Bufomix Easyhaler 80 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 80_4.5 microg inhalation SPC 090620_1604323153.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 18 March 2020

File name

IE Bufomix Easyhaler 80_4.5 microg inhalation SPC 270220_1584542567.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 18 March 2020

File name

IE Bufomix Easyhaler 80_4.5 microg inhalation PIL 301019_1584542263.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 06 April 2018

Reasons for updating

  • 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 4.2 (Posology and method of administration): Inclusion of adolescents (aged 12-17 years) for MART indication withassociated 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 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 03 April 2018

File name

PIL_16806_292.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
  • Change to section 3 - use in children/adolescents

Updated on 31 May 2017

Reasons for updating

  • New SPC for new product

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

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

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 26 May 2017

File name

PIL_16806_764.pdf

Reasons for updating

  • New PIL for new product

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

Information has been added to 'Section 4.5 Interaction with other medicinal products and other forms of interaction'.

The following text has been added: 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 04 August 2016

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 03 August 2016

Reasons for updating

  • New PIL for new product