PULMICORT TURBOHALER 100 Breath-actuated metered dose powder inhaler Ref.[49682] Active ingredients: Budesonide

Posology

When transferring patients to Turbohaler from other devices, treatment should be individualised, whether once or twice daily dosing is being used. The drug and method of delivery should be considered.

Divided doses (twice daily)

The dosage should be individualised.

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

Adults (including the elderly) and children over 12 years of age

When starting treatment, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the dosage in adults should be 200-1600 micrograms daily, in divided doses.

In less severe cases and children over 12 years of age, 200-800 micrograms daily, in divided doses, may be used. During periods of severe asthma, the daily dosage can be increased to up to 1600 micrograms, in divided doses.

Children 5-12 years of age

200-800 micrograms daily, in divided doses. During periods of severe asthma, the daily dose can be increased up to 800 micrograms.

Once daily dosage

The dosage should be individualised.

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

Adults (including the elderly) and children over 12 years of age

200 micrograms to 400 micrograms may be used in patients with mild to moderate asthma who have not previously received inhaled glucocorticosteroids.

Up to 800 micrograms may be used by patients with mild to moderate asthma already controlled on inhaled steroids (e.g. budesonide or beclomethasone dipropionate), administered twice daily.

Children 5-12 years of age

200 micrograms to 400 micrograms may be used in children with mild to moderate asthma who have not previously received inhaled glucocorticosteroids, or who are already controlled on inhaled steroids (e.g. budesonide or beclomethasone dipropionate), administered twice daily.

The patient should be transferred to once daily dosing at the same equivalent total daily dose; the drug and method of delivery should be considered. The dose should subsequently be reduced to the minimum needed to maintain good asthma control.

Patients should be instructed to take the once daily dose in the evening. It is important that the dose is taken consistently and at a similar time each evening.

There are insufficient data to make recommendations for the transfer of patients from newer inhaled steroids to once daily Pulmicort Turbohaler.

Patients, in particular those receiving once daily treatment, should be advised that if their asthma deteriorates (e.g. increased frequency of bronchodilator use or persistent respiratory symptoms) they should double their steroid dose, by administering it twice daily, and should contact their doctor as soon as possible.

In patients where an increased therapeutic effect is desired, an increased dose of Pulmicort is recommended because of the lower risk of systemic effects as compared with a combined treatment with oral glucocorticosteroids.

Patients maintained on oral glucocorticosteroids

Pulmicort Turbohaler may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control. When transferral from oral steroids to Pulmicort is started, the patient should be in a relatively stable phase. A high dose of Pulmicort is then given in combination with the previously used oral steroid dose for about 10 days. After that, the oral steroid dose should be gradually reduced (by for example 2.5 milligrams prednisolone or the equivalent each month) to the lowest possible level. In many cases, it is possible to completely substitute the oral steroid with Pulmicort. For further information on the withdrawal of oral corticosteroids, see section 4.4.

Patients should be reminded of the importance of taking prophylactic therapy regularly, even when they are asymptomatic. A short-acting inhaled bronchodilator should be made available for the relief of acute asthma symptoms.

Method of administration

Pulmicort Turbohaler is for oral inhalation.

Turbohaler is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.

Note: It is important to instruct the patient:

• To carefully read the instructions for use in the patient information leaflet, which is packed with each Turbohaler
• To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs
• Never to breathe out through the mouthpiece
• To minimise the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling.

The patient may not taste or feel any medication when using Turbohaler due to the small amount of drug dispensed.

Symptoms

Acute overdosage with Pulmicort Turbohaler, even in excessive doses, is not expected to be a clinical problem. The only harmful effect that follows inhalation of large amounts of the drug over a short period is suppression of hypothalamic-pituitary-adrenal (HPA) function.

Management

No special emergency action needs to be taken. Treatment with Pulmicort Turbohaler should be continued at the recommended dose to control the asthma.

24 months.

Do not store above 30°C.

Polyethylene container consisting of a cover screwed onto a bottom plate. Inside this is the inhaler with its main parts: a mouthpiece, a dosing mechanism and a substance store.

The device also contains a desiccant.

100 micrograms/actuation. 200 actuations.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

See section 4.2.