Domperidone (Motilium) (10mg *30 tablets) 多潘立酮片(吗丁啉) Janssen

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Brand: Janssen

Functions and Indications:


The name of your medicine is Domperidone 10mg Tablets.
Domperidone is an anti-emetic which can stop you feeling sick.
The active ingredient is domperidone maleate.
Each tablet contains 10mg domperidone as domperidone maleate.
Domperidone is used to treat:
nausea and vomiting
complaints of the stomach, which occur with delayed emptying of the stomach. This can result in symptoms such as feeling full (during or just after eating), bloating, belching, nausea, heartburn and stomach ache.


Important information about one of the ingredients in your medicine
These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
DO NOT TAKE Domperidone 10mg Tablets if you:
have ever had an allergic reaction to domperidone or any of the other ingredients listed in section 6, Further Information
have or think you may have a serious intestinal problem such as internal bleeding (symptom being persistent black bowel motions), or an obstruction or perforation of the stomach or intestine (usually this involves severe stomach cramps)
suffer from a tumour of the pituitary gland called prolactinoma
Before you use Domperidone 10mg Tablets tell your doctor if you:
have a liver or kidney disorder
are pregnant, or likely to become pregnant
are breast-feeding
suffer from heart problems as this medicine may affect your heart rate. This risk may be greater if you are over 60 years of age or if you are on doses of more than 30mg/day.
Driving and using machinery
It is unlikely that these tablets will affect your ability to drive or operate machinery.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicine, even those not prescribed by a doctor, including any of the following:
opioid analgesics, used to treat pain
ketoconazole, used to treat fungal infections
ritonavir, used to treat HIV infection
erythromycin, used to treat infections
antimuscarinics, used to treat bladder or gastro-intestinal disorders
amantadine, used to treat viral infections
bromocriptine or cabergoline, used for the treatment of pituitary tumours or Parkinson s disease
If taken with other medicines the effect of Domperidone 10mg Tablets or the effects of the other medicine may be altered.


These tablets have been prescribed for you by a doctor. Take them exactly as he or she has told you. Please read the label carefully.
Domperidone should be used at the lowest effective dose in adults and children.
The tablets should be swallowed whole with a sufficient quantity of liquid (e.g. one glass of water).
Adults and adolescents (weighing 35kg or more i.e. approximately 5 stone)
The usual dose for the treatment is 1 to 2 tablets taken 3 to 4 times a day before meals. Do not take more than 8 tablets (80mg) in 24 hours.
Infants and Children
Children weighing less than 35kg (5 stone) should not take these tablets. The usual dose for the treatment is 0.25 0.5mg per kg bodyweight taken 3 to 4 times a day before meals. Your pharmacist may be able to help you if you are not sure.
People with kidney problems
Your doctor may tell you to take a lower dose or take the medicine less often.
Your doctor may advise you to take your medicine in a different way, so you should always follow your doctor s advice about how and when to take your medicine and always read the label. If you feel that the effect of Domperidone 10mg Tablets is too strong or too weak, talk to your doctor or pharmacist.
If your complaint shows no improvement after 28 days while taking Domperidone 10mg Tablets, consult your doctor to see if you need to go on taking this medicine.
If you take more Domperidone 10mg Tablets than you should
If you take more tablets than you should, tell your doctor immediately or go to the nearest hospital.
You may be given active charcoal, which can prevent the absorption of domperidone, if taken soon after having taken the overdose. Symptoms of overdose are drowsiness, disorientation, irregular eye movements and strange movements of the body, especially in children.
If you forget to take your tablets
Take your tablets as soon as you remember. If it is almost time for your next dose, wait until that is due and continue as normal. Do not take a double dose to make up for the forgotten dose.

Like all medicines, Domperidone 10mg Tablets can have side
If any of the following side effects occur, STOP TAKING your Domperidone 10mg Tablets and tell your doctor immediately or go to your nearest hospital as it may be an allergic reaction:
welling of the hands, feet, ankles, face, lips or throat
problems with breathing
skin rash, itching or hives
If you experience any of the following, STOP TAKING
Domperidone 10mg Tablets and talk to your doctor:
convulsions (fits)
uncontrolled movements, including irregular eye movements, unusual tongue movements, twisting, turning movements of the neck, or trembling and stiffness of the muscles. This reaction may be more likely to occur in children.
heart rhythm disorders- symptoms include fast or slow heart beat
Rare side effects
In rare cases domperidone may:
cause milk to leak from the breast
disrupt menstrual flow
cause breast growth in men
Very rare side effects
mild stomach cramps
nervousness or restlessness
raised liver function tests (this is detected in a blood test)
Frequency unknown
sudden cardiac death
Domperidone may be associated with an increased risk of heart
rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30mg per day.
Domperidone should be used at the lowest effective dose in adults and children.
If you notice any side effects not mentioned in this leaflet, or if any of the side effects listed become serious or last longer than a few days please inform your doctor or pharmacist.


Do not use your Domperidone 10mg Tablets after the expiry date printed on the package. If you have any tablets that are out of date, please return them to your pharmacist for disposal.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store the tablets in the original package.


Domperidone 10mg Tablets are white coloured, round, biconvex tablets. The active ingredient is domperidone maleate. Each tablet also contains several inactive ingredients. These include lactose monohydrate, maize starch, microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silica and sodium laurilsulfate.

Dosage and Administration:

Oral. Adults 1 piece at a time, three times a day, 15 ~ 30 minutes before meals.

Storage : Store (keep) in a cool and dry place,protect from light (heat).

Product Name : Domperidone (Motilium)

Packing: 10mg *30 tablets/one box 

Manufacturer : Xi 'an Janssen Pharmaceutical  Co. Ltd 


【主要成份】 主要成份多潘立酮10毫克,辅科为淀粉、氢化植物油、含水乳糖、硬脂酸镁、微晶纤维素、聚乙烯吡咯烷酮、预胶化淀粉、十二烷基硫酸钠。

【性 状】 本品为白色片。

【适应症/功能主治】 用于消化不良、腹胀、嗳气、恶心、呕吐、腹部胀痛。



【不良反应】 1.偶见轻度腹部痉挛、口干、皮疹、头痛、腹泻、神经过敏、倦怠、嗜睡、头晕等。 2.有时血清泌乳素水平会升高、溢乳,男子乳房女性化等,但停药后即可恢复正常。 3.罕见情况下出现兴奋、闭经。 4.非常罕见的不良反应包括血管神经性水肿、过敏反应、瘙痒、肝功能检查异常、惊厥、荨麻疹、锥体外系副作用(如流涎、手颤抖等,这些症状在停药后即可自行完全恢复)。

【禁 忌】 1.已知对多潘立酮或本品任一成份过敏者。 2.增加胃动力有可能产生危险时(例如:胃肠道出血、机械性梗阻、穿孔)禁用。 3.分泌催乳素的垂体肿瘤(催乳素瘤)患者禁用。 4.嗜铬细胞瘤、乳癌、机械性肠梗阻、胃肠出血患者禁用。 5.禁止与酮康唑口服制剂、红霉素或其它可能会延长QTc间期的CYP3A4酶强效抑制剂(例如:氟康唑、伏立康唑、克林霉素、胺碘酮、泰利霉素)合用。 6.中重度肝功能不全者禁用。

【注意事项】 1.孕妇慎用,哺乳期妇女使用本品期间应停止哺乳。 2.建议儿童使用多潘立酮混悬液。 3.心脏病患者(心律失常)以及接受化疗的肿瘤患者应用时需慎重,有可能加重心律紊乱。 4.如服用过量或出现严重不良反应,应立即就医。 5.对本品过敏者禁用,过敏体质者慎用。 6.本品性状发生改变时禁止使用。 7.请将本品放在儿童不能接触的地方。 8.如正在使用其他药品,使用本品前请咨询医师或药师。 9.本品含有乳糖,可能不适用于乳糖不耐受、半乳糖血症或葡萄糖/半乳糖吸收障碍的患者。 10.当抗酸剂或抑制胃酸分泌药物与本品合用时,前两类药不能在饭前服用,应于饭后服用,即不宜与本品同时服用。 11.由于多潘立酮主要在肝脏代谢,故肝功能损害的患者慎用。 12.严重肾功能不全(血清肌酐>6毫克/100ml即>0.6mmol/L)患者多潘立酮的消除半衰期由7.4小时增加到20.8小时,但其血药浓度低于健康志愿者。由于经肾脏排泄的原形药物极少,因此肾功能不全的患者单次服药可能不需调整剂量,但需重复给药时,应根据肾功能损害的严重程度将服药频率减为每日1-2次,此类患




【药物相互作用】与抗胆碱药合用会括抗本品治疗消化不良的作用。 抗酸剂和抑制胃酸分泌药物会降低本品的口服生物利用度,不宜与本品同时服用。 多潘立酮主要经CYP3A4酶代谢。体外和人体试验的资料显示,与显著抑制CYP3A4酶的药物合用会导致多潘立酮的血药浓度增加, CYP3A4酶的强效抑制剂举例如下: ?唑类抗真菌药物,例如:氟康唑*、伊曲康唑、酮康唑*和伏立康唑* ?大环内酯类抗生素,例如:红霉素和克拉霉素* ?HIV蛋白酶抑制剂,例如:安泼那韦、阿扎那韦、福沙那韦、茚地那韦、那非那韦、利托那韦、沙奎那韦? ?钙括抗剂,例如:地尔硫萆和维拉帕米 ?胺碘酮* ?阿瑞吡坦? ?奈法唑酮? ?泰利霉素* (*也会延长QTc间期,详见[禁忌]) 在对健康志愿者进行的与酮康唑口服制剂或红霉素口服制剂合用的药代动力学/药效学试验中,酮康唑和红霉素会显著抑制由CYP3A4介导的多潘 立酮的首过效应。 在多潘立酮-酮康唑相互作用试验中,观察到多潘立酮(10毫克/次,4次/曰)与酮康唑(200毫克/次,2次/曰)合用会使QTc间期平均增加9.8毫秒,个体QTc间期的变化范围为1.2-17.5毫秒。在多潘立酮-红霉素相互作用试验中,观察到多潘立酮(10毫克/次,4次/日}与红霉素(500毫克/ 次,3次/日)合用会使QTc间期平均增加9.9毫秒,个体QTc间期的变化范围为1.6~14.3毫秒。在上述相互作用试验中,多潘立酮的稳态Cmax和AUC约升高了3倍。 尚未知多潘立酮血药浓度的升高与QTc间期作用的关系。 在以上与酮康唑和红霉素相互作用试验的观察期内,单独使用多潘立酮(10毫克/次,4次/曰)使QTc间期平均增加1.6毫秒和2.5毫秒。单独使用酮康唑(200毫克/次,2次/日)或红霉素(500毫克/次,3次/日)使QTc间期平均增加3.8毫秒和4.9毫秒。 在另一项对健康志愿者进行的重复剂量研究中,多潘立酮单药稳定治疗剂量达40毫克/次、4次/日(每日160毫克,2倍于最高日剂量)时,无QTc 间期明显延长的记录。此研究中的多潘立酮血桨浓度至少与前几项相互作用研究中的结果相近。 由于多潘立酮具有胃动力药作用,因此理论上会影响合并使用的口服药品(尤其是缓释或肠衣制剂)的吸收。然而,对于服用地髙辛或对乙酰氨基酚血装药物浓度已处于稳定水平的患者.合用多潘立酮不影响其血药浓度。 多潘立酮与下列药物合用: ?神经抑制剂:多潘立酮不增强神经抑制剂的作用。 ?多巴胺能激动剂:多潘立酮会减少多巴胺能激动剂(如溴隐亭.左旋多巴)外周副作用.如消化道症状、恶心及呕吐,但不会括抗其中枢作用。

【药物过量】药物过量主要在婴儿和儿童中报告。药物过量的症状包括兴奋、意识改变、惊厥、定向障碍、嗜睡和锥体外系反应。 本品无特定的解救药。一旦药物过量,洗胃及给予活性炭可能会有帮助,建议进行严密的临床监护及支持疗法。抗胆碱药物或抗帕金森氏症的药物可能对控制锥体外系反应有帮助。

【药理毒理】1.药理作用 本品为外周多巴胺受体阻滞剂,直接作用于胃肠壁,可增加食道下部括约肌张力,防止胃-食道反流,增强胃蠕动,促进两排空,协调胃与十二指肠运动,抑制恶心、呕吐,并能有效地防止胆汁反流,不影响胃液分泌。 本品不易透过血脑屏障。动物试验结果表明,多潘立酮在脑内的浓度很低,同时显示出多潘立酮对外周多巴胺受体有极强的作用。在使用者(尤其成人)中罕见锥体外系反应,但多潘立酮会促进脑垂体催乳素的释放。其抗催吐作用主要是由于其对外周多巴胺受体及血脑屏障外的化学感受器触发区多巴胺受体的双重阻滞作用。 2.毒理研究 在一项用大鼠进行的研究中,在对母体产生毒性的较髙剂量(人体推荐剂量的40倍)下,多潘立酮显示了生殖毒性。但在小鼠和家兔的试验中,未发现此现象。 在体外和体内电生理学研究中,多潘立酮在高浓度下可能会延长QTc间期。

【药代动力学】本品空腹口服后吸收迅速,30 - 60分钟可达峰值血药浓度。胃酸减少会影响多潘立酮的吸收。多潘立酮的血装蛋白结合率为91-93%。健康志愿者单剂量口服本品,血浆半衰期为7-9小时,严重肾功能不全的患者半衰期有所延长。本品几乎全部在肝内代谢。用诊断性抑制剂进行的体外代谢试验表明,CYP3A4是细胞色素P-450参与多潘立酮N-去烃化作用的主要形式,而参与多潘立酮芳香族羟基化作用的有CYP3A4,CYP1A2和CYP2E1。通过尿液排泄总量为31%,原形药占1 % ;粪便排泄总量66%,原形药占10%。

【贮 藏】遮光,密闭保存。

【包 装】铝塑泡罩板包装,30片/板/盒

【有 效 期】60 月