TILADE Pressurised inhalation suspension Ref.[9324] Active ingredients: Nedocromil

Tilade CFC-Free must not be used for the relief of an acute attack of bronchospasm.

Since therapy is prophylactic, it is important that Tilade CFC-Free be used regularly, every day, in those patients who benefit, even if they become asymptomatic. The patient should also be advised that because several doses may be needed to establish benefit, relief may not be apparent immediately, but may take some weeks to develop.

Patients should be advised to have relief medication available (such as an inhaled short-acting bronchodilator) to relieve symptoms of acute asthma, and must be instructed to seek medical attention if their relief medication becomes less effective, or if more inhalations than usual are required to control symptoms.

In those cases where corticosteroid therapy has been reduced or discontinued, such therapy may need to be increased or be re-instated if symptoms of asthma worsen – particularly during periods of stress, such as infection, illness, trauma, severe antigen challenge. Alternative therapeutic management may also need to be considered.

Withdrawal of Tilade CFC-Free therapy

If it is necessary to withdraw this treatment, it should be done progressively over a period of one week. Symptoms of asthma may reoccur.

Nedocromil sodium has been used in association with numerous other drugs in man, including oral and inhaled β-adrenergic agonists, inhaled and oral corticosteroids, theophylline and other methylxanthines and ipratropium bromide. No harmful interactions have been observed in humans or animals.

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

Studies in pregnant and lactating animals have failed to reveal a hazard with nedocromil sodium. However, as with all new medicines, caution should be exercised during pregnancy (especially during the first trimester) and while breast feeding.

Pregnancy

There is no information on the use of nedocromil sodium formulated with propellant HFA-227 or with propellant HFA-227 alone in human pregnancy. However studies of HFA-227 administered to pregnant and lactating animals have not revealed any special risk and cumulative clinical experience with nedocromil sodium formulated with CFC propellants would suggest that nedocromil sodium has no adverse effects on fetal development. Nedocromil sodium formulated with propellant HFA-227 (in Tilade CFC-Free) should only be used in pregnancy where there is a clear need.

Breast-feeding

On the basis of animal studies and its physicochemical properties it is considered that only negligible amounts of nedocromil sodium may pass into human breast milk. There is no evidence to suggest that the use of nedocromil sodium during breast-feeding has any undesirable effects on the baby. However there is no experience to date with nedocromil sodium formulated with propellant HFA-227 or with propellant HFA-227 alone during lactation in female patients with asthma. Nedocromil sodium formulated with propellant HFA-227 (as in Tilade CFC-Free) should only be used in lactation where there is a clear need and its use should be restricted to those situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Tilade CFC Free has no or negligible influence on the ability to drive and use machines.

The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1% and <10%; Uncommon ≥0.1% and <1%; Rare ≥0.01% and <0.1%; Very rare <0.01%; Unknown (cannot be estimated from available data).

In clinical studies conducted in patients treated with nedocromil sodium metered dose inhaler, the following adverse events have been reported at the corresponding frequencies:

Gastrointestinal disorders

Very common: Abdominal pain, vomiting, nausea

Common: Dyspepsia

Respiratory, thoracic and mediastinal disorders

Very common: Cough, bronchospasm

Frequency not known: Throat irritation, pharyngitis

Nervous system disorders

Very common: Headache

Common: Dysgeusia

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing, dyspnoea and/or tightness in the chest following administration. This requires immediate treatment with a fast-acting inhaled bronchodilator and immediate medical attention must be sought straightaway. Therapy with Tilade CFC-Free should be discontinued immediately and alternative treatment instituted.

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.