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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: 08/07/2011
SPC Napratec OP

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 08/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to sections: 7 (MAH holder); 8 (MA numbers) and 10 (Date of revision of the text)
Updated on 07/04/2009 and displayed until 08/07/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 3 – Description of the tablet embossing

Section 6.5 – Nature and contents of container
Updated on 24/09/2008 and displayed until 07/04/2009
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • 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 4.7 - Effects on Ability to Drive and Use Machines
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 in line with the minimum clinical particulars for NSAIDs, as requested by the MHRA
Updated on 06/06/2007 and displayed until 24/09/2008
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:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 4.2 undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms

Section 4.3 addition of severe heart failure

Section 4.4 same statement as above for 4.2, expanded precautions & warnings for patients with CV risk

Section 4.8 addition of adverse events hypertension & cardiac failure, clinical trial & epidemiological data suggest that some NSAIDs may be associated with a small increased risk of arterial thrombotic events
Updated on 20/05/2005 and displayed until 06/06/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  misoprostol
  naproxen