くすりのしおり

Internal
Revised: 2/2014

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 :
Lunabell Combination Tablet LD
 Active ingredient:
Noretisterone
Ethinylestradiol
 Dosage form:
white tablet, diameter 6.5 mm, thickness 2.2 mm
 Print on wrapping:
(Face)LUNABELL LD (Back) ルナベル配合錠LD,NPC31

Effects of this medicine

This medicine reduces pain at menses by inhibition of follicle growth and ovulation.
It is usually used for dysmenorrhea associated with endometriosis. You cannot use this medicine for contraception or birth control.

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 breast cancer, endometrial cancer and/or cancer of the uterine cervix, and suspicion of these malignancies; undiagnosed abnormal genital bleeding; thrombophlebitis, pulmonary embolism, cerebrovascular accident, and/or coronary artery disease, or histories of these conditions; smoking habit; migraine; heart valve disease; diabetes; thrombotic predisposition (including family members); antiphospholipid antibody syndrome; within 4 weeks before surgery; within 2 weeks after surgery; within 4 weeks after delivery; 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.
    If you are growing in stature.
  • 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, take one tablet a day at a fixed time for 21 days. Do not take this medicine for subsequent 7 days (medicine-free period). This 28-day period is regarded as one cycle. From Day 29, irrespective of termination or continuation of bleeding, start taking this medicine from a new sheet of tablets and follow the same procedure as in the first cycle. Strictly follow the instructions.
  • If you are a new user of this medicine, you will start taking this medicine between Day 1 and Day 5 of the menstrual cycle.
  • When you remember you missed taking one tablet on the day before, you should immediately take that one tablet, and you will also take one tablet for the day at your regular time. This means that you will take two tablets on that day. When you remember you missed taking two or more tablets, you should take one tablet for the days before at the time when you remember, and you will also take one tablet at your regular time. You will 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 side effects, e.g., 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 14 cigarettes/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 long periods of time, visit your doctor every 6 months for interview and checkup (e.g., blood pressure measurement, laboratory tests, breast and abdominal examinations). You should also receive cytological examination of the uterine cervix. For breast cancer, check your breasts by yourself.
  • Consult your doctor when your period is late. When your period is absent for two consecutive cycles, you may be pregnant. Visit your doctor promptly for examination.
  • You may experience genital bleeding while taking this medicine. This is called atypical genital bleeding. Usually, this symptom disappears while you are taking this drug, If bleeding continues for long periods of time or is severe, consult your doctor.
  • Be careful 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.
  • Stop taking this medicine when you suspect you have become pregnant.
  • St. John's wort reduces the action of this medicine and increases the possibility of atypical genital bleeding. Do not eat any food product containing St. John's wort.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, nausea, upper abdominal pain, atypical genital bleeding, infrequent menstruation (menstrual cycle longer than 38 days), hypermenorrhea, lower abdominal pain, hypomenorrhea (bleeding volume of menses is extremely low), polymenorrhea (menstrual period shorter than 25 days), breast pain, breast discomfort, rash, drug rush and facial swelling. 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.
  • leg pain and edema, losing strength and paralysis of limbs, sudden shortness of breath, chest pain, headache, anarthria, acute vision disturbance [thrombosis]
  • respiratory distress, hives and itching, angioedema (swelling around the eyes and mouth) [anaphylaxis]
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 light, 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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