Contraindications
Tubercular (active or quiescent) and local viral infections. Individual hypersensitivity to cortisonics. Usually contraindicated in pregnancy and lactation (See special warnings)

Precautions for use
Patients should be properly instructed about the correct use of the inhaler.

The management of treatment in patients already undergoing systemic corticosteroid therapy, needs special precautions and a strict medical control since the reactivation of adrenal function, suppressed by the prolonged systemic corticosteroidal therapy, is slow. In any case, it is necessary that the disease be relatively stabilized by the systemic treatment. At the beginning, Macticort should be administered while continuing the systemic therapy; then, this should be gradually reduced checking the patient regularly (in particular, periodical tests of corticoadrenal function should be carried out) and modifying Macticort posology according to the results obtained. During periods of stress or of severe asthmatic attacks, patients undergoing this passage shall be supported by a supplemental treatment with systemic steroids. Macticort is not effective in asthmatic attack in progress; on the contrary, it represents an essential treatment of the asthmatic disease, therefore it should be regularly taken at the prescribed doses and as long as the physician deems it as suitable.

Interactions
Macticort contains a small amount of ethanol. There is the theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.

Special Warnings
Macticort is not efficacious in asthma attacks in progress; on the contrary, it represents a fundamental treatment of the asthmatic disease: it should be regularly taken at the prescribed doses and as long as the physician deems it as suitable.

Pregnancy and lactation In pregnant women the product should be administered in case of real need and under direct material control. There is inadequate evidence of safety of beclomethasone dipropionate or HFA 134a propellant in humans. Product administration during pregnancy and lactation should be only taken into consideration if the envisaged benefit for the mother outweighs the potential risks for the foetus.

Children born from mothers having received considerable doses of inhaled corticosteroids during pregnancy should be carefully monitored in order to detect a possible hypoadrenalism.

Posology, Method and Fequency of Administration
Adults: Usually 2 inhalations twice a day. Should it be deemed as more suitable, posology can be fractioned even into one inhalation 4 times daily. In case of need, therapy can be increased up to 2 inhalations 3-4 times a day.
Therapy with Macticort should not be abruptly interrupted.

Children: Macticort 250 mcg is not suitable for pediatric use.

The successful result of the treatment depends on correct use of the inhaler.
Inhaler’s working test: before using the inhaler for the first time or if it has not been used for three days or more, remove the mouthpiece protective closure by softly pressing it on its sides and press once in the air to release an actuation, so as to verify the correct working of the inhaler.

Adverse Effects
Occasionally, local mycotic infections (candidiasis) can appear in the oropharyngeal cavity, usually rapidly regressing after local antimycotic therapy and without interrupting the treatment. The occurrence of these mycotic infections can be reduced to the minimum by regularly rinsing the mouth after every application.

A few patients complained about hoarseness and dry mouth.
Systematic side effects are extremely improbable with the recommended doses; however, patients should be kept under strict control during prolonged treatments, in order to timely ascertain the possible occurrence of the systemic diseases (osteoporosis, peptic ulcer, signs of secondary corticoadrenal insufficiency, such as hypotension and weight loss) and in order to avoid, in this latter event, very serious accidents due to acute hypoadrenalism. Inhalation of high doses (> 1500 mcg/day) for prolonged periods may cause adrenal suppression. As with other inhalation therapy paradoxical bronchospasm may occur.

The observance of the instructions contained in the present package insert reduces the risk of undesirable effects. It is important to promptly inform the physician or chemist about any undesirable effect, even if not reported in this leaflet.

Instruction for Use / Handling:

Pharmaceutical Precautions / Storage:
l Macticort inhaler should be stored below 30oC.
l The therapeutic effect of this medication may decrease when the canister is cold.
l Protect from frost, direct sunlight and heat.
l The canister should not be punctured, broken or burnt even when apparently empty.
l Keep all medicines out of the reach of children.

Presentation:
Macticort is available as a metered inhaler sufficient for 200 inhalations.