Canesten 500mg Pessary

  • Name:

    Canesten 500mg Pessary

  • Company:
    info
  • Active Ingredients:

    Clotrimazole

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/01/19

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Summary of Product Characteristics last updated on medicines.ie: 20/10/2015
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Bayer Limited

Bayer Limited

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1 - 0 of 74 items.Total: Infinity pages

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 18 January 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 5 - how to store or dispose

Updated on 3 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 May 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 23 February 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 October 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 20 October 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 20 October 2015 SmPC

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

6.3       Shelf-life

 

5 4 years.

 

6.4       Special precautions for storage

 

Do not store above 30ºC25ºC.

 

10.       DATE OF REVISION OF THE TEXT

 

March 2015October 2015

Updated on 17 April 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 April 2015 PIL

Reasons for updating

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

Updated on 7 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 22 July 2014 PIL

Reasons for updating

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

Updated on 9 June 2014 SmPC

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 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 is updated to include additional usage information.
- Section 4.3 contraindications is reworded.
- Section 4.5 is updated to include information on sirolimus.
- Section 4.6 includes additional information on Fertility, pregnancy and lactation.
- Section 4.7 has been reworded.
- Section 4.8 now includes the adverse reactions of vaginal haemorrhage and erthyema.
- Section 5.1 has included the Pharmacotherapeutic group and updated ATC code. In addition, update of the microorganisms that clotrimazole acts on. 
- Section 5.3 has been reworded.
- Section 10 includes the updated approval date.

Updated on 16 May 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 5 January 2011 PIL

Reasons for updating

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

Updated on 24 November 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Typo correction;
4.2.    Posology and method of administration.

 

Text reads; "3.   Push plunger A until it stops, thereby depositing......"

 

We have removed the capital A.

Updated on 29 October 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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:

 

‘A second treatment may be carried out if necessary.’

 

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.

 

lf the labia and adjacent areas are simultaneously infected, local treatment with an

external cream should also be given.

 

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:

 

To insert the pessary:

 

1.      Pull out plunger  until it stops. Place the pessary  into the applicator.

2.      Carefully insert the applicator containing the pessary as deeply as is comfortable into the vagina. This is best done with the patient  lying on her back with the knees bent up.

3.      Push plunger A until it stops, thereby depositing the pessary into the vagina.

4.      Withdraw the applicator and dispose of it hygienically.’

 

 

Section 4.4

 

The following text was deleted:

 

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten Pessary. Canesten Pessary can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.

 

and the following text was added:

 

Canesten Pessaries 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 4.5

 

The following text was added:

Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506 immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be thoroughly monitored for symptoms of tacromilus overdosage, if necessary by determination of the respective plasma levels.

 

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 dyspnea (PT), hypotension (PT),

syncope (PT), and urticaria (ME),

                      

Reproductive system and breast disorders

Vulvovaginal discomfort (PT), edema (PT), burning (PT), genital peeling, irritation, pruritus (ME), pelvic pain (PT), rash (ME)

 

Gastrointestinal disorders

Abdominal pain (ME)

 

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 6.6:

 

The diagrams were deleted and the following statement was added:

 

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 20 August 2009 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 13 May 2009 SmPC

Reasons for updating

  • 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: MA holder transferred to Bayer Ltd.

Section 8: MA number is now 1410/39/9

Updated on 7 May 2009 PIL

Reasons for updating

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

Updated on 23 January 2009 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Storage details are now: 'Do not store above 30C'

Updated on 17 July 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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 1 Name of the medicinal product changed to:

Canesten 500mg Pessary

 

Section 2 Qualitative and quantitative composition changed to:

Each pessary contains 500mg Clotrimazole. 

For a full list of excipients, see section 6.1

 

Section 6.4 Special precautions for storage changed to:

This medicinal product does not require any special storage conditions.

 

Section 6.5 Nature and contents of container text in ‘bold’ added:

Each pessary is packed into a blister consisting of 25µm PA / 45µm Soft Aluminium 60µm PVC / 20µm Hard Aluminium / 7 GSM HSL. The blister is enclosed in a cardboard carton with a disposable white opaque PE applicator and patient information leaflet. Each pack contains one pessary.

 

Section 6.6

Heading title changed to ‘Special precautions for use and handling’.

 

Section 9 Date of first authorisation / Renewal of Authorisation:

Date of last renewal changed to 14th March 2008

 

Section 10 Date of revision of the text changed to:

July 2008

Updated on 17 July 2008 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change to date of revision

Updated on 30 August 2006 PIL

Reasons for updating

  • Change to date of revision

Updated on 19 January 2006 SmPC

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 3 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 July 2004 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Updated on 1 July 2004 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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