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A.Menarini Pharmaceuticals Ltd
2nd Floor, Castlecourt, Monkstown, Monkstown, Co. Dublin, Ireland
Telephone: +353 1 284 6744
Fax: +353 1 284 6769
E-mail: ireland@menarini.ie
Medical Information Direct Line: 1800 283 045
Summary of Product Characteristics last updated on medicines.ie: 29/06/2010
SPC Osteofos D3

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 29/06/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


 

The main changes to the SmPC are as follows:

  • Section 1 Name of the medicinal product: amend the product name to add the product strength - Osteofos D3 1200 mg/ 800 I.U. powder for oral suspension
  • Section 2 Qualitative and quantitative composition: add information on the excipient Sunset yellow FCF (E110) and sucrose
  • Section 4.8 Undesirable effects: information reformatted according to the MedRA Systme Organ Class.
  • Section 4.9 Overdose: Additional information added on overdose leading to hypervitaminosis and hypercalcaemia, symptoms of hypercalcaemia and treatment.  Information on vitamin D intoxication.
  • Section 6.6 Special precautions for disposal: new sentence added - The appearance of the reconstituted product is a smooth orange opaque suspension with visible white granules.
  • Section 9 Date of the Renewal of the Authorisation updated to 23 September 2009
  • Section 10 Date of revision of the text: Update to May 2010

 
Updated on 24/02/2009 and displayed until 29/06/2010
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.5 Nature and contents of container Addition of 2 sachet pack size
 
Updated on 15/09/2005 and displayed until 24/02/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Updated on 10/08/2004 and displayed until 15/09/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Colecalciferol (Vitamin D3)
  Calcium phosphate