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

Intal CFC-free is for oral inhalation use only. It is essential to instruct the patient how to use the inhaler correctly.

Adults and Children

The initial dose is two inhalations of the aerosol four times daily. Once adequate control of symptoms has been achieved it may be possible to reduce to a maintenance dose of one inhalation four times daily. However, the dose may be increased to two inhalations six or eight times daily in more severe cases or during periods of severe antigen challenge. An additional dose before exercise may also be taken.

Elderly

No current evidence for alteration of the recommended adult dose

Concomitant Bronchodilator Therapy

Where a concomitant aerosol bronchodilator is prescribed it is recommended that this be administered prior to Intal CFC-free.

Concomitant Steroid Therapy

In patients currently treated with steroids, the addition of Intal 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If reduction of a steroid dosage has been possible, Intal CFC-free should not be withdrawn until steroid cover has been reinstituted.

ethod of Administration

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.

1. The inhaler should be well shaken, and the dust cap removed.
2. The patient should be instructed to breathe in slowly and deeply and as inhalation begins the aerosol should be actuated by pressing the can down firmly with the first finger whilst continuing to breathe in.
3. The breath should then be held for several 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.
4. The dust cap should be replaced following use.
5. To prevent excessive accumulation of powder the plastic body and mouthpiece cover should be washed twice a week and then 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 with 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 coordinate actuation of the inhaler with simultaneous breathing, but the medication must be inhaled slowly and deeply from the holding chamber.

Detailed instructions for the inhalation of Intal CFC-free from each of the devices are provided in the respective Patient Information Leaflet supplied with each pack.

Animal studies have shown that sodium cromoglicate has a very low local or systemic toxicity and extended human studies have not revealed any safety hazard with products containing sodium cromoglicate. Overdosage is therefore unlikely to cause problems, but, if suspected, treatment should be supportive and directed to the control of the relevant symptoms.

30 months.

Do not refrigerate or freeze.

As the aerosol inhaler canister is pressurised it should be protected from heat or direct sunlight and should not be punctured or incinerated even when empty.

The aluminium can is fitted with a metering valve which delivers 112 actuations each containing 5 mg of sodium cromoglicate.

Intal CFC-free Inhaler: The cartoned pack consists of an aerosol canister and a plastic adaptor with a dust cap.

Intal CFC-free Syncroner: The cartoned pack consists of either one or two aerosol canisters, each with a spacer device and dust cap.

Not all pack sizes may be marketed.

No special requirements for disposal.