Pulmicort 0,25 mg/ml & 0,5 mg/ml Suspension

PULMICORT Nebulising Suspension is indicated for management of asthma in patients inadequately controlled by bronchodilators, thus necessitating additional treatment with steroids and who are unable to use a pressurised metered dose inhaler or unable to inhale the medicine in powder form. PULMICORT Nebulising Suspension is also recommended for use in infants and children with acute laryngotracheobronchitis-croup.

Instruction for correct use of PULMICORT Nebulising Suspension: PULMICORT Nebulising Suspension should be administered via a jet nebuliser equipped with a mouthpiece or suitable face mask. The nebuliser should be connected to an air compressor with an adequate air flow (5-8 litres/minute), and the fill volume should be 2-4 ml. Carefully read the section, u201cInstruction for correct use of PULMICORT Nebulising Suspensionu201d, added to this package insert.

Ultrasonic nebulisers are not suitable for the administration of PULMICORT Nebulising Suspension and therefore are not recommended.

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

Asthma:

• Adults: Initial Dose: 0,5-1 mg twice daily. In some cases the dose may be further increased.
• Children:
• 12 months - 6 years: Previous therapy: Bronchodilators alone: Recommended starting dose: 0,25 mg twice daily
• 6 years and older: Previous therapy: Bronchodilators alone: Recommended starting dose: 0,25-0,5 mg twice daily
• Inhaled corticosteroids: 0,25 mg twice daily
• Oral corticosteroids: 0,5 mg twice daily

Maintenance dose: 0,25-0,5 mg twice daily. In patients where an increased therapeutic effect is required, an increased dose of PULMICORT Nebulising Suspension should be considered.

Patients dependent on oral steroids: Initially, PULMICORT Nebulising Suspension should be used concurrently with the patientu2019s usual maintenance dose of oral glucocorticosteroid. After approximately 1 week the oral dose is gradually reduced to the lowest possible level, e.g. by about 2,5 mg prednisolone every 2 weeks. A slow rate of withdrawal is strongly recommended. In a proportion of cases, it is possible to completely substitute the oral glucocorticosteroid with PULMICORT Nebulising Suspension. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g. joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with PULMICORT Nebulising Suspension but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should be continued more slowly. During periods of stress or during a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

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.

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

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

PULMICORT Nebulising Suspension 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 glucocorticosteroid.

Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal 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. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

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.

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.

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

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

Special consideration may be needed in patients with pulmonary tuberculosis. On prolonged administration signs or symptoms of systemic glucocorticosteroid effect, including hypofunction of the adrenal gland and reduction of growth velocity, may occur with inhaled glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous steroid exposure, and individual sensitivity.

PULMICORT Nebulising Suspension has no effect on the ability to drive and use of machines.

Budesonide has not been observed to interact with any medicine used for the treatment of asthma. The metabolism of budesonide is primarily mediated by CYP3A4, a subfamily of cytochrome P450. Inhibitors of this enzyme, e.g. ketoconazole and itraconazole, therefore increase systemic exposure to budesonide. At recommended doses, cimetidine has slight but clinically insignificant effect on the pharmacokinetics of oral budesonide.

Pregnancy: Safety in pregnancy has not been established. Lactation: Safety in lactation has not been established. Budesonide is excreted in breast milk. However, at maternal therapeutic doses of PULMICORT Nebulising Suspension, the budesonide plasma levels in infants are at or below minimal measurable concentrations.

Clinical trials and post-marketing experience suggest that the following adverse reactions may occur:

Clinical trials:

• Common (u2265 1/100, < 1/10) Respiratory, thoracic and mediastinal disorders: Mild irritation in the throat, hoarseness, coughing
• Infections and infestations: Candida infection in the oropharynx

Rare (u2265 1/10 000, < 1/1 000) Skin and subcutaneous tissue disorders: Skin bruising

Post marketing experience:

• Psychiatric disorders: Nervousness, restlessness, depression, behavioural disturbances
• Immune system disorders: Immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema, bronchospasm and anaphylactic reaction
• In rare cases, through unknown mechanisms, medicines for inhalation, such as PULMICORT Nebulising Suspension, may cause bronchospasm.

Acute overdosage with PULMICORT Nebulising Suspension, 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.