BECOTIDE EVOHALER Pressurised inhalation, solution Ref.[49849] Active ingredients: Beclometasone

The management of asthma should follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.

Increasing use of short-acting inhaled beta-2-agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient’s therapy plan should be reassessed.

Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to increasing corticosteroid dosage. In patients considered at risk, daily flow monitoring may be instituted.

Becotide Evohaler is not for use in acute attacks but for routine long-term management. Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms.

Patients' inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of the drug to the lungs.

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 an antibiotic if there is an infection.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long 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, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained (see section 4.8).

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.

Certain individuals can show greater susceptibility to the effects of inhaled corticosteroid than do most patients.

Because of the possibility of impaired adrenal response, patients transferring from oral steroid therapy to inhaled beclometasone dipropionate therapy should be treated with special care, and adrenocortical function regularly monitored.

Following introduction of inhaled beclometasone dipropionate, withdrawal of systemic therapy should be gradual and patients encouraged to carry a steroid warning card indicating the possible need for additional therapy in times of stress.

Similarly, 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 Becotide Evohaler should not be stopped abruptly.

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 after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. Becotide Evohaler should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.

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 which have been reported after use of systemic and topical corticosteroids.

Patients should be advised that this product contains small amounts of ethanol and glycerol. At the normal doses the amounts of ethanol and glycerol are negligible and do not pose a risk to patients.

Beclomethasone 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.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.

Becotide Evohaler contains a small amount of ethanol. There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.

Pregnancy

There is inadequate evidence of the safety of beclometasone dipropionate or Norflurane (HFA 134a or Tetrafluoroethane) propellant in human pregnancy.

In animal reproduction studies with beclometasone dipropionate, adverse effects typical of potent corticosteroids are only seen at high systemic exposure levels; direct inhaled application ensures minimal systemic exposure.

Studies of the effect of Norflurane (HFA 134a) on reproductive function and embryo-foetal development in animals have revealed no clinically relevant adverse events.

No clinically relevant adverse events have been associated with the administration of Norflurane (HFA 134a) propellant. Thus, it is unlikely that there will be any adverse effects in humans.

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

Breast-feeding

The excretion of beclometasone dipropionate in milk has not been studied in animals. It is reasonable to assume that beclometasone dipropionate is secreted in milk but at the dosage used for direct inhalation, there is low potential for significant levels in breast milk. Beclometasone dipropionate should only be used in a nursing mother if the expected benefit justifies the risk to the newborn/infant.

Becotide Evohaler has no or negligible influence on the ability to drive and use machines.

Adverse reactions 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 reactions 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 reactions were generally determined from spontaneous data.

Infections and infestations

Very common: Candidiasis of the mouth and throat.

Immune system disorders

Hypersensitivity reactions with the following manifestations have been reported:

Uncommon: Rash, urticaria, pruritus, erythema.

Very rare: Angioedema, respiratory symptoms (dyspnoea and/or bronchospasm) and anaphylactoid/anaphylactic reactions.

Endocrine disorders

Possible systemic effects include (see section 4.4):

Very rare: Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma.

Psychiatric disorders

Very rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children).

Unknown: Depression, aggression (predominantly in children).

Respiratory, thoracic and mediastinal disorders

Common: Hoarseness, throat irritation.

The use of a large volume ‘spacer’ device may be considered.

Very rare: Paradoxical bronchospasm (see section 4.4)

Eye disorder

Not known: Vision, blurred (see section 4.4)

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. Becotide Evohaler 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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie.

Not applicable.