CANESTEN THRUSH INTERNAL CREAM 10% w/w Vaginal cream Ref.[6744] 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 Thrush Internal Cream, 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 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 Thrush Internal Cream 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 Thrush Internal Cream. Canesten Thrush Internal Cream 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.

This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

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 levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Fertility

No human studies of the effects of clotrimazole on fertility have been performed, however, animal studies have not demonstrated any effects of the drug on fertility.

Pregnancy

There are limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following vaginal treatment, harmful effects with respect to reproductive toxicity are not predicted.

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

During pregnancy the treatment should be carried out with clotrimazole pessary, since these can be inserted without using an applicator.

Lactation

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

The medication has no or negligible influence on the ability to drive or use machinery.

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, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

Gastrointestinal disorders: abdominal pain.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.