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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: 01/05/2012
SPC Clomifene 50mg 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 01/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Date of revision of text on the SPC:   13-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 – ‘Pituitary or ovarian tumours’ has been amended to ‘Hormone dependent tumours’

 

Section 4.4 – more detailed information regarding Ovarian Hyperstimulation Syndrome (OHSS) has been included

 

Section 4.7 – information regarding dizziness and lightheadedness has been re-worded adn supplemented with additional information

 

Section 4.8 – addition of ‘scotoma’, ‘nervousness’, ‘vertigo’, ‘urticaria’, ‘acute psychotic reactions’, ‘abnormalities in liver function tests’. Addition of section regarding eye disorders.

 

 
Updated on 21/02/2011 and displayed until 01/05/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   09-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of information regarding ovarian cancer to sections 4.2, 4.4 and 4.8
Updated on 02/09/2008 and displayed until 21/02/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   29-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 -
Product name re-arranged in line with guidelines

Section 7 -
MA holder amended from 'CP Pharmaceuticals Ltd' to 'Wockhardt UK Ltd'

Section 8 -
PL number amended from PL 04543/0424 to PL 29831/0037

Section 9 -
Date of first authorisation amended

Section 10 -
Date of revision amended
Updated on 08/09/2006 and displayed until 02/09/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • 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
Date of revision of text on the SPC:   01/10/04
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - Addition of 'Hypersensitivity' and 'Ovarian Cysts'

Section 4.4 - Addition of lactose warning as per excipient guideline. Addition of information regarding polycystic ovary syndrome. Addition of warnings to use with caution in patients with uterine fibroids, patients suffering from mental depression and patients with or susceptible to thrombophlebitis.

Section 4.6 - Addition of the following text - It is not known whether clomifene is distributed into breast milk.  However, the drug may suppress lactation.

Section 4.7 - Addition of text stating that clomifene therapy may affect the ability to drive or operate machinery.

Section 4.8 - Layout amended as per guidelines. Addition of undesirable effects in the following categories - eye, gastro-intestinal, general, hepato-biliary, metabolic, neurological, pregnancy, psychiatric, reproductive and skin.
Updated on 24/09/2003 and displayed until 08/09/2006
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  clomifene citrate