くすりのしおり

Internal
Revised: 5/2016

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 :
Marvelon 28
 Active ingredient:
Desogestrel
Ethinylestradiol
 Dosage form:
white tablet, diameter 5.0 mm, thickness 2.9 mm; green tablet, diameter 5.0 mm, thickness 2.8 mm (placebo tablet)
 Print on wrapping:
Marvelon 28, マーベロン28

Effects of this medicine

This medicine is combined preparation of estrogen-like and progesterone-like substance. To prevent pregnancy, it suppresses ovulation, inhibits implantation by changing in the endometrial membrane and inhibits sperm penetration by change in the cervical mucus.
It is used to prevent pregnancy.

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 estrogen-dependent cancer (breast cancer, endometrial cancer, etc.), cervical cancer, atypical genital hemorrhage, thrombophlebitis, pulmonary embolism, cerebrovascular disorder, coronary artery disease and these anamnesis, smoking habit, migraine, valvular heart disease, diabetic mellitus, thrombotic predisposition (including family members), antiphospholipid antibody syndrome, long-term bed rest, liver disorder, liver tumor, abnormal lipid metabolism, hypertension, otosclerosis and histories of jaundice, persistent itching and/or gestational herpes during pregnancy. The woman whom bone growth may not have ended.
    If you are scheduled for surgery within the next 4 weeks, had surgery within 2 weeks and/or delivered within 4 weeks.
  • If you are pregnant, possible 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, start taking this medicine on Day 1 of the menstrual cycle. Take one white tablet a day at a fixed time for 21 days, and take one green tablet a day at a fixed time for subsequent 7 days, making 28 consecutive days of medication in total. After you have finished taking green tablets, start taking a white tablet continuously from the next day, regardless of whether menstruation occurs. Repeat the same procedure and continue taking this medicine during the period you need birth control. (Remove the white tablet in the top left corner of the sheet first, and then continue removing the tablets in the direction of the arrow.) 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. Strictly follow the instructions.
  • If you missed taking one white tablet, take that one tablet as soon as possible, and also take one tablet for the day at your regular time. If you missed taking two or more white tablets, you should stop taking this medicine and wait for the next menstruation to restart, and start with a new sheet of medicine. The potential of pregnancy is increased when you miss taking the medicine, so use other birth control method during that cycle.
  • 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

  • Stop smoking since it increase the risk of cardiovascular-related side effects.
  • You may experience atypical genital bleeding at the start of taking this medicine. Usually, this symptom disappears while you are taking this medicine. If bleeding continues for a long period, consult your doctor.
  • If you experience continuing severe diarrhea or vomiting, these symptoms make it difficult to absorb the active ingredients of this medicine, leading to increased potential of pregnancy. Use this medicine in combination with other birth control method, and consult with your doctor or pharmacist.
  • Stop taking this medicine when you suspect you have become pregnant. When your period is absent for two consecutive cycles, you may be pregnant. Visit your doctor promptly for examination.
  • Avoid taking hypericum perforatum (Saint John's wort)-contained food, since it may weaken the therapeutic effects of the medicine.
  • If you wish to become pregnant, consult with your doctor.
  • This medicine does not protect you against HIV infections (AIDS) and other sexually transmitted infections. Use a condom to protect against to these infections.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, breast pain, headache, menorrhagia, atypical genital bleeding, malaise, diarrhea, stomachache, rash, edema, jaundice and visual disturbance. 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.
  • acute pain/swelling in the legs, sudden shortness of breath, severe headache, a tangle of language, the rapid fall of eyesight [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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