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CLENIL MODULITE is a brand name for Beclomethasone (also known as Beclometasone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ClenilR ModuliteR 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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.
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 Clenil Modulite is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 micrograms or greater.
Children:
Clenil Modulite 200 is not recommended for children.
Patients with hepatic or renal impairment:
No dosage adjustment is needed in patients with hepatic or renal impairment. Method of Administration 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.
Instructions for Use 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.
Testing the inhaler:
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.
Adverse events are listed below by system class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000), very rare (<1/10,000), unknown (frequency cannot be estimated from the available data).
4 Special warnings and precautions for use). As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing, shortness of breath and cough after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator.
Clenil Modulite should be discontinued immediately, the patient assessed and, if necessary, alternative therapy instituted. Candidiasis of the mouth and throat occurs in some patients, the incidence increasing with doses greater than 400 micrograms beclometasone dipropionate per day.
Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Patients may find it helpful to rinse their mouth thoroughly with water after inhalation. Symptomatic oral candidiasis can be treated with topical antifungal therapy while continuing with Clenil Modulite.
Hoarseness or throat irritation may occur in some patients. These patients should be advised to rinse the mouth out with water immediately after inhalation. Use of the Volumatic™ spacer device may be considered. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be properly instructed on the use of the inhaler to ensure that the drug reaches the target areas within the lungs. Patients should also be informed that Clenil Modulite should be used on a regular basis, even when they are asymptomatic.
Clenil Modulite does not provide relief of acute asthma symptoms, which require a short-acting inhaled bronchodilator. Patients should have relief medication available. Severe asthma requires regular medical assessment, including lung-function testing, as there is a risk of severe attacks and even death.
Patients should be instructed to seek medical attention if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required as this may indicate deterioration of asthma control. If this occurs, patients should be assessed and the need for increased anti- inflammatory therapy considered (eg.
higher doses of inhaled corticosteroid or a course of oral corticosteroid). Severe exacerbations of asthma must be treated in the usual way, ie. by increasing the dose of inhaled beclometasone dipropionate, giving a systemic steroid if necessary, and/or an appropriate antibiotic if there is an infection, together with β-agonist therapy.
Treatment with Clenil Modulite should not be stopped abruptly. Systemic effects of inhaled corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. These effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
It is important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained. It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Beclomethasone in United Kingdom.
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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.
If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroids, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should also be given to referring the patient to a paediatric respiratory specialist.
Prolonged treatment with high doses of inhaled corticosteroids may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. The transfer to Clenil Modulite of patients who have been treated with systemic steroids for long periods of time or at high doses needs special care, since recovery from possible adrenocortical suppression may take considerable time.
Reduction of the dose of systemic steroid can be commenced approximately one week after initiating treatment with Clenil Modulite. The size of the reduction should correspond to the maintenance dose of systemic steroid. For patients receiving maintenance doses of 10 mg daily or less of prednisolone (or equivalent) reductions in dose of not more than 1 mg are suitable.
For higher maintenance doses, larger reductions in dose may be appropriate. These oral dosage reductions should be introduced at not less than weekly intervals. Adrenocortical function should be monitored regularly as the dose of systemic steroid is gradually reduced.
Some patients feel unwell during withdrawal of systemic steroids despite maintenance or even improvement of respiratory function. They should be encouraged to persevere with inhaled beclometasone dipropionate and to continue withdrawal of systemic steroid, unless there are objective signs of adrenal insufficiency.
Patients weaned off oral steroids whose adrenocortical function is impaired should carry a steroid warning card indicating that they may need supplementary systemic steroids during periods of stress, eg. worsening asthma attacks, chest infections, major intercurrent illness, surgery, trauma, etc.
Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be symptomatically treated with antihistamine and / or topical preparations, including topical steroids.
As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Clenil Modulite contains a small amount of glycerol and ethanol (alcohol), approximately 9 mg per actuation, which is equivalent to 0,24 mg/kg per dose of two actuations in adults. the small amount of alcohol and glycerol in this medicine will not have any noticeable effects.