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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

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: 30/03/2012
SPC Micronor Oral Contraceptive 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 30/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   27-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4

UNDER ‘Conditions requiring supervision’ ADDITION OF

·          Acute or chronic hepatocellular disease with abnormal liver function

 

 

Section 4.8 -section 8 completely updated, below is old text which has been deleted. ADRs deleted Not included in new table) Chnage in libido, chloasma, breast chanages

Side effects are usually self-limiting and of relatively short duration. Amongst th symptoms reported are:

·          Headaches/migraine

·          Nausea

·          Vomiting

·          Breast changes

·          Change in weight

·          Changes in libido

·          Chloasma

·          Breakthrough bleeding and spotting

·          Rash

·          Depression

·          Irregular cycle length (particularly in early cycles of therapy). It is important that patients should be advised that whilst on Micronor therapy they may experience that variation in cycle length and that they should continue taking a tablet every day whether they have a period or not. However, patients should be advised to discontinue Micronor and to consult their doctor if they have gone 45 days without having a period
Updated on 29/02/2012 and displayed until 30/03/2012
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:   27-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 4.2

Tablet intake from the first pack is started on day 1,up to and including day 5 the first day of the menstrual cycle menstruation; no extra contraceptive precautions are necessary.
Updated on 12/10/2011 and displayed until 29/02/2012
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 4.5 - Interaction with other medicinal products 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
Date of revision of text on the SPC:   06-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2, starting treatment, missed tablets and vomiting and diarrhoea has been updated.

In section 4.3, contraindicatioin have been removed, now only two contraindications

Section 4.4 , information moved to section 4,2 and breast cancer infomration has been moved from section 4.8, Warnings and precatuions have been updated.

Section 4.5- new interaction sadded.

Section 4.6, general update.

Sectiomn 4.8 only change breast cancer information moved to section 4.4.

Section 4.9, general update.
Updated on 19/02/2009 and displayed until 12/10/2011
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 09/12/2008 and displayed until 19/02/2009
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:   04-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 9 – Date of Renewal of Authorisation

Addition of:

Renewal of Authorisation: 4 December 2008

 

Change to section 10 – Date of revision of the text

Changed to 4th December 2008
Updated on 22/08/2001 and displayed until 09/12/2008
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 16/10/2000 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 16/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  norethisterone