PACKAGE LEAFLET

Package leaflet: Information for the user

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

nilotinib
Generic medicine
Please read all of 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Nilotinib Mylan is
Nilotinib Mylan is a medicine containing an active substance called nilotinib.
What Nilotinib Mylan is used for
Nilotinib Mylan 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 Mylan 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 effects from previous treatments and who are no longer able to continue taking them.
How Nilotinib Mylan 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 Mylan blocks this signal, thereby stopping the production of these cells.
Monitoring during treatment with Nilotinib Mylan
Regular monitoring, including blood tests, will be performed during treatment. These tests will check:

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

Heart rate will also be monitored using a device that measures the heart's electrical activity (a test called an "ECG").
Your doctor will regularly assess your treatment and decide whether you should continue taking Nilotinib Mylan. If you are told to stop taking this medicine, your doctor will continue to monitor your CML and may instruct you to restart Nilotinib Mylan if your condition indicates that this is necessary.
If you have any questions about how Nilotinib Mylan works or why it has been prescribed for you or your child, please consult your doctor.

2. What you should know before taking Nilotinib Mylan

Follow your doctor’s instructions carefully. These instructions may differ from the general information contained in this leaflet.
Do not take Nilotinib Mylan

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 Mylan.

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

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 lipid levels in the blood (dyslipidemia).
if you have heart problems, such as an abnormal electrical signal called “prolongation of the QT interval”.
if you are being treated with medicines** that lower your cholesterol in the blood (statins) or affect heart rhythm (antiarrhythmics) or the liver (see Other medicines and Nilotinib Mylan).
if you have low levels of potassium or magnesium.
if you have liver or pancreatic disorders.
if you have symptoms such as a tendency to bruise easily, feeling tired, shortness of breath, or if you 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 hepatitis B infection. This is because Nilotinib Mylan 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 Mylan

if you faint (lose consciousness) or experience 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 level of alertness, inform your doctor immediately, as 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, difficulty walking or speaking, pain, color change, or cold sensation in a limb, inform your doctor immediately, as this may be a sign of a cardiovascular event. Serious cardiovascular events, including problems with blood flow to the leg (peripheral obstructive arterial disease), ischemic heart disease, and problems with 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 Mylan and during treatment.
if you experience swelling of the feet or hands, generalized swelling, or a 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 Mylan, inform your doctor if any of the above conditions apply to your child.

Children and adolescents
Nilotinib Mylan 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 Mylan in children under 10 years of age with newly diagnosed CML, and limited experience in patients under 6 years of age who no longer benefit from prior CML treatment. Some children and adolescents taking Nilotinib Mylan may experience slower than normal growth. Your doctor will monitor growth with regular check-ups.
Other medicines and Nilotinib Mylan
Nilotinib Mylan can 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 – an “antiprotease” medicine 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 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 Mylan. 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 cholesterol), talk to your doctor or pharmacist. When taken with certain statins, Nilotinib Mylan may increase the risk of statin-related muscle problems, which in rare cases may lead to severe muscle damage (rhabdomyolysis) and subsequent kidney damage.
Also, inform your doctor or pharmacist before taking Nilotinib Mylan if you are taking any antacid, i.e., a medicine for heartburn. These medicines must be taken separately from Nilotinib Mylan:

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

You should also inform your doctor if you are already taking Nilotinib Mylan and are prescribed a new medicine you have not previously taken during treatment with Nilotinib Mylan.
Nilotinib Mylan with food and drink
Do not take Nilotinib Mylan with food. Food can increase the absorption of Nilotinib Mylan and thus increase the amount of Nilotinib Mylan in the blood to dangerous levels. Do not drink grapefruit juice or eat grapefruit. These can increase the amount of Nilotinib Mylan in the blood to dangerous levels.
Pregnancy and breastfeeding

Nilotinib Mylan 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 may become pregnant are advised to use a highly effective method of contraception during treatment and for two weeks after treatment ends.
Breastfeeding is not recommended during treatment with Nilotinib Mylan and for two weeks after the last dose. Inform your doctor if you are breastfeeding. If you are pregnant, suspect you are pregnant, planning to become pregnant, or 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 affect your ability to drive or operate tools or machinery safely after taking this medicine, you should stop these activities until the side effect resolves.
Nilotinib Mylan contains lactose
This medicine contains lactose (also known as milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Nilotinib Mylan 50 mg and 150 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Nilotinib Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

How much Nilotinib Mylan to take

Use in adults

Patients with newly diagnosed CML: The recommended dose is 600 mg daily. This dose is achieved by taking two 150 mg hard capsules twice daily.
Patients who are no longer benefiting from prior CML treatment: The recommended dose is 800 mg daily. 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 and will tell you which strength and how many Nilotinib Mylan capsules to give your child. The total daily dose administered 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 Mylan can be used in patients aged 65 years and older at the same dose as in other adults.

When to take Nilotinib Mylan
Take the hard capsules:

Twice daily (approximately every 12 hours);
At least 2 hours after eating;
And wait at least 1 hour before eating again.

If you have any questions about when to take this medicine, speak to your doctor or pharmacist. Taking Nilotinib Mylan at the same time each day will help you remember when to take the capsules.

How to take Nilotinib Mylan

Swallow the hard capsules whole with water.
Do not take food at the same time as the hard capsules.
Do not open the hard capsules. If you or your child cannot swallow the capsule whole, a different medicine containing nilotinib should be used instead of Nilotinib Mylan.

How long to take Nilotinib Mylan
Continue taking Nilotinib Mylan every day for as long as your doctor has prescribed it. This is a long-term treatment. Your doctor will monitor your condition regularly to check that the treatment is working as expected.

Your doctor may consider stopping treatment with Nilotinib Mylan based on specific criteria. If you have questions about how long to continue taking Nilotinib Mylan, speak to your doctor.

If you take more Nilotinib Mylan than you should
If you have taken more Nilotinib Mylan than you should, or if someone else has accidentally taken your capsules, contact a doctor or hospital immediately for advice. Show them the capsule packaging and this leaflet. Medical treatment may be necessary.

If you forget to take Nilotinib Mylan
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 missed capsule.

If you stop taking Nilotinib Mylan
Do not stop taking this medicine unless your doctor tells you to. Stopping treatment with Nilotinib Mylan without medical advice may put you at risk of worsening disease, which could be life-threatening. Be sure to discuss with your doctor, nurse, and/or pharmacist if you are considering stopping Nilotinib Mylan.

If your doctor recommends stopping treatment with Nilotinib Mylan
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 Mylan, your doctor will continue to monitor your CML closely before, during, and after stopping Nilotinib Mylan, and may instruct you to restart Nilotinib Mylan if your condition indicates that this is necessary.

If you have any doubts about how to use 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 few days to a few 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, bluish discoloration of the lips, tongue, or skin
signs of arterial blockage: pain, discomfort, weakness, or cramps in the leg muscles, possibly due to reduced blood flow, leg or arm ulcers that do not heal or heal slowly, and noticeable changes in color (bluish or pale) or temperature (coldness) of the affected leg, arm, toes, or hands
signs of underactive thyroid gland: weight gain, fatigue, hair loss, muscle weakness, feeling cold
signs of overactive thyroid gland: fast 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 urine output, difficulty or pain when urinating, urgent need to urinate, blood in the urine, abnormal urine color
signs of high blood sugar levels: excessive thirst, increased urination, increased appetite with weight loss, fatigue
signs of dizziness: dizziness or spinning sensation
signs of pancreatitis: severe upper abdominal pain (in the center or left side)
signs of skin problems: painful red nodules, skin pain, skin redness, peeling or blistering
signs of fluid retention: rapid weight gain, swelling in 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 a 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 problems: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling in 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-colored urine
signs of liver infection: recurrence (reactivation of hepatitis B infection)
signs of eye problems: vision disturbances including blurred vision, double vision, or perception of flashes of light, decreased visual acuity or vision loss, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching or irritation, dry eyes, eyelid swelling or itching
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)

diarrhea
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 Mylan
slowed growth in children and adolescents
upper respiratory tract infection including sore throat, runny or stuffy nose, sneezing
low levels of blood cells (red blood cells, platelets) or hemoglobin
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, gas, bloating or abdominal distension
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, decreased skin sensitivity
weight loss or 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 without an external source (also called tinnitus)
hemorrhoids
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 artery disease: pain, discomfort, weakness, or cramps in the leg muscles, possibly due to reduced blood flow, leg or arm ulcers that do not heal or heal slowly, and noticeable changes in color (bluish or pale) or temperature (coldness) of the legs or arms (possible signs of arterial blockage in the affected leg, arm, toes, or hands)
shortness of breath (also called dyspnea)
mouth ulcers with inflamed gums (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 leukopenia 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 Mylan)
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 changes (including feeling hot or cold)
taste disturbance
frequent urge to urinate
signs of gastric mucosal inflammation: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
memory loss
skin cysts, skin thinning or thickening, thickening of the outermost skin layer, skin color changes
signs of psoriasis: thickened patches 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 a part of the body, usually the legs, associated with discomfort)
signs of sepsis: fever, chest pain, increased or rapid 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 regulating 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 fat levels in the blood
involuntary tremor (also called tremor)
difficulty concentrating
unpleasant or abnormal sensation to touch (also called dysesthesia)
fatigue (also called tiredness)
numbness or tingling in fingers and toes (also called peripheral neuropathy)
facial muscle paralysis
red spot in the white of the eye due to broken blood vessels (also called conjunctival hemorrhage)
blood in the eyes (also called ocular hemorrhage)
eye irritation
signs of heart attack (also called myocardial infarction): sudden, crushing chest pain, fatigue, irregular heartbeat
signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
fungal foot infection
signs of heart failure: shortness of breath, 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 when walking (also called intermittent claudication)
signs of narrowing of limb arteries: possible high blood pressure, painful cramps in one or both hips, thighs, or calves after activities such as walking or climbing stairs, numbness or weakness in legs
bruising (when you have not injured yourself)
fat deposits in arteries that may 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: 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), cough, chest pain, hiccups, rapid breathing
signs of interstitial lung disease: cough, difficulty breathing, painful breathing
signs of pleuritic pain: chest pain
signs of pleuritis: 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, tender 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, fatigue
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 status)
signs of optic neuritis: blurred vision, vision loss
signs of cardiac dysfunction (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
low or high level of insulin in the blood (a hormone regulating blood sugar levels)
low level of insulin C-peptide in the blood (pancreatic function)
sudden death

The following additional side effects have been reported with 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 in feet, ankles, and abdomen.

Reporting of side effects
If you experience any side effects, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nilotinib Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.: The expiry date refers to the last day of that month.
Do not store Nilotinib Mylan 50 mg hard capsules above 30°C. Nilotinib 150 mg and 200 mg do 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. Contents of the Pack and Other Information

What Nilotinib Mylan Contains

The active substance is nilotinib.

Each 50 mg hard capsule contains 50 mg of nilotinib (as hydrochloride dihydrate).
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 Mylan contains lactose and sodium”.

Each 150 mg hard capsule contains 150 mg of nilotinib (as hydrochloride dihydrate).
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 Mylan contains lactose and sodium”.

Each 200 mg hard capsule contains 200 mg of nilotinib (as hydrochloride dihydrate).
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 Mylan contains lactose”.

Description of the Appearance of Nilotinib Mylan and Contents of the Pack

Nilotinib Mylan 50 mg is supplied as hard capsules (capsules) with an opaque red cap and an opaque light yellow body, size 4 (approximate length 14.4 mm), printed with a horizontal black "50 mg" on the body. The hard capsules are filled with a white to yellowish powder.

Nilotinib Mylan 150 mg is supplied as hard capsules (capsules) of opaque red colour, size 1 (approximate length 19.3 mm), printed with a horizontal black "150 mg" on the body. The hard capsules are filled with a white to yellowish powder.

Nilotinib Mylan 200 mg is supplied as hard capsules (capsules) of opaque light yellow colour, size 0 (approximate length 21.4 mm), printed with a horizontal black "200 mg" on the body. The hard capsules are filled with a white to yellowish powder.

Nilotinib Mylan 50 mg hard capsules are packaged in PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium blisters:
Unit packs containing 112 and 120 hard capsules and multiple packs containing 112 (4 packs of 28) and 120 (3 packs of 40) hard capsules.

Nilotinib Mylan 50 mg hard capsules are also packaged in unit-dose divisible blisters made of PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium:
Unit packs containing 112 x 1 and 120 x 1 hard capsules and multiple packs containing 112 x 1 (4 packs of 28 x 1) and 120 x 1 (3 packs of 40 x 1) hard capsules.

Nilotinib Mylan 150 mg hard capsules are packaged in PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium blisters:
Unit packs containing 28, 112 and 120 hard capsules and multiple packs containing 112 (4 packs of 28) and 392 (14 packs of 28) hard capsules.

Nilotinib Mylan 150 mg hard capsules are also packaged in unit-dose divisible blisters made of PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium:
Unit packs containing 112 x 1 and 120 x 1 hard capsules and multiple packs containing 112 x 1 (4 packs of 28 x 1) hard capsules.

Nilotinib Mylan 200 mg hard capsules are packaged in PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium blisters:
Unit packs containing 28, 112 and 120 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 Mylan 200 mg hard capsules are also packaged in unit-dose divisible blisters made of PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium:
Unit packs containing 112 x 1 and 120 x 1 hard capsules and multiple packs containing 112 x 1 (4 packs of 28 x 1) hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 - 20124 Milan, Italy

Manufacturer
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