Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, G6 1PT, UK Trading as: anofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Tilade CFC-Free is recommended for the treatment of bronchial asthma where regular preventative anti-inflammatory therapy is indicated and, in particular, in patients whose asthma is not adequately controlled by bronchodilators alone. Tilade CFC-Free may be given in addition to all existing therapies and in many cases will provide added therapeutic benefit.
For inhalation use.
The initial dose is 4 mg (2 actuations) four times daily. Once control of symptoms has been achieved it may be possible to reduce the dose to a maintenance dose of 4mg (2 actuations) twice daily.
Tilade CFC-Free is intended for regular daily use and should not be used for the relief of symptoms in an acute attack.
Tilade CFC-Free is not recommended for use in children 6 years of age and younger.
Where a concomitant inhaled bronchodilator is prescribed it is recommended that this be administered prior to Tilade CFC-Free.
In patients currently treated with steroids, the addition of Tilade CFC-Free to the regimen may make it possible to reduce the maintenance dose of steroids, or discontinue steroid therapy completely. The patient must be carefully supervised while the steroid dose is reduced; a rate of 10% weekly is suggested.
If a reduction of a steroid dose has been possible, Tilade CFC-Free should not be withdrawn until steroid cover has been re-instituted.
If the inhaler is new, release 4 actuations prior to inhalation. If the inhaler has not been used for more than 3 days, release 2 actuations prior to inhalation.
The inhaler should be well shaken and the dustcap removed. The mouthpiece of the inhaler should be placed in the mouth and the lips closed around it prior to the patient beginning to breathe in. The patient should then be instructed to breathe in slowly and deeply through the mouth and as inhalation begins the aerosol should be actuated by pressing the can down firmly with the first finger whilst continuing to breathe in. The breath should then be held for 10 seconds before exhaling into the air. To avoid condensation of moisture in the inhaler and blocking of the spray, exhalation through the inhaler should be avoided. If the patient needs two actuations they should be instructed to wait for about one minute before repeating the inhalation procedure. The dustcap should be replaced following use. To prevent excessive accumulation of powder the plastic body and mouthpiece cover should be rinsed in hand hot water twice a week and then thoroughly dried. If the Fisonair holding chamber is used this also should be washed in hand hot water twice a week and thoroughly dried.
Children and patients with difficulty in coordinating actuation of the inhaler with inhalation of the aerosol cloud may benefit from using a holding chamber to assist inhalation of the medication. When using a holding chamber the procedure for inhalation is different from that through the standard mouthpiece or the Syncroner spacer device (in which the aerosol cloud is inhaled directly from the mouthpiece). The medication is first released into the holding chamber from which it is subsequently inhaled (in one or more breaths) until the chamber is empty. Thus, there is no need to co-ordinate actuation of the inhaler with simultaneous breathing. However medication must still be inhaled slowly and deeply from the holding chamber. The standard mouthpiece, but not the Syncroner spacer device, is suitable for use with large volume holding chambers such as Fisonair.
Detailed instructions for the inhalation of Tilade CFC-Free from each of the three devices are provided in the respective Patient Information Leaflet supplied with each pack.
Animal studies have not shown evidence of significant toxic effects with nedocromil sodium even at high doses, nor have extended human studies with nedocromil sodium revealed any safety hazard with the drug.
Overdosage is therefore unlikely to cause problems. However, if overdosage is suspected, treatment should be supportive and directed to the control of the relevant symptoms.
Shelf life: 2 years.
Do not store in a refrigerator or freezer. Protect from direct sunlight.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.
The aluminium can is fitted with a metering valve which delivers actuations each containing 2 mg of nedocromil sodium. Each canister contains 112 actuations.
Tilade CFC-Free Inhaler: The cartoned pack consists of;
Tilade CFC-Free Syncroner: The cartoned pack consists of either one or two aerosol canisters, each with a spacer device and a dustcap.
Tilade CFC-Free Fisonair: The cartoned pack consists of an aerosol canister and a plastic adaptor with a dustcap and a holding chamber.
Not applicable.
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