Budesonide/Formoterol Teva Pharma B.V.

Summary of the safety profile Since this medicinal product contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.

Common adverse reactions mainly attributed to β2 adrenoceptor agonist therapy are tremor and palpitations. Common adverse reactions mainly attributed to corticosteroid therapy are candida infections in the oropharynx, pneumonia, mild irritation in the throat, coughing, and dysphonia including hoarseness.

A common adverse reaction that can be contributed to both budesonide and formoterol is headache. Tabulated list of adverse reactions Adverse reactions, which have been associated with budesonide or formoterol, are given below and listed by system organ class and frequency (see table 1).

Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data). g. g. 4 for more information 2Adverse reaction mainly attributed to budesonide 3Adverse reaction mainly attributed to formoterol Description of selected adverse reactions Systemic effects Systemic effects of inhaled corticosteroids may occur, 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.

Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur. 4). 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 the national reporting system listed in Appendix V.

Dosing advice Patients should be reassessed regularly by their physician/healthcare provider so that the dose of GoResp Digihaler remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of this treatment. When it is appropriate to titrate down to a lower strength than is available for GoResp Digihaler, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate dihydrate containing a lower dose of the inhaled corticosteroid is required.

Regular review of patients as treatment is stepped down is important. Patients should be advised to have their rescue inhaler available at all times, either GoResp Digihaler (for asthma patients using this medicinal product as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using this medicinal product as maintenance therapy only).

It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma.

Patients should be reminded to take their medicinal product maintenance dose as prescribed, even when asymptomatic. g. before exercise, has not been studied. g. before exercise. Deterioration of disease This medicinal product should not be used to treat acute asthma symptoms for which a fast- and short- acting bronchodilator is required.

Patients should not be initiated on this medicinal product during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. 8). Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with this medicinal product.

2). Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment. g. a course of oral corticosteroids, or antibiotic treatment if an infection is present.

Systemic effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.

8). 8). 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.

It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained. 8). Long-term studies with inhaled budesonide in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.

No information regarding the effect of a budesonide/formoterol fumarate dihydrate fixed-dose combination at higher doses is available. Adrenal function Treatment with supplementary systematic steroids or inhaled budesonide should not be stopped abruptly.

8). Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Rapid reduction in the dose of steroids can induce acute adrenal crisis. Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.

Paradoxical bronchospasm Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing. If the patient experiences paradoxical bronchopasm, treatment with this medicinal product should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.

8). Transfer from oral therapy If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to a budesonide/formoterol […]

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