SANDIMMUN 25 mg Софт Капсулы

Содержание инструкции

1. Sandimmun Neoral 10 mg soft capsules, 25 mg soft capsules, 50 mg soft capsules, 100 mg soft capsules
   1. What is Sandimmun Neoral and what is it used for
   2. What you need to know before taking Sandimmun Neoral
   3. How to take Sandimmun Neoral
   4. Possible side effects
   5. How to store Sandimmun Neoral
   6. Package contents and other information
2. Sandimmun Neoral 100 mg/ml oral solution
   1. What is Sandimmun Neoral and what is it used for
   2. What you need to know before taking Sandimmun Neoral
   3. How to take Sandimmun Neoral
   4. Possible side effects
   5. How to store Sandimmun Neoral
   6. Contents of the pack and other information

Sandimmun Neoral 10 mg soft capsules, 25 mg soft capsules, 50 mg soft capsules, 100 mg soft capsules

cyclosporine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sandimmun Neoral is and what it is used for
• 2. What you need to know before you take Sandimmun Neoral
• 3. How to take Sandimmun Neoral
• 4. Possible side effects
• 5. How to store Sandimmun Neoral
• 6. Contents of the pack and other information

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

What is Sandimmun Neoral
The name of the medicine is Sandimmun Neoral. It contains the active ingredient cyclosporine. Cyclosporine
belongs to a group of medicines known as immunosuppressants. These medicines
are used to decrease the body's immune reactions.

What Sandimmun Neoral is used for and how Sandimmun Neoral works

• If you have had an organ transplant,bone marrow transplant or a stem cell transplant, the function of Sandimmun Neoral is to control the body's immune system. Sandimmun Neoral prevents rejection of transplanted organs by blocking the development of certain cells that would normally attack the transplanted tissue.
• If you suffer from an autoimmune disease, in which your body's immune response attacks the body's cells, Sandimmun Neoral blocks the immune reaction. These diseases include eye problems that put your sight at risk (endogenous uveitis, including Behçet's uveitis), severe cases of some skin diseases (atopic dermatitis or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease known as nephrotic syndrome.

2. What you need to know before taking Sandimmun Neoral

If you are taking Sandimmun Neoral following a transplant, the medicine will only be prescribed to you by a
doctor with experience in transplants and/or autoimmune diseases.
medicine for a transplant or for an autoimmune disease.
Follow all the doctor's instructions carefully. These may be different from the information

Do not take Sandimmun Neoral:

• if you are allergic to cyclosporine or to any of the other ingredients of this medicine (listed in section 6).
• with products 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 high blood pressure).

Do not take Sandimmun Neoral and tell your doctorif any of the above conditions apply to you.
If you are unsure, ask your doctor before taking Sandimmun Neoral.

Warnings and precautions
Before and during treatment with Sandimmun Neoral, tell your doctor immediately:

• if you have any signs of infection, such as fever or sore throat. Sandimmun Neoral suppresses the immune system and can also affect the body's ability to fight infections.
• if you have liver problems.
• if you have kidney problems. Your doctor will regularly perform blood tests and, if necessary, may adjust the dose.
• if you develop high blood pressure. Your doctor will check your blood pressure regularly and, if necessary, may give you medicine to lower your blood pressure.
• if you have low levels of magnesium in your body. Your doctor may prescribe magnesium supplements, especially shortly after a transplant.
• if you have high levels of potassium in your blood.
• if you have gout.
• if you need to be vaccinated. If any of the above conditions apply to you, before or during treatment with Sandimmun Neoral, tell your doctor immediately.

Exposure to the sun and sun protection
Sandimmun Neoral suppresses the immune system. This increases the risk of developing cancer,
particularly of the skin and the lymphatic system. You must limit exposure to the sun and UV light:

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

Tell your doctor before taking Sandimmun Neoral:

• if you have or have had problems with alcoholism.
• if you have epilepsy.
• if you have any liver problems.
• if you are pregnant.
• if you are breastfeeding.
• if this medicine is to be prescribed to a child. If you experience any of the above conditions (or are unsure), tell your doctor before taking Sandimmun Neoral. This is because this medicine contains alcohol (see the paragraph below “Sandimmun Neoral contains ethanol”).

Monitoring during treatment with Sandimmun Neoral
Your doctor will check:

• the levels of cyclosporine in the blood,especially if you have had a transplant,
• the blood pressurebefore starting treatment and regularly during treatment,
• how your liver and kidneysare functioning,
• the lipids in the blood (fats). If you have any questions about how Sandimmun Neoral works or why this medicine has been prescribed to you, ask your doctor.

In addition, if you are taking Sandimmun Neoral for a disease other than transplant(intermediate uveitis or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis or
nephrotic syndrome), do not take Sandimmun Neoral:

• if you have kidney problems (except nephrotic syndrome).
• if you have an infection that is not controlled with therapy.
• if you have any type of cancer.
• if you have high blood pressure (hypertension) that is not controlled with therapy. If high blood pressure problems occur during treatment and cannot be kept under control, Sandimmun Neoral must be stopped by your doctor. If you experience any of the above conditions, do not take Sandimmun Neoral. If you are unsure, tell your doctor or pharmacist before taking Sandimmun Neoral.

If you are being treated for Behçet's uveitis, your doctor will carefully monitor you for any
neurological symptoms (for example: increased forgetfulness, personality changes observed
over time, psychiatric or mood disorders, burning sensation in the limbs, decreased
sensitivity in the limbs, tingling sensation in the limbs, weakness in the limbs, gait disturbances, headache
with or without nausea and vomiting, visual disturbances including limited eye movement).
If you are elderly and are being treated for psoriasis or atopic dermatitis, your doctor will monitor you
carefully. If you have been prescribed Sandimmun Neoral for the treatment of psoriasis or
atopic dermatitis, you should not be exposed to UVB radiation or phototherapy during treatment.

Children and adolescents
Sandimmun Neoral should not be given to children for diseases other than transplant, except for the
treatment of nephrotic syndrome.

Elderly (65 years of age and over)
There is limited experience with Sandimmun Neoral in elderly patients. Your doctor must check the
good functioning of the kidneys. If you are over 65 years of age and suffer from psoriasis or atopic
dermatitis, you should only be treated with Sandimmun Neoral if the condition is particularly severe.

Other medicines and Sandimmun Neoral
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or
during treatment with Sandimmun Neoral:

• Medicines that can affect potassium levels. These include medicines that contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines that lower blood pressure.
• Methotrexate. It is a medicine used to treat tumors, severe psoriasis and severe rheumatoid arthritis.
• Medicines that can increase or decrease the level of cyclosporine (the active ingredient of Sandimmun Neoral) in the blood. Your doctor may check the level of cyclosporine in the blood at the start or end of treatment with other medicines.
• Medicines that can increase the level of cyclosporine in the blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine,

verapamil, amiodarone), metoclopramide (used against nausea), oral contraceptives,
danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), bile acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat
leukemia or tumors), colchicine, telaprevir (used for the treatment of hepatitis C),
cannabidiol (uses also include the treatment of seizures).

• Medicines that can decrease the level of cyclosporine in the blood include: barbiturates (used to promote sleep), some anticonvulsant medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors of the intestine), antibacterial medicines used to treat tuberculosis, orlistat (used to promote weight loss), herbal medicines containing St John's wort, ticlopidine (used after a stroke), certain medicines that lower blood pressure (bosentan) and terbinafine (an antifungal medicine used to treat foot and nail infections).
• Medicines that can have effects on the kidneys. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, medicines used for urinary tract infections containing trimethoprim, cancer medicines containing melphalan, medicines used to lower the amount of acid in the stomach (acid secretion inhibitors of the H2 receptor antagonist type), tacrolimus, pain relievers (non-steroidal anti-inflammatory drugs such as diclofenac), fibric acid-based medicines (used to lower the amount of fat in the blood).
• Nifedipine. It is used to treat high blood pressure and heart pain. If you are taking nifedipine during treatment with cyclosporine, you may experience swelling of the gums that thickens around the teeth.
• Digoxin (used to treat heart problems), medicines that lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan and specific medicines against cancer called anthracyclines (e.g. doxorubicin).
• Sodium micofenolate or micofenolate mofetil (an immunosuppressant) and eltrombopag (used to treat coagulation disorders). If you experience any of the above conditions (or are unsure), tell your doctor or pharmacist before taking Sandimmun Neoral.

Sandimmun Neoral with food and drink
Do not take Sandimmun Neoral with grapefruit or grapefruit juice. This is because they can
affect the action of Sandimmun Neoral.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you are pregnant or are planning to become pregnant.Experience with Sandimmun Neoral in pregnancy is limited. In general, Sandimmun Neoral should not be taken during pregnancy. If taking this medicine is necessary, your doctor will discuss with you the benefits and potential risks of taking it during pregnancy.
• Tell your doctor if you are breastfeeding.Breastfeeding is not recommended during treatment with Sandimmun Neoral. This is because cyclosporine, the active ingredient, passes into breast milk. This may have effects on the baby.

Hepatitis C
Tell your doctor if you have hepatitis C. Your liver function may change with treatment
for hepatitis C and this may affect the levels of cyclosporine in the blood. Your doctor may need to
carefully monitor the blood levels of cyclosporine and adjust the dose after starting treatment
for hepatitis C.

Driving and using machines
You may feel sleepy, dizzy or have blurred vision after taking Sandimmun.
Be careful driving or operating machinery while taking Sandimmun until you
know how it affects you.

Sandimmun Neoral contains ethanol
Sandimmun Neoral contains 10, 25, 50, 100 mg of alcohol (ethanol) respectively in each capsule of 10,
25, 50 and 100 mg of Sandimmun Neoral, which is equivalent to 11.8% v/v. A 500 mg dose of
Sandimmun Neoral contains 500 mg of ethanol, equivalent to approximately 13 ml of beer or 5 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

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

Sandimmun Neoral contains propylene glycol
This medicine contains 20.84 mg of propylene glycol per 10 mg capsule
This medicine contains 46.42 mg of propylene glycol per 25 mg capsule
This medicine contains 90.36 mg of propylene glycol per 50 mg capsule
This medicine contains 148.31 mg of propylene glycol per 100 mg capsule
If the baby is less than 4 weeks old, talk to your doctor or pharmacist before giving
this medicine, especially if the baby 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,
i.e. essentially ‘sodium-free’.

3. How to take Sandimmun Neoral

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted to your personal needs by the doctor.
Too much medicine can affect kidney function. You will be regularly subjected to blood tests and hospital visits, especially after a transplant. This will give you the opportunity to talk
to your doctor about the treatment and any problems you may have.

How much Sandimmun Neoral to take
The doctor will determine the correct dose of Sandimmun Neoral for you. It depends on your body weight and the
reason why you are taking the medicine. The doctor will also tell you how often to take the
medicine.

• In adults:Organ, bone marrow or stem cell transplant
• The total daily dose is usually between 2 mg and 15 mg per kilogram of body weight. It should be divided into two doses.
• Usually the higher doses are used before and immediately after the transplant. Lower doses are used once the transplanted organ or bone marrow has stabilized.
• The doctor will adjust the dose to the appropriate one for you. To do this, the doctor may need to perform some blood tests. Uveitis
• The total daily dose is usually between 5 mg and 7 mg per kilogram of body weight. It should be divided into two doses. Nephrotic syndrome
• For adults, the total daily dose is usually 5 mg per kilogram of body weight. It should be divided into two doses. In patients with kidney problems, the initial dose taken each day should not exceed 2.5 mg per kilogram of body weight. Severe rheumatoid arthritis
• The total daily dose is usually between 3 mg per kilogram of body weight and 5 mg per kilogram of body weight. It should be divided into two doses. Psoriasis and atopic dermatitis
• The total daily dose is usually between 2.5 mg per kilogram of body weight and 5 mg per kilogram of body weight. It should be divided into two doses.
• In children:Nephrotic syndrome
• For children, the total daily dose is usually 6 mg per kilogram of body weight. It should be divided into two doses. In patients with kidney problems, the initial dose taken each day should not exceed 2.5 mg per kilogram of body weight. Follow your doctor's instructions exactly and never change the dose on your own, even if you feel well.

Switching from Sandimmun to Sandimmun Neoral
You may have already taken another medicine called Sandimmun soft gelatin capsules or
Sandimmun oral solution. The doctor may decide to switch to this medicine, Sandimmun Neoral
oral solution.

• All these medicines contain cyclosporine as the active ingredient.
• Compared to Sandimmun, Sandimmun Neoral is a different, improved formulation of cyclosporine. With Sandimmun Neoral, cyclosporine is better absorbed into the blood and it is less likely that absorption will be affected by taking the medicine with food. This means that cyclosporine levels in the blood will remain more constant with Sandimmun Neoral than with Sandimmun. If the doctor changes the medicine from Sandimmun to Sandimmun Neoral:
• Do not return to taking Sandimmun unless your doctor tells you to.
• Following the switch from Sandimmun to Sandimmun Neoral, the doctor will monitor you more closely for a short period. This is due to the change in how cyclosporine is absorbed into the blood. The doctor will make sure you take the right dose for your individual needs.
• You may experience some unwanted effects. If this happens, contact your doctor or pharmacist. It may be necessary to reduce the dose. Never reduce the dose on your own, unless your doctor tells you to.

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

• The doctor will monitor you more closely for a short period.
• You may experience some unwanted effects. If this happens, contact your doctor or pharmacist. It may be necessary to change the dose. Never change the dose on your own, unless your doctor tells you to.

When to take Sandimmun Neoral
Take Sandimmun Neoral every day at the same time. This is very important if you have had a
transplant.

How to take Sandimmun Neoral
The daily doses must always be taken in 2 divided doses.
Remove the capsules from the blister. Swallow the capsules whole with water.

For how long to take Sandimmun Neoral
The doctor will tell you how long you will need to take Sandimmun Neoral. This depends on whether you are
taking the medicine after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe skin rash, the duration of treatment is
usually 8 weeks.
Continue to take Sandimmun Neoral until your doctor tells you to stop.
If you have any further questions about how long to take Sandimmun Neoral, talk to your doctor or pharmacist.

If you take more Sandimmun Neoral than you should
If you have accidentally taken too much medicine, immediately inform your doctor or go to the nearest hospital emergency room. You may need medical attention.

If you forget to take Sandimmun Neoral

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest them.

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

• As with other medicines that act on the immune system, ciclosporin can affect the body's ability to fight infections and can cause tumors or other types of cancer, particularly of the skin. 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 muscle weakness. These could be signs of a brain infection called progressive multifocal leukoencephalopathy.
• Brain problems with signs such as convulsions, confusion, feeling disoriented, poor responsiveness, personality changes, feeling agitated, insomnia, changes in vision, blindness, coma, paralysis of a part or all of the body, stiff neck, loss of coordination with or without unusual speech or eye movements.
• Swelling in the back of the eye. This may be associated with blurred vision. It can also affect vision due to increased pressure inside the head (benign intracranial hypertension).
• Liver problems and damage with or without yellowing of the skin and eyes, nausea, loss of appetite, and dark urine.
• Kidney problems that can significantly reduce the amount of urine produced.
• Low levels of red blood cells or platelets. Signs include paleness, feeling tired, difficulty breathing, dark urine (this is a sign of red blood cell breakdown), bruising or bleeding for no apparent reason, feeling confused, feeling disoriented, decreased attention, and kidney problems.

Other side effects include:
Very common:May affect more than 1 in 10 people.

• Kidney problems.
• High blood pressure.
• Headache.
• Uncontrollable body shaking.
• Excessive hair growth on the body and face.
• High levels of lipids in the blood. If any of these effects become severe, tell your doctor.

Common:May affect up to 1 in 10 people.

• Seizures (convulsions).
• Liver problems.
• High blood sugar levels.
• Fatigue.
• Loss of appetite.
• Nausea (feeling sick), vomiting, abdominal discomfort/pain, diarrhea.
• Excessive hair growth.
• Acne, hot flushes.
• Fever.
• Low levels of white blood cells in the blood.
• Feeling of numbness or tingling.
• Muscle pain, muscle spasms.
• Stomach ulcer.
• Excessive growth of the gums and covering of the teeth.
• High levels of uric acid or potassium in the blood, low levels of magnesium in the blood. If any of these effects become severe, 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, weakness of the limbs, reduced movements.
• Skin rash.
• Generalized swelling.
• Weight gain.
• Low levels of red blood cells, low levels of platelets in the blood, which may increase the risk of bleeding. If any of these effects become severe, tell your doctor.

Rare:May affect up to 1 in 1000 people.

• Nerve problems with numbness or tingling in the fingers of the hands and feet.
• Inflammation of the pancreas with severe pain in the upper part of the stomach.
• Muscle weakness, loss of muscle strength, pain in the leg or arm muscles or in any part of the body.
• Destruction of red blood cells, which cause kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urine volume, difficulty breathing, chest pain, convulsions, loss of consciousness.
• Changes in the menstrual cycle, enlargement of the male breast gland. If any of these effects become severe, tell your doctor.

Very rare:May affect up to 1 in 10,000 people.

• Swelling in the back of the eye that may be associated with increased pressure inside the head and visual disturbances. If this effect becomes severe, tell your doctor.

Not known:Frequency cannot be estimated from available data.

• Severe liver problems with or without yellowing of the skin or eyes, nausea (feeling sick), loss of appetite, dark urine, swelling of the face, feet, hands and/or entire body.
• Bleeding under the skin or purple spots, sudden bleeding for no apparent reason.
• Migraine or severe headache often with malaise (nausea, vomiting) and sensitivity to light.
• Pain in the legs and feet
• Hearing impairment. If any of these effects become severe, tell your doctor.

If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.

Additional side effects in children and adolescents
No additional side effects are expected in children and adolescents compared to adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Sandimmun Neoral

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging.
• Do not store the capsules in a warm place. Do not store at a temperature above 25°C.
• Store in the original packaging to protect the medicine from moisture.
• Leave the capsules in the blister pack. Only remove the capsules when it is time to take the medicine.
• Upon opening the blister pack, a characteristic odour may be detected. This is normal and does not affect the use of the medicine.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sandimmun Neoral contains

• The active ingredient is ciclosporin. Each capsule contains 10 mg of ciclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, corn oil mono-, di-, and triglycerides, macrogolglycerol hydroxystearate/hydrogenated castor oil polyoxyethylene. o Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. o Imprint: carminic acid (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropyl methylcellulose 2910, isopropyl alcohol/isopropanol.
• The active ingredient is ciclosporin. Each capsule contains 25 mg of ciclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, corn oil mono-, di-, and triglycerides, macrogolglycerol hydroxystearate/hydrogenated castor oil polyoxyethylene. o Capsule shell: black iron oxide (E172), titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin. o Imprint: carminic acid (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropyl methylcellulose 2910, isopropyl alcohol/isopropanol.
• The active ingredient is ciclosporin. Each capsule contains 50 mg of ciclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, corn oil mono-, di-, and triglycerides, macrogolglycerol hydroxystearate/hydrogenated castor oil polyoxyethylene. o Capsule shell: titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin. o Imprint: carminic acid (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropyl methylcellulose 2910, isopropyl alcohol/isopropanol.
• The active ingredient is ciclosporin. Each capsule contains 100 mg of ciclosporin.
• The other ingredients are: o Capsule contents: alpha-tocopherol, absolute ethanol, propylene glycol, corn oil mono-, di-, and triglycerides, macrogolglycerol hydroxystearate/hydrogenated castor oil polyoxyethylene. o Capsule shell: black iron oxide (E172), titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin. o Imprint: carminic acid (E 120), aluminum chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose/hydroxypropyl methylcellulose 2910, isopropyl alcohol/isopropanol.

Description of the appearance of Sandimmun Neoral and package contents
The 10 mg Sandimmun Neoral soft capsules are yellow-white in color, oval in shape and with
“NVR 10” imprinted in red.
The 25 mg Sandimmun Neoral soft capsules are blue-gray in color, oval in shape and with
“NVR 25mg” imprinted in red.
The 50 mg Sandimmun Neoral soft capsules are yellow-white in color, elongated in shape and with
“NVR 50mg” imprinted in red.
The 100 mg Sandimmun Neoral soft capsules are blue-gray in color, elongated in shape and with
“NVR 100mg” imprinted in red.
Sandimmun Neoral 10 mg, 25 mg, 50 mg and 100 mg soft capsules
Pack sizes of 5, 20, 30, 50, 60 & 90 soft capsules
Pack sizes of 100 & 250 soft capsules
Pack sizes of 100 (5 x 20), 250 (5 x 50), 300 (5 x 60) & 500 (10 x 50) soft capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo, 43
20154 Milano MI
Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia
Novartis Farma S.p.A.
Viale Luigi Sturzo, 43
20154 Milano MI
Italy
Novartis Farmaceutica S.A.
Gran Vía de les Corts Catalanes, 764
08013 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Further information
More detailed information on this medicine is available on the website of the Italian Medicines Agency (http://www.aifa.gov.it/)

Sandimmun Neoral 100 mg/ml oral solution

cyclosporine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sandimmun Neoral is and what it is used for
• 2. What you need to know before you take Sandimmun Neoral
• 3. How to take Sandimmun Neoral
• 4. Possible side effects
• 5. How to store Sandimmun Neoral
• 6. Contents of the pack and other information

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

What is Sandimmun Neoral
The name of the medicine is Sandimmun Neoral. It contains the active ingredient cyclosporine. Cyclosporine
belongs to a group of medicines known as immunosuppressants. These medicines
are used to decrease the immune reactions of the body.

What is Sandimmun Neoral used for and how does Sandimmun Neoral work

• If you have had an organ transplant,bone marrow transplant or a stem cell transplant, the function of Sandimmun Neoral is to control the body's immune system. Sandimmun Neoral prevents the rejection of transplanted organs by blocking the development of certain cells that would normally attack the transplanted tissue.
• If you suffer from an autoimmune disease, in which your body's immune response attacks the body's cells, Sandimmun Neoral blocks the immune reaction. These diseases include eye problems that put your vision at risk (endogenous uveitis, including Behçet's uveitis), severe cases of some skin diseases (atopic dermatitis or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease known as nephrotic syndrome.

2. What you need to know before taking Sandimmun Neoral

If you are taking Sandimmun Neoral following a transplant, the medicine will only be prescribed to you by a
doctor with experience in transplants and/or in autoimmune diseases.
medicine for a transplant or for an autoimmune disease.
Follow all the doctor's instructions carefully. These may be different from the information

Do not take Sandimmun Neoral:

• if you are allergic to cyclosporine or to any of the other ingredients of this medicine (listed in section 6).
• with products 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 high blood pressure).

Do not take Sandimmun Neoral and tell your doctorif any of the above conditions apply to you.
If you are unsure, ask your doctor before taking Sandimmun Neoral.

Warnings and precautions
Before and during treatment with Sandimmun Neoral, tell your doctor immediately:

• if you have any signs of infection, such as fever or sore throat. Sandimmun Neoral suppresses the immune system and can also affect the body’s ability to fight infections.
• if you have liver problems.
• if you have kidney problems. The doctor will regularly perform blood tests and, if necessary, may change the dose.
• if you develop high blood pressure. The doctor will check your blood pressure regularly and, if necessary, may give you medicine to lower your blood pressure.
• if you have low levels of magnesium in your body. The doctor may prescribe magnesium supplements, especially shortly after a transplant.
• if you have high levels of potassium in your blood.
• if you have gout.
• if you need to be vaccinated. If any of the above conditions apply to you, before or during treatment with Sandimmun Neoral, tell your doctor immediately.

Exposure to the sun and sun protection
Sandimmun Neoral suppresses the immune system. This increases the risk of developing cancer,
particularly of the skin and the lymphatic system. You must limit exposure to the sun and UV light:

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

Tell your doctor before taking Sandimmun Neoral:

• if you have or have had problems with alcoholism.
• if you have epilepsy.
• if you have any liver problems.
• if you are pregnant.
• if you are breastfeeding.
• if this medicine is about to be prescribed to a child. If you experience any of the above conditions (or are not sure), tell your doctor before taking Sandimmun Neoral. This is because this medicine contains alcohol (see the paragraph below “Sandimmun Neoral contains ethanol”).

Monitoring during treatment with Sandimmun Neoral
The doctor will check:

• the levels of cyclosporine in the blood,especially if you have had a transplant,
• the blood pressurebefore starting treatment and regularly during treatment,
• how your liver and kidneysare functioning,
• the lipids in the blood (fats). If you have any questions about how Sandimmun Neoral works or why this medicine has been prescribed to you, ask your doctor.

In addition, if you are taking Sandimmun Neoral for a disease other than transplant(intermediate uveitis or posterior uveitis and Behçet’s uveitis, atopic dermatitis, severe rheumatoid arthritis or
nephrotic syndrome), do not take Sandimmun Neoral:

• if you have kidney problems (except nephrotic syndrome).
• if you have an infection that is not controlled with therapy.
• if you have any type of cancer.
• if you have high blood pressure (hypertension) that is not controlled with therapy. If blood pressure problems occur during treatment and cannot be kept under control, Sandimmun Neoral must be stopped by your doctor. If you experience any of the above conditions, do not take Sandimmun Neoral. If you are unsure, tell your doctor or pharmacist before taking Sandimmun Neoral.

If you are being treated for Behçet’s uveitis, the doctor will carefully monitor if you present
any neurological symptoms (for example: increased forgetfulness, personality changes observed
over time, psychiatric or mood disorders, burning sensation in the limbs, decreased
sensitivity of the limbs, tingling sensation in the limbs, weakness of the limbs, gait disturbances, headache
with or without nausea and vomiting, visual disturbances including limited eye movement).
If you are elderly and are being treated for psoriasis or atopic dermatitis, your doctor will monitor you
carefully. If you have been prescribed Sandimmun Neoral for the treatment of psoriasis or
atopic dermatitis, you must not expose yourself to UVB radiation or phototherapy during treatment.

Children and adolescents
Sandimmun Neoral should not be given to children for diseases other than transplant, except for the treatment of nephrotic syndrome.

Elderly (65 years of age and over)
There is limited experience with Sandimmun Neoral in elderly patients. The doctor must check the
good functioning of the kidneys. If you are over 65 years of age and suffer from psoriasis or atopic dermatitis, you
should only be treated with Sandimmun Neoral if the condition is particularly severe.

Other medicines and Sandimmun Neoral
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or
during treatment with Sandimmun Neoral:

• Medicines that can affect potassium levels. These include medicines that contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines that lower blood pressure.
• Methotrexate. It is a medicine used to treat tumors, severe psoriasis and severe rheumatoid arthritis.
• Medicines that can increase or decrease the level of cyclosporine (the active ingredient of Sandimmun Neoral) in the blood. The doctor may check the level of cyclosporine in the blood at the beginning or end of treatment with other medicines.
• Medicines that can increase the level of cyclosporine in the blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used against nausea), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), bile acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (uses include, also, the treatment of seizures).
• Medicines that can decrease the level of cyclosporine in the blood include: barbiturates (used to promote sleep), some anticonvulsant medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors of the intestine), antibacterial medicines used to treat tuberculosis, orlistat (used to promote weight loss), herbal medicines containing St John's Wort, ticlopidine (used after a stroke), certain medicines that lower blood pressure (bosentan) and terbinafine (an antifungal medicine used to treat foot and nail infections).
• Medicines that can have effects on the kidneys. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, medicines used for urinary tract infections containing trimethoprim, cancer medicines containing melphalan, medicines used to lower the amount of acid in the stomach (acid secretion inhibitors of the H-receptor antagonist type), tacrolimus, pain relievers (non-steroidal anti-inflammatory drugs such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).
• Nifedipine. It is used to treat high blood pressure and chest pain. If you are taking nifedipine during treatment with cyclosporine, you may experience swelling of the gums that thickens around the teeth.
• Digoxin (used to treat heart problems), medicines that lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan and specific medicines against cancer called anthracyclines (e.g. doxorubicin).
• Sodium micofenolate or micofenolate mofetil (an immunosuppressant) and eltrombopag (used to treat coagulation disorders). If you experience any of the above conditions (or are not sure), tell your doctor or pharmacist before taking Sandimmun Neoral.

Sandimmun Neoral with food and drink
Do not take Sandimmun Neoral with grapefruit or grapefruit juice. This is because they can
affect the action of Sandimmun Neoral.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you are pregnant or planning to become pregnant.Experience with Sandimmun Neoral in pregnancy is limited. In general Sandimmun Neoral should not be taken during pregnancy. If taking this medicine is necessary, your doctor will discuss with you the benefits and potential risks of taking it during pregnancy.
• Tell your doctor if you are breastfeeding.Breastfeeding is not recommended during treatment with Sandimmun Neoral. This is because cyclosporine, the active ingredient, passes into breast milk. This can have effects on the baby.

Hepatitis C
Tell your doctor if you have hepatitis C. Your liver function may change with treatment
for hepatitis C and this may affect the levels of cyclosporine in the blood. Your doctor may need to
carefully check the blood levels of cyclosporine and adjust the dose after starting treatment
for hepatitis C.

Driving and using machines
You may feel sleepy, dizzy or have blurred vision after taking Sandimmun.
Be careful driving or using machines while you are taking Sandimmun until you
know how it affects you.

Sandimmun Neoral contains ethanol
Sandimmun Neoral contains 94.70 mg of alcohol (ethanol) in each ml, which is equivalent to 12% v/v. A
dose of 500 mg of Sandimmun Neoral contains 500 mg of ethanol, equivalent to approximately 13 ml of beer or
5 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Sandimmun Neoral contains castor oil
Sandimmun Neoral contains castor oil which can cause stomach pain and diarrhea.

Sandimmun Neoral contains propylene glycol
This medicine contains 94.70 mg of propylene glycol per ml of oral solution.
If the baby is less than 4 weeks old, talk to your doctor or pharmacist before giving
this medicine, especially if the baby is taking other medicines containing propylene
glycol or alcohol.

3. How to take Sandimmun Neoral

Take this medicine always exactly as your doctor has told you. If you have any doubts ask your
doctor.
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted to your personal needs by the doctor.
Too much medicine can affect the way your kidneys work. You will have regular blood tests and hospital visits, especially after a transplant. This will give you the opportunity to talk
to your doctor about the treatment and any problems you may have.

How much Sandimmun Neoral to take
The doctor will determine the correct dose of Sandimmun Neoral for you. It depends on your body weight and the
reason why you are taking the medicine. The doctor will also tell you how often to take the
medicine.

• In adults:Organ, bone marrow or stem cell transplant
• The total daily dose is usually between 2 mg and 15 mg per kilogram of body weight. It should be divided into two doses.
• Usually the higher doses are used before and immediately after the transplant. Lower doses are used once the transplanted organ or bone marrow has stabilized.
• The doctor will adjust the dose to the appropriate one for you. To do this, the doctor may need to perform some blood tests. Endogenous uveitis
• The total daily dose is usually between 5 mg and 7 mg per kilogram of body weight. It should be divided into two doses. Nephrotic syndrome
• For adults the total daily dose is usually 5 mg per kilogram of body weight. It should be divided into two doses. In patients with kidney problems, the initial dose taken each day should not exceed 2.5 mg per kilogram of body weight. Severe rheumatoid arthritis
• The total daily dose is usually between 3 mg per kilogram of body weight and 5 mg per kilogram of body weight. It should be divided into two doses. Psoriasis and atopic dermatitis
• The total daily dose is usually between 2.5 mg per kilogram of body weight and 5 mg per kilogram of body weight. It should be divided into two doses.
• In children:Nephrotic syndrome
• For children the total daily dose is usually 6 mg per kilogram of body weight. It should be divided into two doses. In patients with kidney problems, the initial dose taken each day should not exceed 2.5 mg per kilogram of body weight. Follow your doctor's instructions exactly and never change the dose on your own, even if you feel well.

Switching from Sandimmun to Sandimmun Neoral
You may have already taken another medicine called Sandimmun soft gelatin capsules or
Sandimmun oral solution. The doctor may decide to switch to this medicine, Sandimmun Neoral
oral solution.

• All these medicines contain cyclosporine as the active ingredient.
• Compared to Sandimmun, Sandimmun Neoral is a different, improved formulation of cyclosporine. With Sandimmun Neoral, cyclosporine is better absorbed into the blood and it is less likely that absorption will be affected by taking the medicine with food. This means that the levels

of cyclosporine in the blood will remain more constant with Sandimmun Neoral compared to
Sandimmun.
If the doctor changes the medicine from Sandimmun to Sandimmun Neoral:

• Do not return to taking Sandimmun unless your doctor tells you to.
• Following the switch from Sandimmun to Sandimmun Neoral, the doctor will monitor you more closely for a short period. This is due to the change in how cyclosporine is absorbed into the blood. The doctor will make sure you are taking the right dose for your individual needs.
• You may experience some unwanted effects. If this happens, contact your doctor or pharmacist. It may be necessary to reduce the dose. Never reduce the dose on your own, unless your doctor tells you to.

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

• The doctor will monitor you more closely for a short period.
• You may experience some unwanted effects. If this happens, contact your doctor or pharmacist. It may be necessary to change the dose. Never change the dose on your own, unless your doctor tells you to.

When to take Sandimmun Neoral
Take Sandimmun Neoral every day at the same time. This is very important if you have had a
transplant.

How to take Sandimmun Neoral
The daily doses must always be taken in 2 divided doses.

• For initial use, follow steps 1-9.
• For subsequent use, follow steps 5-9.

Opening a new bottle of Sandimmun Neoral oral solution

1. 2.

i Lift the tab in the center of the aluminum ring. l a t I a i Remove the safety ring completely. z n e g

3. 4.

Remove the gray cap and discard it. Insert the cannula into the bottle by pushing the white cap firmly into the bottle mouth. F

a r m a c o

Measuring the dose

5. 6. 7.

e Choose the syringe according to the volume of medicine you d need to measure: For volumes of medicine of 1 ml or less, use the 1 ml syringe. a For volumes of medicine greater than 1 ml, use the 4 ml syringe. n Insert the syringe nozzle into the white cap. a Pull the plunger until you draw the correct amount of i medicine. l Position the lower part of the plunger ring in correspondence with the mark showing the amount of a medicine. t I a Push the plunger down several times. This will eliminate any large air bubbles. The presence of some small bubbles in i the syringe is negligible. It will not affect the dose in z any way. n Make sure there is the correct amount of medicine in the syringe. Then remove the syringe from the bottle

8. 9.

Transfer the medicine drawn from the syringe into a small container of glass containing a liquid, preferably orange or apple juice. Make sure the syringe does not come into contact with the liquid contained in the bottle. Shake and drink all the contents of the glass immediately. After use, dry the outside of the syringe with a dry cloth. Then put the syringe back in its case. Leave the white cap and cannula in the bottle. F Close the bottle with the supplied cap. l

a r m a c o

For how long to take Sandimmun Neoral
The doctor will tell you how long you will need to take Sandimmun Neoral. This depends on whether you are
taking the medicine after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe skin rash, the duration of treatment is
usually 8 weeks.
Continue to take Sandimmun Neoral until your doctor tells you to stop.
If you have any other questions about how long to take Sandimmun Neoral, talk to your doctor or pharmacist.

If you take more Sandimmun Neoral than you should
If you have accidentally taken too much medicine, tell your doctor immediately or go to the nearest hospital emergency room. You may need medical attention.

If you forget to take Sandimmun Neoral

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• As with other medicines that act on the immune system, ciclosporin can affect the body's ability to fight infections and can cause tumors or other types of cancer, particularly of the skin. 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 muscle weakness. These may be signs of a brain infection called progressive multifocal leukoencephalopathy.
• Brain problems with signs such as seizures, confusion, feeling disoriented, poor responsiveness, personality changes, feeling agitated, insomnia, changes in vision, blindness, coma, paralysis of a part or all of the body, stiff neck, loss of coordination with or without unusual speech or eye movements.
• Swelling in the back of the eye. This may be associated with blurred vision. It can also affect vision due to increased pressure inside the head (benign intracranial hypertension).
• Liver problems and damage with or without yellowing of the skin and eyes, nausea, loss of appetite, and dark urine.
• Kidney problems that can significantly reduce the amount of urine produced.
• Low levels of red blood cells or platelets. Signs include paleness, feeling tired, difficulty breathing, dark urine (this is a sign of red blood cell breakdown), bruising or bleeding for no apparent reason, feeling confused, feeling disoriented, decreased attention, and kidney problems.

Other side effects include:
Very common:May affect more than 1 in 10 people.

• Kidney problems.
• High blood pressure.
• Headache.
• Uncontrollable body shaking.
• Excessive hair growth on the body and face.
• High levels of lipids in the blood. If any of these effects become severe, tell your doctor.

Common:May affect up to 1 in 10 people.

• Seizures (convulsions).
• Liver problems.
• High blood sugar levels.
• Fatigue.
• Loss of appetite.
• Nausea (feeling sick), vomiting, discomfort/pain in the abdomen, diarrhea.
• Excessive hair growth.
• Acne, hot flushes.
• Fever.
• Low levels of white blood cells in the blood.
• Feeling of numbness or tingling.
• Muscle pain, muscle spasms.
• Stomach ulcer.
• Excessive growth of the gums and covering of the teeth.
• High levels of uric acid or potassium in the blood, low levels of magnesium in the blood. If any of these effects become severe, 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, weakness of the limbs, reduced movements.
• Skin rash.
• Generalized swelling.
• Weight gain.
• Low levels of red blood cells, low levels of platelets in the blood which may increase the risk of bleeding. If any of these effects become severe, tell your doctor.

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

• Nerve problems with numbness or tingling in the fingers of the hands and feet.
• Inflammation of the pancreas with severe pain in the upper part of the stomach.
• Muscle weakness, loss of muscle strength, pain in the leg or arm muscles or in any part of the body.
• Destruction of red blood cells, which involve kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urine volume, difficulty breathing, chest pain, convulsions, loss of consciousness.
• Changes in the menstrual cycle, enlargement of the mammary gland in men. If any of these effects become severe, tell your doctor.

Very rare:May affect up to 1 in 10,000 people.

• Swelling in the back of the eye which may be associated with an increase in pressure inside the head and visual disturbances. If this effect becomes severe, tell your doctor.

Not known:Frequency cannot be estimated from the available data.

• Severe liver problems with and without the appearance of yellow skin or eyes, nausea (feeling sick), loss of appetite, dark urine, swelling of the face, feet, hands and/or whole body.
• Bleeding under the skin or purple spots, sudden bleeding without apparent cause.
• Migraine or severe headache often with feeling unwell (nausea, vomiting) and sensitivity to light.
• Pain in the legs and feet
• Hearing impairment. If any of these effects become severe, tell your doctor.

If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Additional side effects in children and adolescents
There are no additional side effects to be expected in children and adolescents compared to adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sandimmun Neoral

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack.
• Store at room temperature (15°C-30°C).
• Do not refrigerate. Do not store at a temperature below 20°C for more than 1 month. This is because the product contains oils that can solidify at low temperatures.
• If the medicine is mistakenly placed in the refrigerator, allow it to reach room temperature before using it again. The presence of flocculi or small particles (sediment) in the medicine does not affect its action and safety of use. The dose can still be measured correctly with the syringe.
• The contents of the bottle are stable for 2 months after opening. After 2 months, you must use a new bottle.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sandimmun Neoral contains

• The active ingredient is cyclosporine. One ml of oral solution contains 100 mg of cyclosporine.
• The other ingredients are: DL-alpha-tocopherol, absolute ethanol, propylene glycol, mono-di- triglycerides of corn oil, macrogolglycerol hydroxystearate (Ph.Eur.)/hydrogenated castor oil polyoxyl (USP).

Description of the appearance of Sandimmun Neoral and contents of the pack
Sandimmun Neoral is presented as an oral solution. It is a clear, pale yellow to
brownish liquid.

• Pack of 20 ml oral solution
• Pack of 50 ml oral solution
• Pack of 50 ml oral solution with 1 oral dispenser (syringe)
• Pack of 50 ml oral solution with 2 oral dispensers (syringes)
• The 1 ml syringe is used to measure doses of 1 ml or less. Each mark on the syringe is equal to 0.05 ml. This contains 5 mg of cyclosporine.
• The 4 ml syringe is used to measure doses greater than 1 ml and up to 4 ml. Each mark on the syringe is equal to 0.1 ml. This contains 10 mg of cyclosporine.
• Pack of 250 ml (5 x 50) oral solution

Not all pack sizes may be marketed

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo, 43
20154 Milano MI
Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo, 43
20154 Milano MI
Italy
Novartis Farmaceutica S.A.
Gran Vía de les Corts Catalanes, 764
08013 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (http://www.aifa.gov.it/)