Package leaflet: Information for the user

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

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

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

What is Nilotinib Accord
Nilotinib Accord is a medicine containing an active substance called nilotinib.
What Nilotinib Accord is used for
Nilotinib Accord 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 Accord 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 are no longer able to continue taking them.
How Nilotinib Accord 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 Accord blocks this signal, thereby stopping the production of these cells.
Monitoring during treatment with Nilotinib Accord
During treatment, regular check-ups will be performed, including blood tests. These tests will monitor:

the number of blood cells (white blood cells, red blood cells and platelets) to assess how well Nilotinib Accord is tolerated.
the function of the pancreas and liver to evaluate how well Nilotinib Accord is tolerated.
the body's electrolytes (potassium, magnesium). These electrolytes are important for heart function.
blood sugar and fat levels. Heart rate will also be monitored using a device that measures the heart's electrical activity (a test called "ECG").

Your doctor will regularly evaluate your treatment and decide whether you should continue taking Nilotinib Accord. If you are told to stop taking this medicine, your doctor will continue to monitor your CML and may instruct you to restart Nilotinib Accord if your condition indicates that this is necessary.
If you have any questions about how Nilotinib Accord works or why it has been prescribed for you or your child, consult your doctor.

2. What you need to know before taking Nilotinib Accord

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

if you are allergic to nilotinib or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, inform your doctor before taking Nilotinib Accord.

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

if you have had previous cardiovascular events such as 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 lipid levels (dyslipidemia).
if you have heart problems, such as an abnormal electrical signal called “QT interval prolongation”.
if you are being treated with medicines that lower your blood cholesterol, affect heart rhythm (antiarrhythmics), or affect the liver (see Other medicines and Nilotinib Accord).
if you have low levels of potassium or magnesium.
if you have liver or pancreatic disorders.
if you have symptoms such as tendency to bruise easily, feeling tired, shortness of breath, or have had repeated infections.
if you have had 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 Accord can cause reactivation of hepatitis B, which in some cases can be fatal. Patients will be closely monitored by the doctor 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 Accord

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. QT interval prolongation or irregular heartbeat can lead to sudden death. Uncommon cases of sudden death have been reported in patients treated with Nilotinib Accord.
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 rapid breakdown of tumor cells known as tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with Nilotinib Accord.
if you experience chest pain or discomfort, numbness or weakness, difficulty walking or speaking, or 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 Accord. Your doctor should assess your blood lipid and blood sugar levels before starting treatment with Nilotinib Accord and during treatment.
if you experience swelling of the 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 Accord. If you are a parent of a child being treated with Nilotinib Accord, inform your doctor if any of the above conditions apply to your child.

Children and adolescents
Nilotinib Accord 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 Accord 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 treatment for CML. Some children and adolescents taking Nilotinib Accord may experience slower than normal growth. Your doctor will monitor growth with regular check-ups.

Other medicines and Nilotinib Accord
Nilotinib Accord can interfere 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 of 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 “self-defense” ability 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 blood fats;
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 Accord. 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 Accord 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 Accord if you are taking any antacid, i.e., a medicine for heartburn. These medicines must be taken separately from Nilotinib Accord:

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 Accord;
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 Accord.

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

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

Pregnancy and breastfeeding

Nilotinib Accord 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 stopping treatment.
Breastfeeding is not recommended during treatment with Nilotinib Accord and for two weeks after the last dose. Inform your doctor if you are breastfeeding. If you are pregnant, suspect you are pregnant, plan to become pregnant, or are breastfeeding with breast milk, 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 must stop these activities until the effect has disappeared.

Nilotinib Accord contains lactose (as monohydrate)
This medicine contains lactose (also known as milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Nilotinib Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially “sodium-free”.

Nilotinib Accord contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per capsule, i.e., essentially “potassium-free”.

Nilotinib Accord contains Allura Red AC
This medicine contains Allura Red AC, which may cause allergic reactions.

3. How to take Nilotinib Accord

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
How much Nilotinib Accord 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 tell you which capsules and how many of them should be given to 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 respond to treatment.
Elderly people (65 years and older)
Nilotinib Accord can be used in people aged 65 years and older at the same dose as for other adults.
When to take Nilotinib Accord
Take the hard capsules:

twice daily (approximately every 12 hours);
at least 2 hours after eating;
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 Accord at the same time each day will help you remember when to take the hard capsules.

How to take Nilotinib Accord

Swallow the hard capsules whole with water.
Do not eat food at the same time as the hard capsules.
Do not open the hard capsules unless you are unable to swallow them. In this case, you may sprinkle the contents of each hard capsule onto one teaspoon of apple sauce and take it immediately. Do not use more than one teaspoon of apple sauce per hard capsule, and do not use any other food besides apple sauce.

How long to take Nilotinib Accord
Continue taking Nilotinib Accord every day for as long as your doctor has prescribed it. This is a long-term treatment. Your doctor will regularly check your condition to ensure the treatment is working as intended.
Your doctor may consider stopping treatment with Nilotinib Accord based on specific criteria. If you have any questions about how long to take Nilotinib Accord, speak with your doctor.
If you take more Nilotinib Accord than you should
If you have taken more Nilotinib Accord than you should, or if someone else has accidentally taken your hard capsules, contact a doctor or hospital immediately for advice. Show them the pack of hard capsules and this leaflet. Medical treatment may be necessary.
If you forget to take Nilotinib Accord
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten capsule.
If you stop taking Nilotinib Accord
Do not stop taking this medicine unless your doctor tells you to. Stopping Nilotinib Accord without your doctor’s recommendation puts you at risk of worsening of your disease, which may have life-threatening consequences. Make sure to discuss with your doctor, nurse, and/or pharmacist if you are considering stopping Nilotinib Accord.
If your doctor recommends stopping treatment with Nilotinib Accord
Your doctor will regularly assess your treatment with a specific diagnostic test and decide whether you should continue taking this medicine. If you are told to stop Nilotinib Accord, your doctor will continue to monitor your CML closely before, during, and after stopping Nilotinib Accord, and may instruct you to restart Nilotinib Accord if your condition indicates that it 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 gets them. Most side effects are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
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 (sensation 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 hands
signs of underactive thyroid gland: weight gain, tiredness, 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 colour
signs of high blood sugar levels: excessive thirst, increased amount of urine, 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 problems: painful red lumps, skin pain, skin redness, peeling 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, severe or frequent infections, unexplained weakness
signs of venous thrombosis: swelling and pain in 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 of hands and feet
signs of lung problems: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of feet or legs
signs of gastrointestinal problems: abdominal pain, 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-coloured 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 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, tiredness 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 Accord
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, flatulence, abdominal swelling or distension
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, decreased skin sensitivity
weight decrease or increase
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 with 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
redness
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 leg, arm, toes or hands)
shortness of breath (also called dyspnoea)
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 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 Accord)
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 inflammation of the gastric mucosa: 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 red/silvery skin patches
increased skin sensitivity to light
hearing difficulty
joint inflammation
urinary incontinence
intestinal inflammation (also called enterocolitis)
anal abscess
swelling of the nipple
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 or high 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 levels: 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 sensation in fingers of hands and feet (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 when walking (also called intermittent claudication)
signs of narrowing of arteries in 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 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 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, cough, hiccups, rapid breathing
signs of interstitial lung disease: cough, difficulty breathing, painful breathing
signs of pleural 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, 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
inflammation of the thyroid (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 total loss of vision 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, loss of vision
signs of cardiac dysfunction (reduced ejection fraction): tiredness, 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, effort at rest, irregular heartbeat, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling of feet, ankles and abdomen.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nilotinib Accord

This medicine does not require any special storage precautions.
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 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 Accord contains

The active substance is nilotinib.
Each hard capsule contains 50 mg, 150 mg, or 200 mg of nilotinib. The other components are:
Capsule contents: Lactose monohydrate, crospovidone, polysorbate 80 + magnesium aluminium metasilicate, colloidal anhydrous silica, magnesium stearate.
Capsule shell (for 50 mg and 150 mg): Gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).
Capsule shell (for 200 mg): Gelatin, titanium dioxide (E171), iron oxide yellow (E172).
Printing ink (for 50 mg and 150 mg): Shellac, iron oxide black (E172), propylene glycol, potassium hydroxide.
Printing ink (for 200 mg): Shellac, propylene glycol, sodium hydroxide, titanium dioxide (E171), povidone, Allura red AC (E129).

See section 2 “Nilotinib Accord contains lactose, potassium and Allura red AC”.

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

Nilotinib Accord 50 mg is supplied as hard capsules. Opaque red cap and opaque light yellow body hard gelatin capsule (size “4” (approximately 14 mm long), printed with black ink “SML” on the cap and “39” on the body, containing granular powder ranging from white to grey.

Nilotinib Accord 150 mg is supplied as hard capsules. Opaque red cap and opaque red body hard gelatin capsule (size “1” (approximately 19 mm long), printed with black ink “SML” on the cap and “26” on the body, containing granular powder ranging from white to grey.

Nilotinib Accord 200 mg is supplied as hard capsules. Opaque light yellow cap and opaque light yellow body hard gelatin capsule (size “0” (approximately 21 mm long), printed with red ink “SML” on the cap and “27” on the body, containing granular powder ranging from white to grey.

Nilotinib Accord 50 mg hard capsules are available in packs containing 40 hard capsules and in multiple packs containing 120 hard capsules (comprising 3 cartons, each containing 40 hard capsules), or in perforated, divisible unit-dose blisters of 40 x 1 hard capsules and multiple packs of 120 x 1 hard capsules (comprising 3 cartons, each containing 40 x 1 hard capsules).

Nilotinib Accord 150 mg and 200 mg hard capsules are available in packs containing 28 or 40 hard capsules and in multiple packs of 112 hard capsules (comprising 4 cartons, each containing 28 hard capsules), 120 hard capsules (comprising 3 cartons, each containing 40 hard capsules), or 392 hard capsules (comprising 14 cartons, each containing 28 hard capsules), or in perforated, divisible unit-dose blisters of 28 x 1 or 40 x 1 hard capsules and multiple packs of 112 x 1 hard capsules (comprising 4 cartons, each containing 28 x 1 hard capsules), 120 x 1 hard capsules (comprising 3 cartons, each containing 40 x 1 hard capsules), or 392 x 1 hard capsules (comprising 14 cartons, each containing 28 x 1 hard capsules).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6a Planta
08039 Barcelona
Spain

Manufacturers
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Accord Healthcare Polska Sp. z.o.o.
Ul. Lutomierska 50, 95-200,
Pabianice, Poland
APIS Labor GmbH
Resslstraβe 9
9065 Ebenthal in Kärnten, Austria
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64

EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu