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Wockhardt UK Ltd
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

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: 18/05/2012
SPC Levothyroxine 25 micrograms 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 18/05/2012 and displayed until Current
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:   01-May-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.4       Special warnings and precautions for use

 

Addition - ‘hypertension’ and  information regarding ECG.

Re-wording - information regarding disorders pre-disposing to adrenal insufficiency.

 

4.5       Interaction with other medicinal products and other forms of interaction

 

Addition - ‘polystyrene sulphonate’, 'cimetidine’, ‘anticancer drugs’, ‘weight loss drugs’, and information regarding ‘beta-blockers’ and ‘iron salts’.

 

Deletion - ‘ antimalarials’.

Re-wording - information regarding ‘lipid-regulating drugs’, ‘antacids’, ‘oral anticoagulants’, ‘cardiac glycosides’.

4.8       Undesirable effects

 

Addition - information regarding hypersensitivity reactions, psychiatric disorders and skin and subcutaneous tissue disorders.

 

Re-wording - information regarding benign intracranial hypertension.

 

4.9       Overdose

 

Addition - information regarding the symptoms of overdose.

 
Updated on 08/06/2011 and displayed until 18/05/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   02-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - update in line with the PdAR for Levothyroxine. 
Updated on 15/01/2009 and displayed until 08/06/2011
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  levothyroxine sodium