As the drug contains beclometasone dipropionate and formoterol fumarate dihydrate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Undesirable effects which have been associated with beclometasone dipropionate and formoterol administered as a fixed combination and as single agents are given as follows, listed by system organ class. 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) and very rare (≤1/10,000). Common and uncommon ADRs were derived from clinical trials in asthmatic and COPD patients.
Infections and infestations:
Common: Pharyngitis, oral candidiasis. Uncommon: Influenza, oral fungal infection, oropharyngeal and oesophageal candidiasis, vulvovaginal candidiasis, gastroenteritis, sinusitis, rhinitis, pneuomonia*.
Blood and lymphatic system disorders:
Uncommon: Granulocytopenia. Very Rare: Thrombocytopenia.
Immune system disorders:
Uncommon: Allergic dermatitis. Very Rare: Hypersensitivity reactions including erythema, lips, face, eye and pharyngeal oedema.
Very Rare: Adrenal suppression.
Metabolism and nutrition disorders:
Uncommon: Hypokalemia and hyperglycemia.
Uncommon: Restlessness. Unknown: Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children).
Nervous system disorders:
Common: Headache. Uncommon: Tremor, dizziness.
Very rare: Glaucoma, cataract.
Ear and labyrinth disorders:
Uncommon: Palpitations, electrocardiogram QT corrected interval prolonged, electrocardiogram change, tachycardia, tachyarrhythmia, atrial fibrillation*. Rare: Ventricular extrasystoles, angina pectoris.
Uncommon: Hyperaemia, flushing.
Respiratory, thoracic and mediastinal disorders:
Common: Dysphonia. Uncommon: Rhinitis, cough, productive cough, throat irritation, asthmatic crisis. Rare: Paradoxical bronchospasm. Very Rare: Dyspnea, exacerbation of asthma.
Uncommon: Diarrhea, dry mouth, dyspepsia, dysphagia, burning sensation of the lips, nausea, dysgeusia.
Skin and subcutaneous tissue disorders:
Uncommon: Pruritus, rash, hyperhidrosis, urticaria. Rare: Angioedema.
Musculoskeletal, connective tissue and bone disorders:
Uncommon: Muscle spasms, myalgia. Very Rare: Growth retardation in children and adolescents.
Renal and urinary disorders:
General disorders and administration site conditions:
Very Rare: Peripheral oedema.
Uncommon: C-reactive protein increased, platelet count increased, free fatty acids increased, blood insulin increased, blood ketone body increased, blood cortisol decrease*. Rare: Blood pressure increased, blood pressure decreased. Very Rare: Bone density decreased.
* One related non serious case of pneumonia was reported by one patient treated with the drug in a pivotal clinical trial in COPD patients. Other adverse reactions observed in COPD clinical trials were: reduction of blood cortisol and atrial fibrillation.
As with other inhalation therapy, paradoxical bronchospasm may occur (see Precautions).
Among the observed adverse reactions those typically associated with formoterol are: Hypokalaemia, headache, tremor, palpitations, cough, muscle spasms and prolongation of QTc interval.
Adverse reactions typically associated with the administration of beclometasone dipropionate are: oral fungal infections, oral candidiasis, dysphonia, throat irritation.
Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst continuing the treatment with the drug.
Systemic effects of inhaled corticosteroids (e.g. beclometasone dipropionate) may occur particularly when administered at high doses or prescribed for prolonged periods. These may include adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma.
Hypersensitivity reactions including rash, urticaria, pruritus and erythema, and oedema of the eyes, face, lips and throat may also occur.
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.