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

Product name and form

Canesten 100mg Pessary.

Pharmaceutical Form

Pessary.

Qualitative and quantitative composition

Clotrimazole 100mg.

For excipients, see 6.1

Active Ingredient Description
Clotrimazole

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

List of Excipients

Calcium lactate pentahydrate
Maize starch
Crospovidone
Silica, colloidal anhydrous
Lactic acid
Lactose Monohydrate
Magnesium Stearate
Hypromellose
Cellulose, microcrystalline

Pack sizes and marketing

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.

Marketing authorization holder

Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA

Trading as: Bayer plc, Consumer Care Division

Marketing authorization dates and numbers

PL 0010/0015R

Date of first authorisation: 18 August 1988

Date of last renewal of authorisation: 17 February 1999

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