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 a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 uveitis in 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 the patient is taking this medicine due to organ transplantation or autoimmune disease.

The patient should carefully follow all the doctor's instructions. They may differ from the general information contained in this leaflet.

When not to take Sandimmun Neoral:

• if the patient is 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 bozentan and aliskiren(used to lower blood pressure).

The patient should not take Sandimmun Neoral and should tell their doctorif such a situation applies to them. If in doubt, the patient should consult their doctor before taking Sandimmun Neoral.

Warnings and precautions

Before and during treatment with Sandimmun Neoral, the patient should immediately tell their doctor if:

• the patient experiences any symptoms 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;
• the patient has liver disease;
• the patient has kidney disease. The doctor will order regular blood tests and may change the dose of the medicine if necessary;
• the patient has high blood pressure. The doctor will regularly check the patient's blood pressure and may prescribe a medicine to lower blood pressure if necessary;
• the patient has a magnesium deficiency. The doctor may recommend that the patient take magnesium supplements, especially immediately after surgery if the patient has received a transplant;
• the patient has a high level of potassium in the blood;
• the patient has gout;
• the patient needs to be vaccinated. If any of these situations occur before or during treatment with Sandimmun Neoral, the patient should immediately tell their 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. The patient should limit exposure to sunlight and UV radiation by:

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

The patient should consult their doctor before taking Sandimmun Neoral if:

• the patient has a history of alcohol problems, currently or in the past;
• the patient has epilepsy;
• the patient has any liver disease;
• the patient is pregnant;
• the patient is breastfeeding;
• this medicine has been prescribed for a child. If any of these situations apply to the patient (or the patient is unsure), they should tell their 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

The doctor will monitor the following parameters:

• cyclosporin blood levels, especially in patients after transplantation;
• blood pressurebefore starting treatment and regularly during treatment;
• liver and kidney function;
• blood lipid levels. If the patient has any questions about the action of Sandimmun Neoral or the reasons why it has been prescribed for them, they should consult their doctor.

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

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

• the patient has kidney disease (except for nephrotic syndrome);
• the patient has an uncontrollable infection;
• the patient has any malignant tumor;
• the patient has uncontrolled high blood pressure. If high blood pressure occurs during treatment and cannot be controlled with medication, the doctor should discontinue Sandimmun Neoral. The patient should not take Sandimmun Neoral if any of these situations apply to them. If in doubt, the patient should consult their doctor or pharmacist before taking Sandimmun Neoral.

In patients treated for uveitis in 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, psychiatric disorders, or mood changes, burning sensation in the limbs, decreased sensation in the limbs, tingling in the limbs, limb weakness, gait disturbances, headache with nausea and vomiting, or without, vision disturbances, including limited mobility of the eyeballs).

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 patient to treat psoriasis or atopic dermatitis, the patient should not expose themselves to UVB radiation or undergo phototherapy during treatment.

Children and adolescents

Sandimmun Neoral should not be given to children for the treatment of post-transplantation diseases, except for the treatment of nephrotic syndrome.

Elderly patients (65 years and older)

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

Sandimmun Neoral and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

In particular, the patient should tell their doctor or pharmacist if they 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. It is used to treat cancer, severe psoriasis, and severe rheumatoid arthritis.
• Medicines that may increase or decrease the level of cyclosporin (the active substance of Sandimmun Neoral) in the blood. The 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 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 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 drugs such as diclofenac), and medicines containing fibric acid (used to reduce blood lipid levels, so-called fibrates).
• Nifedipine. A medicine used to treat high blood pressure and heart pain. Taking nifedipine during cyclosporin treatment may cause gum swelling and overgrowth around the teeth.
• 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), 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 the patient (or the patient is unsure), they should consult their doctor or pharmacist before taking Sandimmun Neoral.

Sandimmun Neoral with food and drink

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

Pregnancy and breastfeeding

The patient should consult their doctor or pharmacist before taking this medicine.

• The patient should tell their doctor if they are pregnant or planning to become pregnant.Experience with the use of Sandimmun Neoral during pregnancy is limited. Sandimmun Neoral should not be used during pregnancy unless necessary. If the patient needs to take this medicine, the doctor will discuss the benefits and risks of taking it during pregnancy.
• The patient should tell their doctor if they are breastfeeding.Breastfeeding is not recommended during treatment with Sandimmun Neoral, as cyclosporin, the active substance of Sandimmun Neoral, passes into human milk. This may affect the baby.

Hepatitis C

The patient should inform their doctor if they 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 the doctor may be necessary, and the dose may need to be adjusted after starting hepatitis C treatment.

Driving and using machines

The patient may experience drowsiness, disorientation, or blurred vision after taking Sandimmun Neoral. The patient should be careful when driving or operating machinery while taking Sandimmun Neoral until they know how it affects them.

Sandimmun Neoral contains ethanol

Sandimmun Neoral capsules contain 10, 25, 50, or 100 mg of ethanol (alcohol) per 10, 25, 50, or 100 mg, which is equivalent to 11.8% (by volume). A dose of 500 mg 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 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, the patient should consult their 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 means it is essentially "sodium-free".

3. How to take Sandimmun Neoral

The patient should always take this medicine exactly as their doctor has told them. If they are unsure, they should ask their doctor.

The patient should not take more medicine than prescribed.

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

How much Sandimmun Neoral to take

The doctor will adjust the correct dose of Sandimmun Neoral for the patient. It depends on the patient's body weight and the reason for taking the medicine. The doctor will also tell the patient 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 used before and immediately after transplantation. Smaller doses are used after the transplanted organ or bone marrow has stabilized.
• The doctor will adjust the dose of the medicine to be optimal for the individual patient. This may require 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. The patient should carefully follow the doctor's instructions and never change the dose themselves, even if they 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 treatment with Sandimmun Neoral than with Sandimmun.

If the doctor switches the patient from Sandimmun to Sandimmun Neoral:

• The patient should not take Sandimmun again unless the doctor tells them to.
• After switching from Sandimmun to Sandimmun Neoral, the doctor will closely monitor the patient's condition for a short time. This is because of the change in cyclosporin absorption into the blood. The doctor will check that the patient is receiving the correct dose for their needs.
• The patient may experience some side effects. If this happens, they should tell their doctor or pharmacist. The dose of the medicine may need to be reduced. The patient should never reduce the dose themselves unless the doctor tells them to.

If the doctor switches from one oral cyclosporin medicine to another

After switching from one oral cyclosporin formulation to another:

• The doctor will closely monitor the patient's condition for a short time.
• The patient may experience some side effects. If this happens, they should tell their doctor or pharmacist. The dose of the medicine may need to be changed. The patient should never change the dose themselves unless the doctor tells them to.

When to take Sandimmun Neoral

Sandimmun Neoral should be taken every day at the same time. This is very important in patients after transplantation.

How to take Sandimmun Neoral

The daily dose should always be taken in 2 divided doses.

The capsules should be removed from the blister pack. The capsules should be swallowed whole, with a glass of water.

How long to take Sandimmun Neoral

The doctor will tell the patient how long to take Sandimmun Neoral. It depends on whether the patient is taking the medicine after receiving a transplant or for the treatment of severe skin diseases, rheumatoid arthritis, uveitis, or nephrotic syndrome.

Treatment usually lasts 8 weeks in the case of severe flare-ups.

The patient should continue taking Sandimmun Neoral for as long as the doctor tells them. If the patient has any questions about how long to take Sandimmun Neoral, they should consult their doctor or pharmacist.

Taking too much Sandimmun Neoral

If the patient accidentally takes more medicine than prescribed by their doctor, they should immediately tell their doctor or go to the emergency department of the nearest hospital. The patient may need medical attention.

Missing a dose of Sandimmun Neoral

• If the patient forgets to take a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose. The patient should then take the medicine as before.
• The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Sandimmun Neoral

The patient should not stop taking Sandimmun Neoral unless their doctor tells them to.

The patient should continue taking Sandimmun Neoral even if they feel well.

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

If the patient has any further doubts about taking this medicine, they should consult their 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

The patient should immediately tell their doctorif they 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. Symptoms 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 of 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, changes in vision, blindness, coma, paralysis of part 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 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 (a sign of red blood cell breakdown), bruising or bleeding without an obvious reason, feeling confused or disoriented, 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 the patient experiences any of these symptoms, they should tell their 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, 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 levels of uric acid and potassium in the blood, low levels of magnesium in the blood
• If the patient experiences any of these symptoms, they should tell their doctor.

Uncommon: may affect up to 1 in 100 people.

• Brain disorders with symptoms such as sudden seizures, confusion, insomnia, disorientation, vision disturbances, 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 the patient experiences any of these symptoms, they should tell their 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 of 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 the menstrual cycle, breast enlargement in men
• If the patient experiences any of these symptoms, they should tell their 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 the patient experiences any of these symptoms, they should tell their 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 an obvious reason
• Migraine or severe headache, often with nausea and vomiting, and sensitivity to light
• Pain in the legs and feet
• If the patient experiences any of these symptoms, they should tell their doctor.

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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, more information can be collected on the safety of this medicine.

5. How to store Sandimmun Neoral

• The medicine should be stored out of sight and reach of children.
• The patient should not use this medicine after the expiry date stated on the packaging.
• The patient should not store the capsules in a warm place. The patient should not store them at temperatures above 25°C.
• The patient should store the medicine in its original packaging to protect it from moisture.
• The patient should leave the capsules in the blister pack. The capsules should be removed 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. The patient should ask their 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: Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. 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: Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. Capsule shell: iron oxide black (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. 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: Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. 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: Capsule contents: alpha-tocopherol, anhydrous ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, hydroxyethylated and polyoxyethylated hydrogenated castor oil. Capsule shell: iron oxide black (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. 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 oblong, yellow to white, with a red print "NVR 50mg".

Sandimmun Neoral 100 mg soft capsules are oblong, 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., 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.