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 详细处方信息以本药内容附件PDF文件（201891620532934.pdf）的“原文Priscribing Information”为准
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部分中文伊班膦酸处方资料（仅供参考）

IBANDRONATE Bluefish 150 mg薄膜包衣片的应用领域

该药属于一组称为双膦酸盐的药物。它含有伊班膦酸的活性物质。这种药物可以通过阻止大多数骨质流失和增加骨质量来抵消骨质流失，即使他们没有看到或感觉到任何差异。该药可以帮助降低骨折（骨折）的风险。腰椎骨折有所减少，但股骨颈骨折没有。

该药用于治疗绝经后骨质疏松症，因为您的骨折风险增加。骨质疏松症是骨骼的变薄和减弱，在绝经后的女性中很常见。在更年期，卵巢停止产生女性荷尔蒙雌激素，这有助于保持女性的骨骼健康。

女性进入更年期越早，骨质疏松症骨折的风险就越大。其他可能增加骨折风险的因素是：

饮食中缺乏钙和维生素D. 吸烟或喝太多酒精

缺乏运动或其他身体活动 家族史中的骨质疏松症

此外，健康的生活方式将帮助您实现最大可能的治疗成功。

这包括：

富含钙和维生素D的均衡饮食。

运动或其他身体活动 不要吸烟，不要喝太多酒。

IBANDRONATE Bluefish 150 mg薄膜包衣片的剂量

完全按照医生的说法服用此药。如果您不确定，请咨询您的医生或药剂师。

除非医生另有规定，否则通常的剂量是每月一片一片。 进一步摄入

只要您的医生开具药物，您每个月都要服药一点很重要。如果您已服用该药5年，请与您的医生联系，如果您继续服用该药。

如果你服用的比

更多

如果您不小心服用过多的药片，请立即喝一整杯牛奶并与您的医生联系。

不要诱导呕吐而不要躺下 - 这可能会伤害您的食道。

如果你忘了带它

如果您忘记在所选日期的早晨服用平板电脑，请不要在当天晚些时候服用任何平板电脑。

相反，请查看您的日历，了解下次入学的时间安排。

如果您忘记在所选日期服用平板电脑，则需要1至7天才能服用下一次常规剂量

不要在同一周内服用两片药片。等到下一次预定剂量并正常服用您的药片。然后，按照您在日历中标记的原定日期，每月继续使用一片。

如果您忘记在所选日期服用平板电脑，则需要超过7天才能服用下一次常规剂量

在您注意到错过的剂量后，第二天早上服用一片。然后，按照您在日历中标记的原定日期，每月继续使用一片。

IBANDRONATE Bluefish 150 mg薄膜包衣片剂的相互作用

服用其他药物

如果您正在服用，最近服用或可能服用任何其他药物，请告诉您的医生或药剂师。特别是在：

含有钙，镁，铁或铝的补充制剂，因为这些可能会影响药物的效果。

乙酰水杨酸和其他非甾体抗炎药（NSAIDs）（包括布洛芬，双氯芬酸钠和萘普生），因为这些可能会刺激胃和肠道。这种药也可以做到这一点。因此，如果您同时服用止痛药或消炎药，请格外小心。

服用每月一次的药片后等1小时，然后服用任何其他药物，包括胃肠片，钙或维生素补充剂。

带着食物和饮料

药物不得与食物一起服用。与食物一起服用时效果较差。 你可以喝水，但不能喝其他饮料。 服药后，等待食物和饮料。

IBANDRONATE蓝鱼150毫克薄膜包衣片的副作用

像所有药物一样，这种药可能会引起副作用，但不是每个人都能得到它们。 如果您遇到任何列出的严重副作用，请立即告诉医务人员或医生 - 您可能需要立即进行紧急医疗：

罕见:(可能影响100人中的1人）

胸部剧烈疼痛，吞咽食物或饮料时剧烈疼痛，严重恶心或呕吐，吞咽困难。您可能患有严重的食管炎，可能伴有炎症或食道狭窄。

罕见:(可能影响1,000人中的1人）

瘙痒，面部，嘴唇，舌头和喉咙肿胀，伴有呼吸困难。 持续的眼睛疼痛和炎症 大腿，臀部或腹股沟处新出现的疼痛，虚弱或不适。您可能早期发现可能的非典型股骨骨折。

非常罕见:(可能会影响10,000人中的1人）

口腔或下巴疼痛或发炎。您可能有严重下颌问题的早期迹象（颚骨坏死[死骨组织]）

如果您有耳痛，从耳朵和/或耳朵感染，请告诉您的医生。这些可能是耳朵骨损伤的迹象。

严重的，可能危及生命的过敏反应

严重的皮肤反应

其他可能的副作用

常见:(最多可影响10人中的1人） 头痛 胃灼热，吞咽时疼痛，胃或腹痛（可能是由于胃肠道炎症），胃部不适，恶心，腹泻 肌肉痉挛，关节或四肢僵硬 流感样症状，包括发烧，发冷和震颤，不适，骨骼，肌肉和关节疼痛。如果任何这些副作用严重影响您或持续时间超过几天，请咨询您的医生或护士 皮疹

不常见:(可能影响100人中的1人） 头晕 胀气（胀气，胀气的感觉）

背疼 感到疲惫和疲惫 哮喘发作 罕见:(可能影响1000人中的1人） 十二指肠（小肠的第一部分）的炎症，引起腹痛

如果您发现任何副作用，请咨询您的医生或药剂师。这也适用于未指定的副作用

IBANDRONATE蓝鱼150毫克薄膜包衣片的禁忌症

不得服用药物，

如果您对伊班膦酸或该药物的任何其他成分过敏。

如果您无法站立或坐直至少一小时（60分钟）。

如果您的血液中钙含量较低或过去已经摄入过钙。请看你的医生。

对IBANDRONATE Bluefish 150 mg薄膜包衣片进行怀孕和哺乳

该药仅适用于绝经后妇女，不得由仍有孩子的妇女使用。

如果您怀孕或哺乳，请勿服药。服药前请咨询医生或药剂师。

应用于IBANDRONATE Bluefish 150 mg薄膜包衣片

拿每月平板电脑

请务必遵循以下说明。这些旨在帮助平板电脑快速到达您的胃部，使其不太可能刺激您的食道。

每月服用一片150毫克片剂。

选择您可以轻松记住的一个月中的某一天。您可以选择相同的日期（例如每月的第1天）或同一天（例如每个月的第一个星期日）来拍摄平板电脑。选择最适合您日程安排的日期。

在最后一次食用或饮用（水除外）后至少6小时服用您的药片。

拿起平板电脑

早上起床后，和 在你吃或喝任何东西之前（空腹）。 用一整杯水（至少180毫升）吞下你的平板电脑。不要在平板电脑中加入富含钙的水，果汁或其他饮料。如果担心自来水（硬水）中的钙含量可能很高，建议使用含有少量矿物质的瓶装水。 完全吞下您的平板电脑 - 不要咀嚼或压碎平板电脑，确保它不会溶解在口中。

片剂后一小时（60分钟）

不要躺下;如果你不直立或坐着，一些药物可能会回到你的食道

不要吃任何东西

不要喝任何东西（如有必要，除水外）

不要服用其他药物。

等了一个小时后，您可以享用每日第一餐和饮料。如果你已经吃过，你可以躺下，如果你愿意，可以根据需要服用其他药物

IBANDRONATE Bluefish 150 mg薄膜包衣片的患者信息

警告和注意事项

市场推出后，在用这种骨质疏松症制剂治疗的患者中很少报道副作用，即所谓的颌骨坏死（颌骨损伤）。治疗结束后也可能发生颚骨坏死。 尝试防止颚骨坏死的发展是很重要的，因为它非常疼痛并且难以治疗。为了降低发生颚骨坏死的风险，您应该采取一些预防措施。

在开始治疗之前，请通知医疗保健专业人员：

您的口腔或牙齿有问题，例如牙齿不好，牙龈疾病，或者如果您有牙齿可以拔牙。

您没有经常去牙科检查或长时间没有进行牙科检查

你吸烟（因为这会增加牙齿问题的风险）

您过去曾接受过双膦酸盐治疗（用于治疗或预防骨病）

他们服用所谓的皮质类固醇（包括泼尼松龙或地塞米松） 你有癌症

在您开始使用该药治疗之前，您的医生可能会要求您进行牙科检查。

在治疗期间，您必须具有良好的口腔卫生（包括定期刷牙）和定期牙科检查。如果您戴着义齿，请确保它适合。如果您正在接受牙科治疗或需要牙科护理（例如，如果需要拔牙），请告诉医生这种治疗方法并告诉您的牙医您正在接受该药治疗。 如果您的口腔或牙齿有问题，请立即告诉您的医生和牙医，包括牙齿松动，疼痛或肿胀，伤口愈合不良或口腔内分泌物过期。这些问题可能是颚骨坏死的迹象。

有些人在服用这种药物时需要格外小心。请在服用此药前咨询您的医生

。

如果您有任何矿物质代谢紊乱（例如维生素D缺乏症）。

如果您的肾脏无法正常工作。

如果吞咽或消化有问题。

食道中的刺激，炎症或溃疡，通常会出现严重胸痛，吞咽食物和/或饮料时剧烈疼痛，严重恶心或呕吐等症状，尤其是如果您不喝一整杯水和/或您在服药一小时后失效。如果您出现这些症状，请立即停止服用该药并立即与您的医生联系。

儿童和青少年

该产品不应用于18岁以下的儿童或青少年。

驾驶和使用机器

您可以驾驶和操作机器，因为预计该药对驱动和使用机器的能力没有影响或可忽略不计。

Areas of application of IBANDRONATE Bluefish 150 mg film-coated tablets

The medicine belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. The drug can counteract bone loss by stopping most bone loss and increasing bone mass in most women taking it, even if they do not see or feel any difference. The medicine can help reduce the risk of bone fractures (fractures). There was a decrease in lumbar spine fractures, but not in femoral neck fractures.

The drug is prescribed for the treatment of postmenopausal osteoporosis because you are at an increased risk for fractures. Osteoporosis is a thinning and weakening of bones that is common in postmenopausal women. During the menopause, the ovaries stop producing the female hormone estrogen, which helps to keep a woman's skeleton healthy.

The sooner a woman enters menopause, the greater the risk of bone fractures in osteoporosis. Other factors that can increase the risk of fractures are:

a lack of calcium and vitamin D in the diet smoke or too much alcohol

a lack of exercise or other physical activity Osteoporosis in the family history

I

n addition, a healthy lifestyle will help you achieve the greatest possible treatment success.

This includes:

a balanced diet rich in calcium and vitamin D.

Exercise or other physical activity not to smoke and not to drink too much alcohol.

Dosage of IBANDRONATE Bluefish 150 mg film-coated tablets

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the usual dose is one tablet once a month. Further intake

It is important that you take the medicine every month as long as your doctor prescribes it. If you have been taking the medicine for 5 years, talk to your doctor if you should continue taking it.

If you take more than you should

If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately.

Do not induce vomiting and do not lie down - this could injure your esophagus.

If you forgot to take it

If you forget to take your tablet on the morning of your chosen day, do not take any tablet later in the day.

Instead, look in your calendar to see when the next intake is scheduled.

If you forget to take your tablet on your chosen day and it takes only 1 to 7 days to take your next regular dose

Never take two tablets within the same week. Wait until the next scheduled dose and take your tablet as normal. Then continue to take one tablet per month on the originally scheduled days that you have marked in your calendar.

If you forget to take your tablet on your chosen day and it takes more than 7 days to take your next regular dose

Take one tablet the next morning after you have noticed the missed dose. Then continue to take one tablet per month on the originally scheduled days that you have marked in your calendar.

Interactions of IBANDRONATE Bluefish 150 mg film-coated tablets

Taking with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially at:

Supplementary preparations containing calcium, magnesium, iron or aluminum, as these may possibly influence the effect of the medicine.

Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen), as these may irritate the stomach and intestines. This medicine can also do this. Therefore, take extra care if you are taking painkillers or anti-inflammatories with this medicine at the same time.

Wait 1 hour after taking your monthly tablet before taking any other medicine, including gastrointestinal tablets, calcium or vitamin supplements.

Taking along with food and drink

The medicine must not be taken with food. It is less effective when taken with food. You can drink water but not other drinks. After taking the medicine, wait for food and drinks.

Side effects of IBANDRONATE Bluefish 150 mg film-coated tablets

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell a healthcare professional or doctor immediately if you experience any of the listed serious side effects - you may need emergency medical treatment immediately:

Uncommon: (may affect up to 1 in 100 people)

severe pain in the chest, severe pain when swallowing food or drink, severe nausea or vomiting, difficulties in swallowing. You may have severe esophagitis, possibly with inflammation or narrowing of the esophagus.

Rare: (may affect up to 1 in 1,000 people)

Itching, swelling of the face, lips, tongue and throat, accompanied by difficulty in breathing. persistent eye pain and inflammation newly occurring pain, weakness or discomfort in the thigh, hip or groin. You may have an early indication of a possible, atypical femoral fracture.

Very rare: (may affect up to 1 in 10,000 people)

Pain or inflammation in the mouth or jaw. You may have early signs of severe jaw problems (necrosis [dead bone tissue] in the jawbone)

Talk to your doctor if you have earache, discharge from the ear and / or ear infection. These could be signs of bone damage in the ear.

serious, possibly life-threatening, allergic reaction

severe skin reactions

Other possible side effects

Common: (may affect up to 1 in 10 people) a headache Heartburn, pain when swallowing, stomach or abdominal pain (possibly due to inflammation in the gastrointestinal tract), upset stomach, nausea, diarrhea Muscle cramps, stiffness in the joints or limbs Flu-like symptoms, including fever, chills and tremors, malaise, bone, muscle and joint pain. Talk to your doctor or nurse if any of these side effects affect you severely or last longer than a few days

skin rash

Uncommon: (may affect up to 1 in 100 people) dizziness

Flatulence (flatulence, feeling of being bloated)

back pain Feeling of fatigue and exhaustion

asthma attacks Rare: (may affect up to 1

in 1,000 people) Inflammation of the duodenum (first section of the small intestine), which causes abdominal pain

If you notice any side effects, consult your doctor or pharmacist. This also applies to side effects that are not specified

Contraindications for IBANDRONATE Bluefish 150 mg film-coated tablets

The medicine must not be taken,

if you are allergic to ibandronic acid or any of the other ingredients of this medicine.

if you are unable to stand or sit upright for at least one hour (60 minutes).

if you have a low level of calcium in the blood or have had it in the past. Please see your doctor.

Pregnancy and breast-feeding to IBANDRONATE Bluefish 150 mg film-coated tablets

This medicine is only for use in postmenopausal women and must not be used by women who may still have children.

Do not take the medicine if you are pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking this medicine.

Application to IBANDRONATE Bluefish 150 mg film-coated tablets

Taking the monthly tablet

It is important that you follow the instructions below carefully. These are designed to help the tablet reach your stomach quickly, making it less likely to irritate your esophagus.

Take one 150 mg tablet once a month.

Choose a day of the month that you can easily remember. You can choose either the same date (such as the 1st in every month) or the same day (such as the first Sunday of each month) to take your tablet. Choose the date that best fits your schedule.

Take your tablet at least 6 hours after the last consumption of food or drink (except water).

Take your tablet

after getting up in the morning, and before you eat or drink anything (on an empty stomach). Swallow your tablet with a full glass of water (at least 180 ml). Do not take your tablet with calcium-rich water, fruit juice or other drinks. If there are concerns about potentially high calcium levels in tap water (hard water), it is recommended to use bottled water with a low level of minerals. Swallow your tablet completely - do not chew or crush the tablet, making sure it does not dissolve in the mouth.

During the hour following the tablet (60 minutes)

do not lie down; If you do not stand upright or sit, some of the medicine could get back into your esophagus

do not eat anything

do not drink anything (except water, if necessary)

Do not take other medicines.

After waiting for an hour, you can have your first daily meal and drinks. If you have eaten, you can lie down, if you like, and take other medicines as needed

Patient Information on IBANDRONATE Bluefish 150 mg Film-coated Tablets

Warnings and Precautions

After the market introduction, a side effect, so-called jaw bone necrosis (bone damage of the jaw), has been reported very rarely in patients treated with this preparation for osteoporosis. A jawbone necrosis may also occur after treatment has ended. It is important to try to prevent the development of jawbone necrosis, as it is very painful and can be difficult to treat. To reduce the risk of developing jawbone necrosis, you should take certain precautions.

Before beginning treatment, inform the healthcare professional if:

You have problems with your mouth or teeth, such as bad teeth, gum disease, or if you have a tooth to pull.

You do not regularly go to the dental check or for a long time no dental check-up has been performed at you

You smoke (as this can increase the risk of dental problems)

You have already been treated with a bisphosphonate in the past (used to treat or prevent bone disease)

They take so-called corticosteroids (including prednisolone or dexamethasone) You have cancer

Your doctor may ask you to have a dental check up before you start treatment with this medicine.

During treatment, you must have good oral hygiene (including regular brushing) and regular dental check-ups. If you are wearing a denture, make sure it fits well. If you are undergoing dental treatment or need dental care (for example, if a tooth needs to be pulled), tell your doctor about this treatment and tell your dentist that you are being treated with this medicine. Tell your doctor and dentist immediately if you have problems with your mouth or teeth, including loose teeth, pain or swelling, non-healing wounds, or expiring secretion in the mouth. These problems can be signs of jawbone necrosis.

Some people need to be extra careful while taking this medicine. Please talk to your doctor

before taking this medicine.

if you have any disorders of the mineral metabolism (eg a vitamin D deficiency).

if your kidneys are not working normally.

if you have problems swallowing or digesting.

Irritation, inflammation or ulceration in the esophagus, often with symptoms such as severe chest pain, severe pain when swallowing food and / or drinks, severe nausea or vomiting may occur, especially if you do not drink a full glass of water and / or you have lapsed within an hour of taking the medicine. If you develop these symptoms, stop taking this medicine and contact your doctor immediately.

Children and adolescents

The product should not be used on children or adolescents under the age of 18 years.

Driving and using machines

You can drive and operate machinery as it is expected that this medicine will have no or negligible influence on the ability to drive and use machines.

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 详细处方信息以本药内容附件PDF文件（201891620532934.pdf）的“原文Priscribing Information”为准
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