Canesten Cream
- Name:
Canesten Cream
- Company:
Bayer Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/08/19
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
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 22 August 2019 PIL
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 PIL
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 PIL
Reasons for updating
- New PIL for new product
Updated on 30 April 2015 PIL
Reasons for updating
- Improved electronic presentation
Updated on 9 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: 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 9 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 9 April 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 6 May 2014 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 26 February 2014 SmPC
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 4.3 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 PIL
Reasons for updating
- Change to side-effects
Updated on 26 November 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to dosage and administration
Updated on 2 November 2010 SmPC
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 SmPC
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 8: PA number is now PA 1410/39/2
Updated on 8 July 2009 PIL
Reasons for updating
- Change to marketing authorisation holder
- Change due to user-testing of patient information
Updated on 11 July 2008 SmPC
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 PIL
Reasons for updating
- Change to date of revision
Updated on 25 July 2006 SmPC
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
Updated on 3 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 13 August 2003 SmPC
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 SmPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only