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    TACROLIMUS

    TACROLIMUS TOPICAL (PROTOPIC)

    Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established

    Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including PROTOPIC Ointment.

    Therefore:
    -Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
    - PROTOPIC Ointment is not indicated for use in children less than 2 years of age. Only 0.03% PROTOPIC Ointment is indicated for use in children 2-15 years of age

    BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP
    CHICKEN POX; INFECTION.
    * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding.
    * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use.
    HOW MEDICINE IS ADMINISTERED? TOP
    Use this medicine exactly as directed on the label, unless instructed differently by your doctor
    * This medication is for EXTERNAL USE only.
    * Keep this medicine away from the EYES, NOSE, MOUTH, & other mucous membranes. Do not use OCCLUSIVE dressing unless directed to do so by your doctor.
    * Wipe areas DRY before applying.
    * WASH hands immediately after using medication.
    WARNINGS/PRECAUTIONS: TOP
    * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):-
    * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching.
    * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR.
    * DO NOT place bandages, dressing, cosmetics, or other skin products over the affected area unless directed by your doctor.
    * This medicine may cause increased sensitivity to the sun. You should AVOID prolonged or excessive exposure to direct and/or artificial sunlight.
    * AVOID exposure to sunlight, and wear protective clothing while on treatment.
    * Pediatric: The safety or efficacy of this medicine in pediatric patients below 2 years of age has not been established.
    * Improvement may take 2-4 weeks or longer.
    * It is important that you do not stop taking your medications without consulting your doctor.
    * Notify your doctor if condition worsens or shows no improvement.
    * AVOID concurrent use of alcohol.
    * FLUSHING and a sensation of warmth, especially of the face and upper body, may occur. Avoid hot liquids with or immediately after administration.
    ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience:
    Shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching.
    Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience:
    Flu-like symptoms; Fever; Infection.
    Other Common Side Effects: TOP
    Burning sensation; Itching; Skin redness; Headache; Transient stinging; Skin rash; Increased sensitivity to sunlight; Hot sensation and redness of face; Difficulty falling asleep; Acne; Stomach discomfort or pain; Worsening of asthma; Back pain; Bronchitis; Cough; Eye inflammation; Skin inflammation; Diarrhea; Dry skin; Difficult and painful menstruation; Generalized pain; Memory difficulty; Nausea; Swelling of the extremities; Inflammation of the pharynx; Nasal congestion; Inflammation of the sinuses; Severe skin itching with patches; Vomiting; Muscle weakness.
    Other Common Side Effects:
    If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients.



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