Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 micorgram/10 microgram per metered dose pressurised inhalation, suspension. *

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 28 June 2021

File name

spc_1624869661.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Section 2: Addition of details of excipient with known effect.

Section 4.4: Addition of excipient warning.

Updated on 11 March 2020

File name

Approved_SPC_Pressurised_Inhalation_English_Flutiform_Combined_Paediatric_medicines_ie_1583941065.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

160 corrected to 60 in section 4.2

Updated on 23 January 2019

File name

Approved_package_leaflet_Flutiform_all_Paediatric_IE _Paediatric_1548241547.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 January 2019

File name

Approved_SPC_Pressurised_Inhalation_English_Flutiform_Combined_Paediatric_medicines_ie_1548241117.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.1, 4.2, 4.4, 4.5, 4.8 and 5.1 of the SPC following the registration of the addition of a new paediatric indication for children aged 5 to less than 12 for the treatment of Asthma

Updated on 10 July 2018

File name

Approved_SPC_Pressurised_Inhalation_English_Flutiform_combined for medicines_ie.docx

Reasons for updating

  • 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

Update to date of revision due to renewal

Updated on 14 October 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic 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

‘For inhalation use’ has been deleted from the beginning of the sentence ‘Patients will need to be trained on the use of the inhaler ….’

The following text in red has been added

The actuator has an integrated counter which counts down the number of actuations (puffs) remaining. This counter is also colour coded.  It starts off green then, when there are less than 50 puffs (actuations) left it changes to yellow and when there are less than 30 puffs (actuations) left it changes to red.  The counter counts down from 120 to 160 in intervals of 10, and from 60 to 0 in intervals of 5.  When this is getting near to zero the patient should be advised to contact their prescriber for a replacement inhaler. The inhaler must not be used after the dose indicator reads “0”.

Format changes have been made to Steps to follow when using the inhaler and changes to the steps to follow when using the inhaler

Section 4.3 Contraindications

Now reads

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Section 4.5 Interaction with other medicinal products and other forms of interaction

Formoterol fumarate, as with other β2 agonists, should be administered with extreme caution to patients

(extreme has been deleted).

Section 4.8 Undesirable effects

Changes to frequency of some adverse events.

‘Oral fungal infections – Rare ‘ has been added/

Fluticasone propionate: Hypersensitivity reactions including, urticaria, pruritus, angiooedema (mainly facial and oropharyngeal), anaphylactic reactions.  Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods.  These may include Cushing’s Syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, sleep disorders, contusion, skin atrophy and susceptibility to infections.  The ability to adapt to stress may be impaired.

‘sleep disorders’ has been deleted.

 

Section 5.1 Pharmacodynamic properties

Text in red has been added

Pharmacotherapeutic Group:  Drugs for obstructive airways, adrenergics in combination with corticosterioids or other drugs excl. anticholinergics

 

Section 5.2 Pharmacokinetic properties

Metabolism has been replaced with  ’ Biotransformation’

Section 6.6 Special precautions for disposal and other handling

Now reads:

No special requirements for disposal.

For detailed instructions on the use of the medicinal product see section 4.2

Updated on 14 October 2015

Reasons for updating

  • New SPC for new product

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

Updated on 08 October 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 08 October 2015

File name

PIL_15611_631.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 November 2013

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

In section 6.5 the following has been added:

Pack sizes:

1 inhaler (120 actuations)

multipack of 3 x 1 inhaler (120 actuations)

 

Not all pack sizes may be marketed.

Updated on 26 September 2013

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5

We have removed

Pack sizes:

1 inhaler (120 actuations)

multipack of 3 x 1 inhaler (120 actuations)

 

Not all pack sizes may be marketed.


 As the 3 x inhaler will not be marketed in ROI we should not have included this update in the SPC.  This was the only change to the SPC.

Therefore the revision of text is as per our previous SPC October 2012.

Updated on 11 September 2013

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

The following has been added to section 6.5:



        Multipack of 3 x 1 inhaler (120 actuations)

        Not all pack sizes may be marketed.

Updated on 07 February 2013

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 04 February 2013

Reasons for updating

  • New PIL for new product