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Canesten Combi Pessary & Cream

*
Pharmacy Only: Non-prescription

  • Company:

    Bayer Limited

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Clotrimazole

    *Additional information is available within the SPC or upon request to the company

  • 3125_canesten_combi_angle_OOP.jpeg
  • 3125_canesten_combi_front.jpeg
  • 3125_canesten_combi_angle.jpeg

Updated on 26 October 2022

File name

Canesten Combi 500mg Pessary & Cream 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 Combi 500mg Pessary & Cream 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 Combi Pessary & Cream 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 Combi Pessary & Cream leaflet Jan 2022.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 April 2021

File name

Canesten Combi Pessary & Cream SPC April 2021.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only

Updated on 22 September 2020

File name

BCH19017_Can pess_CC_PL_proposed_20191128.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_CAN1_17256.pdf

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 03 May 2017

File name

PIL_8615_920.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 09 April 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 09 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 08 April 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

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 02 May 2014

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

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

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 07 March 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 24 November 2010

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

Reasons for updating

  • Change to improve clarity and readability
  • Change to name of manufacturer

Updated on 07 August 2009

Reasons for updating

  • Change to marketing authorisation holder
  • Improved electronic presentation

Updated on 08 July 2009

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 7: PA holder is now Bayer Ltd.

Section 8: PA number is now 1410/39/1 

Updated on 08 July 2008

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

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 3 - Pharmaceutical form
  • 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