Canesten 200mg Pessary
Last Updated on eMC 15-Jun-2015 View document | Bayer plc Contact details
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 15-Jun-2015 and displayed until Current
Reasons for adding or updating:
- Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC: 03-Jun-2015
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.8: Addition of mandatory wording to SPC section 4.8 regarding suspected ADR reporting (Yellow card scheme)Updated on 27-Nov-2014 and displayed until 15-Jun-2015
Reasons for adding or updating:
- Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC: 17-Nov-2014
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
6.4 - To change the storage condition of the finished product to Do not store above 25C.Updated on 03-Jan-2014 and displayed until 27-Nov-2014
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Fertility, 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC: 29-Nov-2013
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
4.2 - Addition of ‘Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.’
4.5 - Elaboration on interaction with immunosuppressants, now referring to sirolimus as well as tacrolimus.
4.6 - Further elaboration on Fertility, Pregnancy and Lactation section, including specific advice on administration of intravenous clotrimazole and risks associated
4.7 - Further elaboration on warning on driving or operating machinery.
4.8 - Addition of side effects ‘erythema’ and ‘vaginal haemorrhage’
4.9 - Addition of ‘No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.’
5.1 - Elaboration of pharmacodynamics section
5.3 - Inclusion of non-clinical data
6.6 - Replaced section with ‘No special requirements.’
Updated on 20-Sep-2010 and displayed until 03-Jan-2014
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
Date of revision of text on the SPC: 12-Aug-2010
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Update to section 4.5 Interaction with other medicinal products and other forms of interaction - To include interaction of vaginally applied clotrimazole with oral tacrolimus Update to section 4.8 Undesirable effects - To include oedema, stinging/burning and genital peeling, rearrange according to the MedDRA system organ class and using MedDRA terminology
Updated on 20-Aug-2010 and displayed until 20-Sep-2010
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC: 07-Jan-2010
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Update to Section 4.2 Posology and method of administration
- To add the following advice: Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product. Update to Section 4.6 Pregnancy and Lactation - to change the advice on use of an applicator for administration during pregnancy. The advice is different for pessary and internal cream
Updated on 16-Jan-2006 and displayed until 20-Aug-2010
Reasons for adding or updating:
- 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 4.6 - Pregnancy and Lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 6.2 - Incompatibilities
- Change to section 6. 4 - Special Precautions for Storage
- Change to section 7 - Marketing Authorisation Holder
Updated on 06-Aug-2002 and displayed until 16-Jan-2006
Reasons for adding or updating:
- Change to section 6.1 - List of Excipients
- Change to section 10 (date of (partial) revision of the text
Updated on 19-Jul-2001 and displayed until 06-Aug-2002
Reasons for adding or updating:
- Transferred from eMC version 1
Updated on 18-Dec-2000 and displayed until 19-Jul-2001
Reasons for adding or updating:
- No reasons supplied
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
+44 (0)1635 563 393
+44 (0)1635 563 000
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?
Active ingredients
Legal categories
This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue