Caltrate 600mg/400IU Film-coated Tablets
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 April 2023
File name
Master-ie-CALTRATE - SPC - Clean - Apr2023.pdf
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updates to section:
4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2,
Updated on 27 April 2023
File name
Master-ie CALTRATE - PIL - Clean - Apr2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
GDS Update- Sections affected:
Do not take Caltrate
Warnings and Precaution
Before taking Caltrate tell your doctor or pharmacist
Other Medicines and Caltrate
Pregnancy and breastfeeding
How to take Caltrate
If you take more Caltrate than you should
If you forget to take Caltrate
Updated on 21 April 2023
File name
MASTER-ie-SPC-caltratetablets-clean-feb2023.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
MAH was changed to
Haleon Ireland Limited
12 Riverwalk,
CityWest Business Campus,
Dublin 24,
Ireland.
Updated on 21 April 2023
File name
Master-ie-pil-caltrate-clean-Mar2023.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH was changed to Haleon Ireland Limited and the manufacturer was changed to Haleon Italy Manufacturing S.r.l., Via Nettunense 90, 04011 Aprilia (LT), Italy.
Updated on 09 June 2022
File name
Caltrate Med.ie Nov2020 Mockup.pdf
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Updating text version to printed mockup version. No information on the leaflet has changed.
Updated on 04 March 2021
File name
1731_Caltrate IE_SmPC_20_345_November 2020 _clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 04 March 2021
File name
1731_Caltrate_PIL_20_345_EU Excpients Guideline_Nov 2020_clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 12 January 2021
File name
1731_Caltrate IE_SmPC_20_021_August 2020 _clean.pdf
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
File name
SmPC_Calcium Carbonate, Colecalciferol(Caltrate)_Film Coated Tablet_600 mg, 400 IU_July 2019_ENG.doc.pdf
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
File name
1561_Caltrate tablets_PIL_20_021_PAA147731_Oct 2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 16 July 2019
File name
PIL_Calcium Carbonate, Colecalciferol(Caltrate)_Film Coated Tablets_600 mg, 400 IU_05 July 2019 .docx.pdf
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
File name
SmPC_Calcium Carbonate, Colecalciferol(Caltrate)_Film Coated Tablet_600 mg, 400 IU_July 2019_ENG.doc.pdf
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
File name
PIL_14522_730.pdf
Reasons for updating
- New PIL for new product
Updated on 30 August 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 30 August 2017
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
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 July 2015
Reasons for updating
- Change to name of manufacturer
Updated on 14 May 2015
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
Reasons for updating
- Change to side-effects
Updated on 16 April 2015
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
Updated on 15 April 2015
Reasons for updating
- Change of inactive ingredient
Updated on 14 July 2014
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 10, the date of revision has changed to 'July 2014'
Updated on 10 July 2014
Reasons for updating
- Change to further information section
- Change to date of revision
- Introduction of new pack/pack size
Updated on 13 February 2013
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
Reasons for updating
- Change to marketing authorisation holder
Updated on 05 October 2012
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
Nephrolithiasis added as a effect, frequency unknown.
Updated on 03 October 2012
Reasons for updating
- Change to side-effects
Updated on 14 March 2011
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 11 March 2011
Reasons for updating
- Change to instructions about overdose
Updated on 29 June 2010
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
Reasons for updating
- Change to marketing authorisation holder
Updated on 19 January 2010
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 15 January 2010
Reasons for updating
- New PIL for new product