Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 01

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 01/2016
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:Triquilar Tablets 21
Active ingredient:Levonorgestrel
Ethinylestradiol
Dosage form:reddish brown tablet, white tablet and pale yellowish brown tablet
(diameter: 5.7 mm, thickness: 3.6 mm)
Print on wrapping:(face) Triquilar, トリキュラー錠 21
(back) トリキュラー錠 21, 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 before adolescence.
・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 21 days at the appointed order with a medicine cessation
period of 7 days. 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.
・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, 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.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nausea, breast engorgement, headahce, vomiting, lower
abdominal pain, rash, hives, atypical genital bleeding (minor bleeding midway through the menstrual period) and
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breast pain. 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/edema, shortness of breath, chest pain, headache, sudden difficulty seeing [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
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For further information, talk to your doctor or pharmacist.
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