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.
X
Change to section 7 – Marketing Authorisation Holder
Change to section 10 – Date of revision of text
Change to section 1 – trade name
Changed to state 20mg/g
Change to section 2 – quantitative and qualitative composition
Includes all excipients
Change to section 6.2 - Incompatibilities
Changed to ‘Not Applicable’
Change to section 6.5 – Nature and Contents of Container
Not all pack sizes may be marketed
Change to section 9 – Date of Renewal of Authorisation
Change to May 2008
4.
Add number 4
4.1
Therapeutic Indications
Add tinea after vulvitis). Add Malassezia furfur (previously called Pityrosporum ovale)
4.2
Posology and method of administration
Replace Pityriasis with tinea
4.4
Special Warnings and Precautions for Use
Add to prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical…..etc.
4.5
Interaction with other medicinal products and other forms of interaction
Change to Interaction with other medicinal products. Remove paragraph and replace with None Known.
4.8
Undesirable effects
Add Topical treatment with Nizoral Cream is usually well tolerated.
Add burning sensation. Also in rare circumstances, allergic local skin phenomena etc
5.
PHARMACOLOGICAL PROPERTIES
Add the number 5
5.1
Pharmacodynamic properties
Remove Nizoral cream does not produce detectable blood levelsafter topical administration.
5.2
Pharmacokinetic properties
Nizoral cream does not produce detectable blood levels after topical administration.
10.
DATE OF REVISION OF THE TEXT
Remove Partial before Revision. I think the date here should be Aug 2006