Loading…
EASYHALER BECLOMETASONE 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: Beclometasone dipropionate given by inhalation offers preventative treatment for asthma. It provides effective anti-inflammatory action in the lungs with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically. It also offers preventive treatment of…
Verbatim from this product's MHRA label. Tap a section to expand.
Easyhaler® Beclometasone 200 micrograms/dose is for oral inhalation use only. Patients should be made aware of the prophylactic nature of therapy with inhaled beclometasone dipropionate and that it should be taken regularly everyday even when they are asymptomatic.
Patients should be given a starting dose of inhaled beclometasone dipropionate appropriate to the severity of their disease. The dose may then be adjusted until control is achieved and should be titrated to the lowest dose at which effective control of asthma is maintained.
Adults The usual starting dose is 200 micrograms twice a day. In more severe cases the starting dose may need to increase to 600 to 800 micrograms per day which may then be reduced when the patient’s asthma has stabilised. The total daily dose may be administered as two, three, or four divided doses.
Paediatric population Easyhaler® Beclometasone 200 micrograms/dose is not recommended for children. Special Patient Groups There is no need to adjust the dose in older people or in those with hepatic or renal impairment.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common ( 1/10), common ( 1/100 and <1/10), uncommon ( 1/1000 and <1/100), rare ( 1/10,000 and <1/1000), very rare (<1/10,000) including isolated reports and not known (cannot be estimated from the available data).
Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo and comparator group has not been taken into account in estimation of these frequencies. Rare and very rare events were generally determined from spontaneous data.
System Organ Class Adverse Event Frequency Infections & Infestations Candidiasis of the mouth and throat.
Very Common Hypersensitivity reactions with the following manifestations:
Rashes, urticaria, pruritis, erythema. 4) Not known Hoarseness/throat irritation, cough Common Paradoxical bronchospasm Very Rare Respiratory, Thoracic & Mediastinal Disorders Eosinophilic pneumonia Not Known Skin and subcutaneous tissue disorders Easy bruising, skin thinning Not known Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence increasing with doses greater than 400 micrograms of 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 using the inhaler. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with Easyhaler® Beclometasone 200 micrograms/dose treatment.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. 4 Special Warnings and Precautions for Use). In some patients inhaled beclometasone dipropionate may cause hoarseness, cough, throat irritation and sore throat.
Patients should be instructed in the proper use of the inhaler, and their technique checked, to ensure that the drug reaches the target areas within the lungs. They should also be made aware that Easyhaler® Beclometasone 200 micrograms/dose has to be used regularly every day for optimum benefit.
Patients should be made aware of the prophylactic nature of therapy with Easyhaler® Beclometasone 200 micrograms/dose and that they should be used regularly, even when they are asymptomatic. Easyhaler® Beclometasone 200 micrograms/dose is not designed to relieve acute asthma symptoms for which an inhaled short-acting bronchodilator is required.
Patients should be advised to have such rescue medication available. Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death. Increasing use of bronchodilators, in particular short-acting inhaled beta2 agonists to relieve symptoms indicates deterioration of asthma control.
If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought. g. higher doses of inhaled corticosteroid or a course of oral corticosteroid) considered.
Severe exacerbations of asthma must be treated in the normal way. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include Cushing's syndrome, Cushingoid features, 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).
1 (lactose monohydrate, which contains small amounts of milk proteins). Special care is necessary in patients with active or quiescent pulmonary tuberculosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Beclomethasone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
It may be helpful to rinse the mouth out with water immediately after inhalation. As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator.
The beclometasone dipropionate preparation should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted. 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.
It is important therefore 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 corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
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.
Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Lack of response or severe exacerbations of asthma should be treated by increasing the dose of inhaled beclometasone dipropionate and, if necessary, by giving a systemic steroid and/or antibiotic if there is an infection, and by use of beta-agonist therapy.
For the transfer of patients being treated with oral corticosteroids:
The transfer of oral steroid-dependent patients to Easyhaler® Beclometasone 200 micrograms/dose and their subsequent management needs special care as recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy, may take a considerable time.
Patients who have been treated with systemic steroids for long periods of time or at a high dose may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously.
After approximately a week, gradual withdrawal of the systemic steroid is commenced. Decrements in dosages should be appropriate to the level of maintenance systemic steroid, and introduced at not less than weekly intervals. For maintenance doses of prednisolone (or equivalent) of 10mg daily or less, the decrements in dose should not be greater than 1mg per day, at not less than weekly intervals.
For maintenance doses of prednisolone in excess of 10mg daily, it may be appropriate to employ cautiously, larger decrements in dose at weekly intervals. Some patients feel unwell in a non-specific way during the withdrawal phase despite maintenance or even improvement of the respiratory function.
They should be encouraged to persevere with Easyhaler® Beclometasone 200 micrograms/dose and withdrawal of systemic steroid continued, unless there are objective signs of adrenal insufficiency. g. 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.
Treatment with Easyhaler® Beclometasone 200 micrograms/dose should not be stopped abruptly. As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis. Easyhaler® Beclometasone contains approximately 7mg of lactose per dose.
This […]