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Caltrate 600mg/400IU Film-coated Tablets

  • Name:

    Caltrate 600mg/400IU Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Calcium Carbonate, Vitamin D3

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/11/20

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Summary of Product Characteristics last updated on medicines.ie: 12/1/2021

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Address: 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Medical Information Direct Line: 1800 441 442

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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 12 January 2021 SPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 30 November 2020 SPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 30 November 2020 PIL

Reasons for updating

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

Updated on 16 July 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 16 July 2019 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 30 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 August 2017 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Updated on 30 August 2017 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.8        Undesirable effects

 

 

Gastrointestinal disorders

Rare: constipation, flatulence, nausea, abdominal pain and diarrhoea.

Not known: vomiting (usually an overdose symptom see section 4.9 of the SmPC.)

 

Immune system disorders

Not known: hypersensitivity reactions including angioedema and laryngeal oedema.

4.9       Overdose

 

An overdose can lead to hypervitaminosis and hypercalcaemia. The symptoms of hypercalcaemia can include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, skeletal pain, renal calcinosis, kidney stones, alkalosis, hypophosphataemia, and in severe cases, cardiac arrhythmia, “Burnett’s syndrome”.

Updated on 30 August 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 15 July 2015 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 14 May 2015 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.8        Undesirable effects

 



 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Updated on 11 May 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 April 2015 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Added Silicon dioxide & 'hydrolysed' after bovine gelatin 

Updated on 15 April 2015 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 14 July 2014 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 6.5, the additional pack size of '20' was added

In section 10, the date of revision has changed to 'July 2014'

Updated on 10 July 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 13 February 2013 SPC

Reasons for updating

  • Change to marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

7.       MARKETING AUTHORISATION HOLDER

 

Pfizer Healthcare Ireland,

9 Riverwalk,

National Digital Park,

Citywest Business Campus,

Dublin 24,

Ireland.

 

8.         MARKETING AUTHORISATION NUMBER(S)

 

P.A.822/173/001

Updated on 12 February 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 5 October 2012 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable Effects. 

Nephrolithiasis added as a effect, frequency unknown.  

Updated on 3 October 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 14 March 2011 SPC

Reasons for updating

  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Burnett's syndrome added as possible side effect of overdose.

Updated on 11 March 2011 PIL

Reasons for updating

  • Change to instructions about overdose

Updated on 29 June 2010 SPC

Reasons for updating

  • Change to marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

7.       MARKETING AUTHORISATION HOLDER

 

Pfizer Consumer Healthcare Ltd,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ, UK.

 

Updated on 24 June 2010 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 19 January 2010 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 15 January 2010 PIL

Reasons for updating

  • New PIL for new product