Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom
Clenil Modulite is indicated for the prophylactic management of mild, moderate, or severe asthma in adults or children:
Mild asthma: Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular basis.
Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.
Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms.
Clenil Modulite is for inhalation use only. The Volumatic spacer device may be used by patients who have difficulty synchronising aerosol actuation with inspiration of breath.
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.
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 Clenil Modulite is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 micrograms or greater.
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.
Clenil Modulite 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.
No dosage adjustment is needed in patients with hepatic or renal impairment.
The aerosol spray is inhaled through the mouth into the lungs. The correct administration is essential for successful therapy. The patient must be instructed on how to use Clenil Modulite correctly and advised to read and follow the instructions printed on the Patient Information Leaflet carefully.
Patients should be instructed in the proper use of their inhaler (see patient information leaflet)
During inhalation, the patient should preferably sit or stand. The inhaler has been designed for use in a vertical position.
If the inhaler is new or has not been used for three days or more, one puff should be released into the air. It is not necessary to shake the inhaler before use because this is a solution aerosol.
Instruct the patient to remove the mouthpiece cover and check that it is clean and free from foreign objects. The patient should then be instructed to breathe out before placing the inhaler into their mouth. They should then close their lips around the mouthpiece and breathe in steadily and deeply. They must not bite the mouthpiece. After starting to breathe in through the mouth, the top of the inhaler should be pressed down. Whilst the patient is still breathing in, the patient should then remove the inhaler from their mouth and hold their breath for about 5 to 10 seconds, or as long as is comfortable, and then breathe out slowly. The patient must not breathe out into the inhaler. If another dose is required, the patient should be advised to wait 30 seconds before repeating the procedure just described. Finally, patients should breathe out slowly and replace the mouthpiece cover.
The patient should be told not to rush the procedure described. It is important that the patient breathes in as slowly as possible prior to actuation. Inform the patient that if a mist appears on inhalation, the procedure should be repeated.
There is a dose indicator on the back of the inhaler which tells you how many puffs are left, the dose indicator rotates by a small amount when a puff is delivered. The number of puffs remaining is displayed in intervals of 20.
Patients should consider getting a replacement when the indicator shows the number 20. The indicator will stop at 0 when all the recommended puffs have been used. Replace the inhaler when the indicator reads 0.
It may be helpful to advise children and patients with weak hands to hold the inhaler with two hands, by placing both forefingers on top of the inhaler and both thumbs at the bottom of the device.
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.
Advise the patient to thoroughly rinse the mouth or gargle with water or brush the teeth immediately after using the inhaler.
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 VolumaticTM spacer device for the correct instructions on its use and cleaning.
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.
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.
Shelf life: 3 years.
Do not store above 30°C.
As with most inhaled medicines in aerosol canisters, the therapeutic effect may decrease when the canister is cold.
Protect from frost and direct sunlight.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.
Clenil Modulite 50 is supplied in an aluminium canister fitted with a metering valve, actuator and dust cap.
Each inhaler delivers 200 actuations.
Not applicable.
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