Product Name : FLUANXOL TAB 0.5MG

gistration No.: HK-19690

Certificate Holder: LUNDBECK EXPORT A/S

Certificate Holder Address：FLAT 4303 43/F CENTRAL PLAZA,
18 HARBOUR ROAD WAN CHAI,HK

Ingredients: FLUPENTHIXOL

 -------------------------------------------------------

部分中文处方资料（仅供参考）

 中文通用名称：癸酸氟哌噻吨
英文通用名称：Flupentixol Decanoate
中文其它名称：三氟噻吨癸酸酯, 癸氟哌噻吨, 氟哌噻吨癸酸酯, 癸酸顺三氟噻吨, 长效复康素, 氟哌噻吨，癸酸酯, 氟哌噻吨癸酸酯注射液, 孚岚素, 复康素
英文其它名称：Cis-Flupenthixol Decanoate, Lu5-110, Fluanxol Depot, Fluanxol(癸酸氟哌噻吨), Cis(Z)-Flupentixol Decanoate, Cis(Z)-Flupentixol Decanoate Injection, Fluanxol
产品所属分类：精神障碍用药\抗精神病药\硫杂蒽类

用于各种急、慢性精神分裂症。本药具有控制幻觉、妄想、思维和意志行为障碍等阳性症状的作用。对思维贫乏、情感淡漠、意向活动减退等阴性症状亦有较好的疗效。长期用药可维持疗效预防复发，并可进一步改善慢性病人的症状。
2.用于各种原因引起的抑郁或焦虑症状。
3.用于癫痫、老年性痴呆、精神发育迟滞以及酒精、药物依赖等伴发的精神症状。

成人
*常规剂量
*口服给药
1.精神病：初始剂量为一次5mg，一日1次，以后视情况可逐渐加量，必要时可增至一日40mg。维持剂量为一次5-20mg，一日1次。
2.抑郁性神经症：一次1mg，一日2次。一日极量为3mg。
*肌内注射
癸酸氟哌噻吨注射液：初始剂量为一次10mg，注射1次，1周后可酌情加量。治疗剂量为一次20-40mg，每2周1次。维持剂量为一次20mg，每2-4周注射1次。
[国外用法用量参考]
成人
*常规剂量
*口服给药
1.精神分裂症：急性精神分裂症用量为一日16-224mg，慢性精神分裂症应选用中等剂量。
2.抑郁症：一次0.5-2mg。
*肌内注射
1.精神分裂症：慢性精神分裂症的维持治疗可使用长效癸酸氟哌噻吨针剂，常用量为一次20-40mg，每2-4周1次。有效剂量的范围为每月10mg至每周100mg。
2.抑郁症：长效癸酸氟哌噻吨注射液，一次5-10mg，每2周1次。
3.可卡因脱瘾：先肌内注射苯扎托品4mg，再给予长效癸酸氟哌噻吨注射液，一次10-20mg，每2-4周1次。
*老年人剂量
老年人对本药的不良反应更加敏感，可能需要调整用量。
儿童
*常规剂量
8口服给药
行为障碍：有报道，一日0.4-2mg，治疗6个月至2年，可改善睡眠、减轻攻击性。
任何疑问，请遵医嘱！

1.合用抗胆碱能药物(如盐酸苯海索等)可减轻锥体外系症状。长期使用本药应注意迟发性运动障碍的发生。
2.用药时应按照剂量个体化的原则，从小剂量开始，根据疗效及不良反应调整剂量至适宜用量。
3.用药过量的表现：可见不同程度的意识障碍直至昏迷、瞳孔缩小、锥体外系症状、血压下降、心动过速、休克、体温下降等。
4.用药过量的处理：同一般药物中毒的处理。
(1)洗胃、催吐。
(2)支持治疗，如给予保温、吸氧、预防感染、抗惊厥等措施，并注意维持水、电解质和酸碱平衡。
(3)对症治疗，如抗休克、纠正心律失常。使用中枢兴奋剂应慎重，必要时可将贝美格50-150mg溶于100-200ml葡萄糖注射液中静脉滴注，或哌甲酯30-50mg肌内注射(或静脉注射)。

1.常见的不良反应为锥体外系反应，表现为肌张力增高、震颤、静坐不能等，多在治疗初期出现。
2.偶见失眠、头晕、口干、便秘等。
3.很少引发接触性皮炎、光敏感度增加、皮肤和眼球色素沉着以及粒细胞减少的不良反应。
4.对心、肝、肾和造血系统未见明显的毒性反应报道。
[国外不良反应参考]
1.血液系统
可见白细胞增多。
2.心血管系统
有出现心脏停搏的个案报道。
3.精神神经系统
可见锥体外系反应，长期用药可导致迟发性运动障碍。还有引起躁狂的个案报道。
4.代谢/内分泌系统
可见神经阻滞剂恶性综合征(NMS)和体重增加。
5.泌尿生殖系统
有引起阴茎异常勃起的个案报道。

1.禁忌症
(1)对本药过敏者。
(2)有严重心、肝、肾等器官或系统疾患者。
(3)急性中毒、昏迷、谵妄者。
(4)妊娠早期。
(5)兴奋、躁动者不宜使用。
2.慎用
易出现运动功能失调的患者(国外资料)。
3.药物对妊娠的影响
国内资料中建议妊娠早期禁用本药；美国药品和食品管理局(FDA)对本药妊娠安全性分级为C级。
4.药物对哺乳的影响
有报道，本药可分泌入乳汁。
5.用药前后及用药时应当检查或监测
(1)定期做眼科检查。
(2)用药期间应每6个月检查一次全血细胞计数及肝功能。

----------------------------------------------------------------------

How does it work?

Fluanxol tablets contain the active ingredient flupentixol (previously spelt flupenthixol in the ), which is a type of medicine called an antipsychotic.

In high doses, flupentixol is used to treat schizophrenia and other psychotic illnesses (see the Depixol factsheets linked at the end of this page for more information about this use of flupentixol). Fluanxol tablets contain a lower dose of flupentixol and are used to treat depression.

It is not fully understood how low doses of flupentixol work in treating depression, but its mechanism of action is not the same as that of other antidepressants.

Flupentixol is thought to work by affecting the activity of a natural compound called dopamine in the brain. Dopamine is known as a neurotransmitter, and is involved in transmitting messages between brain cells. It is known to be involved in regulating mood and behaviour, amongst other things.

Unlike other antidepressants, flupentixol usually starts to produce an antidepressant effect within two to three days. However, it may not make you feel fully better for at least few weeks.

It is recommended that you avoid drinking alcohol while taking this medicine because it may make any drowsiness worse.

Although it can cause drowsiness, this medicine can also have an alerting effect, so you should avoid taking it in the evening because it may cause you problems sleeping.

Depression and other psychiatric illnesses are associated with an increased risk of suicide, self-harm, and thoughts about harming or killing yourself. You should be aware that although this medicine may start to work in two to three days, it may not make you feel fully better for at least few weeks. However, it is important that you keep taking it in order for it to work properly and for you to feel better. If you feel your depression or anxiety has got worse, or if you have any distressing thoughts, or feelings about suicide or harming yourself in the first few weeks of treatment, or indeed at any point during treatment or after stopping treatment, then it is very important to talk to your doctor.

You should not suddenly stop taking this medicine unless your doctor tells you otherwise, as this may cause withdrawal symptoms such as nausea, vomiting, diarrhoea, sweating, pins and needles sensations, difficulty sleeping, restlessness, anxiety or tremor. Withdrawal symptoms are temporary and are not due to addiction or dependence on the medicine. They can usually be avoided by stopping the medicine gradually. Follow the instructions given by your doctor when it is time to stop treatment with this medicine.

If you experience any abnormal movements of your hands, legs, face, neck or tongue while taking this medicine, for example tremor, twitching or rigidity, you should let your doctor know as your treatment may need to be stopped.

Consult your doctor immediately if you experience the following symptoms while taking this medicine: high fever, sweating, muscle stiffness, faster breathing and drowsiness or sleepiness. These symptoms may be due to a rare side effect known as the neuroleptic malignant syndrome, and if so your treatment should be stopped.

---------------------------------------------------------

Use with caution in

History of suicidal behaviour or thoughts.

Liver disease.

Kidney failure.

Severe disease affecting the lungs or airways.

Disease involving the heart and blood vessels (cardiovascular disease).

People who have recently had a heart attack.

Heart failure.

Irregular heart beats (arrhythmias).

Personal or family history of a type of abnormal heart rhythm, seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.

Very slow heart rate (bradycardia).

People with disturbances in the normal levels of salts (electrolytes) in their blood, for example low magnesium or potassium levels.

Elderly people with dementia (antipsychotic medicines have been shown to increase the risk of stroke and death in this group of patients). People with risk factors for having a stroke, for example a history of stroke or mini-stroke (TIA), smoking, diabetes, high blood pressure, or a type of irregular heartbeat called atrial fibrillation.

Epilepsy.

People with conditions that increase the risk of convulsions, eg brain damage or withdrawal from alcohol.

arkinson's disease.

Abnormal muscle weakness (myasthenia gravis).

Closed angle glaucoma.

Enlarged prostate gland (prostatic hypertrophy).

Tumour of the adrenal gland (phaeochromocytoma).

Underactive or overactive thyroid gland.

Diabetes.

Hereditary blood disorders called porphyrias.

Allergy to other similar antipsychotic medicines, eg zuclopenthixol.

This medicine is not recommended for excitable or agitated people.

People with a decreased level of consciousness due to any cause (eg, intoxication with alcohol, barbiturates or opiates).

Unresponsive unconscious states (comatose states).

Failure of the blood circulatory system (circulatory collapse).

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Fluanxol tablets contain lactose).

Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (Fluanxol tablets contain sucrose).

This medicine is not recommended for use in children and adolescents under 18 years of age.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

-------------------------------------------------------------------Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. It should be avoided during pregnancy, particularly in the first and third trimesters, unless the expected benefit to the mother outweighs any possible risks to the developing baby. Seek medical advice from your doctor. If you do get pregnant while taking this medicine it is important to consult your doctor straight away for advice. You should not suddenly stop taking this medicine unless your doctor tells you to, as this could cause withdrawal symptoms (see warning above).

This medicine passes into breast milk and could have harmful effects on a nursing infant. The manufacturer recommends that mothers who need to take this medicine should not breastfeed and bottlefeed instead. Seek further medical advice from your doctor.

----------------------------------------------------

Label warnings

This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic dMedicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).

Anxiety, restlessness and agitation (akathisia).

Increased salivation or dry mouth.

Sleepiness.

Rhythmical involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia - see warning section above). Increased heart rate (tachycardia).

Irregular heart beats (arrhythmias).

A drop in blood pressure (hypotension) that may cause dizziness.

Interference with the body's temperature regulation (this is more common in elderly people and may cause heat stroke in very hot weather or hypothermia in very cold weather).

Headache.

Changes in appetite and weight.

Problems with attention or speech.

Feelings of being mentally dulled or slowed down.

Difficulty sleeping (insomnia).

Visual disturbances.

Disturbances of the gut such as constipation, indigestion, nausea and vomiting.

Difficulty passing urine, increased need to pass urine, or urinary incontinence.

Excessive sweating.

Skin reactions such as rashes, itching, increased sensitivity to sunlight.

Sexual problems, such as erectile dysfunction.

Seizures (convulsions).

High blood prolactin (milk producing hormone) level (hyperprolactinaemia). Sometimes this can lead to symptoms such as breast enlargement, production of milk and stopping of menstrual periods.

High temperature combined with falling levels of consciousness, paleness, sweating and a fast heart beat (neuroleptic malignant syndrome). Requires stopping the medicine and immediate medical treatment - see warning section above.

Uncontrolled rolling of the eyes and neck (oculogyric crisis). Requires immediate treatment.

Disturbances in the normal numbers of blood cells in the blood. Tell your doctor if you get a fever, sore throat, mouth ulcers or other signs of infections while taking this medicine, as these symptoms could suggest a problem with your white blood cells. Your doctor may want you to have a blood test to check the numbers of blood cells in your blood.

Liver problems.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

----------------------------------------------------------------------

 于2011-03-08更新