Clenil Modulite 50 microgramsClenil R Modulite R micrograms per actuation pressurised inhalation solution. The solution is clear and clenil modulite 200. Clenil Modulite clenjl indicated for the prophylactic management of mild, moderate, or severe asthma in adults or children:. Clenil modulite 200 requiring intermittent symptomatic bronchodilator asthma medication on a regular basis. Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.
Clenil Modulite micrograms - Summary of Product Characteristics (SmPC) - (eMC)
Clenil R Modulite R micrograms per actuation pressurised inhalation solution. The solution is clear and colourless. Clenil Modulite is indicated for the prophylactic management of mild, moderate, or severe asthma in adults or children:. Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular basis. Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.
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 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 micrograms twice daily. In severe cases this may be increased to to 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.
Patients with hepatic or renal impairment: 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. 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. 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.
Young children may find it difficult to use the inhaler properly and will require help. 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 Volumatic TM spacer device for the correct instructions on its use and cleaning. 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. Severe exacerbations of asthma must be treated in the usual way, ie.
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. 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. Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.
Patients should be advised that this product contains small amounts of ethanol approximately 9 mg per actuation and glycerol. At the normal doses, the amounts of ethanol and glycerol are negligible and do not pose a risk to patients see section 4.
Clenil Modulite contains a small amount of ethanol. There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole. Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors e.
There is no experience of the use of this product in pregnancy and lactation in humans. It should not be used in pregnancy or lactation unless the expected benefits to the mother are thought to outweigh any potential risks to the fetus or neonate. There is inadequate evidence of safety of beclometasone dipropionate in human pregnancy.
Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore, be a risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Beclometasone dipropionate is delivered directly to the lungs by the inhaled route and so avoids the high level of exposure that occurs when corticosteroids are given by systemic routes.
No specific studies examining the transfer of beclometasone dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that beclometasone dipropionate is secreted in milk, but at the dosages used for direct inhalation there is low potential for significant levels in breast milk. There is no experience with or evidence of safety of propellant HFAa in human pregnancy or lactation.
However, studies of the effect of HFAa on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects. Adverse events are listed below by system class and frequency. Frequencies are defined as: Rash, urticaria, pruritus, erythema. Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disorders predominantly in children. 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 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. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.