SOPROBEC Pressurised inhalation solution Ref.[27642] Active ingredients: Beclometasone

Posology

The starting dose of inhaled beclometasone dipropionate should be adjusted to the severity of the disease. The dose may then be adjusted until control is achieved and then should be titrated to the lowest dose at which effective control of asthma is maintained.

Adults (including the elderly)

The usual starting dose is 200 micrograms twice daily. In severe cases this may be increased to 600 to 800 micrograms daily. This may then be reduced when the patient’s asthma has stabilised. The total daily dosage should be administered as two to four divided doses.

The Volumatic spacer device must always be used when Soprobec is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 micrograms or greater.

Children

The usual starting dose is 100 micrograms twice daily. Depending on the severity of asthma, the daily dose may be increased up to 400 micrograms administered in two to four divided doses.

Soprobec must always be used with the Volumatic spacer device when administered to children and adolescents 15 years of age and under, whatever dose has been prescribed.

Patients with hepatic or renal impairment

No dosage adjustment is needed in patients with hepatic or renal impairment.

Method of Administration

Soprobec is for inhalation use.

To ensure proper administration of the medicinal product, 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 Package Leaflet carefully and follow the instructions for use as given in the Leaflet.

Testing the inhaler

Before using the inhaler for the first time or if the inhaler has not been used for 3 days or more, the patient should release one actuation into the air in order to ensure that the inhaler is working properly. Whenever possible patients should stand or sit in an upright position when inhaling from their inhaler.

Instructions for Use

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 about 5 to 10 seconds or as long as comfortable, and then breathe out slowly. If another dose is required, they should be advised to wait 30 seconds before repeating the procedure just described. Finally, they should remove the inhaler from the mouth and breathe out slowly. Patients should not breathe out into the inhaler.

IMPORTANT: patients should not perform steps 2 to 5 too quickly.

After use, patients should close the inhaler with protective cap.

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).

Patients who find it difficult to co-ordinate actuation with inspiration of breath should be told to use a Volumatic spacer device to ensure proper administration of the product.

Young children may find it difficult to use the inhaler properly and will require help. Using the inhaler with the Volumatic spacer device with a face mask may help in children under 5 years.

The patient should be told of the importance of cleaning the inhaler at least weekly to prevent any blockage and to carefully follow the instructions on cleaning the inhaler printed on the Patient Information Leaflet. The inhaler must not be washed or put in water.

The patient should be told also to refer to the Patient Information Leaflet accompanying the Volumatic spacer device for the correct instructions on its use and cleaning.

There is no specific treatment for beclomethasone dipropionate overdose. In case of overdose, the patient must receive the necessary support treatment and appropriate follow-up.

Acute: Inhalation of doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not require emergency action. In these patients treatment should be continued at a dose sufficient to control asthma; adrenal function recovers in a few days and can be verified by measuring plasma cortisol.

Chronic: Use of inhaled beclometasone dipropionate in daily doses in excess of 1,500 micrograms over prolonged periods may lead to adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment should be continued at a dose sufficient to control asthma.

2 years.

As with most inhaled medicines in aerosol canisters, the therapeutic effect may decrease when the canister is cold.

Do not freeze.

Store in the original package in order to protect from the light.

The canister contains a pressurised liquid. Do not expose to temperatures higher than 50 °C. Do not pierce the canister, even when it´s empty.

50mcg:

Soprobec is supplied in an aluminium canister fitted with a metering valve, cream coloured actuator and dark brown colour dust cap.

Each pack contains either a single inhaler, or two inhalers.

Each inhaler delivers 200 actuations.

Not all pack sizes may be marketed.

Not applicable.