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Wyeth Pharmaceuticals
Huntercombe Lane South, Taplow, Maidenhead, Berks, SL6 0PH
Telephone: +44 (0)1628 604 377
Fax: +44 (0)1628 666 368
Medical Information Direct Line: +44 (0)845 367 0098
Medical Information e-mail: ukmedinfo@wyeth.com
Medical Information Fax: +44 (0)845 367 0777
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Summary of Product Characteristics last updated on the eMC: 12/08/2008
SPC Prempak-C

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 12/08/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   29-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2
New wording added under subheading 'Prophylaxis of Osteoporosis'

Section 4.8
Table revised and additional side effects added

Section 4.9
Wording updated in line with global company prescribing information
Updated on 26/09/2007 and displayed until 12/08/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/09/2007 and displayed until 26/09/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 3 - Tablets are now branded, so the wording - marked with "1.25“ in black ink - has been added.
 
Section 6.1 - branding excipients have been added.
 
Section10 - Date of revision has changed.
Updated on 02/02/2006 and displayed until 25/09/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/04/2005 and displayed until 02/02/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • 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 4.8 - 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. 4 - Special Precautions for Storage
  • Change to section 7 - Marketing Authorisation Holder
Updated on 19/02/2004 and displayed until 13/04/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 29/09/2003 and displayed until 19/02/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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 4.8 - 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 7 - Marketing Authorisation Holder
Updated on 06/02/2002 and displayed until 29/09/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 01/08/2001 and displayed until 06/02/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 03/07/2000 and displayed until 01/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 24/05/2000 and displayed until 03/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 24/05/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  norgestrel
  oestrogens, conjugated


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