Canesten Duopak 500mg, 100mg / 10g Vaginal Tablet & Cream

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

Cream: Candida infections of the labia and adjacent areas as well as candidal balanitis.

CANESTEN u00ae Vaginal Tablet should be inserted as deeply as possible into the vagina in the evening before going to bed (see instructions for use of applicator). Insertion is best achieved when lying back with the legs slightly drawn up. CANESTEN u00ae Vaginal Tablet needs moisture in the vagina to dissolve completely, otherwise non-dissolved pieces of the vaginal tablet might crumble out of the vagina. To prevent this, it is important to insert the medication as deeply as possible into the vagina at bedtime. Should the vaginal tablet not dissolve completely within one night, the use of CANESTEN u00ae vaginal cream should be considered.

CANESTEN u00ae Cream is applied thinly to the affected areas (from the external genital organs to the anus in woman; glans and prepuce in men) 2 - 3 times a day and rubbed in. The usual period of treatment is 1 - 2 weeks.

Hypersensitivity to clotrimazole or any of the ingredients of CANESTEN u00ae DUOPAK.

• 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. The patient 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 preparations should not be used while using this CANESTEN u00ae DUOPAK.
• Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this CANESTEN u00ae DUOPAK.
• During pregnancy the vaginal tablet should be inserted without an applicator.
• CANESTEN u00ae DUOPAK may reduce the effectiveness and safety of latex products such as condoms and diaphragms. Additional contraceptive measures are required when using CANESTEN u00ae DUOPAK. 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.
• CANESTEN u00ae DUOPAK is intended for use by adults and children 12 years of age and older only.
• Cetostearyl alcohol contained in the CANESTEN u00ae DUOPAK Cream may cause local skin reactions (e.g. contact dermatitis).

Concomitant medication with CANESTEN u00ae DUOPAK and oral tacrolimus (FK-506; immunosuppressant) leads 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 and efficacy of CANESTEN u00ae DUOPAK have not been established in pregnancy. There is limited amount of data from the use of CANESTEN u00ae DUOPAK 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 DUOPAK during the first trimester of pregnancy. During pregnancy, the treatment should be carried out with CANESTEN u00ae Vaginal Tablet without using an applicator.

Available pharmacodynamics/toxicological data in animals have shown excretion of clotrimazole and its metabolites in milk. Breastfeeding should be discontinued during treatment with CANESTEN u00ae DUOPAK.

CANESTEN u00ae DUOPAK has no or negligible influence on the ability to drive and use machinery.

The following adverse reactions have been identified during post-approval use of CANESTEN u00ae DUOPAK. 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 u2013 (this is a result of the natural exfoliation process of removing damaged vaginal epithelium), pruritus, rash, edema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

See side effects. In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.