Canesten 500mg Vaginal Pessary.

Clotrimazole 500mg.

For excipients, see 6.1.

Pessary.

White convex pessary.

Canesten 500mg Vaginal Pessary is recommended for the treatment of candidal vaginitis and mixed vaginal infections where Trichomonas is present or suspected. This product is not recommended as sole treatment for pure Trichomoniasis except in cases where systemic therapy is contra-indicated.

The pessary should be inserted into the vagina, as high as possible, using the applicator provided.

Adults: One 500mg pessary should be inserted at night. Using the applicator provided, the pessary should be inserted as high as possible into the vagina. This is best achieved when lying back with legs bent up. 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.

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: As the product is used with an applicator, paediatric usage is not recommended.

Hypersensitivity to clotrimazole or any ingredient in this medicine.

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

Before using Canesten 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 sexually transmitted disease or exposure to partner with sexually transmitted disease.

- pregnancy or suspected pregnancy.

- aged under 16 or over 60 years.

- known hypersensitivity to imidazoles or other vaginal antifungal products.

Canesten Pessaries should not be used if the patient has any of the following symptoms where upon medical advice should be sought:

- irregular vaginal bleeding.

- abnormal vaginal bleeding or a blood-stained 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 or chills.

- nausea or vomiting.

- diarrhoea.

- foul smelling vaginal discharge.

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten 500mg Vaginal Pessary. Canesten 500mg Vaginal 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.

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 closely monitored for signs and symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels.

Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child. To date, no relevant epidemiological data are available.

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

During pregnancy the pessary should be inserted without using an applicator.

Not applicable.

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

Immune system disorders:

allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus)

Reproductive system and breast disorders:

genital peeling, pruritus, rash, oedema, discomfort, burning, irritation, pelvic pain

Gastrointestinal disorders:

abdominal pain

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.

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.

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.

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.

Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3 – 10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 500mg dose were less than 10 ng/ml, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.

There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SmPC.

Lactose Monohydrate

Cellulose, Microcrystalline

Lactic Acid

Maize Starch

Crospovidone

Calcium Lactate Pentahydrate

Magnesium Stearate

Silica, Colloidal Anhydrous

Hypromellose

Not applicable.

60 months.

No special precautions for storage.

Each pessary is packed into a blister consisting of 25µm PA (polyamide) / 45µm Soft Aluminium / 60µm PVC and 20µm Hard Aluminium / 7 GSM HSL (Heat seal lacquer). The blister and an applicator are enclosed in a cardboard carton.

The pessary is also available with a 10g tube of Canesten Thrush Cream as Canesten Combi 500mg Pessary and 2% Cream (Shelf life 36 months).

No special requirements

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

United Kingdom

Trading as Bayer plc, Consumer Care Division.

PL 0010/0258

16 September 2005

12 August 2010