« Back to Medicines list

Calcichew-D3 Forte Chewable Tablets

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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 22/5/2020

Click on this link to Download PDF directly

Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Actos tablets Active Ingredients pioglitazone hydrochloride
Medicine Name Adcetris 50 mg powder for concentrate for solution for infusion Active Ingredients Brentuximab vedotin
Medicine Name Alofisel 5 million cells/mL suspension for injection Active Ingredients Human Allogeneic Mesenchymal Adult Stem Cells
Medicine Name Alunbrig Active Ingredients Brigatinib
Medicine Name Blopress Plus Tablets Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Blopress tablets Active Ingredients Candesartan Cilexetil
Medicine Name Calcichew 500mg Chewable Tablets Active Ingredients Calcium Carbonate
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)
Medicine Name Competact 15 mg/850 mg film-coated Tablets Active Ingredients Metformin Hydrochloride, pioglitazone hydrochloride
Medicine Name Condyline Cutaneous Solution 5 mg/ml Active Ingredients Podophyllotoxin
Medicine Name Edarbi Tablets Active Ingredients Azilsartan medoxomil potassium
Medicine Name Entyvio 108 mg solution for injection in pre-filled syringe/pre-filled pen Active Ingredients Vedolizumab
Medicine Name Entyvio 300 mg powder for concentrate for solution for infusion Active Ingredients Vedolizumab
Medicine Name Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container Active Ingredients fentanyl citrate
Medicine Name Matrifen Transdermal patch Active Ingredients Fentanyl
Medicine Name Mepact 4mg powder for suspension for infusion Active Ingredients Mifamurtide
Medicine Name Midon 2.5 mg Tablets Active Ingredients Midodrine Hydrochloride
Medicine Name Midon 5 mg Tablets Active Ingredients Midodrine Hydrochloride
Medicine Name NINLARO 2.3 mg, 3 mg, 4 mg hard capsules Active Ingredients Ixazomib Citrate
Medicine Name Prostap 3 DCS Active Ingredients Leuprorelin Acetate
Medicine Name Prostap 6 DCS Active Ingredients Leuprorelin Acetate
Medicine Name Prostap SR DCS Active Ingredients Leuprorelin Acetate
Medicine Name Protium 20mg Active Ingredients Pantoprazole sodium sesquihydrate
Medicine Name Protium 40mg Active Ingredients Pantoprazole sodium sesquihydrate
1 - 0 of 27 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 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

Reasons for updating

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

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

Reasons for updating

  • File format updated to PDF

Updated on 11 June 2018

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

Reasons for updating

  • New SmPC 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