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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: 03/10/2011
SPC Premique 0.625mg/5mg Coated 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 03/10/2011 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-Sep-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 15/07/2011 and displayed until 03/10/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   24-Jun-2011
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 04/05/2010 and displayed until 15/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.8, Undesirable Effects - 'Pulmonary embolism' moved from Rare to Uncommon in the table under Vascular disorders.

In section 10, Date of Revision of the Text
Updated on 28/01/2010 and displayed until 04/05/2010
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:   14-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Name changed from Premique to Premique 0.625mg/5mg Coated Tablets.
Updated on 12/08/2008 and displayed until 28/01/2010
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
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

Update to text under 'Maintenance/Continuation/Extended Treament'

Section 4.8

Additional side effects added.

Section 4.9

Wording updated in line with global company prescribing information.
Updated on 24/06/2008 and displayed until 12/08/2008
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   23-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4

The following sentence has been added ' Keep blister in outer carton to protect from light.'

Section 6.5

Text has been replaced as follows:

Primary container

Polyvinylchloride (PVC)/Aluminium foil blister pack.

 

Secondary container

Cardboard carton.

 

Presentation

Each carton contains 28 tablets (1 blister pack) or 84 tablets (3 blister packs).

 

Not all pack sizes may be marketed.
Updated on 07/05/2008 and displayed until 24/06/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2  (Posology and method of administration) the following text has been added:

Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.

Section 10 (DATE OF REVISION OF THE TEXT) the date has been amended to:

15th April 2008
Updated on 18/01/2007 and displayed until 07/05/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 07/11/2006 and displayed until 18/01/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
3. PHARMACEUTICAL FORM - Added text as follows:  “unmarked or marked with ‘0.625/5’” to page 1.
 

6.1 List of excipients - Inserted “For tablets marked with ‘0.625/5’, Stearic acid, Edible Ink (Opacode Black S-8-27741)†

†Opacode black ink contains iron oxide black (E172), shellac, purified water, ethanol, N-butyl alcohol, propylene glycol, ethyl acetate.

Updated on 15/09/2006 and displayed until 07/11/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/02/2006 and displayed until 15/09/2006
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. 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 26/09/2003 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
Updated on 06/02/2002 and displayed until 26/09/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 24/08/2001 and displayed until 06/02/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 11/07/2000 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 24/05/2000 and displayed until 11/07/2000
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

 
  medroxyprogesterone acetate
  oestrogens, conjugated