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Winthrop Pharmaceuticals UK Ltd
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

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: 05/07/2011
SPC Fenofibrate 267mg 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 05/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 reworded to: Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
Overall the indication remains the same but it has been reworded.

Section 5.1 reformatted and section 10 date amended to 27/05/2011
Updated on 16/06/2011 and displayed until 05/07/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   27-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1

Table and following text has been deleted. 'Fenofibrate should only be used in patients in whom a full investigation has been performed to define their abnormality. Other risk factors, such as hypertension and smoking, may also require management.'

Following information added; Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

Section 5.1

Following information added; There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.
Updated on 17/11/2010 and displayed until 16/06/2011
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   28-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update sections 4.3, 4.4 and 4.5 of SPC to bring in line with innovator.
Updated on 02/11/2009 and displayed until 17/11/2010
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

 
  fenofibrate