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Calcichew-D3 Forte Chewable Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/05/20

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Summary of Product Characteristics last updated on medicines.ie: 22/5/2020

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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Medicine Name Calcichew-D3 Forte Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
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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 22 May 2020 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

In section 6, the MAH (Takeda Products Ireland Ltd) address has been changed to 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland

This is the new legally registered office.

The date of revision of the PIL is February 2020.

Updated on 22 May 2020 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

In section 7, the MAH (Takeda Products Ireland Ltd) address has been changed to 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland

This is the new legally registered office.

The date of revision of the SmPC is 4th May 2020.

Updated on 22 August 2019 SPC

Reasons for updating

  • File format updated to PDF

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

Updated on 11 June 2018 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

MA holder has been updated to Takeda Pharmaceutical Ireland Ltd. Date of revision updated to 25 May 2018.

Updated on 11 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 9 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 October 2017 PIL

Reasons for updating

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

Updated on 19 September 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 19 September 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 19 September 2017 SPC

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

Change to section

Details of change

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Excipients with known effect: Contains sorbitol (E420) 390 mg, isomalt (E953) 49.90 mg, aspartame (E951) 1mg and sucrose 0.77 mg.

For a the full list of excipients, see Section 6.1

4.4 Special warnings and precautions for use

Calcichew-D3 Forte Chewable Tablets contain aspartame (E951, a source of phenylalanine) which may be harmful for people with phenylketonuria.

Calcichew-D3 Forte Chewable Tablets contain sorbitol (E420), isomalt (E953) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

6.1 List of excipients

Xylitol (E967)

Sorbitol (E420)

Povidone Isomalt (E953)

Flavouring (lemon)

Fatty acid mono- and diglycerides

Sucralose (E955) Aspartame (E951)

Magnesium stearate

Sucrose

Modified maize starch

Triglycerides, medium-chain

Sodium ascorbate

Silica, colloidal anhydrous

Tocopherol

10. DATE OF THE REVISION OF THE TEXT

8th August 2016  21st April 2017

 

Updated on 26 August 2016 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf life of the SmPC has been updated to reduce the shelf-life of Calcichew D3 Forte Chewable Tablets from 3 years to 30 months.

Updated on 16 May 2016 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Various sections of the SmPC have been updated due to a safety change and a change to the Core Safety Data Sheet

Updated on 13 May 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to date of revision

Updated on 23 September 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 20 February 2015 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8- following text has been added:

Other special populations

Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis. See section 4.4.

Further wording added for reporting of suspected adverse reactions to HPRA

Date of revision amended to 5th of Feburary 2015

Updated on 16 February 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 20 November 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 7 October 2014 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Changes are in the following sections:

 

SECTION 7. MARKETING AUTHORISATION HOLDER

 

Takeda UK Limited

Building 3

Glory Park

Glory Park Avenue

Wooburn Green

Bucks

HP10 0DF

 

SECTION 10. DATE OF REVISION OF THE TEXT

 

26/09/2014

 

Updated on 7 October 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 25 February 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 February 2014 SPC

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