Patient Information Leaflet

Nilotinib Accord 50mg Hard Capsules

Nilotinib Accord 150mg Hard Capsules

Nilotinib Accord 200mg Hard Capsules

nilotinib

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

What is Nilotinib Accord

Nilotinib Accord is a medication that contains an active ingredient called nilotinib.

What is Nilotinib Accord used for

Nilotinib Accord is used to treat a type of leukemia called chronic myeloid leukemia with Philadelphia chromosome positive (CML Ph-positive). CML is a blood cancer that causes the body to produce an excess of abnormal white blood cells.

Nilotinib Accord is used in adult and pediatric patients with newly diagnosed CML or in patients with CML who no longer benefit from previous treatment, including imatinib..It is also used in adult and pediatric patients who have experienced severe adverse effects with previous treatment and 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 therefore interrupts the production of these cells.

Monitoring during Nilotinib Accord treatment

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

• the amount of blood cells in the body (white blood cells, red blood cells, and platelets) to check if Nilotinib Accord is well tolerated.
• the function of the pancreas and liver of the body to check if Nilotinib Accord is well tolerated.
• the body's electrolytes (potassium, magnesium). These are important for heart function.
• the level of sugar and fats in the blood.

Heart rate will also be monitored using a machine that measures the heart's electrical activity (an ECG test).

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

If you have any questions about how Nilotinib Accord works or the reason why you or your child have been prescribed this medication, consult your doctor.

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

Do not take Nilotinib Accord

-if you areallergicto nilotinib or to any of the other components of this medication (listed in section6).

If you think you may be allergic, inform your doctorbeforetaking Nilotinib Accord.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nilotinib Accord:

• if you have had previous 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 diseases such as high blood pressure (hypertension), diabetes or problems with lipid levels in your blood.
• if you have aheart condition, such as an abnormal electrical signal called«prolongation of the QT interval».
• if you are receivingmedicationsthat lower cholesterol in the blood (statins) or that affect heart rhythm (antiarrhythmics) or the liver (seeUse of Nilotinib Accord withothermedications).
• if you have a lack of potassium or magnesium.
• if you have a liver or pancreas disorder.
• if you have symptoms such as easy bruising, fatigue or difficulty breathing or have had repeated infections.
• if you have had a surgical procedure that involved the complete removal of the stomach (total gastrectomy).
• if you have ever had or may have a hepatitis B virus infection at this time. This is because Nilotinib Accord may reactivate hepatitis B, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.

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

During treatment with Nilotinib Accord

• if you experience a fainting spell (loss of consciousness) or have an irregular heart rhythm while taking this medication,inform your doctor immediatelyas this may be a sign of a serious heart problem. Prolongation of the QT interval or irregular heart rhythm may cause sudden death. There have been rare cases of sudden death in patients taking Nilotinib Accord.
• if you experience sudden palpitations, severe muscle weakness or paralysis, convulsions or sudden changes in behavior or level of alertness,inform your doctor immediatelyas this may be a sign of a rapid breakdown of cancer cells called tumor lysis syndrome. There have been rare cases of tumor lysis syndrome in patients treated with Nilotinib Accord.
• if you develop chest pain or discomfort, numbness or weakness, walking or speech problems, pain, discoloration or coldness in a limb,inform your doctor immediatelyas this may be a sign of a cardiovascular event. There have been reports of severe cardiovascular events including peripheral arterial occlusive disease, coronary artery disease and cerebral ischemia in patients taking Nilotinib Accord. Your doctor should evaluate your lipid and blood sugar levels before starting treatment with Nilotinib Accord and during treatment.
• if you develop swelling of the feet or hands, generalized swelling or rapid weight gain, inform your doctor as these may be signs of severe fluid retention. There have been rare cases of severe fluid retention in patients treated with Nilotinib Accord.

If you are the parents of a child being treated with Nilotinib Accord, inform your doctor if any of the conditions described above 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 medication in children under 2years of age. There is no experience with the use ofNilotinib Accordin children under 10years of age with a new diagnosis and there is limited experience in children under 6years of age with patients who did not benefit from previous treatment for CML, including imatinib.

Some children and adolescents being treated with Nilotinib Accord may experience slower than normal growth. Your doctor will monitor growth during regular visits.

Other medications and Nilotinib Accord

Nilotinib Accord may interact with other medications.

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. These include, in particular:

• antiarrhythmics – used to treat irregular heart rhythm;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin‑medications that may have an undesirable effect on the heart's electrical activity;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
• ritonavir – a medication in the group of«protease inhibitors» used to treat HIV;
• carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;
• rifampicin – used to treat tuberculosis;
• St. John's Wort – a product derived from plants used to treat depression and other conditions (also known as Hypericum perforatum);
• midazolam – used to alleviate anxiety before surgery;
• alfentanil and fentanyl– used to treat pain and as sedatives before or during surgery or medical procedures;
• ciclosporin, sirolimus and tacrolimus– medications that suppress the body's ability to “self‑defend” and fight infections and are often used to prevent organ transplant rejection such as the liver, heart or kidney;
• dihydroergotamine and ergotamine– used to treat dementia;
• lovastatin, simvastatin– used to treat high levels of cholesterol in the blood;
• warfarin – used to treat blood clotting disorders (such as blood clots or thrombosis);
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine).

You should avoid using these medications during treatment with Nilotinib Accord. If you are taking any of these medications, your doctor may prescribe alternative medications.

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

Also, inform your doctor or pharmacist before taking Nilotinib Accord if you are taking any antacids, which are medications for stomach acid. These medications should be taken separately from Nilotinib Accord:

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

You should also inform your doctorif you are already taking Nilotinib Accordand are prescribed a new medication that you have not taken before during treatment with Nilotinib Accord.

Taking Nilotinib Accord with food and drinks

Do not take Nilotinib Accord with meals.Foods 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, possibly to a dangerous level.

Pregnancy and breastfeeding

• Nilotinib Accord is not recommended during pregnancyunless it is clearly necessary. If you are pregnant or think you may be pregnant, inform your doctor, who will discuss with you whether you can take this medication during pregnancy.
• Women who may become pregnantshould use very effective contraception during treatment and for two weeks after completing treatment.
• Nilotinib Accord is not recommended during breastfeedingduring treatment and for two weeks after the last dose. Inform your doctor if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Nilotinib Accord contains lactose (as monohydrate)

This medication 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 medication.

Nilotinib Accord contains sodium

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

Nilotinib Accord contains potassium

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

Nilotinib Accord contains Red Allura AC

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much Nilotinib Accord to take

Use in adults

• Patients with newly diagnosed LMC:The recommended dose is 600mg per day. The dose is achieved by taking two hard capsules of 150mg, twice a day.
• Patients with LMC who did not benefit from their previous treatment:The recommended dose is 800mg per day. This dose is achieved by taking two capsules of 200mg twice a day.

Use in children and adolescents

• The dose given to your child will depend on their body weight and height. Your doctor will calculate the correct dose to use and will indicate which and how many Nilotinib Accord capsules to give to your child. The total daily dose given to your child should not exceed 800mg.

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

Patients aged 65years and older

Nilotinib Accord can be used in patients aged 65years and older at the same dose as the rest of adults.

When to take Nilotinib Accord

Take the hard capsules:

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

Consult your doctor or pharmacist if you have any doubts about when to take this medication. Taking Nilotinib Accord every day at the same time 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 trouble swallowing, including pediatric patients who cannot swallow the hard capsules, another suitable medication containing nilotinib should be used.

For how long to take Nilotinib Accord

Take Nilotinib Accord every day for the time your doctor tells you. This is a long-term treatment. Your doctor will monitor your situation 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 else accidentally takes your hard capsules, contact a doctor or hospital quickly. Show the box 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 missed capsule.

If you interrupt treatment with Nilotinib Accord

Do not stop treatment with this medication unless your doctor tells you to. Stopping treatment with Nilotinib Accord without your doctor's recommendation puts you at risk of worsening your disease, which could have fatal consequences. Make sure to discuss it with your doctor, nurse, and/or pharmacist if you are thinking of 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 medication. If they tell you to stop Nilotinib Accord, they will continue to monitor your LMC before, during, and after stopping Nilotinib Accord, and if necessary, they may recommend that you restart treatment with Nilotinib Accord.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Some side effects can be serious.

• Musculoskeletal pain signs: joint and muscle pain
• Cardiac disorder signs: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (sensation of rapid heartbeat), dizziness, blue discoloration of the lips, tongue, or skin
• Artery obstruction signs: pain, discomfort, weakness, or cramps in the muscles of the legs, which may be due to decreased blood flow, ulcers in the legs or arms that heal slowly or not at all, and notable changes in color (blue or pale) or temperature (cold) in the legs, arms, affected fingers, or hands
• Subclinical hypothyroidism signs: weight gain, fatigue, hair loss, muscle weakness, sensation of cold
• Hyperthyroidism signs: rapid heartbeat, bulging eyes, weight loss, swelling in the front of the neck
• Renal or urinary tract disorder signs: thirst, dry skin, irritability, dark urine, decreased urine output, difficulty and pain urinating, excessive need to urinate, blood in the urine, abnormal urine color
• High blood sugar signs: excessive thirst, high urine volume, increased appetite with weight loss, fatigue
• Dizziness signs: dizziness or sensation of spinning
• Pancreatitis signs: intense pain in the upper abdomen (middle or left)
• Skin disorder signs: painful red bumps, skin pain, skin redness, peeling, or blisters
• Water retention signs: rapid weight gain, swelling of hands, ankles, feet, or face
• Migraine signs: intense headache often accompanied by nausea, vomiting, and light sensitivity
• Blood disorder signs: fever, easy bruising or bleeding, unexplained bleeding, frequent or severe infections, unexplained weakness
• Coagulation within a vein signs: swelling and pain in a part of the body
• Nervous system disorder signs: weakness or paralysis of the limbs or face, difficulty speaking, intense headache, seeing, feeling, or hearing things that do not exist, changes in vision, loss of consciousness, confusion, disorientation, tremors, numbness, pain, or tingling in the fingers of the hands or feet
• Pulmonary disorder signs: difficulty breathing or chest pain, cough, wheezing with or without fever, swelling of the feet or legs
• Gastrointestinal disorder signs: abdominal pain, nausea, vomiting with blood, black or bloody stools, constipation, heartburn, acid reflux, swollen abdomen
• Liver disorder signs: yellow skin and eyes, nausea, loss of appetite, dark urine
• Reactivation of hepatitis B infection signs
• Eye disorder signs: visual disturbances including blurry vision, double vision, or flashes of light, decreased sharpness or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching, dryness, or swelling of the eyelids
• Electrolyte imbalance signs: nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal blood test results (such as high potassium, uric acid, and phosphate levels and low calcium levels)

Contact your doctor immediately if you notice any of the side effects described.

Some side effects are very common(may affect more than 1 in 10patients)

• Diarrea
• Headache
• Lack of energy
• Muscle pain
• Itching, rash
• Nausea
• Constipation
• Vomiting
• Hair loss
• Pain in the limbs, bone pain, and back pain when stopping Nilotinib Accord treatment
• Slowed growth in children and adolescents
• Upper respiratory tract infection, including sore throat and nasal discharge, sneezing
• Low levels of blood cells (red blood cells, platelets) or hemoglobin
• High levels of lipase in the blood (pancreatic function)
• High levels of bilirubin in the blood (liver function)
• High levels of alanine aminotransferases in the blood (liver enzymes)

Some side effects are common(may affect up to 1 in 10patients)

• Pneumonia
• Abdominal pain, stomach discomfort after meals, flatulence, abdominal swelling
• Bone pain, muscle spasms
• Pain (including neck pain)
• Dry skin, acne, decreased skin sensitivity
• Weight gain or loss
• Insomnia, depression, anxiety
• Nocturnal sweating, excessive sweating
• General feeling of discomfort
• Nasal bleeding
• Gout signs: joint pain and swelling
• Impotence
• Influenza-like symptoms
• Sore throat
• Bronchitis
• Ear pain, hearing ringing sounds (e.g., tinnitus)
• Hemorrhoids
• Heavy periods
• Itching on hair follicles
• Oral or vaginal candidiasis
• Conjunctivitis signs: eye discharge with itching, redness, and swelling
• Eye irritation, red eyes
• Hypertension signs: high blood pressure, headache, dizziness
• Angina
• Peripheral artery disease signs: pain, discomfort, weakness, or cramps in the muscles of the legs, which may be due to decreased blood flow, ulcers in the legs or arms that heal slowly or not at all, and notable changes in color (blue or pale) or temperature (cold) in the legs or arms (possible signs of obstruction of a leg, arm, or foot artery)
• Dyspnea (difficulty breathing)
• Mouth sores with inflammation of the gums (stomatitis)
• High levels of amylase in the blood (pancreatic function)
• High levels of creatinine in the blood (renal function)
• High levels of alkaline phosphatase or creatine phosphokinase in the blood
• High levels of aspartate aminotransferases in the blood (liver enzymes)
• High levels of gamma-glutamyltransferases in the blood (liver enzymes)
• Leukopenia or neutropenia signs: low white blood cell count
• Increased number of platelets or white blood cells in the blood
• Low levels of magnesium, potassium, sodium, calcium, or phosphate in the blood
• High levels of potassium, calcium, or phosphate in the blood
• High levels of lipids in the blood (including cholesterol)
• High levels of uric acid in the blood

Some side effects are uncommon(may affect up to 1 in 100patients)

• Allergy (hypersensitivity to Nilotinib Accord)
• Dry mouth
• Breast pain
• Pain or discomfort in the side
• Increased appetite
• Male breast enlargement
• Herpes virus infection
• Muscle stiffness and joint swelling, joint pain
• Sensation of body temperature change (including feeling hot or cold)
• Altered sense of taste
• Increased frequency of urination
• Signs of gastric mucosal inflammation: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• Memory loss
• Cutaneous cyst, skin thinning or thickening, skin thickening, skin discoloration
• Psoriasis signs: thickened, red, or silvery patches on the skin
• Increased skin sensitivity to light
• Difficulty hearing
• Joint inflammation
• Urinary incontinence
• Enterocolitis (inflammation of the intestine)
• Anal abscess
• Nipple swelling
• Restless leg syndrome symptoms (irresistible urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
• Sepsis signs: fever, chest pain, rapid heartbeat, difficulty breathing or rapid breathing
• Skin infection (subcutaneous abscess)
• Wart on the skin
• Increased eosinophils (a type of white blood cell)
• Signs of lymphopenia: low white blood cell count
• High levels of parathyroid hormone in the blood (a hormone that regulates calcium and phosphate levels)
• High levels of lactate dehydrogenase in the blood (an enzyme)
• Signs of low blood sugar: nausea, sweating, weakness, dizziness, tremors, headache
• Dehydration
• Abnormal lipid levels in the blood
• Involuntary movements (also called tremor)
• Difficulty concentrating
• Unpleasant and abnormal sensation when touching (also called dysesthesia)
• Fatigue (also called fatigue)
• Numbness or tingling in the fingers of the hands or 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 myocardial infarction (heart attack): sudden and oppressive chest pain, fatigue, irregular heartbeat
• Signs of heart murmur: fatigue, chest pain, dizziness, pain, palpitations
• Fungal infection of the feet
• Signs of heart failure: dyspnea, difficulty breathing when lying down, swelling of the feet or legs
• Pain behind the sternum (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 extremity artery occlusion: 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 the legs
• Hematomas (when you haven't been injured)
• Deposits of fat 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: dyspnea
• Signs of pleural effusion: accumulation of fluid between the layers of tissue that surround the lungs and the chest cavity (which, if severe, can reduce the heart's ability to pump blood), chest pain, cough, hiccups, rapid breathing
• Signs of interstitial lung disease: cough, difficulty breathing, chest pain
• Signs of pleurisy: cough, painful breathing
• Hoarseness
• Signs of pulmonary hypertension: high blood pressure in the pulmonary arteries
• Wheezing
• Sensitivity in the teeth
• Signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
• High levels of urea in the blood (renal function)
• Change in blood proteins (low globulin levels or presence of paraprotein)
• High levels of unconjugated bilirubin in the blood
• High levels of troponins in the blood

Some side effects are rare(may affect up to 1 in 1,000patients)

• Redness and/or swelling and possibly peeling of the palms of the hands and soles of the feet (also called hand-foot syndrome)
• Warts in the mouth
• Sensation of breast hardness or stiffness
• Thyroid gland inflammation (also called thyroiditis)
• Altered mood or depression
• 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, dizziness (sensation of spinning), numbness or tingling, loss of coordination, dizziness, or confusion
• Swelling of the brain (possible headache and/or changes in mental state)
• Signs of optic neuritis: blurry vision, loss of vision
• Signs of heart dysfunction (reduced ejection fraction): fatigue, chest pain, dizziness, pain, palpitations
• Low or high insulin levels in the blood (a hormone that regulates blood sugar levels)
• Low levels of proinsulin C-peptide in the blood (pancreatic function)
• Sudden death

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

• Signs of heart dysfunction (ventricular dysfunction): difficulty breathing, exertion at rest, irregular heartbeat, chest pain, dizziness, pain, palpitations, excessive urination, swelling of the feet, ankles, and abdomen.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directlythrough the national notification system included in theAppendix V. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

• This medication does not require special storage conditions.
• Keep this medication out of the sight and reach of children.
• Do not use this medication 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 medication if you observe that the packaging is damaged or shows signs of manipulation.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Nilotinib Accord

• The active ingredient is nilotinib.

• Cada cápsula dura contiene 50mg, 150 mg y 200 mg de nilotinib.

The other components are:

Content of the capsule: Lactose monohydrate, Crospovidone, Polisorbate 80 + Magnesium aluminosilicate, Colloidal anhydrous silica, Magnesium stearate.

Capsule coating (for 50mg and 150 mg): Gelatin, Titanium dioxide (E171), Iron oxide red (E172), Iron oxide yellow (E172).

Capsule coating (for 200 mg): Gelatin, Titanium dioxide (E171), Iron oxide yellow (E172).

Printing ink (for 50mg and 150 mg): Shellac, Iron oxide black (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 packaging contents

Nilotinib Accord 50mg is presented as hard capsules. The gelatin hard capsules are size “4” (approximately 14mm 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 white to grayish powder.

Nilotinib Accord 150mg is presented as hard capsules. The gelatin hard capsules are size “1” (approximately 19mm 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 white to grayish powder.

Nilotinib Accord 200mg is presented as hard capsules. The gelatin hard capsules are size “0” (approximately 21mm 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 white to grayish powder.

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

Nilotinib Accord 150mg and 200 mg is available in packs containing 28 or 40hard capsules and in multipacks of 112hard capsules (4 packs of 28hard capsules each), 120hard capsules (3 packs of 40hard capsules each) or 392hard capsules (14 packs of 28hard capsules each), or in blister packs of 28 x 1 or 40 x 1hard capsules and in multipacks of 112hard capsules (4 packs of 28x 1 hard capsules each), 120hard capsules (3 packs of 40 x 1hard capsules each) or 392 x 1hard capsules (14 packs of 28x 1 hard capsules each).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6a Planta

08039 Barcelona

Spain

Manufacturer responsible

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 LaborGmbH

Resslstraβe 9

9065 Ebenthal in Kärnten, Austria

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

For more 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.

Τηλ: +30 210 74 88 821

Last revision date of this leaflet: August 2024

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