MYCORIL Vaginal tablet Ref.[28282] Active ingredients: Clotrimazole

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

Before using Mycoril, 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 12 or over 60 years.
• known hypersensitivity to imidazoles or other vaginal antifungal products.

Mycoril 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 (vaginal haemorrhage) 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 (temperature of 38°C or above) or chills.
• nausea or vomiting.
• diarrhoea.
• foul smelling vaginal discharge.
• back pain.
• associated shoulder pain.

Avoid contact with eyes and do not swallow.

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 and similarly with sirolimus. Patients should thus be closely monitored for 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 do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of clotrimazole during the first trimester of pregnancy.During pregnancy the treatment should be carried out with clotrimazole vaginal tablets, since these can be inserted without using an applicator.

Breast-feeding

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk (see section 5.3). Breast-feeding should be discontinued during treatment with clotrimazole.

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

The following adverse reactions have been identified during post-approval use of clotrimazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Immune system disorders

Allergic reaction with symptoms such as syncope, hypotension, dyspnea and urticaria.

Reproductive system and breast disorders

Vulvovaginal discomfort, genital peeling, pruritus, rash, edema, erythema, 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 national reporting system.

Cyprus: Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

Not applicable.