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Shire Pharmaceuticals Limited
Hampshire International Business Park, Chineham, Basingstoke, Hampshire , RG24 8EP
Telephone: +44 (0)1256 894 000
WWW: http://www.shire.com
Medical Information Direct Line: 0800 055 6614
Medical Information e-mail: medinfoUK@shire.com
Customer Care direct line: +44 (0)1256 894 107

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 20/04/2012
SPC Calcichew D3 Chewable Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 20/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Oct-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2:  change to quantitiy of sucrose from 0.76 to 0.39mg and removal of soya bean oil, hydrogenated 0.15mg
Section 4.3:  removal of hypersensitivity to soya or peanut
Section 6.1: removal of gelatin, soya bean oil, hydrogenated, maize starch, additon of modified maize starch, triglycerides, medium-chain, sodium ascorbate and silica, colloidal anhydrous
Section 10:  Date of revison amended to October 2011
Updated on 01/09/2010 and displayed until 20/04/2012
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   09-Jun-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Reinstatement of interactions with levothyroxine and the introduction of interactions with quinolones; reinstatement of side effects for milk alkali syndrome and addition of dyspepsia. 
Updated on 29/09/2009 and displayed until 01/09/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   26-Apr-2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 27/06/2007 and displayed until 29/09/2009
Reasons for adding or updating:
  • 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 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   04/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to add 'May be chewed or sucked" to posology, naming of excipients and removal of 'to protect from moisture'; addition of soybean oil warning in contraindications; update to warnings.
Updated on 16/03/2007 and displayed until 27/06/2007
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   02/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update Section 4.9 Overdosage in line with MHRA guidelines on gastric lavage
Updated on 15/03/2007 and displayed until 16/03/2007
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   02/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update to Section 4.9 Overdose in line with MHRA guidelines on Gastric Lavage
Updated on 27/05/2004 and displayed until 15/03/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/02/2003 and displayed until 27/05/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 07/02/2003 and displayed until 10/02/2003
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 23/10/2001 and displayed until 07/02/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 12/07/2001 and displayed until 23/10/2001
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/09/1999 and displayed until 12/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  calcium carbonate
  colecalciferol