Prospect: Information for the patient

Sandimmun 50mg/ml concentrate for infusion solution

ciclosporina

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.See section 4.

1.What is Sandimmun and for what it is used

2.What you need to know before starting to use Sandimmun

3.How to use Sandimmun

4.Possible adverse effects

5.Storage of Sandimmun

6.Contents of the package and additional information

What isSandimmun

The name of your medication is Sandimmun.It contains the active ingredientciclosporina.The concentrate is used to prepare a solution that is administered via intravenous perfusion.It belongs to a group of medications known as immunosuppressants.These medications are used to decreasethe immune system reactions of the body

What is Sandimmun used for and how it works

Sandimmun is used to control the immune system of your bodyafteran organ transplant, including bone marrow and stem cell transplants.It prevents organ transplant rejection by inhibiting the development of certain cells that would normally attack the transplanted tissue.

Only a doctor with experience in transplantation will prescribe Sandimmun.

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

Do not use Sandimmun:

• If you are allergic to ciclosporin or any of the other ingredients in this medicine (including those 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 dabigatrán etexilate (used to prevent blood clots after surgery)or bosentán and aliskirén(used to lower high blood pressure).

If this applies to you, do not use Sandimmun andinform your doctor. If you are unsure, consult your doctor before using Sandimmun.

Warnings and precautions

Inform 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 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 change your dose as needed.
• if you have high blood pressure. Your doctor will monitor your blood pressure regularly and may prescribe a medication to lower your blood pressure if necessary.
• if you have low levels of magnesium in your body. Your doctor may prescribe magnesium supplements, especially after your operation if you have undergone a transplant.
• if you have high levels of potassium in your blood.
• if you suffer from gout.
• if you need to receive a vaccine.

If you experience any of the above situations before or during treatment with Sandimmun, inform your doctor immediately.

Protection from the sun and sunlight

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

• Wear protective clothing.
• Apply 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 suffer from epilepsy.
• if you have any liver problems.
• if you are pregnant.
• if you are breastfeeding.
• if this medicine is prescribed to a child.

If any of these situations apply to you (or you are unsure), inform your doctor before taking Sandimmun. This is because this medicine contains alcohol (see section “Sandimmun contains castor oil and ethanol”, below).

Monitoring during treatment with Sandimmun

Your doctor will monitor:

• the levels of ciclosporin in your blood, especially if you have undergone a transplant,
• your blood pressure before starting treatment and regularly during treatment,
• how your liver and kidneys are functioning,
• your levels of lipids in the blood (fats).

If you have any questions about how Sandimmun works or why you have been prescribed this medicine, consult your doctor.

Children and adolescents

There is limited experience with Sandimmun in children.

Older adults (65 years and older)

There is limited experience with Sandimmun in older adults. Your doctor should monitor how your kidneys are functioning.

Other medicines and Sandimmun

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Particularly inform your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Sandimmun:

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

• Medicines that can increase or decrease the levels of ciclosporin (the active ingredient in Sandimmun) in your blood. Your doctor may check the level of ciclosporin in your blood when you start or stop taking other medicines.

• Medicines that can increase the level of ciclosporin in your blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to prevent vomiting), oral contraceptives, danazol (used to treat menstrual disorders), medicines used to treat gout (allopurinol), bile acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir (used to treat hepatitis C),cannabidiol (its use includes, among others, the treatment of epilepsy seizures).
• Medicines that can decrease the level of ciclosporin in your blood include: barbiturates (used to help you sleep), certain anticonvulsants (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumours in the intestine), tuberculosis antibiotics, orlistat (used to help you lose weight), 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 fungal infections of the fingers and toes).

• Medicines that can affect your kidneys. These include: antibiotics (gentamicin, tobramycin, ciprofloxacin), antifungals that contain amphotericin B, antibiotics used to treat urinary tract infections that contain trimethoprim, cancer medicines that contain melphalan, medicines used to reduce stomach acid (H2 receptor antagonists), tacrolimus, analgesics (non-steroidal anti-inflammatory drugs, such as diclofenac), acidophilic medicines (used to reduce the amount of fat in the blood).
• Nifedipine.It is used to treat high blood pressure and chest pain. You may develop inflamed gums that can grow over your teeth if you take nifedipine during your treatment with ciclosporin.
• Digoxin (used to treat heart problems), cholesterol-lowering medicines (HMG-CoA reductase inhibitors also known as statins), prednisolone, etoposide (used to treat cancer), repaglinide (an oral antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan and specific cancer medicines called anthracyclines (such as doxorubicin).
• Mycophenolate sodium or mycophenolate mofetil (an immunosuppressant) and eltrombopag (used to treat bleeding disorders).

If any of these situations apply to you (or you are unsure), inform your doctor or pharmacist before using Sandimmun.

Use of Sandimmun with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medicine.

• Inform your doctor if you are pregnant or intend to become pregnant.The experience with Sandimmun in pregnant women is limited. In general, Sandimmun should not be administered during pregnancy. If you need to use this medicine, your doctor will discuss the potential benefits and risks of using it during pregnancy.
• Inform your doctor if you are breastfeeding.Breastfeeding is not recommended during treatment with Sandimmun. This is because ciclosporin, the active ingredient, passes into breast milk and may affect your baby.

Hepatitis C

Inform your doctor if you have hepatitis C. Your liver function may change with hepatitis C treatment, which may affect ciclosporin levels in the blood. Your doctor may need to closely monitor ciclosporin levels in the blood and adjust the dose after starting hepatitis C treatment.

Driving and operating machinery

You may feel drowsy, disoriented or have blurred vision after taking Sandimmun. Be careful when driving or operating machinery until you know how Sandimmun affects you.

Sandimmun contains castor oil and ethanol

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

Sandimmun concentrate for infusion solution contains 278 mg of alcohol (ethanol) per ml, which corresponds to 34.4% v/v.A dose of 100 mg ofSandimmuncontains 556 mg of ethanol, which is equivalent to approximately14ml of beer or 6ml of wine.The small amount of alcohol in this medicine will have no perceptible effect.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor again.

How much Sandimmun you will receive

Your doctor will indicate the correct dose ofSandimmunfor you. This depends on your body weight and the purpose for which this medication is being administered.

• The usual total daily dose is typically between3 and 5mg per kilogram of body weight. This is divided into two doses.
• Higher doses are usually used before and just after your transplant. Lower doses are used once your transplanted organ or bone marrow are stabilized.
• Your doctor will adjust the dose to one that is ideal for you. To do this, your doctor may need to perform some blood tests.

How Sandimmun will be used

The medication will be diluted before usebetween the1:20and the 1:100with saline solution or 5% glucose, using an appropriate aseptic techniqueand will be administered via slow infusionover2 to6hours. The medication dilutions should be discarded after 24hours of preparation.

How long Sandimmun will be used

You will be switched to cyclosporine 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 have

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

If you believe you have received too much Sandimmun, inform your doctor immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious

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

• Appearance of signs of anaphylactoid reactions after intravenous administration of Sandimmun. These reactions may consist of facial flushing and upper chest redness, 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 may affect your body's ability to fight certain infections and may cause tumors or other malignant diseases, especially of the skin. Signs of infection may be fever or sore throat.
• Visual disturbances, lack of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These may be signs of a brain infection called progressive multifocal leukoencephalopathy.
• Brain problems with signs such as seizures, confusion, disorientation, decreased sensitivity, changes in personality, 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 blurry vision. It may also affect your vision due to an increase in pressure within the head (benign intracranial hypertension).
• Liver damage and alteration with or without yellow discoloration of the eyes or skin, nausea, loss of vision, and dark urine.
• Kidney problems, which may significantly reduce the amount of urine you produce.
• Decrease in the number of red or white blood cells. These signs include pale skin, fatigue, shortness of breath, dark urine (sign of red blood cell rupture), unexplained bleeding or bruising, confusion, disorientation, lack of attention, and kidney problems.

Other side effects include:

Very common:may affect more than 1 in 10people

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

If any of them severely affect you,inform your doctor.

Common:may affect up to 1 in 10people

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

If any of them severely affect you,inform your doctor.

Rare:may affect up to 1 in 100people

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

If any of them severely affect you,inform your doctor.

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

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

If this affects you severely,inform your doctor.

Frequency not known:Cannot be estimated from available data.

• Severe liver problems with and without yellow discoloration of the eyes or skin, nausea (feeling of dizziness), loss of appetite, dark urine, facial, foot, hand, and/or body inflammation.
• Bleeding under the skin or purple-colored skin spots, sudden unexplained bleeding.
• Migraine or severe headache, often with dizziness or feeling of the same (nausea, vomiting) and light sensitivity.
• Pain in the legs and feet.
• Hearing loss.

If any of them severely affect you,inform your doctor.

If you experience side effects, consult your doctor or pharmacist, even if it is about side effects that do not appear in this prospectus.

Other side effects in children and adolescents

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

Reporting of side effects

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

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging.
• This medication does not require any special storage temperature.
• Once the vial has been opened, the contents must be diluted using an appropriate 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 storage and infusion is less than 24 hours. Discard any unused diluted solution.

Medications should not be disposed of through drains or in the trash. This will help protect the environment.

Composition of Sandimmun

• The active ingredient is cyclosporin.Onemlof concentrate for solution for infusion contains50mgofcyclosporina.
• The other components are: anhydrous ethanol, polioxylated ricin oil.

Appearance of Sandimmun and contents of the package

Sandimmunconcentrate for solution for infusion is supplied in ampoules containing1mlofconcentrate.The concentrate is a yellow-brownish, transparent oily liquid.It will be used by your doctor or nurse to prepare a solution that will be administered to you through a slow intravenous infusion.

Package with 10 ampoules of 1 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)

Telephone: +34 93 306 42 00

Responsible for manufacturing

• 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 Vienna

Austria

• Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

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 Nuremberg

Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet: 03/2025

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/