部份中文西比灵处方资料（仅供参考）
药品名称：盐酸氟桂利嗪胶囊
商品名称：西比灵
英文药名：sibelium(Flunarizine Hydrochloride)
适应证
(1)脑血供不足，椎动脉缺血，脑血栓形成后等。
(2)耳鸣，脑晕。
(3)偏头痛预防。
(4)癫痫辅助治疗。
用法用量
(1)包括椎基地底动脉供血不全在内的中枢性眩晕及外周性眩晕，选用氟桂利嗪每日10～20mg，2～8周为1疗程。
(2)特发性耳鸣者，氟桂利嗪10mg，每晚1次，10天为一个疗程。
(3)间歇性跛行，氟桂利嗪每日10～20mg。
(4)偏头痛预防，氟桂利嗪5～10mg，每日两次。
(5)脑动脉硬化，脑梗塞恢复期;氟桂利嗪每日5～10mg。
作用
1) 本品是一种钙通道阻断剂。能防止因缺血等原因导致的细胞内病理性钙超载而造成的细胞损害。
本品具有：
(1)缓解血管痉挛，对血管收缩物质引起的持续性血管痉挛有持久的抑制作用，尤其对基底动脉和颈内动脉明显，其作用比脑益嗪强15倍;
(2)前庭抑制作用，能增加耳蜗小动脉血流量，改善前庭器官循环;
(3)抗癫痫作用，本品可阻断神经细胞的病理性钙超载而防止阵发性去极化，细胞放电，从而避免癫痫发作;
(4)保护心肌，明显减轻缺血性心肌损害;⑸氟桂利嗪尚有改善肾功能之作用，可用于慢性肾功能衰竭;另外本品还有抗组织胺作用。
药代动力学
本品口服2～4小时达血浆峰值，T1/2为2.4～5.5小时,体内主要分布于肝、肺、胰、并在骨髓、脂肪中积蓄。连服5～6周达稳态血浓度，90%与血浆蛋白结合，可通过血脑屏障，并可随乳汁分泌。绝大部分经肝脏代谢，并由消化道排泄。经胆汁进入肠道，经大便排泄。
药物相互作用
(1)与酒精、催眠药或镇静药合用时， 加重镇静作用。
(2)与苯妥英钠，卡马西平联合应用时， 可以降低氟桂利嗪的血药浓度。(3)放射治疗病人合用桂利嗪，可提高对肿瘤细胞的杀伤力。
(4)在应用抗癫痫药物治疗的基础上加用氟桂利嗪可以提高抗癫痫效果。
不良反应
(1)中枢神经系统的不良反应有：
①嗜睡和疲惫感为最常见。
②长期服用者可以出现抑郁症，以女性病人较常见。
③椎体外系症状，表现为不自主运动、下颔运动障碍、强直等。多数用药3周后出现，停药后消失。老年人中容易发生。
④少数病人可出现失眠，焦虑等症状。
(2)消化道症状表现为：胃部烧灼感，胃纳亢进，进食量增加，体重增加。(3)其他：少数病人可出现皮疹，口干，溢乳，肌肉酸痛等症状。但多为短暂性，停药可以缓解。
禁忌症
有本药物过敏史，或有抑郁症病史时，禁用此药，急性脑出血性疾病忌用。
注意事项
(1)用药后疲惫症状逐步加重者应当减量或停药。
(2)严格控制药物应用剂量，当应用维持剂量达不到治疗效果或长期应用出现锥体外系症状时，应当减量或停服药。
(3)患有帕金森病等锥体外系疾病时，应当慎用本制剂。
(4)由于本制剂可随乳汁分泌，虽然尚无致畸和对胚胎发育有影响的研究报告。但原则上孕妇和哺乳期妇女不用此药。
(5)驾驶员和机械操作者慎用，以免发生意外。
孕妇及哺乳期妇女用药
由于本药能透过胎盘屏障，且可随乳汁分泌，虽尚无致畸和对胚胎发育影响的报告，但原则上孕妇和哺乳妇女不用此药。
儿童用药
由于本药能透过血脑屏障，有明确的中枢神经系统不良反应且儿童中枢神经系统对药物的反应敏感;代谢机能相对较弱，目前虽无详细的儿童用药研究资料，原则上儿童慎用或忌用此药。
老年患者用药
由于老年患者神经系统较敏感，代谢能力较弱，在给药剂量上应酌情减少。
贮藏方法
遮光，密封保存
生产企业
杨森制药有限公司
SIBELIUM® 5 mg capsules
SCHEDULING STATUS
Schedule 2.
PROPRIETARY NAME
(and dosage form)
SIBELIUM® 5 mg capsules
COMPOSITION
Each capsule contains 5,9 mg flunarizine hydrochloride equivalent to 5 mg flunarizine base.
PHARMACOLOGICAL CLASSIFICATION
A 5.7.1 Drugs Affecting Autonomic Functions. Antihistamines.
PHARMACOLOGICAL ACTION
SIBELIUM is a selective calcium antagonist. It prevents cellular calcium overload by reducing excessive transmembrane calcium influxes. Flunarizine is well absorbed from the gut, reaching peak plasma levels within 2 - 4 hours and reaching steady state at 5 - 6 weeks. After extensive hepatic metabolism, flunarizine and its metabolites are excreted through the faeces via the bile. The mean terminal elimination half-life is about 18 days. Plasma protein binding is 99%.
INDICATIONS
SIBELIUM is indicated in:
– Prophylaxis of classic (with aura) or common (without aura) migraine.
– Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
CONTRA-INDICATIONS
Hypersensitivity to flunarizine. SIBELIUM is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
Pregnancy
Safety in pregnancy and lactation has not been established.
WARNINGS
SIBELIUM may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants.
Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents.
SIBELIUM is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of SIBELIUM.
This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. SIBELIUM should therefore be used with caution in such patients.
DOSAGE AND DIRECTIONS FOR USE
Migraine Prophylaxis
Starting Dose:
Two 5 mg capsules (10 mg) SIBELIUM at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
Maintenance Treatment:
If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week.
Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo
The same dosage should be used as for migraine, but the starting treatment should not be given longer than needed for symptom control, which generally takes less than two months.
After one month of treatment for chronic vertigo or after two months treatment for paroxysmal vertigo, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-Effects
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur.
The following adverse experiences have been reported during chronic treatment with SIBELIUM: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk.
Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
Special Precautions
SIBELIUM should be used with care in patients with depression or those being prescribed other agents, such as phenothiazines, concurrently, which may cause extrapyramidal side-effects.
Fatigue may increase progressively during SIBELIUM therapy; in this event therapy should be discontinued.
The recommended dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment, so that extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued. If during maintenance treatment the therapeutic effects subside, treatment should also be discontinued (for duration of treatment see "Dosage and Directions for Use").
Interactions
Galactorrhoea has been reported in few woman on oral contraceptives within the first two months of SIBELIUM treatment.
Hepatic enzyme inducers such as carbamazepine and phenytoin may interact with flunarizine by increasing its metabolism. An increase in dosage of flunarizine may be required.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Acute overdosage has been reported and the observed symptoms were sedation, agitation and tachycardia.
Treatment of acute overdosage consists of charcoal administration, induction of emesis or gastric lavage, and supportive measures. No specific antidote is known.
IDENTIFICATION
Capsule with red, opaque cap and dark grey, opaque body.
PRESENTATION
Carton containing one or more blister packs of 20 capsules each.
STORAGE INSTRUCTIONS
Store below 25°C. Protect from light and strore in a dry place.
Keep out of reach of children.
REGISTRATION NUMBER
M/5.7.1/529
NAME AND BUSINESS ADDRESS OF APPLICANT
JANSSEN -CILAG logo
Janssen Pharmaceutica (Pty) Ltd.
(Reg No. 1980/011122/07)
15th Road, Halfway House, 1685
www.janssencilag.co.za
DATE OF PUBLICATION OF THIS PACKAGE INSERT
18 March 1987.
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产地国家：意大利
原产地英文商品名:
SIBELIUM 5mg/Caps 20Caps/box 
原产地英文药品名:
Flunarizine Hydrochloride
中文参考商品译名:
西比灵胶囊 5毫克/胶囊 20胶囊/盒 
中文参考药品译名:
盐酸氟桂利嗪
生产厂家中文参考译名:
JANSSEN -CILAG
生产厂家英文名:
JANSSEN -CILAG
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产地国家：英国
原产地英文商品名:
SIBELIUM 5mg/Caps 20Caps/box 
原产地英文药品名:
Flunarizine Hydrochloride
中文参考商品译名:
西比灵胶囊 5毫克/胶囊 20胶囊/盒 
中文参考药品译名:
盐酸氟桂利嗪
生产厂家中文参考译名:
JANSSEN -CILAG
生产厂家英文名:
JANSSEN -CILAG