くすりのしおり

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Revised: 4/2014

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Protopic Ointment 0.1%
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
white to pale yellow ointment
 Print on wrapping:
プロトピック軟膏0.1%, 5g

Effects of this medicine

This medicine suppresses cytokine synthesis and allergic reactions, thus decreaseing inflammation.
It is usually used to treat atopic dermatitis.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have: ulcerated or erosive (sores) skin, kidney impairment, hyperkalaemia or ichthyosiform erythroderma (a condition by which the skin peels off the body as with fish-scaling).
    If you are undergoing ultraviolet treatment.
    If you have skin infections.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults, apply an appropriate amount of the ointment on the affected area, once or twice daily. The applied dose should not exceed 5 g (5 mg of tacrolimus) at a time. Strictly follow the instructions.
  • Wash your hands before using the medicine. Wash the fingers you used well after using the medicine.
  • Do not apply the medicine on areas where the skin is oozing or sore, on boils or pimples, on other surfaces than skin such as the mucosa of the mouth, nose, etc. or on the vulva.
  • Pay close attention when you apply the medicine around your eyes to avoid it from getting into your eyes. If the medicine gets into your eyes by accident, wash it away with water. If you feel any abnormal sensation, consult with an ophthalmologist.
  • If you miss a dose, use one dose as soon as possible, but the next dose should be at least 12 hours apart. You should never use two doses at one time.
  • If you accidentally use more than your prescribed dose, wipe it off immediately. If you use more than 1 tube of the medicine at one time, consult with your doctor or pharmacist.
  • Do not stop using this medicine unless your doctor instructs you to do so. If improvement was not observed after two weeks of continuous use, consult with your doctor or pharmacist.

Precautions while taking this medicine

  • Wear appropriate clothing to prevent the skin area where the ointment was applied from being exposed to sunlight for a long time. Avoid using tanning or ultraviolet lamps.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include feeling hot (burning sensation, feeling of hot flushes), pain (tingling feeling, smarting feeling), itching, folliculitis, Kaposi's varicelliform eruption, herpes simplex, acne, acneiform eruption, papules, dry skin, contact dermatitis, erythema, rosacea-like dermatitis and application site oedema. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of infants and children. Store away from direct sunlight, heat and humidity.
  • Discard the remainder. Do not store it. Consult with your dispensing pharmacy or medical institution when you discard the medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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