CANESTEN COMBI PESSARY & CREAM 500 mg/2%w Pessaries and Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOTRIMAZOLE CLOTRIMAZOLE

Available from:

G & A Licensing Limited

INN (International Name):

CLOTRIMAZOLE CLOTRIMAZOLE

Dosage:

500 mg/2%w

Pharmaceutical form:

Pessaries and Cream

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2013-02-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Combi Pessary & Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The pessary contains clotrimazole 500mg.
Each gram of cream contains 20mg clotrimazole (equivalent to 2%w/w).
Excipients: cetostearyl alcohol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pessary and vaginal cream.
_Product imported from the UK:_
White, convex pessary marked ‘BAYER’ on one side and ‘MU’ on the other side.
A white oil-in-water cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The pessary is recommended for the treatment of candidal vaginitis.
The cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of
candidal vaginitis.
The cream can also be used for treatment of the sexual partner’s penis to prevent re-infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The pessary should be inserted intravaginally, as high as possible, using the applicator provided.
ADULTS:
Insert one pessary, preferably at night. A second treatment may be carried out if necessary.
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/10/2011_
_CRN 2106337_
_page number: 1_
To insert the pessary:
GENERALLY:
Treatment during the menstrual period should be avoided due to the risk of the pessary being washed out by the
mestrual