Osteofos D3
- Name:
Osteofos D3
- Company:
A. Menarini Pharmaceuticals Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/17
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What OSTEOFOS D3 is and what it is used for
1. What OSTEOFOS D3 is and what it is used for
2. What you need to know before you take OSTEOFOS D3
2. What you need to know before you take OSTEOFOS D3
3. How to take OSTEOFOS D3
3. How to take OSTEOFOS D3
4. Possible side effects
4. Possible side effects
5. How to store OSTEOFOS D3
5. How to store OSTEOFOS D3
6. Contents of the pack and other information
6. Contents of the pack and other information
Print ViewKeyword Search SmPC
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
A. Menarini Pharmaceuticals Ireland Ltd
Company Products
When a pharmaceutical company changes any document, 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 4 May 2017 PIL
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 4 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 4 May 2017 SmPC
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
Updated on 4 May 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 June 2010 SmPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 24 February 2009 SmPC
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
Updated on 24 February 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
- Introduction of new pack/pack size
Updated on 15 September 2005 PIL
Reasons for updating
- Change of contraindications
Updated on 15 September 2005 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2004 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 August 2004 PIL
Reasons for updating
- New PIL for new product