くすりのしおり

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Revised: 10/2019

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 :
DIVIGEL1mg
 Active ingredient:
Estradiol
 Dosage form:
milky white clear gel
 Print on wrapping:
ディビゲル1 mg

Effects of this medicine

This medicine relieves symptoms due to decreased estrogen by maintaining the blood level of the medicine through transdermal absorption of natural female hormone.
It is usually used to treat hot flush (hot flash) and sweating, which are vasomotor symptoms associated with climacteric disorder or ovarian deficiency symptoms due to ovarian resection.

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 or are suspected of having breast cancer/endometrium cancer.
    If you have a history of breast cancer or acute attacks of porphyria.
    If you have or have a history of thrombophlebitis/pulmonary embolism/coronary heart disease/stroke.
    If you have endometrial hyperplasia (under treatment or treatment unfinished), liver disorder, or undiagnosed abnormal genital bleeding.
  • If you are pregnant, possibly 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 1 packet (1.0 g [1 mg of the active ingredient]) once a day. Apply this medicine to your right or left thigh or lower abdomen with your hands over an area of approximately 400 cm2. Strictly follow the instructions.
  • Use this medicine immediately after opening the packet. Let dry for a few minutes after applying. Do not wash the application site for at least one hour.
  • Change the application site every day as much as possible. Wash your hands after applying this medicine. Do not let anyone touch the application site immediately after applying this medicine.
  • Pay attention so that this medicine does not get in your eyes. Do not take this medicine orally.
  • Do not apply this medicine to the chest, face, vulva or mucosa. Avoid applying to areas with wound, eczema/dermatitis, etc.
  • If you miss a dose, apply the missed dose immediately if less than half a day has passed. If half a day has passed, skip the missed dose and follow your regular dosing schedule from the next day. You should never apply two doses at one time.
  • If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop using this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • This medicine contains alcohol. Ventilate your room adequately after applying this medicine, and avoid using fire and smoking until the gel dries.
  • Avoid using moisturizing creams, sunscreen creams, etc. and this medicine at the same time as much as possible.
  • Pay attention to the way this medicine is stored and disposed of so that children will not touch it (apply it or put it in their mouths) by mistake.
  • Pay attention that any food containing St. John's wort (a kind of herb) may promote drug metabolism and diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include uterine bleeding, breast tension, erythema/itch on application site and vaginal discharge. 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.
  • respiratory distress, hives, general malaise [anaphylaxis]
  • leg pain/edema, chest pain, shortness of breath [venous thromboembolism, thrombophlebitis]
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 away from direct sunlight, heat, moisture and fire.
  • 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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