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Bayer plc

Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 02/04/2012
SPC Feminax Ultra 250mg Gastro-resistant Tablets

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 02/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   13-Jan-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



4.2 Posology & Method of Administration: Not to be broken or crushed

4.3 Contraindications: Hepatic or renal failure; during the last trimester of pregnancy

4.4 Special Warnings & Precautions for Use: New sections on elevations of liver function tests; use in cardiac impairment, uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, cirrhosis; renal effects; contraindication in patients with baseline creatine clearance less than 30ml/min (was 20ml/min); information on risk of GI bleeding, ulceration or perforation; risk of aseptic meningitis; precautions related to female infertility

4.5 Interaction with other medicinal products and other forms of interaction: Addition of hydantoin, sulphonamide or sulphonylurea, tacrolimus and zidovudine

4.6 Pregnancy and Lactation: Addition of further information; naproxen is contraindicated during the last trimester of pregnancy

4.8 Undesirable effects: Addition of several adverse events reported with naproxen and NSAIDs

4.9 Overdose: Addition of further information

5.2 & 5.3 Pharmacological Properties: Addition of further information

Updated on 05/03/2009 and displayed until 02/04/2012
Reasons for adding or updating:
  • New SPC for new product
  • 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:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   naproxen