Canesten Combi Pessary and Cream
- Name:
Canesten Combi Pessary and Cream
- Company:
Bayer Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/09/20

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Bayer Limited

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 14 April 2021 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only
Updated on 22 September 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Site transfer to Grenzach
Updated on 18 January 2019 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - excipient warnings
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 3 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 3 May 2017 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 9 April 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.8. Undesirable effects
…
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
10. DATE OF REVISION OF THE TEXT
May 2014March 2015
Updated on 9 April 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 8 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 9 June 2014 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Gynaecological antiinfectives and antiseptics – imidazole derivatives. Antifungals for topical use – imidazole and triazole derivatives.
ATC Code: D01A CF01 G01AF02
10. DATE OF (PARTIAL) REVISION OF THE TEXT
February May 2014
Updated on 2 May 2014 PIL
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 26 February 2014 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - 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 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
- Additional wording to clarify some points, use before bed, and avoidance of vaginal intercoursr are included in section 4.2.
- Section 4.3 is reworded.
- Similar warnings to tacrolimus are included in section 4.5 for sirolimus.
- Section 4.6 includes additional information on Fertility, pregnancy and lactation.
- Section 4.7 is reworded.
- Vaginal haemorrhage and erythema are added to the list of adverse reactions in section 4.8.
- Section 5.1 updated to include the pharmacotherapeutic group, and an update to the ATC code. Additionally, there is minor amendments to the the listing of the microorganisms clotrimazole acts on.
- Section 5.3 updated stating that based on conventional tests, non clinical data reveal no special hazard for human use.
- Section 10 updated to include the new revision date.
Updated on 10 May 2012 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 7 March 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 24 November 2010 SPC
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2
The following text was deleted:
‘A second treatment may be carried out if necessary.’
and the following text was added:
’…and children of 12 years of age and over:
If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor.
The treatment can be repeated if necessary, however, recurrent infections may
indicate an underlying medical cause, including diabetes or HIV infection.
Patient should seek medical advice if symptoms return within 2 months.
Do not use tampons, intravaginal douches, spermicides or other vaginal products
while using this product.
Avoidance of vaginal intercourse is recommended while using this product
because the infection could be transferred to your partner, and the effectiveness
and safety of latex products such as condoms and diaphragms may be reduced.
Children under 12 years of age:
To insert the pessary:
1. Pull out plunger until it stops. Place the pessary into the applicator.
2. Carefully insert the applicator containing the pessary as deeply as is comfortable into the vagina. This is best done with the patient lying on her back with the knees bent up.
3. Push plunger A until it stops, thereby depositing the pessary into the vagina. Withdraw the applicator and dispose of it hygienically.’
Section 4.4
The following text was deleted:
Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten Pessary. Canesten Pessary can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.
and the following text was added:
Canesten Pessaries should not be used if the patient has any of the following symptoms whereupon medical advice should be sought:
abnormal vaginal bleeding (vaginal haemorrhage)
fever (temperature of 38oC or above)
back pain.
associated shoulder pain.
Avoid contact with eyes and do not swallow.
Section 4.5
The following text was added:
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506 immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be thoroughly monitored for symptoms of tacromilus overdosage, if necessary by determination of the respective plasma levels.
Section 4.8
The entire section was revised to the following:
The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories is not possible.
Immune system disorders
Allergic reaction (ME) with symptoms such as dyspnea (PT), hypotension (PT),
syncope (PT), and urticaria (ME),
Reproductive system and breast disorders
Vulvovaginal discomfort (PT), edema (PT), burning (PT), genital peeling, irritation, pruritus (ME), pelvic pain (PT), rash (ME)
Gastrointestinal disorders
Abdominal pain (ME)
Section 5.1
The following text was updated to:
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062 – 8.0 mg/ml substrate.
Section 6.6:
The diagrams were deleted and the following statement was added:
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how dispose of medicines no longer required. These measures will
help to protect the environment.
Updated on 11 June 2010 PIL
Reasons for updating
- Change to improve clarity and readability
- Change to name of manufacturer
Updated on 7 August 2009 PIL
Reasons for updating
- Change to marketing authorisation holder
- Improved electronic presentation
Updated on 8 July 2009 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 8: PA number is now 1410/39/1
Updated on 8 July 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 2 Qualitative and quantitative composition:
Each gram of cream contains 20mg clotrimazole (equivalent to 2% w/w). Excipients: Cetostearyl alcohol 100mg/g added.
'For a full list of excipients, see section 6.1 added' added.
Section 3 Pharmaceutical form:
‘Pessary and cream’ changed to ‘Pessary and vaginal cream’
Section 4.2 Posology and method of administration:
Pictures and instructions for use previously in section 6.6 added here.
Section 6.3 Shelf life:
36 months changed to 3 years.
Section 6.6 Instructions for use/handling:
Pictures and instructions for use deleted and moved to section 4.2.
Section 9 Date of first authorisation / Renewal of Authorisation:
Date of First Authorisation: 24th August 2001
Date of Last Renewal: 24th August 2006
Updated on 14 November 2006 PIL
Reasons for updating
- Change to date of revision
Updated on 19 January 2006 SPC
Reasons for updating
- 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 4.6 - 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
Legal category: Supply through pharmacy only
Updated on 3 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 20 July 2004 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
Legal category: Supply through pharmacy only
Updated on 27 May 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only