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概述

巴氯芬是骨骼肌松弛剂。

鞘内使用BaclofenSintetica®适用于患有严重的慢性痉挛症的患者，这种患者由于创伤，多发性硬化症或其他脊髓疾病而对口服baclofen或其他口服抗痉挛药无反应。

它在脊髓水平上抑制了单突触和多突触反射的传递。 它改善了活动能力并减轻了痉挛性痉挛，而没有改变呼吸和神经肌肉刺激的传递。 BaclofenSintetica®通过植入体内的鞘内泵给药。

 

 

本单有什么

在给予Sintetica Baclofen鞘内注射之前，请仔细阅读此传单。

本传单回答了有关鞘内注射Sintetica Baclofen的一些常见问题。它不包含所有可用信息。可以从www.ebs.tga.gov.au下载最新的《消费医学信息》。

阅读本传单并不能代替您与医生或药剂师交谈。

所有药物都有风险和益处。您的医生已权衡了将Sintetica Baclofen鞘内注射给您的风险与该药可为您带来的好处。

如果您对服用这种药物有任何疑问，请咨询您的医生或药剂师。

将此传单与药物一起保存。

您可能想再次阅读。

Sintetica Baclofen鞘内用药的用途

Sintetica Baclofen鞘内注射可减少肌肉中引起痉挛的张力。这些痉挛发生在多种疾病中，例如多发性硬化症，脑瘫和其他疾病或脊髓或脑部受伤。

由于这种药物可减轻痉挛和随之而来的痛苦，因此有助于使您更加机动。这可以帮助您管理日常活动，并使理疗更容易。

Sintetica Baclofen鞘内注射属于一组称为肌肉松弛剂的药物。它在注射或输注溶液中含有活性成分巴氯芬。当口服药物不能很好地起作用或引起太多副作用时，可以使用它。

使用专用泵将安瓿瓶中的溶液注入您的背部（椎管）。从泵中，恒定量的巴氯芬通过一根细管进入脊髓周围的空间。

这种药物可用于成人和四岁或以上的儿童。

您的医生可能出于其他原因开了这种药。

询问您的医生是否对为什么为您开处方有任何疑问。

Sintetica Baclofen鞘内注射只能在医生的处方下使用。

Sintetica Baclofen鞘内注射不会上瘾。

 

在给予Sintetica Baclofen鞘内注射之前

Sintetica Baclofen鞘内注射并不适合所有人。

什么时候不给你

如果您患有不受治疗控制的癫痫病，则不得给予Sintetica Baclofen鞘内注射。如果您在服药后仍然感到不适或抽搐。

如果您对任何含有巴氯芬或本传单末尾所列成分的药物过敏，则不得鞘内注射Sintetica Baclofen。

过敏反应的症状可能包括荨麻疹或皮疹发痒，面部潮红，面部，嘴唇或舌头肿胀，晕厥，胸部紧绷感，喘鸣或呼吸困难。

包装上印有的有效期（EXP）之后，或者包装破损或有篡改迹象时，不得使用Sintetica Baclofen鞘内注射。使用前溶液必须澄清。

如果不确定是否应鞘内注射Sintetica Baclofen，请咨询您的医生或药剂师。

在给你之前

告诉您的医生或药剂师您是否对任何其他药物，食物，防腐剂或染料过敏。

如果您发现植入的设备不起作用并且还注意到停药症状，请寻求紧急医疗帮助（请参阅“如果必须停药”）。

告诉医生您是否有任何健康状况，尤其是以下情况：

•任何形式的感染

•精神分裂症或其他精神疾病，尤其是当它使您有时感到困惑时

•帕金森氏病

•由于癫痫或其他原因引起的癫痫发作

•植物神经反射异常，这是一种与极高的血压，剧烈的头痛，大量出汗，视力模糊和其他症状相关的紧急情况

•脑部血液流动问题

•心脏或肺部疾病

• 肾脏疾病

• 肝病

•呼吸问题

•现在或过去任何时候的胃溃疡。

您的医生可能需要进行测试，例如脊柱成像，在用Sintetica Baclofen鞘内注射治疗前检查是否有任何不应该给予的理由。

告诉医生您是孕妇还是母乳喂养。

尚无针对孕妇或哺乳期妇女的鞘内注射巴林芬Sintetica的研究。您的医生将讨论在妊娠和哺乳期间鞘内注射Sintetica Baclofen可能带来的风险和益处。

告诉医生您是否超过65岁。

老年人对副作用的敏感性更高，您可以通过逐渐改变剂量来控制您的医生。

如果您没有将上述任何事情告诉您的医生或药剂师，请先告知他们，然后再给予Sintetica Baclofen鞘内注射。

 

服用其他药物

告诉您的医生您是否正在服用其他药物，包括您在药房，超级市场或健康食品商店购买的没有处方的药物。

告诉正在为您开新药的任何医疗保健专业人员，您正在使用Sintetica Baclofen鞘内注射。

某些药物和Sintetica Baclofen鞘内注射可能相互干扰。这些包括：

•左旋多巴，卡比多巴和其他类似药物称为DDC抑制剂（用于治疗帕金森氏病）

•用于使您在手术过程中入睡的全身麻醉剂，例如芬太尼和丙泊酚

•吗啡或其他鸦片制剂，用于控制疼痛

•一些抗抑郁药，称为三环类

•用于治疗高血压的药物

•苯二氮卓类药物，用于治疗焦虑症，失眠，癫痫发作或肌肉痉挛

•影响中枢神经系统的任何药物或药物（脑或脊髓）。

以上药物可能会受到Sintetica Baclofen鞘内注射的影响，或者可能会影响其效果。您可能需要鞘内注射不同剂量的Sintetica Baclofen或可能需要服用不同的药物。

您的医生和药剂师有更多关于药物的信息，在使用Sintetica Baclofen鞘内注射时要小心或避免。

如何给予Sintetica Baclofen鞘内注射

怎么给

这种药物只能由经验丰富的医生使用特殊的医疗设备来给予。您至少在治疗开始时需要住院。

您的医生将向您的椎管内注入少量的Sintetica Baclofen鞘内注射，看看它是否可以改善肌肉痉挛。

如果是这样，那么将在腹部皮肤下植入专用的泵。该泵将始终为您提供少量药物。

首次注射后和进行泵植入后，将在设备齐全且配备人员的环境中严密监视您。每次更改剂量后，您都会接受评估，以了解可能的副作用或感染的证据。还将检查泵的功能。

将向您或您照顾的人展示如何在家护理泵，以及如何使植入泵的皮肤免受感染。

 

 

会给多少

您的医生将决定您将获得多少Sintetica Baclofen鞘内注射。可能需要几天的时间才能找到最适合您的药物量。您的医生将在这段时间内密切监视您。

之后，您的医生仍希望定期与您见面，以检查进度并确保泵工作正常。

该剂量将取决于您的病情以及身体对治疗的反应方式。每天通常在276-800微克之间。 12岁以下的儿童通常需要比年龄较大的患者更低的剂量。

询问您的医生或药剂师是否需要有关如何管理剂量的更多信息。

多久给您一次

您的医生将计算出您需要多久返回一次，以在泵用完之前先向泵中注入额外的Sintetica Baclofen鞘内注射。重要的是，不允许泵用尽，因为如果突然停止治疗，可能会引起严重的反应。

密切遵循医院工作人员给您的指示，并在更改任何治疗预约之前先与您的医生讨论。

如果必须停药

如果由于某种原因必须停止使用这种药物，您的医生将逐渐减少剂量，以免产生不良副作用。鞘内突然停止Sintetica Baclofen或迅速降低剂量可能会导致严重的副作用，在少数情况下，这些副作用是致命的。

不要突然停止Sintetica Baclofen鞘内注射或让泵内的药物耗尽。如果发生这种情况，请立即告诉医生，并注意以下症状。

除非立即治疗，否则这些症状可能导致更严重的副作用。

突然停药可能导致：

•严重且不受控制的肌肉痉挛

•肌肉运动困难

•血压低引起的头昏眼花或头昏眼花

•手脚严重瘙痒，麻木或刺痛

•抽搐（癫痫发作）

•阴茎持续性勃起疼痛（阴茎异常勃勃）

• 高烧

•精神状况改变，例如焦虑，躁动，精神错乱，幻觉，思维和行为异常或抽搐（发作），持续存在

•阴茎痛苦勃起（阴茎异常勃勃）和感染（败血症）。

泵的问题，例如由于电池问题，导管问题，警报功能障碍或设备故障而引起的问题，也可能引起抽血症状。

如果您有上述任何迹象，请立即告诉您的医生。除非立即治疗，否则这些迹象可能会带来更严重的副作用（包括死亡）。

 

当您使用Sintetica Baclofen鞘内注射时

你必须做的事

仔细按照医生的指示。确保正确保养了泵和插入泵的位置。

否则，泵可能无法正常工作，或者可能导致严重的皮肤感染。如果您不确定该怎么办，或者不确定是否存在问题，请咨询您的医生。

遵守所有医生的约会安排，以便可以补充药物并检查病情。

非常重要的是，在药物用完之前要重新加注泵，因为突然停止治疗并不安全。另外，您的医生需要检查您的进度，以确保您的剂量正确。

如果您觉得病情没有改善或正在恶化，请去看医生。

您的剂量可能需要调整，或者泵可能有问题。

如果需要对泵进行任何调整，包括对泵的流量（剂量）进行调整，请确保在医生的监督下进行。

调节泵时出错会导致严重的副作用。

如果您的肌肉痉挛突然或逐渐发作，请告诉医生。

您的医生可能可以更改鞘内注射Sintetica Baclofen的剂量，以使其对您更好。

如果在治疗过程中背部，肩膀，颈部和臀部疼痛，请立即告诉医生。

如果您的病情恶化，并且出现异常的瘙痒，头晕，头晕或手或脚刺痛，请立即就医。

泵可能出现问题，导致您停止服药。这可能会危及生命，您可能需要立即就医。

如果您即将开始使用任何新药，请告诉您的医生和药剂师您正在使用Sintetica Baclofen鞘内注射。同样，请告诉其他任何正在治疗您的医生，牙医和药剂师您正在接受这种药物治疗。

如果您要进行手术，请告诉外科医生和麻醉师您正在使用这种药物。

它可能会影响手术期间使用的其他药物。

如果您在使用这种药物时怀孕，请立即告诉医生。

你绝对不能做的事

不要突然停止Baclofen Sintetica鞘内注射。

有关更多信息，请参见“如果必须停药”。

即使他们的症状似乎与您的症状相同，也不要将此药给予他人。

要注意的事情

小心驾驶或操作机械，直到您知道Sintetica Baclofen鞘内注射对您有何影响。

它可能会导致困倦，头昏，协调不力或视力问题，并在某些人中产生幻觉。在驾驶汽车，操作机械或进行其他可能会引起危险的危险操作之前，请确保您知道如何反应。如果您喝酒，或服用强效止痛药或巴比妥类药物，效果可能会更糟。

小心饮酒，直到您知道Sintetica Baclofen鞘内注射对您有何影响。

如果您正在接受Sintetica Baclofen鞘内注射治疗，酒精对您的影响可能更大。您可能比平时更困倦或头晕。

在楼梯和不平坦的表面上要小心，以免跌落。

Sintetica Baclofen鞘内注射可减轻肌肉紧张。它可能会导致虚弱并影响反射和协调。如果您遇到问题，请与您的医生联系，因为他们可能需要更改剂量。

 

 

 

如果过量

如果给你太多

如果您认为鞘内注射Sintetica Baclofen的次数过多，请立即致电您的医生或Poisons信息中心（电话13 11 26），或去就近的医院进行急诊。

即使没有不适或中毒的迹象，也要这样做。

您可能需要紧急医疗护理。

人们对鞘内注射Sintetica Baclofen的敏感性各不相同。有些人可能以对其他人安全的剂量服用过量药物。

特别是在治疗开始时，更换剂量后或重新开始治疗后（如果有休息的话），请特别小心。

重要的是，您和那些关心您的人都知道可能发生用药过量的迹象。服用过量的症状可能包括极度虚弱，异常嗜睡，头晕，头晕，嗜睡，唾液过多，恶心或呕吐。更严重的症状包括健美，呼吸困难，心律缓慢，失去知觉，昏迷和死亡。

过量的迹象可能突然发生或发生得更慢（例如，由于泵工作不正常）。

副作用

如果您在使用Sintetica Baclofen鞘内注射时感觉不适，请尽快告诉您的医生或药剂师。

像所有药物一样，Sintetica Baclofen鞘内注射有时会在某些人中引起副作用。有时他们很认真，大多数时候却不是。如果您有些副作用，则可能需要就医。

某些副作用可能与输送系统有关。

请您的医生或药剂师回答您可能遇到的任何问题。

如果发现以下任何情况，请告诉医生，他们会担心您：

•嗜睡，疲倦或精神不振

•头晕或头晕

•头痛

•感到恶心或呕吐

•食欲不振，体重减轻

•便秘

•手脚麻木或刺痛

•肌肉无力，痉挛或疼痛或肌张力改变

•协调与平衡问题

• 言语不清

•模糊或双眼

•感到焦虑，困惑，迷失方向或无法入睡

•注意力或记忆力问题

•口干，味觉下降

•腹泻

•唾液增加

•性功能问题

•脱发。

如果发现以下任何情况，请立即告诉医生：

•呼吸缓慢或困难，或胸闷，疼痛或充血

•发烧，发冷或其他感染迹象，肺炎

•面部，脚踝，脚或小腿肿胀

•腿部疼痛，麻木或沉重的感觉

•心跳异常缓慢

•癫痫发作（发作）

•抑郁或其他严重的情绪或精神障碍（妄想症）

•吞咽困难

•皮疹或皮肤瘙痒

•持续的无法控制的眼球运动

•失去膀胱（尿）控制或其他膀胱问题

•严重的呕吐，腹泻或便秘

•脊柱侧弯弯曲度增加（一种称为脊柱侧弯的脊柱畸形）

•极度幸福的感觉（欣快感）

•困惑，迷失方向

•自杀观念和自杀企图

•幻觉

•极度嗜睡

上述副作用可能很严重。您可能需要医疗护理。

告诉您的医生或药剂师是否发现其他任何使您感到不适的症状。

在某些患者中也可能发生上面未列出的其他副作用。

请勿担心此副作用列表。

您可能没有任何经历。

给予Sintetica Baclofen鞘内注射后

存储

Sintetica Baclofen鞘内注射将在建议的存储条件下存储在药房或病房中。

必须将其放在温度低于25°C的阴凉干燥处，避免光线直射。不要冷藏或冷冻。

处置方式

任何过期的Sintetica Baclofen鞘内注射或使用后遗留在容器中的药物，都将由您的医生，护士或药剂师以安全的方式处置。

产品描述

看起来像什么

Sintetica Baclofen鞘内注射是一种透明，无色的注射或输注溶液。

它提供以下尺寸的玻璃安瓿瓶：

•1毫升含50微克巴氯芬–每包10安瓿

•5毫升含10毫克巴氯芬–每包10安瓿

•20毫升含10毫克巴氯芬–每包1安瓿

•20毫升含40毫克巴氯芬–每包1安瓿。

配料

有效成分：

•巴氯芬

非活性成分：

•氯化钠

•注射用水。

 

 

What is in this leaflet

Please read this leaflet carefully before you are given Sintetica Baclofen Intrathecal.

This leaflet answers some common questions about Sintetica Baclofen Intrathecal. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au.

Reading this leaflet does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of giving you Sintetica Baclofen Intrathecal against the benefits this medicine is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What Sintetica Baclofen Intrathecal is used for

Sintetica Baclofen Intrathecal is used to reduce tension in your muscles which causes spasms. These spasms happen in various illnesses such as multiple sclerosis, cerebral palsy and other diseases or injuries of the spinal cord or brain.

Because this medicine reduces spasms and the pain that goes with them, it helps to make you more mobile. This helps you to manage your daily activities and makes physiotherapy easier.

Sintetica Baclofen Intrathecal belongs to a group of medicines called muscle relaxants. It contains the active ingredient, baclofen, in a solution for injection or infusion. It is used when medicines taken by mouth do not work well enough or when they cause too many side effects.

The solution in the ampoule is injected into your back (spinal canal) using a special pump. From the pump, a constant amount of baclofen goes into the space surrounding your spinal cord through a tiny tube.

This medicine can be used for adults and for children aged four years or older.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why it has been prescribed for you.

Sintetica Baclofen Intrathecal is only available with a doctor's prescription.

Sintetica Baclofen Intrathecal is not addictive.

Before you are given Sintetica Baclofen Intrathecal

Sintetica Baclofen Intrathecal is not suitable for everyone.

When you must not be given it

You must not be given Sintetica Baclofen Intrathecal if you have epilepsy not controlled by treatment, e.g. if you continue to have fits or convulsions despite medication.

You must not be given Sintetica Baclofen Intrathecal if you are allergic to any medicine containing baclofen or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include hives or an itchy skin rash, flushing of the face, swelling of the face, lips or tongue, faintness, tight feeling in the chest, wheezing or difficulty breathing.

Sintetica Baclofen Intrathecal must not be used after the expiry date (EXP) printed on the pack, or if the packaging is torn or shows signs of tampering. The solution must be clear before use.

If you are not sure whether you should be given Sintetica Baclofen Intrathecal, talk to your doctor or pharmacist.

Before you are given it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Get urgent medical help if you observe that your implanted device is not working and you also notice withdrawal symptoms (see "If the medicine must be stopped").

Tell your doctor if you have or have had any medical conditions, especially the following:

· an infection of any kind

· schizophrenia or other mental illness, especially if it makes you feel confused at times

· Parkinson’s disease

· seizures due to epilepsy or any other reason

· autonomic dysreflexia, an emergency condition associated with extremely high blood pressure, intense headaches, profuse sweating, blurred vision and other symptoms

· problems with blood flow to the brain

· heart or lung disease

· kidney disease

· liver disease

· breathing problems

· stomach ulcer now or at anytime in the past.

Your doctor may need to do tests, e.g. spinal imaging, before treating you with Sintetica Baclofen Intrathecal to check if there is any reason you should not be given it.

Tell your doctor if you are pregnant or breastfeeding.

There are no studies using Sintetica Baclofen Intrathecal in women who are pregnant or breastfeeding. Your doctor will discuss the possible risks and benefits of you being given Sintetica Baclofen Intrathecal during pregnancy and breastfeeding.

Tell your doctor if you are over 65 years old.

Elderly persons may be more sensitive to side effects which your doctor can manage by changing the dose gradually.

If you have not told your doctor or pharmacist about any of the above, tell them before you are given Sintetica Baclofen Intrathecal.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Tell any healthcare professional who is prescribing a new medicine for you that you are using Sintetica Baclofen Intrathecal.

Some medicines and Sintetica Baclofen Intrathecal may interfere with each other. These include:

· levodopa, carbidopa and other similar medicines known as DDC inhibitors (used to treat Parkinson’s disease)

· general anaesthetics used to put you to sleep during surgery, such as fentanyl and propofol

· morphine or other opiates, used to control pain

· some antidepressants, known as tricyclics

· medicines used to treat high blood pressure

· benzodiazepines, used to treat anxiety, insomnia, seizures or muscle spasms

· any medicine or drug which affects the Central Nervous System (brain or spinal cord).

The above medicines may be affected by Sintetica Baclofen Intrathecal, or may affect how well it works. You may need different amounts of Sintetica Baclofen Intrathecal or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Sintetica Baclofen Intrathecal.

How Sintetica Baclofen Intrathecal is given

How it is given

This medicine can only be given by experienced doctors using special medical equipment. You will need to stay in hospital, at least at the beginning of treatment.

Your doctor will inject a small amount of Sintetica Baclofen Intrathecal into your spinal canal to see if it improves your muscle spasms.

If it does, then a special pump will be implanted under the skin of your abdomen. The pump will give you a small amount of medicine all the time.

You will be monitored closely in a fully equipped and staffed environment after the first injection and following pump implant. You will be assessed after each change of dose for possible side effects or evidence of infection. The functioning of the pump will also be checked.

You or the person caring for you will be shown how to look after the pump at home and how to keep the skin where it has been implanted free from infection.

How much will be given

Your doctor will decide how much Sintetica Baclofen Intrathecal you will be given. It may take several days to find the amount of medicine that suits you best. Your doctor will keep a close watch on you during this time.

After that, your doctor will still want to see you regularly to check your progress and make sure your pump is working well.

This dose will depend on your condition and how your body responds to the treatment. It is usually between 276-800 micrograms a day. Children under 12 years of age usually require lower doses than older patients.

Ask your doctor or pharmacist if you would like more information about how your dose is managed.

How often you will be given it

Your doctor will work out how often you need to return to have the pump filled with additional Sintetica Baclofen Intrathecal before it runs out. It is important that the pump not be allowed to run out because you can have a serious reaction if you stop treatment suddenly.

Follow closely the instructions given to you by the hospital staff and discuss with your doctor first before changing any of your treatment appointments.

If the medicine must be stopped

If this medicine must be stopped for any reason, your doctor will reduce the dose gradually to avoid unwanted side effects. Suddenly stopping Sintetica Baclofen Intrathecal or rapidly reducing the dose can cause serious side effects which in a few rare cases have been fatal.

Do not stop Sintetica Baclofen Intrathecal suddenly or allow the pump to run out of medicine. If it should happen, tell your doctor immediately and watch out for the symptoms listed below.

These symptoms can lead to more severe side effects unless treated immediately.

Stopping this medicine suddenly may cause:

· severe and uncontrolled muscle spasms

· difficulty in muscle movements

· dizziness or light-headedness due to low blood pressure

· severe itching and numbness or tingling in hands and feet

· convulsions (seizures)

· persistant painful erection of the penis (priapism)

· high fever

· altered mental conditions, for example anxiety, agitation, confusion, hallucination, abnormal thinking and behaviour or convulsions (seizures), persistent

· painful erection of the penis (priapism) and infection (sepsis).

Problems with the pump, for example, due to battery problems, catheter problems, alarm dysfunction or device malfunctions may also cause withdrawal symptoms.

If you have any of the above signs, tell your doctor immediately. These signs may be followed by more serious side effects (including death) unless you are treated immediately.

While you are using Sintetica Baclofen Intrathecal

Things you must do

Follow your doctor's instructions carefully. Make sure the pump and the site where the pump was inserted are looked after properly.

If not, the pump may not work properly or you could get a serious skin infection. If you’re not sure what to do, or if you’re not sure if there’s a problem, talk to your doctor.

Keep all of your doctor’s appointments so that your medicine can be refilled and your progress can be checked.

It is very important that your pump is refilled before your medicine runs out as it is not safe to stop treatment suddenly. Also, your doctor needs to check on your progress to make sure you are on the right dose.

See your doctor if you feel that your condition is not improving or is getting worse.

Your dose may need adjusting or there might be a problem with the pump.

If any adjustments to the pump are needed, including to the pump flow rate (dose), make sure this is supervised by a doctor.

Errors in adjusting the pump can lead to serious side effects.

If your muscle spasms come back, either suddenly or gradually, tell your doctor.

Your doctor may be able to change the dose of Sintetica Baclofen Intrathecal to make it work better for you.

Tell your doctor immediately if you have pain in your back, shoulders, neck and buttock during treatment.

See your doctor immediately if your condition is worsening and you experience unusual itching, dizziness, light-headedness or tingling in the hands or feet.

There may be a problem with the pump that is stopping you getting your medicine. This can be life-threatening and you may need immediate medical attention.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using Sintetica Baclofen Intrathecal. Likewise, tell any other doctors, dentists and pharmacists who are treating you that you are being given this medicine.

If you are going to have surgery, tell the surgeon and anaesthetist that you are using this medicine.

It may affect other medicines used during surgery.

If you become pregnant while using this medicine, tell your doctor immediately.

Things you must not do

Do not stop Baclofen Sintetica Intrathecal suddenly.

See "If the medicine must be stopped" for more information.

Do not give this medicine to anyone else, even if their symptoms seem to be the same as yours.

Things to be careful of

Be careful driving or operating machinery until you know how Sintetica Baclofen Intrathecal affects you.

It may cause sleepiness, dizziness, problems with coordination or vision, and hallucinations in some people. Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you feel less alert. If you drink alcohol, or take strong pain killers or barbiturates, the effects may be worse.

Be careful drinking alcohol until you know how Sintetica Baclofen Intrathecal affects you.

Alcohol may have a greater effect on you if you are being treated with Sintetica Baclofen Intrathecal. You may feel more sleepy or dizzy than usual.

Be careful on stairs and uneven surfaces to avoid falling.

Sintetica Baclofen Intrathecal works by reducing muscle tone. It may cause weakness and affect reflexes and coordination. Talk to your doctor if you are having problems as they may need to change your dose.

In case of overdose

If you are given too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you may have been given too much Sintetica Baclofen Intrathecal.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

People vary in their sensitivity to Sintetica Baclofen Intrathecal. Some people may have signs of overdose at doses that are safe for other people.

Take care particularly at the start of treatment, after a dose change or after restarting treatment if you have had a break.

It is very important that you and those caring for you know the signs of overdose that can happen. Symptoms of an overdose may include extreme weakness, unusual drowsiness, light-headedness, dizziness, sleepiness, excessive saliva, nausea or vomiting. More severe symptoms include fits, difficulty breathing, slow heartbeat, loss of consciousness, coma and death.

Signs of overdose may happen suddenly or more slowly (for example, because the pump is not working properly).

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Sintetica Baclofen Intrathecal.

Like all medicines, Sintetica Baclofen Intrathecal may occasionally cause side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Some side effects could be associated with the delivery system.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

· drowsiness, tiredness or lack of energy

· dizziness or feeling light-headed

· headache

· feeling sick or vomiting

· loss of appetite, weight loss

· constipation

· numbness or tingling in the hands and feet

· muscle weakness, spasms or pain or change in muscle tone

· problems with coordination and balance

· slurred speech

· blurred or double vision

· feeling anxious, confused, disorientated or unable to sleep

· problems with concentration or memory

· dry mouth, decreased sense of taste

· diarrhoea

· increase in saliva

· problems with sexual function

· hair loss.

Tell your doctor immediately if you notice any of the following:

· slow or difficult breathing, or chest tightness, pain or congestion

· fever, chills or other signs of infection, pneumonia

· swelling of the face, ankles, feet or lower legs

· pain, numbness or heavy feeling in the legs

· unusually slow heart beat

· seizures (fits)

· depression or other severe mood or mental disorders (paranoia)

· difficulty in swallowing

· rash or itching of skin

· continuous uncontrollable eye movements

· loss of bladder (urine) control or other bladder problems

· severe vomiting, diarrhoea or constipation

· increase in sideways curvature of the spine (a type of spinal deformity called scoliosis)

· feeling of extreme happiness (euphoria)

· confusion, disorientation

· suicidal ideas and suicide attempt

· hallucinations

· extreme sleepiness

The above side effects could be serious. You may need medical attention.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some patients.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After being given Sintetica Baclofen Intrathecal

Storage

Sintetica Baclofen Intrathecal will be stored in the pharmacy or on the ward under the recommended storage conditions.

It must be kept in a cool dry place, protected from light, where the temperature stays below 25°C. Do not refrigerate or freeze.

Disposal

Any Sintetica Baclofen Intrathecal which has passed its expiry date, or is left in the container after use, will be disposed of in a safe manner by your doctor, nurse or pharmacist.

Product description

What it looks like

Sintetica Baclofen Intrathecal is a clear, colourless solution for injection or infusion.

It is available in glass ampoules in the following sizes:

· 1 mL containing 50 microgram baclofen – 10 ampoules in each pack

· 5 mL containing 10 mg baclofen – 10 ampoules in each pack

· 20 mL containing 10 mg baclofen – 1 ampoule in each pack

· 20 mL containing 40 mg baclofen – 1 ampoule in each pack.

Ingredients

Active ingredient:

· baclofen

Inactive ingredients:

· sodium chloride

· water for injections.