When a pharmaceutical company changes an SPC or PIL, 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.
Update to Section 4.8 Deletion of the statement regarding adolescents and over 65's - in line with the P-RMS Final Assessment Report of the PSUR)
Merck Sharp & Dohme Ireland (Human Health Limited
Pelham House
South County Business Park
Leopardstown
Dublin 18
Ireland
Change of ownership from Schering-Plough Ltd to Merck Sharpe & Dohme Limited. Therefore the following sections have been updated with the new details.
MARKETING AUTHORISATION HOLDER
Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UK
MARKETING AUTHORISATION NUMBER
PA 1286/39/2
Also update to section 4.5, 4.6, 4.8, 6.1 and 6.5 in line with the company core data sheet.:
In section 4.5 the active name has been written out fully, so now reads mometasone furoate.
In section 4.6 it is now stated that breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Section 4.8 table now includes Immune System disorders, asthma aggravation. There is also additional information on Bronchospasm and how the patient should discontinue Asmanex immediately if this is to occur.
Section 6.1 now references that lactose anhydrous contains trace amounts of milk protein.
Section 6.5 makes reference to the strength of the product.
Section 4.2
Method of Administration, the following sentence has been added at the start of this section:
Patients should be in an upright position when inhaling this product
Section 4.4
The following paragraph has been added to this section:
As with other inhaled asthma medications, bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with the Asmanex Twisthaler 200 or 400 micrograms Inhalation Powder, immediate treatment with a fast-acting inhaled bronchodilator is recommended; thus, the patient should be told to keep an appropriate bronchodilator inhaler on hand at all times. In such cases, treatment with Asmanex Twisthaler 200 or 400 micrograms Inhalation Powder is then discontinued immediately and alternative therapy instituted.
The following paragraph has been changed from:
It is recommended that the height of children or adolescents receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, review therapy with the aim of reducing the dose of inhaled corticosteroids if possible, to the lowest dose at which effective control of symptoms is achieved. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
To:
If growth is slowed, review therapy with the aim of reducing the dose of inhaled corticosteroids if possible, to the lowest dose at which effective control of symptoms is achieved. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
The following paragraph has changed from:
Patients with lactose intolerance: The maximum recommended daily dose contains lactose 4.64 mg per day. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patients with lactose intolerance: The maximum recommended daily dose contains lactose 4.64 mg per day. This amount does not normally cause problems in lactose intolerant people.
Section 4.8
Updated Table 1
The following paragraph’s have been removed from this section
With twice daily dosing, oral candidiasis was reported in 6 % and 15 % of patients on the 200 microgram and 400 microgram dose regimens, respectively, and in 2%, on both of the once-daily regimens.
With the twice daily regimen, treatment-related pharyngitis was reported in 4 % (200 micrograms) and 8 % (400 micrograms) of patients. On the once-daily regimen, the incidence was 4% (200 micrograms) and 2% (400 micrograms).
Section 6.3
Changed from:
2 years3 months after opening.
As packaged for sale: 2 years
After first opening: 3 months.
Section 6.4
First line changed from:
Store in original package until opened.
Store in original package until required for use.
Section 6.5
Individual units of 14 (400 micrograms only), 30 and 60 metered actuations. Not all pack sizes may be marketed.
Individual units of 14 (400 micrograms only) 30 and 60 delivered doses. Not all pack sizes may be marketed.
Section 9
Date of renewal of authorisation added
Section 10
Date of revision of text updated