通用名：雷奈酸锶　　

化学名：2-[N,N-二(羧甲基)氨基]-3-氰基-4-羧甲基-噻吩-5-甲酸二锶盐 　　

英文名：strontium ranelate 　　

分子式：C12H6N2O8SSr8•8H2O 　　

分子量：513.49 　　

适应症：主要用于治疗和预防绝经后妇女的骨质疏松，显著降低椎骨骨折及髋骨骨折发生的危险。 　　

制剂规格：口服混悬颗粒, 2g/袋。 　　

用法用量：推荐口服日剂量为一袋，每日一次，小袋中的颗粒须悬浮在一杯水中后立即饮用。推存该药应在两餐之间或就寝时服用，最好在进食后至少2小时服用。 　　

注意事项：肾功能不全：肌酐清除率高于15ml/min的肾功能不全患者不需要调整给药剂量，肌酐清除率低于15ml/min的肾功能不全患者，缺乏研究数据，应慎用本品。 　　

不良反应：常见的副作用是恶心、头痛、腹泻和皮肤刺激。

How does it work?

Protelos granules contain the active ingredient strontium ranelate, which is a medicine that strengthens bone.

Bone is not a static structure. It is continually shaped, reformed and rebuilt by cells called osteoblasts and osteoclasts. These cells continously deposit and remove calcium and phophorous, stored in a protein network that makes up the structure of the bone. Old bone is broken down by the osteoclasts and new bone is formed by the osteoblasts.

In women at the menopause, blood levels of the female hormone oestrogen start to decrease. This results in an increase in bone breakdown by the osteoclasts, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis - a condition in which the bones become weak and brittle and break (fracture) more easily.

Strontium ranelate is used to treat osteoporosis in women who have passed the menopause. It works by binding very tightly to the bone and preventing the calcium being removed by the osteoclasts. This stops the osteoclasts from breaking down the bone. Strontium ranelate also stimulates the formation of new bone by the osteoblasts. Both actions help to keep the bones strong and less likely to break.

In women who have passed the menopause, strontium ranelate has been shown to reduce the risk of spinal and hip fractures.

If your dietary intake of calcium and vitamin D is low, your doctor may also ask you to take supplements of these to help keep your bones strong. If so, do not take any calcium supplements at the same time of day as this medicine.

What is it used for?

• Osteoporosis in women who have passed the menopause.

Warning!

• Protelos granules should be mixed in a glass of water before taking. The suspension should be taken on an empty stomach, preferably at bedtime at least two hours after food, milk, milk products or calcium supplements. You should not eat for at least two hours after taking the granules. This is because food, milk, milk products and calcium can interfere with the absorption of the medicine from the gut and hence make it less effective.
• People with kidney problems should have their kidney function monitored regularly while taking this medicine.
• If you are due to have surgery or be immobile for a long period of time, you should talk to your doctor about continuing to take this medicine, as it may increase the risk of blood clots in the veins (eg deep vein thrombosis).
• Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms while taking this medicine: stabbing pains or swelling in one leg; pain on breathing or coughing; breathlessness; or coughing up blood.
• This medicine may rarely cause serious allergic reactions. For this reason, if you develop a skin rash, fever, swollen glands, swelling of the face, tongue or throat, or difficulty breathing or swallowing during treatment, you should stop taking this medicine and consult your doctor immediately.

Use with caution in

• Decreased kidney function.
• History of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).
• Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden.
• An inherited disorder of protein metabolism called phenylketonuria. (Protelos granules contain aspartame, which is a source of phenylalanine.)

Not to be used in

• Children.
• Pregnancy.
• Breastfeeding.
• This medicine is not recommended for people with severely decreased kidney function.

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 during pregnancy has not been established. It should not be used by pregnant women.
• This medicine passes into breast milk. It should not be used by women who are breastfeeding.

Label warnings

• Dissolve or mix with water before taking.
• Do not take indigestion remedies at the same time as this medicine.

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.

• Nausea.
• Diarrhoea.
• Headache.
• Eczema.
• Blood clots in the blood vessels (venous thromboembolism, eg deep vein thrombosis).
• Fainting.
• Memory loss.
• Seizures.
• Vomiting.
• Sore mouth.
• Abdominal pain.
• Allergic reactions.

The side effects listed above may not include all of the side effects reported by the drug'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.

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 medicines while taking this one, to ensure that the combination is safe.

The following medicines should not be taken in the two hours before or the two hours after taking your Protelos granules, as they may reduce the absorption of the medicine from the gut and make it less effective:

• calcium supplements
• multivitamins or other medicines containing calcium.

You should also avoid taking antacids (indigestion remedies) for at least two hours after taking Protelos granules. However, if this is not possible they can be taken at the same time.

This medicine may reduce the absorption of tetracycline antibiotics (eg tetracycline, minocycline, doxycycline) and quinolone antibiotics (eg ciprofloxacin, norfloxacin, nalidixic acid) from the gut and could make them less effective. If you are prescribed a course of one of these types of antibiotics the manufacturer recommends that you stop taking this medicine during the course of antibiotics.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain strontium ranelate as the active ingredient.

【原产地英文商品名】PROTEOS Granules 2G*28/BOX
【原产地英文药品名】strontium ranelate
【中文参考商品译名】PROTEOS 口服混悬颗粒 2克/袋 28袋/盒
【中文参考药品译名】雷尼酸锶
【生产厂家中文参考译名】施维雅公司
【生产厂家英文名】Servier S.I