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Ricesteele Manufacturing Ltd
Unit 31, Cookstown Industrial Estate, Tallaght, Dublin 24,
Telephone: +353 1 451 0144
Fax: +353 1 452 1875
Summary of Product Characteristics last updated on medicines.ie: 20/10/2011
SPC Rubex Orange 1000mg Effervescent Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   18-Oct-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
In section 2 addition of the excipient orange oil [containing natural orange oil and ethanol (0.00131 microlitres per tablet)] is added.

Section 4.1 is rewritten as 'Rubex is used for the prevention and treatment of ascorbic acid (vitamin C) deficiency'.

Section 4.2 is changed to 'To be taken orally.  One tablet to be taken dissolved in water (hot or cold) daily.  Rubex is not recommended for use in children.'

Section 4.3 'Patients with rare glucose-galactose malabsorption should not take this medicine'. has been removed and added to section 4.4.  'Hypersesitivity to ascorbic acid or to any of the other constituents.' has been added.

Section 4.4 'Patients with rare glucose-galactose malabsorption should not take this medicine'. and 'This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per tablet.' have been added. 

Section 10 updated to October 2011.
Updated on 03/02/2011 and displayed until 20/10/2011
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Nov-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
In section 6.4 'Keep the tube tightly closed.' has been added.

Section 10 has been revised to November 2010.
Updated on 24/10/2007 and displayed until 03/02/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   08/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

1.  TRADE NAME OF THE MEDICINAL PRODUCT

    

     Rubex Orange 1000mg Effervescent Tablets

 

 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION

    

     Each tablet contains 1000mg of Ascorbic Acid.

    

Excipients: also includes glucose monohydrate 663mg per tablet, sunset yellow FCF (E110) 1.94 mg per tablet and sodium 273 mg per tablet.

     For a full list of excipients, see section 6.1

 

 

3.  PHARMACEUTICAL FORM

    

     Effervescent tablet

Mottled orange, flat, circular, orange flavoured effervescent tablets 25mm in diameter
 
 
6.4  Special Precautions for Storage

 

       Store below 250C.  Store in original container.
 

10. DATE OF REVISION OF THE TEXT             

 

August 2007 

Updated on 25/05/2005 and displayed until 24/10/2007
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 10 - Date of revision of the text
Updated on 22/07/2004 and displayed until 25/05/2005
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 22/07/2004 and displayed until 22/07/2004
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 04/06/2003 and displayed until 22/07/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ascorbic Acid (Vitamin C)