Nilotinib Accord 200 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

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

nilotinib

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the 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 Nilotinib Accord is

Nilotinib Accord is a medicine that contains an active substance called nilotinib.

What Nilotinib Accord is used for

Nilotinib Accord is used to treat a type of leukemia called Philadelphia chromosome-positive chronic myeloid leukemia (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 pediatric patients with newly diagnosed CML or in patients with CML who are no longer benefiting from prior therapy, including imatinib. It is also used in adult and pediatric patients who have experienced severe adverse reactions to prior therapy and who cannot continue using it.

How Nilotinib Accord works

In patients with CML, a change in DNA (genetic material) generates a signal that causes the body to produce abnormal white blood cells. Nilotinib Accord blocks this signal and thereby interrupts the production of these cells.

Monitoring during treatment with Nilotinib Accord

During treatment, regular monitoring will be performed, including blood tests. These tests will monitor:

the number of blood cells in the body (white blood cells, red blood cells, and platelets) to assess whether Nilotinib Accord is well tolerated.
the function of the pancreas and liver to assess whether Nilotinib Accord is well tolerated.
the body's electrolytes (potassium, magnesium), which are important for heart function.
blood sugar and fat levels.

Your heart rate will also be monitored using a machine 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 Accord. If your doctor advises you to stop this medicine, they will continue to monitor your CML and, if necessary, may instruct you to restart treatment with Nilotinib Accord.

If you have any questions about how Nilotinib Accord works or why it has been prescribed for you or your child, please consult your doctor.

2. What you need to know before taking Nilotinib Accord

Carefully follow all instructions from your doctor, even if they 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 may be allergic, inform your doctor before taking Nilotinib Accord.

Warnings and precautions

Talk to your doctor or pharmacist before starting Nilotinib Accord:

if you have previously had cardiovascular events such as a heart attack, chest pain (angina), problems with blood supply to your brain (stroke), or problems with blood flow to your leg (claudication), or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes, or problems with fat levels in your blood (lipid abnormalities).
if you have a heart condition, such as an abnormal electrical signal called "QT interval prolongation".
if you are receiving treatment with medications that lower cholesterol in the blood (statins) or affect heart rhythm (antiarrhythmics) or the liver (see Use of Nilotinib Accord with other medicines).
if you have low potassium or magnesium levels.
if you have a liver or pancreatic disorder.
if you experience symptoms such as easy bruising, feeling tired, difficulty breathing, or have had repeated infections.
if you have undergone surgery involving complete removal of the stomach (total gastrectomy).
if you have ever had or may currently have a hepatitis B virus infection. This is because Nilotinib Accord could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.

If any of these situations apply to you or your child, inform your doctor.

During treatment with Nilotinib Accord

if you faint (lose consciousness) or have an irregular heartbeat while taking this medicine, inform your doctor immediately, as this may be a sign of a serious heart problem. QT interval prolongation or irregular heart rhythm can lead to sudden death. Rare cases of sudden death have been reported in patients taking Nilotinib Accord.
if you experience sudden palpitations, severe muscle weakness or paralysis, seizures, or sudden changes in behavior or alertness, inform your doctor immediately, as this may be a sign of rapid breakdown of cancer cells known as tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with Nilotinib Accord.
if you develop chest pain or discomfort, numbness or weakness, walking or speech difficulties, pain, discoloration, or cold sensation in a limb, inform your doctor immediately, as this may indicate a cardiovascular event. Cases of serious cardiovascular events, including problems with blood flow to the leg (peripheral arterial occlusive disease), ischemic heart disease, and impaired blood supply to the brain (cerebrovascular ischemia), have been reported in patients taking Nilotinib Accord. Your doctor should assess your blood fat (lipid) and sugar levels before starting and during treatment with Nilotinib Accord.
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. Rare cases of severe fluid retention have been reported in patients treated with Nilotinib Accord.

If you are the parent of a child receiving treatment with Nilotinib Accord, inform the doctor if any of the above conditions occur in your child.

Children and adolescents

Nilotinib Accord is used to treat 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 children under 6 years of age who did not benefit from prior treatment for CML, including imatinib.

Some children and adolescents receiving Nilotinib Accord may grow more slowly than normal. Your doctor will monitor growth during regular visits.

Other medicines and Nilotinib Accord

Nilotinib Accord may interact with certain medicines.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. These include, 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" group used to treat HIV;
carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;
rifampicin – used to treat tuberculosis;
St. John’s wort – a plant-derived product used to treat depression and other conditions (also known as Hypericum perforatum);
midazolam – used to relieve anxiety before surgery;
alfentanil and fentanyl – used for pain treatment and as sedatives before or during surgery or medical procedures;
cyclosporine, sirolimus, and tacrolimus – medicines that suppress the body’s "self-defense" ability and fight infections, often used to prevent rejection of transplanted organs such as liver, heart, or kidney;
dihydroergotamine and ergotamine – used to treat dementia;
lovastatin, simvastatin – used to treat high blood fat levels;
warfarin – used to treat clotting disorders (such as blood clots or thrombosis);
astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

The use of these medicines should be avoided during treatment with Nilotinib Accord. If you are taking any of these drugs, your doctor may prescribe alternative medicines.

If you are taking statins (a type of medicine that lowers blood cholesterol), speak with your doctor or pharmacist. Taking Nilotinib Accord with certain statins may increase the risk of statin-related muscle problems, which in rare cases can lead to severe muscle breakdown (rhabdomyolysis) that may result in kidney damage.

Additionally, inform your doctor or pharmacist before taking Nilotinib Accord if you are taking any antacids, which are medicines for stomach acidity. These medicines should 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 are prescribed a new medicine you have not taken before during treatment with Nilotinib Accord.

Taking Nilotinib Accord with food and drink

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

Pregnancy and breastfeeding

Nilotinib Accord is not recommended during pregnancy unless clearly necessary. If you are pregnant or think you might be, inform your doctor, who will discuss with you whether you can take this medicine during pregnancy.
Women who can become pregnant should use highly effective 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 or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

If you experience side effects (such as dizziness or vision problems) that may affect your ability to drive safely or operate tools or machinery after taking this medicine, you should avoid these activities until the effects have passed.

Nilotinib Accord contains lactose (as monohydrate)

This medicine contains lactose (also known as milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Nilotinib Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule; hence, it is essentially "sodium-free".

Nilotinib Accord contains potassium

This medicine contains potassium, less than 1 mmol (39 mg) per capsule; hence, it is essentially "potassium-free".

Nilotinib Accord contains Allura Red AC

This medicine contains Allura Red AC, which may cause allergic-type reactions.

3. How to take Nilotinib Accord

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 with CML who did not benefit from their previous treatment: The recommended dose is 800 mg daily. This dose is achieved by taking two 200 mg capsules twice daily.

Use in children and adolescents

The dose given to your child will depend on their body weight and height. The doctor will calculate the correct dose and will tell you which capsules and how many capsules of Nilotinib Accord to give your child. The total daily dose given to your child must not exceed 800 mg.

Your doctor may prescribe you a lower dose depending on how you respond to treatment.

Elderly patients (aged 65 years and older)

Nilotinib Accord may be used in patients aged 65 years and older at the same dose as other adults.

When to take Nilotinib Accord

Take the hard capsules:

twice daily (approximately every 12 hours);
at least 2 hours after eating food;
and wait 1 hour before eating again.

Consult your doctor or pharmacist if you have any doubts about when to take this medicine. 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 take any food with the hard capsules.
Do not open the hard capsules except if 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 apart from apple sauce.

How long to take Nilotinib Accord

Take Nilotinib Accord every day for as long as your doctor tells you to. This is a long-term treatment. Your doctor will monitor your condition periodically to check that the treatment is having the desired effect.

Your doctor may consider stopping your treatment with Nilotinib Accord based on specific criteria. If you have any doubts about how long you should take Nilotinib Accord, consult your doctor.

If you take more Nilotinib Accord than you should

If you have taken more Nilotinib Accord than you should, or if someone accidentally takes your hard capsules, contact a doctor or hospital immediately. Show the pack of hard capsules and this leaflet. You may need medical treatment.

If you forget to take Nilotinib Accord

If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for the forgotten hard capsule.

If you stop taking Nilotinib Accord

Do not stop treatment with this medicine unless your doctor tells you to. Stopping treatment with Nilotinib Accord without your doctor's recommendation puts you at risk of worsening of your disease, which could have fatal consequences. Be sure to discuss this with your doctor, nurse and/or pharmacist if you are considering stopping treatment with Nilotinib Accord.

If your doctor recommends stopping treatment with Nilotinib Accord

Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether you should continue taking this medicine. If your doctor tells you to stop Nilotinib Accord, they will continue to monitor your CML before, during, and after stopping Nilotinib Accord, and if necessary, may instruct you to restart treatment with Nilotinib Accord.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most adverse reactions are mild to moderate and usually disappear after a few days or weeks of treatment.

Some adverse reactions may be serious.

signs of musculoskeletal pain: joint and muscle pain
signs of cardiac disorders: 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, which may be due to reduced blood flow; leg ulcers or arms healing slowly or not healing; and noticeable changes in color (bluish or pale) or temperature (cold) in the legs, arms, toes, or fingers affected
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 at the front of the neck
signs of kidney or urinary tract disorders: thirst, dry skin, irritability, darkening of urine, decreased urine output, difficulty and pain when urinating, strong urge to urinate, blood in urine, abnormal urine color
signs of high blood sugar levels: excessive thirst, increased urine volume, increased appetite with weight loss, tiredness
signs of dizziness: dizziness or spinning sensation
signs of pancreatitis: severe pain in the upper abdomen (middle or left side)
signs of skin disorders: painful red lumps, skin pain, skin redness, peeling, or blisters
signs of fluid retention: rapid weight gain, swelling of hands, ankles, feet, or face
signs of migraine: severe headache often accompanied by nausea, vomiting, and light sensitivity
signs of blood disorders: fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
signs of blood clot in a vein: 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, feeling, or hearing things that are not there, vision changes, loss of consciousness, confusion, disorientation, tremors, tingling, pain, or numbness in fingers or toes
signs of lung disorders: difficulty breathing or pain when breathing, cough, wheezing with or without fever, swelling of feet or legs
signs of gastrointestinal disorders: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, stomach reflux, bloated abdomen
signs of liver disorders: yellowing of the skin and eyes, nausea, loss of appetite, dark urine
signs of liver infection: recurrence (reactivation of hepatitis B infection)
signs of eye disorders: visual disturbances including blurred vision, double vision, or perceived flashes of light, reduced sharpness or loss of vision, blood in the eye, increased eye sensitivity to light, eye pain, redness, itching or irritation, dry eyes, swelling or itching of the eyelids
signs of electrolyte imbalance: nausea, difficulty breathing, irregular heartbeat, cloudy urine, tiredness and/or joint discomfort 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 adverse effects described.

Some adverse reactions are very common (may affect more than 1 in 10 patients)

diarrhea
headache
lack of energy
muscle pain
itching, rash
nausea
constipation
vomiting
hair loss
pain in limbs, bone pain, and spinal pain when stopping treatment with Nilotinib Accord
slowed growth in children and adolescents
upper respiratory tract infection, including sore throat and nasal discharge or congestion, sneezing
low levels of blood cells (red blood cells, platelets) or hemoglobin
elevated levels of lipase in blood (pancreatic function)
elevated levels of bilirubin in blood (liver function)
elevated levels of alanine aminotransferase in blood (liver enzymes)

Some adverse reactions are common (may affect up to 1 in 10 patients)

pneumonia
abdominal pain, stomach discomfort after meals, flatulence, bloating of the abdomen
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, decreased skin sensitivity
weight gain or weight loss
insomnia, depression, anxiety
night sweats, excessive sweating
general feeling of discomfort
nosebleeds
signs of gout: joint pain and swelling
inability to achieve or maintain an erection
flu-like symptoms
sore throat
bronchitis
ear pain, hearing noises (e.g., ringing, buzzing) not coming from an external source (also called tinnitus)
hemorrhoids
heavy menstrual periods
itching in hair follicles
oral or vaginal candidiasis
signs of conjunctivitis: itchy eye discharge, redness, and swelling
eye irritation, red eyes
signs of hypertension: high blood pressure, headache, dizziness
hot flushes
signs of peripheral arterial occlusive disease: pain, discomfort, weakness, or cramps in leg muscles, possibly due to reduced blood flow; leg or arm ulcers healing slowly or not healing; and noticeable changes in color (bluish or pale) or temperature (cold) in legs or arms (possible signs of blockage in an artery of the leg, arm, or affected toes or fingers)
difficulty breathing (also called dyspnea)
mouth sores with inflamed gums (also called stomatitis)
elevated levels of amylase in blood (pancreatic function)
elevated levels of creatinine in blood (kidney function)
elevated levels of alkaline phosphatase or creatine phosphokinase in blood
elevated levels of aspartate aminotransferase (liver enzymes) in blood
elevated levels of gamma-glutamyltransferase (liver enzymes) in blood
signs of leukopenia or neutropenia: low white blood cell count
increased number of platelets or white blood cells in blood
low levels of magnesium, potassium, sodium, calcium, or phosphorus in blood
increased levels of potassium, calcium, or phosphorus in blood
elevated blood fat levels (including cholesterol)
elevated levels of uric acid in blood

Some adverse reactions are uncommon (may affect up to 1 in 100 patients)

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 temperature change in the body (including feeling hot or cold)
altered sense of taste
increased frequency of urination
signs of inflammation of the stomach lining: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
memory loss
skin cyst, thinning or thickening of the skin, thickening of the outermost skin layer, skin discoloration
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
swelling of the nipple
symptoms of restless legs syndrome (an irresistible urge to move a body part, usually the leg, accompanied by uncomfortable sensations)
signs of sepsis: fever, chest pain, increased heart rate, difficulty breathing or rapid breathing
skin infection (subcutaneous abscess)
skin wart
increase in a specific type of white blood cell (called eosinophils)
signs of lymphopenia: low white blood cell count
elevated levels of parathyroid hormone in blood (a hormone regulating calcium and phosphorus levels)
elevated levels of lactate dehydrogenase in blood (an enzyme)
signs of low blood sugar: nausea, sweating, weakness, dizziness, tremors, headache
dehydration
abnormal blood fat levels
involuntary movements (also called tremor)
difficulty concentrating
unpleasant or abnormal sensation when touching (also called dysesthesia)
tiredness (also called fatigue)
numbness or tingling in fingers or toes (also called peripheral neuropathy)
paralysis of any facial muscle
red spot on the white of the eye caused by 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, tiredness, irregular heartbeat
signs of heart murmur: tiredness, chest discomfort, dizziness, chest pain, palpitations
fungal infection of the feet
signs of heart failure: dyspnea, 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 arterial occlusion in limbs: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after certain activities such as walking or climbing stairs, numbness or weakness in legs
bruising (when no injury has occurred)
fat deposits in arteries that may cause blockage (also called atherosclerosis)
signs of low blood pressure (also called hypotension): lightheadedness, dizziness, or fainting
signs of pulmonary edema: dyspnea
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, pain when 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
tooth sensitivity
signs of inflammation (also called gingivitis): bleeding gums, sensitive or enlarged gums
elevated levels of urea in blood (kidney function)
changes in blood proteins (low globulin levels or presence of paraprotein)
elevated levels of unconjugated bilirubin in blood
elevated levels of troponins in blood

Some adverse reactions are rare (may affect up to 1 in 1,000 patients)

redness and/or swelling and possibly peeling of the palms of the hands and soles of the feet (called hand-foot syndrome)
warts in the mouth
sensation of hardness or stiffness in the breasts
inflammation of the thyroid gland (also called thyroiditis)
altered or depressed mood
signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, tiredness
signs of blockage of brain arteries: loss of vision in part or all of both eyes, double vision, vertigo (spinning sensation), 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): tiredness, chest discomfort, dizziness, pain, palpitations
low or high insulin levels in blood (a hormone regulating blood sugar levels)
low levels of insulin C-peptide in blood (pancreatic function)
sudden death

The following adverse reactions have been reported with unknown frequency (cannot be estimated from available data):

signs of cardiac dysfunction (ventricular dysfunction): difficulty breathing, breathlessness at rest, irregular heartbeat, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling in feet, ankles, and abdomen.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nilotinib Accord

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP, and on the blister after CAD. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nilotinib Accord

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 aluminometasilicate, 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.

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

Appearance of Nilotinib Accord and contents of the pack

Nilotinib Accord 50 mg is presented as hard capsules. The hard gelatin capsules are size “4” (approximately 14 mm in length) with an opaque red cap and an opaque light yellow body, printed with “SML” in black ink on the cap and “39” on the body, containing a granular powder ranging from whitish to grey in colour.

Nilotinib Accord 150 mg is presented as hard capsules. The hard gelatin capsules are size “1” (approximately 19 mm in length) with an opaque red cap and an opaque red body, printed with “SML” in black ink on the cap and “26” on the body, containing a granular powder ranging from whitish to grey in colour.

Nilotinib Accord 200 mg is presented as hard capsules. The hard gelatin capsules are size “0” (approximately 21 mm in length) with an opaque light yellow cap and an opaque light yellow body, printed with “SML” in black ink on the cap and “27” on the body, containing a granular powder ranging from whitish to grey in colour.

Nilotinib Accord 50 mg is available in packs containing 40 hard capsules and in multipacks containing 120 hard capsules (3 packs of 40 hard capsules each), or in perforated unit dose blisters of 40 × 1 hard capsules and in multipacks of 120 × 1 hard capsules (3 packs of 40 × 1 hard capsules each).

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Manufacturer

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 more information about this medicine, contact the local representative of the Marketing Authorisation 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

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of the most recent revision of this leaflet: August 2024

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.