FOSTER PRESSURISED INHALATION SOLUTION 200MCG/6MCG PER ACTUATION [SIN17100P]

Product Info

FOSTER PRESSURISED INHALATION SOLUTION 200MCG/6MCG PER ACTUATION

[SIN17100P]

4.1 Therapeutic indications
Foster is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta₂-agonist) is appropriate:

• patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta₂-agonist or

• patients already adequately controlled on both inhaled corticosteroids and long-acting beta₂-agonists.

Foster is indicated in adults.

Note: there are no relevant clinical data on the use of Foster for the treatment of acute asthma attacks.

4.2 Posology and method of administration

Posology

FOSTER is not intended for the initial management of asthma. The dosage of the components of Foster 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 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 are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation). Therefore, the total daily dose of beclometasone dipropionate administered in Foster 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; the dose of beclometasone dipropionate should be lower and will need to be adjusted to the individual needs of the patients.

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

Foster 200/6 should be used as maintenance therapy only. A lower strength (Foster 100/6) is available for maintenance and reliever therapy.

Patients should be advised to have their separate short-acting bronchodilator available for rescue use at all times.
Patients should be regularly reassessed by a doctor, so that the dosage of Foster 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 long term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone. Foster 200/6 should not be used for step-down treatment but a lower strength of the beclometasone dipropionate component in the same inhaler is available for step-down treatment (Foster 100/6 micrograms).”

Patients should be advised to take Foster every day even when asymptomatic.

Special patient groups:
There is no need to adjust the dose in elderly patients. There are no data available for use of Foster in patients with hepatic or renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose recommendations for children and adolescents under 18 years:

Foster 200/6 should not be used in children and adolescent less then 18 years.

Method of administration
FOSTER is for inhalation use.

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. Foster inhaler is provided with a counter on the back of the actuator, which shows how many doses are left. For the 120 doses presentation each time the patient presses the canister, a puff of medicine is released and the counter counts down by one. F. 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.

Use of the inhaler:
If the inhaler has been exposed to severe cold, patients should warm it with their hands for a few minutes before using it. They should never warm it by artificial means.
Whenever possible patients should stand or sit in an upright position when inhaling from their 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 breath 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 or indicator 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The canister contains a pressurised liquid. Patients should be advised not to expose to temperatures higher than 50°C and not to pierce the canister.

Cleaning
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, pharmacist or a nurse 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.

4.3 Contraindications
Hypersensitivity to active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.