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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 31/08/2011
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 31/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
MAH address change in section 7, PA number change section 8.
Updated on 15/03/2011 and displayed until 31/08/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   12-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Inclusion of the contraindication ‘Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4)’
Updated on 07/09/2010 and displayed until 15/03/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10 - Date of Revision of the Text
Date amended from 12 July 2010 to 12 August 2010.
Updated on 20/07/2010 and displayed until 07/09/2010
Reasons for adding or updating:
  • 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:   12-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4

 

16. Estrogens should be used with caution in individuals with disease that can predispose to severe hypocalcaemia (e.g. hypoparathyroidism).

 

18.  Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema.

 

19.  Visual abnormalities: Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.


Section 4.8

Adverse drug reactions (ADRs)


Addition of Growth potentiation of benign meningioma and Ischemic colitis.
Updated on 31/03/2010 and displayed until 20/07/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 1 - Name of the Medicinal Product, addition of "/0.15mg Coated Tablets"

Change to Section 10 - Date of Revision of the Text, new approval date added
Updated on 12/08/2008 and displayed until 31/03/2010
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