Bufomix Easyhaler 160 micrograms/4.5 micrograms

Product Information *

  • Company:

    Orion Pharma (Ireland) Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 02 November 2020

File name

IE Bufomix Easyhaler 160_4.5 microg inhalation SPC 090620_1604323258.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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

Updated on 14 September 2020

File name

IE Bufomix Easyhaler 160_4.5 microg inhalation PIL 010620_1600093337.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

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. 

Updated on 14 September 2020

File name

IE Bufomix Easyhaler 160_4.5 microg inhalaation SPC 210720_1600092980.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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.

 

Updated on 18 March 2020

File name

IE Bufomix Easyhaler 160_4.5 microg inhalation PIL 301019_1584542748.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

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

Updated on 18 March 2020

File name

IE Bufomix Easyhaler 160_4.5 microg inhalation SPC 270220_1584542658.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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

Updated on 06 April 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 April 2018

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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.’

Updated on 03 April 2018

File name

PIL_16039_978.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 April 2018

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents

Updated on 08 September 2017

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of a new pack size in section 6.5 of the text:
240 doses (2 x 120 doses) added

It is important to note that not all pack sizes listed in this section are marketed.

Updated on 08 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 September 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 05 September 2017

File name

PIL_16039_587.pdf

Reasons for updating

  • New PIL for new product

Updated on 31 May 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following has been added to Section 4.4 of the text:
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 (CSCR) which have been reported after use of systemic and topical corticosteroids.

Section 4.8, undesirable effects has also been updated to reflect the change to section 4.4 of the Summary of Product Characteristics i.e. blurred vision has been added to the table of adverse reactions.

Updated on 26 May 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 25 April 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following information has been added to section 4.5 of the SPC:
Co-treatment with cobicistat-containing products is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Updated on 20 April 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 25 January 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The information with regards to pneumonia in patients with COPD has been updated in sections 4.4 and 4.8 of the text.  In summary, an increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.

Updated on 24 January 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 April 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The use of the product as maintenance and reliever therapy added to the indication.

Updated on 08 April 2016

Reasons for updating

  • Change to dosage and administration

Updated on 20 April 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



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.

Updated on 15 April 2015

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 11 July 2014

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 July 2014

Reasons for updating

  • New PIL for new product