NILOTINIB ACCORD 150 mg HARD CAPSULES

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 others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Nilotinib Accord

Nilotinib Accord is a medicine that contains the active substance nilotinib.

What is Nilotinib Accord used for

Nilotinib Accord is used to treat a type of leukaemia called Philadelphia chromosome-positive chronic myeloid leukaemia (CML). CML is a cancer of the blood in which the bone marrow produces too many abnormal white blood cells.

Nilotinib Accord is used in adult and child patients with CML who are newly diagnosed or in patients with CML who are no longer benefiting from previous treatment, including imatinib. It is also used in adult and child patients who have experienced severe side effects with previous treatment and cannot continue it.

How Nilotinib Accord works

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

Monitoring during treatment with Nilotinib Accord

During treatment, regular checks will be carried out, including blood tests. These tests will check:

• the number of blood cells in the body (white blood cells, red blood cells, and platelets) to see if Nilotinib Accord is being tolerated.
• the function of the pancreas and liver to see if Nilotinib Accord is being tolerated.
• the body's electrolytes (potassium, magnesium). These are important for the heart to work properly.
• the level of sugar and fat in the blood.

Your heart rate will also be checked using a machine that measures the electrical activity of the heart (a test called an “ECG”).

Your doctor will regularly assess your treatment and decide if you should continue taking Nilotinib Accord. If your doctor tells you to stop taking this medicine, they will continue to monitor your CML and may tell you to restart treatment with Nilotinib Accord if necessary.

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

2. What you need to know before you take Nilotinib Accord

Follow your doctor’s instructions carefully, even if they are different from the general information contained in this leaflet.

Do not take Nilotinib Accord

• if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, tell your doctor beforetaking Nilotinib Accord.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Nilotinib Accord:

• if you have had heart problems in the past, such as a heart attack, angina, stroke, or poor circulation (peripheral arterial disease).
• if you have a heart condition called “prolonged QT interval”.
• if you are taking medicines that lower cholesterol (statins) or affect heart rhythm (anti-arrhythmics) or liver function.
• if you have low potassium or magnesium levels.
• if you have liver or pancreas problems.
• if you have symptoms such as easy bruising, feeling tired, or difficulty breathing, or if you have had repeated infections.
• if you have had surgery to remove your entire stomach (total gastrectomy).
• if you have ever had or may currently have a hepatitis B infection. This is because Nilotinib Accord could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment.

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

During treatment with Nilotinib Accord

• if you faint (lose consciousness) or have an irregular heartbeat while taking this medicine, tell your doctor immediatelyas this can be a sign of a serious heart problem. Prolonged QT interval or irregular heartbeat can cause sudden death. There have been rare reports of sudden death in patients taking Nilotinib Accord.
• if you experience sudden heart palpitations, severe muscle weakness, or paralysis, seizures, or sudden changes in behavior or level of alertness, tell your doctor immediatelyas this can be a sign of a condition called tumour lysis syndrome. There have been rare reports of tumour lysis syndrome in patients treated with Nilotinib Accord.
• if you develop chest pain or discomfort, numbness or weakness, walking problems, or speech problems, tell your doctor immediatelyas this can be a sign of a cardiovascular event. There have been reports of serious cardiovascular events, including peripheral arterial disease, ischaemic heart disease, and cerebrovascular disease, in patients taking Nilotinib Accord. Your doctor should check your lipid and sugar levels before starting treatment with Nilotinib Accord and during treatment.
• if you develop swelling of the feet or hands, general swelling, or rapid weight gain, tell your doctor as these can be signs of serious fluid retention. There have been rare reports of serious fluid retention in patients treated with Nilotinib Accord.

If you are the parent of a child taking Nilotinib Accord, tell your doctor if any of the above conditions apply to 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 limited experience with the use of Nilotinib Accord in children under 10 years of age who are newly diagnosed and in children under 6 years of age who are not benefiting from previous treatment for CML, including imatinib.

Some children and adolescents taking Nilotinib Accord may have slower than normal growth. Your doctor will monitor growth during regular visits.

Other medicines and Nilotinib Accord

Nilotinib Accord may interfere with some medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include, in particular:

• anti-arrhythmics – used to treat irregular heartbeat;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin – medicines that can affect the heart’s electrical activity;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
• ritonavir – a protease inhibitor 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;
• ciclosporin, sirolimus, and tacrolimus– medicines that suppress the body’s immune system and are used to prevent organ rejection in transplant patients;
• dihydroergotamine and ergotamine– used to treat dementia;
• lovastatin and simvastatin– used to treat high cholesterol;
• warfarin – used to treat blood clotting disorders;
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

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

If you are taking statins (a type of medicine that lowers cholesterol), talk to your doctor or pharmacist. If you take Nilotinib Accord with certain statins, it may increase the risk of muscle problems associated with statins, which can rarely cause serious muscle damage (rhabdomyolysis) that can lead to kidney damage.

Also, tell your doctor or pharmacist before taking Nilotinib Accord if you are taking any antacids, which are medicines used to treat stomach acidity. These medicines should be taken separately from Nilotinib Accord:

• H2 blockers, which reduce stomach acid production. 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 simeticone, which neutralize stomach acidity. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking Nilotinib Accord.

You should also tell your doctor if you are already taking Nilotinib Accordand are prescribed a new medicine that 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 can 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 can increase the amount of Nilotinib Accord in the blood, possibly to a dangerous level.

Pregnancy and breast-feeding

• Nilotinib Accord is not recommended during pregnancyunless clearly necessary. If you are pregnant or think you may be pregnant, tell your doctor, who will discuss with you whether you can take this medicine during pregnancy.
• Women who can become pregnantshould use effective contraception during treatment and for up to 2 weeks after finishing treatment.
• Breast-feeding is not recommendedduring treatment with Nilotinib Accord and for 2 weeks after the last dose. Tell your doctor if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects such as dizziness or vision problems that may affect your ability to drive or use tools or machines after taking this medicine, you should avoid these activities until the effect has stopped.

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 some sugars, contact them before taking this medicine.

Nilotinib Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule; this is essentially “sodium-free”.

Nilotinib Accord contains potassium

This medicine contains potassium, less than 1 mmol (39 mg) per capsule; this is essentially “potassium-free”.

Nilotinib Accord contains Red Allura AC

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

3. How to take Nilotinib Accord

Follow the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

How much Nilotinib Accord to take

Adult use

• Patient with CML who are newly diagnosed:The recommended dose is 600 mg a day. The dose is achieved by taking two 150 mg hard capsules twice a day.
• Patient with CML who are not benefiting from previous treatment:The recommended dose is 800 mg a day. This dose is achieved by taking two 200 mg capsules twice a day.

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 tell you which and how many Nilotinib Accord capsules to give to your child. The total daily dose given to your child should not exceed 800 mg.

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

Elderly patients (65 years of age and over)

Nilotinib Accord can be used in patients 65 years of age and over at the same dose as for other adults.

When to take Nilotinib Accord

Take the hard capsules:

• twice a day (approximately every 12 hours);
• at least 2 hours after eating;
• and then wait 1 hour before eating again.

Ask your doctor or pharmacist if you have any doubts about when to take this medicine. Taking Nilotinib Accord at the same time every 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.
• For patients who have problems swallowing, including paediatric patients who cannot swallow hard capsules, an alternative nilotinib-containing medicine should be used.

How long to take Nilotinib Accord

Take Nilotinib Accord every day for as long as your doctor tells you. This is a long-term treatment. Your doctor will regularly check your condition to see if 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 to take Nilotinib Accord, ask 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 taken 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 miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten hard capsule.

If you stop taking Nilotinib Accord

Do not stop taking this medicine unless your doctor tells you to. Stopping treatment with Nilotinib Accord without your doctor’s advice may put you at risk of your disease getting worse, which could be fatal. Make sure to discuss this with your doctor, nurse, and/or pharmacist if you are thinking of stopping treatment with Nilotinib Accord.

If your doctor tells you to stop taking Nilotinib Accord

Your doctor will regularly assess your treatment and decide if you should continue taking this medicine. If your doctor tells you to stop taking Nilotinib Accord, they will continue to monitor your CML before, during, and after stopping Nilotinib Accord and may tell you to restart treatment with Nilotinib Accord if necessary.

If you have any other 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 all people suffer from them. Most adverse reactions are mild to moderate and usually disappear after a few days or weeks of treatment.

Some adverse reactions can be serious.

• signs of musculoskeletal pain: pain in the joints and muscles
• signs of cardiac disorders: pain or discomfort in the chest, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of rapid heartbeats), fainting, bluish discoloration of the lips, tongue, or skin)
• signs of arterial obstruction: pain, discomfort, weakness, or cramps in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal slowly or not at all, and noticeable changes in color (bluish or pale) or temperature (cold) in the legs, arms, toes, or fingers.
• signs of hypothyroidism: weight gain, fatigue, hair loss, muscle weakness, feeling of cold
• signs of hyperthyroidism: rapid heartbeats, bulging eyes, weight loss, swelling in the front of the neck
• signs of renal or urinary tract disorders: thirst, dry skin, irritability, darkening of urine, decreased urine output, difficulty and pain when urinating, exaggerated need to urinate, blood in the urine, abnormal urine color
• signs of high blood sugar levels: excessive thirst, high urine volume, increased appetite with weight loss, fatigue
• signs of vertigo: dizziness or feeling of spinning
• signs of pancreatitis: severe pain in the upper abdomen (middle or left)
• signs of skin disorders: painful red bumps, skin pain, skin redness, peeling, or blisters
• signs of water retention: rapid weight gain, swelling of hands, ankles, feet, or face
• signs of migraine: severe headache often accompanied by nausea, vomiting, and sensitivity to light
• signs of blood disorders: fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
• signs of blood clotting in a vein: swelling and pain in a part of the body
• signs of nervous system disorders: weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling, or hearing things that do not exist, changes in vision, loss of consciousness, confusion, disorientation, tremors, tingling sensation, pain, or numbness in the fingers of the hands and feet
• signs of pulmonary 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 with blood, black or bloody stools, constipation, acidity, stomach reflux, swollen abdomen
• signs of liver disorders: yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine
• signs of liver infection: recurrence (reactivation of hepatitis B infection)
• signs of eye disorders: visual disturbances including blurred vision, double vision, or flashes of light perceived, decreased sharpness or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching, or irritation, dry eye, swelling, or itching of the eyelids
• signs of electrolyte imbalance: nausea, difficulty breathing, irregular heartbeats, cloudy urine, fatigue, 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 the 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 secretion or congestion, sneezing
• low levels of blood cells (red blood cells, platelets) or hemoglobin
• high levels of lipase in blood (pancreatic function)
• high levels of bilirubin in blood (liver function)
• high levels of alanine aminotransferases 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, abdominal swelling
• pain in the bones, muscle spasms
• pain (including neck pain)
• dry skin, acne, decreased skin sensitivity
• weight gain or loss
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of discomfort
• nosebleeds
• signs of gout: pain and swelling in the joints
• inability to achieve or maintain an erection
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing noises (such as ringing, buzzing) that do not come from any external source (also called tinnitus)
• hemorrhoids
• heavy periods
• itching in the 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
• hot flashes
• signs of peripheral arterial occlusive disease: pain, discomfort, weakness, or cramps in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal slowly or not at all, and noticeable changes in color (bluish or pale) or temperature (cold) in the legs or arms (possible signs of obstruction of an artery in the leg, arm, or toes or fingers)
• difficulty breathing (also called dyspnea)
• mouth sores with gum inflammation (also called stomatitis)
• high levels of amylase in blood (pancreatic function)
• high levels of creatinine in blood (kidney function)
• high levels of alkaline phosphatase or creatine phosphokinase in blood
• high levels of aspartate aminotransferases (liver enzymes) in blood
• high levels of gamma-glutamyltransferase (liver enzymes) in blood
• signs of leucopenia or neutropenia: low level of white blood cells
• increase in the number of platelets or white blood cells in blood
• low levels of magnesium, potassium, sodium, calcium, or phosphorus in blood
• high levels of potassium, calcium, or phosphorus in blood
• high levels of fats in blood (including cholesterol)
• high 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
• muscle and joint stiffness, joint swelling
• feeling of temperature change in the body (including feeling of heat, feeling of cold)
• altered sense of taste
• increased frequency of urination
• signs of stomach lining inflammation: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• memory loss
• skin cyst, thinning or thickening of the skin, thickening of the outer layer of the skin, skin discoloration
• signs of psoriasis: thickened patches of red/silver skin
• increased sensitivity of the skin to light
• difficulty hearing
• joint inflammation
• urinary incontinence
• inflammation of the intestine (also called enterocolitis)
• anal abscess
• swelling of the nipple
• symptoms of restless legs syndrome (an irresistible urge to move a part of the body, 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 levels of white blood cells
• high levels of parathyroid hormone in blood (a hormone that regulates calcium and phosphorus levels)
• high levels of lactate dehydrogenase in blood (an enzyme)
• signs of low blood sugar levels: nausea, sweating, weakness, dizziness, tremors, headache
• dehydration
• abnormal levels of fats in the blood
• involuntary movements (also called tremor)
• difficulty concentrating
• unpleasant and abnormal sensation when touching (also called dysesthesia)
• fatigue (also called tiredness)
• feeling of numbness or tingling in the fingers of the 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 hemorrhage)
• blood in the eyes (also called ocular hemorrhage)
• eye irritation
• signs of heart attack (also called myocardial infarction): sudden and oppressive chest pain, fatigue, irregular heartbeats
• signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
• fungal infection of the feet
• signs of heart failure: shortness of breath, difficulty breathing when lying down, swelling of the feet or legs
• pain behind the breastbone (also called pericarditis)
• signs of hypertensive crisis: severe headache, dizziness, nausea
• pain in the legs and weakness caused by walking (also called intermittent claudication)
• signs of obstruction of the arteries of the limbs: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after performing certain activities such as walking or climbing stairs, numbness or weakness in the legs
• bruises (when you have not injured yourself)
• fat deposits in the arteries that can cause obstruction (also called arteriosclerosis)
• signs of low blood pressure (also called hypotension): dizziness, dizziness, or fainting
• signs of pulmonary edema: shortness of breath
• signs of pleural effusion: accumulation of fluid between the layers of tissue that cover the lungs and the thoracic cavity (which, if severe, can decrease 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 pleurisy: chest pain, painful breathing
• hoarseness
• signs of pulmonary hypertension: high blood pressure in the arteries of the lungs
• wheezing
• sensitivity in the teeth
• signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
• high levels of urea in blood (kidney function)
• change in blood proteins (low level of globulins or presence of paraprotein)
• high levels of unconjugated bilirubin in blood
• high 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 the soles of the feet (called hand-foot syndrome)
• warts in the mouth
• feeling of hardening 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, fatigue
• signs of cerebral artery occlusion: loss of vision in part or all of both eyes, double vision, vertigo (feeling that everything is spinning), 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, loss of vision
• signs of cardiac dysfunction (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
• low or high levels of insulin in blood (a hormone that regulates blood sugar levels)
• low levels of C-peptide of insulin in blood (pancreatic function)
• sudden death

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

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

Reporting of Adverse Effects

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

5. Storage of Nilotinib Accord

• This medicine does not require special storage conditions.
• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging after CAD, and on the blister pack after EXP. The expiration date is 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 should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Nilotinib Accord

• The active substance is nilotinib.

• Each hard capsule contains 50 mg, 150 mg, and 200 mg of nilotinib.

The other components are:

Capsule content: Lactose monohydrate, Crospovidone, Polysorbate 80 + Magnesium aluminometasilicate, Colloidal anhydrous silica, Magnesium stearate.

Capsule shell (for 50 mg and 150 mg): Gelatin, Titanium dioxide (E171), Red iron oxide (E172), Yellow iron oxide (E172).

Capsule shell (for 200 mg): Gelatin, Titanium dioxide (E171), Yellow iron oxide (E172).

Printing ink (for 50 mg and 150 mg): Shellac, Black iron oxide (E172), Propylene glycol, and Potassium hydroxide.

Printing ink (for 200 mg): Shellac, Propylene glycol, Sodium hydroxide, Titanium dioxide (E171), Povidone, and Red Allura AC.

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

Appearance of Nilotinib Accord and Container Content

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, "SML" printed in black ink on the cap and "39" on the body, containing a granulated powder of white to gray color.

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, "SML" printed in black ink on the cap and "26" on the body, containing a granulated powder of white to gray color.

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, "SML" printed in black ink on the cap and "27" on the body, containing a granulated powder of white to gray color.

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

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

Only some 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

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

Resslstraße 9

9065 Ebenthal in Kärnten, Austria

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

For further information about this medicinal product, 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

Date of the last revision of this leaflet: August 2024

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