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

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

Before using Canesten 100mg Pessaries, medical advice must be sought if any of the following are applicable:

• more than two infections of candidal vaginitis in the last six months.
• previous history of a 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 100mg 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 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 100mg 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.

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

Not applicable.