160 corrected to 60 in section 4.2

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

Update to date of revision due to renewal

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

Pack sizes:

1 inhaler (120 actuations)

multipack of 3 x 1 inhaler (120 actuations)

Not all pack sizes may be marketed.

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.