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Osteofos D3 *
Pharmacy Only: Prescription

  • Osteofos D3 Carton and Sachet Pack Shot Dec 21.jpeg

Updated on 23 May 2021

File name

ie-spc Osteofos D3 clean Approved April 21_1621792294.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - Excipient content of propylene glycol (E 1520) added

Section 4.4 - Sucrose and propylene glycol excipient content warnings added 

Section 6.1 - Enumber for propylene glycol added (E 1520) 

Section 10 - Date of revision updated 

Updated on 23 May 2021

File name

ie-leaflet Osteofos D3 clean Dec 2020 Approved April 21_1621792053.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Section 2 - Excipient warnings for sodium and propylene glycol (E 1520) added

Section 6 - E number for propylene glycol added - (E1520)

Change to other sources of information - removed product names for other markets. 

Updated on 04 May 2017

File name

PIL_7920_396.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 May 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 May 2017

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The changes are to align the SmPC to the latest QRD template. 

Updated on 04 May 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 29 June 2010

Reasons for 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
  • 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

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 22 June 2010

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 24 February 2009

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

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 24 February 2009

Reasons for updating

  • Change due to user-testing of patient information
  • Introduction of new pack/pack size

Updated on 15 September 2005

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 September 2005

Reasons for updating

  • Change of contraindications

Updated on 10 August 2004

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 August 2004

Reasons for updating

  • New PIL for new product