Reasons for adding or updating:

• Change to section 6.3 - Shelf life
• Change to section 6.4 - Special precautions for storage

Date of revision of text on the SPC: 20-Nov-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To reduce the shelf life of the finished product from 60 months to 48 months. To change the storage conditions of the finished product from "No special precautions for storage" to "Do not store above 25C". Consequentially sections 6.3 and 6.4 of the SPC have  been updated.

Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• Change to section 4.1 - Therapeutic indications
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 05-Nov-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updated to include new brand name "Canesten 500mg Pessary" to sections 1, 1.4, 4.4 and 4.8 of the SPC.

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 4.5 - 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: 28-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.’

4.5 - 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:

• 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:POM

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

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:POM

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.

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

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

Reasons for adding or updating:

• Change to section 1 - trade name
• Change to section 2 - qualitative and quantitative composition
• 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. 5 - Nature and Contents of Container
• Change to section 10 (date of (partial) revision of the text
• Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

• Change to section 6. 5 - Nature and Contents of Container
• Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

• Change to section 6. 5 - Nature and Contents of Container

Reasons for adding or updating:

• No reasons supplied