Bufomix Easyhaler 160 micrograms/4.5 micrograms

Local representative of the Marketing Authorisation Holder details added.

Revised date updated.

Section 4.8 - Undesirable Effects:  Dysphonia including hoarseness has been added as a common adverse drug reaction.

Added to Section 1:  If agreed with the doctor Bufomix Easyhaler can also to prevent asthma symptoms from happening (for example, when exercising or on exposure to allergens).

Added to Section 3:  It is important that you discuss with your doctor the use of Bufomix Easyhaler to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that it is prescribed to you. 

The following updates have been made to the SPC:

Addition to Section 4.2: For patients taking Bufomix Easyhaler as reliever, preventative use of Bufomix Easyhaler for allergen- or exercise-induced bronchoconstriction should be discussed between physician and patient; the recommended use should take into consideration the frequency of need. In case of frequent need of bronchodilation without corresponding need for an increased dose of inhaled corticosteroids, an alternative reliever should be used.  

Addition to Section 4.4: Complete withdrawal of inhaled corticosteroids should not be considered unless it  is temporarily required to confirm diagnosis of asthma.

The instructions on how to use Easyhaler have updated images and these instructions have been moved to the end of the leaflet.

The only updates are to the revised dates of the text.

Section 4.1 (Indications): FEV1 now stated as 'forced expiratory volume in 1 second (FEV1)'.

Section 4.2 (Posology and method of administration):

- Text added ‘Children (6 years and older): A lower strength (80 micrograms/4.5 micrograms/inhalation) is available for children 6-11 years.’ and associated editorial changes.

- Inclusion of adolescents for MART indication and associated editorial changes.

Section 4.5 (Interactions): Text added ‘Hypokalaemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics.’

Section 5.1 (Pharmacodynamic properties):  Text added  ‘Comparable efficacy and safety in adolescents and adults was demonstrated in 6 double-blind studies, comprising the 5 studies mentioned above and an additional study using a higher maintenance dose of 160/4.5 micrograms, two inhalations twice daily. These assessments were based on a total of 14385 asthma patients of whom 1847 were adolescents. The number of adolescent patients taking more than 8 inhalations on at least one day as part of budesonide/formoterol maintenance and reliever therapy was limited, and such use was infrequent.’

Section 5.2 (Pharmacokinetic properties): Text updated to ‘The pharmacokinetics of budesonide or formoterol in children and patients with renal failure are unknown.’

Section 4.1:     The following text has been added to the indication for asthma ‘in adults and adolescents aged 12-17 years’, and this text has been added to the indication for COPD ‘Bufomix Easyhaler is indicated in adults, aged 18 years and older’.

Section 4.5:     Monoamine oxidase inhibitors have been removed from the list of drugs interacting with Bufomix Easyhaler. 

A statement has been added:  Paediatric populations: Interaction studies have only been performed in adults.

Section 4.6:     The following statement has been added: Fertility: There is no data available on the potential effect of budesonide on fertility.  Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section 5.3).

Section 4.8:     The information about pneumonia has been expanded:  Pneumonia has been reported in patients with COPD following administration with inhaled corticosteroids.  A case controlled study has shown an increased risk of pneumonia in patients with newly diagnosed COPD starting treatment with inhaled corticosteroids.  However, a weighted assessment of 8 pooled clinical trials involving 4643 COPD patients treated with budesonide and 3643 patients randomized to non-ICS treatments did not demonstrate an increased risk for pneumonia for budesonide. The results from the first 7 of these 8 trials have been published as a metaanalysis.

                        The following statement has been added:  Paediatric populations:  It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored (see section 4.4).

                        The details for reporting of suspected adverse reactions have been updated.

Section 5.1:     The Pharmacotherapeutic group description has been updated to: Drugs for obstructive airway diseases.: Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics.

Section 5.2:     A new section has been added:  Linearity/non-linearity:  Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered dose.