NILOTINIB 50 mg Капсулы

Содержание инструкции

1. Nilotinib EG 50 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is Nilotinib EG and what is it used for
   2. What you need to know before taking Nilotinib EG
   3. How to take Nilotinib EG
   4. Possible side effects
   5. How to store Nilotinib EG
   6. Contents of the pack and other information

Nilotinib EG 50 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Generic medicine

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

1. What is Nilotinib EG and what is it used for

What is Nilotinib EG
Nilotinib EG is a medicine containing an active substance called nilotinib.

What is Nilotinib EG used for
Nilotinib EG is used for the treatment of a type of leukemia called chronic myeloid leukemia
Philadelphia chromosome positive (CML Ph-positive). CML is a cancer of the blood that causes the
body to produce too many abnormal white blood cells.
Nilotinib EG is used in adult and pediatric patients with newly diagnosed CML or in patients with CML
who no longer benefit from previous treatments including imatinib. It is also used in adult
and pediatric patients who have experienced serious side effects following previous treatments and who are
no longer able to continue taking them.

How does Nilotinib EG work
In patients with CML, a change in DNA (genetic material) triggers a signal that tells the body
to produce abnormal white blood cells. Nilotinib EG blocks this signal, and therefore interrupts the production
of these cells.

Monitoring during treatment with Nilotinib EG
During treatment, regular checks will be performed, including blood tests. These tests
will allow you to check:

• the amount of blood cells (white blood cells, red blood cells and platelets) to see how Nilotinib EG is tolerated.
• the function of the pancreas and liver to check how Nilotinib EG is tolerated.
• the electrolytes in the body (potassium, magnesium). These electrolytes are important for the functioning of the heart.
• the level of sugar and fats in the blood.

The heart rate will also be checked using an instrument that measures the electrical activity of the heart
(an examination called “ECG”).
Your doctor will regularly evaluate the treatment and decide whether you should continue to take Nilotinib
EG. If you are told to stop this medicine, your doctor will continue to monitor the CML and
may tell you to resume Nilotinib EG if your condition indicates that this is necessary.
If you have any questions about how Nilotinib EG works or why it has been prescribed for you or for your child, please
consult your doctor.

2. What you need to know before taking Nilotinib EG

Follow all of your doctor's instructions carefully. These instructions may be different from the

Do not take Nilotinib EG

• if you are allergic to nilotinib or to any of the other ingredients of this medicine (listed in section 6).
• if you think you may be allergic, tell your doctor before taking Nilotinib EG.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nilotinib EG:

• if you have had previous cardiovascular events such as a heart attack, chest pain (angina), problems with blood flow to the brain (stroke) or problems with blood flow to the leg (claudication) or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes or problems with blood fat levels (dyslipidemia).
• if you have heart problems, such as an abnormal electrical signal called “prolongation of the QT interval”.
• if you are taking medicinesthat lower your blood cholesterol (statins) or affect your heart rhythm (antiarrhythmics) or your liver (see Other medicines and Nilotinib EG).
• if you suffer from a lack of potassium or magnesium.
• if you have liver or pancreas problems.
• if you have symptoms such as a tendency to bruise easily, feeling tired or short of breath or have had repeated infections.
• if you have had surgery that involved the removal of your entire stomach (total gastrectomy).
• if you have ever had or may currently have a hepatitis B infection. This is because Nilotinib EG can cause hepatitis B to reactivate, which in some cases can be fatal. Patients will be carefully examined by the doctor for signs of this infection before starting treatment. If any of these conditions apply to you or your child, tell your doctor.

During treatment with Nilotinib EG

• if you faint (loss of consciousness) or have an irregular heartbeat during treatment with this medicine, tell your doctor immediatelyas this may be a sign of a serious heart condition. Prolongation of the QT interval or an irregular heartbeat can lead to sudden death. Uncommon cases of sudden death have been reported in patients treated with nilotinib.
• if you experience sudden palpitations, severe muscle weakness or paralysis, seizures or sudden changes in thinking or level of consciousness, tell your doctor immediatelyas this may be a sign of a rapid breakdown of tumor cells called tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with nilotinib.
• if you experience chest pain or discomfort, numbness or weakness, problems walking or speaking, pain, color change or coldness in a limb, tell your doctor immediatelyas this may be a sign of a cardiovascular event. Serious

cardiovascular events, including problems with blood flow to the leg (obstructive peripheral arteriopathy), ischemic heart disease and problems with blood flow to the brain (ischemic cerebrovascular disease) have been reported in patients treated with nilotinib. The doctor should assess the level of fats (lipids) and sugar in the blood before starting treatment with Nilotinib EG and during treatment.

• if you experience swelling of the feet or hands, generalized swelling or rapid weight gain, tell your doctor as these may be signs of severe fluid retention. Uncommon cases of severe fluid retention have been reported in patients treated with nilotinib. If you are the parent of a child who is being treated with Nilotinib EG, tell the doctor if any of the above conditions apply to them.

Children and adolescents
Nilotinib EG is a treatment for children and adolescents with CML. There is no experience with the use of this medicine in children under 2 years of age. There is no experience with the use of Nilotinib EG in newly diagnosed children under 10 years of age and there is limited experience in patients under 6 years of age who no longer benefit from previous CML treatment.
Some children and adolescents taking Nilotinib EG may experience slower than normal growth. The doctor will monitor growth with regular visits.

Other medicines and Nilotinib EG
Nilotinib EG can interfere with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes in particular:

• antiarrhythmics - used to treat irregular heartbeat;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines that can have an undesirable effect on the electrical activity of the heart;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin - used to treat infections;
• ritonavir - a medicine from the “protease inhibitor” class used to treat HIV;
• carbamazepine, phenobarbital, phenytoin - used to treat epilepsy;
• rifampicin - used to treat tuberculosis;
• St John's wort - a herbal product used to treat depression and other conditions (also known as Hypericum perforatum);
• midazolam - used for anxiety relief before surgery;
• alfentanil and fentanyl - used to treat pain and as sedatives before or during surgery or medical procedures;
• cyclosporine, sirolimus and tacrolimus - drugs that suppress the body's “self-defense” capabilities and fight infections and are commonly used to prevent rejection of transplanted organs, such as liver, heart and kidneys;
• dihydroergotamine and ergotamine - used to treat dementia;
• lovastatin, simvastatin - used to treat high levels of fats in the blood;
• warfarin - used to treat blood clotting disorders (such as blood clots or thrombosis);
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine).

These medicines should be avoided during treatment with Nilotinib EG. If you are taking any of these medicines, your doctor may prescribe other medicines as an alternative.
If you are taking a statin (a medicine that lowers your blood cholesterol), talk to your doctor or pharmacist. When taken with some statins, Nilotinib EG may increase the risk of muscle problems related to statins, which in rare cases can lead to severe muscle injury (rhabdomyolysis) with subsequent kidney damage.
Also, tell your doctor or pharmacist before taking Nilotinib EG if you are taking any antacid, i.e. a medicine for heartburn. These medicines should be taken separately from Nilotinib EG:

• H2 blockers, which decrease acid production in the stomach. H2 blockers should be taken about 10 hours before and about 2 hours after taking Nilotinib EG;
• antacids containing aluminum hydroxide, magnesium hydroxide and simethicone, which neutralize high acidity in the stomach. These antacids should be taken about 2 hours before or about 2 hours after taking Nilotinib EG.

You should also tell your doctor if you are already taking Nilotinib EGand you have been prescribed a new medicine that you were not taking previously during treatment with Nilotinib EG.

Nilotinib EG with food and drink
Do not take Nilotinib EG with food.Food may increase the absorption of Nilotinib EG and therefore increase the amount of Nilotinib EG in the blood, up to a dangerous level. Do not drink grapefruit juice or eat grapefruit. It may increase the amount of Nilotinib EG in the blood, up to a dangerous level.

Pregnancy and breastfeeding

• Nilotinib EG is not recommended during pregnancyunless strictly necessary. If you are pregnant or think you may be, tell your doctor who will discuss with you whether you can take this medicine during pregnancy.
• Women who may become pregnantare advised to use a very effective method of contraception during treatment and for two weeks after the end of treatment.
• Breastfeeding is not recommendedduring treatment with Nilotinib EG and for two weeks after the last dose. Tell your doctor if you are breastfeeding. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
If you experience side effects (such as dizziness or vision problems) that may affect your ability to drive safely or use tools or machines after taking this medicine, you must stop these activities until the effect has worn off.

Nilotinib EG contains lactose
This medicine contains lactose (also known as milk sugar). If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

Nilotinib EG 50 mg and 150 mg contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Nilotinib EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

How much Nilotinib EG to take
Use in adults

• Patients with newly diagnosed CML: The recommended dose is 600 mg per day. This dose is achieved by taking two 150 mg hard capsules twice a day.
• Patients who no longer benefit from previous CML treatment: The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg hard capsules twice a day.

Use in children and adolescents

• The dose given to your child will depend on the child's weight and height. The doctor will calculate the correct dose to use and will tell you which and how many Nilotinib EG capsules should be given to your child. The total daily dose to be given to your child must not exceed 800 mg.

The doctor may prescribe a lower dosage depending on how you respond to treatment.

Elderly people (65 years and over)
Nilotinib EG can be used by people 65 years and over at the same dose as for other adults.

When to take Nilotinib EG
Take the hard capsules:

• twice a day (approximately every 12 hours);
• at least 2 hours after any food;
• then wait 1 hour before eating again. If you have questions about when to take this medicine, talk to your doctor or pharmacist. Taking Nilotinib EG at the same time each day will help you remember when to take the hard capsules.

How to take Nilotinib EG

• Swallow the hard capsules whole with water.
• Do not take food together with the hard capsules.
• Do not open the hard capsules. If you or your child are unable to swallow the whole capsule, other medicines containing nilotinib should be used instead of Nilotinib EG.

For how long to take Nilotinib EG
Continue to take Nilotinib EG every day for as long as it has been prescribed by your doctor.
This is a long-term treatment. The doctor will regularly check your condition to verify
that the treatment is having the desired effect.
The doctor may consider stopping treatment with Nilotinib EG based on specific criteria. If you have
questions about how long to take Nilotinib EG, talk to your doctor.

If you take more Nilotinib EG than you should
If you have taken more Nilotinib EG than you should, or if someone else has accidentally taken your capsules
hard capsules, contact a doctor or hospital immediately for advice. Show them the packaging of the

If you forget to take Nilotinib EG
If you forget to take a dose, take the next dose as scheduled. Do not take a double
dose to make up for the forgotten hard capsule.

If you stop taking Nilotinib EG
Do not stop treatment with this medicine unless your doctor tells you to do so.
Stopping Nilotinib EG without your doctor's recommendation puts you at risk of worsening
of the disease which may have life-threatening consequences. Make sure you discuss with your doctor,
nurse, and/or pharmacist if you are considering stopping Nilotinib EG.

If your doctor recommends stopping treatment with Nilotinib EG
The doctor will regularly evaluate the treatment with a specific diagnostic test and decide whether you should
continue to take this medicine. If you are told to stop Nilotinib EG, the doctor will
continue to carefully monitor CML before, during and after stopping Nilotinib EG and may
tell you to restart Nilotinib EG if your condition indicates that this is necessary.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most side effects are mild to moderate and usually disappear after a
treatment period of a few days to a few weeks.

Some side effects can be serious.

• signs of musculoskeletal pain: joint and muscle pain
• signs of heart disorders: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of a rapid heartbeat) fainting, bluish discoloration of the lips, tongue or skin
• signs of artery blockage: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, ulcers on the legs or arms that do not heal or heal slowly, and noticeable changes in color (bluish or paleness) or temperature (coldness) of the affected leg, arm, feet or hands
• signs of thyroid gland underactivity: weight gain, fatigue, hair loss, muscle weakness, feeling cold
• signs of thyroid gland overactivity: fast heartbeat, bulging eyes, weight loss, swelling in the front of the neck
• signs of kidney or urinary tract disorders: thirst, dry skin, irritability, dark urine, decreased amount of urine, difficulty and pain when urinating, urgent need to urinate, blood in the urine, abnormal urine color
• signs of a high blood sugar level: excessive thirst, increased amount of urine, increased appetite with weight loss, fatigue
• signs of dizziness: dizziness or a spinning sensation
• signs of pancreatitis: severe upper abdominal pain (in the center or on the left)
• signs of skin disorders: painful red bumps, skin pain, skin redness, scaling or blisters
• signs of fluid retention: rapid weight gain, swelling of the hands, ankles, feet or face
• signs of migraine: severe headache often accompanied by nausea, vomiting and sensitivity to light
• signs of blood disorders: fever, tendency to bruise or unexplained bleeding, serious or frequent infections, unexplained weakness
• signs of venous thrombosis: swelling and pain in a part of the body
• signs of nervous system disorders: weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, hearing, or sensing things that are not there, changes in vision, loss of consciousness, confusion, disorientation, tremors, tingling, pain or numbness in the fingers of the hands and feet
• signs of lung disorders: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the feet or legs
• signs of gastrointestinal disorders: abdominal pain, nausea, vomiting of blood, black stools or stools containing blood, constipation, heartburn, acid reflux, bloated abdomen
• signs of liver disorders: yellowing of the skin and eyes, nausea, loss of appetite, dark urine
• signs of liver infection: recurrence (reactivation of hepatitis B infection)
• signs of eye disorders: visual disturbances including blurred vision, double vision or perception of flashes of light, decreased visual acuity or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching or irritation, dry eyes, swelling or itching of the eyelids
• signs of electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and/or joint disorders associated with abnormal blood test results (such as high levels of potassium, uric acid and phosphorus and low levels of calcium) Contact your doctor immediately if you notice any of the above side effects.

Some side effects are very common(may affect more than 1 in 10 people)

• diarrhea
• headache
• lack of energy
• muscle pain
• itching, rash
• nausea
• constipation
• vomiting
• hair loss
• pain in the limbs, bone pain and spinal pain after stopping treatment with Nilotinib EG
• slowed growth in children and adolescents
• upper respiratory tract infection including sore throat and runny or stuffy nose, sneezing
• low level of blood cells (red blood cells, platelets) or hemoglobin
• high level of lipase in the blood (pancreas function)
• high level of bilirubin in the blood (liver function)
• high level of alanine aminotransferase in the blood (liver enzymes)

Some side effects are common(may affect up to 1 in 10 people)

• pneumonia
• abdominal pain, stomach discomfort after meals, intestinal gas, bloating or abdominal distension
• bone pains, muscle spasms
• pain (including neck pain)
• dry skin, acne, decreased skin sensitivity
• decrease or increase in weight
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of discomfort
• nosebleeds
• signs of gout: painful and swollen joints
• inability to achieve or maintain an erection
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing noises (e.g. ringing, buzzing) in the ears that have no external source (also called tinnitus)
• hemorrhoids
• heavy menstrual bleeding
• itching of hair follicles
• oral or vaginal candidiasis
• signs of conjunctivitis: eye discharge with itching, redness and swelling
• eye irritation, red eyes
• signs of hypertension: high blood pressure, headache, dizziness
• flushing
• signs of occlusive peripheral artery disease: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, ulcers on the legs or arms that do not heal or heal slowly, and noticeable changes in color (bluish or paleness) or temperature (coldness) of the legs or arms (possible signs of blockage of an artery in the leg, arm, feet or hands)
• shortness of breath (also called dyspnea)
• mouth ulcers with inflammation of the gums (also called stomatitis)
• high level of amylase in the blood (pancreas function)
• high level of creatinine in the blood (kidney function)
• high level of alkaline phosphatase or creatine phosphokinase in the blood
• high level of aspartate aminotransferase in the blood (liver enzymes)
• high level of gamma-glutamyl transferase in the blood (liver enzymes)
• signs of leukopenia or neutropenia: low level of white blood cells
• increased number of platelets or white blood cells in the blood
• low levels in the blood of magnesium, potassium, sodium, calcium or phosphorus
• increased level of potassium, calcium and phosphorus in the blood
• high level of fats (including cholesterol) in the blood
• high level of uric acid in the blood

Some side effects are uncommon(may affect up to 1 in 100 people)

• allergy (hypersensitivity to Nilotinib EG)
• dry mouth
• breast pain
• pain or discomfort in the side
• increased appetite
• enlargement of the breast gland in men
• herpes virus infection
• stiffness of muscles and joints, swelling of the joints
• feeling of change in body temperature (including feeling of heat, feeling of cold)
• taste disorder
• frequent urge to urinate
• signs of inflammation of the gastric mucosa: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• memory loss
• skin cysts, thinning or thickening of the skin, thickening of the outermost layer of the skin, change in skin color
• signs of psoriasis: thickened areas of red/silvery skin
• increased skin sensitivity to light
• difficulty hearing
• joint inflammation
• urinary incontinence
• inflammation of the intestine (also called enterocolitis)
• anal abscess
• nipple swelling
• symptoms of restless legs syndrome (an irresistible urge to move a part of the body, usually the legs, associated with uncomfortable sensations)
• signs of sepsis: fever, chest pain, increased heart rate/increased heart rate, shortness of breath or rapid breathing
• skin infection (subcutaneous abscess)
• skin wart
• increased number of specific types of white blood cells (called eosinophils) in the blood
• signs of lymphopenia: low level of white blood cells
• high level of parathyroid hormone in the blood (a hormone that regulates calcium and phosphorus levels)
• high level of lactate dehydrogenase in the blood (an enzyme)
• signs of low blood sugar: nausea, sweating, weakness, dizziness, tremor, headache
• dehydration
• abnormal level of fats in the blood
• involuntary tremor (also called tremor)
• difficulty concentrating
• unpleasant and abnormal sensation to the touch (also called dysesthesia)
• fatigue (also called fatigue)
• feeling of numbness or tingling in the fingers of the hands and feet (also called peripheral neuropathy)
• paralysis of any muscle of the face
• red spot in the white of the eye caused by rupture of blood vessels (also called conjunctival hemorrhage)
• blood in the eyes (also called eye hemorrhage)
• eye irritation
• signs of heart attack (also called myocardial infarction): sudden and crushing chest pain, fatigue, irregular heartbeat
• signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
• fungal infection of the feet
• signs of heart failure: shortness of breath, difficulty breathing when lying down, swelling of the feet or legs
• pain behind the breastbone (also called pericarditis)
• signs of hypertensive crisis: severe headache, dizziness, nausea
• leg pain and weakness caused by walking (also called intermittent claudication)
• signs of narrowing of the arteries in the brain: partial or total loss of vision in both eyes, double vision, dizziness (feeling of dizziness), numbness or tingling, loss of coordination, dizziness or confusion
• bruising (when you have not injured yourself)
• deposits of fat in the arteries that can cause blockage (also called arteriosclerosis)
• signs of low blood pressure (also called hypotension): dizziness, lightheadedness or fainting
• signs of pulmonary edema: shortness of breath
• signs of pleural effusion: accumulation of fluid between the layers of tissue lining the lungs and the chest cavity (which, if severe, can reduce the heart's ability to pump blood), cough with chest pain, hiccups, rapid breathing
• signs of interstitial lung disease: cough, difficulty breathing, painful breathing
• signs of pleuritic pain: chest pain
• signs of pleurisy: cough, painful breathing
• hoarse voice
• signs of pulmonary hypertension: high blood pressure in the arteries of the lungs
• wheezing
• sensitive teeth
• signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
• high level of urea in the blood (kidney function)
• change in blood proteins (low level of globulins or presence of paraprotein)
• high level of unconjugated bilirubin in the blood
• high level of troponin in the blood

Some side effects are rare(may affect up to 1 in 1,000 people)

• redness and/or swelling and possible peeling of the palms of the hands and soles of the feet (so-called hand-foot syndrome)
• warts in the mouth
• feeling of hardening or stiffness of the breast
• inflammation of the thyroid gland (also called thyroiditis)
• disturbed or depressed mood
• signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
• signs of narrowing of the arteries in the brain: partial or total loss of vision in both eyes, double vision, dizziness (feeling of dizziness), numbness or tingling, loss of coordination, dizziness or confusion
• brain swelling (possible headache and/or changes in mental state)
• signs of optic neuritis: blurred vision, loss of vision
• signs of heart failure (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
• low or high level of insulin in the blood (a hormone that regulates blood sugar levels)
• low level of C-peptide in the blood (pancreas function)
• sudden death

The following other side effects have been reported with unknown frequency (cannot be defined
based on available data):

• signs of heart failure (ventricular dysfunction): shortness of breath, effort at rest, irregular heartbeat, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling of the feet, ankles and abdomen.

Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report undesirable effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting undesirable effects can help provide
more information on the safety of this medicine.

5. How to store Nilotinib EG

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the package and blister after Exp. The expiry date refers to the last day of that month.
• Only for the 50 mg dosage packaged in Al-PVC/PE/PVdC blisters: Do not store at a temperature above 30°C.
• For the 150, 200 mg dosages packaged in Al-PVC/PE/PVdC blisters and for the 50, 150, 200 mg dosages packaged in Al-OPA/Al/PVC blisters: This medicine does not require any special storage conditions.
• Do not use this medicine if you notice that the package is damaged or tampered with.
• 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 Nilotinib EG contains

• The active substance is nilotinib.

Each hard capsule containing 50 mg contains 50 mg of nilotinib (as dihydrate hydrochloride).
The other ingredients are:
Capsule content: Lactose monohydrate, crospovidone Type A (E1202), anhydrous colloidal silica (E551),
magnesium stearate (E470b)
Capsule shell: Hypromellose (E464), purified water, carrageenan (E407), potassium chloride (E508),
erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171)
Impression ink: Gum lac (E904), propylene glycol (E1520), potassium hydroxide (E525),
black iron oxide (E172)
See paragraph 2, “Nilotinib EG contains lactose and sodium”.
Each hard capsule containing 150 mg contains 150 mg of nilotinib (as dihydrate hydrochloride).
The other ingredients are:
Capsule content: Lactose monohydrate, crospovidone Type A (E1202), anhydrous colloidal silica (E551),
magnesium stearate (E470b)
Capsule shell: Hypromellose (E464), purified water, carrageenan (E407), potassium chloride (E508),
erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171)
Impression ink: Gum lac (E904), propylene glycol (E1520), potassium hydroxide (E525),
black iron oxide (E172)
See paragraph 2, “Nilotinib EG contains lactose and sodium”.
Each hard capsule containing 200 mg contains 200 mg of nilotinib (as dihydrate hydrochloride).
The other ingredients are:
Capsule content: Lactose monohydrate, crospovidone Type A (E1202), anhydrous colloidal silica (E551),
magnesium stearate (E470b)
Capsule shell: Hypromellose (E464), purified water, carrageenan (E407), potassium chloride (E508),
yellow iron oxide (E172), titanium dioxide (E171)
Impression ink: Gum lac (E904), propylene glycol (E1520), potassium hydroxide (E525),
black iron oxide (E172)
See paragraph 2, “Nilotinib EG contains lactose”.

Description of the appearance of Nilotinib EG and contents of the pack
Nilotinib EG 50 mg is provided in the form of hard capsules (capsules) with an opaque red cap and an opaque
light yellow body, size 4 (length approximately 14.4 mm), with black horizontal printing “50 mg” on the body. The
hard capsules are filled with powder from white to yellowish.
Nilotinib EG 150 mg is provided in the form of hard capsules (capsules) opaque red, size 1 (length approximately
19.3 mm), with black horizontal printing “150 mg” on the body. The hard capsules are filled with powder from
white to yellowish.
Nilotinib EG 200 mg is provided in the form of hard capsules (capsules) opaque light yellow, size 0 (length
approximately 21.4 mm), with black horizontal printing “200 mg” on the body. The hard capsules are filled with
powder from white to yellowish.
Nilotinib EG 50 mg hard capsules are packaged in PVC/PE/PVdC/Al or OPA/Al/PVC/Al blisters in:
Unit pack containing 40 hard capsules and multiple packs of 120 hard capsules (3 packs
of 40).
Nilotinib EG 50 mg hard capsules are packaged in PVC/PE/PVdC/Al or OPA/Al/PVC/Al blisters
divisible for unit dose in:
Unit pack containing 40x1 hard capsules and multiple packs of 120x1 hard capsules (3
packs of 40x1).
Nilotinib EG 150 mg hard capsules are packaged in PVC/PE/PVdC/Al or OPA/Al/PVC/Al blisters in:
Unit packs containing 28, 40 hard capsules and multiple packs of 112 (4 packs of 28), 120 (3
packs of 40) and 392 (14 packs of 28) hard capsules.
Nilotinib EG 150 mg hard capsules are packaged in PVC/PE/PVdC/Al or OPA/Al/PVC/Al blisters
divisible for unit dose in:
Unit packs containing 28x1, 40x1 hard capsules and multiple packs of 112x1 (4 packs of
28x1), 120x1 (3 packs of 40x1) and 392x1 (14 packs of 28x1) hard capsules.
Nilotinib EG 200 mg hard capsules are packaged in PVC/PE/PVdC/Al or OPA/Al/PVC/Al blisters in:
Unit packs containing 28, 40 hard capsules and multiple packs of 112 (4 packs of 28), 120 (3
packs of 40) and 392 (14 packs of 28) hard capsules.
Nilotinib EG 200 mg hard capsules are packaged in PVC/PE/PVdC/Al or OPA/Al/PVC/Al blisters
divisible for unit dose in:
Unit packs containing 28x1, 40x1 hard capsules and multiple packs of 112x1 (4 packs of
28x1), 120x1 (3 packs of 40x1) and 392x1 (14 packs of 28x1) hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan

Manufacturers
PharOS MT Ltd., HF62X, Hal Far Industrial Estate, Birzebbugia BBG3000, Malta
PharOS Pharmaceutical Oriented Services Ltd ., Lesvou Street End, Thesi Loggos Industrial Zone,
Metamorfossi, 144 52 , Greece
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
AT Nilotinib STADA 50 mg, 150 mg, 200 mg Hard Capsules
BE Nilotinib EG 50 mg, 150 mg, 200 mg hard capsules
CY Nilotinib Stada 50mg, 150mg, 200mg σκληρό καψάκιο
CZ Nilotinib STADA
DE Nilotinib AL 50 mg, 150 mg, 200 mg Hard Capsules
DK Nilotinib STADA
EE Nilotinib STADA
EL Nilotinib Stada
ES Nilotinib STADA 150 mg, 200 mg cápsulas duras EFG
FI Nilotinib STADA 50 mg, 150 mg, 200 mg capsules, hard
FR NILOTINIB EG 50 mg, 150 mg, 200 mg, capsule
HR Nilotinib STADA 50 mg, 150 mg, 200 mg hard capsules
HU Nilotinib STADA 50 mg, 150 mg, 200 mg kemény kapszula
IE Nilotinib Clonmel 50 mg, 150 mg, 200 mg hard capsules
IS Nilotinib STADA 50 mg, 150 mg, 200 mg hörð hylki
IT Nilotinib EG
LT Nilotinib STADA 50 mg, 150 mg, 200 mg kietosios kapsulės
LU Nilotinib EG 50 mg, 150 mg, 200 mg capsules
LV Nilotinib STADA 50 mg, 150 mg, 200 mg cietās kapsulas
MT Nilotinib Clonmel 50 mg, 150 mg, 200 mg hard capsules
NL Nilotinib CF 50 mg, 150 mg, 200 mg hard capsules
NO Nilotinib STADA
PL Nilotinib STADA
PT Nilotinib Stada
RO Nilotinib Stada 50 mg, 150 mg, 200 mg capsule
SE Nilotinib STADA
SI Nilotinib STADA 50 mg, 150 mg, 200 mg trde kapsule
SK Nilotinib STADA 50 mg, 150 mg, 200 mg tvrdé kapsuly