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 详细处方信息以本药内容附件PDF文件（20105923514840.pdf）的“原文Priscribing Information”为准
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部分中文Circadin处方资料（仅供参考）

    Circadin(R) 是一种创新型睡眠药物，已经由欧盟委员会 (European Commission) 药品管理机构和以色列卫生部批准用于原发性失眠的短期治疗，该病症以55岁及以上患者睡眠质量较差为特点。批准的依据是一些临床研究，这些研究显示这种药物在睡眠质量、睡眠诱导以及最重要的次日警觉性和机能方面有着积极的作用。
    对790多名18-80岁失眠症患者进行的这种新的双盲安慰剂对照试验显示，采用 Circadin(R) 进行的6个月连续治疗是安全而又有效的。试验显示睡眠潜伏期、睡眠质量和早晨的警觉性，特别是中老年患者的睡眠潜伏期、睡眠质量和早晨的警觉性有所改善，而且没有断瘾症状和失眠症状的回弹。Neurim Pharmaceuticals 首席科学官 (CSO) Nava Zisapel 教授表示：“我们为三期试验的这些初步结果而感到振奋，因为先前显示为针对睡眠质量差的独特的短期疗法的 Circadin(R) 现在已经显示出了长期的功效和安全性。”

Circadin(R) 简介：
    Circadin(R) 是第一种同时也是唯一一种受知识产权保护的有待于卫生部门批准成为一种处方药的缓释褪黑激素。对原发性失眠患者施用 Circadin(R) 能改善睡眠质量和早晨的警觉性，并且可以促进55岁及以上的患者入睡。Circadin(R) 现在已经由灵北制药公司 (H.Lundbeck A/S) 和奈科明 (Nycomed) 在欧洲推广，由 Teva 在以色列推广，在美国、亚太和拉丁美洲市场则正在进行注册。

Neurim Pharmaceuticals 简介：
    Neurim Pharmaceuticals 总部位于以色列，在瑞士和英国设有办事处。该公司创立于1991年，致力于发现和开发用于治疗与年龄有关的功能失调药物，特别是中枢神经系统功能失调的药物。

CIRCADIN(Melatonin) 
How does it work?
Circadin tablets contain the active ingredient melatonin, which is a type of hormone that is produced naturally in the body.

Melatonin is a hormone made by the pineal gland, a structure in the brain. It is normally released soon after it starts to get dark. The amount produced then increases until about two to four am, and then drops off again. Melatonin is linked with the control of circadian rhythms and promoting sleep. It works by acting on melatonin receptors in the brain.

The release of natural melatonin starts to decrease as we get older. Taking this medicine before bed may therefore be particularly helpful for people aged over 55 years who are suffering from primary insomnia. Primary insomnia is characterised by difficulty in getting to sleep or staying asleep, or poor quality of sleep for at least one month.

The melatonin in this medicine works in exactly the same way as natural melatonin, by acting on the melatonin receptors in the brain. It has been shown to reduce the time it takes to fall asleep, and to improve the quality of sleep and morning alertness in people over 55 years of age with primary insomnia.

One Circadin tablet should be taken after food, one or two hours before bedtime, for a three week period.

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What is it used for?
Short-term treatment of primary insomnia in people over 55 years old.

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Warning!
Circadin tablets are prolonged release tablets. They are designed to release the melatonin slowly and continuously over a few hours. These tablets should be swallowed whole and must not be chewed, crushed or cut in half, as this would damage the prolonged release action.

You should avoid drinking alcohol while you are taking this medicine, as it can reduce the effect of melatonin on sleep.

This medicine is taken to aid sleep. As such, if it makes you feel drowsy you should avoid potentially hazardous tasks, such as driving or operating machinery. If you suffer from ongoing drowsiness after taking this medicine then consult your doctor.

Smoking may make this medicine less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver.

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Use with caution in
People with decreased kidney function.

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Not to be used in
People with decreased liver function.
People with autoimmune diseases (where the immune system attacks the body's own tissues) such as systemic lupus erythematosus.
Circadin tablets contain lactose and may not be suitable for people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
This medicine is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.

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.

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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. The manufacturer states that it is not recommended for use by women who are pregnant, or for women who are planning a pregnancy.

Melatonin that is produced naturally by the body passes into breast milk. This suggests that this medicine is also highly likely to pass into breast milk. Therefore, the manufacturer recommends that women who are taking this medicine should not breastfeed. Seek medical advice from your doctor.

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Label warnings
This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
This medication is to be swallowed whole, not chewed.
Take this medicine with or after food.

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Side effects
Medicines 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.

Common (affect between 1 in 10 and 1 in 100 people)
Headache.
Inflammation of the throat (pharyngitis).
Back pain.
Weakness or loss of strength (asthenia).

Uncommon (affect between 1 in 100 and 1 in 1000 people)
Migraine.
Abnormal dreams.
Irritability, restlessness or nervousness.
Dizziness.
Sleepiness (somnolence).
Abdominal pain.
Constipation.
Dry mouth.
Raised levels of a bile pigment produced by the liver called bilirubin (hyperbilirubinaemia).
Excessive sweating.
Increased weight.

Rare (affect between 1 in 1000 and 1 in 10,000 people)
Changes in mood.
Aggression or agitation.
Increased sex drive.
Disturbances in attention or memory.
Changes in vision, such as blurred vision, increased watering of eyes.
Decrease in the number of platelets or white blood cells in the blood (thrombocytopenia or leucopenia).
Abnormal results of liver function tests.
Disturbances of the gut, such as upset stomach, vomiting, flatulence, increased salivation and bad breath.
Hot flushes and night sweats.
Persistent painful erection of the penis (priapism).
Skin reactions such as rash, eczema, itching.

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.

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How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicine's while taking this one, to ensure that the combination is safe.

The following medicines may prevent the breakdown of melatonin by the liver and so could increase the amount of melatonin in the blood. These medicines could therefore increase the chance of experiencing side effects of melatonin:
cimetidine
fluvoxamine (this medicine should be avoided in people taking fluvoxamine)
psoralen, such as 5- or 8-methoxypsoralen (used to treat psoriasis)
quinolone antibiotics, such as ciprofloxacin
oestrogens, found in contraceptives or hormone replacement therapy.

The following medicines may increase the breakdown of melatonin in the body. This could decrease the level of melatonin in your blood and may make it less effective:
carbamazepine
rifampicin.

There will be increased drowsiness and sedation if this medicine is taken in combination with any of the following (which can also cause drowsiness):
antidepressants, eg thioridazine, imipramine
benzodiazepines, eg diazepam, temazepam
sleeping tablets, eg zalepon, zolpidem, zopiclone.

Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain melatonin as the active ingredient.

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 详细处方信息以本药内容附件PDF文件（20105923514840.pdf）的“原文Priscribing Information”为准
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