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Canesten Cream (1%)

*
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_20g_1_angle.jpeg
  • 3125_canesten_20g_1_front.jpeg
  • 3125_canesten_50g_1_angle.jpeg
  • 3125_canesten_50g_1_front.jpeg

Updated on 26 October 2022

File name

Canesten Cream 1% 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 Cream 1% 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 16 November 2021

File name

Canesten Cream 1 SmPC Nov 2021.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Updated on 16 November 2021

File name

Canesten Cream 1 leaflet Nov 2021.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Updated on 22 August 2019

File name

18283_PL_CC_CAN2_20190822.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 January 2019

File name

20181219_PL_CC_CAN2_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 contains

Updated on 30 April 2015

File name

PIL_8616_597.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 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 06 May 2014

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 26 February 2014

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.1 has been updated to remove Trichomonas as a species sensitive to the anti-infective.
- Section 4.3 contraindications has been reworded.
- Section 4.6 has been updated to include further information on Fertility, pregnancy and lactation.
- Section 4.7 has been updated to reflect appropriate templates.
- Section 4.8 has been updated to include erythema as an adverse reaction.
- Section 5.1 has been updated to include the pharmacotheraeutic group. Additionally, it amends the information on the microorganisms clotrimazole acts on.
- Section 5.3 has been reworded to give more information.
- Section 10 has been updated to include the new approval date.

Updated on 27 January 2012

Reasons for updating

  • Change to side-effects

Updated on 26 November 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

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 5.2 - 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 added:

 

Patients should notify their physician if there is no improvement after 4 weeks of treatment.

 

Section 4.4

 

The following text was added:

 

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 dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 mg/ml, suggesting that clotrimazole applied topically on the skin 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 13 July 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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 7: PA holder is now Bayer Ltd

Section 8: PA number is now PA 1410/39/2

Updated on 08 July 2009

Reasons for updating

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

Updated on 11 July 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 
 

Section 2 Qualitative and quantitative composition changed to:

Contains clotrimazole 1% w/w (equivalent to 10mg/g).

Excipients: contains 10% w/w cetostearyl alcohol. 

For a full list of excipients, see section 6.1.

Updated on 13 November 2006

Reasons for updating

  • Change to date of revision

Updated on 25 July 2006

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • 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

4.6  The text has been harmonised with the company core data sheet
4.8  'If this is severe, treatment should be discontinued' has been removed.  The text has been harmonised with the company core date sheet.
4.9   'as soon as possible after ingestion'  has been replace with ' only if clinical symptoms of overdose become apparent ...
5.1 & 5.2 The text has been harmonised with the company core data sheet
7.  'Consumer Care Division'  has been removed
10.  Changed from March 2003 to August 2005 

Updated on 03 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 August 2003

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

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