Canesten 200mg Pessary

  • Name:

    Canesten 200mg Pessary

  • Company:
    info
  • Active Ingredients:

    Clotrimazole

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/08/19

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Summary of Product Characteristics last updated on medicines.ie: 10/4/2015
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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 22 August 2019 PIL

Reasons for updating

  • 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 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 17 April 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 April 2015 PIL

Reasons for updating

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

Updated on 10 April 2015

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

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 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

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.

 

 

6.4       Special precautions for storage

 

There are no special precautions for storageDo not store above 25°C.

 

 

10.       DATE OF REVISION OF THE TEXT

 

May 2014March 2015.

Updated on 23 July 2014 PIL

Reasons for updating

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

Updated on 9 June 2014 SPC

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 SPC

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 has included rewording on some usage instructions. 
- Section 4.3 contraindication has been reworded.
- In section 4.5, interaction with sirolimus warning included.
- In section 4.6 additional information on fertility, pregnancy and lactation has been included.
- Section 4.7 has been reworded.
- In section 4.8, the adverse reactions vaginal haemorrhage and erthyema have been included.
- In section 5.1, the pharmacotherapeutic group has been updated, along with the ATC code. Additionally, minor amendments to the information on the action of clotrimazole on microorganisms.  
- In section 5.3, the text has been reworded.
- Section 10 updated to include the new approval date.

Updated on 15 May 2012 PIL

Reasons for updating

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

Updated on 29 March 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 28 March 2011 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 4.6 (Fertility, pregnancy and lactation) has been changed to read as follows:

BEFORE:
"Well-conducted epidemiological studies indicate no adverse effects of clotrimazole on pregnancy or on the health of the fetus/newborn child.

Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

During pregnancy, extra care should be taken when using the applicator to prevent the possibility of mechanical trauma."

AFTER:
"While controlled clinical studies in pregnant women do not exist epidemiological investigations give no indication that harmful effects on the mother and child should be anticipated when Canesten 200mg pessary is used during pregnancy. However, as with all drugs in the first 3 months of pregnancy, Canesten 200mg pessary should only be used after first consulting a doctor.
During pregnancy the treatment should be carried out with Canesten pessary, since these can be inserted without using an applicator.

Well-conducted epidemiological studies indicate no adverse effects of clotrimazole on pregnancy or on the health of the fetus/newborn child.

Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife"

Section 10 (Date of revision of the text) has been changed from "November 2010" to "March 2011"

Updated on 17 December 2010 SPC

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

Deleted text:  Red, strikethrough

Inserted text: Blue, bold italics

  

4.2       Posology and method of administration

 

            Canesten 200mg Pessaries should be inserted intravaginally, as high as possible, using the applicator supplied.

 

            Adults and children of 12 years of age and older:

            Insert one pessary daily, preferably at night, for three consecutive days. A second treatment may be carried out if necessary.

 

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. 

 

            Canesten pessaries need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the pessary might crumble out of the vagina. Pieces of undissolved pessary may be noticed by women who experience vaginal dryness. To help prevent this it is important that the pessary is inserted as high as possible into the vagina at bedtime.

           

            Generally:

            Treatment during the menstrual period should not be performed due to the risk of the pessary being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.

 

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:

            As this product is administered with a vaginal applicator, paediatric usage is not recommended.

 

To insert the pessary:

 

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

 

2.      Insert applicator containing the pessary carefully 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 until it stops, thereby depositing the pessary into the vagina. Remove the applicator.

 

4.      After use, remove plunger completely by pulling it out of the applicator. Then wash it in warm (not boiling) soapy water, rinse and dry carefully.


 

4.4       Special warnings and special precautions for use

 

     

 

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.

 

            Before using Canesten 200mg Pessaries, medical advice must be sought if any of the following are applicable:

 

            -           More than two infections of candidal vaginitis in the last 6 months.

            -           Previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease.

            -           Pregnancy or suspected pregnancy.

            -           Aged under 162 or over 60 years.

            -           Known hypersensitivity to imidazoles or other vaginal antifungal products.

 

            Canesten 200mg Pessaries should not be used if the patient has any of the following symptoms whereupon medical advice should be sought:

            -           Irregular vaginal bleeding

            -           Abnormal vaginal bleeding (vaginal haemorrhage) or a bloodstained discharge.

            -           Vulval or vaginal ulcers, blisters or sores.

            -           Lower abdominal pain or dysuria
-           Any adverse events such as redness, irritation or swelling associated with the treatment.

            -           Fever (temperature of 38oC or above) or chills 
 -           Nausea or vomiting.

            -           Diarrhoea.

-Diarrhoea.

            -           Foul smelling vaginal discharge.

            -           Back pain.

            -           Associated shoulder pain.

 

Avoid contact with eyes and do not swallow.

 

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten 200mg Pessaries. The pessaries 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.

 

            All possibly infected areas should be treated at the same time.

    
 

4.5       Interaction with other medicaments and other forms of interaction

 

            Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives.  Consequently, the effectiveness of such contraceptives may be reduced.  Patients should be advised to use alternative precautions for at least five days after using this product.

 

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.

 

 4.8       Undesirable effects

Rarely patients may experience local mild burning immediately after inserting the pessary. Very rarely the patient may find this irritation intolerable and stop treatment.

 

Other undesirable effects:

 

Body as a whole:                    allergic reaction (syncope, hypotension, dyspnea, gastrointestinal disorders), pain

 

            Skin and appendages:                        pruritis, rash

 

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)

 

 

 

5.1       Pharmacodynamic properties

           

            ATC Code: G01A F02

 

Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity.

 

            Mechanism of Action

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

 

Pharmacodynamic Effects

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

 

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062 – 4 (-8.0) mg/ml substrate. The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.

 

In addition to its antimycotic action, clotrimazole also acts on Trichomonas vaginalis, gram-positive microorganisms (streptococci/staphylococci) and gram-negative microorganisms (Bacteroides/Gardnerella vaginalis).  It has no effect on lactobacilli.

 

            In vitro, clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci – with the exception of enterococci – in concentrations of 0.5 – 10 mg/ml substrate and exerts a trichomonacidal action at 100 mg/ml.

 

            Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

 

 

 

6.6.            Instructions for use and handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 

1.      Pull out plunger A until it stops.

      Place a pessary into the applicator B.

 

2.      Insert applicator containing the pessary carefully 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. Remove the applicator.

 

4.      After use, remove plunger A completely by pulling it out of the applicator B. Then wash it in warm (not boiling) soapy water, rinse and dry carefully.

                                 *
*Note: the diagram from section 6.6 has also been removed

 

Updated on 20 August 2009 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 7 April 2009 SPC

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: Details of the Marketing Authorisation Holder have been updated to:
                        Bayer Limited
                        The Atrium
                        Blackthorn Road
                        Dublin 18
 
Section 8: Details of the Marketing Authorisation Number have been updated to:
                        PA1410/39/8

Updated on 7 April 2009 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 30 August 2006 PIL

Reasons for updating

  • Change to date of revision

Updated on 25 January 2006 SPC

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 16 May 2005 SPC

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • 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

Updated on 3 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 May 2003 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only