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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to Cipla (EU) Ltd on 0800 0472144, drugsafety@cipla.com
Bibecfo 100/6mcg and 200/6mcg are indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting β₂-agonist) is appropriate:
or
Bibecfo 100/6mcg is indicated in the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Bibecfo 100/6mcg and 200/6mcg are indicated in adults 18 years and above. For Bibecfo 100/6mcg in asthma, no recommendation on a dose can be made in children and adolescents 17 years and under.
Fostair is a registered trademark of Chiesi Ltd.
Adults 18 years and older:1
Asthma (Maintenance therapy):
One or two inhalations twice daily
Maximum daily dose is 4 inhalations
Asthma (Maintenance and reliever therapy):
One inhalation twice daily with one additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken
Maximum daily dose is 8 inhalations
COPD:
Two inhalations twice daily
Asthma (Maintenance therapy):
Two inhalations twice daily
Maximum daily dose is 4 inhalations
Patients using Bibecfo may experience side effects.
As Bibecfo contains beclometasone dipropionate and formoterol, 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.
As with other inhalation therapy, paradoxical bronchospasm may occur.
Common adverse events associated with beclometasone dipropionate and formoterol - either individually or as combination therapy - are listed below.
System Organ Class | Adverse Reaction | Frequency |
---|---|---|
Infections and Infestations | Pharyngitis, oral candidiasis, pneumonia* (in COPD patients) | Common |
Nervous system disorders | Headache | Common |
Respiratory, thoracic and mediastinal disorders | Dysphonia | Common |
*One related non-serious case of pneumonia was reported by one patient treated with beclometasone dipropionate/formoterol in a pivotal clinical trial in COPD patients.
Frequencies are defined as: common (≥1/100 to <1/10)
For more information about side effects, please refer to the Summary of Product Characteristics.
COPD = chronic obstructive pulmonary disease; FEV1 = forced expiratory volume; ICS = inhaled corticosteroid; MART = maintenance and reliever therapy; pMDI = pressurised metered dose inhaler; R&D = research and development