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4.2 POSOLOGY AND METHOD OF ADMINISTRATION

Foster 100/6 is for inhalation use.
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ASTHMA

Foster 100/6 is not intended for the initial management of asthma. The dosage of the components of Foster 100/6 is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta2-agonists and/or corticosteroids by individual inhalers should be prescribed.
Beclometasone dipropionate in Foster 100/6 is characterised by an extrafine particle size distribution which results in a more potent effect than formulations of beclometasone dipropionate with a non- extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Foster 100/6 are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Therefore, the total daily dose of beclometasone dipropionate administered in Foster 100/6 should be lower than the total daily dose of beclometasone dipropionate administered in a non-extrafine beclometasone dipropionate formulation.
This should be taken into consideration when a patient is transferred from a beclometasone dipropionate non-extrafine formulation to Foster 100/6; the dose of beclometasone dipropionate should be lower and will need to be adjusted to the individual needs of the patients.

There are two treatment approaches:

A. Maintenance therapy: Foster 100/6 is taken as regular maintenance treatment with a separate as needed rapid-acting bronchodilator.

B. Maintenance and reliever therapy: Foster 100/6 is taken as regular maintenance treatment and as needed in response to asthma symptoms.

A. Maintenance therapy

Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.

Dose recommendations for adults 18 years and above:
One or two inhalations twice daily.
The maximum daily dose is 4 inhalations.

B. Maintenance and reliever therapy
Patients take their daily maintenance dose of Foster 100/6 and in addition take Foster 100/6 as needed in response to asthma symptoms. Patients should be advised to always have Foster 100/6 available for rescue use.

Foster 100/6 maintenance and reliever therapy should especially be considered for patients with : 
• not fully controlled asthma and in need of reliever medication
• asthma exacerbations in the past requiring medical intervention Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Foster 100/6 as-needed inhalations.

Dose recommendations for adults 18 years and above:
The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening).

Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken.

The maximum daily dose is 8 inhalations.

Patients requiring frequent use of rescue inhalations daily, should be strongly recommended to seek medical advice. Their asthma should be reassessed and their maintenance therapy should be reconsidered.


Dose recommendations for children and adolescents under 18 years:
The safety and efficacy of Foster 100/6 in children and adolescents under 18 years of age have not been established yet. No data are available with Foster 100/6 in children under 12 years of age.
Only limited data are available in adolescents between 12 and 17 years of age. Therefore Foster 100/6 is not recommended for children and adolescents under 18 years until further data become available.


Patients should be regularly reassessed by a doctor, so that the dosage of Foster 100/6 remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
Patients should be advised to take Foster 100/6 every day even when asymptomatic.

COPD

Dose recommendations for adults 18 years and above:
Two inhalations twice daily.

Special patient groups:
There is no need to adjust the dose in elderly patients. There are no data available for use of Foster 100/6 in patients with hepatic or renal impairment (see section 5.2).

Method of administration
To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professional. Correct use of the pressurised metered dose inhaler is essential in order that treatment is successful. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use as given in the Leaflet.
Foster 100/6 inhaler is provided with a counter on the back of the actuator, which shows how many doses are left. Each time the patient presses the canister, a puff of medicine is released and the counter counts down by one. Patients should be advised not to drop the inhaler as this may cause the counter to count down.


Testing the inhaler
Before using the inhaler for the first time or if the inhaler has not been used for 14 days or more, the patient should release one actuation into the air in order to ensure that the inhaler is working properly.
After testing the inhaler for the first time, the counter should read 120.
Whenever possible patients should stand or sit in an upright position when inhaling from their inhaler.

Use of the inhaler:

1. Patients should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
2. Patients should breathe out as slowly and deeply as possible.
3. Patients should hold the canister vertically with its body upwards and put the lips around the mouthpiece without biting the mouthpiece
4. At the same time, patients should breathe in slowly and deeply through the mouth. After starting to breathe in, they should press down on the top of the inhaler to release one puff.
5. Patients should hold the breath for as long as possible and, finally, they should remove the inhaler from the mouth and breathe out slowly. Patients should not breathe out into the inhaler.

To inhale a further puff, patients should keep the inhaler in a vertical position for about half a minute and repeat steps 2 to 5.


IMPORTANT: patients should not perform steps 2 to 5 too quickly.
After use, patients should close the inhaler with protective cap and check the dose counter.

Patients should be advised to get a new inhaler when the dose counter shows the number 20. They should stop using the inhaler when the counter shows 0 as any puffs left in the device may not be enough to release a full dose.


If mist appears following inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.

For patients with weak hands it may be easier to hold the inhaler with both hands. Therefore the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler.

Patients should rinse their mouth or gargle with water or brush the teeth after inhaling (see section 4.4).

Cleaning
Patients should be advised to read the Patient Information Leaflet carefully for cleaning instructions.
For the regular cleaning of the inhaler, patients should remove the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth. They should not remove the canister from the actuator and should not use water or other liquids to clean the mouthpiece.

Patients who find it difficult to synchronise aerosol actuation with inspiration of breath, may use the AeroChamber Plus® spacer device. They should be advised by their doctor or pharmacist in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. This may be obtained by the patients using the AeroChamber Plus® by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation.