NILOTINIB 50 mg Капсулы

Содержание инструкции

1. Nilotinib Accord 50 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is Nilotinib Accord and what it is used for
   2. Cosa deve sapere prima di prendere Nilotinib Accord
   3. How to take Nilotinib Accord
   4. Possible side effects
   5. How to store Nilotinib Accord
   6. Package Contents and Other Information

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

nilotinib

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What is Nilotinib Accord
Nilotinib Accord is a medicine containing an active substance called nilotinib.

What is Nilotinib Accord used for
Nilotinib Accord is used for the treatment of a type of leukemia called chronic myeloid leukemia
Philadelphia chromosome positive (CML Ph-positive). CML is a cancer of the blood 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 no longer benefit from previous treatments including imatinib. It is also used
in adult and pediatric patients who have experienced serious side effects following previous
treatments and who are no longer able to continue taking them.

How does Nilotinib Accord work
In patients with CML, a change in DNA (genetic material) triggers a signal that tells the
body to produce 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 check-ups will be performed, including blood tests. These tests
will allow to check:

• the amount of blood cells (white blood cells, red blood cells and platelets) to see how Nilotinib Accord is tolerated.
• the function of the pancreas and liver to check how Nilotinib Accord is tolerated
• the electrolytes in the body (potassium, magnesium). These electrolytes are important for the functioning of the heart.
• the level of sugar and fats in the blood. The heart rate will also be checked using an instrument that measures the electrical activity of the heart (an examination called “ECG”).

The doctor will regularly evaluate the treatment and decide whether you should continue to take Nilotinib
Accord. If you are told to stop this medicine, the doctor will continue to monitor the
CML and may tell you to resume Nilotinib Accord if your condition indicates that this is necessary.
If you have any questions about how Nilotinib Accord works or why it has been prescribed for you or for your
child, please ask your doctor.

2. Cosa deve sapere prima di prendere Nilotinib Accord

Segua attentamente tutte le istruzioni del medico. Queste istruzioni possono essere differenti dalle

Non prenda Nilotinib Accord

• se è allergico a nilotinib o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6). Se pensa di essere allergico, informi il medico prima di prendereNilotinib Accord.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Nilotinib Accord:

• se ha avuto precedenti eventi cardiovascolari come per esempio un attacco di cuore, dolore al petto (angina), problemi di afflusso di sangue al cervello (ictus) o problemi con il flusso di sangue alla gamba (claudicatio) oppure se presenta fattori di rischio per malattie cardiovascolari come pressione alta (ipertensione), diabete o problemi con il livello dei grassi nel sangue (dislipidemie).
• se ha disturbi cardiaci, come per esempio un segnale elettrico anormale chiamato “prolungamento dell’intervallo QT”.se è in trattamento con medicinaliche abbassano il suo colesterolo nel sangue o influiscono sul ritmo cardiaco (antiaritmici) o sul fegato (vedere Altrimedicinali e Nilotinib Accord).
• se soffre di mancanza di potassio o di magnesio.
• se ha disturbi al fegato o al pancreas.
• se ha sintomi quali predisposizione ai lividi, sensazione di stanchezza o respiro corto o ha manifestato ripetute infezioni.
• se ha avuto un intervento chirurgico che ha comportato la rimozione dell’intero stomaco (gastrectomia totale).se lei ha mai avuto o può avere in corso un’infezione da epatite B. Questo perché Nilotinib Accord può causare la riattivazione dell’epatite B, che in alcuni casi può essere fatale. I pazienti verranno esaminati attentamente dal medico per i segni di questa infezione prima di iniziare il trattamento. Se qualcuna di queste condizioni riguarda lei o il suo bambino, informi il medico.

Durante il trattamento con Nilotinib Accord

• se le capita di svenire (perdita di coscienza) o ha un battito cardiaco irregolare durante il trattamento con questo medicinale, informi immediatamente il medicoperché questo può essere un segno di una grave condizione cardiaca. Il prolungamento dell’intervallo QT o un battito cardiaco irregolare può portare a morte improvvisa. Casi non comuni di morte improvvisa sono stati riportati in pazienti in trattamento con Nilotinib Accord.
• se ha improvvise palpitazioni cardiache, debolezza muscolare grave o paralisi, convulsioni o improvvise alterazioni del pensiero o del livello di vigilanza, informi immediatamente ilmedicoin quanto ciò può essere un segno di una veloce rottura delle cellule tumorali chiamato sindrome da lisi tumorale. Rari casi di sindrome da lisi tumorale sono stati riportati nei pazienti in trattamento con Nilotinib Accord.
• se presenta dolore o fastidio al petto, sensazione di intorpidimento o debolezza, problemi nel camminare o nel parlare, dolore, alterazione del colore o sensazione di freddo in un arto, informi immediatamente il medicopoiché questo può essere un segno di un evento cardiovascolare. Eventi cardiovascolari gravi, tra cui problemi con il flusso di sangue alla gamba (arteriopatia periferica ostruttiva), cardiopatia ischemica e problemi di afflusso di sangue al cervello (malattia cerebrovascolare ischemica) sono stati riportati nei pazienti trattati con

Nilotinib Accord. Il medico deve valutare il livello dei grassi (lipidi) e dello zucchero nel
sangue prima di iniziare il trattamento con Nilotinib Accord e durante il trattamento.

• se presenta gonfiore dei piedi o delle mani, gonfiore generalizzato o un rapido aumento di peso informi il medico in quanto questi possono essere segni di una grave ritenzione di liquidi. Casi non comuni di grave ritenzione di liquidi sono stati riportati in pazienti trattati con Nilotinib Accord. Se è il genitore di un bambino che è in trattamento con Nilotinib Accord, informi il medico se alcune delle condizioni sopra riportate lo riguardano.

Bambini e adolescenti
Nilotinib Accord è un trattamento per bambini e adolescenti con LMC. Non vi è esperienza con l’uso
di questo medicinale nei bambini di età inferiore ai 2 anni. Non vi è esperienza con l’uso di Nilotinib
Accord nei bambini di nuova diagnosi di età inferiore ai 10 anni e vi è limitata esperienza nei pazienti
di età inferiore ai 6 anni che non hanno più alcun beneficio dal precedente trattamento per LMC.
Alcuni bambini e adolescenti che assumono Nilotinib Accordpossono manifestare una crescita più
lenta del normale. Il medico monitorerà la crescita con visite regolari.

Altri medicinali e Nilotinib Accord
Nilotinib Accord può interferire con altri medicinali.
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere
qualsiasi altro medicinale. Questo comprende in particolare:

• antiaritmici - utilizzati per il trattamento del battito cardiaco irregolare;
• clorochina, alofantrina, claritromicina, aloperidolo, metadone, moxifloxacina - medicinali che possono avere un effetto indesiderato sull’attività elettrica del cuore;
• ketoconazolo, itraconazolo, voriconazolo, claritromicina, telitromicina - utilizzati per il trattamento di infezioni;
• ritonavir - un medicinale della classe “antiproteasi” utilizzato per il trattamento dell’HIV;
• carbamazepina, fenobarbitale, fenitoina - utilizzati per il trattamento dell’epilessia;
• rifampicina - utilizzata per il trattamento della tubercolosi;
• erba di San Giovanni - un prodotto vegetale utilizzato per il trattamento della depressione e di altre condizioni (anche noto come Hypericum perforatum);
• midazolam - utilizzato per il sollievo dall’ansia prima di un intervento chirurgico;
• alfentanil e fentanil - utilizzati per il trattamento del dolore e come sedativi prima o durante intervento chirurgico o procedure mediche;
• ciclosporina, sirolimus e tacrolimus - farmaci che sopprimono le capacità di “autodifesa” dell’organismo e di combattere le infezioni e sono comunemente usati per prevenire il rigetto di organi trapiantati, come fegato, cuore e reni;
• diidroergotamina e ergotamina - utilizzati per il trattamento della demenza;
• lovastatina, simvastatina - utilizzati per il trattamento di alti livelli di grassi nel sangue;
• warfarin - utilizzato per il trattamento dei disturbi della coagulazione del sangue (come per esempio coaguli del sangue o trombosi);
• astemizolo, terfenafina, cisapride, pimozide, chinidina, bepridil o alcaloidi dell’ergot (ergotamina, diidroergotamina).

Questi medicinali devono essere evitati durante il trattamento con Nilotinib Accord. Se sta prendendo
qualcuno di questi medicinali, il medico può prescriverle altri medicinali in alternativa.
Se sta prendendo una statina (un medicinale che abbassa il suo colesterolo nel sangue), si rivolga al
medico o al farmacista. Se assunto con alcune statine, Nilotinib Accord può aumentare il rischio di
problemi muscolari correlati alle statine, che in rare occasioni può portare a grave lesione muscolare
(rabdomiolisi) con conseguente danno renale.
Inoltre, informi il medico o il farmacista prima di prendere Nilotinib Accord se sta assumendo un
qualunque antiacido, cioè un medicinale contro il bruciore di stomaco. Questi medicinali devono
essere assunti separatamente da Nilotinib Accord:

• bloccanti H2, che diminuiscono la produzione di acido nello stomaco. I bloccanti H2 devono essere assunti circa 10 ore prima e circa 2 ore dopo aver assunto Nilotinib Accord;
• antiacidi come quelli contenenti alluminio idrossido, magnesio idrossido e simeticone, che neutralizzano l’elevata acidità nello stomaco. Questi antiacidi devono essere assunti circa 2 ore prima o circa 2 ore dopo aver assunto Nilotinib Accord. Deve informare anche il medico se sta già assumendoNilotinib Accorde le è stato prescritto un nuovo medicinale che non aveva assunto in precedenza durante il trattamento con Nilotinib Accord.

Nilotinib Accordcon cibi e bevande
Non assuma Nilotinib Accord con il cibo.Il cibo può aumentare l’assorbimento di Nilotinib Accord
e quindi aumentare la quantità di Nilotinib Accord nel sangue, fino ad un livello pericoloso. Non beva
succo di pompelmo o mangi pompelmo. Può aumentare la quantità di Nilotinib Accord nel sangue,
fino ad un livello pericoloso.

Gravidanza e allattamento

• Nilotinib Accord non è raccomandato in gravidanzase non strettamente necessario .Se è in gravidanza o pensa di esserlo, informi il medico che discuterà con lei se può assumere questo medicinale durante la gravidanza.
• Alle donne in cui può verificarsi una gravidanzasi consiglia di utilizzare un metodo di contraccezione molto efficace durante il trattamento e fino a due settimane dopo la fine del trattamento.
• L’allattamento al seno non è raccomandatodurante il trattamento con Nilotinib Accord e per due settimane dopo l’ultima dose. Informi il medico se sta allattando al seno. Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando con latte materno chieda consiglio al medico o al farmacista prima di prendere questo medicinale.

Guida di veicoli e utilizzo di macchinari
Se manifesta effetti indesiderati (quali capogiri o problemi della vista) con un potenziale impatto sulla
capacità di guidare in modo sicuro veicoli o utilizzare strumenti o macchinari dopo aver assunto questo
medicinale, deve interrompere tali attività fino a scomparsa dell’effetto.

Nilotinib Accord contiene lattosio (come monoidrato)
Questo medicinale contiene lattosio (noto anche come zucchero del latte). Se il medico le ha
diagnosticato una intolleranza ad alcuni zuccheri, lo contatti prima di prendere questo medicinale.

Nilotinib Accord contiene sodio
Questo medicinale contiene meno di 1 mmol (23 mg) di sodio per capsula, cioè essenzialmente “senza
sodio”

Nilotinib Accord contiene potassio
Questo medicinale contiene potassio, meno di 1 mmol (39 mg) per capsula, cioè essenzialmente “senza
potassio”.

Nilotinib Accord contiene rosso allura AC
Questo medicinale contiene rosso allura AC, che può causare reazioni allergiche.

3. How to take Nilotinib Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

How much Nilotinib Accord to take
Use in adults

• Patients with newly diagnosed CML: The recommended dose is 600 mg per day. This dose is achieved by taking two 150 mg hard capsules twice a day.
• Patients who no longer benefit from previous CML treatment: The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg hard capsules twice a day.

Use in children and adolescents

• The dose given to your child will depend on the child's weight and height. The doctor will calculate the correct dose to use and tell you which and how many Nilotinib Accord capsules to give to your child. The total daily dose to be given to your child should not exceed 800 mg.

The doctor may prescribe a lower dosage depending on how you respond to treatment.

Elderly people (65 years and over)
Nilotinib Accord can be used by people aged 65 years 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 any food;
• then wait 1 hour before eating again. If you have questions about when to take this medicine, talk to your doctor or pharmacist. Taking Nilotinib Accord at the same time each day will help you remember when to take the hard capsules.

How to take Nilotinib Accord

• Swallow the hard capsules whole with water.
• Do not take food together with the hard capsules.
• For patients who have difficulty swallowing, including pediatric patients who are unable to swallow the hard capsules, another suitable medicine containing nilotinib should be taken.

For how long to take Nilotinib Accord
Continue to take Nilotinib Accord every day for as long as it has been prescribed for you by your
doctor. This is a long-term treatment. The doctor will regularly check your condition
to verify that the treatment is having the desired effect.
The doctor may consider stopping treatment with Nilotinib Accord based on specific
criteria. If you have questions about how long to take Nilotinib Accord, talk to your doctor.

If you take more Nilotinib Accord than you should
If you have taken more Nilotinib Accord than you should, or if someone else has accidentally taken your
hard capsules, contact a doctor or hospital immediately for advice. Show them the
medicine.

If you forget to take Nilotinib Accord
If you forget to take a dose, take the next dose as scheduled. Do not take a
double dose to make up for the missed hard capsule.

If you stop taking Nilotinib Accord
Do not stop taking this medicine unless your doctor tells you to do so.
Stopping Nilotinib Accord without your doctor's recommendation puts you at risk of
worsening of the disease which may have life-threatening consequences. Make sure you discuss
with your doctor, nurse, and/or pharmacist if you are considering stopping
Nilotinib Accord.

If your doctor recommends stopping treatment with Nilotinib Accord
The doctor will regularly assess the treatment with a specific diagnostic test and decide whether you need to
continue taking this medicine. If you are told to stop Nilotinib Accord, the doctor will
continue to carefully monitor the CML before, during, and after stopping Nilotinib Accord
and may tell you to resume Nilotinib Accord if your condition indicates that this is necessary.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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 period of treatment lasting from a few days to a few weeks.

Some side effects can be serious.

• signs of musculoskeletal pain: joint and muscle pain
• signs of heart 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 artery blockage: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, ulcers on the legs or arms that do not heal or heal slowly and obvious changes in color (bluish or paleness) or temperature (coldness) of the affected leg, arm, toes or hands
• signs of thyroid gland underactivity: weight gain, fatigue, hair loss, muscle weakness, feeling cold
• signs of thyroid gland overactivity: fast heartbeat, bulging eyes, weight loss, swelling in the front of the neck
• signs of kidney or urinary tract disorders: thirst, dry skin, irritability, dark urine, decreased urine output, difficulty and pain when urinating, urgent need to urinate, blood in the urine, abnormal urine color
• signs of a high blood sugar level: excessive thirst, increased urine output, increased appetite with weight loss, fatigue
• signs of dizziness: dizziness or a spinning sensation
• signs of pancreatitis: severe upper abdominal pain (in the center or on the left)
• signs of skin disorders: painful red nodules, skin pain, skin redness, scaling or blisters
• signs of fluid retention: rapid weight gain, swelling of the hands, ankles, feet or face
• signs of migraine: severe headache often accompanied by nausea, vomiting and sensitivity to light
• signs of blood disorders: fever, tendency to bruise or unexplained bleeding, serious or frequent infections, unexplained weakness
• signs of venous thrombosis: swelling and pain in a part of the body
• signs of nervous system disorders: weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, hearing, or sensing things that are not there, changes in vision, loss of consciousness, confusion, disorientation, tremors, tingling, pain or numbness in the fingers of the hands and feet
• signs of lung disorders: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the feet or legs
• signs of gastrointestinal disorders: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, acid reflux, bloated abdomen
• signs of liver disorders: yellow 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 perception of flashes of light, decreased visual acuity or vision loss, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching or irritation, dry eyes, swelling or itching of the eyelids
• signs of electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and/or joint disorders associated with abnormal blood test results (such as high levels of potassium, uric acid and phosphorus and low levels of calcium) Contact your doctor immediately if you notice any of the above side effects. Some side effects are very common(may affect more than 1 in 10 people)
• diarrhea
• headache
• lack of energy
• muscle pain
• itching, rash
• nausea
• constipation
• vomiting
• hair loss
• pain in the limbs, bone pain and spinal pain after discontinuation of Nilotinib Accord treatment
• slowed growth in children and adolescents
• upper respiratory tract infection including sore throat and runny or stuffy nose, sneezing
• low level of blood cells (red blood cells, platelets) or hemoglobin
• high level of lipase in the blood (pancreas function)
• high level of bilirubin in the blood (liver function)
• high level of alanine aminotransferase in the blood (liver enzymes)

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

• pneumonia
• abdominal pain, stomach discomfort after meals, gas, bloating or abdominal distension
• bone pains, muscle spasms
• pain (including neck pain)
• dry skin, acne, decreased skin sensitivity
• weight loss or gain
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of discomfort
• nosebleeds
• signs of gout: painful and swollen joints
• inability to achieve or maintain an erection
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing noises (e.g. ringing, buzzing) in the ears that have no external source (also called tinnitus)
• hemorrhoids
• heavy menstrual bleeding
• itching of hair follicles
• oral or vaginal candidiasis
• signs of conjunctivitis: eye discharge with itching, redness and swelling
• eye irritation, red eyes
• signs of hypertension: high blood pressure, headache, dizziness
• flushing
• signs of occlusive peripheral arterial disease: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, ulcers on the legs or arms that do not heal or heal slowly and obvious changes in color (bluish or paleness) or temperature (coldness) of the legs or arms (possible signs of artery blockage in the leg, arm, toes or hands affected)
• shortness of breath (also called dyspnea)
• mouth ulcers with inflammation of the gums (also called stomatitis)
• high level of amylase in the blood (pancreas function)
• high level of creatinine in the blood (kidney function)
• high level of alkaline phosphatase or creatine phosphokinase in the blood
• high level of aspartate aminotransferase in the blood (liver enzymes)
• high level of gamma-glutamyl transferase in the blood (liver enzymes)
• signs of leukopenia or neutropenia: low level of white blood cells
• increased number of platelets or white blood cells in the blood
• low levels in the blood of magnesium, potassium, sodium, calcium or phosphorus
• increased level of potassium, calcium and phosphorus in the blood
• high level of fats (including cholesterol) in the blood
• high level of uric acid in the blood

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

• allergy (hypersensitivity to Nilotinib Accord)
• dry mouth
• breast pain
• pain or discomfort in the side
• increased appetite
• enlargement of the breast gland in men
• herpes virus infection
• stiffness of muscles and joints, swelling of the joints

cold)

• taste disorder
• frequent urge to urinate
• signs of inflammation of the gastric mucosa: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• memory loss
• skin cysts, thinning or thickening of the skin, thickening of the outermost layer of the skin, change in skin color
• signs of psoriasis: thickened areas of red/silvery skin
• increased skin sensitivity to light
• difficulty hearing
• joint inflammation
• urinary incontinence
• inflammation of the intestine (also called enterocolitis)
• anal abscess
• nipple swelling
• symptoms of restless legs syndrome (an irresistible urge to move a part of the body, usually the legs, associated with uncomfortable sensations)
• signs of sepsis: fever, chest pain, elevated heart rate/increased heart rate, shortness of breath or rapid breathing
• skin infection (subcutaneous abscess)
• skin wart
• increased specific types of white blood cells (called eosinophils) in the blood
• signs of lymphopenia: low level of white blood cells
• high level of parathyroid hormone in the blood (a hormone that regulates calcium and phosphorus levels)
• high level of lactate dehydrogenase in the blood (an enzyme)
• signs of low blood sugar: nausea, sweating, weakness, dizziness, tremor, headache
• dehydration
• abnormal level of fats in the blood
• involuntary tremor (also called tremor)
• difficulty concentrating
• unpleasant and abnormal sensation to the touch (also called dysesthesia)
• fatigue (also called asthenia)
• 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 rupture of blood vessels (also called subconjunctival hemorrhage)
• blood in the eyes (also called eye hemorrhage)
• eye irritation
• signs of heart attack (also called myocardial infarction): sudden and crushing chest pain, fatigue, irregular heartbeat
• 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 sternum (also called pericarditis)
• signs of hypertensive crisis: severe headache, dizziness, nausea
• leg pain and weakness caused by walking (also called intermittent claudication)
• signs of narrowing of the arteries in the limbs: possible high blood pressure, painful cramps in one or both hip, thigh or calf muscles after some activity such as walking or climbing stairs, numbness or weakness in the legs
• bruising (when you haven't hurt yourself)
• deposits of fat in the arteries that can cause blockage (also called arteriosclerosis)
• signs of low blood pressure (also called hypotension): dizziness, lightheadedness or fainting
• signs of pulmonary edema: shortness of breath
• signs of pleural effusion: accumulation of fluid between the layers of tissue lining the lungs and the chest cavity (which, if severe, can reduce the heart's ability to pump blood), cough with chest pain, hiccups, rapid breathing
• signs of interstitial lung disease: cough, difficulty breathing, painful breathing
• signs of pleuritic pain: chest pain
• signs of pleurisy: cough, painful breathing
• hoarse voice
• signs of pulmonary hypertension: high blood pressure in the arteries of the lungs
• wheezing
• sensitive teeth
• signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
• high level of urea in the blood (kidney function)
• change in blood proteins (low level of globulins or presence of paraprotein)
• high level of unconjugated bilirubin in the blood
• high level of troponin in the blood

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

• redness and/or swelling and possible peeling of the palms of the hands and soles of the feet (so-called hand-foot syndrome)
• warts in the mouth
• feeling of hardening or stiffness of the breast
• inflammation of the thyroid gland (also called thyroiditis)
• disturbed or depressed mood
• signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
• signs of narrowing of the arteries in the brain: partial or total loss of vision in both eyes, double vision, dizziness (feeling of spinning), numbness or tingling, loss of coordination, dizziness or confusion
• swelling of the brain (possible headache and/or changes in mental status)
• signs of optic neuritis: blurred vision, vision loss
• signs of heart failure (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
• low or high level of insulin in the blood (a hormone that regulates blood sugar levels)
• low level of C-peptide in the blood (pancreas function)
• sudden death

The following other side effects have been reported with unknown frequency (cannot be
defined based on available data):

• signs of heart failure (ventricular dysfunction): shortness of breath, effort at rest, irregular heartbeat, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling of the feet, ankles and abdomen.

Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, please contact
your doctor or pharmacist. You can also report undesirable effects directly through the national
reporting system as indicated in Appendix V. Reporting undesirable effects can help
to provide more information on the safety of this medicine.

5. How to store Nilotinib Accord

• This medicine does not require any particular precautions for storage.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the box and on the blister after EXP. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice that the packaging is damaged or has been tampered with.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Nilotinib Accord Contains

• The active ingredient is nilotinib.
• Each hard capsule contains 50 mg, 150 mg and 200 mg of nilotinib. The other ingredients are: Capsule content: Lactose monohydrate, Crospovidone, Polysorbate 80+Magnesium aluminium metasilicate, Anhydrous colloidal 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) Impression ink (for 50 mg and 150 mg): Gum lac, Black iron oxide (E172), Propylene glycol, Potassium hydroxide Impression ink (for 200 mg): Gum lac, Propylene glycol, Sodium hydroxide, Titanium dioxide (E171), Povidone, Allura Red AC (E129) See section 2 “Nilotinib Accord contains lactose, potassium and Allura Red AC”.

Description of the Appearance of Nilotinib Accord and Package Contents
Nilotinib Accord 50 mg is provided as hard capsules. Hard gelatin capsule (size “4”
(length approximately 14 mm) with an opaque red cap and an opaque light yellow body with lettering with
black ink “SML” on the cap and “39” on the body containing granular powder of colour from
whitish to grey.
Nilotinib Accord 150 mg is provided as hard capsules. Hard gelatin capsule (size “1”
(length approximately 19 mm) with an opaque red cap and an opaque red body with lettering with black ink
“SML” on the cap and “26” on the body containing granular powder of colour from whitish to
grey.
Nilotinib Accord 200 mg is provided as hard capsules. Hard gelatin capsule (size “0”
(length approximately 21 mm) with an opaque light yellow cap and an opaque light yellow body with lettering with
red ink “SML” on the cap and “27” on the body containing granular powder of colour from
whitish to grey.
Nilotinib Accord 50 mg hard capsules are available in packs containing 40 hard capsules and in
multiple packs of 120 hard capsules (comprising 3 blisters, each containing 40 hard capsules) or perforated divisible unit-dose blisters of 40 x 1 hard capsules and in multiple packs
of 120 x 1 hard capsules (comprising 3 blisters, each containing 40 x 1 hard capsules).
Nilotinib Accord 150 mg and 200 mg hard capsules are available in packs containing 28 or
40 hard capsules and in multiple packs of 112 hard capsules (comprising 4 blisters, each containing 28 hard capsules), 120 hard capsules (comprising 3 blisters, each containing
40 hard capsules) or 392 hard capsules (comprising 14 blisters, each containing 28 hard capsules) or perforated divisible unit-dose blisters of 28 x 1 or 40 x 1 hard capsules and in multiple packs
of 112 x 1 hard capsules (comprising 4 blisters, each containing 28 x 1 hard capsules),
120 x 1 hard capsules (comprising 3 blisters, each containing 40 x 1 hard capsules) or 392 x 1
hard capsules (comprising 14 blisters, each containing 28 x 1 hard capsules).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Resslstraβe 9
9065 Ebenthal in Kärnten, Austria
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
For further information on 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
EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821

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