Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product

Date of revision of text on the SPC: 23-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



·         Removal of obsolete name Canesten Combi 500mg Soft Gel Pessary and 2% Cream from the section 1 of the SmPC

Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 17-Nov-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

1 - To add a new brand name Canesten Combi Soft Gel Pessary & External Cream 500mg / 2% w/w  vaginal capsule & cream

2- consequential name change

 

4.8 –addition of  information on Yellow Card Scheme

Reasons for adding or updating:

• 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 4.4 - 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 - 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

Date of revision of text on the SPC: 29-Nov-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.1 – Removal of ‘and mixed vaginal infections where Trichomonas is present or suspected. This product is not recommended as sole treatment for pure Trichomoniasis except in cases where systemic therapy is contra-indicated’

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.’

4.3 - Removal of specific cetostearyl warning, instead only referring to excipients.

4.4 – Addition of ‘This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).’

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

Reasons for adding or updating:

• New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO