DASATINIB ACCORD HEALTHCARE 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dasatinib Accord Healthcare 20 mg film-coated tablets

Dasatinib Accord Healthcare 50 mg film-coated tablets

Dasatinib Accord Healthcare 70 mg film-coated tablets

Dasatinib Accord Healthcare 80 mg film-coated tablets

Dasatinib Accord Healthcare 100 mg film-coated tablets

Dasatinib Accord Healthcare 140 mg film-coated tablets

dasatinib

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

1. What is Dasatinib Accord Healthcare and what is it used for

Dasatinib Accord Healthcare contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children aged 1 year and above. Leukaemia is a type of cancer of the white blood cells. These white blood cells usually help the body to fight infection. In patients with CML, a type of white blood cell called granulocytes start to multiply out of control. Dasatinib Accord Healthcare inhibits the growth of these leukaemic cells.

Dasatinib Accord Healthcare is also used to treat Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in adults, adolescents and children aged 1 year and above and lymphoid blast CML in adults who have not benefited from previous treatments. In patients with Ph+ ALL, a type of white blood cell called lymphocytes multiply too quickly and live too long. Dasatinib Accord Healthcare inhibits the growth of these leukaemic cells.

If you have any questions about how Dasatinib Accord Healthcare works or why you have been prescribed it, ask your doctor.

2. What you need to know before you take Dasatinib Accord Healthcare

Do not take Dasatinib Accord Healthcare

• if you are allergicto dasatinib or any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting Dasatinib Accord Healthcare

• if you are taking medicines to thin your bloodor prevent blood clots (see Using Dasatinib Accord Healthcare with other medicines)
• if you have or have had any liver or heart problems
• if you start to experience difficulty breathing, chest pain or coughwhile taking Dasatinib Accord Healthcare: this may be a sign of fluid build-up in the lungs or chest (which may be more frequent in patients 65 years or older) or due to changes in the blood vessels supplying the lungs
• if you have ever had or may currently have a hepatitis B virus infection
• This is because Dasatinib Accord Healthcare 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 you experience bruising, bleeding, fever, fatigue and confusion while taking Dasatinib Accord Healthcare, contact your doctor. This may be a sign of damage to the blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will regularly check your condition to see if Dasatinib Accord Healthcare is having the desired effect. You will also have regular blood tests while taking Dasatinib Accord Healthcare.

Children and adolescents

Do not give this medicine to children under 1 year of age. Experience with the use of Dasatinib Accord Healthcare in this age group is limited. In children taking Dasatinib Accord Healthcare, growth and bone development should be closely monitored.

Other medicines and Dasatinib Accord Healthcare

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines.

Dasatinib Accord Healthcare is mainly broken down in the liver. Some medicines may interfere with the effect of Dasatinib Accord Healthcare when taken together.

The following medicines must not be used during treatment with Dasatinib Accord Healthcare:

• ketoconazole, itraconazole – medicines for fungi
• erythromycin, clarithromycin, telithromycin – antibiotics
• ritonavir – an antiviral medicine
• phenytoin, carbamazepine, phenobarbital – treatments for epilepsy
• rifampicin – a treatment for tuberculosis
• famotidine, omeprazole – medicines that block stomach acid production
• St John's Wort - a herbal medicine that can be bought without a prescription for the treatment of depressionand other conditions (also known as Hypericum perforatum)

Do not takemedicines that neutralise stomach acid (antacidssuch as aluminium hydroxide/magnesium hydroxide) in the 2 hours before or 2 hours after taking Dasatinib Accord Healthcare.

Tell your doctorif you are taking medicines to thin your bloodor prevent blood clots.

Taking Dasatinib Accord Healthcare with food and drinks

Do not take Dasatinib Accord Healthcare with grapefruit or grapefruit juice.

Pregnancy and breast-feeding

If you are pregnantor think you may be pregnant, tell your doctor immediately. Dasatinib Accord Healthcare must not be used during pregnancyunless clearly necessary. Your doctor will inform you of the potential risk of taking Dasatinib Accord Healthcare during pregnancy.

Both men and women should use effective contraception during treatment with Dasatinib Accord Healthcare.

If you are breast-feeding, tell your doctor.You should interrupt breast-feeding while taking Dasatinib Accord Healthcare.

Driving and using machines

Be careful when driving or using machines if you experience side effects such as dizziness or blurred vision.

Dasatinib Accord Healthcare contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Dasatinib Accord Healthcare contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially ‘sodium-free’.

3. How to take Dasatinib Accord Healthcare

Dasatinib Accord Healthcare will only be prescribed by a doctor with experience in the treatment of leukaemia. Follow exactly the instructions given to you by your doctor. If you are unsure, consult your doctor or pharmacist again. Dasatinib Accord Healthcare is prescribed for adults and children aged 1 year and above.

The recommended starting dose for adult patients with CML in the chronic phase is 100 mg once a day.

The recommended starting dose for adult patients with CML in the accelerated phase or blast crisis or Ph+ ALL is 140 mg once a day.

Dosing regimen in children with CML in the chronic phase or Ph+ ALL based on body weight.Dasatinib Accord Healthcare is given orally once a day as either Dasatinib Accord Healthcare tablets or Dasatinib powder for oral suspension. Dasatinib Accord Healthcare tablets are not recommended in patients weighing less than 10 kg. The powder for oral suspension should be used in patients weighing less than 10 kg and in patients who cannot swallow the tablets. A change in dose may be required when changing between formulations (i.e. tablets and powder for oral suspension), so do not switch between formulations.

Your doctor will decide on the correct formulation and dose based on your weight, side effects and response to treatment. In children, the starting dose of Dasatinib Accord Healthcare is calculated based on body weight as shown below:

There is no recommendation for the use of Dasatinib Accord Healthcare in children under 1 year of age.

Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose, or may even interrupt treatment briefly. To take higher or lower doses you may need to take combinations of tablets of different strengths.

How to take Dasatinib Accord Healthcare

Take the tablets at the same time each day.Swallow the tablets whole. Do not crush, cut or chew them. Do not take the tablets dissolved. You cannot be sure that you will receive the correct dose if you crush, cut, chew or dissolve the tablets. Dasatinib Accord Healthcare tablets can be taken with or without food.

Special handling instructions for Dasatinib Accord Healthcare

It is unlikely that Dasatinib Accord Healthcare tablets will break, but if they do, people other than the patient should wear gloves when handling Dasatinib Accord Healthcare.

How long to take Dasatinib Accord Healthcare

Take Dasatinib Accord Healthcare every day until your doctor tells you to stop. Make sure you take Dasatinib Accord Healthcare for as long as your doctor has prescribed it.

If you take more Dasatinib Accord Healthcare than you should

If you accidentally take too many tablets, contact your doctor immediately.

You may need medical attention.

If you forget to take Dasatinib Accord Healthcare

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you have any further questions on the use of this product, 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.

• The following may be signs of serious adverse effects:
• if you have chest pain, difficulty breathing, coughing, and fainting
• if you have unexpected bleeding or bruisingwithout injury
• if you notice blood in your vomit, stools, or urine, or have black stools
• if you develop infection symptoms, such as fever, intense chills
• if you have fever, mouth or throat pain, itching, or skin and/or mucous membrane peeling

Contact your doctor immediatelyif you notice any of the above.

Very Common Adverse Effects (may affect more than 1 in 10 patients)

• Infections(caused by bacteria, viruses, and fungi)
• Heart and lungs: difficulty breathing
• Digestive problems: diarrhea, feeling unwell (nausea, vomiting)
• Skin, hair, eyes, general: skin rash, fever, swelling in the face, hands, and feet, headache, fatigue, or weakness, bleeding
• Pain: muscle pain (during or after stopping treatment), abdominal pain
• Laboratory Tests: low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs

Common Adverse Effects (may affect up to 1 in 10 patients)

• Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, severe blood or tissue infection (including rare cases with fatal outcomes)
• Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, high blood pressure in the lungs, coughing
• Digestive problems: changes in appetite, changes in taste, abdominal distension or swelling, colon inflammation, constipation, gastroesophageal reflux, mouth ulcers, weight loss, weight gain, gastritis
• Skin, hair, eyes, general: tingling sensation on the skin, itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, visual disturbances (including blurred vision and distorted vision), dry eyes, bruising, depression, insomnia, hot flashes, dizziness, bruising, anorexia, drowsiness, generalized edema
• Pain: joint pain, muscle weakness, chest pain, pain in the hands and feet, chills, muscle and joint stiffness, muscle spasms
• Laboratory tests: fluid around the heart, fluid in the lungs, heart arrhythmias, febrile neutropenia, deficiency in all blood cells, gastrointestinal bleeding, high levels of uric acid in the blood

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

• Heart and lungs: heart attack (including fatal outcome), inflammation of the membrane surrounding the heart (pericarditis), irregular heartbeat, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of the airways that could cause breathing difficulties, asthma, high blood pressure in the arteries (blood vessels) that go to the lungs
• Digestive problems: pancreas inflammation, peptic ulcer, digestive tract inflammation, abdominal swelling, tear in the skin of the anal canal, difficulty swallowing, gallbladder inflammation, bile duct blockage, gastroesophageal reflux (acid and other stomach contents return to the throat)
• Skin, hair, eyes, general: allergic reactions including sensitivity, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, low sex drive, fainting, tremors, eye inflammation that can cause redness or pain, skin disease characterized by sensitivity, redness, and well-defined spots with sudden onset of fever and elevated white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, visual disturbances, increased eye tearing, changes in skin color, inflammation of the fatty tissue under the skin, skin ulcers, blisters on the skin, changes in nails, changes in hair, changes in hands and feet, kidney failure, frequent urination, breast enlargement in men, changes in menstruation, general weakness and discomfort, low thyroid function, loss of balance while walking, osteonecrosis (a disease where blood supply to the bones is reduced, which can cause bone loss and death), arthritis, skin swelling anywhere on the body
• Pain: inflammation of the veins that can cause redness, sensitivity, and swelling, tendon inflammation
• Brain: memory loss
• Additional Tests: abnormal blood test results and possibly kidney failure caused by tumor waste products during healing (tumor lysis syndrome), low albumin levels in the blood, low lymphocyte levels (a type of white blood cell) in the blood, high cholesterol levels in the blood, swelling of the lymph nodes, cerebral hemorrhage, irregular heart activity, enlarged heart, liver inflammation, protein in the urine, elevated creatine phosphokinase (an enzyme found mainly in the heart, brain, and skeletal muscles), elevated troponin (an enzyme found mainly in the heart and skeletal muscle), elevated gamma-glutamyl transferase (an enzyme found mainly in the liver), milky fluid around the lungs (chylous effusion)

Rare Adverse Effects (may affect up to 1 in 1000 patients)

• Heart and lungs: dilation of the right ventricle of the heart, heart muscle inflammation, set of symptoms produced by the blockage of blood supply to the heart muscle (acute coronary syndrome), heart attack (interruption of blood supply to the heart), coronary artery disease (of the heart), inflammation of the tissue that covers the heart and lungs, blood clots, blood clots in the lungs
• Digestive problems: loss of vital nutrients such as proteins from the digestive system, intestinal obstruction, anal fistula (abnormal opening of the anus to the surrounding skin), kidney failure, diabetes
• Skin, hair, eyes, general: seizures, inflammation of the optic nerve that can cause complete or partial vision loss, bluish-purple spots on the skin, abnormally high thyroid function, thyroid gland inflammation, ataxia (associated with loss of muscle coordination), difficulty walking, spontaneous abortion, skin inflammation of blood vessels, skin fibrosis
• Brain: stroke, temporary episode of neurological failure due to loss of blood flow, facial nerve paralysis, dementia
• Immune system: severe allergic reactions
• Connective tissue and musculoskeletal system: delayed fusion of the rounded ends that form joints (epiphysis); slow or delayed growth

Other Adverse Effects with Unknown Frequency (cannot be estimated from available data)

• Lung inflammation
• Bleeding in the stomach or intestine that can cause death
• Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection)
• Reaction with fever, blisters on the skin, and mucous membrane ulcers
• Kidney disorders with symptoms such as edema and abnormal laboratory test results such as protein in the urine and low protein levels in the blood
• Damage to blood vessels known as thrombotic microangiopathy (TMA), which includes decreased red blood cell count, decreased platelet count, and blood clot formation

Your doctor will check if you have any of these effects during your treatment.

Reporting 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 Dasatinib Accord Healthcare

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister or packaging after EXP or CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dasatinib Accord Healthcare

• The active ingredient is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, or 140 mg of dasatinib (as monohydrate).
• The other ingredients are:

• Tablet core:lactose monohydrate; microcrystalline cellulose; PH 101 (E460); sodium croscarmellose (E468); hydroxypropylcellulose (E463); microcrystalline cellulose PH 112 (E460); magnesium stearate (E470)
• Film coating:hypromellose (E464); titanium dioxide (E171); triacetin (E1518)

Appearance of Dasatinib Accord Healthcare and Package Contents

Dasatinib Accord Healthcare 20 mg: the film-coated tablets are white to off-white, biconvex, approximately 5.5 mm, round, with "IV1" engraved on one side and smooth on the other

Dasatinib Accord Healthcare 50 mg: the film-coated tablets are white to off-white, biconvex, approximately 10.70 x 5.70 mm, oval, with "IV2" engraved on one side and smooth on the other

Dasatinib Accord Healthcare 70 mg: the film-coated tablets are white to off-white, biconvex, approximately 8.7 mm, round, with "IV3" engraved on one side and smooth on the other

Dasatinib Accord Healthcare 80 mg: the film-coated tablets are white to off-white, biconvex, approximately 10.20 x 9.95 mm, triangular, with "IV4" engraved on one side and smooth on the other

Dasatinib Accord Healthcare 100 mg: the film-coated tablets are white to off-white, biconvex, approximately 14.70 x 7.10 mm, oval, with "IV5" engraved on one side and smooth on the other

Dasatinib Accord Healthcare 140 mg: the film-coated tablets are white to off-white, biconvex, approximately 10.9 mm, round, with "IV6" engraved on one side and smooth on the other

Dasatinib Accord Healthcare 20 mg and 50 mg film-coated tablets are available in packages containing 56 or 60 film-coated tablets in blisters and in packages with 56 x 1 or 60 x 1 film-coated tablets in single-dose blisters

Dasatinib Accord Healthcare 70 mg film-coated tablets are available in packages containing 56 or 60 film-coated tablets and in packages containing 56 x 1 or 60 x 1 film-coated tablets in single-dose blisters

Dasatinib Accord Healthcare 80 mg and 140 mg film-coated tablets are available in packages with 30 or 56 film-coated tablets in blisters and in packages with 30 x 1 or 56 x 1 film-coated tablets in single-dose blisters

Dasatinib Accord Healthcare 100 mg film-coated tablets are available in packages with 30 or 56 film-coated tablets and in packages with 30 x 1 or 56 x 1 film-coated tablets in single-dose blisters

Not all package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6a Planta

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

Pabianice, 95-200

Poland

Accord Healthcare B.V.

Winthontlaan 200

Utrecht, 3526 KV

Netherlands

Pharmadox Healthcare Limited

Kw20a Kordin Industrial Park

Paola, PLA 3000

Malta

To obtain any 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

Date of the Last Revision of this Leaflet:

Other Sources of Information

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