Sandimmun Neoral

Patient Information Leaflet: Important Information

Sandimmun Neoral, 100 mg/ml, Oral Solution

Cyclosporin

Read the Leaflet Carefully Before Taking the Medication

• Keep this leaflet to read again if needed.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not give it to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

• 1. What is Sandimmun Neoral and What is it Used For
• 2. Important Information Before Taking Sandimmun Neoral
• 3. How to Take Sandimmun Neoral
• 4. Possible Side Effects
• 5. How to Store Sandimmun Neoral
• 6. Package Contents and Other Information

1. What is Sandimmun Neoral and What is it Used For

What is Sandimmun Neoral

This medication is called Sandimmun Neoral. It contains the active substance cyclosporin. This medication belongs to a group of medicines called immunosuppressants. These medicines are used to reduce the body's immune response.

What is Sandimmun Neoral Used For and How Does it Work

• In patients who have received an organ, bone marrow, or stem cell transplant, Sandimmun Neoral works by controlling the immune system. Sandimmun Neoral prevents the rejection of the transplanted organ by blocking the development of certain cells that would normally attack the transplanted tissue.
• In patients with autoimmune diseases, where the immune system attacks the body's own cells, Sandimmun Neoral stops this immune response. These diseases include eye diseases that can cause blindness (endogenous uveitis, including Behçet's disease), severe cases of certain skin diseases (atopic dermatitis or psoriasis), severe rheumatoid arthritis, and a kidney disease called nephrotic syndrome.

2. Important Information Before Taking Sandimmun Neoral

In patients taking Sandimmun Neoral after a transplant, this medication will only be prescribed by a doctor with experience in transplantation and/or autoimmune diseases. The instructions in this leaflet may vary depending on whether you are taking this medication due to a transplant or an autoimmune disease. Follow your doctor's instructions carefully. They may differ from the general information in this leaflet.

When Not to Take Sandimmun Neoral

• If you are allergic to cyclosporin or any of the other ingredients of this medication (listed in section 6);
• With medications containing Hypericum perforatum(St. John's Wort);
• With medications containing dabigatran etexilate(used to prevent blood clots after surgery) or bosentan and aliskiren(used to lower blood pressure).

Do not take Sandimmun Neoral and inform your doctor if any of these conditions apply to you. If in doubt, consult your doctor before taking Sandimmun Neoral.

Warnings and Precautions

Before and During Treatment with Sandimmun Neoral, Inform Your Doctor Immediately If:

• You experience any signs of infection, such as fever or sore throat. Sandimmun Neoral 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 regularly check your blood and may adjust the dose of the medication if necessary;
• You have high blood pressure. Your doctor will regularly check your blood pressure and may prescribe a medication to lower it if necessary;
• You have a magnesium deficiency. Your doctor may recommend magnesium supplements, especially after surgery if you have received a transplant;
• You have high levels of potassium in your blood;
• You have gout;
• You need to be vaccinated. If any of these situations occur before or during treatment with Sandimmun Neoral, inform your doctor immediately.

Protection from Sunlight and Sun Exposure

Sandimmun Neoral suppresses the immune system, which increases the risk of developing malignant tumors, especially skin and lymphatic system tumors. Limit sun exposure and UV radiation by:

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

Inform Your Doctor Before Taking Sandimmun Neoral If:

• You have or have had problems with alcohol;
• You have epilepsy;
• You have liver disease;
• You are pregnant;
• You are breastfeeding;
• This medication has been prescribed for a child. If any of these situations apply to you (or you are unsure), inform your doctor before taking Sandimmun Neoral. This is because the medication contains alcohol (see also "Sandimmun Neoral contains ethanol" below).

Monitoring During Sandimmun Neoral Treatment

Your doctor will monitor the following parameters:

• Cyclosporin blood levels, especially in transplant patients;
• Blood pressurebefore starting treatment and regularly during treatment;
• Liver and kidney function;
• Blood lipid levels. If you have any questions about the action of Sandimmun Neoral or the reasons why it has been prescribed for you, consult your doctor.

In Addition, Patients Taking Sandimmun Neoral for Indications Other Than Transplantation

(intermediate or posterior uveitis and Behçet's disease, atopic dermatitis, severe rheumatoid arthritis, or nephrotic syndrome) should not take Sandimmun Neoral if:

• They have kidney disease (except for nephrotic syndrome);
• They have an uncontrolled infection;
• They have any malignant disease;
• They have uncontrolled high blood pressure. If high blood pressure develops during treatment and cannot be controlled with medication, the doctor should stop Sandimmun Neoral treatment. Do not take Sandimmun Neoral if any of these situations apply to you. If in doubt, consult your doctor or pharmacist before taking Sandimmun Neoral.

In patients treated for Behçet's disease, the doctor will closely monitor the patient if they experience neurological symptoms (e.g., increased forgetfulness, personality changes during treatment, psychiatric disorders, or mood changes, burning sensation in the limbs, reduced sensation in the limbs, tingling in the limbs, weakness in the limbs, gait disturbances, headache with or without nausea and vomiting, vision disturbances, including limited eye movement).

The doctor will closely monitor treatment in elderly patients and those treated for psoriasis or atopic dermatitis. If Sandimmun Neoral has been prescribed for the treatment of psoriasis or atopic dermatitis, you must not expose yourself to UVB radiation or undergo phototherapy during treatment.

Children and Adolescents

Sandimmun Neoral should not be given to children for non-transplant-related diseases, except for the treatment of nephrotic syndrome.

Elderly Patients (65 Years and Older)

Experience with Sandimmun Neoral in elderly patients is limited. In these patients, the doctor should monitor kidney function. Elderly patients with psoriasis or atopic dermatitis should only be treated with Sandimmun Neoral if their disease is particularly severe.

Sandimmun Neoral and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or plan to take, including those purchased without a prescription.

• Medications that may affect potassium levels, including potassium-containing medications, potassium supplements, and certain diuretics (potassium-sparing diuretics) and some blood pressure-lowering medications.
• Methotrexate, used to treat cancer, severe psoriasis, and severe rheumatoid arthritis.
• Medications that may increase or decrease cyclosporin (the active substance of Sandimmun Neoral) blood levels. Your doctor may need to monitor cyclosporin blood levels when starting or stopping other medications.
• Medications that may increase cyclosporin blood levels include antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), heart medications or high blood pressure medications (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to treat vomiting), oral contraceptives, danazol (used to treat menstrual problems), medications 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), and cannabidiol (used to treat seizures).

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

Sandimmun Neoral with Food and Drink

Do not take Sandimmun Neoral with grapefruit or grapefruit juice, as they may affect how Sandimmun Neoral works.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before taking this medication.

• Tell your doctor if you are pregnant or plan to become pregnant.Experience with Sandimmun Neoral during pregnancy is limited. Sandimmun Neoral should not be taken during pregnancy unless necessary. Your doctor will discuss the benefits and risks of taking this medication during pregnancy.
• Tell your doctor if you are breastfeeding.Breastfeeding is not recommended during treatment with Sandimmun Neoral, as cyclosporin, the active substance, passes into breast milk and may affect the baby.

Hepatitis C

Inform your doctor if you have hepatitis C. Liver function may change during hepatitis C treatment, which may affect cyclosporin blood levels. Close monitoring of cyclosporin blood levels by your doctor and dose adjustment after starting hepatitis C treatment may be necessary.

Driving and Operating Machines

You may experience drowsiness, disorientation, or blurred vision after taking Sandimmun Neoral. Be cautious when driving or operating machines while taking Sandimmun Neoral until you know how it affects you.

Sandimmun Neoral Contains Ethanol

Sandimmun Neoral contains 94.70 mg of ethanol (alcohol) per milliliter, which is equivalent to 12.0% (by volume). A 500 mg dose of Sandimmun Neoral contains 500 mg of ethanol, equivalent to approximately 13 ml of beer or 5 ml of wine. The small amount of alcohol in this medication is unlikely to have noticeable effects.

Sandimmun Neoral Contains Castor Oil

Sandimmun Neoral contains castor oil, which may cause stomach discomfort and diarrhea.

Sandimmun Neoral Contains Propylene Glycol

The medication contains 94.70 mg of propylene glycol per milliliter of oral solution. Before administering the medication to a child under 4 weeks of age, consult your doctor or pharmacist, especially if the child is taking other medications containing propylene glycol or alcohol.

3. How to Take Sandimmun Neoral

Always take this medication exactly as your doctor has instructed. If you are unsure, consult your doctor. Do not take more than the recommended dose. Your doctor will carefully adjust the dose to your individual needs. Taking too much medication may affect kidney function. You will need to have regular blood tests and hospital visits, especially after a transplant. This will be an opportunity to discuss your treatment and any problems you may be experiencing.

How Much Sandimmun Neoral to Take

Your doctor will determine the correct dose of Sandimmun Neoral for you, based on your body weight and the reason for taking the medication. Your doctor will also inform you how often to take the medication.

• For Adults:

Organ, Bone Marrow, or Stem Cell Transplant

• The total daily dose usually ranges from 2 mg to 15 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 ensure it is optimal for you, which may involve blood tests.

Endogenous Uveitis

• The total daily dose usually ranges from 5 mg to 7 mg per kilogram of body weight, divided into two doses.

Nephrotic Syndrome

• The total daily dose is usually 5 mg per kilogram of body weight, divided into two doses. In patients with kidney disease, the first dose given each day should not exceed 2.5 mg per kilogram of body weight.

Severe Rheumatoid Arthritis

• The total daily dose usually ranges from 3 mg to 5 mg per kilogram of body weight, divided into two doses.

Psoriasis and Atopic Dermatitis

• The total daily dose usually ranges from 2.5 mg to 5 mg per kilogram of body weight, divided into two doses.
• For Children:

Nephrotic Syndrome

• The total daily dose is usually 6 mg per kilogram of body weight, divided into two doses. In patients with kidney disease, the first dose given each day should not exceed 2.5 mg per kilogram of body weight. Always follow your doctor's instructions and never change the dose yourself, unless your doctor instructs you to do so.

Switching from Sandimmun to Sandimmun Neoral

In patients already taking another medication called Sandimmun capsules or Sandimmun oral solution, your doctor may decide to switch to Sandimmun Neoral oral solution.

• All these medications contain cyclosporin as the active ingredient.
• Sandimmun Neoral is a different, improved formulation of cyclosporin compared to Sandimmun. Cyclosporin is better absorbed into the blood from Sandimmun Neoral, and there is less likelihood that absorption will be affected by food intake. This means that cyclosporin blood levels will remain more stable during Sandimmun Neoral treatment compared to Sandimmun treatment.

If your doctor switches you from Sandimmun to Sandimmun Neoral:

• Do not take Sandimmun again unless your doctor instructs you to do so.
• After switching from Sandimmun to Sandimmun Neoral, your doctor will closely monitor your condition for a short period. This is due to the change in cyclosporin absorption into the blood. Your doctor will ensure you are receiving the correct dose for your needs.
• You may experience some side effects. If this happens, inform your doctor or pharmacist. Your doctor may need to reduce your dose. Never reduce the dose yourself unless your doctor instructs you to do so.

If Your Doctor Switches You from One Oral Cyclosporin Medication to Another

After switching from one oral cyclosporin formulation to another:

• Your doctor will closely monitor your condition for a short period.
• You may experience some side effects. If this happens, inform your doctor or pharmacist. Your doctor may need to adjust your dose. Never change your dose yourself unless your doctor instructs you to do so.

When to Take Sandimmun Neoral

Take Sandimmun Neoral every day at the same time. This is especially important for transplant patients.

How to Take Sandimmun Neoral

Always take the daily dose in 2 divided doses.

• First use: follow steps 1 to 9.
• Subsequent use: follow steps 5 to 9.

Opening a New Bottle of Sandimmun Neoral Oral Solution

1. 2. 3. 4.

Lift the middle part of the metal seal ring. Completely remove the seal ring. Remove and discard the gray cap. Push the white cap with the tube firmly onto the neck of the bottle.

Measuring the Dose

5.

Choose a syringe based on the prescribed volume of medication: For doses less than 1 ml or equal to 1 ml, use a 1 ml syringe. For doses greater than 1 ml, use a 4 ml syringe. Place the syringe tip into the white cap.

6. 7. 8. 9.

Draw up the prescribed volume of solution. The position of the lower, round part of the plunger at the front of the scale corresponds to the prescribed volume of solution. Push and pull the plunger several times. This will remove large air bubbles. The presence of a few small bubbles does not matter and does not affect the dose. Make sure the correct amount of medication is in the syringe. Then remove the syringe from the bottle. Expel the drawn-up solution from the syringe into a small glass containing a small amount of liquid, preferably apple or orange juice. Avoid touching the syringe to the liquid in the glass. Mix and drink the prepared mixture immediately. After use, wipe the syringe with a dry cloth only on the outside. Then put the syringe back in its packaging. Leave the white cap and tube on the bottle. Close the bottle with the provided cap.

How Long to Take Sandimmun Neoral

Your doctor will inform you how long to take Sandimmun Neoral, depending on whether you are taking it after a transplant or for the treatment of severe skin diseases, rheumatoid arthritis, uveitis, or nephrotic syndrome. For severe flare-ups, treatment usually lasts 8 weeks. Continue taking Sandimmun Neoral for as long as your doctor has prescribed. If you have questions about how long to take Sandimmun Neoral, consult your doctor or pharmacist.

Taking More Sandimmun Neoral Than Prescribed

If you accidentally take more medication than prescribed by your doctor, inform your doctor or go to the emergency room of your nearest hospital immediately. You may need medical attention.

Missing a Dose of Sandimmun Neoral

• If you forget to take a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Then continue taking your medication as before. Do not take a double dose to make up for the missed dose.

Stopping Sandimmun Neoral Treatment

Do not stop taking Sandimmun Neoral unless your doctor instructs you to do so. Continue taking Sandimmun Neoral even if you feel well. Stopping Sandimmun Neoral treatment may increase the risk of rejecting the transplanted organ. If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Sandimmun Neoral can cause side effects, although not everyone will experience them.

Some Side Effects Can Be Serious

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

• Like other medications that affect the immune system, cyclosporin may change the body's ability to fight infections and may cause tumors or other malignant diseases, especially skin and lymphatic system tumors. Signs of infection may include fever or sore throat.
• Changes in vision, loss of coordination, tremors, memory loss, difficulty speaking or understanding speech, and weakness. These may be symptoms of a brain infection called progressive multifocal leukoencephalopathy.
• Brain disorders with symptoms such as seizures, confusion, disorientation, decreased responsiveness, personality changes, agitation, insomnia, vision changes, blindness, coma, paralysis of parts or all of the body, stiffness of the neck, and loss of coordination with (or without) speech or eye movement disorders.
• Swelling of the back of the eye. This may be associated with blurred vision. It may also affect vision due to increased pressure in the head (non-tumor-related increased intracranial pressure).
• Liver disorders with yellowing of the skin and eyes, nausea, loss of appetite, and dark urine, or without these symptoms.
• Kidney disorders that can significantly reduce the amount of urine produced.
• Low red blood cell or platelet count. Symptoms may include pale skin, fatigue, shortness of breath, dark urine (indicating red blood cell breakdown), bruising or bleeding without an obvious cause, confusion, disorientation, decreased alertness, and kidney problems.

Other Side Effects Include:

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

• Kidney function disorders
• High blood pressure
• Headache
• Uncontrolled shaking of the body
• Excessive hair growth on the body and face
• High blood lipid levels. If you experience any of these symptoms, tell your doctor.

Common: may affect up to 1 in 10 people.

• Seizures (fits)
• Liver function disorders
• High blood sugar levels
• Fatigue
• Loss of appetite
• Nausea, vomiting, abdominal discomfort or pain, diarrhea
• Excessive hair growth
• Acne, flushing
• Fever
• Low white blood cell count
• Numbness or tingling
• Muscle pain, muscle spasms
• 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, weakness in the limbs, movement disorders
• Rash
• General swelling
• Weight gain
• Low red blood cell count, low 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 in 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 in the body
• Destruction of red blood cells, including kidney disorders with symptoms such as swelling of the face, abdomen, hands, and/or feet, reduced urine output, breathing difficulties, chest pain, seizures, loss of consciousness
• Changes in 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 these symptoms, nausea, loss of appetite, dark urine, swelling of the face, hands, feet, and/or entire body
• Bleeding under the skin or purple spots on the skin, sudden bleeding without an 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 Medicinal Product Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Sandimmun Neoral

• Keep the medication out of sight and reach of children.
• Do not use this medication after the expiration date stated on the packaging.
• Store at room temperature (15°C to 30°C).
• Do not store in the refrigerator. Do not store below 20°C for more than 1 month, as the medication contains oily ingredients that may solidify at low temperatures.
• If the medication is accidentally stored in the refrigerator, remove it and wait until it reaches room temperature before using it again. Small flakes or minor sediment do not affect the efficacy and safety of the medication. Dosing with a syringe is accurate.
• The contents of the bottle remain stable for 2 months after opening. After 2 months, use medication from a new bottle.
• Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Sandimmun Neoral Contains

• The active substance is cyclosporin. One milliliter of oral solution contains 100 mg of cyclosporin.
• The other ingredients are: DL-alpha-tocopherol, absolute ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, macrogolglycerol hydroxystearate (European Pharmacopoeia)/hydrogenated castor oil Polyoxyl 40 (US Pharmacopeia).

What Sandimmun Neoral Looks Like and Contents of the Package

Sandimmun Neoral is an oral solution. It is a clear liquid with a color ranging from pale yellow to brownish-yellow.

• Packaging of 50 ml with 2 oral dosing syringes (1 ml and 4 ml)
• The 1 ml syringe is used to measure doses less than 1 ml or equal to 1 ml. Each 0.05 ml scale mark corresponds to 5 mg of cyclosporin.
• The 4 ml syringe is used to measure doses greater than 1 ml, up to 4 ml. Each 0.1 ml scale mark corresponds to 10 mg of cyclosporin.

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; Demetriades & Papaellinas Ltd., 179 Giannou Kranidioti, 2235 Latsia, Nicosia, Cyprus; 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.º 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:

Germany: Sandimmun Optoral; Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Greece, Finland, Hungary, Iceland, Italy, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Spain: Sandimmun Neoral; Belgium, Luxembourg: Neoral-Sandimmun; Ireland, Netherlands, United Kingdom (Northern Ireland): Neoral; France: Néoral; Date of Last Revision of the Leaflet:10/2024

Other Sources of Information

Detailed information on this medication can be found on the website of the {Polish, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products}