Sandimmun

Leaflet attached to the packaging: patient information

Sandimmun, 50 mg/ml, concentrate for solution for infusion

Cyclosporin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sandimmun and what is it used for
• 2. Important information before using Sandimmun
• 3. How to use Sandimmun
• 4. Possible side effects
• 5. How to store Sandimmun
• 6. Contents of the packaging and other information

1. What is Sandimmun and what is it used for

What is Sandimmun

This medicine is called Sandimmun. It contains the active substance cyclosporin. The concentrate is used to prepare a solution that is administered intravenously. This medicine belongs to a group of medicines called immunosuppressants. These medicines are used to reduce the body's immune response.

What is Sandimmun used for and how does it work

Sandimmun is used to control the activity of the immune system after organ transplantation, including bone marrow and stem cell transplantation. It prevents the rejection of transplanted organs by blocking the development of certain cells that would normally attack the transplanted tissue.

2. Important information before using Sandimmun

Sandimmun will only be prescribed by a doctor with experience in transplantation. You must carefully follow all the doctor's instructions. They may differ from the general information contained in this leaflet.

When not to use Sandimmun

• with medicines containing Hypericum perforatum (St. John's Wort);
• with medicines containing dabigatran etexilate (used to prevent blood clots after surgery) or bosentan and aliskiren (used to lower blood pressure). You must not use Sandimmun and you must tell your doctor if this applies to you. If in doubt, consult your doctor before using Sandimmun.

Warnings and precautions

Before and during treatment with Sandimmun, tell your doctor immediately if:

• you experience any signs of infection, such as fever or sore throat. Sandimmun suppresses the immune system and may also affect the body's ability to fight infections;
• you have liver disease;
• you have kidney disease. Your doctor will order regular blood tests and may change the dose of the medicine if necessary;
• you have high blood pressure. Your doctor will regularly check your blood pressure and may prescribe a medicine to lower it if necessary;
• you have a low level of magnesium. Your doctor may recommend that you take magnesium supplements, especially after surgery if you have had a transplant;
• you have a high level of potassium in your blood;
• you have gout;
• you need to be vaccinated. If any of these situations apply to you before or during treatment with Sandimmun, tell your doctor immediately.

Protection from sunlight and sun exposure

Sandimmun suppresses the immune system, which increases the risk of developing malignant tumors, especially of the skin and lymphatic system. You should limit exposure to sunlight and UV radiation by:

• wearing protective clothing;
• frequently using sunscreens with a high protection factor.

You should talk to your doctor before using Sandimmun if:

• you have problems with alcohol, currently or in the past;
• you have epilepsy;
• you have any liver disease;
• you are pregnant;
• you are breastfeeding;
• this medicine has been prescribed for a child. If any of these situations apply to you (or you are not sure), tell your doctor before using Sandimmun. This is because the medicine contains alcohol (see also below "Sandimmun contains castor oil and ethanol").

Monitoring during Sandimmun treatment

Your doctor will monitor the following parameters:

• cyclosporin levels in the blood, especially in patients after transplantation;
• blood pressurebefore starting treatment and regularly during treatment;
• liver and kidney function;
• lipid levels in the blood. If you have any questions about the action of Sandimmun or the reasons why it has been prescribed for you, ask your doctor.

Children and adolescents

Experience with the use of Sandimmun in children is limited.

Older people (65 years and over)

Experience with the use of Sandimmun in older people is limited. In these patients, the doctor should monitor kidney function.

Sandimmun and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Sandimmun:

• Medicines that may affect potassium levels. These include potassium-containing medicines, potassium supplements, diuretics (known as potassium-sparing diuretics), and some blood pressure-lowering medicines.
• Methotrexate. It is used to treat cancer, severe psoriasis, and severe rheumatoid arthritis.
• Medicines that may increase or decrease the levels of cyclosporin (the active substance of Sandimmun) in the blood. Your doctor may recommend monitoring cyclosporin levels in the blood when starting or stopping treatment with other medicines.
• Medicines that may increase cyclosporin levels in the blood include: antibiotics (such as erythromycin or azithromycin), antifungal medicines (voriconazole, itraconazole), medicines used to treat heart disease or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to treat nausea and vomiting), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), cholic acid and its derivatives (used to treat gallstones), HIV protease inhibitors, imatinib (used to treat leukemia or cancer), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (used to treat seizures).
• Medicines that may decrease cyclosporin levels in the blood include: barbiturates (used as sleeping pills), some antiepileptic medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors), antibacterial medicines used to treat tuberculosis, orlistat (used to aid weight loss), herbal medicines containing St. John's Wort, ticlopidine (used after a stroke), certain blood pressure-lowering medicines (bosentan), and terbinafine (an antifungal medicine used to treat fungal infections of the toes and fingernails).
• Medicines that affect kidney function. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, medicines used to treat urinary tract infections containing trimethoprim, anticancer medicines containing melphalan, medicines used to reduce stomach acid (H2 receptor antagonists), tacrolimus, painkillers (non-steroidal anti-inflammatory medicines such as diclofenac), medicines containing fibric acid (used to lower blood lipid levels, known as fibrates).
• Nifedipine. A medicine used to treat high blood pressure and chest pain. Using nifedipine during cyclosporin treatment may cause gum swelling and overgrowth around the teeth.
• Digoxin (used to treat heart disease), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also known as statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressant medicines (everolimus, sirolimus), ambrisentan, and specific anticancer medicines known as anthracyclines (such as doxorubicin).
• Myfortic (an immunosuppressant medicine) and eltrombopag (used to treat bleeding disorders).

If any of these situations apply to you (or you are not sure), talk to your doctor or pharmacist before using Sandimmun.

Sandimmun with food and drink

Do not take Sandimmun with grapefruit or grapefruit juice, as they may affect the way Sandimmun works.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you are pregnant or planning to become pregnant.Experience with the use of Sandimmun during pregnancy is limited. Sandimmun should not be used during pregnancy unless necessary. If you need to take this medicine, your doctor will discuss the benefits and risks with you.
• Tell your doctor if you are breastfeeding.Breastfeeding is not recommended during treatment with Sandimmun, as cyclosporin, the active substance, passes into breast milk. This may affect your baby.

Hepatitis C

Tell your doctor if you have hepatitis C. Liver function may change during hepatitis C treatment, which may affect cyclosporin levels in the blood. Your doctor may need to closely monitor your cyclosporin levels and adjust the dose after starting hepatitis C treatment.

Driving and using machines

You may feel drowsy, disoriented, or have blurred vision after taking Sandimmun. Be careful when driving or using machines while taking Sandimmun until you know how it affects you.

Sandimmun contains castor oil and ethanol

Sandimmun concentrate for solution for infusion contains castor oil, which may cause severe allergic reactions. Sandimmun concentrate for solution for infusion contains 278 mg of ethanol (alcohol) per milliliter, which is equivalent to 34.4% (by volume). A dose of 100 mg of Sandimmun contains 556 mg of ethanol. This is equivalent to almost 14 ml of beer or 6 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to use Sandimmun

Follow your doctor's instructions carefully. If you are unsure, ask your doctor.

How much Sandimmun will be given

Your doctor will decide the correct dose of Sandimmun for you. It depends on your body weight and what you are taking the medicine for.

• The total daily dose is usually 3 to 5 mg per kilogram of body weight, divided into two doses.
• Larger doses are usually given before and immediately after transplantation. Smaller doses are given after the transplanted organ or bone marrow has stabilized.
• Your doctor will adjust the dose to suit you. This may involve blood tests.

How Sandimmun will be given

This medicine will be diluted with a physiological saline solution or 5% glucose solution in a ratio of 1:20 to 1:100 using aseptic techniques, and then administered as a slow infusion over 2 to 6 hours. After 24 hours, the diluted infusion solutions should be discarded.

How long Sandimmun will be used

Treatment will be switched to cyclosporin capsules or oral solution (both taken by mouth) as soon as possible.

Using more Sandimmun than prescribed

Taking too much of the medicine may affect the kidneys. Regular blood tests and hospital visits will be necessary. You will be able to discuss treatment and any problems with your doctor. If you think you have taken too much Sandimmun, tell your doctor immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sandimmun can cause side effects, although not everybody gets them.

Some side effects can be serious

Tell your doctor immediatelyif you notice any of the following serious side effects:

• After intravenous administration of Sandimmun, anaphylactic reactions have occurred. These reactions may include flushing of the face and upper chest, fluid in the lungs, shortness of breath, wheezing, changes in blood pressure (you may feel like you are going to faint), and rapid heartbeat (tachycardia).
• Like other medicines that affect the immune system, cyclosporin may change the body's ability to fight infections and may cause the development of tumors or other malignant diseases, especially of the skin and lymphatic system. Signs of infection may include fever or sore throat.
• Changes in vision, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others are saying, and muscle weakness. These may be symptoms of a brain infection called progressive multifocal leukoencephalopathy.
• Brain disorders with symptoms such as seizures (fits), confusion, disorientation, decreased responsiveness, personality changes, agitation, insomnia, changes in vision, blindness, coma, paralysis of part or all of the body, stiffness of the neck, loss of coordination with (or without) speech or eye movement disorders.
• Swelling of the back of the eye, which may be associated with blurred vision. It may also affect vision due to increased pressure in the head (non-tumor-related intracranial hypertension).
• Liver disorders with yellowing of the eyes or skin, or without, nausea, loss of appetite, dark urine, swelling of the face, hands, and (or) feet.
• Kidney disorders, which may significantly reduce the amount of urine produced.
• Low red blood cell or platelet count. Symptoms of these disorders include pale skin, feeling tired, shortness of breath, dark urine (a sign of red blood cell breakdown), bruising or bleeding without obvious cause, feeling confused, feeling disoriented, decreased alertness, and kidney problems.

Other side effects include:

Very common: may affect more than 1 in 10 people.

• Kidney problems;
• High blood pressure;
• Headache;
• Uncontrolled shaking of the body;
• Excessive hair growth on the body and face;
• High levels of lipids in the blood.

If you experience any of these symptoms, tell your doctor. Common: may affect up to 1 in 10 people.

• Seizures (fits);
• Liver disorders;
• High blood sugar levels;
• Fatigue;
• Lack of appetite;
• Nausea, vomiting, discomfort/pain in the abdomen, diarrhea;
• Excessive hair growth;
• Acne, flushing;
• Fever;
• Low white blood cell count;
• Numbness or tingling;
• Muscle pain, muscle cramps;
• Stomach ulcers;
• Gum overgrowth covering the teeth;
• High levels of uric acid and potassium in the blood, low levels of magnesium in the blood. If you experience any of these symptoms, tell your doctor.

Uncommon: may affect up to 1 in 100 people.

• Brain disorders, including sudden seizures, confusion, insomnia, disorientation, vision changes, loss of consciousness, feeling of weakness in the limbs, movement disorders;
• Rash;
• General swelling;
• Weight gain;
• Low red blood cell or platelet count, which may increase the risk of bleeding. If you experience any of these symptoms, tell your doctor.

Rare: may affect up to 1 in 1,000 people.

• Nerve disorders with numbness or tingling of the fingers and toes;
• Pancreatitis with severe abdominal pain;
• Muscle weakness, loss of muscle strength, muscle pain in the legs or hands or other muscles of the body;
• Destruction of red blood cells, including kidney disorders with symptoms such as swelling of the face, abdomen, hands, and (or) feet, decreased urine production, difficulty breathing, chest pain, seizures, loss of consciousness;
• Changes in the menstrual cycle, breast enlargement in men. If you experience any of these symptoms, tell your doctor.

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

• Swelling of the back of the eye, which may be associated with increased pressure in the head and vision changes. If you experience any of these symptoms, tell your doctor.

Frequency not known: frequency cannot be estimated from the available data.

• Severe liver disorders with yellowing of the eyes or skin, or without, nausea, loss of appetite, dark urine, swelling of the face, hands, and (or) feet;
• Bleeding under the skin or purple spots on the skin, sudden bleeding without obvious cause;
• Migraine or severe headache, often with nausea or vomiting and sensitivity to light;
• Pain in the legs and feet. If you experience any of these symptoms, tell your doctor.

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Additional side effects in children and adolescents

No additional side effects are expected in children and adolescents compared to adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Sandimmun

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging.
• No special storage instructions are required.
• After opening the ampoule, the contents should be diluted using aseptic techniques and administered immediately by medical personnel. If the diluted solution is not administered immediately, it can be stored in a refrigerator at a temperature between 2°C and 8°C, provided that the total storage and infusion time is less than 24 hours. Dispose of any unused diluted solutions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sandimmun contains

• The active substance is cyclosporin. One milliliter of the concentrate for solution for infusion contains 50 mg of cyclosporin.
• The other ingredients are: anhydrous ethanol, polyoxyethylated castor oil.

What Sandimmun looks like and contents of the pack

Sandimmun concentrate for solution for infusion is available in ampoules containing 1 ml of the concentrate. The concentrate is a clear, brownish-yellow, oily liquid. It is used by a doctor or nurse to prepare a solution for slow intravenous infusion. The clinical packaging contains 10 ampoules of 1 ml each.

Marketing authorization holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, Tel. +48 22 375 48 88

Manufacturer/Importer

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany; Novartis Pharma GmbH, Jakov-Lind-Straße 5, Top 3.05, 1020 Wien, Austria; Novartis Pharma nv/sa, Medialaan 40/Bus 1, 1800 Vilvoorde, Belgium; Novartis Healthcare A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark; Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finland; Novartis Pharma S.A.S., 8-10 rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France; Novartis (Hellas) S.A.C.I., 12th km National Road Athens-Lamia, 14451 Metamorphoses, Greece; Novartis Farmaceutica SA, Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain; Novartis Pharma B.V., Haaksbergweg 16, 1101 BX Amsterdam, Netherlands; Novartis Pharma GmbH, Sophie-Germain-Strasse 10, 90443 Nürnberg, Germany; Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, Poland; Novartis Farma - Produtos Farmacêuticos S.A., Avenida Professor Doutor Cavaco Silva, n.10E, Taguspark, 2740-255 Porto Salvo, Portugal; Novartis Sverige AB, Torshamnsgatan 48, 164 40 Kista, Sweden; Novartis Hungária Kft., Bartók Béla út 43-47, 1114 Budapest, Hungary; Novartis Farma S.p.A., Via Provinciale Schito 131, 80058 Torre Annunziata, NA, Italy; Novartis Farma S.P.A., Largo Umberto Boccioni,1, 21040 Origgio (VA), Italy

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Netherlands: Sandimmune; Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Sandimmun

Date of last revision of the leaflet:03/2025

Other sources of information

Detailed information on this medicine is available on the website https://www.gov.pl/web/urpl.