くすりのしおり

Internal
Published: 5/2019

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 :
YazFlex Combination Tablets
 Active ingredient:
Drospirenone
Ethinylestradiol betadex
 Dosage form:
pale red tablet, diameter: 6 mm, thickness: 2.90 mm
 Print on wrapping:
(face) ヤーズフレックス配合錠
(back)

Effects of this medicine

This medicine reduces pain derived from menses and/or endometriosis by inhibition of ovulation and endometrial proliferation. It is usually used to improve pain due to endometriosis and to treat dysmenorrhea.

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 have a suspect of breast cancer, cancer of endometrium and/or cancer of uterine cervix.
    If you have undiagnosed abnormal genital bleeding.
    If you have or have a history of thrombophlebitis, pulmonary embolism, cerebrovascular accident and/or coronary artery disease.
    If you have smoking habit.
    If you have migraine, heart valve disease, diabetes mellitus, thrombotic predisposition or antiphospholipid antibody syndrome.
    If you are scheduled to undergo surgery within 4 weeks, have undergone surgery within 2 weeks, have delivered a baby within 4 weeks or are on long-term bed rest.
    If you have liver disorder, liver tumor, abnormal lipid metabolism, hypertension or otosclerosis.
    If you have a history of jaundice, persistent itching or gestational herpes during pregnancy.
    If you are growing in stature.
    If you have renal disorder or acute renal failure.
  • 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))
  • Improvement of pain associated with endometriosis: Take 1 tablet a day. Continue taking this medicine till Day 24 regardless of whether menstruation occurs. If you have bleeding (including petechial hemorrhage) on or after Day 25 for 3 consecutive days or have taken this medicine for 120 consecutive days, stop taking the medicine for 4 days. After the 4-days medicine free period, start continuous dosing irrespective of termination or continuation of bleeding. Repeat the continuous dosing and medicine free period in the same manner as above.
    Dysmenorrhea: Take this medicine in either of the following ways.
    [To take this medicine120-consecutive days with a medicine free period of 4 days] Take 1 tablet a day. Continue taking this medicine till Day 24 regardless of whether menstruation occurs. If you have bleeding (including petechial hemorrhage) on or after Day 25 for 3 consecutive days or have taken this medicine for 120 consecutive days, stop taking the medicine for 4 days. After the 4-days medicine free period, start continuous dosing irrespective of termination or continuation of bleeding. Repeat the continuous dosing and medicine free period in the same manner as above.
    [To take this medicine in 28-day cycle] Take 1 tablet a day for 24 consecutive days and then take medicine free period for 4 days. This 28-day period is regarded as 1 cycle. From Day 29, irrespective of termination or continuation of bleeding, start taking a tablet for the next cycle. Repeat the same procedure.
    Strictly follow the instructions in any case.
  • Take this medicine every day at the same time.
  • The medicine free period should not exceed 4 days.
  • If you are a new user of this medicine, you will start taking this medicine on Day 1 of the menstrual cycle. If you started taking this medicine after Day 1 of your menstrual cycle, use other birth control method for the first 7 days together with this medicine.
  • When you remember you missed taking one tablet on the day before, you may immediately take one tablet and also take one tablet for the day at your regular time. When you remember you missed taking tablets for more than two days, you should take one tablet for the day before at the time when you remember, and you will also take one tablet for the day at your regular time. You may then continue taking this medicine as in the original schedule.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Smoking has been reported to increase the risk of adverse reactions, such as venous thrombosis, pulmonary embolism, myocardial infarction, and stroke. This risk is reportedly increased with age (35 years or older) and with heavy smoking (more than 15 cigarettes a day). It is thus needed to stop smoking before taking this medicine if you are a smoker and 35 years or older.
  • When you take this medicine for a long time, visit your doctor every 6 months for interview and checkup (blood pressure measurement, laboratory tests, breast and abdominal examinations, etc.). Examination of pelvic organs such as the uterus and ovary are conducted at least once a year. You may receive a cytological examination of uterine cervix once a year. For breast cancer, check your breasts by yourself.
  • If you are precisely taking this medicine in 28-day cycle but bleeding during medicine free period fails to occur for 2 consecutive cycles, consult with your doctor.
  • You may experience genital bleeding while taking this medicine. This is called atypical genital bleeding. Usually, this symptom disappears while you continue taking this medicine. If bleeding continues for a long time or is severe, consult with your doctor.
  • Pay attention if continuous severe diarrhea or vomiting occurs. These symptoms may interfere the absorbance of the active ingredients of this medicine, leading to increased incidence of atypical genital bleeding and possibility of pregnancy.
  • Stop taking this medicine when you suspect you have become pregnant.
  • Do not take any food containing St. John's wort, since it may diminish medicinal effects and increase possibility of atypical genital bleeding.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include genital bleeding, nausea and headache. 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.
  • [Symptoms to seek emergency treatment] sudden pain/swelling of legs, muscle weakness/ paralysis of limbs, sudden shortness of breath and squeezing chest pain, severe headache, difficulty with speech (or slurred speech), sudden visual impairment (eg., poor vision or narrowed visual field) [thrombosis]
  • [Symptoms to consult your doctor] pain in the leg/ swelling/ numbness/ redness/ hot flushes, headache, vomiting/ nausea [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.
  • 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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