Sandimmun Neoral

Patient Information Leaflet: Information for the Patient

Sandimmun Neoral, 10 mg, Soft Capsules

Sandimmun Neoral, 25 mg, Soft Capsules

Sandimmun Neoral, 50 mg, Soft Capsules

Sandimmun Neoral, 100 mg, Soft Capsules

Cyclosporin

Read the leaflet carefully before taking 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 for you only. 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, please inform your doctor or pharmacist. See section 4.

Contents of the Leaflet

• 1. What Sandimmun Neoral is and what it is 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. Contents of the pack and other information

1. What Sandimmun Neoral is and what it is used for

What Sandimmun Neoral is

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

What Sandimmun Neoral is used for and how it works

• In patients after organ, bone marrow, and stem cell transplantation, 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 threaten vision loss (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 transplantation, this medicine will be prescribed only 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 medicine after organ transplantation or for the treatment of an autoimmune disease.

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

When not to take Sandimmun Neoral:

• if you are allergic to cyclosporin 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 clots after surgery) or bosentan andaliskiren(used to lower blood pressure).

Do not take Sandimmun Neoral and tell your doctorif any of these apply to you. If in doubt, consult 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 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 magnesium level. Your doctor may recommend magnesium supplements, especially after surgery if you have received a transplant;
• you have a high potassium level in the blood;
• you have gout;
• you need to be vaccinated. If any of these situations occur before or during treatment with Sandimmun Neoral, tell 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.

Tell your doctor before taking Sandimmun Neoral if:

• you have or have had problems with alcohol;
• 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 taking Sandimmun Neoral. This is because the medicine contains alcohol (see also below "Sandimmun Neoral contains ethanol").

Monitoring during treatment with Sandimmun Neoral

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 why it has been prescribed for you, ask your doctor.

In addition, patients taking Sandimmun Neoral for indications other than post-transplantation

(intermediate or posterior uveitis and Behçet's uveitis, 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 uveitis, the doctor will closely monitor the patient's condition if they develop neurological symptoms (e.g., increased forgetfulness, personality changes during treatment, psychiatric disorders, or mood changes, burning sensation in the limbs, decreased sensation in the limbs, tingling in the limbs, weakness in the limbs, gait disturbances, headache with nausea and vomiting or without, vision disturbances, including limited eye movement).

The doctor will closely monitor treatment in elderly patients and in patients treated for psoriasis or atopic dermatitis. If Sandimmun Neoral has been prescribed for the treatment of psoriasis or atopic dermatitis, the patient should not be exposed to UVB radiation or undergo phototherapy during treatment.

Children and adolescents

Sandimmun Neoral should not be given to children for the treatment of diseases other than 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 medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Sandimmun Neoral:

• Medicines that may affect potassium levels. These include potassium-containing medicines, potassium supplements, diuretics called potassium-sparing diuretics, and some blood pressure-lowering medicines.
• Methotrexate, used to treat cancer, severe psoriasis, and severe rheumatoid arthritis.
• Medicines 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 medicines.
• Medicines that may increase cyclosporin blood levels include: antibiotics (such as erythromycin or azithromycin), antifungal medicines (voriconazole, itraconazole), medicines used to treat heart diseases or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to treat 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), and cannabidiol (used to treat seizures).
• Medicines that may decrease cyclosporin blood levels include: barbiturates (used as sedatives), certain 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), and 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 (nonsteroidal anti-inflammatory medicines such as diclofenac), and medicines containing fibric acid (used to lower blood lipid levels, so-called fibrates).
• Nifedipine, a medicine used to treat high blood pressure and heart pain. Taking nifedipine with cyclosporin may cause gum overgrowth and gingival hyperplasia.
• Digoxin (used to treat heart diseases), 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 called anthracyclines (such as doxorubicin).
• Mycofenolate sodium or mycophenolate mofetil (an immunosuppressant medicine) and eltrombopag (used to treat bleeding disorders). If any of these situations apply to you (or you are not sure), 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 the way Sandimmun Neoral works.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine.

• Tell your doctor if you are pregnant or planning to become pregnant.Experience with Sandimmun Neoral during pregnancy is limited. Sandimmun Neoral should not be taken during pregnancy unless necessary. If you need to take this medicine, your doctor will discuss the benefits and risks of taking it 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. This may affect the baby.

Hepatitis C

Tell your doctor if you have hepatitis C. Liver function may change during treatment for hepatitis C, which may affect cyclosporin blood levels. Close monitoring of cyclosporin blood levels by your doctor may be necessary, and the dose may need to be adjusted after starting hepatitis C treatment.

Driving and using machines

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

Sandimmun Neoral contains ethanol

Sandimmun Neoral capsules contain 10, 25, 50, or 100 mg of ethanol (alcohol) per 10, 25, 50, or 100 mg dose, which is equivalent to 11.8% (v/v). A 500 mg dose of Sandimmun Neoral contains 500 mg of ethanol, which is equivalent to almost 13 ml of beer or 5 ml of wine.

The small amount of alcohol in this medicine will not 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 medicine contains 20.84 mg of propylene glycol in each 10 mg capsule.

The medicine contains 46.42 mg of propylene glycol in each 25 mg capsule.

The medicine contains 90.36 mg of propylene glycol in each 50 mg capsule.

The medicine contains 148.31 mg of propylene glycol in each 100 mg capsule.

Before giving this medicine to a child under 4 weeks of age, consult your doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Sandimmun Neoral contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 10, 25, 50, or 100 mg capsule, which is essentially sodium-free.

3. How to take Sandimmun Neoral

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Do not take more medicine than prescribed.

Your doctor will carefully adjust the dose of this medicine to your individual needs. Taking too much medicine may affect kidney function. You will have regular blood tests and hospital visits, especially after transplantation. This will be an opportunity to discuss your treatment and any problems you may have.

How much Sandimmun Neoral to take

Your doctor will adjust the correct dose of Sandimmun Neoral for you. It depends on your body weight and the reason you are taking this medicine. Your doctor will also tell you how often to take it.

• For adults:

Organ, bone marrow, or stem cell transplantation

• The total daily dose usually ranges from 2 mg to 15 mg per kilogram of body weight. It is 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 of the medicine to be optimal for you. This may involve blood tests.

Intermediate or posterior uveitis

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

Nephrotic syndrome

• The total daily dose is usually 5 mg per kilogram of body weight. It is 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. It is 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. It is divided into two doses.
• For children:

Nephrotic syndrome

• The total daily dose is usually 6 mg per kilogram of body weight. It is 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, even if you feel better.

Changing treatment from Sandimmun to Sandimmun Neoral

In patients who are already taking another medicine called Sandimmun capsules or Sandimmun oral solution, the doctor may decide to switch to Sandimmun Neoral oral solution.

• All these medicines contain cyclosporin as the active substance.
• 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. This means that cyclosporin blood levels will remain more stable during treatment with Sandimmun Neoral than with Sandimmun.

If your doctor changes your treatment from Sandimmun to Sandimmun Neoral:

• Do not take Sandimmun again unless your doctor tells you to.
• After switching from Sandimmun to Sandimmun Neoral, your doctor will closely monitor your condition for a short time. This is because of the change in cyclosporin absorption into the blood. Your doctor will check that you are receiving the correct dose for your needs.
• You may experience some side effects. If this happens, tell your doctor or pharmacist. Your doctor may need to reduce the dose of the medicine. Never reduce the dose yourself unless your doctor tells you to.

If your doctor changes one oral cyclosporin medicine to another

After changing from one oral cyclosporin formulation to another:

• Your doctor will closely monitor your condition for a short time.
• You may experience some side effects. If this happens, tell your doctor or pharmacist. Your doctor may need to change the dose of the medicine. Never change the dose yourself unless your doctor tells you to.

When to take Sandimmun Neoral

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

How to take Sandimmun Neoral

Always take the daily dose in 2 divided doses.

Remove the capsules from the blister pack. 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 are taking the medicine after transplantation or for the treatment of severe skin diseases, rheumatoid arthritis, uveitis, or nephrotic syndrome.

For severe psoriasis, treatment usually lasts 8 weeks.

Continue taking Sandimmun Neoral for as long as your doctor tells you. If you have questions about how long to take Sandimmun Neoral, ask your doctor or pharmacist.

If you take more Sandimmun Neoral than you should

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

If you forget to take Sandimmun Neoral

• If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Then take the medicine as you normally would.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Sandimmun Neoral

Do not stop taking Sandimmun Neoral unless your doctor tells you to.

Continue taking Sandimmun Neoral even if you feel better.

Stopping treatment with Sandimmun Neoral may increase the risk of rejecting the transplanted organ.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sandimmun Neoral 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:

• 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 skin and lymphatic system tumors. Signs of infection may include fever or sore throat.
• Changes in vision, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the muscles. 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 part or all of the body, stiffness in 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 increased intracranial pressure).
• Liver disorders with yellowing of the eyes or skin, nausea, loss of appetite, 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 of these disorders include pale skin, feeling tired, shortness of breath, dark urine (a sign of red blood cell breakdown), bruising or bleeding without an obvious cause, feeling confused or 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 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 problems
• High blood sugar levels
• Tiredness
• Loss 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 spasms
• Stomach ulcers
• Gum overgrowth covering the teeth
• High potassium and magnesium levels 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 weak 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 in the fingers and toes
• Pancreatitis with severe abdominal pain
• Muscle weakness, loss of muscle strength, muscle pain in the legs or arms 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, decreased urine production, 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 disturbances. 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, nausea, loss of appetite, dark urine, or without these symptoms
• Bleeding under the skin or purple spots on the skin, sudden bleeding without an obvious cause
• Migraine or severe headache, often with nausea and 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, 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 medicine.

5. How to store Sandimmun Neoral

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging.
• Do not store the capsules in a hot place. Do not store above 25°C.
• Store in the original packaging to protect from moisture.
• Leave the capsules in the blister pack. Remove the capsules from the blister pack immediately before use.
• A characteristic smell may be noticed after opening the blister pack. This is normal and does not mean that the capsules are not suitable for use.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sandimmun Neoral contains

Sandimmun Neoral, 10 mg

• The active substance is cyclosporin. Each capsule contains 10 mg of cyclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. o Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. o Printing ink: carmine (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropylmethylcellulose 2910, isopropanol/isopropyl alcohol. Sandimmun Neoral, 25 mg
• The active substance is cyclosporin. Each capsule contains 25 mg of cyclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. o Capsule shell: iron oxide black (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. o Printing ink: carmine (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropylmethylcellulose 2910, isopropanol/isopropyl alcohol. Sandimmun Neoral, 50 mg
• The active substance is cyclosporin. Each capsule contains 50 mg of cyclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. o Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. o Printing ink: carmine (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropylmethylcellulose 2910, isopropanol/isopropyl alcohol. Sandimmun Neoral, 100 mg
• The active substance is cyclosporin. Each capsule contains 100 mg of cyclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. o Capsule shell: iron oxide black (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. o Printing ink: carmine (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropylmethylcellulose 2910, isopropanol/isopropyl alcohol.

What Sandimmun Neoral looks like and contents of the pack

Sandimmun Neoral 10 mg soft capsules are oval, yellow to white, with a red print "NVR 10".

Sandimmun Neoral 25 mg soft capsules are oval, blue to gray, with a red print "NVR 25mg".

Sandimmun Neoral 50 mg soft capsules are elongated, yellow to white, with a red print "NVR 50mg".

Sandimmun Neoral 100 mg soft capsules are elongated, blue to gray, with a red print "NVR 100mg".

Sandimmun Neoral 10 mg capsules - the pack contains 60 capsules.

Sandimmun Neoral 25 mg, 50 mg, and 100 mg capsules - the packs contain 50 capsules 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

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

Lek Pharmaceuticals d.d.

Trimlini 2D,

9220 Lendava

Slovenia

Novartis Pharmaceutical Manufacturing LLC

Verovskova Ulica 57

Ljubljana, 1000

Slovenia

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, Estonia, Greece, Finland, Hungary, Iceland, Italy, Lithuania, Latvia, 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 medicine is available on the website of the {Polish, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products}