Sandimmun Neoral 25 mg. 50 capsules

NOVARTIS
Sandimmun Neoral 25 mg. 50 capsules
€ 49.00
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What Sandimmun Neoral and what is it used?
Your medicine is called Sandimmun Neoral. It contains the active substance cyclosporin. It belongs to a group of drugs known as immunosuppressants. These drugs are used to suppress immune reactions of the body.
What is Savdimun Neoral and Sandimmun Neoral how it works?
• If you have undergone organ transplants, bone marrow transplants and stem cell transplantation, the function of Sandimmun Neoral is to control your immune system. Sandimmun Neoral prevents the rejection of transplanted organs by blocking the formation of cells that would normally attack the transplanted tissue.
• If you have an autoimmune disease in which the immune response is directed against your own cells, Sandimmun Neoral stops this immune response. These diseases include eye problems that threaten your vision (endogenous uveitis, including uveitis in Behcet's disease), severe cases of certain skin disorders (atopic dermatitis or eczema and psoriasis), severe rheumatoid arthritis and a kidney condition called nephrotic syndrome.
2. What you need to know before taking Sandimmun Neoral?
If you are taking Sandimmun Neoral suffered after transplant, it will only be prescribed by a doctor with experience in transplantation medicine and / or autoimmune diseases
The recommendations in this leaflet may be different, depending on whether taking the drug due to transplant or because of an autoimmune disease.
Carefully follow your doctor's instructions. They may differ from the general information in this leaflet.
Do not take Sandimmun Neoral:
if you are allergic to cyclosporine or any of the other ingredients of this medicine (listed in section 6).
with medicines containing Hypericum perforatum (St. John's wort).
with medicines containing dabigatran etexilate (used to prevent blood clotting after surgery) or bosentan and aliskiren (used to lower blood pressure).
Do not take Sandimmun Neoral and tell your doctor if written above applies to you. If you are unsure, talk to your doctor before taking Sandimmun Neoral.
Warnings and Precautions
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 suppresses the immune system and can affect the body's ability to fight infections.
if you have liver problems.
If you have kidney problems. Your doctor will conduct regular blood tests and, if necessary, it is possible to change your dose.
if you get high blood pressure, your doctor will monitor your blood pressure regularly and may prescribe medication to reduce it if necessary.
if you have low levels of magnesium in the body. Your doctor may prescribe taking magnesium supplementation, especially immediately after surgery if you were transplanted.
if you have high levels of potassium in the blood.
if you have gout.
if you need to be vaccinated.
If any of the above, applies to you before or during treatment with Sandimmun Neoral, tell your doctor immediately.
Sunlight and sun
Sandimmun Neoral suppresses the immune system. This increases the risk of developing cancer, particularly of the skin and lymphatic system. Therefore you should limit your exposure to sunlight and ultraviolet light, such as:
Wear suitable protective clothing.
Often apply sunscreen with a high protection factor.
Talk to your doctor before you start taking Sandimmun Neoral:
• if you have or have had problems with alcohol.
• if you have epilepsy.
• if you have any liver problems.
• if you are pregnant.
• if you are breastfeeding.
• If the drug is prescribed for a child.
If any of the above, it applies to you (or if you are unsure), tell your doctor before you start taking Sandimmun Neoral. The reason for this is that this drug contains alcohol (see. Below point 'Sandimmun Neoral contains ethanol ").
Monitoring during treatment with Sandimmun Neoral
Your doctor will check:
• the level of cyclosporin in your blood, especially if you have had a transplant;
• Your blood pressure before treatment initiation and periodically during treatment;
• How do your liver and kidneys;
• lipids (fats) in your blood.
If you have any questions about the operation of Sandimmun Neoral, or why you have been prescribed this medicine, ask your doctor.
In addition, if you do not take Sandimmun Neoral due transplant (intermediate or posterior uveitis and uveitis in Behcet's disease, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Sandimmun Neoral:
If you have kidney problems (with the exception of nephrotic syndrome).
if you have an infection that is not controlled by the administered drugs.
if you have any cancer.
if you have high blood pressure (hypertension), which is not controlled by administered drugs. If you get high blood pressure during treatment and can not be controlled, your doctor should stop taking Sandimmun Neoral.
Do not take Sandimmun Neoral if something is written above applies to you. If you are unsure about something, talk to your doctor or pharmacist before taking Sandimmun Neoral.
If you are being treated for uveitis in Behcet's disease, your doctor will monitor particularly carefully if you have neurological symptoms (eg forget more often, changes in personality, established over time, psychiatric disorders or mood swings, burning sensation in extremities, decreased sensation in the extremities, tingling, weakness in the limbs, abnormal gait, headache with or without vomiting, visual disturbances, including restricted movements of the eyeballs).
Your doctor will monitor you closely if you are elderly or if being treated for psoriasis or atopic dermatitis. If it is prescribed Sandimmun Neoral for the treatment of psoriasis or atopic dermatitis, you should not be exposed to ultraviolet rays or phototherapy during treatment.
Children and adolescents
Sandimmun Neoral should not be administered to children to treat diseases other than transplantation, with the exception of the treatment of nephrotic syndrome.
Elderly (aged 65 years and over)
There is limited experience with the use of Sandimmun Neoral in the elderly. Your doctor will monitor your kidney function. If you are over 65 and you have psoriasis or atopic dermatitis should be treated with Sandimmun Neoral only if your condition is particularly severe.
Other medicines and Sandimmun Neoral
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Especially tell your doctor or pharmacist if you are taking any of these medicines before or during treatment with Sandimmun Neoral:
Drugs that can affect the levels of potassium. They include drugs that contain potassium, potassium supplements, water pills / diuretics / called potassium-sparing diuretics, and some drugs that lower blood pressure.
Methotrexate. It is used to treat tumors, severe psoriasis and severe rheumatoid arthritis.
Drugs that may increase or decrease the level of ciclosporin (the active substance of Sandimmun Neoral) in the blood. Your doctor may check the level of cyclosporine in the blood when starting or stopping treatment with other drugs.
Drugs that can increase the level of the cyclosporin in the blood, antibiotics (such as erythromycin or azithromycin), antifungal agents (voriconazole, itraconazole), drugs that are used to treat heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone) metoclopramide (used to stop vomiting), oral contraceptives, danazol (used to treat menstrual problems), drugs used for gout (allopurinol), cholic acid and derivatives (used for the treatment of gallstones) protease inhibitors used to treat HIV, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C).
Drugs that may decrease levels of cyclosporine in the blood: barbiturates (used to aid sleep), certain anticonvulsants (such as carbamazepine or phenytoin), octreotide (used for treatment of acromegaly and neuroendocrine tumors of the bowel), antibacterial agents that used to treat tuberculosis, orlistat (used to help weight loss), herbal medicinal products containing St. John's wort, ticlopidine (used after a stroke), certain drugs that lower blood pressure (bosentan), and terbinafine (antifungal medicine that It is used to treat infections of the toes and nails).
Drugs that can affect the kidneys. Also included are antibacterial agents (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, drugs used to treat urinary tract infections containing trimethoprim, drugs used for treating cancers comprising melphalan, pharmaceutical which are used for reducing the amount of acid in the stomach (acid secretion inhibitors such as H2-receptor antagonists), tacrolimus, painkillers
Pregnancy and lactation
Ask your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the potential risks of taking Sandimmun Neoral during pregnancy.
• Tell your doctor if you are pregnant or planning a pregnancy. Experience with Sandimmun Neoral during pregnancy is limited. Overall Sandimmun Neoral should not be taken during pregnancy. If you need to take this medicine, your doctor will discuss with you the benefits and potential risks of taking it during pregnancy.
• Tell your doctor if you are breast-feeding. It is not recommended to breast-feed during treatment with Sandimmun Neoral. The reason for this is that the cyclosporine, the active substance passes into breast milk. This can affect your baby.
Driving and using machines
Sandimmun Neoral contains alcohol. This can affect your ability to drive and use machines.
Sandimmun Neoral contains ethanol
Sandimmun Neoral contains approximately 12.0 vol. % Ethanol (alcohol), which corresponds to 500 mg per dose used in transplant patients. This is equivalent to 15 ml of beer or wine 5 ml per dose.
Alcohol can be harmful if you have problems related to alcohol intake, epilepsy, brain damage, liver problems or if you are pregnant or breast-feeding. May be harmful also, if the drug is given to children.
Sandimmun Neoral contains castor oil
Sandimmun Neoral contains castor oil which may cause stomach upset or diarrhea.
3. How to take Sandimmun Neoral?
Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor.
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted by your doctor about your individual needs. Taking too high a dose of the drug can affect the kidneys. Regularly you will have blood tests and will visit the hospital, especially after transplantation. This will allow you to talk to your doctor about treatment and any problems you have.
How Sandimmun Neoral to take?
Your doctor will adjust the dose you need Sandimmun Neoral. It will depend on your body weight and testimony, because you are taking the drug. Your doctor will tell you also, how often to take your medicine.
• For adults:
Organ transplantation, bone marrow or stem cells
The total daily dose is usually between 2 mg per kilogram of body weight and 15 mg per kilogram of body weight. Divide it into two servings.
Typically, before and after transplantation are accepted at higher doses. Lower doses are administered once transplanted organ or bone marrow is stabilized.
Your doctor will adjust the dose to the most appropriate for you. To do so, it may need some blood tests.
endogenous uveitis
The total daily dose is usually between 5 mg and 7 mg per kg bodyweight. Divide it into two servings.
nephrotic syndrome
The total daily dose for adults is usually 5 mg per kilogram body weight. Divide it into two servings. In patients with kidney problems, the first dose of the day should not be more than 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. Divide it into two servings.
Psoriasis and atopic dermatitis
The total daily dose is usually between 2,5 mg per kg body weight and 5 mg per kilogram of body weight. Divide it into two servings.
• In children:
nephrotic syndrome
The total daily dose for children is usually 6 mg per kilogram body weight. Divide it into two servings. In patients with kidney problems, the first dose of the day should not be more than 2,5 mg per kilogram body weight.
Follow exactly your doctor's instructions and never change your dose even if you feel well.
Switching from Sandimmun to Sandimmun Neoral
It is possible now to take another medicine called Sandimmun soft gelatin capsules or oral solution Sandimmun. Your doctor may decide to change this medicine with Sandimmun Neoral soft gelatin capsules.
All these drugs containing cyclosporin as an active ingredient.
Sandimmun Neoral is different, an improved formulation of cyclosporin compared to Sandimmun. Cyclosporine is better absorbed by the body in the form of Sandimmun Neoral and is less likely to be affected absorption by food intake. This means that the average levels of cyclosporin in the body are more stable in Sandimmun Neoral than Sandimmun.
If your doctor decides to switch from Sandimmun to Sandimmun Neoral:
Do not stop taking Sandimmun until I tell you to do.
After switching from Sandimmun to Sandimmun Neoral, your doctor will monitor you more closely for some time. The reason for this is the change in the manner of absorption of cyclosporin in the blood. Your doctor should make sure that you get the correct dose for your individual needs.
It is possible to get some side effects. If this happens, tell your doctor or pharmacist. It may be necessary to reduce your dose. Never reduce your dose alone, unless your doctor has told you to do it.
If your doctor decides to switch from an oral form of cyclosporine to another
After switching from one form of oral cyclosporin to another:
Your doctor will monitor you more closely for some time.
It is possible to get some side effects. If this happens, tell your doctor or pharmacist. It may be necessary to reduce your dose. Never reduce your dose alone, unless your doctor has told you to do it.
When taking Sandimmun Neoral
Take Sandimmun Neoral at the same time each day. This is very important if you have been transplanted.
How to take Sandimmun Neoral?
The daily dose should always be divided into two doses. Remove capsule from the blister. Swallow the capsules whole with water.
How long to take Sandimmun Neoral?
Your doctor will tell you how long to take Sandimmun Neoral. It depends on whether you take it after a transplant or to treat serious skin disorders, rheumatoid arthritis, uveitis or nephrotic syndrome. Treatment of severe rash usually lasts 8 weeks.
Take Sandimmun Neoral as long as your doctor tells you to.
If you have questions about how long to take Sandimmun Neoral, talk to your doctor or pharmacist.
If you take more than the amount of Sandimmun Neoral
If you take more of your medicine, tell your doctor immediately or go to the nearest emergency medical care. You may need medical care.
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 before.
Do not take a double dose to make up the missed dose.
If you stop taking Sandimmun Neoral
Do not stop taking Sandimmun Neoral until your doctor tells you to do so.
Keep taking Sandimmun Neoral, even if you feel well. Stopping treatment with Sandimmun Neoral may increase the risk of rejection of the transplanted organ.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. 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 notice any of the following side effects:
As with other drugs that affect the immune system, cyclosporin can affect the body's ability to fight infections and cause tumors or other cancers, particularly of the skin. Signs of infection may be fever or sore throat.
Changes in vision, loss of coordination, clumsiness, memory loss, difficulty speaking or difficulty understanding what others say, and muscle weakness. This can indicate an infection of the brain called progressive multifocal leukoencephalopathy.
Brain problems with signs such as seizures, confusion, feeling disorganized, irresponsible behavior, changes in personality, sense of anxiety, insomnia, changes in vision, blindness, coma, paralysis of the body or the whole body, stiffness in the neck, loss of coordination, with or without abnormal speech or eye movements.
Swelling of the fundus. This may be associated with amblyopia. It is also possible to affect visual acuity due to increased pressure inside the head (benign intracranial hypertension).
Liver problems and damage with or without yellowing of the eyes or skin, nausea, loss of appetite and dark urine.
Kidney problems, which can reduce the amount of urine.
Reduced number of red blood cells or platelets. The signs include pale skin, tiredness, breathlessness, dark urine (this is a sign of destruction of red blood cells), bruising or bleeding, with or without an objective reason, confusion, disorientation, disturbance in attention and onset of kidney problems.
Other side effects include:
Rare side effects: These side effects may affect between 1 and 10 in every 10,000 people:
Nerve problems with numbness and tingling in fingers and toes.
Inflammation of the pancreas with severe pain in the upper abdomen.
Muscle weakness, loss of muscle strength, pain in the muscles of the arms, legs or anywhere on the body.
Destruction of red blood cells, including kidney problems with symptoms such as swelling of the face, abdomen, arms and / or legs, decreased urine output, difficulty breathing, chest pain, seizures, unconsciousness.
Changes in menstrual cycle, enlargement of breasts in men.
If any of these affects you in more severe, tell your doctor.
Very rare side effects: These side effects may affect between 1 and 10 in every 100 000 people:
Swelling of the fundus, which could be related to increased pressure inside the head, and visual disturbances.
If any of these affects you in more severe, tell your doctor.
Other side effects not known: From the data available frequency can be determined:
Serious liver problems with or without yellowing of the eyes or skin, nausea (feeling sick), loss of appetite, dark urine, swelling of the face, legs, arms and / or the entire body.
Subcutaneous bleeding or formation of purple spots on the skin, sudden bleeding for no apparent reason.
Migraine or severe headache often accompanied by nausea and vomiting, increased sensitivity to light.
Pain in the legs and feet.
If any of these affects you in more severe, tell your doctor.
If you get any side effects, contact your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
Additional side effects in children and adolescents
There are no additional side effects to be expected in children and adolescents compared to those seen in adults.
Adverse event reporting

5. How to store Sandimmun Neoral?
• Keep out of reach of children.
• Do not use this medicine after the expiry date stated on the packaging.
• Do not store the capsules in hot areas (maximum temperature 25 ° C).
• Leave the capsules in foil. Take them only when there is time to take your medicine.
• When the blister is open feel characteristic odor. This is normal and does not mean that something is wrong with the capsule.
• Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Sandimmun Neoral?
Sandimmun Neoral 25 mg soft capsules
The active substance is cyclosporin. Each capsule contains 25 mg of cyclosporin;
Other ingredients are:
Capsule contents: alpha-tocopherol, ethanol, anhydrous, propylene glycol, corn fatty mono-di-triglycerides, makrogolglitserolov hydroxystearate / polyoxyl hydrogenated castor oil;
Capsule shell: Black iron oxide (E172), titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin;
Caption: carminic acid (E120).
€ 49.00
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