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  • Epiduo Forte 0.3% /2.5%
    / A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL


    Active Ingredient *
    Adapalene 0.3% w/w
    Benzoyl Peroxide 2.5% w/w

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Gel

    not in the basket chart 34941 5771

    Related information


    Dosage

    This medical product should be applied once a day in the evening to the entire acne affected areas of the face and the trunk on a clean and dry skin.
    The duration of treatment should be determined based on the overall clinical condition and on the therapeutic response to the treatment. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment. If no improvement is observed after 4-8 weeks of treatment, the benefit of continued treatment should be reconsidered.


    Indications

    Cutaneous treatment of moderate to severe acne vulgaris in which there are comedones and numerous papules and pustules.


    Contra-Indications

    * Pregnancy, pregnancy planning
    * Hypersensitivity to the active substances or to any of the excipients


    Special Precautions

    * Damaged skin, broken skin (cuts or abrasions), sunburned, or eczematous areas should not be treated with this product.
    * Contact with the eyes, lips, mouth, nostrils, or mucous membranes should be avoided.
    * If sensitivity to any component of the formula occurs, use of this product should be discontinued.
    * Excessive exposure to sunlight or UV radiation should be avoided.
    See prescribing information for full details


    Side Effects

    Common: Atopic dermatitis, eczema, skin burning sensation, skin irritation
    See prescribing information for full details


    Drug interactions

    No interaction studies have been conducted


    Pregnancy and Lactation

    Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
    Pregnancy: this medical product is contraindicated in pregnancy, or in women planning a pregnancy. There are no or limited amount of data from the use of adapalene topically in pregnant womenIf the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
    Lactation:
    No study on animal or human milk transfer was conducted after cutaneous application. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy weighting the benefit of breast-feeding for the child and the benefit of therapy for the woman.
    To avoid contact exposure of the infant, application to the chest should be avoided when used during breast-feeding.


    Overdose

    Excessive application may result in severe irritation. In this event, discontinue use and wait until the skin has recovered. In case of accidental ingestion, appropriate symptomatic measures should be taken.


    Manufacturer
    Laboratories Galderma, France
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