BECLAZONE 250mg Pressurised inhalation, solution Ref.[28142] Active ingredients: Beclometasone

Steroid‑dependent patients: The transfer of steroid‑dependent patients to beclometasone dipropionate anhydrous inhalers and their subsequent management, needs special care mainly because recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy, is slow. The patient should be in a reasonably stable state before being given beclometasone dipropionate anhydrous inhaler in addition to his usual maintenance dose of systemic steroid. After about a week, gradual withdrawal of the systemic steroid is started by reducing the daily dose by 1mg prednisolone, or its equivalent of other corticosteroids, at not less than weekly intervals. Patients treated with systemic steroids for long periods of time or who have received high doses may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously. Some patients feel unwell (i.e. headache, nausea, articular or muscular discomfort) during the withdrawal phase despite maintenance or even improvement of respiratory function. They should be encouraged to persevere with the inhaler and withdrawal of systemic steroid continued unless there are objective signs of adrenal insufficiency. Spirometric and clinical assessments should be provided while reducing oral corticotherapy. Most patients can be successfully transferred to beclometasone dipropionate anhydrous inhaler with maintenance of good respiratory function, but special care is necessary for the first months after the transfer until the pituitary‑adrenal system has sufficiently recovered to enable the patient to cope with emergencies such as trauma, surgery or infections.

Transferred patients whose adrenocortical function is impaired should carry a warning card indicating that they need supplementary systemic steroid during periods of stress or elective surgery.

They should also be given a supply of oral steroid to use in emergency, for example when the asthma worsens as a result of a chest infection. The dose of beclometasone dipropionate anhydrous inhaler should be increased at this time and then reduced to the maintenance level after the systemic steroid has been discontinued.

Patients with high blood levels of Candida precipitins, indicating a previous infection, are more likely to develop candidiasis of the mouth and throat (thrush), (see section 4.8 “Undesirable effects”). All patients may find it helpful to rinse their mouth with water after using the inhaler.

Paradoxical bronchospasm may occur. If such does appear, use should cease and alternative therapy introduced.

Replacement of systemic steroid treatment with beclometasone dipropionate anhydrous inhaler 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.

Patients should be instructed in the proper use of the inhaler to ensure that the drug reaches the target areas within the lungs. Actuation of the aerosol should be synchronised with inspiration. They should also be made aware that beclometasone dipropionate anhydrous has to be used regularly for optimum benefit even when they are asymptomatic. Patients being treated with Beclazone 50 or 100 micrograms CFC-Free Inhaler may be transferred directly to treatment with beclometasone dipropionate anhydrous 250 micrograms CFC-Free Inhaler (at the same total daily dose up to a maximum of 1000mcg). In the majority of patients no significant effects on plasma or urinary free cortisol occur until doses of 1000 micrograms per day are exceeded. Some patients receiving 2,000μg of beclometasone dipropionate anhydrous CFC-Free per day have shown reduced plasma or urinary free cortisol although short-term adrenal reserve remains intact. In any patients the risk of developing adrenal suppression should be balanced against the therapeutic advantages and precautions should be taken to provide systemic steroid cover in situation of prolonged stress.

Particular care is required in patients with a history of, or existent tuberculosis.

Particular care should be taken to minimise the use of topical corticosteroids in patients with immunosuppression.

Beclometasone dipropionate anhydrous inhaler is not intended for the treatment of acute asthma attack.

Special care is needed in patients with viral, bacterial, and fungal infections of the eye or the mouth or respiratory tract. In case of bacterial infection of the respiratory tract an adequate antibiotic co-medication may be required.

Increasing use of bronchodilators, in particular short-acting inhaled 2-agonists, to relieve symptoms indicates deterioration of asthma control.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. The 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, 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.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended dose, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Concurrent administration of barbiturates, phenytoin or rifampicin may enhance the metabolism and reduce the effects of oral corticosteroids. Response to anti‑coagulants may be reduced and, on some occasions enhanced, by oral corticosteroids. Concurrent administration of oral corticosteroids or the potassium‑depleting diuretics such as thiazides or frusemide may cause excessive potassium loss. No known interactions have been reported for inhaled beclometasone dipropionate anhydrous.

No specific studies have been performed examining the safety in human pregnancy and lactation for BDP HFA. Beclometasone inhalation may be associated with intrauterine growth retardation in humans. Studies in animals have shown reproductive toxicity (see section 5.3). The use of beclometasone in pregnancy requires that the possible benefits of the drug be weighed against the possible hazards.

The transfer of beclometasone into milk has not been examined. It is reasonable to assume that beclometasone is excreted in milk but at the doses used for inhalation there is low potential for significant levels in breast milk.

Beclazone 250 micrograms CFC-Free Inhaler has no influence on the ability to drive and use machines.

Frequency estimate: very common = 10%, common = 1% to <10%, uncommon = 0.1% to <1%, rare = 0.01% to <0.1%, very rare <0.01%

Infections and infestations

Common (>1/100 and <1/10): Candidiasis in mouth and throat

Immune system disorders

Rare (>1/10,000 and <1/1000): Allergic reactions: angioedema in eyes, throat, lips and face

Endocrine disorders

Very rare (<1/10,000, including isolated reports): Adrenal suppression (systemic effect), Growth retardation in children and adolescents

Eye disorders

Very rare (<1/10,000, including isolated reports): Cataract, glaucoma (systemic effect)

Respiratory, thoracic and mediastinal disorders

Common (>1/100 and <1/10): Hoarseness and throat irritation

Rare (>1/10,000 and <1/1000): Paradoxical bronchospasm

Skin and subcutaneous tissue disorders

Very rare (<1/10,000, including isolated reports): Urticaria, rash, pruritus, erythaema

Musculoskeletal and connective tissue disorders

Very rare (<1/10,000, including isolated reports): Decreased bone mineral density (systemic effect).

Psychiatric disorders

Frequency unknown: Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children)

Not applicable.