Canesten 1 Vc 500mg / 5g Vaginal Cream

Infections of the genital region (vaginitis) caused by Candida.

CANESTEN u00ae 1 VC is a single dose treatment. The content of the applicator of CANESTEN u00ae 1 VC (about 5 g) should be inserted as deeply as possible into the vagina in the evening before going to bed. Insertion is best achieved when lying back with the legs slightly drawn up.

• Hypersensitivity to clotrimazole or to any of the excipients of CANESTEN u00ae 1 VC (Vaginal Cream).

If symptoms persist for more than 7 days, the patient should be evaluated by a medical practitioner. Recurrent infections may indicate an underlying medical cause. Patients should seek medical advice if symptoms return within 2 months. Treatment during the menstrual period should not be performed. The treatment should be completed before the onset of menstruation. Tampons, intravaginal douches, spermicides or other vaginal products should not be used while using CANESTEN u00ae 1 VC. Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using CANESTEN u00ae 1 VC as the partner could become infected. CANESTEN u00ae 1 VC is intended for use by adults and children 12 years of age and older only. CANESTEN u00ae 1 VC may reduce the effectiveness and safety of latex products such as condoms and diaphragms when applied on the genital area (women: intravaginally, labia and adjacent area of the vulva; men: prepuce and glans of the penis). Additional contraceptive measures are required when using CANESTEN u00ae 1 VC. As Canesten may reduce the effectiveness of condoms and diaphragms, patients should be advised to refrain from sexual intercourse to prevent transmission of HIV and sexually transmitted diseases (STDu2019s) during treatment until the symptoms of the candidiasis infection have resolved. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Special Precautions Contact with eyes should be avoided. CANESTEN u00ae 1 VC should not be swallowed.

Concomitant medication with CANESTEN u00ae 1 VC and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be thoroughly monitored for symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Safety in pregnancy and lactation has not been established. Pregnancy There is limited amount of data from the use of CANESTEN u00ae 1 VC in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of CANESTEN u00ae 1 VC during the first trimester of pregnancy. Lactation Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole and its metabolites in milk. Breastfeeding should be discontinued during treatment with CANESTEN u00ae 1 VC.

CANESTEN u00ae 1 VC 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 CANESTEN u00ae 1 VC. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency. Immune system disorders Allergic reaction (syncope, hypotension, dyspnoea, urticaria) Gastrointestinal disorders Abdominal pain Reproductive system and breast disorders Genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

See side-effects. Gastro-intestinal disturbances and central nervous system depression may follow accidental ingestion. Treatment is symptomatic and supportive.