Velphoro 500 mg chewable tablets

  • Name:

    Velphoro 500 mg chewable tablets

  • Company:
    info
  • Active Ingredients:

    Sucroferric oxyhydroxide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/04/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 1/4/2019

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Vifor Pharma UK Limited

Vifor Pharma UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Ferinject (ferric carboxymaltose) Active Ingredients Ferric carboxymaltose
Medicine Name Velphoro 500 mg chewable tablets Active Ingredients Sucroferric oxyhydroxide
Medicine Name Veltassa (Patiromer) Active Ingredients Patiromer Sorbitex Calcium
Medicine Name Venofer (iron sucrose) Active Ingredients Iron Sucrose
1 - 0 of 4 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 1 April 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - what the product contains

Updated on 1 April 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

Added '(potato starch and pregelatinised maize starch)'

paediatric population:

Added: 'and adolescents'

Hepatic impairment:

removal: 'Generally'

4.4 Special warnings and precautions for use

Information about sucrose and starches (carbohydreates)

substituted 'starches' with 'potato starch and pregelatinised maize starch'.

4.8 Undesirable effects

substituted ADR with adverse reactions.

tabulated list of adverse reactions:

added 'The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).

Description of selected adverse reactions:

removed word 'treatment related' and ' events' added word 'reactions'.

4.9 Overdose

added example '(e.g hypophosphataemia)

6.5 nature and contents of container:

added 'perforated unit-dose' and 'multipack of 90 (3 packs of 30 × 1)'

 

 

Updated on 6 June 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Change to Section 6.3 Shelf Life - Shelf life after first opening of the bottle changed from 45 days to 90 days

Updated on 24 April 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 22 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

In section 4.2 ( Titration and maintenance) mg in front of 1500 has been removed.

In section 4.2 ( Elderly Population) the number of people that has been administered Velphoro has been changed from 245 to 248.

in section 4.4 ( information about sucrose and starches (carbohydrates)) allergy to gluten or diabetes removed and replaced with diabetes.  Approximately 1.4g of carbohydrates equivalent to 0.116 bread units changed from 0.116 bread units approximately 1.4g of carbohydrates.

in section 4.8 ( tabulated list of adverse reactions) discoloured faeces removed and replaced with faeces discoloured.

in section 5.1 ( clinical efficacy) iron added to 1,000/day and 250/day.

in section 5.2 ( Absorption) iron added to 2,000 mg .

Updated on 22 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 January 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 19 September 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to marketing authorisation holder

Updated on 19 September 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • SPC retired pending re-submission

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

Free text change information supplied by the pharmaceutical company

6.3 Shelf life

3 years
Shelf life after first opening of the bottle: 45 days

7. MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France
100-101 Terrasse Boieldieu
Tour Franklin- La Défense 8
92042 Paris la Défense Cedex
France

10. DATE OF REVISION OF THE TEXT

September 2016.

Updated on 31 October 2015 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

4.5     Interaction with other medicinal products and other forms of interaction



When administering any medicinal product that is already known to interact with iron (like alendronate and doxycycline) or
has the potential to interact with Velphoro based only on in vitro studies likelevothyroxine the medicinal product should be administered at least one hour before or two hours after Velphoro

In vitro studies with the following active substances did not show any relevant interaction: acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone and quinidine

Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of HMG-CoA reductase inhibitors (e.g., atorvastatin and simvastatin). In addition, post-hoc analyses from clinical studies demonstrated no impact of Velphoro on iPTH lowering effect of oral Vitamin D analogues. Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged.

Updated on 16 December 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 December 2014 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided