BUDIAIR PRESSURISED INHALATION SOLUTION 200MCG/ACTUATION [SIN13831P]

Product Info

BUDIAIR PRESSURISED INHALATION SOLUTION 200MCG/ACTUATION

[SIN13831P]

4.1 Therapeutic Indications

Budiair is indicated for patients with bronchial asthma who require maintenance treatment with glucocorticosteroids for control of the underlying airways inflammation.

4.2 Posology and Method of Administration

Posology should be adjusted according to the single patient and relating to severity of asthma and therapy phase.

When transferring a patient to Budiair from other inhalation devices, the treatment should be individualised. The previous active substance, dose regimen, and method of delivery should be considered.

The maintenance dose is individual, and should be the minimum dose allowing suppression of symptoms. Budiair is a symptomatic therapy with no demonstrated effect on acute disorders.

Initially, at the beginning of inhaled corticosteroid therapy, for therapy during periods of severe asthma or when scaling down or withdrawing oral corticosteroids, the recommended dosage is:

♦ Adults: 200 micrograms (1 puff) 2–4 times daily. During the periods of severe asthma, the daily posology can be increased up to a maximum of 1600 micrograms.

♦ Children > 12 years old: 200–800 micrograms daily divided into 2–4 administrations.

♦ Children from 6 to 12 years of age: 200–400 micrograms daily divided into 2–4 administrations. The age limit depends on the possibility of properly using the product.

The dose should be reduced to the minimum needed to maintain good asthma control.

Contains alcohol, not suitable for children <6 years old.

Patients not treated with corticosteroids: the therapeutic effect of budesonide generally occurs within 10 days of therapy start: however, for patients with abundant bronchial secretion, such as to hinder mucosal absorption of the active ingredient, short-term concomitant treatment (about two weeks) with oral corticosteroids is recommended. This should be started at full dosage and reduced gradually until maintenance with Budiar only is achieved. Asthma exacerbations due to bacterial infections should be treated with antibiotics while increasing the posology of Budiair.

Patients treated with corticosteroids: switch from oral corticosteroidal therapy to treatment with Budiair requires special attention, due to the slow reactivation of those hypothalamic functions impaired by the prolonged oral corticosteroidal therapy. Introducing Budiair into therapy should occur when the patient is relatively stabilised.

Budiair will have to be administered concomitantly with oral corticosteroids for about 10 days; then this should be gradually reduced, down to the minimum dose that, combined with Budiair, ensures a stable response. In many cases it is possible to completely withdraw the oral therapy, whilst in some patients it will be necessary to continue treatment with a minimum oral corticosteroids dose. Nevertheless, in some cases when switching from oral therapy to Budiair, the systemic steroidal effect may decrease, with occurrence of rhinitis, eczema, headache, muscular and articular pain, and, rarely, of nausea and vomiting. Should these events occur, the physician shall evaluate the opportunity to maintain the patient on inhalation therapy. It might take a long time to recover the physiological production of natural corticosteroids, and in some conditions, such as physical stress due to severe infections, injuries or surgery, it may be necessary to combine Budiair with oral corticosteroidal therapy; also in case of asthma exacerbations, especially when associated with increased viscosity and formation of mucus plugs, a short-term concomitant treatment with oral steroids may be necessary. It is of utmost importance that the patient follows the instructions for use.

Method of Administration

For use, perform the following operations:

The successful result of treatment depends on a 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 cover by gently squeezing its sides and release one puff into the air to make sure that the inhaler works properly.

For use, carefully follow the instructions below:

1. Hold the inhaler upright between thumb and index, with the mouthpiece downwards;

2. Remove the mouthpiece cover;

3. Breathe out steadily, then place the mouthpiece firmly between the lips;

4. Start breathing in steadily and deeply through your mouth and press down once on the top of the inhaler. After the inhalation, hold your breath as long as possible, remove the inhaler from your mouth.

5. If you need to take another puff, if recommended for you by your doctor, repeat steps 3–4.

Once completed the prescribed number of inhalations, replace the mouthpiece cover.

Rinse your mouth with water to remove any excess medicine (do not swallow).

The mouthpiece should always be kept clean. For cleaning, remove the pressurised canister and rinse the mouthpiece in lukewarm water. Leave to dry thoroughly in a warm place. Avoid excessive heat.

Inhalation in children should be supervised by an adult person. It is useful to close the child’s nostrils during inhalation.

Clinical efficacy of Budiair inhaler in use with a spacer device has not been demonstrated.

Hence, for patients who cannot coordinate the release of dose and inhalation, monitoring of the patient’s asthma control is advisable if Budiair inhaler is used together with a spacer device.

4.3 Contraindications

History of hypersensitivity to budesonide or any of the excipients.