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BECOLEX 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: Becolex 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…
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Becolex 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 Becolex 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 Becolex Modulite should be used on a regular basis, even when they are asymptomatic.
Becolex 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 Becolex 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.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Becolex 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 Becolex 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.
88 mg/kg per dose of eight actuations in adults and 1,54 mg/kg per dose of four actuations in children. The small amount of alcohol and glycerol in this medicine will not have any noticeable effects.