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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 17/10/2011
SPC Lustral

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 17/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to section 4.9: Overdose
Updated on 06/10/2011 and displayed until 17/10/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3    Pharmaceutical Form – 50 mg (only): Tablet Description of score line function added
Section 4.4    Special warnings and special precautions for use – Grapefruit juice added
Section 4.5    Interactions with other medicinal products and other forms of interaction – Grapefruit juice interaction added
Section 5.2    Pharmacokinetic properties
Section 6.1    List of Excipients updated to include film coating components and the inclusion of additional E numbers
Section 6.4    Storage conditions harmonised to: Do not store above 30°C.
Section 6.5    Nature and contents of container – Additional pack sizes
Updated on 05/08/2010 and displayed until 06/10/2011
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:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC Section 4.6 to include comment on PPHN and 4.8 to include a class effect of bone fracture
Updated on 28/07/2010 and displayed until 05/08/2010
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:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.6 has been updated to include information on PPHN (persistant pulmonary hypertension in the newborn).  Section 4.8 has been updated to include a class effect of increased bone fracture.
Updated on 07/01/2010 and displayed until 28/07/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Based on a review of existing literature, the MAH’s clinical trial and safety database, the MAH has revised Section 4.4 Special warnings and precautions for use of the Lustral SPC to include new text regarding Serotonin Syndrome (SS) and Neuroleptic Malignant Syndrome (NMS).
Updated on 05/11/2009 and displayed until 07/01/2010
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Harmonisation of SmPC following Article 30 referral with extensive changes including to all parts of section 4
Updated on 15/01/2009 and displayed until 05/11/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Dates updated in Sections 9 and 10 to reflect grant of renewal
Updated on 26/08/2008 and displayed until 15/01/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to section 4.6 of the SPC - Regarding ‘Persistent Pulmonary Hypertension in the Newborn’.
Updated on 06/03/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 

4.4 – Amendment of wording regarding suicidal thoughts or clinical worsening

4.8 – addition of suicidal ideation and behaviour
Updated on 06/11/2007 and displayed until 06/03/2008
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 – Update to this section

4.3 – Update to this section

4.4 - Update to this section

4.8 - Update to this section
Updated on 09/03/2006 and displayed until 06/11/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/12/2003 and displayed until 09/03/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/06/2003 and displayed until 10/12/2003
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/05/2002 and displayed until 20/06/2003
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
Updated on 24/08/2001 and displayed until 17/05/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 20/02/2001 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 04/02/2000 and displayed until 20/02/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 04/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  sertraline hydrochloride