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Aurobindo Pharma Ltd
Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD
Telephone: + 44 (0)208 845 8811
Fax: +44 (0)208 845 8735
WWW: http://www.aurobindo.com
Medical Information Direct Line: +44 (0)208 839 0959
Medical Information e-mail: medinfo@aurobindo.com
Customer Care direct line: +44 (0)208 845 8811
Medical Information Fax: +44 (0)208 845 8795

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 24/08/2011
SPC Fluoxetine 20mg Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 24/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   15-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated in line with innovator.
Updated on 27/06/2011 and displayed until 24/08/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   15-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following information has been added to sections 4.6 and 4.8


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

 

Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.  The mechanism leading to this risk is unknown.
Updated on 14/05/2010 and displayed until 27/06/2011
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  fluoxetine hydrochloride