Canesten 100mg Pessary Ref.[2676] Active ingredients: Clotrimazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2010  Publisher: Bayer plc Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA Trading as: Bayer plc, Consumer Care Division

Therapeutic indications

Canesten 100mg Pessaries are recommended for the treatment of candidal vaginitis.

Posology and method of administration

The pessaries should be inserted into the vagina, as high as possible, using the applicator provided. This is best achieved when lying back with legs bent up.

Adults: Two pessaries should be inserted daily (preferably at night) for three consecutive days. Alternatively, one pessary may be inserted daily for six days, preferably at night. A second treatment may be carried out if necessary.

There is no separate dosage schedule for the elderly.

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.

Children: Not for use in children under 16.

Overdose

In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). It should be carried out only if the airway can be protected adequately.

Shelf life

48 months.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

Six pessaries are packed in a blister pack (foil 25µm PA + 45µm Al soft + 60µm PVC) sealed with aluminium backing foil (foil 20µm Al hard + 7g/m² HSL sealable to PVC/PVDC). An applicator is also provided.

The pessaries and applicator are enclosed in a cardboard carton.

Special precautions for disposal and other handling

  1. Pull out plunger A 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 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.

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