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.
4.6. Pregnancy and lactation
Some epidemiological studies suggest an increased risk of cardiovascular defects associated with the use of fluoxetine during the first trimester. The mechanism is unknown. Overall the data suggest that the risk of having an infant with a cardiovascular defect following maternal fluoxetine exposure is in the region of 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population.
Epidemiological data have suggested that the use of SSRIs in pregnancy, particular in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur. 4.8 Undesirable effects Class Effects: Epidemiological studies, mainly in patients 50 years of age or older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown. 10 Date of Revision of the Text September 2010
4.8 Undesirable effects Class Effects: Epidemiological studies, mainly in patients 50 years of age or older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown. 10 Date of Revision of the Text September 2010
Class Effects: Epidemiological studies, mainly in patients 50 years of age or older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.
10 Date of Revision of the Text
September 2010
2. Qualitative and Quantitative Composition
For excipients, see 6.1. Changed to read For a full list of excipients, see section 6.1.
6.4. Special precautions for storage
Blister: Do not store above 25°C. Store in the original package.
Bottle: Do not store above 25°C. Keep the bottle tightly closed.
Change to read
Do not store above 25°C. Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Removed: HDPE bottle with snap-on cap
7 Marketing Authorisation number inserted Clondalkin
9. Date of First Authorisation / Renewal of Authorisation
26th November 1999/26th November 2004
Changed to read
Date of first authorisation: 26 November 1999
Date of last renewal: 26 November 2004
10. Date of Revision of the Text
Changed from June 2008 to Jan 2010
Section 4.1. Therapeutic Indications
Bulimia nervosa: Fluoxetine had been updated to Affex
Section 4.4: Special Warnings and Precautions for Use
Addition of the following:
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions for which Affex 20mg Hard Capsules is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be altered about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Deletion of the following:
Suicide: As improvement may not occur during the first few weeks of treatment, in common with all antidepressants, patients should be closely monitored during this period. The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. It is general clinical experience with all therapies for depression that the risk of suicide may increase in the early stages of recovery.
Section 4.8. Undesirable effects
Addition of the following section: Suicidal ideation and behaviour: Cases of suicidal ideation and suicidal behaviour have been reported during Affex 20mg Hard Capsules therapy or early after treatment discontinuation (see section 4.4).
Section 5.1. Pharmacodynamic properties
Histaminergic1 format updated to histaminergic1
Section 10: Date of Revision of the Text
Updated to June 2008
The IMB requested that the SPC for Affex 20mg Hard Capsules be updated in line with the EU Commission decision on product containing Fluoxetine dated 13th May 2003 and 19th August 2005.
The following sections of the SPC were therefore updated, largely in full:
Section 4.1 Therapeutic Indications
Section 4.2 Posology and Method Administration
Section 4.3 Contraindications
Section 4.4 Special Warnings and Precautions for Use
Section 4.5 Interactions with other Medicaments and other forms of Interaction
Section 4.6 Pregnancy and lactation
Section 4.7 Effects on ability to drive and use machines
Section 4.8 Undesirable effects
Section 4.9 Overdosage
Section 5.1 Pharmacodynamic properties
Section 5.2 Pharmacokinetic properties
Section 5.3 Preclinical safety data
The following sections have also been updated:
Section 7: Marketing Authorisation Holder changed to Astellas Pharma Co. Ltd.
Section 8: Marketing Authorisation Number changed to 1241/11/1
Section 9: Date of First Authorisation/Renewal of the Authorisation:
Previously this section read “26th of November 1999”. The product was renewed since the SPC was first put on IPHA, so this section now reads
“26th of November 1999/26th November 2004”
Section 10: Date of revision of text changed to May 2006