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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

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: 08/05/2008
SPC Folicare 0.4mg/5ml Oral Solution

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 08/05/2008 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   31-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 16/04/2008 and displayed until 08/05/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Product name re-arrangement
Section 6.1: Flavour change (now includes propylene glycol)
Updated on 10/04/2007 and displayed until 16/04/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3: "Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency" added
Section 4.5: Amended as per: "Folic Acid has been observed to reduce plasma phenytoin levels of anticonvulsants, particularly phenytoin and primidone and therefore patients should be carefully monitored by the physician and the anti-epileptic  anticonvulsant drug dose adjusted as necessary."
Section 4.8: Amended as per: "Allergenic Allergic reactions to Folic Acid have been reported."
Updated on 05/04/2007 and displayed until 10/04/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3: Added: "Malignant disease unless megaloblastic anaemia due to folic acid deficiency"
Section 4.5: Broader statement on anticonvulsants
Section 4.8: "Allergenic" amended to "Allergic"
Updated on 01/05/2003 and displayed until 05/04/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/09/2002 and displayed until 01/05/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/09/2002 and displayed until 27/09/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  folic acid