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Novo Nordisk Limited
Broadfield Park, Brighton Road, Crawley, West Sussex, RH11 9RT
Telephone: +44 (0)1293 613555
Fax: +44 (0)1293 613535
Medical Information Direct Line: +44 (0)845 600 5055
Medical Information e-mail: ukmedicalinfo@novonordisk.com
Customer Care direct line: +44 (0)845 600 5055
Medical Information Fax: +44 (0)1293 613211

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: 16/04/2012
SPC Kliofem

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 16/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • 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. 3 - Shelf Life
  • 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:   30-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to text to algin this with the latest HRT EU Core SmPC.

 

 
Updated on 15/06/2011 and displayed until 16/04/2012
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   07-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The  update is for the substitution of gelatine with hydroxypropycellulose in section 6.1 and removal of the storage requirement to keep the product below 25°C in section 6.4
Updated on 07/07/2010 and displayed until 15/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The Summary of Product Characteristics (SmPC) has been updated for Kliofem®.     

The update is for a change to the wording for ovarian cancer (applies to all systemic HRT products). The changes which have been made are as follows: 

Section  4.4

 

Previous wording: Long term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRT confers a different risk than oestrogen-only products.

New wording: Long-term (at least 5 -10 years) use of combined HRTs and oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see Section 4.8)

Section 4.8

 

New addition

 

Long-term use of oestrogen-only and combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer. In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.

 
Updated on 24/07/2008 and displayed until 07/07/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   18-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special warnings and precautions for use

 

Medical examination: “see ‘Breast cancer’ below” changed to “see ‘Breast cancer’ section below”

 

Section 4.6 Pregnancy and lactation

 

Sub-heading ‘Lactation’ added.

 

Section 5.1 Pharmacodynamic properties

 

‘Oestrogen and progestogen for continuous combined hormone replacement therapy (HRT).’

changed to

‘Oestrogen and progestogen for continuous combined HRT treatment.’

 

Section 6.1 List of excipients

 

E-number added to excipient hypromellose (E464).

 

Section 6.3 Shelf life

 

Maximum temperature for storage (25˚ C) added.

 

Section 9 Date of first authorisation/renewal

 

New date of renewal (18/6//2008) inserted.

 

Section 10 Date of revision of the text

 

New date (18/6/2008) inserted.
Updated on 16/07/2007 and displayed until 24/07/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Minor change to warning on lactose and change to tablet colour from yellow to white.  The changes are as follows:

4.4  Special Warnings and Precautions for Use

 

A new sentence has been added: “Kliofem tablets contain lactose.”  The paragraph now reads:

 

Kliofem tablets contain lactose.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

6.1 List of excipients

 

This section has been updated with the excipients for white tablets which are hypromellose and triacetin and those for the yellow tablets have been removed (methyl hydroxypropyl cellulose, titanium dioxide, iron oxide and propylene glycol).

 
 
 
 
Updated on 10/01/2006 and displayed until 16/07/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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 10 (date of (partial) revision of the text
Updated on 11/12/2003 and displayed until 10/01/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/09/2002 and displayed until 11/12/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/01/2002 and displayed until 25/09/2002
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
Updated on 10/08/2001 and displayed until 24/01/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 30/08/2000 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 30/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
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