SANDIMMUN 250 mg/5 ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Sandimmun 250mg/5 ml concentrate for solution for infusion

cyclosporin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Sandimmun is and what it is used for
2. What you need to know before you use Sandimmun
3. How to use Sandimmun
4. Possible side effects
5. Storage of Sandimmun
6. Contents of the pack and other information

1. What Sandimmun is and what it is used for

What isSandimmun

The name of your medicine is Sandimmun. It contains the active substance cyclosporin. The concentrate is used to prepare a solution that is administered by intravenous infusion. It belongs to a group of medicines known as immunosuppressants. These medicines are used to reduce the body's immune reactions.

What Sandimmun is used for and how it works

Sandimmun is used to control your body's immune system after an organ transplant, including bone marrow and stem cell transplants. It prevents the rejection of transplanted organs by slowing down the development of certain cells that would normally attack the transplanted tissue.

2. What you need to know before you use Sandimmun

Sandimmun will only be prescribed for you by a doctor with experience in transplants.

Follow your doctor's instructions carefully. They may be different from the general information contained in this leaflet.

Do not use Sandimmun:

• If you are allergic to cyclosporin or any of the other ingredients of this medicine (listed in section 6; also see section "Sandimmun contains castor oil and ethanol").
• with medicines that contain Hypericum perforatum(St. John's Wort).

• with medicines that contain dabigatran etexilate (used to prevent blood clots after an operation) or bosentan and aliskiren (used to lower high blood pressure).

If any of these apply to you, do not use Sandimmun and tell your doctor. If you are not sure, consult your doctor before using Sandimmun.

Warnings and precautions

Tell your doctor immediately:

• if you have any signs of infection, such as fever or sore throat. Sandimmun suppresses the immune system and may also affect your body's ability to fight infections.
• if you have liver problems.
• if you have kidney problems. Your doctor will perform regular blood tests and may adjust your dose if necessary.
• if you have high blood pressure. Your doctor will check your blood pressure regularly and may give you a medicine to lower your blood pressure if necessary.
• if you have low magnesium levels in your body. Your doctor may give you magnesium supplements, especially just after your operation if you have had a transplant.
• if you have high potassium levels in your blood.
• if you have gout.
• if you need to receive a vaccine.

If you experience any of the above while taking Sandimmun, tell your doctor immediately.

Sun protection and sunlight

Sandimmun suppresses your immune system. This may increase the risk of developing cancer, mainly of the skin and lymphatic system. Therefore, you should limit your exposure to the sun and UV rays as follows:

• Wearing protective clothing.
• Applying a sunscreen with a high protection factor frequently.

Consult your doctor before taking Sandimmun:

• if you have or have had problems related to alcohol.
• if you have epilepsy.
• if you have any liver problems.
• if you are pregnant.
• if you are breast-feeding.
• if this medicine is prescribed for a child.

If any of these apply to you (or you are not sure), tell your doctor before taking Sandimmun. This is because this medicine contains alcohol (see section "Sandimmun contains castor oil and ethanol", below).

Monitoring during your treatment with Sandimmun

Your doctor will check:

• your cyclosporin blood levels, especially if you have had a transplant,
• your blood pressurebefore starting treatment and regularly during treatment,
• how well your liver and kidneysare working,
• your blood lipid levels(fats).

If you have any questions about how Sandimmun works or why it has been prescribed for you, ask your doctor.

Children and adolescents

There is limited experience with Sandimmun in children.

Elderly population (65 years of age and over)

There is limited experience with Sandimmun in elderly patients. Your doctor should check how well your kidneys are working.

Other medicines and Sandimmun

Tell your doctor or pharmacist if you are taking, 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:

• Medicines that may affect your potassium levels. These include medicines that contain potassium, potassium supplements, potassium-sparing diuretics, and some medicines that lower your blood pressure.
• Methotrexate. It is used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.

• Medicines that may increase or decrease cyclosporin (the active substance of Sandimmun) levels in your blood. Your doctor may check your cyclosporin blood levels when you start or stop treatment with other medicines.

• Medicines that may increase cyclosporin levels in your blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart disorders or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop vomiting), oral contraceptives, danazol (used to treat menstrual disorders), medicines used to treat gout (allopurinol), ursodeoxycholic acid and derivatives (used to treat bile stones), HIV protease inhibitors, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (its use includes, among others, the treatment of epileptic seizures).
• Medicines that may decrease cyclosporin levels in your blood include: barbiturates (used to help you sleep), certain anticonvulsants (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors in the intestine), antibacterial medicines used to treat tuberculosis, orlistat (used to help with weight loss), herbal medicines that contain St. John's Wort, ticlopidine (used after a stroke), certain medicines that lower blood pressure (bosentan), and terbinafine (an antifungal medicine, used to treat infections of the toes and nails).

• Medicines that may affect your kidneys. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines that contain amphotericin B, medicines used for urinary tract infections that contain trimethoprim, cancer medicines that contain melphalan, medicines used to reduce the amount of acid in your stomach (acid secretion inhibitors of the H2 receptor antagonist type), tacrolimus, painkillers (non-steroidal anti-inflammatory medicines, such as diclofenac), fibrates (used to lower the amount of fat in the blood).
• Nifedipine. It is used to treat high blood pressure and chest pain. You may have swollen gums that may grow over your teeth if you are taking nifedipine during your treatment with cyclosporin.
• Digoxin (used to treat heart disorders), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an oral antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin).
• Mycophenolate sodium or mycophenolate mofetil (an immunosuppressant) and eltrombopag (used to treat bleeding disorders).

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

Using Sandimmun with food and drink

Do not use Sandimmun with grapefruit or grapefruit juice. This is because it may affect how Sandimmun works.

Pregnancy and breast-feeding

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 Sandimmun in pregnant women is limited. In general, Sandimmun should not be taken during pregnancy. If it is necessary for you to use this medicine, your doctor will discuss the benefits and risks with you.
• Tell your doctor if you are breast-feeding.Breast-feeding is not recommended during treatment with Sandimmun. This is because cyclosporin, the active substance, passes into breast milk and may affect your baby.

Hepatitis C

Tell your doctor if you have hepatitis C. Your liver function may change with hepatitis C treatment and this may affect cyclosporin levels in your blood. Your doctor may need to closely monitor your cyclosporin blood levels and adjust your 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 operating machinery while taking Sandimmun until you know how it affects you.

Sandimmun contains castor oil and ethanol

This medicine may cause severe allergic reactions because it contains castor oil.

Sandimmun concentrate for solution for infusion contains 278 mg of alcohol (ethanol) per ml, which corresponds to 34.4% v/v. A dose of 100 mg of Sandimmun contains 556 mg of ethanol, which is equivalent to approximately 14 ml of beer or 6 ml of wine. The small amount of alcohol in this medicine will have no noticeable effect.

3. How to use Sandimmun

Follow your doctor's instructions exactly. If you are not sure, ask your doctor again.

How much Sandimmun you will receive

Your doctor will tell you the correct dose of Sandimmun for you. This depends on your body weight and what you are being treated for.

• The usual daily dose is between 3 and 5 mg per kilogram of body weight. This is divided into two doses.
• High doses are usually used before and just after your transplant. Lower doses are used once your transplanted organ or bone marrow is stable.
• Your doctor will adjust your dose to one that is right for you. To do this, your doctor may need to perform some blood tests.

How Sandimmun will be used

The medicine will be diluted before use between 1:20 and 1:100 with saline or 5% glucose solution, using adequate aseptic technique, and will be administered by slow infusion over 2 to 6 hours. The medicine dilutions should be discarded after 24 hours of preparation.

How long you will use Sandimmun

You will be switched to cyclosporin in the form of capsules or oral solution (both are taken by mouth) as soon as possible.

If you have received more Sandimmun than you should

Too much of the medicine may affect your kidneys. You will have regular blood tests and hospital visits. This will give you the opportunity to discuss your treatment and any problems you may have with your doctor.

If you think you have received 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious

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

• Appearance of signs of anaphylactoid reactions after intravenous administration of Sandimmun. These reactions may consist of redness of the face and upper chest, fluid in the lungs, difficulty breathing, wheezing, changes in blood pressure (you may feel like you are going to faint) and rapid heart rate (tachycardia).
• Like other medicines that act on the immune system, cyclosporine can influence your body's ability to fight certain infections and may cause tumors or other malignant diseases, especially of the skin. Signs of infection could be fever or sore throat.
• Visual disturbances, lack of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the muscles. These could be signs of a brain infection called progressive multifocal leukoencephalopathy.
• Brain problems with signs such as seizures, confusion, disorientation, decreased sensitivity, personality changes, agitation, insomnia, visual disturbances, blindness, coma, paralysis of part or all of the body, torticollis, lack of coordination with or without abnormal speech or eye movement.
• Inflammation in the back of the eye that may be associated with blurred vision. It can also affect your vision due to an increase in pressure inside the head (benign intracranial hypertension).
• Liver damage and alteration with or without yellowing of the eyes or skin, nausea, loss of vision, and dark urine.
• Kidney problems, which can greatly decrease the amount of urine you produce.
• Decrease in the number of red blood cells or platelets. These signs include pale skin, fatigue, shortness of breath, dark urine (sign of red blood cell breakdown), bleeding or bruising without apparent reason, confusion, disorientation, lack of attention, and kidney problems.

Other adverse effects include:

Very common:may affect more than 1 in 10 people

• Kidney problems.
• High blood pressure.
• Headache.
• Uncontrollable body agitation.
• Excessive growth of facial and body hair.
• Increased lipids in the blood.

If any of these affect you severely, tell your doctor.

Common:may affect up to 1 in 10 people

• Seizures (convulsions).
• Liver problems.
• Increased blood sugar.
• Fatigue.
• Lack of appetite.
• Nausea (feeling of dizziness), vomiting, discomfort/pain in the abdomen, diarrhea.
• Excessive hair growth.
• Acne, hot flashes.
• Fever.
• Decrease in the number of white blood cells.
• Feeling of numbness or tingling.
• Muscle pain, muscle spasms.
• Stomach ulcer.
• Excessive growth of gum tissue, which can cover your teeth.
• Excess uric acid or potassium in the blood, decrease in magnesium levels in the blood.

If any of these affect you severely, tell your doctor.

Uncommon:may affect up to 1 in 100 people

• Symptoms of brain disorders including sudden attacks, mental confusion, insomnia, disorientation, visual disturbances, unconsciousness, feeling of weakness in the limbs, movement deterioration.
• Skin rash.
• Generalized inflammation.
• Weight gain.
• Decrease in the number of red blood cells and platelets in the blood, which can lead to a higher risk of bleeding.

If any of these affect you severely, tell your doctor.

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

• Nerve damage with numbness or tingling in the fingers of the hands and feet.
• Pancreatitis with severe pain in the upper part of the stomach.
• Muscle weakness, loss of strength in the muscles, muscle pain in the legs or hands or any part of the body.
• Destruction of red blood cells, which includes kidney problems with symptoms such as swelling of the face, stomach, hands, and/or feet, decreased urine production, difficulty breathing, chest pain, seizures, unconsciousness.
• Changes in the menstrual cycle, breast growth in men.

If any of these affect you severely, tell your doctor.

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

• Inflammation in the back of the eye that may be associated with an increase in pressure inside the head and vision deterioration.

If this affects you severely, tell your doctor.

Frequency not known:Cannot be estimated from the available data.

• Severe liver problems with or without yellowing of the eyes or skin, nausea (feeling of dizziness), loss of appetite, dark urine, facial swelling, hands, feet, and/or whole body.
• Bleeding under the skin or purple spots on the skin, sudden bleeding without apparent cause.
• Migraine or severe headache, often with dizziness or feeling of it (nausea, vomiting) and sensitivity to light.
• Pain in the legs and feet.
• Hearing impairment.

If any of these affect you severely, tell your doctor.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Other adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Sandimmun

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging.
• This medicine does not require any special storage temperature.
• Once the ampoule is opened, the contents must be diluted using an adequate aseptic technique and administered immediately by a healthcare professional. If it is not administered immediately, the diluted solution can be stored between 2°C and 8°C (in the refrigerator), provided that the total duration of both storage and infusion is less than 24 hours. Discard any unused diluted solution.

Medicines should not be thrown away through wastewater or household waste. This way, you will help protect the environment.

6. Package Contents and Additional Information

Sandimmun Composition

• The active ingredient is cyclosporine. One ml of concentrate for solution for infusion contains 50 mg of cyclosporine. A 5 ml ampoule contains 250 mg of cyclosporine.
• The other components are: anhydrous ethanol, polyoxyethylated castor oil.

Sandimmun Appearance and Package Contents

Sandimmun concentrate for solution for infusion is supplied in ampoules containing 5 ml of concentrate. The concentrate is a clear, yellow-brown oily liquid. Your doctor or nurse will use it to prepare a solution that will be administered to you through a slow intravenous infusion.

Package with 10 ampoules of 5 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona (Spain)

Phone: +34 93 306 42 00

Manufacturer

• Novartis (Hellas) S.A.C.I.

12th km National Road Athens-Lamia

14451 Metamorphoses

Greece

• Novartis Farma - Produtos Farmacêuticos S.A.

Avenida Professor Doutor Cavaco Silva, n.º 10E

Taguspark

2740-255 Porto Salvo

Portugal

• Novartis Farma S.p.A.

Via Provinciale Schito 131

80058 Torre Annunziata, NA

Italy

• Novartis Farmaceutica SA
• Gran Via de les Corts Catalanes, 764
• 08013 Barcelona

Spain

• Novartis Finland Oy

Metsänneidonkuja 10

02130 Espoo

Finland

• Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

• Novartis Hungária Kft.

Bartók Béla út 43-47.

1114 Budapest

Hungary

• Novartis Pharma B.V.
• Haaksbergweg 16

1101 BX Amsterdam

Netherlands

• Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Wien

Austria

• Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

• Novartis Pharma nv/sa

Medialaan 40/Bus 1

1800 Vilvoorde

Belgium

• Novartis Pharma S.A.S.

8-10, rue Henri Sainte-Claire Deville,

92500 Rueil-Malmaison,

France

• Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

• Novartis Farma S.P.A.

Viale Luigi Sturzo, 43

20154-Milano (MI)

Italy

• Novartis Poland Sp. z o.o.

15 Marynarska Street

02-674 Warsaw

Poland

• Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

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

Date of the last revision of this prospectus: 03/2025

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/