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Canesten HC Cream

  • Name:

    Canesten HC Cream

  • Company:
    info
  • Active Ingredients:

    Clotrimazole, Hydrocortisone

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/06/20

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Summary of Product Characteristics last updated on medicines.ie: 9/6/2020

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Bayer Limited

Bayer Limited

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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 June 2020 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 10 April 2015 SmPC

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 SmPC

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

- Update of the SPC to QRD template.
- 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 SmPC

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

Addition of wording, "Treatment should be continued for no more than 7days."

Updated on 8 September 2010 SmPC

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 7: MA holder has been changed from Bayer plc to Bayer Ltd

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 SmPC

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

In section 1 (Name of the medicinal product), the name has been changed from 'Canesten HC Cream' to:
    '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.
For a full list of excipients, see 6.1.'

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 SmPC

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

Section 4.3 has been updated to the following: The following contra-indications apply to the hydrocortisone component: specific bacterial skin diseases (syphilis, tuberculosis), chicken pox, vaccination reactions, perioral dermatitis, viral skin diseases (e.g. herpes simplex, rosacea, shingles), use on broken skin, acne Section 4.4: The following text was deleted: Long-term continuous therapy to extensive areas of the skin and application under occlusive dressing should be avoided, particularly in infants and children, because of the possibility of adrenocortical suppression. Section 4.8: Has been updated to the following: Side-effects include local irritation or burning. If this is severe, treatment should be discontinued. Hypersensitivity reactions may occur. After use on large areas (more than 10% of the body surface) and/or after long-term use (longer than 2-4 weeks) or use under occlusive dressings, local skin alterations such as skin atrophy, telangiectasis, hypertrichosis, striations, hypopigmentation, secondary infection and acneiform symptoms may occur. Section 4.9:The following text was deleted: ‘as soon as possible after ingestion’ Section 5.1:The following text was deleted: Clotrimazole has a broad spectrum of activity (yeast, dermatophytes, moulds and a number of other fungi). It also exhibits activity against Trichomonas vaginalis, staphylococci, streptococci and Bacteroides. Hydrocortisone has a vasoconstrictive effect thus reducing inflammation and oedema. It also has an antipruritic effect. Section 5.2:The following was deleted: Following application of 1% 14C-clotrimazole cream (8mg clotrimazole – 200cm2 with occlusive dressing for six hours) to five healthy volunteers, urinary excretion within six days amounted to a maximum of 0.2% of the activity applied. Maximum equivalent concentrations of clotrimazole in the serum remained below 0.0001mcg/ml. A study of 16 healthy volunteers following topical application of 1.5 – 2.5g Canesten HC Cream (doses of 15 – 25mg hydrocortisone) resulted in no measurably effective levels of hydrocortisone in the blood or urine (analytical method used was Amerlex Cortisol 125I RIA).

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)