GIONA EASYHALER INHALATION POWDER 100 MCG/DOSE [SIN12618P]

Product Info

GIONA EASYHALER INHALATION POWDER 100 MCG/DOSE

[SIN12618P]

4.1 Therapeutic indications

Bronchial asthma requiring maintenance treatment with glucocorticoids for control of underlying airway inflammation.

(Note: Giona Easyhaler is not suitable for the treatment of acute asthma attacks.)

4.2 Dosage and method of administration
Method of administration: For inhalation use. For optimum response, Giona Easyhaler™ inhalation powder should be used regularly.
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 starting dose for adults with mild asthma (Step 2) 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 and the dose for periods of severe asiluua can be up to 1600 micrograms/day.
For children 5 –7 years old, the starting dose and the dose for periods of severe asthma is 200 –400 mcg daily. For children over 7 years old, the starting dose and the dose for periods of severe asthma is 200 –800 mcg daily.

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. The dose should be adjusted until control is achieved and then titrated to the lowest dose at which effective control of asthma is maintained.

Twice daily dosing

Adults with mild and moderate or severe asthma: 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 over 7 years: The usual maintenance dose is 100–200 micrograms twice daily.

Once daily dosing

Adults with mild and moderate asthmatics: 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 400 micrograms may be used.

Children over 7 years 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 increase the frequency of dosing and the daily dose. They should be advised to contact their doctor as soon as possible.

There is no experience of treatment of patients with impaired hepatic or renal function. Since budesonide is predominantly eliminated through hepatic metabolism, increased exposure may be expected in patients with severe cirrhosis of the liver.

A rapid-acting inhaled bronchodilator should be available for the relief of acute symptoms of asthma at all times.

Instruction for use and handling:
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

• 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

• 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.

4.3 Contra-indications
Hypersensitivity to budesonide or to the excipient listed in section 6.1 (lactose, which contains small amounts of milk protein) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.