Caltrate 600mg/400IU Film-coated Tablets
- Name:
Caltrate 600mg/400IU Film-coated Tablets
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/07/19
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
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Company Products
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 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
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Updated on 30 August 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 30 August 2017
Reasons for updating
- New SmPC 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
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 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
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
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
Updated on 15 January 2010 PIL
Reasons for updating
- New PIL for new product