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Novartis Consumer Health

Novartis Consumer Health UK Ltd, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Fax: +44 (0)1403 324 024

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: 25/10/2011
SPC Sandocal 1000 Effervescent 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 25/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-May-2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Changes as a result of product licence renewal. Formal approval received in 2011.

 

 

Section 2

Addition of :

Excipients: 3323mg of citric acid anhydrous (fine granulate), 30mg of aspartame (E 951), 500 mg of sodium hydrogen carbonate, 30 mg of Orange flavour powder (containing sorbitol (E 420) and dextrose).

 

Addition of words ‘a full list of’ inbetween ‘For’ and ‘excipients’.

 

 

Section 4.2

Calcium Sandoz changed to Sandocal 1000.

 

Section 4.4

Three references to Calcium Sandoz changed to Sandocal 1000.

 

Section 4.5

Two references to Calcium Sandoz changed to Sandocal 1000.

 

Section 4.6

Reference to Calcium Sandoz changed to Sandocal 1000.

 

Section 4.7

Reference to Calcium Sandoz changed to Sandocal 1000.

 

Section 5.2

Reference to Calcium Sandoz changed to Sandocal 1000.

 

Section 9

Addition of dates 4 September 2000 / 14 May 2007

 

Section 10

Date change from 20 October 2006 to 14 May 2007

Updated on 28/09/2007 and displayed until 25/10/2011
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
   calcium carbonate
   calcium lactate gluconate