くすりのしおり

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Published: 6/2015

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 :
LUTINUSR Vaginal Tablet 100mg
 Active ingredient:
Progesterone
 Dosage form:
white vaginal tablet, major axis: approx. 22 mm, minor axis: approx. 13 mm, thickness: approx. 5 mm
 Print on wrapping:
FPI 100

Effects of this medicine

This medicine, by replacing deficient corpus luteum hormone (progesterone), creates an environment in which a fertilized egg is implanted in endometrial membrane and maintains pregnancy after implantation.
It is usually used for corpus luteum hormone replacement therapy in assisted reproduction technology.

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 genital bleeding, liver dysfunction (effects of this medicine may be intensified), porphyria (a disease in which excessive porphyrin accumulates in the body due to enzymatic abnormality), heart or renal dysfunction, or diabetes mellitus.
    If you have a medical history of or have been suspected of having a breast or genital cancer.
    If you have or have a medical history of thromboembolism, thrombophlebitis, epilepsy, depression, migraine or asthma.
    If you have had missed abortion (a state in which the fetus dies and remains in the uterus) or have extra-uterine pregnancy.
    If you are a smoker 35 years old or over and in a situation where atherosclerotic disease may easily develop (if you have hypertension, hyperlipidemia or diabetes mellitus).
  • If you are 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, place 1 tablet (100 mg of the active ingredient) at a time, 2 or 3 times a day, in the vagina. Use this medicine for a maximum duration of medication of 10 weeks (or until the 12th week of pregnancy) from the date of ovum collection (or the time that the endometrium gets thick enough using estrogen in frozen embryo transfer under hormone replacement cycle). Strictly follow the instructions.
  • This applicator is used only to insert this medicine. Do not use for any other purpose.
  • Insert this medicine into the vagina using a dedicated applicator.
  • If pregnancy cannot be confirmed or continued, consult with your doctor.
  • You do not have to lie down immediately after use and rest. You may do housework or go to work. However, avoid heavy exercise such as tennis or physical labor.
  • Avoid taking a bath for at least about a few hours after use, and take a shower instead. (You may get hot water in the vagina, and the medicine may flow out.)
  • If you miss a dose, consult with your doctor or pharmacist. In general, for patients who use this medicine twice a day, use the missed dose as soon as you remember (however, skip the missed dose and follow your regular dosing schedule if there are less than 2 to 3 hours before the next dose). For patients who use this medicine 3 times a day, skip the missed dose and follow your regular dosing schedule. You should not use 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. Pay attention that you may experience anxiety or mood swing after you stop using this medicine.

Precautions while taking this medicine

  • This medicine may cause drowsiness or dizziness. Pay attention when operating dangerous machinery, such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, drowsiness and genital bleeding. 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.
  • paralysis or numbness of limbs, difficulty speaking, chest pain [thrombosis]
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 and moisture.
  • Remove tablets from the blister sheet just before use.
  • Discard the dedicated applicator after use.
  • 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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