英文药名：YAZ TAB(Drospirenone/Ethinylestradiol Betadex) 中文药名：复方屈螺酮/乙炔雌二醇 Betadex片 生产厂家：拜耳药品 类别名称 口服促黄体激素促卵泡激素的混合物痛经疗法 商標名 YAZ 構造式 一般名 ドロスピレノン（Drospirenone）JAN 化学名 3-Oxo-6β,7β:15β,16β-dimethano-17α-pregn-4-ene-21,17-carbolactone 分子式 C24H30O3 分子量 366.49 性状 本品是一种白色粉末。 该产品乙腈或N，并且易溶于N-二甲基甲，略溶于甲醇，乙醇（99.5），以微溶到几乎不溶于水。 構造式 一般名 エチニルエストラジオール　ベータデクス（Ethinylestradiol Betadex）JAN 化学名 19-Nor-17α-pregna-1,3,5（10）-triene-20-yne-3,17-diol―di-β-cyclodextrin 分子式 C20H24O2・2C42H70O35 分子量 2,566.37 性状 本品是一种白色粉末。 此产品是在水中微溶。 本产品是吸湿。 成份组成 制剂组成的膜包衣片的两片28淡红色片剂（24片）和白色片剂（4片）。 成份含量 淡红色膜包衣片剂：本品为复方制剂，每片含炔雌醇0.020mg含有作为屈螺酮为3mg和炔雌醇Betadekusu 药效药理 排卵抑制作用和本剂子宫内膜生长的抑制作用，通过抑制这样的前列腺素的过度产生抑制子宫收缩运动，并且被认为是减轻痛经等症状的痛苦。 适应证 痛经 剂量和给药方法 根据订单1天（从淡红色药片起）规定的1片，每天一定时间的连续口服28天。 在28天给药和一个或多个周期，而不论是否继续或出血两端分别施用的片剂在29日的第二天期间，下同重复。 包装规格： 錠剤 PTP包装　28錠×3，28錠×6，28錠×30 生产厂家：拜耳药品日本公司 YAZ tablets（Drospirenone, ethinylestradiol betadex） Brand name : YAZ 　Active ingredient: Drospirenone, ethinylestradiol betadex 　Dosage form: light red (diameter 6 mm, thickness 2.90 mm), white tablets (diameter 6 mm, thickness 2.85 mm) 　Print on wrapping: (Face) ヤーズ配合錠,YAZ,Bayer Shcering Pharma (Back) ヤーズ配合錠,Bayer Effects of this medicine This medicine reduces pain at menses by inhibition of follicular growth and ovulation. It is usually used for dysmenorrhea. Before using this medicine, be sure to tell your doctor and pharmacist •If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. 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 nephropathy or acute renal failure. •If you are 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 28 days. This 28-day period is regarded as one cycle. From Day 29, irrespective of termination or continuation of bleeding, you may start taking this medicine 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 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 days before at the time when you remember, and you will also take one tablet 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/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.). You may also receive cytological examination of 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 medicine, If bleeding continues for a long 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 possibility of pregnancy. •Stop taking this medicine when you suspect you have become pregnant. •St. John's wort reduces the action of this medicine and increased possibility of pregnancy 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, atypical uterine bleeding, genital bleeding, menses painful, and lower abdominal pain. If any of them occurs, check with your doctor/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, sudden shortness of breath, and pain in chest or head [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. http://www.info.pmda.go.jp/go/pack/2482011F1020_1_10/ Bayer Yakuhin, Ltd.Internal Published: 9/2010 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.