ALVESCO 80 Pressurised inhalation, solution Ref.[6668] Active ingredients: Ciclesonide

The medicinal product is for inhalation use only.

Posology

Dosing recommendation for adults and adolescents

The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. In patients with severe asthma and while reducing or discontinuing oral corticosteroids, a higher dose of up to 640mcg/day (given as 320mcg twice daily) may be used (see sec 5.1). Patients should be given a dose of inhaled ciclesonide which is appropriate to the severity of their disease. Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated to the minimum dose needed to maintain good asthma control. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients.

Alvesco should preferably be administered in the evening although morning dosing of Alvesco has also been shown to be effective. The final decision on evening or morning dosing should be left to the discretion of the physician.

Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. In this situation, patients should be reassessed and consideration given to the need for increased anti-inflammatory treatment therapy (e.g. a higher dose of Alvesco for a short period [see section 5.1] or a course of oral corticosteroids). Severe asthma exacerbations should be managed the usual way.

To address specific patient needs, such as finding it difficult to press the inhaler and breathe in at the same time, Alvesco can be used with the AeroChamber Plus spacer device.

Elderly and patients with renal or hepatic impairment

There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment.

Paediatric population

To date, there are insufficient data available in the treatment of children under 12 years of age with ciclesonide.

Method of administration

Precautions to be taken before handling or administering the medicinal product

The patient needs to be instructed how to use the inhaler correctly.

If the inhaler is new or has not been used for one week or more, three puffs should be released into the air. No shaking is necessary as this is a solution aerosol.

During inhalation, the patient should preferably sit or stand, and the inhaler should be held upright with the thumb on the base, below the mouthpiece.

Instruct the patient to remove the mouthpiece cover, place the inhaler into their mouth, close their lips around the mouthpiece, and breathe in slowly and deeply. While breathing in through the mouth, the top of the inhaler should be pressed down. Then, patients should remove the inhaler from their mouth, and hold their breath for about 10 seconds, or as long as is comfortable. The patient is not to breathe out into the inhaler. Finally, patients should breathe out slowly and replace the mouthpiece cover.

The mouthpiece should be cleaned with a dry tissue or cloth weekly. The inhaler should not be washed or put in water.

For detailed instructions see Patient Information Leaflet.

Acute

Inhalation by healthy volunteers of a single dose of 2880 micrograms of ciclesonide was well tolerated.

The potential for acute toxic effects following overdose of inhaled ciclesonide is low. After acute overdosage no specific treatment is necessary.

Chronic

After prolonged administration of 1280 micrograms of ciclesonide, no clinical signs of adrenal suppression were observed. However, if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression cannot be excluded. Monitoring of adrenal reserve may be necessary.

30 metered actuations: 1 year.

60 and 120 metered actuations: 3 years.

This medicinal product does not require any special storage conditions.

The container contains a pressurised liquid. Do not expose to temperatures higher than 50°C.

The container should not be punctured, broken or burnt even when apparently empty.

The inhaler comprises a pressurised container made from aluminium and is sealed with a metering valve, mouthpiece, and cap.

30 metered actuations
60 metered actuations
120 metered actuations

Not all pack sizes may be marketed.

Patients should be carefully instructed in the proper use of their inhaler (see Patient Information Leaflet).

As with most inhaled medicinal products in pressurised containers, the therapeutic effect of this medicinal product may decrease when the container is cold. However, Alvesco delivers a consistent dose from –10°C to 40°C.

No special requirements for disposal.

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