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Osteofos D3

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 4/5/2017
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A. Menarini Pharmaceuticals Ireland Ltd

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Medicine NameActive Ingredients
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Medicine Name Adenuric 80 mg film-coated tablets Active Ingredients febuxostat
Medicine Name Brimica Genuair 340 micrograms /12 micrograms inhalation powder Active Ingredients Aclidinium Bromide, Formoterol fumarate dihydrate
Medicine Name Drynol 10 mg orodispersible tablets Active Ingredients Bilastine
Medicine Name Drynol 2.5 mg/ml oral solution Active Ingredients Bilastine
Medicine Name Drynol 20 mg tablets Active Ingredients Bilastine
Medicine Name Eklira Genuair 322 micrograms inhalation powder Active Ingredients Aclidinium Bromide
Medicine Name Fastum 2.5% w/w gel Active Ingredients Ketoprofen
Medicine Name Frovex Active Ingredients Frovatriptan succinate monohydrate
Medicine Name Keral 25 mg granules for oral solution Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 25mg Tablets Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 50 mg/2ml Solution for injection/infusion Active Ingredients Dexketoprofen trometamol
Medicine Name Konverge film-coated tablets Active Ingredients Amlodipine besilate, olmesartan medoxomil
Medicine Name Konverge Plus film-coated tablets Active Ingredients Amlodipine besilate, Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Nebilet Active Ingredients Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Omesar 10mg, 20mg and 40mg Film-Coated Tablets Active Ingredients olmesartan medoxomil
Medicine Name Omesar Plus 20 mg/12.5 mg & 20 mg/25 mg Film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Omesar Plus 40 mg/12.5 mg & 40 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Osteofos D3 Active Ingredients Calcium phosphate, Colecalciferol (Vitamin D3)
Medicine Name Priligy 30 mg and 60 mg film-coated tablets Active Ingredients Dapoxetine hydrochloride
Medicine Name Quofenix 300 mg powder for concentrate for solution for infusion Active Ingredients Delafloxacin Meglumine
Medicine Name Quofenix 450 mg tablets Active Ingredients Delafloxacin Meglumine
Medicine Name Ranexa prolonged-release tablets Active Ingredients Ranolazine
1 - 0 of 31 items.Total: Infinity pages

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 SPC

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 4 May 2017

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 SPC

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 SPC

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 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 SPC

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 SPC

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