等待内容更新

【药品名称】 

  通用名称：环孢素软胶囊

  英文名称：Ciclosporin Soft Capsules

【主要成份】 本品主要成份为：环孢素。其化学名称为：环[[(E)-(2S，3R，4R)-3-羟基-4-甲基-2-（甲氨基）-6-辛烯酰]-L-2氨基丁酰-N-甲基甘氨酰-N-甲基-L-亮氨酰-L-缬氨酰-N-甲基-L-亮氨酰-L-丙氨酰-D-丙氨酰-N-甲基-L-亮氨酰-N-甲基-L-亮氨酰-N-甲基-L-缬氨酰]。

【成 份】 

  分子式：C62H111N11O12

   分子量：1202.63

【性 状】 本品为软胶囊，内容物为淡黄色或黄色的澄明粘稠油状液体。

【适应症/功能主治】 1.适用于预防同种异体肾、肝、心、骨髓等器官或组织移植所发生的排斥反应，也适用于预防及治疗骨髓移植时发生的移植物抗宿主反应（GVHD）。 2.经其它免疫抑制剂治疗无效的狼疮肾炎、难治性肾病综合症等自身免疫性疾病。

【规格型号】25mg*50s(田可)

【用法用量】 1.器官移植：采用三联免疫抑制方案时，起始剂量6～11 mg/kg/日，并根据血药浓度调整剂量，根据血药浓度每2周减量0.5～1 mg/kg/日，维持剂量2～6 mg/kg/日，分2次口服。在整个治疗过程，必须在有免疫抑制治疗经验医生的指导下进行。 2.骨髓移植： 预防移植物抗宿主病：移植前一天起先用环孢素注射液，2.5 mg/kg/日，分2次静脉滴注，待胃肠反应消失后（约0.5～1月），改服本品，起始剂量6 mg/kg/日，分2次口服，一月后缓慢减量，总疗程半年。 治疗移植物抗宿主病：单独或在原用肾上腺皮质激素基础上加用本品，2～3 mg/kg/日，分2次口服，待病情稳定后缓慢减量，总疗程半年以上。 3.狼疮肾炎、难治性肾病综合征：初始剂量4～5 mg/kg/日，分2次口服，出现明显疗效后缓慢减量至2～3 mg/kg/日，疗程3～6月以上。

【不良反应】 1、较常见的有厌食、恶心、呕吐等胃肠道反应，牙龈增生伴出血、疼痛、约1/3用药者有肾毒性，可出现血清肌酐、尿素氮增高、肾小球滤过率减低等肾功能损害、高血压等。牙龈增生一般可在停药6个月后消失。慢性、进行性肾中毒多于治疗后约12个月发生。 2、不常见的有惊厥，其原因可能为本品对肾脏毒性及低镁血症有关。此外本品尚可引起氨基转移酶升高、胆汁郁积、高胆红素血症、高血糖、多毛症、手震颤、高尿酸血症伴血小板减少、微血管病性溶血性贫血、四肢感觉异常、下肢痛性痉挛等。此外，有报告本品可促进ADP诱发血小板聚集，增加血栓烷A2的释放和凝血活酶的生成，增强因子Ⅶ的活性，减少前列环素产生，诱发血栓形成。 3、罕见的有过敏反应、胰腺炎、白细胞减少、雷诺综合征、糖尿病、血尿等。（过敏反应一般只发生在经静脉途径给药的患者，表现为面、颈部发红，气喘、呼吸短促等。）严重各种不良反应大多与使用剂量过大有关，防止反应的方法是经常监测本品的血药浓度，调节本品的全血浓度，使能维持在临床能起免疫抑制作用而不致有严重不良反应的范围内。有报道认为如在下次服药前测得的本品全血谷浓度约为100～200ng／ml，则可达上述效应。如发生不良反应，应立即给相应的治疗，并减少本品的用量或停用。

【禁 忌】 1.对环孢素过敏者禁用。 2.有病毒感染时禁用本品：如水痘、带状疱疹等。

【注意事项】 1、本品经动物实验证明有增加致癌的危险性。在人类虽也有并发淋巴瘤、皮肤恶性肿瘤的报告，但尚无导致诱变性的证据。 2、本品可以通过胎盘。应用2～5倍于人类的剂量对鼠、兔胚胎及胎儿可产生毒性，但按人类常规剂量用药，未见到该类动物的胚胎有致死或致畸的发生。 3、下列情况慎用：肝功能不全、高钾血症、感染、肠道吸收不良、肾功能不全、对服本品不耐受等。 4、对诊断的干扰： (1)用本品最初几日，血尿素氮及肌酐可升高，这并不一定表明是肾脏移植的排斥反应； (2)血清丙氨酸氨基转移酶[ALT]、门冬氨酸氨基转移酶[AST]、淀粉酶、碱性磷酸酶、血胆红素可因本品对肝脏的毒性而升高； (3)血清镁浓度可减低，此与本品的肾毒性有关； (4)血清钾、血尿酸可能升高。 5、若本品已引起肾功能不全或有持续负氮平衡，应立即减量或至停用。 6、若发生感染，应立即用抗生素治疗，本品亦应减量或停用。 7、若移植发生排斥，本品剂量应加大。 8、在预防治疗器官或组织移植排斥反应及治疗自身免疫性疾病方面，本品的剂量常因治疗的疾病、个体差异、用本品后的血药浓度不相同而并不完全统一，小儿对本品的清除率较快，故用药剂量可适当加大。 9、仅在服用前，才从铝箔泡罩中取出。

【儿童用药】儿童用量可按或稍大于成人剂量计算。

【老年患者用药】老年患者因易合并肾功能不全，故应慎用本品。

【孕妇及哺乳期妇女用药】本品可进入乳汁。对哺乳的婴儿可产生高血压、肾毒性、恶性肿瘤等不良作用的潜在危险性，故用本品期间不宜哺乳。

【药物相互作用】 1.本品与雌激素、雄激素、西咪替丁、地尔硫卓、红霉素、酮康唑等合用，可增加本品的血浆浓度。因而可能使本品的肝、肾毒性增加。故与上述各药合用时须慎重，应监测患者的肝、肾功能及本品的血药浓度。 2.与吲哚美辛等非甾体消炎镇痛药合用时，可使发生肾功能衰竭的危险性增加。 3.用本品时如输注贮存超过10日的库存血或本品与保钾利尿剂、含高钾的药物等合用，可使血钾增高。 4.与肝酶诱导剂合用：由于会诱导肝微粒体的酶而增加本品的代谢。故须调节本品的剂量。 5.与肾上腺皮质激素、硫唑嘌呤、苯丁酸氮芥、环磷酰胺等免疫抑制剂合用。可能会增加引起感染和淋巴增生性疾病的危险性，故应谨慎。 6.与洛伐他汀(降血脂药)合用于心脏移植患者，有可能增加横纹肌溶解和急性肾功能衰竭的危险性。 7.与能引起肾毒性的药合用，可增加对肾脏的毒性。如发生肾功能不全，应减低药品的剂量或停药。

【药物过量】未进行该项实验且无可靠参考文献。

【药理毒理】环孢素(又称环孢素A)为11个氨基酸组成的环状多肽。本品是一种强效免疫抑制剂，可逆地特异作用于淋巴细胞。动物试验表明环孢素可延长同种异体器官(皮肤、心脏、肾脏、胰脏、骨髓、小肠和肺)移植的存活时间、抑制细胞介导免疫反应(包括同种异体免疫反应、迟发性皮肤过敏反应、实验性变应性脑脊髓炎、弗氏佐剂性关节炎、移植物抗宿主反应和依赖T细胞的抗体生成)。本品尚能抑制淋巴因子(包括IL—II)的合成和释放，阻断静止淋巴细胞于细胞周期G0期G1期的早期。本品不抑制红细胞生成，亦不影响吞噬细胞功能。使用本品患者与应用其他免疫抑制剂患者相比感染发生率较低。

【药代动力学】环孢素主要分布于血管外的全身各组织中，脂肪内浓度最高，其次为肝、肾上腺和胰脏。血液中33～47%的环孢素存在于血浆中，4～9%存在于淋巴细胞中，5～12%在粒细胞中，41～58%在红细胞中，血浆中90%的环孢素与蛋白（主要为脂蛋白）结合。 环孢素经肝脏代谢，已知代谢产物有15种，消除半衰期为10～27小时左右，主要以代谢物经胆汁及粪便排泄，尿中仅0.1%以原药形式排出。

【贮 藏】遮光，密闭保存。

 

 

 

 

 

Neoral Capsules

Ciclosporin

 

Brand Information

Brand name

Neoral Capsules

Active ingredient

Ciclosporin

Schedule

S4

 

What is in this leaflet

This leaflet answers some common questions about Neoral.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Neoral against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What Neoral is used for

Neoral is used for people who have had a kidney, heart or liver transplant, to prevent the body from rejecting the new organ. It does this by blocking the development of special cells which would normally attack the transplanted tissue.

Neoral is also used to treat several other conditions which are thought to be caused by a problem with the immune system:

· a kidney disease called nephrotic syndrome

· severe cases of rheumatoid arthritis (a disease, affecting the joints with pain and swelling)

· severe cases of:
- psoriasis (a skin disease with thickened patches of red skin, often with silvery scales)
- atopic dermatitis (skin allergies)

Neoral contains the active ingredient, cyclosporin. It belongs to a group of medicines called immuno-suppressive agents. These medicines help to control your body's immune system.

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

Your doctor may have prescribed it for another reason.

Neoral is only available with a doctor's prescription. It is not addictive.

Before you take NeoralWhen you must not take it

Do not take Neoral if you have ever had an allergic reaction to cyclosporin, the active ingredient in Neoral, or to any of the other ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include hives or an itchy skin rash, swelling of the face, lips or tongue, faintness, wheezing or troubled breathing.

If you think you may be allergic to Neoral, ask your doctor for advice.

Do not take Neoral after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

In that case, return it to your pharmacist.

Do not give Neoral to a child under 16 years of age to treat severe rheumatoid arthritis, psoriasis or atopic dermatitis.

There is not enough information to recommend its use for these diseases in children under 16 years of age. However, Neoral can be used in children younger than 16 who have had an organ transplant or who have nephrotic syndrome.

Before you start to take it

If you have been prescribed Neoral for nephrotic syndrome, rheumatoid arthritis, psoriasis or atopic dermatitis, tell your doctor if you also have any of these health problems/medical conditions:

· high blood pressure that is not controlled

· any uncontrolled infection

· a poorly functioning immune system

· problems with your kidneys or liver

· severe heart, lung or blood vessel disease

· any type of cancer, including skin cancer

Your doctor may not want you to take Neoral or may want to take special precautions if you have any of these conditions.

If you are being treated with Neoral for psoriasis or atopic dermatitis, you should not concurrently receive UVB-rays or phototherapy.

Tell your doctor if you are pregnant or intend to become pregnant.

Experience with Neoral in pregnancy is very limited. The use of immunosuppressant medicines, including cyclosporin, during pregnancy has been shown to increase the risk of problems in the mother and the unborn child. If it is necessary for you to take this medicine, your doctor will discuss with you the benefits and risks of taking it during pregnancy.

Tell your doctor if you are breast-feeding.

Breast-feeding is not recommended since cyclosporin, the active ingredient in Neoral, passes into breast milk and may affect your baby.

Taking other medicines

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

Many other medicines may be affected by Neoral or they may affect how well Neoral works. This includes:

· St John's wort, an ingredient in many medicines that you can buy without a prescription from a pharmacy, health food shop or supermarket

· methotrexate, a medicine to treat severe rheumatoid arthritis, some types of cancers, and psoriasis

· antibacterial amino glycoside-type agents (e.g. gentamicin, tobramycin)

· antifungal agents containing amphotericin B

· antibacterial agents containing ciprofloxacin

· cytostatics containing melphalan

· agents used to treat urinary tract infection containing trimethoprim

· medicines used to treat pain (non-steroid anti-inflammatory drugs, e.g. diclofenac)

· acid secretion inhibitors of the H2-receptor antagonist type (e.g. cimetidine, ranitidine) , which are used to reduce the amount of acid in your stomach

· other drugs which may affect the kidneys

· antibacterial agents of the macrolide type (e.g. clarithromycin, azithromycin, erythromycin)

· antifungal agents of the azole type (e.g. fluconazole, itraconazole, ketoconazole, voriconazole) or terbinafine

· oral contraceptives (Levonorgestrel and Norethisterone)

· protease inhibitors, used to treat or prevent infections caused by viruses

· imatinib, a medicine used to treat some cancers

· anthracycline anticancer medicines, such as doxorubicin

· certain blood pressure reducing agents of the calcium antagonist type (e.g. nifedipine, amlodipine, verapamil, diltiazem, amiodarone) or of the endothelin receptor antagonist type (e.g. bosentan, ambrisentan)

· certain anticonvulsives, used to prevent fits or seizures (e.g. carbamazepine, phenytoin)

· digoxin, a medicine used to treat heart failure

· colchicine, used to treat gout disease with painful, swollen joints

· HMG-CoA reductase inhibitors (statins), or fibric acid derivatives, which are used to treat high cholesterol

· prednisolone, a corticosteroid used to treat inflammatory diseases such as arthritis, asthma, colitis

· etoposide, used to treat cancer

· repaglinide, used to treat Type II diabetes

· aliskiren, used to treat high blood pressure

· potassium sparing drugs or potassium containing drugs

· triclopidine (a medicine that is used after a stroke)

· octreotide, a medicine used to treat excess growth hormone, relieve the symptoms of certain types of cancer, or having surgery on the pancreas

· orlistat, used to help with weight loss

· danazol, a medicine used to treat menstrual disorders

· allopurinol, a medicine used to treat gout (a disease with painful, swollen joints caused by uric acid crystals)

· metoclopramide, a medicine used to prevent nausea and vomiting

· cholic acid and derivatives, which are used to treat gallstones

· tacrolimus, everolimus, or sirolimus, which are medicines that lower your immunity

· dabigatran, an anticoagulant medicine used to prevent stroke

You may need to take different amounts of your medicines or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Neoral.

If you have not told your doctor about any of these things, tell him/her before you take Neoral.

How to take Neoral

Follow all directions given to you by your doctor and pharmacist carefully.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

If you are changing from Sandimmun® to Neoral

Some patients who have been prescribed Neoral would have taken Sandimmun in the past. Like Neoral, Sandimmun contains the medicine, cyclosporin. Neoral, however, is designed to improve the way cyclosporin gets into your bloodstream. Because of this, your dose of Neoral may eventually be less than the dose of Sandimmun you used to take.

If you are changing from Sandimmun to Neoral, your doctor will perform some extra blood tests and then decide whether to change your dose of Neoral.

Do not change from Neoral to Sandimmun or from Sandimmun to Neoral unless it is under the strict supervision of your doctor.

Do not take Neoral and Sandimmun at the same time.

How much to take

The dose of Neoral is worked out for each person. It will depend on how much you weigh, what condition is being treated, how well Neoral works for you, and whether you have any side effects from this medicine. Your dose may be changed from time to time.

How to take it

Capsules:

· Do not remove the capsules from the foil blister pack until you are ready to take them.

· Swallow the capsules whole with a full glass of water.

· Do not chew them.

Oral solution:

The oral solution is provided with two syringes for measuring the doses. The 1-mL syringe is used to measure doses less than or equal to 1 mL (each graduation of 0.05 mL corresponds to 5 mg of cyclosporin). The 4-mL syringe is used to measure doses greater than 1 mL and up to 4 mL (each graduation of 0.1 mL corresponds to 10 mg of cyclosporin). The oral solution should be diluted in a glass, not plastic container.

· Measure out the dose using the syringe provided.

· Add the dose to a glass of orange juice, apple juice or soft drink just before you take it.

· Do not use grapefruit juice.

· Make sure the syringe does not touch the liquid in the glass.

· Stir the liquid well immediately before drinking it.

· Rinse the container with more juice or soft drink to make sure that the whole dose has been taken.

· Wipe the outside of the syringe with a clean, dry tissue and put it back into its case. Do not wash the syringe with water, alcohol or any other liquid.

For full details on how to take Neoral oral solution, read the separate leaflet contained in the carton.

When to take it

Always take Neoral twice a day. It is best to take the doses 12 hours apart if possible. Take them at about the same time each day.

Taking your doses 12 hours apart and at the same time each day will have the best effect. It will also help you remember when to take them.

How long to take it

Keep taking this medicine for as long as your doctor recommends.

The length of treatment will depend on what medical condition you have.

For transplant patients: 
you will need to take one or more immunosuppressant medicines for as long as you have the transplanted organ.

For nephrotic syndrome: 
you may take Neoral for 3 months to start with. If it helps your condition, your doctor may decide to continue Neoral treatment for as long as it helps you and does not cause serious side effects.

For severe rheumatoid arthritis: 
you will usually take Neoral for 3 months to start with. It may take this long to know whether Neoral will help your condition. If Neoral is effective, your doctor may then lower the dose and you will continue treatment at the lowest dose that is suitable for you.

For severe psoriasis: 
you will usually take Neoral for up to 6 weeks to start with. If your condition improves, your doctor may want you to continue treatment at the lowest effective dose. You can only expect to benefit from this medicine while you continue to take it.

For severe atopic dermatitis: 
you will usually take Neoral for up to 8 weeks to start with. Once your condition has improved, the dose may be slowly reduced, and in some cases, may even be stopped. Once you have stopped taking Neoral, your condition is likely to return, although this may take several weeks or months. Your doctor may then want you to start taking Neoral again.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the one that you missed.

This may increase the chance of you getting an unwanted side effect.

If you miss more than one dose, contact your doctor as soon as possible.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (Overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone number 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Neoral. Do this even if there are no signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

While you are taking NeoralThings you must do

Take Neoral exactly as your doctor has prescribed.

You must take this medicine exactly as prescribed so that it will work properly and to prevent unwanted side effects.

Make sure that you keep all of your doctor's appointments and have any tests done that are ordered by your doctor.

Your doctor may ask you to have tests from time to time to check how well your kidneys and liver are working. It may be necessary to measure the amount of cyclosporin, as well as the levels of other chemicals (eg. potassium) in your blood. Your blood pressure will also be checked regularly.

Avoid eating large amounts of foods that are high in potassium.

In some people taking Neoral, the amount of potassium in the blood can increase (called hyperkalaemia). The amount of potassium in the blood can also be increased by eating certain foods. Your doctor can tell you which foods to avoid.

If you become pregnant while taking Neoral, tell your doctor.

Your doctor can discuss with you the risks of taking it while you are pregnant.

If you develop lumps anywhere on/in your body, or develop any moles, or you notice changes in existing moles, tell your doctor.

This may be an early sign of a cancer. Immunosuppressant medicines, including Neoral, may increase the risk of developing certain cancers, including skin cancer and lymphoma (cancer of the lymphatic system).

Limit your exposure to sunlight and UV light. If you go out in the sun, wear a hat, appropriate protective clothing and a sunscreen with a high protection factor.

This will help to prevent the development of skin cancer.

If you have psoriasis or atopic dermatitis, you must be especially careful about developing skin cancer. Visit your skin specialist regularly for check-ups.

Take special care of your teeth and gums.

If you experience any symptoms of infection (e.g. fever, sore throat), inform your doctor immediately.

People taking immunosuppressant medicines are at a greater risk of getting infections. Taking good care of your teeth and gums will help to prevent dental and mouth infections.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Neoral.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Neoral.

Things you must not do

Do not take Neoral with grapefruit or grapefruit juice since this can influence Neoral's effects.

Do not have any vaccinations without first checking with your doctor.

Some vaccines may be less effective or they may cause unwanted side effects while you are taking Neoral.

Do not give this medicine to anyone else even if their condition seems similar to yours.

Do not take it to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to be alert while you are taking Neoral until you know how it affects you.

This medicine can cause tiredness, lack of energy or confusion in some people. If you have any of these symptoms, do not drive or do anything else that could be dangerous.

Neoral soft gelatin capsules and oral solution contain alcohol (ethanol). The capsules contain 11.8 vol. % alcohol, i.e. up to 500 mg per dose in the transplantation indications equivalent to 12.6 mL beer, 5 mL wine per dose. The oral solution contains 12.0 vol. % alcohol, i.e. up to 500 mg per dose in the transplantation indications equivalent to 12.6 mL beer, 5.3 mL wine per dose.

Alcohol may be harmful for those suffering from alcoholism, epilepsy, brain injury or liver disease as well as for pregnant or breast-feeding women and children.

Like other medicines that dampen the immune system, cyclosporin may influence your body's ability to fight against infection and may cause tumours or other malignancies, particularly of the skin.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Neoral, even if you do not think it is connected with the medicine.

All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects. Your doctor may be able to relieve some of the side effects of Neoral by lowering the dose.

If you are over 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your doctor.

As people grow older, they are more likely to get side effects from medicines.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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:

· tiredness, lack of energy

· burning feeling in hands and feet, usually during the first week of treatment

· excessive growth of body and facial hair

· overgrown, thickened, swollen or bleeding gums

· stomach upset, including nausea (feeling sick), vomiting, loss of appetite, diarrhoea, stomach cramps, stomach ulcer

· tremor (shaking)

· headache, including migraine

· sensitivity to light

· weight loss or gain

· feeling depressed (sad)

· flushing of face, acne, darkening of skin

· painful menstrual periods or lack of periods

· increase in size of breasts in males and females

· muscle cramps, tenderness or weakness

· blocked or stuffy nose

· pain of lower extremities

The above side effects are not usually serious.

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

· fever (temperature above 37°C)

· constant "flu-like" symptoms such as chills, sore throat, aching joints, swollen glands, or any other signs of infection

· unusual bleeding or bruising

· signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing

· new lumps or moles, or changes to existing moles, anywhere on the body

· swelling of the eyelids, hands or feet due to excess fluid

· a change in the amount of urine passed or in the number of times you urinate, pain on urinating, bloody or smelly urine

· yellowing of the skin and/or eyes (jaundice) often accompanied by generally feeling unwell (for example, tiredness, lack of energy, loss of appetite, nausea and vomiting, pain in the abdomen)

· severe pain or tenderness in the stomach or abdomen

· vomiting blood or material that looks like coffee grounds; black sticky bowel motions or bloody diarrhoea

· unusual tiredness or weakness, which may be accompanied by dizziness, spots before the eyes, shortness of breath and pale skin

· numbness or "pins and needles" in the hands and feet

· a disturbance in brain function which may cause a variety of symptoms, including personality changes, confusion, disorientation, agitation, inability to sleep, decreased responsiveness, weakness and loss of coordination in arms and legs with or without abnormal speech or eye movements, seizures (fits), clumsiness, memory loss, difficulty speaking or understanding what others say, visual hallucinations (seeing things that are not there) or other problems with vision, coma, paralysis of part or all of the body, stiff neck

· buzzing or ringing in the ears, difficulty hearing

The above are serious side effects that need medical attention.

Some side effects may not give you any symptoms and can only be found when tests are done. Some of these side effects include:

· changes in kidney or liver function, or liver injury (with or without yellow eyes or skin)

· raised blood pressure

· increase in the amount of potassium or cholesterol in the blood

· decrease in the amount of magnesium in the blood

· increase in the amount of uric acid in the blood, which can lead to gout

· increase in blood sugar

· low white blood cell count

· low levels of red blood cells

· low levels of platelets in the blood

Your doctor will make sure that tests are done regularly to watch for these side effects.

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

If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Other side effects not listed here may happen in some people.

After using NeoralStorage

Capsules:

· Keep your capsules in the foil blister pack until it is time to take them. If you take the capsules out of the blister pack, they will not keep well.

· Store the pack in a cool dry place where the temperature stays below 25°C.

Oral solution:

· Do not keep the bottle of oral solution in the fridge. Store it in a cool dry place, where the temperature stays between 20°C and 25°C. At low temperatures, the solution may start to go cloudy, or even start to set like a jelly. It will turn back to a liquid when kept at a warmer temperature. There may still be some small flakes in the liquid after it warms up. These flakes will not affect how Neoral works.

· Once the bottle has been opened, use the solution within 2 months. After that time, dispose of any solution that is left over.

Keep the medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Neoral or it has passed its expiry date, ask your pharmacist what to do with any medicine you have left over.

Product descriptionWhat it looks like

Neoral 10 mg capsules: 
yellow-white, oval, soft gelatin capsules, printed in red with the "NVR" and "10" in foil blister packs of 60.

Neoral 25 mg capsules: 
blue-grey, oval, soft gelatin capsules, printed in red with the "NVR" and "25 mg;" in foil blister packs of 30.

Neoral 50 mg capsules: 
yellow-white, oblong, soft gelatin capsules, printed in red with the "NVR" and "50 mg;" in foil blister packs of 30.

Neoral 100 mg capsules: 
blue-grey, oblong, soft gelatin capsules, printed in red with the "NVR" and "100 mg;" in foil blister packs of 30.

Neoral oral solution: 
clear, faintly yellow-brownish liquid in a 50 mL glass bottle, with a 1mL and 4mL syringe for measuring the dose.

Ingredients

Neoral capsules contain 10 mg, 25 mg, 50 mg or 100 mg of cyclosporin. Neoral oral solution contains cyclosporin 100 mg in each mL of solution.

The capsules and oral solution also contain:

· dl-alpha-tocopherol

· alcohol

· propylene glycol

· corn glycerides

· polyoxyl 40 hydrogenated castor oil

Neoral capsule shells contain:

· gelatin

· propylene glycol

· glycerol (E422)

· titanium dioxide (E171)

· iron oxide black CI 77499 (E172) (25 mg & 100 mg capsule shells only)

The printing ink on the capsules contains:

· carminic acid CI 75470 (E120)

· aluminium chloride

· sodium hydroxide

· hydroxypropyl methylcellulose 2910 [E464]

Sponsor

Neoral is supplied in Australia by:

NOVARTIS Pharmaceuticals
Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone: 1 800 671 203
® = Registered Trademark

Australian Registration Numbers:

Neoral 10mg capsule AUST R 59614

Neoral 25mg capsule AUST R 49722

Neoral 50mg capsule AUST R 49723

Neoral 100mg capsule AUST R 49724

Neoral oral solution AUST R 49725

This leaflet was prepared in November 2014

(neo041114c.doc) based on PI (neo041114i.doc)