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| cyclosporine |
What Sandimmun Neoral is and what it is used for
What Sandimmun Neoral is
The name of this drug is Sandimmun Neoral. It contains the active substance ciclosporin. It belongs to a group of medicines called immunosuppressants. These drugs are used to suppress the body’s immune reactions.
What Sandimmun Neoral is used for and how Sandimmun Neoral works
- If you have had an organ transplant or undergone a bone marrow and stem cell transplant, Sandimmun Neoral is used to control the body’s immune system. Sandimmun Neoral prevents transplanted organs from being rejected by blocking the development of certain cells that would normally attack the transplanted tissue.
- If you have an autoimmune disease, which means that the body’s immune system attacks your cells, Sandimmun Neoral stops this immune response. Such diseases can be eye problems that threaten your vision ( endogenous uveitis, also Behçets uveitis ), severe cases of certain skin diseases (atopic dermatitis ie eczema, and psoriasis ), severe rheumatoid arthritis, and a kidney disease called nephrotic syndrome.
Ciclosporin contained in Sandimmun Neoral may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Sandimmun Neoral
Do not use this medicine
If you are taking Sandimmun Neoral after a transplant, it will only be prescribed to you by a doctor who has experience with transplants and/or autoimmune diseases.
The advice given in this leaflet may vary depending on whether you are taking the medicine after a transplant or because of an autoimmune disease.
Always follow your doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Do not take Sandimmun Neoral:
- if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
- together with agents containing Hypericum perforatum ( St. John’s wort ).
- together with agents containing dabigatran etexilate (used to prevent blood clots after surgery) or bosentan and aliskiren (used to lower high blood pressure ).
Do not take Sandimmun Neoral and tell your doctor if the above applies to you. If you are not sure, talk to your doctor before taking Sandimmun Neoral.
Warnings and cautions
Before and during treatment with Sandimmun Neoral, tell your doctor immediately:
- if you have any signs of infection, such as fever or sore throat. Sandimmun Neoral weakens the immune system and can also affect the body’s ability to fight infection.
- if you have liver problems.
- if you have kidney problems. Your doctor will take blood samples at regular intervals and may change your dose if necessary.
- if you get high blood pressure. Your doctor will check your blood pressure at regular intervals and may, if necessary, give you a medicine that lowers your blood pressure.
- if you have low magnesium levels in your body. Your doctor may give you magnesium supplements, especially immediately after surgery.
- if you have high potassium levels in your blood.
- if you have gout.
- if you are to be vaccinated.
If any of the above applies to you before or during treatment with Sandimmun Neoral, tell your doctor straight away.
Sunlight and sun protection
Sandimmun Neoral weakens your immune system. This increases your risk of getting cancer, especially skin cancer and cancer of the lymphatic system. You should limit your exposure to sunlight and UV light by:
- wear appropriate clothing that protects.
- often apply sunscreen with a high protection factor.
Talk to your doctor before taking Sandimmun Neoral:
- if you have or have had alcohol-related problems.
- if you have epilepsy.
- if you have any liver problems.
- if you are pregnant.
- if you are breastfeeding.
- if this medicine is prescribed for a child.
If any of the above apply to you (or you are not sure), tell your doctor before taking Sandimmun Neoral. The reason for this is that the medicine contains alcohol (see section “Sandimmun Neoral contains alcohol” below).
Check during treatment with Sandimmun Neoral
Your doctor will check:
- the level of cyclosporine in your blood, especially if you have had a transplant,
- your blood pressure before starting treatment and at regular intervals during treatment,
- how well your liver and kidneys are working,
- your blood fats.
If you have any further questions on the use of Sandimmun Neoral or why it has been prescribed for you, ask your doctor.
If you are prescribed Sandimmun Neoral for reasons other than transplantation ( intermediate or posterior uveitis and Behçet’s uveitis, atopic dermatitis, severe rheumatoid arthritis, or nephrotic syndrome ), you should not take Sandimmun Neoral:
- if you have kidney problems (except nephrotic syndrome ).
- if you have an infection that has not healed after drug treatment.
- if you have any type of cancer.
- if you have high blood pressure ( hypertension ) that has not improved with medication. If you get high blood pressure during treatment and it can not be controlled with drug treatment, your doctor should stop treatment with Sandimmun Neoral.
Do not take Sandimmun Neoral if any of the above apply to you. Talk to your doctor or pharmacist before taking Sandimmun Neoral if you feel unsure.
If you are being treated for Behçet’s uveitis, your doctor will check you especially closely if you have neurological symptoms (for example, if you become more forgetful, notice that your personality changes, get psychiatric illnesses or mood swings, a burning sensation in the arms or legs, decreased sensation in arms or legs, tingling in arms or legs, weakness in arms or legs, difficulty walking, headache with or without nausea and vomiting, visual disturbances including restriction of eyeball movements).
Your doctor will monitor you closely if you are older and being treated for psoriasis or atopic dermatitis. If you have been prescribed Sandimmun Neoral for the treatment of psoriasis or atopic dermatitis, you must not be exposed to UVB radiation or phototherapy (light therapy) during treatment.
Children and young people
Sandimmun Neoral should not be given to children for a non-transplant disease, except for treatment of the nephrotic syndrome.
Elderly people (from 65 years)
Experience in treating elderly patients with Sandimmun Neoral is limited. Your doctor should monitor how well your kidneys are working. If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Sandimmun Neoral if your disease is very serious.
Other medicines and Sandimmun Neoral
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Sandimmun Neoral:
- Drugs that can affect your potassium levels. These include medicines containing potassium, potassium supplements, diuretics, so-called potassium-sparing diuretics, and certain medicines that lower blood pressure.
- Methotrexate is used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.
- Drugs that may increase or decrease the level of ciclosporin (the active substance in Sandimmun Neoral) in the blood. Your doctor may need to check the level of ciclosporin in your blood when you start or stop taking other medicines.
- Drugs that can increase ciclosporin levels in the blood are antibiotics (for example erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines for heart problems or high blood pressure ( diltiazem, nicardipine, verapamil, loperamide ), metokamide -pills, danazol (for menstrual disorders), medicines for gout (allopurinol), cholic acid and its derivatives (used for gallstones ), protease inhibitors for HIV, imatinib (used for leukemia or tumors ), colchicine, telaprevir (used for hepatitis C).
- Drugs that can lower ciclosporin levels in the blood are barbiturates (for difficulty sleeping), certain seizures (such as carbamazepine or phenytoin ), octreotide (used for acromegaly or neuroendocrine tumors in the stomach), antibacterial drugs for tuberculosis ( or listen), orlistat, herbal medicines containing St. John’s wort, ticlopidine (used after stroke ), certain medicines that lower blood pressure ( bosentan ), and terbinafine (a medicine used to treat fungus on the toes and nails).
- Drugs that can affect your kidneys. These include antibacterial drugs (gentamycin, tobramycin, ciprofloxacin ), antifungal drugs that contain amphotericin B, drugs for urinary tract infections that contain trimethoprim, cancer drugs that contain melphalan, drugs that lower the acid content of the stomach (acid receptor) tacrolimus, analgesics (non-steroidal anti-inflammatory drugs such as diclofenac ), drugs containing fibrates (used to lower blood fats).
- Nifedipine is used to treat high blood pressure and pain in the heart. You can get swollen gums that grow down over your teeth if you take nifedipine while taking ciclosporin.
- Digoxin (for heart problems), cholesterol-lowering drugs (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used in cancer), repaglinide (for diabetes ), immunosuppressive drugs (everolimus, sirolimus), ambrisentan and specific cold drugs anthracyclines (eg doxorubicin).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Sandimmun Neoral.
Sandimmun Neoral with food and drink
Do not take Sandimmun Neoral with grapefruit or grapefruit juice. These can affect how Sandimmun Neoral works.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the possible risks of taking Sandimmun Neoral during pregnancy.
- Tell your doctor if you are pregnant or planning to become pregnant. Experience with Sandimmun Neoral during pregnancy is limited. Generally, Sandimmun Neoral should not be taken during pregnancy. If you need to be treated with this medicine, your doctor will talk to you about the benefits and possible risks of taking it during pregnancy.
- Tell your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment with Sandimmun Neoral. The active substance ciclosporin passes into breast milk. This can affect the baby.
Hepatitis C
Tell your doctor if you have hepatitis C. Your liver function may change when you treat hepatitis C and this may affect the levels of ciclosporin in your blood. Your doctor may need to monitor your ciclosporin levels in the blood closely and make dose adjustments after you start treatment for hepatitis C.
Driving and using machines
Sandimmun Neoral contains alcohol. This may affect your ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sandimmun Neoral contains alcohol
Sandimmun Neoral contains 10, 25, 50, 100 mg alcohol ( ethanol ) per 10, 25, 50, 100 mg Sandimmun Neoral capsule, corresponding to 11.8% by volume. A 500 mg dose of Sandiummun Neoral contains 500 mg of ethanol, which is equivalent to almost 13 ml of beer or 5 ml of wine.
The low amount of alcohol in this medicine does not produce any noticeable effects.
Sandimmun Neoral contains macrogol glycerol hydroxy stearate
Sandimmun Neoral contains macrogol glycerol hydroxy stearate which may cause stomach upset and diarrhea.
Sandimmun Neoral contains propylene glycol
This medicine contains 20.84 mg of propylene glycol per 10 mg capsule
This medicine contains 46.42 mg propylene glycol per 25 mg capsule
This medicine contains 90.36 mg propylene glycol per 50 mg capsule
This medicine contains 148.31 mg propylene glycol per 100 mg capsule
If your child is younger than 4 weeks, consult a doctor or pharmacist before using the medicine, especially if the child is taking other medicines that contain propylene glycol or alcohol.
Sandimmun Neoral contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 10, 25, 50, and 100 mg capsules, ie. is next to “sodium-free”
How to take Sandimmun Neoral
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Do not take more than the recommended dose.
The dose of one of these medicines will be carefully adjusted by your doctor to suit you. Too high a dose of medicine can affect your kidneys. Blood tests and hospital visits will be done regularly, especially after a transplant. Then you get the opportunity to talk to the doctor about the treatment and any problems.
How much Sandimmun Neoral to take
Your doctor will decide which dose of Sandimmun Neoral is right for you. It depends on your body weight and the reason you are taking the medicine. Your doctor will also tell you how often to take this medicine.
- For adults:
Organ, bone marrow, or stem cell transplantation- The total daily dose is usually between 2 mg and 15 mg per kilogram of body weight. This is divided into two occasions per day.
- Higher doses are often used before and shortly after transplantation. Lower doses are used as soon as the transplanted organ or bone marrow has stabilized.
- Your doctor will adjust the dose so that it is the best for you. To be able to do this, the doctor may need to take some blood samples. Endogenous uveitis
- The total daily dose is usually between 5 mg and 7 mg per kilogram of body weight. This is divided into two occasions per day. Nephrotic syndrome
- The total daily dose for adults is usually 5 mg per kilogram of body weight. This is divided into two occasions per day. In patients with kidney problems, the first dose taken daily should not exceed 2.5 mg per kilogram body weight. Severe rheumatoid arthritis
- The total daily dose is usually between 3 mg per kilogram of body weight and 5 mg per kilogram of body weight. This is divided into two occasions per day. Psoriasis and atopic dermatitis
- The total daily dose is usually between 2.5 mg per kilogram of body weight and 5 mg per kilogram of body weight. This is divided into two occasions per day.
- For children:
Nephrotic syndrome- The total daily dose for children is usually 6 mg per kilogram of body weight. This is divided into two occasions per day. In patients with kidney problems, the first dose taken daily should not exceed 2.5 mg per kilogram body weight.
Follow your doctor’s instructions exactly and never change the dose yourself, even if you are feeling well.
Switching from Sandimmun to Sandimmun Neoral
You may have previously taken another medicine called Sandimmun soft capsules or Sandimmun oral solution. Your doctor may decide that you should switch to Sandimmun Neoral soft capsules instead.
- The active substance in all these medicines is cyclosporine.
- Sandimmun Neoral is another improved form of ciclosporin compared to Sandimmun. Ciclosporin is better absorbed into the bloodstream with Sandimmun Neoral. The risk that the uptake will be affected by the medicine being taken with food is also less. This means that the cyclosporin level in your blood is kept more constant with Sandimmun Neoral compared to Sandimmun.
If your doctor changes medicines from Sandimmun to Sandimmun Neoral:
- Do not switch back to Sandimmun unless your doctor tells you to.
- After switching from Sandimmun to Sandimmun Neoral, your doctor will follow you up for a short period. This is due to the change in how ciclosporin is absorbed into your bloodstream. Your doctor will make sure you get the dose you need.
- You may experience some side effects. If this happens, tell your doctor or pharmacist immediately. Your dose may need to be reduced. Never reduce the dose yourself unless your doctor tells you to.
If your doctor changes a cyclosporine preparation to be swallowed for another
After switching from one cyclosporine product to another:
- Your doctor will monitor you extra closely for a short time.
- You may experience some side effects. If this happens, tell your doctor or pharmacist immediately. Your dose may need to be changed. Never change the dose yourself unless your doctor tells you to.
When you take Sandimmun Neoral
Take Sandimmun Neoral at the same time each day. This is very important if you have undergone a transplant.
How to take Sandimmun Neoral
Your daily doses should always be divided into two occasions.
Remove the capsules from the blister. Swallow the capsules whole with water.
How long to take Sandimmun Neoral
Your doctor will tell you how long you need to take Sandimmun Neoral. It depends on whether you take it after a transplant or to treat a severe skin disease, rheumatoid arthritis, uveitis, or nephrotic syndrome. In case of severe skin rash, the treatment usually lasts for about 8 weeks.
Keep taking Sandimmun Neoral for as long as your doctor tells you to.
If you have any further questions on the use of Sandimmun Neoral, ask your doctor or pharmacist.
If you take more Sandimmun Neoral than you should
If you have ingested too much medicine or if e.g. If a child has accidentally taken the medicine, contact a doctor or hospital immediately for risk assessment and advice.
If you forget to take Sandimmun Neoral
- If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Then continue as usual.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Sandimmun Neoral
Do not stop taking Sandimmun Neoral unless your doctor tells you to.
Continue to take Sandimmun Neoral even if you are feeling well. Discontinuation of Sandimmun Neoral therapy may increase the risk of rejection of the transplanted organ.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious
Tell your doctor immediately if you get any of the following serious side effects:
- Like other drugs that act on the immune system, cyclosporine can affect the body’s ability to fight infections and can also cause tumors or other cancers, especially in the skin. Signs of infection can be fever or sore throat.
- Vision changes, coordination difficulties, clumsiness, memory loss, difficulty speaking or understanding what others are saying, and muscle weakness. This may be a sign of an infection in the brain, called progressive multifocal leukoencephalopathy.
- Impact on the brain with signs such as seizures, confusion, disorientation, less constructability, personality changes, agitation, insomnia, vision changes, blindness, coma, paralysis in all or parts of the body, neck stiffness, impaired coordination with or without unusual speech or unusual eye movements.
- Swelling in the back of the eye. This can lead to blurred vision. It can also affect vision due to higher pressure in the head ( benign intracranial hypertension ).
- Liver problems and liver damage with or without yellowing of the skin and eyes, nausea, loss of appetite, and dark urine.
- Kidney problems can lead to significantly less urine being produced in the body.
- A low number of red blood cells or platelets. Signs of this are pale skin, fatigue, shortness of breath, dark urine (a sign that the red blood cells are broken down), bruising or bleeding without an obvious cause, confusion, disorientation, you feel less alert and kidney problems.
Other side effects can be:
Very common: may affect more than 1 in 10 people
- Kidney problems.
- High blood pressure.
- Headache.
- Uncontrollable tremors in the body.
- Abnormally strong growth of body and facial hair.
- High levels of blood fats.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Common: may affect up to 1 in 10 people
- Seizures.
- Liver problem.
- High blood sugar.
- Fatigue.
- Loss of appetite.
- Nausea, vomiting, abdominal discomfort/pain, diarrhea.
- Abnormal hair growth.
- Acne, hot flashes.
- Fever.
- Low white blood cell count.
- Numbness or tingling.
- Muscle pain, muscle twitching.
- Gastric ulcer.
- Overgrowth of the gums on the teeth.
- High levels of uric acid or potassium in the blood, and low magnesium levels in the blood.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Uncommon: may affect up to 1 in 100 people
- Symptoms of brain disease include sudden seizures, mental confusion, insomnia, disorientation, visual disturbances, unconsciousness, the feeling of weakness in arms and legs, and impaired movement patterns.
- Rash.
- General swelling.
- Weight gain.
- The low number of red blood cells anNanda’sda low nuandothe f platelets can increase the risk of bleeding.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Rare: may affect up to 1 in 1,000 people
- Nerve problems with numbness or tingling in fingers and toes.
- Inflammation of the pancreas with severe pain in the upper abdomen.
- Weakness in the muscles, loss of muscle strength, muscle pain in the legs or hands, or the whole body.
- Degradation of red blood cells which includes problems with the kidneys with symptoms such as swelling of the face, stomach, hands, and/or feet, decreased urination, difficulty breathing, chest pain, seizures, and unconsciousness.
- Altered menstrual cycle, enlargement of the mammary glands in men.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Very rare: may affect up to 1 in 10,000 people
- Swelling in the posterior parts of the eye may be associated with increased pressure in the head and with visual disturbances.
If this side effect affects you badly, tell your doctor.
Has been reported: occurs in unknown numbers of people.
- Severe liver problems both with and without yellowing of the eyes and skin, nausea, loss of appetite, dark-colored urine, swelling of the face, feet, hands, and/or whole body.
- Bleeding under the skin or purple spots on the skin, sudden bleeding for no apparent reason.
- Migraine or severe headache, often with nausea, vomiting, and photosensitivity.
- Pain in legs and feet.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
Additional side effects are in children and adolescents
No additional side effects are expected in children and adolescents compared to adults.
How to store Sandimmun Neoral
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton.
- Do not store the capsules in a hot place. Do not store above 25 ° C.
- Store in the original package. Moisture sensitive.
- Leave the capsules in the pressure pack. Take them out only when it’s time to take your medicine.
- When a blister is opened, a characteristic odor is felt. This is normal and does not mean that there is anything wrong with the capsules.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is cyclosporine. One capsule contains 10 mg, 25 mg, 50 mg, or 100 mg of cyclosporine.
- Other ingredients are:
- Capsule content: alpha-tocopherol, anhydrous ethanol, propylene glycol, corn oil (mono-di- triglycerides ), macrogol glycerol hydroxy stearate / polyoxyl hydrogenated castor oil.
- Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. The 25 mg and 100 mg capsules also contain black iron oxide (E 172).
- Capsule pressure: carmine (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropylmethylcellulose 2910, isopropanol/isopropyl alcohol.
What the medicine looks like and the contents of the pack
Sandimmun Neoral 10 mg soft capsules are yellowish-white oval and marked with “NVR 10” in red.
Sandimmun Neoral 25 mg soft capsules are blue-gray oval and marked with “NVR 25mg” in red.
Sandimmun Neoral 50 mg soft capsules are yellowish-white oblong and marked with “NVR 50mg” in red.
Sandimmun Neoral 100 mg soft capsules are blue-gray oval and marked with “NVR 100mg” in red.
The capsules are supplied in pressure packs of 60 (capsules 10 mg) or 50 (capsules 25, 50, and 100 mg).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Sverige AB, Box 1218, 164 28 Kista