Canesten 3 Vc 20mg / 1g Vaginal Cream

    Canesten 3 Vc 20mg / 1g Vaginal Cream

    S1
    PDF Leaflet Revision Date: 26 October 2012

    API: Clotrimazole | Company: Bayer

    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Relief of vaginal itching, burning, and discharge from yeast infections.

    Dosage (summary)

    Insert 5 g nightly for 3 days; may use 2 applications daily for 6-12 days if needed.

    Special Populations

    • Girls under 12 years

    Pregnancy & Breastfeeding

    Use only on medical advice; not recommended in the first trimester.

    Key Drug Interactions

    • May reduce effectiveness of latex products

    Contraindications

    • Hypersensitivity to clotrimazole or cetostearyl alcohol

    Common side effects

    • Burning
    • Pruritus
    • Rash

    Counselling Points

    • Use as directed
    • Complete treatment even if symptoms improve
    • Consult if symptoms recur within 2 months

    Serious warnings

    • Consult doctor if no improvement in 3 days
    • Discontinue if new irritation occurs
    Important Disclaimer

    The Canesten 3 Vc 20mg / 1g Vaginal Cream professional information leaflet below is the property of Bayer and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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    Clinical Particulars

    Section 4 of the official insert — extracted exactly as issued, no alterations

    4.1 Therapeutic indications

    For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis).

    4.2 Posology and method of administration

    Fill enclosed vaginal applicator to the top (i.e. 5 g CANESTEN 3VC). Insert deeply into the vagina every night on retiring for three consecutive days even if symptoms disappear. This is best achieved when lying on the back with the legs pulled in a little towards the body. If individual cases should require it, two applications of 5 g Canesten 3VC can be used daily i.e. one in the morning and one in the evening, for 6 - 12 days. Use even during menstruation, although it is recommended that the treatment should not be carried out during menstruation but should be completed before menstruation begins. For candida vulvitis or vulvo-vaginitis the vaginal cream should be applied thinly to the external genitalia 2 or 3 times a day for 1 - 2 weeks. For the prevention of re-infection, the partner should be treated locally with CANESTEN Cream at the same time in so far as symptoms (e.g. pruritus, inflammation, etc.) are present. CANESTEN preparations are colourless and do not stain the underwear.

    4.3 Contraindications

    Possible hypersensitivity to clotrimazole and / or cetostearyl alcohol.

    4.4 Special warnings and precautions for use

    i. Use only if you have already had a vaginal yeast infection diagnosed by a medical practitioner and you have the same symptoms now, otherwise consult your doctor. These symptoms include itching and burning of the vagina and sometimes a white discharge.
    ii. If there is no improvement in 3 days or if symptoms have not disappeared within 7 days, then consult a medical practitioner as not all vaginal infections are caused by yeasts.
    iii. Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling, or a vaginal discharge before or during use of this medication.
    iv. If symptoms recur within 2 months, consult a medical practitioner.
    v. Do not use in girls under 12 years of age, except on the advice of a medical practitioner.
    vi. If skin rash or new irritation occurs, discontinue use.
    vii. Direct contact with Canesten Vaginal Cream may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.

    4.6 Fertility, pregnancy and lactation

    Safety has not been established. CANESTEN Vaginal Cream may only be used during pregnancy on the advice of a medical doctor. CANESTEN Vaginal Cream should not be administered to pregnant women during the first trimester, since the safety in this regard has not been established. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.

    4.8 Undesirable effects

    Skin and appendages : burning, pruritus, and rash. Contact allergic dermatitis has been reported.
    Body as a whole : allergic reaction (syncope, hypotension, dyspnoea, gastrointestinal disorders), pain.

    4.9 Overdose

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

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