INTAL CFC-FREE Pressurised inhalation, suspension Ref.[7203] Active ingredients: Cromoglicic acid

Intal CFC-free must not be used for relief of an acute attack of bronchospasm.

Since therapy is prophylactic, it is important that Intal CFC-free should 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 have relief medication, such as an inhaled short-acting bronchodilator, available 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 reinstated if symptoms of asthma worsen – particularly during periods of stress, such as infection, illness, trauma, or severe antigen challenge. Alternative therapeutic management may also need to be considered.

Intal CFC-Free should be discontinued if eosinophilic pneumonia appears.

Withdrawal of Intal 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 recur.

Sodium cromoglicate has been used for the treatment of a variety of indications in man for many years and no interactions with other drugs have been reported, nor are expected for sodium cromoglicate, due to its pharmacokinetic properties (no metabolism, moderate plasma protein binding, low plasma concentrations) and its high safety profile.

Pregnancy

As with all medication, caution should be exercised especially during the first trimester of pregnancy. Although there is no information with the new HFA-227 formulation in human pregnancy cumulative clinical experience with sodium cromoglicate formulated with CFC propellants, suggests that the active ingredient sodium cromoglicate has no adverse effects on foetal development. In addition, both the new HFA-227 propellant and sodium cromoglicate have been separately shown to be free of adverse effects on the foetus in laboratory animals. It should only be used in pregnancy where there is a clear need.

Breast-feeding

It is not known whether sodium cromoglicate is excreted in human breast milk but on the basis of its physico-chemical properties this is considered unlikely. There is no evidence to suggest that the use of sodium cromoglicate has any undesirable effects on the baby, however, there is no experience to date with either the new HFA-227 propellant alone or formulated with sodium cromoglicate, during lactation in asthmatic patients. It should only be used in lactation where there is a clear need.

Intal CFC-free has no or negligible influence on ability to drive and use machines.

Mild throat irritation, coughing and transient bronchospasm may occur. Headache and rhinitis have also been reported in clinical trials of Intal CFC-free. Hypersensitivity reactions, including angioedema, bronchospasm, hypotension and collapse, have been reported extremely rarely, in patients using inhaled sodium cromoglicate.

As with other inhalation therapy, paradoxical bronchospasm may occur immediately after administration: in such cases immediate treatment with a fast-acting bronchodilator is required and immediate medical attention must be sought. Therapy with Intal CFC-free should be discontinued and alternative treatment instituted.

Very rare cases of eosinophilic pneumonia have been reported.

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.