Discovery Pharmaceuticals Ltd

The Old Vicarage, Market Place, Castle Donington, Derbyshire, DE74 2JB

Telephone: +44 (0) 845 2416616
Fax: +44 (0) 845 2419919
Medical Information Direct Line: 0
Medical Information e-mail: medinfo@discoverypharma.co.uk

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Summary of Product Characteristics last updated on the eMC: 07/03/2012

SPC	Oxactin 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 07/03/2012 and displayed until Current

Reasons for adding or updating:
Change to section 1 -Name of the Medicinal product Change to section 2 - Qualitative and quantitative composition Change to section 4.1 - Therapeutic indications Change to section 4.2 - Posology and method of administration Change to section 4.3 - Contraindications Change to section 4.4 - Special warnings and precautions for Use Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 4.6 - Pregnancy and Lactation Change to section 4.7 - Effects on Ability to Drive and Use Machines Change to section 4.8 - Undesirable Effects Change to section 4.9 - Overdose Change to section 5 - Pharmacological Properties Change to section 5.1 - Pharmacodynamic Properties Change to section 5.2 - Pharmacokinetic Properties Change to section 5.3 - Preclinical Safety Data Change to section 6.1 - List of Excipients Change to section 6.2 - Incompatibilities Change to section 6. 3 - Shelf Life Change to section 6. 4 - Special Precautions for Storage Change to section 6. 5 - Nature and Contents of Container Change to section 6. 6 - Instructions for use, handling and disposal Change to section 7 - Marketing Authorisation Holder Change to section 8 - MARKETING AUTHORISATION NUMBER(S) Change to section 9 - Date of first Authorisation/renewal of the Authorisation Change to section 10 date of revision of the text Change of Marketing Authorisation Holder Change of manufacturer Change to manufacturer contact details Change to MA holder contact details Change due to harmonisation of SPC Change of inactive ingredient
Date of revision of text on the SPC: 12-Jul-2011
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Completely new SPC to reflect the change of Manufacturer/ MA Holder & formulation

Updated on 04/11/2010 and displayed until 07/03/2012

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: 10-Aug-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
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 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 26/05/2010 and displayed until 04/11/2010

Reasons for adding or updating:
Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC: 03-Mar-2009
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Increase the shelf life of Fluoxetine/Oxactin 20mg Capsules in the UK from 36 months to 48 months

Updated on 18/02/2010 and displayed until 26/05/2010

Reasons for adding or updating:
Change to section 4.4 - Special warnings and precautions for Use Change to section 7 - Marketing Authorisation Holder Improved Electronic Presentation Change to MA holder contact details
Date of revision of text on the SPC: 03-Mar-2009
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
· Change name of MA holder (SPUK to Genus Pharmaceuticals Ltd) 03/02/2005 · Update in line with originator & addition of lactose warning 05/03/2008 · Change of address for MAH (Benham Valence to Park View House) 15/01/2008 · Update to SmPC in line with PhVWP recommendations 2007(sent to therapeutic review group) 07/03/2009