Canesten 500mg Pessary
*Company:
Bayer LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 October 2022
File name
Canesten 500mg Pessary PIL Oct 2022 BCH22024.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 26 October 2022
File name
Canesten 500mg Pessary SPC Oct 2022 BCH22024.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 25 January 2022
File name
Canesten 500mg Pessary SmPC Jan 2022.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Updated on 25 January 2022
File name
Canesten 500mg Pessary leaflet Jan 2022.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 22 September 2020
File name
ie-pl-approved_cropped.pdf
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
File name
20181127_PL_CC_CAN9_17256.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 5 - how to store or dispose
Updated on 03 May 2017
File name
PIL_8609_880.pdf
Reasons for updating
- New PIL for new product
Updated on 03 May 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 February 2016
Reasons for updating
- Improved electronic presentation
Updated on 20 October 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 20 October 2015
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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
6.3 Shelf-life
5 4 years.
6.4 Special precautions for storage
Do not store above 30ºC25ºC.
10. DATE OF REVISION OF THE TEXT
March 2015October 2015
Updated on 20 October 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 17 April 2015
Reasons for updating
- Improved electronic presentation
Updated on 07 April 2015
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 07 April 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 22 July 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 09 June 2014
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 26 February 2014
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
- Section 4.3 contraindications is reworded.
- Section 4.5 is updated to include information on sirolimus.
- Section 4.6 includes additional information on Fertility, pregnancy and lactation.
- Section 4.7 has been reworded.
- Section 4.8 now includes the adverse reactions of vaginal haemorrhage and erthyema.
- Section 5.1 has included the Pharmacotherapeutic group and updated ATC code. In addition, update of the microorganisms that clotrimazole acts on.
- Section 5.3 has been reworded.
- Section 10 includes the updated approval date.
Updated on 16 May 2012
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 05 January 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to dosage and administration
Updated on 24 November 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Typo correction;
4.2. Posology and method of administration.
Text reads; "3. Push plunger A until it stops, thereby depositing......"
We have removed the capital A.
Updated on 29 October 2010
Reasons for updating
- 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
- Change to section 6.6 - Special precautions for disposal and other handling
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.
lf the labia and adjacent areas are simultaneously infected, local treatment with an
external cream should also be given.
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.
4. 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 20 August 2009
Reasons for updating
- Change to name of manufacturer
Updated on 13 May 2009
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 8: MA number is now 1410/39/9
Updated on 07 May 2009
Reasons for updating
- Change due to user-testing of patient information
- Change to storage instructions
- Change to marketing authorisation holder
- Change to date of revision
Updated on 23 January 2009
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Storage details are now: 'Do not store above 30C'
Updated on 17 July 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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 1 Name of the medicinal product changed to:
Canesten 500mg Pessary
Section 2 Qualitative and quantitative composition changed to:
Each pessary contains 500mg Clotrimazole.
For a full list of excipients, see section 6.1
Section 6.4 Special precautions for storage changed to:
This medicinal product does not require any special storage conditions.
Section 6.5 Nature and contents of container text in ‘bold’ added:
Each pessary is packed into a blister consisting of 25µm PA / 45µm Soft Aluminium 60µm PVC / 20µm Hard Aluminium / 7 GSM HSL. The blister is enclosed in a cardboard carton with a disposable white opaque PE applicator and patient information leaflet. Each pack contains one pessary.
Section 6.6
Heading title changed to ‘Special precautions for use and handling’.
Section 9 Date of first authorisation / Renewal of Authorisation:
Date of last renewal changed to 14th March 2008
Section 10 Date of revision of the text changed to:
July 2008
Updated on 17 July 2008
Reasons for updating
- Change of trade or active ingredient name
- Change to storage instructions
- Change to date of revision
Updated on 30 August 2006
Reasons for updating
- Change to date of revision
Updated on 19 January 2006
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 03 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 20 July 2004
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through pharmacy only
Updated on 01 July 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Updated on 27 May 2003
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only