Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product

Date of revision of text on the SPC: 22-Sep-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of obsolete name from section 1

Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• Change to section 4.8 - Undesirable effects

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:



1 - To add a new brand name Canesten Thrush Soft Gel Pessary 500mg vaginal capsule
4.8 – addition of  information on Yellow Card Scheme

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.’

Reasons for adding or updating:

• New SPC for new product

Legal Category:P

Black Triangle (CHM): NO