Canesten Antifungal Cream
Last Updated on eMC 08-Apr-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 08-Apr-2015 and displayed until Current
Reasons for adding or updating:
- Change to section 1 - Name of the medicinal product
Date of revision of text on the SPC: 03-Mar-2015
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section1: The name Canesten Fungal Infection 1% w/w Cream has been added to the licence of Canesten Antifungal Cream. Additionally the standard wording on reporting side-effects via the MHRA Yellow Card system has been added to the joint SPC for Canesten Antifungal Cream/Canesten Fungal Infection 1% w/w Cream.Updated on 03-Jan-2014 and displayed until 08-Apr-2015
Reasons for adding or updating:
- 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 4.6 - 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: 28-Nov-2013
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
2 – Addition of ‘Excipient with known effect: cetostearyl alcohol’
4.1 – Removal of ‘Clotrimazole is a broad spectrum antifungal. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides. It has no effect on lactobacilli.
4.2 - Further elaboration of dosing instructions, addition of ‘. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand’
4.3 – Specific mentions of clotrimazole and cetostearyl alcohol removed and updated to ‘Hypersensitivity to the active substance or to any of the excipients listed in section 6.1’
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 ‘erythema’ as a side effect.
4.9 - Elaboration of overdose section
5.1 - Elaboration of pharmacodynamics section, in particular of its antibacterial properties.
5.3 - Inclusion of non-clinical data
6.6 - Change of title to ‘Special Precautions for Disposal’
Updated on 21-Jul-2010 and displayed until 03-Jan-2014
Reasons for adding or updating:
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable Effects
- Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC: 02-Jul-2010
Legal Category:P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
- To update section 4.3 (Contraindications) of the SPC to add hypersensitivity to cetostearyl alcohol
- To update section 4.8 (Undesirable effects) of the SPC to include blisters, oedema and peeling of skin using MedDRA terminology
- To update section 5.2 (Pharmacokinetic Properties) of the SPC to improve clarity of information
Updated on 02-Aug-2001 and displayed until 21-Jul-2010
Reasons for adding or updating:
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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