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.
Changes for Florinef SPC following renewal approval and psychiatric class effects variation approval: Section 2: Lactose content added
Section 2: Lactose content added
Section 3: " The tablets can be divided into equal halves." added.
Section 4.4: Following paragraph added:
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.
Section 4.8: Following paragraph added
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
Section 6.3: Shelf life expressed in years
Section 6.4: Storage conditions revised to change the word container to bottle and 'To protect from moisture included.
Section 6.5: Amber glass bottles described as Type III
Section 9: Dates of last renewal revised to 1 April 2008
Section 10: Date of revision revised to 31 May 2010
Section 3: Changed from Light, pink coloured, round flat faced tablets to Round, biconvex, white tablets.
Section 4.4: Warning re galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption included.
Section 6.1: Erythrosine E127 deleted. Anhydrous and monohydrate included for Lactose.
Section 6.3: Shelf life increased from 12 months to 24 months
Section 6.4: Storage changed from 'Do not store above 25°C' to 'Store in a refrigerator (2-8°C). Keep container tightly closed.'
Section 6.5: Changed from Bottles of 56's to Amber glass bottles of 100 tablets, with a cotton plug, induction seal and polypropylene caps.
Section 10.: Date of revision changed to 21 March 2007