Budoneb 0,25mg & 0,5 mg/ml Nebuliser Suspension

BUDONEB is indicated for:

• Management of asthma in patients inadequately controlled by bronchodilators, thus necessitating treatment with steroids and who are unable to use a pressurised metered dose inhaler or unable to inhale the medicine in powder form.
• BUDONEB is also recommended in infants and children with acute laryngotracheobronchitis (croup).

The dosage of BUDONEB is individual, and should be titrated to the lowest effective maintenance dose once control of asthma is achieved.

Asthma:

Adults: Initial dose: 0,5 to 1 mg twice daily. In some cases the dose may be further increased.

Children 12 months u2013 6 years 6 years and older

Previous therapy Recommended starting dose Recommended starting dose

• Bronchodilators alone 0,25 mg twice daily 0,25 u2013 0,5 mg twice daily
• Inhaled corticosteroids 0,25 mg twice daily 0,25 u2013 0,5 mg twice daily
• Oral corticosteroids 0,5 mg twice daily 0,25 u2013 1 mg twice daily

Maintenance dose: 0,25 u2013 0,5 mg twice daily 0,25 u2013 0,5 mg twice daily

In patients where an increased therapeutic effect is required, an increased dose of BUDONEB should be considered.

Acute laryngotracheobronchitis (croup): In infants and children with croup the usual dose is 2 mg of nebulised budesonide. This dose is given as a single administration or as two 1 mg doses separated by 30 minutes.

Patients dependent on oral steroids: Initially, BUDONEB should be used concurrently with the patientu2019s usual maintenance dose of oral glucocorticosteroid. After approximately one week the oral dose is gradually reduced to the lowest possible level, e.g. by about 2,5 mg prednisolone every two weeks. A slow rate of withdrawal is strongly recommended.

• Hypersensitivity to budesonide or any of the ingredients of BUDONEB.
• Lung tuberculosis, fungal and viral infections in the airways.
• Safety and efficacy for children less than 12 months have not been established.

BUDONEB is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required. If patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought. In this situation consideration should be given to the need for increased anti-inflammatory therapy, e.g. higher doses of inhaled budesonide or a course of oral glucocorticosteroids.

The long-term local and systemic effects of BUDONEB in human subjects are not completely known. The dose should be titrated to the lowest effective maintenance dose once control of asthma is achieved.

Medical practitioners should closely monitor the growth of children and adolescents taking corticosteroids by any route and weigh the benefit of corticosteroid therapy and asthma control against the possibility of growth suppression.

Reduced liver function may affect the elimination of corticosteroids. This may be clinically relevant in patients with severely compromised liver function.

Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies, e.g. rhinitis and eczema, which were previously controlled by the systemic medicine. These allergies should be symptomatically controlled with an antihistamine and/or topical preparations.

Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired renal function for a considerable time.

Patients who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress.

Less frequently, through unknown mechanisms, medicines for inhalation may cause bronchospasm.

On prolonged administration signs or symptoms of systemic glucocorticosteroids effects, including hypofunction of the adrenal gland and reduction of growth velocity, may occur with inhaled BUDONEB, probably depending on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity.

Facial skin irritation may occur when a nebuliser with facemask is used. To prevent irritation the facial skin should be washed with water after use of the facemask. To minimise oropharyngeal thrush, the patient should rinse the mouth out with water after each dosing occasion.

Some patients feel unwell in a non-specific way during the withdrawal phase, e.g. pain in muscles and joints.

A general insufficient glucocorticosteroid effect should be suspected if, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.

Long-term treatment may induce cataract formation. Referral to a doctor is recommended if a patient presents with symptoms such as blurred vision or other visual disturbances for evaluation of possible causes which may include cataract, glaucoma or diseases such as central serous chorioretinapathy (CSCR).

BUDONEB has no effect on the ability to drive and use machines. Long term use may affect vision.

Clinical trials, literature reports and post-marketing experience suggest that the following adverse reactions may occur.

Infections and infestations:

• Frequent: Candida infection in the oropharynx.

Immune system disorders:

• Less Frequent: Immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm.

Psychiatric disorders:

• Less frequent: Nervousness, restlessness, depression, behavioural disturbances.

Respiratory, thoracic and mediastinal disorders:

• Frequent: Mild irritation in the throat, hoarseness, coughing.

Skin and subcutaneous tissue disorders:

• Less frequent: skin bruising.

Eye disorders:

• Less frequent: Cataract, vision blurred (see WARNINGS AND SPECIAL PRECAUTIONS).
• Frequency unknown: Glaucoma.

Acute overdosage with BUDONEB even in excessive doses is not expected to be a clinical problem. Treatment should be discontinued and appropriate measures taken to protect the patient against stress situations. Treatment is supportive and symptomatic.