Sandimmun neoral: detailed information

Patient Information Leaflet

Sandimmun Neoral, 10 mg, soft capsules
Sandimmun Neoral, 25 mg, soft capsules
Sandimmun Neoral, 50 mg, soft capsules
Sandimmun Neoral, 100 mg, soft capsules
cyclosporine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Sandimmun Neoral is and what it is used for
Important information before taking Sandimmun Neoral
How to take Sandimmun Neoral
Possible side effects
How to store Sandimmun Neoral
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 cyclosporine. This medicine belongs to a group of medicines called immunosuppressants. These medicines are used to reduce the body's immune response.

What Sandimmun Neoral is used for and how it works

In patients who have received an organ, bone marrow, or stem cell transplant, Sandimmun Neoral works by suppressing the immune system. It prevents rejection of the transplanted organ by blocking the development of certain cells that would normally attack the transplanted tissue.
In patients with autoimmune diseases, in which the immune system attacks the body's own cells, Sandimmun Neoral suppresses this immune reaction. Such diseases include sight-threatening eye disorders (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 using Sandimmun Neoral

In patients taking Sandimmun Neoral after transplantation, this medicine will be prescribed exclusively by a physician experienced in transplantation and/or autoimmune diseases.
The information provided in this leaflet may differ depending on whether the patient is taking this medicine due to organ transplantation or for the treatment of an autoimmune disease.
Carefully follow all instructions given by the physician. These may differ from the general information contained in this leaflet.

When not to use Sandimmun Neoral:

if the patient is allergic to cyclosporine 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 and aliskiren (used to reduce blood pressure).

Do not take Sandimmun Neoral and tell your doctor if any of these situations apply to the patient. If in doubt, speak with the doctor before taking Sandimmun Neoral.

Warnings and precautions
Before and during treatment with Sandimmun Neoral, inform the doctor immediately if:

the patient develops 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;
the patient has liver disease;
the patient has kidney disease. The doctor will order regular blood tests and may adjust the dose if necessary;
the patient has high blood pressure. The doctor will regularly monitor the patient's blood pressure and may prescribe medication to lower it if needed;
the patient has magnesium deficiency. The doctor may recommend magnesium supplements, especially shortly after surgery if the patient has received a transplant;
the patient has high levels of potassium in the blood;
the patient has gout;
the patient requires vaccination. If any of these situations occur before or during treatment with Sandimmun Neoral, inform the doctor immediately.

Protection from sunlight and sun exposure
Sandimmun Neoral suppresses the immune system, increasing the risk of developing malignant tumors, especially of the skin and lymphatic system. Exposure to sunlight and UV radiation should be limited by:

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

Talk to the doctor before using Sandimmun Neoral if:

the patient has alcohol-related 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), inform the doctor before using Sandimmun Neoral. This is due to the alcohol content of this medicine (see also below "Sandimmun Neoral contains ethanol").

Monitoring tests during treatment with Sandimmun Neoral
The doctor will monitor the following parameters:

blood levels of cyclosporine, especially in transplant patients;
blood pressure before starting treatment and regularly during treatment;
function of the liver and kidneys;
levels of lipids (fats) in the blood. If there are any questions about how Sandimmun Neoral works or why it has been prescribed, consult the doctor.

Additionally, patients taking Sandimmun Neoral for indications other than post-transplantation (intermediate or posterior uveitis, 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 nephrotic syndrome);
the patient has an infection that cannot be controlled with medication;
the patient has any malignant tumor;
the patient has untreated or treatment-resistant high blood pressure (hypertension). If high blood pressure develops during treatment and cannot be controlled with medication, the doctor should discontinue Sandimmun Neoral. Do not use Sandimmun Neoral if any of these situations apply to the patient. If in doubt, consult the doctor or pharmacist before using Sandimmun Neoral.

In patients being treated for uveitis in Behçet's disease, the doctor will monitor the patient particularly closely if neurological symptoms occur (e.g. increased tendency to forgetfulness, personality changes during treatment, psychiatric or mood disorders, burning sensation in the limbs, reduced sensation in the limbs, tingling in the limbs, limb weakness, walking difficulties, headache with or without nausea and vomiting, visual disturbances including limited eye movement).
The doctor will closely monitor treatment in elderly patients and in patients being treated for psoriasis or atopic dermatitis. If Sandimmun Neoral has been prescribed for the treatment of psoriasis or atopic dermatitis, the patient must 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 non-transplant-related 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. Patients aged 65 years and older with psoriasis or atopic dermatitis should only be treated with Sandimmun Neoral if their condition is particularly severe.

Sandimmun Neoral and other medicines
Tell the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
In particular, inform the doctor or pharmacist if the patient is 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 known as potassium-sparing diuretics, and certain blood pressure-lowering medicines.
Methotrexate. It is used in the treatment of cancers, severe psoriasis, and severe rheumatoid arthritis.
Medicines that may increase or decrease blood levels of cyclosporine (the active substance in Sandimmun Neoral). The doctor may recommend monitoring cyclosporine blood levels when starting or stopping treatment with other medicines.
- Medicines that may increase cyclosporine 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 disorders), medicines used to treat gout (allopurinol), bile acid and its derivatives (used to treat gallstones), protease inhibitors used in HIV treatment, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (used, among others, to treat epileptic seizures).
- Medicines that may decrease cyclosporine blood levels include: barbiturates (e.g., used as sleeping pills), certain anticonvulsants (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine intestinal tumors), antibacterial medicines used to treat tuberculosis, orlistat (used to support weight loss), herbal medicines containing St. John's wort, ticlopidine (used after stroke), certain blood pressure-lowering medicines (bosentan), and terbinafine (an antifungal medicine used to treat foot and nail infections).
Medicines affecting 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 (acid secretion inhibitors acting as H\ receptor antagonists), tacrolimus, painkillers (nonsteroidal anti-inflammatory drugs such as diclofenac), medicines containing fibric acid (used to reduce blood fat levels, so-called fibrates).
Nifedipine. A medicine used to treat high blood pressure and angina. Taking nifedipine during cyclosporine treatment may cause gum swelling and overgrowth around the teeth.
Digoxin (used to treat heart conditions), 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).
Sodium mycophenolate or mycophenolate mofetil (immunosuppressive medicines) and eltrombopag (used to treat bleeding disorders). If any of these situations apply to the patient (or the patient is unsure), consult the doctor or pharmacist before using Sandimmun Neoral.

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

Pregnancy and breastfeeding
Consult the doctor or pharmacist before using this medicine.

Tell the doctor if the patient is pregnant or planning to become pregnant. Experience with using Sandimmun Neoral during pregnancy is limited. Generally, Sandimmun Neoral should not be used during pregnancy. If it is necessary for the patient to take this medicine, the doctor will discuss the benefits and risks associated with its use during pregnancy.
Tell the doctor if the patient is breastfeeding. Breastfeeding is not recommended during treatment with Sandimmun Neoral, as cyclosporine, the active ingredient, passes into human milk and may affect the infant.

Hepatitis C
Inform the doctor if the patient has hepatitis C. Liver function may change during hepatitis C treatment, which could affect cyclosporine blood levels. Close monitoring of cyclosporine blood levels by the doctor and dose adjustment after starting hepatitis C treatment may be necessary.

Driving and operating machinery
The patient may experience drowsiness, disorientation, or blurred vision after taking Sandimmun Neoral. Exercise caution when driving or operating machinery during treatment with Sandimmun Neoral until the effect of the medicine on the body is known.

Sandimmun Neoral contains ethanol
Sandimmun Neoral capsules contain 10, 25, 50, and 100 mg of alcohol (ethanol) per 10, 25, 50, and 100 mg dose, respectively, equivalent to 11.8% by volume. A 500 mg dose of Sandimmun Neoral contains 500 mg of ethanol, equivalent to nearly 13 ml of beer or 5 ml of wine.
The small amount of alcohol in this medicine will not cause 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, contact the 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, and 100 mg capsule, meaning the medicine is considered "sodium-free".

3. How to take Sandimmun Neoral

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
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 high a dose
may affect kidney function. You will need to attend regular blood tests and hospital visits,
especially after transplantation. These visits provide an opportunity to discuss your treatment
and any potential problems with your doctor.
How much Sandimmun Neoral should be taken
Your doctor will determine the appropriate dose of Sandimmun Neoral for you. The dose depends on
your body weight and the reason for which this medicine is being used. Your doctor will also inform you
how often you should take this medicine.

In adults: Organ, bone marrow or stem cell transplantation
- The total daily dose usually ranges between 2 mg and 15 mg per kilogram of body weight. This is divided into two doses.
- Higher doses are usually used before and immediately after transplantation. Lower doses are used once stable function of the transplanted organ or bone marrow has been achieved.
- Your doctor will adjust the dose of the medicine to be optimal for you. Blood tests may be necessary for this purpose. Endogenous uveitis
- The total daily dose usually ranges between 5 mg and 7 mg per kilogram of body weight. This is divided into two doses. Nephrotic syndrome
- The total daily dose is usually 5 mg per kilogram of body weight. This is divided into two doses. In patients with kidney disease, the first daily dose should not exceed 2.5 mg per kilogram of body weight. Severe rheumatoid arthritis
- The total daily dose usually ranges between 3 mg and 5 mg per kilogram of body weight. This is divided into two doses. Psoriasis and atopic dermatitis
- The total daily dose usually ranges between 2.5 mg and 5 mg per kilogram of body weight. This is divided into two doses.
In children: Nephrotic syndrome
- The total daily dose is usually 6 mg per kilogram of body weight. This is divided into two doses. In patients with kidney disease, the first daily dose should not exceed 2.5 mg per kilogram of body weight. You must carefully follow your doctor's instructions and never change the dose on your own, even if you feel well.

Switching from Sandimmun to Sandimmun Neoral
For patients already taking another medicine called Sandimmun soft capsules or Sandimmun
oral solution, your doctor may decide to switch you to Sandimmun Neoral oral solution.

All these medicines contain cyclosporine as the active ingredient.
Sandimmun Neoral is a different, improved formulation of cyclosporine compared to Sandimmun. Cyclosporine is better absorbed into the blood from Sandimmun Neoral, and absorption is less dependent on food intake. This means that cyclosporine blood levels remain more stable when taking Sandimmun Neoral than when taking Sandimmun.

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

Do not restart Sandimmun unless your doctor specifically instructs you to do so.
After switching from Sandimmun to Sandimmun Neoral, your doctor will monitor your condition more closely for a short period. This is due to the change in cyclosporine absorption into the blood. Your doctor will ensure you are receiving the appropriate dose for your needs.
You may experience certain side effects. If this occurs, inform your doctor or pharmacist. It may be necessary to reduce the dose of the medicine. Never reduce the dose on your own unless instructed by your doctor.

If your doctor switches you from one oral cyclosporine medicine to another
After switching from one oral cyclosporine formulation to another:

Your doctor will monitor your condition more closely for a short period.
You may experience certain side effects. If this occurs, inform your doctor or pharmacist. It may be necessary to adjust the dose of the medicine. Never change the dose on your own unless instructed by your doctor.

When to take Sandimmun Neoral
Sandimmun Neoral should be taken at the same time every day. This is very important
for patients who have undergone transplantation.
How to take Sandimmun Neoral
The daily dose should always be taken in two divided doses.
Remove the capsules from the blister pack. Swallow the capsules whole with water.
How long to take Sandimmun Neoral
Your doctor will inform you how long to take Sandimmun Neoral. This depends on whether
you are taking the medicine after transplantation or for the treatment of severe skin diseases,
rheumatoid arthritis, uveitis, or nephrotic syndrome.
In cases of severe rash, treatment usually lasts 8 weeks.
Continue taking Sandimmun Neoral for as long as your doctor prescribes.
If you have any questions about how long to take Sandimmun Neoral, speak with your doctor or
pharmacist.
Taking more Sandimmun Neoral than prescribed
If you accidentally take more medicine than prescribed by your doctor, contact your doctor immediately
or go to the nearest hospital emergency department. You may require medical assistance.
Missed dose of Sandimmun Neoral

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

Stopping Sandimmun Neoral
Do not stop taking Sandimmun Neoral unless your doctor tells you to do so.
Continue taking Sandimmun Neoral even if you feel well.
Stopping treatment with Sandimmun Neoral may increase the risk of rejection of the transplanted
organ.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody gets them.
Some adverse reactions may be serious
You should tell your doctor immediately if you notice any of the following serious adverse reactions:

As with other medicines affecting the immune system, cyclosporine may alter the body's ability to fight infections and may cause the development of tumours or other malignant neoplasms, especially of the skin. Signs of infection may include fever or sore throat.
Changes in vision, loss of coordination, motor incoordination, memory loss, difficulty speaking or understanding what others are saying, and muscle weakness. These may be symptoms of a brain infection called progressive multifocal leukoencephalopathy.
Brain disorders with symptoms such as seizures, confusion, disorientation, reduced alertness, personality changes, agitation, insomnia, visual disturbances, blindness, coma, paralysis of part or all of the body, neck stiffness, 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-tumour intracranial hypertension).
Liver disorders and damage with yellowing of the skin and eyes, nausea, loss of appetite and dark urine, or without these symptoms.
Kidney disorders, which may significantly reduce the amount of urine produced.
Low number of red blood cells or platelets. Symptoms of these disorders include pale skin, feeling tired, breathlessness, dark-coloured urine (a sign of red blood cell breakdown), bruising or bleeding without obvious cause, feeling confused, feeling disoriented, reduced alertness and kidney problems.

Other adverse reactions include:
Very common: may affect more than 1 in 10 people.

Kidney function disorders
High blood pressure
Headache
Uncontrollable shaking of the body
Excessive growth of hair on the body and face
High levels of lipids in the blood. If any of these symptoms occur, you should tell your doctor.

Common: may affect up to 1 in 10 people.

Seizures (convulsions)
Liver function disorders
High blood sugar levels
Fatigue
Loss of appetite
Nausea, vomiting, abdominal discomfort/pain, diarrhoea
Excessive hair growth
Acne, flushing
Fever
Low number of white blood cells
Numbness or tingling
Muscle pain, muscle cramps
Stomach ulcer
Overgrowth of the gums covering the teeth
High levels of uric acid and potassium in the blood, low levels of magnesium in the blood. If any of these symptoms occur, you should tell your doctor.

Uncommon: may affect up to 1 in 100 people.

Symptoms of brain disorders, including sudden seizures, confusion, insomnia, disorientation, visual disturbances, loss of consciousness, feeling of limb weakness, movement disorders
Rash
Generalised swelling
Weight gain
Low number of red blood cells, low number of platelets, which may increase the risk of bleeding. If any of these symptoms occur, you should tell your doctor.

Rare: may affect up to 1 in 1,000 people.

Nerve disorders with numbness or tingling of fingers of hands and feet
Pancreatitis with severe pain in the upper abdomen
Muscle weakness, loss of muscle strength, muscle pain in legs or hands or other body muscles
Destruction of red blood cells, involving kidney disorders with symptoms such as swelling of the face, abdomen, hands and (or) feet, reduced urine output, difficulty breathing, chest pain, seizures, loss of consciousness
Changes in menstrual cycle, breast enlargement in men. If any of these symptoms occur, 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 inside the head and visual disturbances. If any of these symptoms occur, you should tell your doctor.

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

Severe liver disorders with yellowing of eyes or skin or without, nausea, loss of appetite, dark-coloured urine, swelling of the face, feet, hands and (or) the whole body
Subcutaneous bleeding or purple spots on the skin, sudden bleeding without obvious cause
Migraine or severe headache often with nausea or vomiting and sensitivity to light
Pain in legs and feet. If any of these symptoms occur, you should tell your doctor.

If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist.
Additional adverse reactions in children and adolescents
No additional adverse reactions are expected in children and adolescents compared to adults.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Sandimmun Neoral

Keep this medicine 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.
Keep the capsules in the foil. Remove the capsules from the foil just before taking.
After opening the blister, a characteristic odour may be noticeable. This is normal and does not indicate that the capsules are unsuitable for use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 cyclosporine. Each capsule contains 10 mg of cyclosporine.
Other components of the medicine are:
o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, mono-, di- and triglycerides of corn oil, macrogolglycerides hydroxystearate / polyoxyl 60 hydrogenated castor oil.
o Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
o Printing ink: carmine acid (E 120), aluminium chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose / hydroxypropylmethylcellulose 2910, isopropanol / isopropyl alcohol.

Sandimmun Neoral, 25 mg

The active substance is cyclosporine. Each capsule contains 25 mg of cyclosporine.
Other components of the medicine are:
o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, mono-, di- and triglycerides of corn oil, macrogolglycerides hydroxystearate / polyoxyl 60 hydrogenated castor oil.
o Capsule shell: black iron oxide (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
o Printing ink: carmine acid (E 120), aluminium chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose / hydroxypropylmethylcellulose 2910, isopropanol / isopropyl alcohol.

Sandimmun Neoral, 50 mg

The active substance is cyclosporine. Each capsule contains 50 mg of cyclosporine.
Other components of the medicine are:
o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, mono-, di- and triglycerides of corn oil, macrogolglycerides hydroxystearate / polyoxyl 60 hydrogenated castor oil.
o Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
o Printing ink: carmine acid (E 120), aluminium chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose / hydroxypropylmethylcellulose 2910, isopropanol / isopropyl alcohol.

Sandimmun Neoral, 100 mg

The active substance is cyclosporine. Each capsule contains 100 mg of active substance.
Other components of the medicine are:
o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, mono-, di-, and triglycerides of corn oil, macrogolglycerides hydroxystearate / polyoxyl 60 hydrogenated castor oil.
o Capsule shell: black iron oxide (E 172), titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
o Printing ink: carmine acid (E 120), aluminium 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 in colour, with a red print “NVR 10”.
Sandimmun Neoral 25 mg soft capsules are oval, blue to grey in colour, with a red print “NVR 25mg”.
Sandimmun Neoral 50 mg soft capsules are elongated, yellow to white in colour, with a red print “NVR 50mg”.
Sandimmun Neoral 100 mg soft capsules are elongated, blue to grey in colour, with a red print “NVR 100mg”.

Sandimmun Neoral 10 mg soft capsules – pack contains 60 soft capsules.
Sandimmun Neoral 25 mg, 50 mg and 100 mg soft capsules – packs contain 50 soft capsules each.

Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Tel. + 48 22 375 48 88

Manufacturer/Importer
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Wien
Austria
Demetriades & Papaellinas Ltd.
179 Giannou Kranidioti
2235 Latsia, Nicosia
Cyprus
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 Nuremberg
Germany
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 authorised for marketing 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, Sandimmun Neoral
Greece, Finland, Hungary, Iceland, Italy, Lithuania, Latvia, Malta,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Sweden, Spain
Belgium, Luxembourg Neoral-Sandimmun
Ireland, Netherlands, United Kingdom (Northern Ireland) Neoral
France Néoral

Other sources of information
Detailed information on this medicine is available on the website of {Poland, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products}