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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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Summary of Product Characteristics last updated on the eMC: 13/03/2012
SPC Cilest

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 13/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   08-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Addition of :

Drugs that affect absorption

Colesevelam, given together with a combined oral hormonal contraceptive, has been shown to significantly decrease the AUC of ethinyl estradiol. No interaction was seen when the contraceptive was given 4 hours before colesevelam

 

Increase in Plasma Hormone Levels Associated With Co-Administered Drugs

·                       etoricoxib

 

Section 4.8 Undesirable effects

Deletion of:

PSYCHIATRIC DISORDERS: Rare  Loss of libido

Addition of:

VASCULAR DISORDERS: Frequency not known   Arterial Thromboembolism

Updated on 08/12/2011 and displayed until 13/03/2012
Reasons for adding or updating:
  • 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:   05-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.4          Special warnings and precautions for use

Addition of text in BOLD:

Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

Other conditions

·         Known hyperlipidaemias.  A small proportion of women will have persistent hypertriglyceridemia while on the pill.  Changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.  However, routine screening of women with hypertriglyceridaemia is not considered appropriate. Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

·         Crohn’s disease and ulcerative colitis have been associated with COC use.

 

If any of the following conditions developed or worsened during a prior pregnancy or during previous COC use, they may occur while taking Cilest

·         haemolytic uraemic syndrome

·         Sydenham’s chorea
Updated on 05/07/2011 and displayed until 08/12/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 4.5

addition of interactions with  specific epilepetic drugs, bosentan, HIV medication, modanifil, metoclopramide, ciclosporin, laotrigine, prednisolone , theophylline
Updated on 31/03/2011 and displayed until 05/07/2011
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:   24-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
updated analysis of side effects seen in clinical trials and reportes in post marketing experience.
Updated on 15/10/2010 and displayed until 31/03/2011
Reasons for adding or updating:
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   11-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 4.2  

‘Starting treatment’  and ‘Use after miscarriage’ information updated in line with UK FFPRH guidelines.

 ‘Post-partum administration’ and ‘to skip a period’ moved from section 4.4.

 ‘Missed pill information’  moved from section 4.4 , previously called ‘Forgotten tablets’ updated in line with MHRA guidance.

‘Vomiting and diarrhoea’ updated in line with In line with UK FFPRH First prescription of COC guidelines Updated January 2007 (page 11)

Section 4.3

Substantially changed. Some contraindications added, some , some conditions ‘down-graded’ to just requiring supervision or even where benefit usually outweighs risk. In line with UK Minimum Eligibility Criteria 2009 Category 4 (A condition which represents an unacceptable health risk if the contraceptive method is used)Section 4.4
Information moved from section 4.4 to 4.2 (see section 4.2 comments). New HIV statement - In line with UK MEC 2009. ‘Conditions requiring supervision’ In line with UK Minimum Eligibility Criteria 2009 Category 3 (A condition where the theoretical or proven risks usually outweigh the advantages of using the method).  Cervical Cancer and breast cancer information moved from 4.8. Laboratory tests updated.  ‘Other condition’ added ;In line with UK Minimum Eligibility Criteria 2009 Category 2 (A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.

Section 4.6 - updated in line withUK MEC 2009

 Section 4.8 - Introductory paragraph updated . ADRs now listed in a table and updated,  Thrombo-embolism risk factors listed in 4.4 Breast cancer  and cervical cancer moved to 4.4

Section 4.9 - statement updated
 
Updated on 22/04/2010 and displayed until 15/10/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

Change to 5.1 Pharmacodynamic properties

·  Updated in line with the “Guideline on Summary of product Characteristics (SmPC) (September 2009).

·  The pharmacotherapeutic group and ATC code have been added.

·  It is a recognised action of progestogens that they decrease fallopian tube motility thus limiting the ability of the fertilised egg to implant. This information is therefore being added to the SmPC.

Change to 5.2 Pharmacokinetic properties

·  Updated with more detailed information in line with current CCDS.

Change to section 10 – Date of revision of the text

Changed to 16th April 2010

 
Updated on 17/02/2009 and displayed until 22/04/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 7 - New MAH address
Change to section 10 - Changed to 11 February 2009
Updated on 14/01/2009 and displayed until 17/02/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 9 - Date of the Renewal Authorisation
Change to section 10 - Changed to 07th January 2009
Updated on 27/08/2004 and displayed until 14/01/2009
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • 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 10 (date of (partial) revision of the text
Updated on 02/07/2002 and displayed until 27/08/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 29/08/2001 and displayed until 02/07/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 24/08/2001 and displayed until 29/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 31/10/2000 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 11/08/2000 and displayed until 31/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ethinylestradiol
  norgestimate