英文药名: LIPIDIL(Fenofibrate Tablets) 中文药名: 非诺贝特片 生产厂家: 科研制药 リピディル錠53.3mg／リピディル錠80mg 类别名称 高脂血症剂 商標名 LIPIDIL TABLETS 一般名 フェノフィブラート Fenofibrate［JAN］ 化学名 Isopropyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropionate 分子式 C20H21ClO4 化学構造式 分子量 360.83 融　点 80～83℃ 性　状 白是一种浅黄色结晶性粉末。 乙腈，丙酮，溶于乙酸乙酯或二乙醚，乙醇（95），以容易地微溶到微溶于己烷，和几乎不溶于水。 操作注意事项 1.因为它可以被改变至淡黄色的光，使后开口被存储在黑暗中。 2.开封后应存放，避免受潮。 适应证 适用于除高脂蛋白血症Ⅰ型和纯合子家族性高胆固醇血症外的各种高脂蛋白血症的治疗。最适用于治疗高三酰甘油血症及以TG增高为主的混合型高脂血症。 禁忌证 严重肝肾功能不全者、孕妇、对本品过敏者禁用。 注意事项 长期服用者应定期进行肝肾功能检查，若有明显异常，应及时减量或停药。 不良反应 服药后偶有口干、食欲减退、大便次数增多、湿疹、失眠、乏力和性欲减退，停药后可消失。个别病例可见一过性转氨酶及尿毒氮或肌酐升高，一般停药后通迅速回到正常。 用法用量 成人一日口服106.6mg-160mg（餐后）。另外，它要取决于患者的年龄，症状服用。剂量超过每天不超过160mg 包装规格： 片：53.3mg： 100片（10片×10） 500片（10片×50 瓶） 700片（14片×50） 片：80毫克 100片（10片×10） 500片（10片×50 瓶） 700片（14片×50） 1000片（10片×100） 生产商：科研制药 LIPIDIL TABLETS(Fenofibrate) Brand name : LIPIDIL TABLETS 53.3mg 　Active ingredient: Fenofibrate 　Dosage form: white to faintly yellowish white tablet, diameter: 7.5 mm, thickness: 3.4 mm, weight: approx. 173 mg 　Print on wrapping: (face) リピディル錠53.3mg, AK120, 53.3mg (back) LIPIDIL TABLETS 53.3mg, リピディル, 53.3mg, 高脂血症治療剤 --------------------------------------- Brand name : LIPIDIL TABLETS 80mg 　Active ingredient: Fenofibrate 　Dosage form: white to faintly yellowish white tablet, diameter: 8.5 mm, thickness: 4.0 mm, weight: approx. 259 mg 　Print on wrapping: (face) リピディル錠80mg, AK130, 80mg (back) LIPIDIL TABLETS 80mg, リピディル, 80mg, 高脂血症治療剤 --------------------------------------- Effects of this medicine This medicine activates PPARα, nuclear receptors, to regulate expression of proteins, and comprehensively improves lipid metabolism. It consequently lowers cholesterol and triglyceride (neutral fat) in the blood and increases HDL cholesterol. It is usually used in the treatment of hyperlipidemia (including familial hyperlipidemia). 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: hepatic disorder, renal dysfunction or gallbladder disease. •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, for adults, take 106.6 to 160 mg of the active ingredient at a time, once daily, after meal. The dosage may be adjusted according to the age or symptoms, however, the daily dose won't be exceeded 160 mg. This preparation contains 80 mg of the active ingredient in a tablet. Strictly follow the instructions. •In particular, you should strictly follow the instructions by your doctor if you are an elderly patient. •If you miss a dose, take a dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time. •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 •Possible adverse reactions to this medicine The most commonly reported adverse reactions include gastric discomfort, nausea, rash, itch, hives, erythema multiforme, loss of hair, photosensitivity, cholelithiasis and cholecystitis (upper abdominal pain, fever). 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. •muscle pain, muscle weakness, brown urine  [rhabdomyolysis] •general malaise, loss of appetite, yellowing in skin and white of eyes  [hepatic disorder] •severe upper abdominal pain or lumbar back pain, nausea, fever  [pancreatitis] 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. ASKA Pharmaceutical Co.,LtdInternal Published: 12/2011 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. http://www.info.pmda.go.jp/go/pack/2183006F3023_1_06/