Sandimmun Neoral

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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. Contents of the packaging and other information

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

What is Sandimmun Neoral

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 body's immune response.

What is Sandimmun Neoral used for and how does it work

• In patients after organ, bone marrow, and stem cell transplantation, the action of Sandimmun Neoral is to control 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 eczema and 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 due to organ transplantation or autoimmune disease treatment.
You should carefully follow all your doctor's instructions. 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).

You should not take Sandimmun Neoral and you should tell your doctorif this applies to you. If in doubt, consult your doctor before taking Sandimmun Neoral.

Warnings and precautions

Before and during treatment with Sandimmun Neoral, you should immediately tell your doctor 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 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 that you take magnesium supplements, especially immediately after surgery if you have received a transplant;
• you have a high potassium level in your blood;
• you have gout;
• you need to be vaccinated. If any of these situations occur before or during treatment with Sandimmun Neoral, you should immediately tell your doctor.

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. You should limit exposure to sunlight and UV radiation by:

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

You should talk to 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), you should tell your doctor before taking Sandimmun Neoral. This is because the medicine contains alcohol (see also below "Sandimmun Neoral contains ethanol").

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

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

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 uncontrollable infection;
• they have any malignant tumor;
• they have uncontrolled high blood pressure. If high blood pressure occurs during treatment and cannot be controlled with medication, the doctor should stop Sandimmun Neoral treatment. You should 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's condition if they experience neurological symptoms (e.g., increased forgetfulness, personality changes during treatment, mental 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 you to treat psoriasis or atopic dermatitis, you should not expose yourself to UVB radiation or undergo phototherapy during treatment.

Children and adolescents

Sandimmun Neoral should not be given to children for post-transplantation treatment, except for 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines before or during Sandimmun Neoral treatment:

• Medicines that may affect potassium levels. These include potassium-containing medicines, potassium supplements, diuretics (diuretics that spare potassium), and some blood pressure-lowering medicines.
• Methotrexate. It is used to treat cancer, severe psoriasis, and severe rheumatoid arthritis.
• Medicines that may increase or decrease cyclosporin (the active substance of Sandimmun Neoral) blood levels. Your doctor may recommend monitoring cyclosporin blood levels when starting or stopping treatment with 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 disease 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), cannabidiol (used to treat seizures).
• Medicines that may decrease cyclosporin blood levels include: barbiturates (used as sleeping pills), some antiepileptic medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors), antibacterial medicines used to treat tuberculosis, orlistat (used to aid weight loss), herbal medicines containing St. John's Wort, ticlopidine (used after a stroke), 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), medicines containing fibric acid (used to lower blood lipid levels, so-called fibrates).
• Nifedipine. A medicine used to treat high blood pressure and chest pain. Taking nifedipine during cyclosporin treatment may cause gum swelling and overgrowth around the teeth.
• Digoxin (used to treat heart disease), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also known as statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressive medicines (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin).
• Mycofenolate sodium or mycophenolate mofetil (an immunosuppressive medicine) and eltrombopag (used to treat bleeding disorders). If any of these situations apply to you (or you are not sure), you should talk to your doctor or pharmacist before taking Sandimmun Neoral.

Sandimmun Neoral with food and drink

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

Pregnancy and breastfeeding

You should consult your doctor or pharmacist before taking this medicine.

• You should 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.
• You should tell your doctor if you are breastfeeding.Breastfeeding is not recommended during Sandimmun Neoral treatment, as cyclosporin, the active substance of Sandimmun Neoral, passes into breast milk. This may affect the baby.

Hepatitis C

You should 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 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. You should 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, 100 mg of ethanol (alcohol) per 10, 25, 50, 100 mg, which is equivalent to 11.8% (by volume). 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.
A small amount of alcohol in this medicine 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 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 administering the medicine to a child under 4 weeks of age, you should consult a 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, 100 mg capsule, which means it is essentially "sodium-free".

3. How to take Sandimmun Neoral

You should always take this medicine exactly as your doctor has told you. If you are unsure, you should 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 talk to your doctor about 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 the medicine. Your doctor will also tell you how often to take the medicine.

• In 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.

Endogenous 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 usually is 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 be more than 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.
• In children:

Nephrotic syndrome

• The total daily dose usually is 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 be more than 2.5 mg per kilogram of body weight. You should carefully follow your doctor's instructions and never change the dose yourself, even if you feel well.

Switching from Sandimmun to Sandimmun Neoral

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

• All these medicines 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 than during Sandimmun treatment.

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

• You should 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, you should tell your doctor or pharmacist. It may be necessary to reduce the dose of the medicine. You should never reduce the dose yourself unless your doctor tells you to.

If your doctor switches you from one oral cyclosporin medicine to another

After switching 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, you should tell your doctor or pharmacist. It may be necessary to change the dose of the medicine. You should never change the dose yourself unless your doctor tells you to.

When to take Sandimmun Neoral

You should take Sandimmun Neoral every day at the same time. This is especially important in transplant patients.

How to take Sandimmun Neoral

The daily dose should always be taken 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.
Treatment usually lasts 8 weeks for severe flare-ups.
You should continue taking Sandimmun Neoral for as long as your doctor tells you. If you have questions about how long to take Sandimmun Neoral, you should talk to your doctor or pharmacist.

Taking too much Sandimmun Neoral

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

Missing a dose of Sandimmun Neoral

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

Stopping Sandimmun Neoral treatment

You should not stop taking Sandimmun Neoral unless your doctor tells you to.
You should 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 medicine, you should talk to 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

You should immediately tell your doctorif 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 are saying, 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. 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 eyes or skin, or without, nausea, loss of appetite, dark urine, or swelling of the face, hands, feet, and (or) whole body.
• Kidney disorders that can significantly reduce the amount of urine produced.
• A low number of red blood cells or platelets. Symptoms of these disorders include pale skin, feeling tired, shortness of breath, dark urine, or bleeding without a clear reason.

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, you should tell your doctor.

Common: may affect up to 1 in 10 people.

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

Uncommon: may affect up to 1 in 100 people.

• Brain disorders, including sudden seizures, confusion, insomnia, disorientation, vision changes, loss of consciousness, feeling of weakness in the limbs, movement disorders
• Rash
• General swelling
• Weight gain
• Low red blood cell count, low platelet count, which may increase the risk of bleeding If you experience any of these symptoms, you should 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 pain in the upper abdomen
• 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, decreased urine output, difficulty breathing, chest pain, seizures, loss of consciousness
• Changes in the menstrual cycle, breast enlargement in men If you experience any of these symptoms, you should 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, you should tell your doctor.

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

• Severe liver disorders with yellowing of the eyes or skin, or without, nausea, loss of appetite, dark urine, or swelling of the face, hands, feet, and (or) whole body
• Bleeding under the skin or purple spots on the skin, sudden bleeding without a clear reason
• 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, you should tell your doctor.

If you experience any side effects, including those not listed in this leaflet, you should 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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

• The medicine should be stored out of 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 warm 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.
• After opening the blister pack, a characteristic smell can be noticed. 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sandimmun 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 the active substance.
• 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 capsules with a color ranging from yellow to white, with a red print "NVR 10".
Sandimmun Neoral 25 mg soft capsules are oval capsules with a color ranging from blue to gray, with a red print "NVR 25mg".
Sandimmun Neoral 50 mg soft capsules are oblong capsules with a color ranging from yellow to white, with a red print "NVR 50mg".
Sandimmun Neoral 100 mg soft capsules are oblong capsules with a color ranging from blue to gray, with a red print "NVR 100mg".
Sandimmun Neoral 10 mg soft capsules - the pack contains 60 soft capsules.
Sandimmun Neoral 25 mg, 50 mg, and 100 mg soft capsules - the packs contain 50 soft capsules each.

Marketing authorization holder

Novartis Poland Sp. z o.o.
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.
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 {Poland, Office for Registration of Medicinal Products, Medical Devices, and Biocides}