くすりのしおり

External
Published: 11/2011

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 :
BESELNA Cream 5% [for actinic keratosis]
 Active ingredient:
Imiquimod
 Dosage form:
white to slightly yellow cream
 Print on wrapping:
(divided aluminum package)ベセルナクリーム5%, 250mg, MO 651

Effects of this medicine

This medicine enhances immunocompetence to help with killing cells in the lesions affected by actinic keratosis.
It is usually used in the treatment of actinic keratosis (only for lesions in the face and bald spots).

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 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, apply appropriate amount of the medicine to the treatment site once a day, 3 times a week (e.g. on Monday, Wednesday and Friday, or on Tuesday, Thursday and Saturday to avoid continuous use of it), before going to bed. After applying, leave the application site as it is, and wash the applied medicine off with soap and water or warm water when you get up the next morning (approx. 8 hours after applying it). Use the medicine for 4 weeks, then interrupt it for 4 weeks. If the lesion has disappeared, you may stop the treatment. If the effect is insufficient, you need to continue the treatment for another 4 weeks. Strictly follow the instructions.
  • You may apply a whole package of the medicine at a maximum to the treatment site (up to 25 square centimeters), then rub until it becomes invisible.
  • Do not apply the medicine to sites other than the face and bald spots.
  • Do not apply the medicine to a treatment site with wounds.
  • Pay attention not to let the medicine get into your eyes, lips and nostrils.
  • Do not seal the application site with a bandaid or tape.
  • If you miss a dose, apply a dose before going to bed the next night that you missed the application. Do not apply two days in a row after that.
  • If you accidentally apply more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop applying the medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Strictly follow the dosage regimen as instructed by your doctor or pharmacist because severe redness, skin sore, ulcer or epidermal desquamation may occur in the application site or its surroundings.
  • In the process of healing, redness, skin sore, epidermal desquamation or swelling may occur in the application site or its surroundings. If these symptoms develop heavily, wash the medicine off with soap and water or warm water, then contact with your doctor or pharmacist promptly.
  • Flulike symptoms such as chilliness, fever or muscular pain may occur. If these symptoms develop, contact with your doctor or pharmacist promptly.
  • The skin may become discolored or depigmented after using the medicine, and never return in some cases.
  • If the application site is exposed to sunlight, photosensitivity reaction (rash, blister, excessive sunburn, pigmentation or itch) may occur. Wash off the medicine left on your fingers or accidentally attached to the areas other than the treatment site with soap and water or warm water after applying the medicine.
  • The medicine may cause an increased sensitivity to sun tanning. Avoid exposing the treatment sites to sunlight during the treatment including during interruption and follow-up.
  • If you got sun tanning, do not use the medicine until inflammation associated by sun tanning disappears.
  • See your doctor after the termination of the treatment. Actinic keratosis may progress to recurrence or intradermal invasive spinocellular carcinoma.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include erythema, scab, edema, desquamation/dryness, erosion/ulcer, wetting/effusion, itch and eczema on the application site. 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.
  • severe ulcer, skin sore, redness, swelling or epidermal desquamation on the application site [skin disorders including serious ulcer, erosion, erythema, edema, epidermal desquamation]
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 children. Store below 25 degrees Celsius and away from direct sunlight and moisture. Avoid freezing.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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