Canesten HC Cream
- Name:
Canesten HC Cream
- Company:
Bayer Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/01/21

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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 9 March 2021 SPC
Reasons for updating
- Other
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Correction of previous version uploaded.
Updated on 21 January 2021 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 21 January 2021 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 21 January 2021 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 21 January 2021 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 9 June 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
ADR reporting wording update
Updated on 9 June 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Excipient guideline & ADR reporting wording update
Updated on 21 May 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 May 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated SPC due to new PRAC guidance regarding vision
Section 4.4- Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Section 4.8
Eye disorders
Blurred vision may occur, however the frequency is not known (see section 4.4)
Updated on 27 April 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 27 April 2015 PIL
Reasons for updating
- Improved electronic presentation
Updated on 10 April 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 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: Product subject to medical prescription which may be renewed (B)
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 10 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 9 October 2013 SPC
Reasons for updating
- 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: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Updates to section 4.6, Fertility, pregnancy and lactation to align with the QRD template, and also include more streamlined text regarding fertility.
- Update to section 4.7 to detail the medicine has no or negligible influence on the ability to drive or use machinery.
- The undesirable effects has been updated into the appropriate Organ system classes.
- Section 5.1 has been updated to include the Pharmacotherapeutic group of this medicine. In addition, it gives some further information about Hydrocortisone.
- Preclinical safety data, section 5.3, has also been updated to provide information regarding the 2 active ingredients, and also Clotrimazole plus hydrocortisone.
Updated on 2 October 2013 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 4 November 2010 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 8 September 2010 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: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 8: MA number is now 1410/40/1
Updated on 1 September 2010 PIL
Reasons for updating
- Change of licence holder
- Change to date of revision
Updated on 17 June 2010 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.3 - Shelf life
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
'Canesten HC Cream
Clotrimazole 1.0% w/w
Hydrocortisone 1.0% w/w'
In section 2 (Qualitative and quantitative composition), the following changes have been made:
BEFORE:
'The cream contains 1%w/w of Clotrimazole and 1% w/w of hydrocortisone. For excipients, see 6.1'
AFTER:
'The cream contains 1% w/w of clotrimazole and 1% w/w of hydrocortisone.
Also contains 10% cetostearyl alcohol.
In section 6.3 (Shelf Life), the shelf has been changed from '2.5 years' to '2 years'
The date of renewal of authorisation in section 9 (Date of first authorisation/renewal of authorisation) has been changed from '15th August 2004' to '15th August 2009'.
In addition, the date of revision of the text in section 10 (Date of revision of the text) has been changed from 'February 2005' to 'June 2010'.
Updated on 14 June 2010 PIL
Reasons for updating
- Improved electronic presentation
Updated on 27 August 2009 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 4.3 - Contraindications
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 August 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 30 August 2006 PIL
Reasons for updating
- Change to date of revision
Updated on 5 September 2005 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - 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 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 11 August 2005 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 16 May 2005 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 22 February 2005 PIL
Reasons for updating
- Change of manufacturer
Updated on 3 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 1 July 2004 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 August 2003 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 May 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)