Canesten Thrush Cream *

  • Company:

    Bayer Limited
  • Status:

    No Recent Update
  • Legal Category:

    Supply through pharmacy only
  • Active Ingredient(s):

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

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 20 November 2019

File name

18281_PL_CC_CAN12_20181119_1574264055.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 18 January 2019

File name

20181219_PL_CC_CAN12_17256_1547822573.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 contains

Updated on 22 April 2015

File name

PIL_8611_835.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 April 2015

Reasons for updating

  • Improved electronic presentation

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 09 April 2015

Reasons for updating

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

Updated on 23 July 2014

Reasons for updating

  • Change to storage instructions

Updated on 22 July 2014

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 21 July 2014

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.     PHARMACEUTICAL PARTICULARS

 

6.3.      Shelf life

 

            43 years.

 

6.4.      Special precautions for storage

 

            Do not store above 25o C. This medicinal product does not require any special storage conditions.

 

10.       DATE OF REVISION OF THE TEXT

 

May 2014July 2014

Updated on 10 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 4.6 - 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 4.2, rewording on the warnings on avoidance of vaginal intercourse, with use of this product.
- Section 4.3, rewording of the text of  the contraindciations.
- Section 4.6, inclusion of additional information on Fertility, pregnancy and lactation.  
- Section 4.7, rewording of the effect on the ability to drive and use machines.
- Section 4.8, inclusion of erythema (PT) as an adverse reaction. Rewording of the introduction to the list of adverse reactions.
- Section 5.1, inclusion of pharmacotherapeutic group, updated ATC code, and change of location of Gardnerella vagiinalis.
- Section 5.3, inclusion of information that no special hazards for humans are identified in conventional tests.
- Change to approval date.

Updated on 27 January 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 26 November 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 02 November 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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:

 

‘'However, if after concomitant treatment of the vaginitis, the symptoms do not improve within seven days, the patient should consult a doctor.’

 

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:

 

Section 4.4

 

The following text was updated:

 

            Before using Canesten Thrush Cream medical advice must be sought if any of the following are applicable:

 

 ‘ – aged under 16 or over 60 years’ was changed to ‘– aged under 12 or over 60 years’

 

and the following text was added:

 

Canesten Thrush Cream 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 4.8

 

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 urticaria (ME), dyspnoe (PT), hypotension (PT) and syncope (PT)).

                                          

Skin and subcuteaneous tissue disorders

Pruritus (ME), rash (ME), blisters (PT), peeling/exfoliation (PT), discomfort/pain (PT), stinging/burning (PT), edema (PT), burning (PT), irritation.

 

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 5.2

 

This section was revised to read:

 

Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3 – 10%) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 500mg dose were less than 10 nanog/ml, suggesting that clotrimazole applied intravaginally is unlikely to lead to measurable systemic effects or side effects.

 

 

Section 6.6:

 

‘No special requirements’ was replaced with:

 

‘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 22 May 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: MA holder is now Bayer Ltd.

Section 8: MA number is now PA  1410/39/12

Updated on 21 May 2009

Reasons for updating

  • Change due to user-testing of patient information
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 30 August 2006

Reasons for updating

  • Change to date of revision

Updated on 14 February 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life

Legal category:Supply through pharmacy only

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 22 February 2005

Reasons for updating

  • Change of manufacturer

Updated on 03 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 01 July 2004

Reasons for updating

  • Change to section 6.1 - List of excipients

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