Giona Easyhaler Dosage/Direction for Use

Posology: The therapeutic effect begins after a few days' treatment and reaches its maximum after some weeks of treatment.
When transferring a patient to Giona Easyhaler from other inhalation devices, the treatment should be individualised. The previous active substance, dose regimen, and method of delivery should be considered.
The patients should be prescribed a starting dose of inhaled budesonide which is appropriate for the severity or level of control of their disease. The dose should be adjusted until control is achieved and then titrated to the lowest dose at which effective control of asthma is maintained.
Lower strengths of Giona Easyhaler are available for appropriate dose adjustment, if necessary.
The starting dose for adults (including the elderly and adolescents over 12 years to 17 years) with mild asthma (Step 2) and for children 6 to 11 years is 200-400 micrograms/day. If needed, the dose can be increased up to 800 micrograms/day. For adult patients with moderate (Step 3) and severe (Step 4) asthma the starting dose can be up to 1600 micrograms/day. The maintenance dose should be adjusted to meet the requirements of an individual patient, taking into account the severity of the disease and the clinical response of the patient.
Twice daily dosing: Adults with mild and moderate or severe asthma (including the elderly and adolescents 12 to 17 years): The usual maintenance dose is 100-400 micrograms twice daily. During periods of severe asthma, the daily dose may be increased up to 1600 micrograms administered in divided (two) doses and subsequently reduced when asthma has stabilised.
Children 6 to 11 years: The usual maintenance dose is 100-200 micrograms twice daily. If needed, the dose may be increased up to 800 micrograms administered in divided (two) doses and subsequently reduced when asthma has stabilised.
Once daily dosing: Adults with mild and moderate asthmatics (including the elderly and adolescents 12 to 17 years): In patients who have not previously received inhaled corticosteroids the usual maintenance dose is 200-400 micrograms once daily. In patients already controlled on inhaled corticosteroids (eg budesonide or beclometasone dipropionate) administered twice daily, once daily dosing up to 800 micrograms may be used.
Children 6 to 11 with mild to moderate asthma: In steroid naive patients or patients controlled on inhaled corticosteroids (eg budesonide or beclometasone dipropionate) administered twice daily the usual maintenance dose is 200-400 micrograms once daily.
The patient should be transferred to once daily dosing at the same equivalent total daily dose (with consideration of the drug and the method of delivery). The dose should be subsequently 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 the same time each evening.
There are insufficient data to make recommendations for the transfer of patients from newer inhaled steroids to once daily Giona Easyhaler.
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 twice daily. They should be advised to contact their doctor as soon as possible.
A rapid-acting inhaled bronchodilator should be available for the relief of acute symptoms of asthma at all times.
Patients maintained on oral glucocorticosteroids: The transfer of patients treated with oral corticosteroids to the inhaled corticosteroid 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.
Method of administration: For inhalation use. For optimum response, Giona Easyhaler inhalation powder should be used regularly.
Instructions for use and handling: It should be ensured that the patient is instructed in the use of the inhaler by a doctor or pharmacist. Easyhaler is an inspiratory flow-driven device. This 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 together with each inhaler.
That it is recommended to keep the device in the protective cover after opening the laminate pouch to enhance the stability of the product during use and makes the inhaler more tamper proof.
To shake and actuate the device prior to each inhalation.
In the sitting or standing position, 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 as this will result in a reduction in the delivered dose. Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure.
Never to actuate the device more than once without inhalation of the powder. Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure.
To always replace the dust cap and close the protective cover after use to prevent accidental actuation of the device (which could result in either overdosing or under dosing the patient when subsequently used).
To rinse the mouth out with water or brush the teeth after inhaling the prescribed dose to minimise the risk of oropharyngeal candidiasis and hoarseness.
To clean the mouthpiece with a dry cloth at regular intervals. Water should never be used for cleaning because the powder is sensitive to moisture.
To replace Giona Easyhaler when the counter reaches zero even though powder can still be observed within the device.