relenza is administered. Relenza should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza is circulating in the community.

Relenza is effective only against illness caused by influenza viruses. There is no evidence for the efficacy of Relenza in any illness caused by agents other than influenza viruses. Neuropsychiatric events have been reported during administration of Relenza in patients with influenza, especially in children and adolescents.

8).

1. Contraindicated in patients with severe milk protein allergy.