PACKAGE LEAFLET

Package leaflet: information for the user

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

Generic medicine
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Nilotinib EG is and what it is used for
What you need to know before taking Nilotinib EG
How to take Nilotinib EG
Possible side effects
How to store Nilotinib EG
Contents of the pack and other information

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

What Nilotinib EG is
Nilotinib EG is a medicine containing an active substance called nilotinib.
What Nilotinib EG is used for
Nilotinib EG is used to treat a type of leukaemia called Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML). CML is a blood cancer that causes the body to produce too many abnormal white blood cells.
Nilotinib EG is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who no longer benefit from prior treatments, including imatinib. It is also used in adult and paediatric patients who have experienced severe adverse reactions to prior treatments and who are no longer able to continue taking them.
How Nilotinib EG works
In patients with CML, a change in DNA (genetic material) triggers a signal that causes the body to produce abnormal white blood cells. Nilotinib EG blocks this signal, thereby stopping the production of these cells.
Monitoring during treatment with Nilotinib EG
Regular check-ups, including blood tests, will be carried out during treatment. These tests will monitor:

blood cell counts (white blood cells, red blood cells, and platelets) to assess how well Nilotinib EG is tolerated.
pancreatic and liver function to assess how well Nilotinib EG is tolerated.
electrolyte levels in the body (potassium, magnesium). These electrolytes are important for heart function.
blood sugar and blood lipid levels.

Heart rate will also be monitored using an instrument that measures the heart's electrical activity (a test called an "ECG").
Your doctor will regularly evaluate your treatment and decide whether you should continue taking Nilotinib EG. If you are told to stop taking this medicine, your doctor will continue to monitor your CML and may instruct you to restart 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 your child, consult your doctor.

2. What you need to know before taking Nilotinib EG

Follow all your doctor's instructions carefully. These instructions may differ from the
general information contained in this leaflet.
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, inform 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), reduced 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 lipid levels (dyslipidemia).
if you have heart problems, such as an abnormal electrical signal known as “prolongation of the QT interval”.
if you are taking medicines that lower your blood cholesterol (statins) or affect your heart rhythm (antiarrhythmics) or your liver (see Other medicines and Nilotinib EG).
if you have low levels of potassium or magnesium.
if you have liver or pancreatic disorders.
if you experience symptoms such as easy bruising, feeling tired, shortness of breath, or have had repeated infections.
if you have undergone surgery involving removal of the entire stomach (total gastrectomy).
if you have ever had or may currently have a hepatitis B infection. This is because Nilotinib EG may cause reactivation of hepatitis B, which in some cases can be fatal. Your doctor will carefully monitor you for signs of this infection before starting treatment. If any of these conditions apply to you or your child, inform your doctor.

During treatment with Nilotinib EG

if you faint (lose consciousness) or develop an irregular heartbeat while taking this medicine, inform your doctor immediately, as this may be a sign of a serious heart condition. Prolongation of the QT interval or an irregular heartbeat may 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 alertness, inform your doctor immediately, as these may be signs 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, difficulty walking or speaking, or pain, colour change, or cold sensation in a limb, inform your doctor immediately, as these may be signs of a cardiovascular event. Serious cardiovascular events, including problems with blood flow to the leg (peripheral obstructive arterial disease), ischemic heart disease, and reduced blood flow to the brain (ischemic cerebrovascular disease), have been reported in patients treated with nilotinib. Your doctor should assess your blood lipid and glucose levels before starting treatment with Nilotinib EG and during treatment.
if you develop swelling in your feet or hands, generalized swelling, or rapid weight gain, inform 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 being treated with Nilotinib EG, inform your doctor if any of the above conditions apply to your child.

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 children under 10 years of age with newly diagnosed disease, and limited experience in patients under 6 years of age who no longer benefit from prior CML treatment.
Some children and adolescents taking Nilotinib EG may experience slower than normal growth. Your doctor will monitor growth through regular check-ups.

Other medicines and Nilotinib EG
Nilotinib EG may interact with other medicines.
Inform 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 may have an undesirable effect on the heart's electrical activity;
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 to relieve anxiety before surgery;
alfentanil and fentanyl – used to treat pain and as sedatives before or during surgery or medical procedures;
cyclosporine, sirolimus, and tacrolimus – medicines that suppress the body’s immune defenses and ability to fight infections, 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 blood lipid levels;
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 must be avoided during treatment with Nilotinib EG. If you are taking any of these medicines, your doctor may prescribe alternative treatments.
If you are taking a statin (a medicine that lowers your blood cholesterol), talk to your doctor or pharmacist. When taken together with certain statins, Nilotinib EG may increase the risk of statin-related muscle problems, which in rare cases may lead to severe muscle damage (rhabdomyolysis) and subsequent kidney damage.
Additionally, inform your doctor or pharmacist before taking Nilotinib EG if you are taking any antacid, i.e., a medicine for heartburn. These medicines must be taken separately from Nilotinib EG:

H2 blockers, which reduce acid production in the stomach. H2 blockers should be taken approximately 10 hours before or approximately 2 hours after taking Nilotinib EG;
antacids such as those containing aluminium hydroxide, magnesium hydroxide, and simethicone, which neutralize high stomach acidity. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking Nilotinib EG.

You must also inform your doctor if you are already taking Nilotinib EG and are prescribed a new medicine that you have not taken previously during your treatment with Nilotinib EG.

Nilotinib EG with food and drinks
Do not take Nilotinib EG with food. Food can increase the absorption of Nilotinib EG and thus increase the amount of Nilotinib EG in the blood to a dangerous level. Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of Nilotinib EG in the blood to a dangerous level.

Pregnancy and breastfeeding

Nilotinib EG is not recommended during pregnancy unless strictly necessary. If you are pregnant or think you may be pregnant, inform your doctor, who will discuss with you whether you can take this medicine during pregnancy.
Women who could become pregnant are advised to use a highly effective method of contraception during treatment and for two weeks after stopping treatment.
Breastfeeding is not recommended during treatment with Nilotinib EG and for two weeks after the last dose. Inform your doctor if you are breastfeeding. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
If you experience side effects (such as dizziness or vision problems) that could potentially affect your ability to drive safely or operate tools or machinery after taking this medicine, you should stop these activities until the side effects resolve.

Nilotinib EG contains lactose
This medicine contains lactose (also known as milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult 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 daily.
Patients who no longer benefit from prior CML treatment: The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg hard capsules twice daily.

Use in children and adolescents

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

Your doctor may prescribe a lower dose depending on how you or your child responds to treatment.
Elderly patients (65 years and older)
Nilotinib EG may be used in patients aged 65 years and older at the same dose as other adults.
When to take Nilotinib EG
Take the hard capsules:

twice daily (approximately every 12 hours);
at least 2 hours after eating;
and then wait 1 hour before eating again. If you have any questions about when to take this medicine, speak with your doctor or pharmacist. Taking Nilotinib EG at the same time each day will help you remember when to take the 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 cannot swallow the capsule whole, another nilotinib-containing medicine should be used instead of Nilotinib EG.

How long to take Nilotinib EG
Continue taking Nilotinib EG every day for as long as your doctor has prescribed it.
This is a long-term treatment. Your doctor will regularly monitor your condition to check
that the treatment is working as intended.
Your doctor may consider stopping treatment with Nilotinib EG based on specific criteria. If you
have any questions about how long to take Nilotinib EG, speak with 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, contact a doctor or hospital immediately for advice. Show them the pack of the
hard capsules and this patient information leaflet. Medical treatment may be necessary.
If you forget to take Nilotinib EG
If you forget to take a dose, take the next dose at the usual scheduled time. Do not take a
double dose to make up for the forgotten capsule.
If you stop taking Nilotinib EG
Do not stop treatment with this medicine unless your doctor tells you to.
Stopping Nilotinib EG without medical advice may increase the risk of worsening of your
disease, which could be life-threatening. Be sure to discuss with your doctor,
nurse, and/or pharmacist if you are considering stopping Nilotinib EG.
If your doctor recommends stopping treatment with Nilotinib EG
Your doctor will regularly assess your treatment using a specific diagnostic test and will decide whether
you should continue taking this medicine. If you are told to stop taking Nilotinib EG, your doctor
will continue to monitor your CML carefully before, during, and after stopping Nilotinib EG, and may
instruct you to restart Nilotinib EG if your condition indicates that this is necessary.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. Most side effects are mild to moderate and usually disappear after a few days or weeks of treatment.
Some side effects may be serious.

signs of musculoskeletal pain: joint and muscle pain
signs of heart problems: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of rapid heartbeat), fainting, blue colouring of the lips, tongue or skin
signs of arterial blockage: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, leg or arm ulcers that do not heal or heal slowly, and noticeable changes in colour (bluish or pale) or temperature (coldness) of the affected leg, arm, toes or fingers
signs of underactive thyroid gland: weight gain, tiredness, hair loss, muscle weakness, feeling cold
signs of overactive thyroid gland: rapid heartbeat, bulging eyes, weight loss, swelling in the front of the neck
signs of kidney or urinary tract problems: thirst, dry skin, irritability, dark urine, reduced amount of urine, difficulty and pain when urinating, urgent need to urinate, blood in the urine, abnormal urine colour
signs of high blood sugar levels: excessive thirst, increased urine output, increased appetite with weight loss, tiredness
signs of dizziness: dizziness or sensation of spinning
signs of pancreatitis: severe upper abdominal pain (in the centre or left side)
signs of skin disorders: painful red nodules, skin pain, skin redness, peeling or blistering
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, severe or frequent infections, unexplained weakness
signs of venous thrombosis: swelling and pain in one part of the body
signs of nervous system disorders: weakness or paralysis of 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 fingers and toes
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 blood, black or bloody stools, constipation, heartburn, gastric reflux, bloated abdomen
signs of liver problems: 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: vision disturbances including blurred vision, double vision or perception of flashes of light, reduced visual acuity or vision loss, 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 problems 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)

diarrhoea
headache
lack of energy
muscle pain
itching, rash
nausea
constipation
vomiting
hair loss
limb pain, bone pain and spinal pain after stopping treatment with Nilotinib EG
slowed growth in children and adolescents
upper respiratory tract infection including sore throat, runny or blocked nose, sneezing
low levels of blood cells (red blood cells, platelets) or haemoglobin
high level of lipase in the blood (pancreatic 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, abdominal swelling or distension
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, decreased skin sensitivity
weight loss or weight gain
insomnia, depression, anxiety
night sweats, excessive sweating
general feeling of being unwell
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)
haemorrhoids
heavy menstrual periods
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 arterial disease: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, leg or arm ulcers that do not heal or heal slowly, and noticeable changes in colour (bluish or pale) or temperature (coldness) of the legs or arms (possible signs of arterial blockage in the affected leg, arm, toes or fingers)
shortness of breath (also called dyspnoea)
mouth ulcers with gum inflammation (also called stomatitis)
high level of amylase in the blood (pancreatic 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 leucopenia or neutropenia: low white blood cell count
increased number of platelets or white blood cells in the blood
low blood levels of magnesium, potassium, sodium, calcium or phosphorus
increased levels of potassium, calcium and phosphorus in the blood
high levels 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
breast enlargement in men
herpes virus infection
stiffness of muscles and joints, joint swelling
sensation of body temperature change (including feeling hot or cold)
taste disturbance
frequent urge to urinate
signs of gastric mucosal inflammation: abdominal pain, nausea, vomiting, diarrhoea, abdominal distension
memory loss
skin cysts, thinning or thickening of the skin, thickening of the outer layer of the skin, skin colour changes
signs of psoriasis: thickened areas of red/silvery skin
increased skin sensitivity to light
hearing difficulty
joint inflammation
urinary incontinence
intestinal inflammation (also called enterocolitis)
anal abscess
nipple swelling
symptoms of restless legs syndrome (an irresistible urge to move part of the body, usually the legs, associated with uncomfortable sensations)
signs of sepsis: fever, chest pain, increased heart rate, shortness of breath or rapid breathing
skin infection (subcutaneous abscess)
skin wart
increased levels of specific types of white blood cells (called eosinophils) in the blood
signs of lymphopenia: low white blood cell count
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 blood fat levels
involuntary tremor (also called tremor)
difficulty concentrating
unpleasant and abnormal sensation to touch (also called dysaesthesia)
tiredness (also called fatigue)
numbness or tingling in fingers and toes (also called peripheral neuropathy)
paralysis of any facial muscle
red spot in the white of the eye caused by broken blood vessels (also called conjunctival haemorrhage)
blood in the eyes (also called eye haemorrhage)
eye irritation
signs of heart attack (also called myocardial infarction): sudden, crushing chest pain, tiredness, irregular heartbeat
signs of heart murmur: tiredness, chest discomfort, dizziness, chest pain, palpitations
fungal foot infection
signs of heart failure: breathlessness, difficulty breathing when lying down, swelling of 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 arteries in the limbs: possible high blood pressure, painful cramps in one or both hips, thighs or calves after certain activities such as walking or climbing stairs, numbness or weakness in the legs
bruising (when you have not injured yourself)
fat deposits in the arteries that may cause blockage (also called arteriosclerosis)
signs of low blood pressure (also called hypotension): dizziness, lightheadedness or fainting
signs of pulmonary oedema: breathlessness
signs of pleural effusion: fluid accumulation between the layers of tissue lining the lungs and chest cavity (which, if severe, may reduce the heart's ability to pump blood), chest pain with cough, hiccups, rapid breathing
signs of interstitial lung disease: cough, difficulty breathing, painful breathing
signs of pleural pain: chest pain
signs of pleurisy: cough, painful breathing
hoarseness
signs of pulmonary hypertension: high blood pressure in the lung arteries
wheezing
sensitive teeth
signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
high level of urea in the blood (kidney function)
changes in blood proteins (low globulin levels 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
sensation of hardness or stiffness in the breast
thyroid inflammation (also called thyroiditis)
disturbed or depressed mood
signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, tiredness
signs of narrowing of arteries in the brain: partial or complete vision loss in both eyes, double vision, vertigo (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, vision loss
signs of cardiac dysfunction (reduced ejection fraction): tiredness, chest discomfort, dizziness, pain, palpitations
low or high level of insulin in the blood (a hormone that regulates blood sugar levels)
low level of insulin C-peptide in the blood (pancreatic function)
sudden death

The following additional side effects have been reported at an unknown frequency (cannot be estimated from the available data):

signs of cardiac dysfunction (ventricular dysfunction): shortness of breath, exertion at rest, irregular heartbeat, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling of feet, ankles and abdomen.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side 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 which is stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
For the 50 mg dosage packed in Al-PVC/PE/PVdC blisters only: Do not store above 30°C.
For the 150 mg and 200 mg dosages packed in Al-PVC/PE/PVdC blisters and for the 50 mg, 150 mg and 200 mg dosages packed 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 packaging is damaged or tampered with.
Do not dispose of any medicine via wastewater 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 Nilotinib EG contains

The active substance is nilotinib.

Each 50 mg hard capsule contains 50 mg of nilotinib (as dihydrochloride).
The other components are:
Capsule contents: Monohydrate lactose, 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)
Printing ink: Shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)
See section 2, “Nilotinib EG contains lactose and sodium”.

Each 150 mg hard capsule contains 150 mg of nilotinib (as dihydrochloride).
The other components are:
Capsule contents: Monohydrate lactose, 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)
Printing ink: Shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)
See section 2, “Nilotinib EG contains lactose and sodium”.

Each 200 mg hard capsule contains 200 mg of nilotinib (as dihydrochloride).
The other components are:
Capsule contents: Monohydrate lactose, 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)
Printing ink: Shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)
See section 2, “Nilotinib EG contains lactose”.

Description of the appearance of Nilotinib EG and contents of the pack

Nilotinib EG 50 mg is supplied as hard capsules (capsules) with an opaque red cap and an opaque light yellow body, size 4 (approximately 14.4 mm in length), printed horizontally in black with “50 mg” on the body. The hard capsules are filled with powder ranging from white to pale yellow.

Nilotinib EG 150 mg is supplied as hard capsules (capsules) in opaque red, size 1 (approximately 19.3 mm in length), printed horizontally in black with “150 mg” on the body. The hard capsules are filled with powder ranging from white to yellowish.

Nilotinib EG 200 mg is supplied as hard capsules (capsules) in opaque light yellow, size 0 (approximately 21.4 mm in length), printed horizontally in black with “200 mg” on the body. The hard capsules are filled with powder ranging from white to yellowish.

Nilotinib EG 50 mg hard capsules are packaged in PVC/PE/PVdC/Al blisters or OPA/Al/PVC/Al blisters:
Unit pack containing 40 hard capsules and multiple packs containing 120 hard capsules (3 packs of 40).

Nilotinib EG 50 mg hard capsules are also packaged in PVC/PE/PVdC/Al blisters or OPA/Al/PVC/Al blisters, unit-dose divisible packaging:
Unit pack containing 40x1 hard capsules and multiple packs containing 120x1 hard capsules (3 packs of 40x1).

Nilotinib EG 150 mg hard capsules are packaged in PVC/PE/PVdC/Al blisters or OPA/Al/PVC/Al blisters:
Unit packs containing 28 or 40 hard capsules and multiple packs containing 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 also packaged in PVC/PE/PVdC/Al blisters or OPA/Al/PVC/Al blisters, unit-dose divisible packaging:
Unit packs containing 28x1 or 40x1 hard capsules and multiple packs containing 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 blisters or OPA/Al/PVC/Al blisters:
Unit packs containing 28 or 40 hard capsules and multiple packs containing 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 also packaged in PVC/PE/PVdC/Al blisters or OPA/Al/PVC/Al blisters, unit-dose divisible packaging:
Unit packs containing 28x1 or 40x1 hard capsules and multiple packs containing 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 Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

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 Wien, Austria

This medicinal product is authorized in the European Economic Area countries under the following names:

AT Nilotinib STADA 50 mg, 150 mg, 200 mg Hartkapseln
BE Nilotinib EG 50 mg, 150 mg, 200 mg harde capsules
CY Nilotinib Stada 50mg, 150mg, 200mg σκληρό καψάκιο
CZ Nilotinib STADA
DE Nilotinib AL 50 mg, 150 mg, 200 mg Hartkapseln
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 kapseli, kova
FR NILOTINIB EG 50 mg, 150 mg, 200 mg, gélule
HR Nilotinib STADA 50 mg, 150 mg, 200 mg tvrde kapsule
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 gélules
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 harde 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