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SOPROBEC 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: Soprobec is indicated for the maintenance treatment of asthma, when the use of pressurised metered dose inhaler is appropriate.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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 Soprobec is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 micrograms or greater.
Children:
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. Soprobec 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.
Patients with hepatic or renal impairment:
No dosage adjustment is needed in patients with hepatic or renal impairment. Method of Administration Soprobec is for inhalation use. To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other health professional.
Correct use of the pressurised metered dose inhaler is essential in order that treatment is successful. The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the Leaflet.
Testing the inhaler Before using the inhaler for the first time or if the inhaler has not been used for 3 days or more, the patient should release one actuation into the air in order to ensure that the inhaler is working properly. Whenever possible patients should stand or sit in an upright position when inhaling from their inhaler.
Instructions for Use 1. Patients should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects. 2. Patients should breathe out as slowly and deeply as possible.
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). 4 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 Soprobec. 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.
4 Special warnings and special precautions for use 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 be reminded to take Soprobec daily as prescribed even when asymptomatic.
Soprobec should not be used for treatment of acute asthma attacks patients. For such cases patients should be advised to have their rapid-acting bronchodilator available at all times. It is recommended that treatment with Soprobec should not be stopped abruptly.
If patients find the treatment ineffective medical attention must be sought. Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Sudden and progressive deterioration in control of asthma is potentially life- threatening and the patient should undergo urgent medical assessment.
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 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).
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.
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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3. Patients should hold the canister vertically with its body upwards and put the lips around the mouthpiece without biting the mouthpiece 4. At the same time, patients should breathe in slowly and deeply through the mouth. After starting to breathe in, they should press down on the top of the inhaler to release one puff.
5. Patients should hold the breath for about 5 to 10 seconds or as long as comfortable, and then breathe out slowly. If another dose is required, they should be advised to wait 30 seconds before repeating the procedure just described.
Finally, they should remove the inhaler from the mouth and breathe out slowly. Patients should not breathe out into the inhaler. IMPORTANT: patients should not perform steps 2 to 5 too quickly. After use, patients should close the inhaler with protective cap.
If mist appears following inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2. For patients with weak hands it may be easier to hold the inhaler with both hands. Therefore, the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler.
4). 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. 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™ spacer device for the correct instructions on its use and cleaning.
Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Situations which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage.
Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Care should be taken when transferring patients to Soprobec therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy. Patients transferring from oral to inhaled corticosteroids may remain at risk of impaired adrenal reserve for a considerable time.
Patients who have required high dose emergency corticosteroid therapy in the past or have received prolonged treatment with high doses of inhaled corticosteroids may also be at risk. This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered.
The extent of the adrenal impairment may require specialist advice before elective procedures. 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.
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. Soprobec should be discontinued immediately, the patient assessed and, if necessary, alternative therapy institute.
To reduce the risk of Candida infection, patients should be recommended to rinse their mouth properly after each drug administration. Special care is necessary in patients with viral, bacterial and fungal infections of the eye, mouth or respiratory tract..
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.
47 mg of alcohol (ethanol) in each actuation which is equivalent to 13% w/w. The amount of alcohol in each actuation is equivalent to less than 4 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.