くすりのしおり

Internal
Revised: 6/2020

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 :
Triquilar Tablets 28
 Active ingredient:
Levonorgestrel
Ethinylestradiol
 Dosage form:
reddish brown tablet, white tablet and pale yellowish brown tablet diameter: 5.7 mm thickness: 3.6 mm placebo diameter: 6.8 mm placebo thickness: 3.7 mm
 Print on wrapping:
(face) Triquilar, トリキュラー錠28
(back) トリキュラー錠28, Bayer

Effects of this medicine

This medicine shows gestagenic and estrogenic actions. It mainly suppresses ovulation, inhibits implantation by changing in the endometrial membrane and inhibits sperm penetration by change in the cervical mucus, thereby preventing pregnancy.
It is usually 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 breast cancer, endometrial cancer, cervical cancer or are suspected of them.
    If you have undiagnosed genital bleeding, thrombophlebitis, pulmonary embolism, cerebrovascular disorder and coronary artery disease or have a history of them.
    If you have smoking habit of more than 15 cigarettes a day at the age of 35 or older, migraine, valvular heart disease, diabetic mellitus, thrombotic predisposition, antiphospholipid antibody syndrome, long-term bed rest, hepatic disorder, hepatic tumor, abnormal lipid metabolism, hypertension, otosclerosis, and histories of jaundice, persistent pruritus and/or gestational herpes during pregnancy.
    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 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 1 tablet a day at a fixed time every day for 28 days at the appointed order. The 28-day period is regarded as one cycle. After you finished the first cycle, regardless of whether menstruation occurs, start taking a tablet for the next cycle continuously from the 29th day of the first cycle. Repeat the same procedure and continue taking medicine. Strictly follow the instructions.
  • Take this medicine every day at the same time.
  • For the first prescription, start taking this medicine on the first day of your menstrual period. If you start this medicine on the second day of your menstrual period or later, use other birth control method for the first 7 days together with this medicine.
  • If you miss a dose (except for slightly larger white tablet), take the missed dose as soon as possible and continue your regular dosing schedule. However, if you missed 2 or more doses, 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 in this case, 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

  • This medicine does not protect you against HIV infections (AIDS) and other sexually transmitted infections (syphilis, genital herpes, gonorrhea, chlamydial infection, condyloma acuminatum, trichomoniasis vaginitis, type B hepatitis, etc.).
  • Stop smoking while taking this medicine since it may cause thrombosis (vessel clogging).
  • If you experience continuing severe diarrhea or vomiting, these symptoms may weaken the medicinal effects. The potential of pregnancy is increased in this case, so use other birth control method during that cycle.
  • 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.
  • 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, consult with your doctor.
  • If bleeding during medicine free period fails to occur for 2 consecutive cycles, consult with your doctor.
  • Stop taking this medicine when you suspect you have become pregnant.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include lower abdominal pain, breast engorgement, nausea, vomiting 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.