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.
3. PHARMACEUTICAL FORM
Round, biconvex, brick-red film-coated tablet with inscription “379” on one side. Film-coated tablet. Brick-red, round, biconvex, film-coated tablets imprinted 'S' on one side and '379' on the other
In section 2, information about the product composition has been updated in line with the latest guidelines. Please note that the composition itself has not changed.
In section 5, details about the Pharmacotherapeutic group to which estradiol belongs have been inserted.
In section 6.1, the list of excipients (inactive ingredients) has been updated in line with the latest guidelines. Please note that the composition itself has not changed.
In section 7, the name of the Marketing Authorisation Holder has changed to Abbott Healthcare Products Ltd.
In section 9, the date of the last renewal has been updated to 16 April 2009.
In section 10, the revision date has been updated to November 2010.
4.3 Contraindications
Non hyterectomized women without opposing progestogen
Added under (in bold below):
Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction, cerebral vascular accident);
4.4 Special warnings and special precautions for use
4.8 Undesirable effects
MedDRA system organ class
Common
>1/100, <1/10
Uncommon
>1/1,000, <1/100
Rare
>1/10,000, <1/1,000
Very rare <1/10,000 incl. isolated reports
Immue system disorders
Hypersensitivity reactions
Changes in carbohydrate metabolism have been reported.
10. DATE OF REVISION OF THE TEXT
January 2007