Giona Easyhaler Special Precautions

GIONA EASYHALER is not indicated for the treatment of acute dyspnoea or status asthmaticus. These conditions should be treated in the normal way.
Patients should be aware that GIONA EASYHALER inhalation powder is prophylactic therapy and therefore has to be used regularly even when asymptomatic for optimum benefit and should not be stopped abruptly.
The transfer of patients treated with oral corticosteroids to the inhaled steroid and their subsequent management requires special care. The patients should be in a reasonably stable state before initiating a high dose of inhaled corticosteroid through twice daily dosing in addition to their usual maintenance dose of systemic corticosteroid. After about 10 days, withdrawal of the systemic corticosteroid is started by reducing the daily dose gradually (by for example 2.5 milligrams prednisolone or the equivalent each month) to the lowest possible level. It may be possible to completely replace the oral corticosteroid with inhaled corticosteroid. Transferred patients whose adrenocortical function is impaired may need supplementary systemic corticosteroid during periods of stress e.g. surgery, infection or worsening asthma attacks. This applies also to patients who have received prolonged treatment with high doses of inhaled corticosteroids. They may also have impaired adrenocortical function which may result in clinically significant adrenal suppression and may need systemic corticosteroid cover during periods of stress.
During transfer from oral therapy to inhaled budesonide symptoms may appear that had previously been suppressed by systemic treatment with glucocorticosteroids, for example symptoms of allergic rhinitis, eczema, muscle and joint pain. Specific treatment should be co-administered to treat these conditions.
Some patients feel unwell in a non-specific way during the withdrawal of systemic corticosteroids despite maintenance or even improvement in respiratory function. Such patients should be encouraged to continue treatment with inhaled budesonide and withdrawal of oral corticosteroid unless there are clinical signs to indicate the contrary, for example signs which might indicate adrenal insufficiency.
As with other inhalation therapies paradoxical bronchospasm may occur, manifested by an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. Budesonide should be discontinued immediately, the patient should be assessed and, if necessary, alternative treatment instituted.
When, despite a well monitored treatment, an acute episode of dyspnoea occurs, a rapid-acting inhaled bronchodilator should be used and medical reassessment should be considered. If, despite maximum doses of inhaled corticosteroids, asthma symptoms are not adequately controlled, patients may require short-term treatment with systemic corticosteroids. In such a case, it is necessary to maintain the inhaled corticosteroid therapy in association with treatment by the systemic route.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
Patients who have previously been dependent on oral corticosteroids may, as a result of prolonged systemic corticosteroid therapy, experience effects of impaired adrenal function. Recovery may take a considerable amount of time after cessation of oral corticosteroid therapy and hence oral steroid-dependent patients transferred to budesonide may remain at risk from impaired adrenocortical function for some considerable time. In such circumstances hypothalamic pituitary adrenocortical (HPA) axis function should be monitored regularly.
To reduce the risk of oral candidiasis and hoarseness patients should be advised to rinse out the mouth properly or brush the teeth after each administration of inhaled corticosteroid. Oral candidiasis can be rapidly controlled by local antimycotic treatment, without the need to discontinue the treatment with inhaled budesonide.
Exacerbation of clinical symptoms of asthma may be due to acute respiratory tract bacterial infections and treatment with appropriate antibiotics may be required. Such patients may need to increase the dose of inhaled budesonide and a short course of oral corticosteroids may be required. A rapid-acting inhaled bronchodilator should be used as "rescue" medication to relieve acute asthma symptoms.
Special care and adequate specific therapeutic control of patients with active and quiescent tuberculosis is necessary before commencing treatment with GIONA EASYHALER. Similarly patients with fungal, viral or other infections of the airways require close observation and special care and should use GIONA EASYHALER only if they are also receiving adequate treatment for such infections.
In patients with excessive mucous secretion in the respiratory tract, short-term therapy with oral corticosteroid may be necessary.
In patients with severe hepatic dysfunction, treatment with inhaled budesonide can result in a reduced elimination rate and thus enhanced systemic availability. Possible systemic effects may then result and therefore HPA axis function in these patients should be monitored at regular intervals.
Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should be avoided (see Interactions). If this is not possible the time interval between administration of the interacting drugs should be as long as possible.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Physicians should remain vigilant for the possible development of pneumonia in patient with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Risk factors for pneumonia in patients with COPD include current smoking status, older age, low body mass index (BMI) and severe COPD.
Effects on ability to drive and use machines: No effects on ability to drive and use machines have been observed.