盐酸曲美他嗪片说明书 中英文对照说明书

盐酸曲美他嗪片说明书
请仔细阅读说明书并在医师指导下使用。

[药品名称]
通用名称：盐酸曲美他嗪片
商品名称：万爽力®
英文名称：Trimetazidine Dihydrochloride Tablets (V ASOREL®）
汉语拼音：Yansuan Qumeitaqin Pian
[成份]
化学名称：盐酸曲美他嗪，1-(2,3,4-三甲氧基苯甲基)哌嗪二盐酸盐
分子式：C14H22N2O3 · 2HCl
分子量：339.3
[性状]
本品为薄膜衣片，除去薄膜衣后呈白色。

[适应症]
心绞痛发作的预防性治疗。

眩晕和耳鸣的辅助性对症治疗。

[规格]
20mg
[用法用量]
每24小时60mg：每日3次，每次1片，三餐时服用。

[不良反应]
罕见胃肠道不适（恶心，呕吐）。

由于辅料中有日落黄FCF S（E110）及胭脂红A（E124）成份，可能会发生过敏反应。

[禁忌]
对药品任一组份过敏者禁用。

哺乳期通常不推荐使用（参见［孕妇及哺乳期妇女用药］）。

[注意事项]
此药不作为心绞痛发作时的对症治疗用药，也不适用于对不稳定心绞痛或心肌梗死的初始治疗。

此药不应用于入院前或入院后最初几天的治疗。

心绞痛发作时，对冠状动脉病况应重新评估，并考虑治疗的调整（药物治疗和可能的血运重建）。

[孕妇及哺乳期妇女用药]
妊娠
动物实验没有提示致畸作用；但是由于缺乏临床资料，致畸的危险不能排除。

因此，从安全的角度考虑，最好避免在妊娠期间服用该药物。

哺乳
由于缺乏通过乳汁分泌的资料，建议治疗期间不要哺乳。

[儿童用药]
儿童用药的安全性和有效性尚未确定。

[老年用药]
参见其他项下内容或遵医嘱。

核准日期：2006-12-26236300002
[贮藏]
30℃以下贮藏
[包装]
铝铝泡罩包装，15片，30片，60片/盒
[有效期]
36个月
[执行标准]
YBHI13562005
[批准文号]
国药准字H20055465
[生产企业]
Insert of Trimetazidine Dihydrochloride Tablets Carefully read insert and conform to the physician’s prescription.
[Drug names]
Generic name: Trimetazidine dihydrochloride tablets
Trade name: V ASOREL®
English name: Trimetazidine Dihydrochloride Tablets (V ASOREL®)
Chinese Pinyin: Yansuan Qumeitaqin Pian
[Ingredients]
Chemical name: Trimetazidine dihydrochloride, 1-(2,3,4-trimethoxybenz yl) piperazine dihydrochloride
Molecular formula: C14H22N2O3·2HCl
Molecular weight: 339.3
[Description]
Film-coated tablet with white core
[Indications]
Prophylactic treatment of episodes of angina pectoris.
Adjuvant symptomatic treatment of vertigo and tinnitus.
[Strength] 20mg
[Dosage and administration]
60 mg per 24 hours: 1 tablet to be taken 3 times a day at meal times. [Adverse reactions]
Rare cases of gastrointestinal disorders (nausea and vomiting). Because of the presence of sunset yellow FCF S (E110) and cochineal red A (E124), risk of allergic reactions.
[Contraindications]
This drug should never be used in case of hypersensitivity to any one of t he product's constituents. This drug is generally not recommended during breastfeeding (Cf. Pregnancy and lactation).
[Precautions]
This drug is not a curative treatment for angina attacks, nor is it indicated as initial treatment for unstable angina, or myocardial infarction. It should not be used in the pre-hospital phase nor during the first days of hospitali zation; In the event of an angina attack, the coronaropathy should be reev aluated and an adaptation of the treatment considered (drug treatment and possibly revascularisation).
[Pregnancy and lactation]
Pregnancy
Studies in animals have not demonstrated a teratogenic effect however, i n the absence of clinical data, the risk of mal-formation cannot be exclude d. Therefore, for safety reasons, it is preferable to avoid prescription durin g pregnancy.
Breast feeding
In the absence of data on excretion in breast milk, breastfeeding is not rec ommended during treatment.
[Use in Children]
Safety and effectiveness in pediatric patients have not been established. [Use in Elderly]
See information in other items or follow physician’s instructions. [Storage] below 30°C
[Package] Alu-Alu blister; 15, 30, 60 tablets/box
[Shelf life] 36 months [Specification No.] YBH13562005 [Approval No.] 国药准字H20055465 [Manufacturer]。