Dasatinib Accord Healthcare

Package leaflet: Information for the user

Dasatinib Accord Healthcare 20 mg film-coated tablets, 50 mg film-coated tablets, 70 mg film-coated tablets, 80 mg film-coated tablets, 100 mg film-coated tablets, 140 mg film-coated tablets

dasatinib
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Dasatinib Accord Healthcare is and what it is 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 at least 1 year of age.
Leukaemia is a cancer of the white blood cells. White blood cells normally
help the body fight infections. In people with CML, white blood cells called granulocytes
start to grow uncontrollably. Dasatinib Accord Healthcare inhibits the
growth of these leukaemic cells.
Dasatinib Accord Healthcare is also used to treat Philadelphia chromosome-positive (Ph+) acute
lymphoblastic leukaemia (ALL) in adults, adolescents, and children at least 1 year of age, and for the treatment of lymphoid blast phase CML in adults who have not benefited from previous therapies. In people with ALL, white blood cells 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 it has been
prescribed for you, consult your doctor.

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

Do not take Dasatinib Accord Healthcare
if you are allergic to dasatinib or to 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
Talk to your doctor or pharmacist before taking Dasatinib Accord Healthcare
if you are taking medicines that thin the blood or prevent clotting (see "Other
medicines and Dasatinib Accord Healthcare")
if you have or have had liver or heart problems
if you start experiencing breathing difficulties, chest pain or cough while taking Dasatinib
Accord Healthcare: these symptoms could indicate fluid retention in the lungs or chest cavity
(which may be more common in patients aged 65 years or older), or they could be due to changes in the blood vessels supplying the lungs
if you have ever had or may currently have hepatitis B infection. This is because Dasatinib
Accord Healthcare could cause reactivation of hepatitis B, which in some cases may be fatal. Your doctor will carefully monitor you for signs of this infection before starting treatment.
if you develop bruising, bleeding, fever, fatigue or confusion while taking Dasatinib Accord Healthcare, contact your doctor. These may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will need to monitor your clinical condition regularly to ensure Dasatinib Accord Healthcare is having the desired effect. In addition, you will have regular blood tests while taking Dasatinib Accord Healthcare.

Children and adolescents
Do not give this medicine to children under one year of age. Experience with Dasatinib Accord Healthcare in this age group is limited. Bone growth and development in children taking Dasatinib Accord Healthcare will be closely monitored.

Other medicines and Dasatinib Accord Healthcare
Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Dasatinib Accord Healthcare is mainly metabolized by the liver. Some medicines may interfere with the effect of Dasatinib Accord Healthcare when taken at the same time.

The following medicines must not be used with Dasatinib Accord Healthcare:
ketoconazole, itraconazole – which are antifungal medicines
erythromycin, clarithromycin, telithromycin – which are antibiotics
ritonavir – which is an antiviral medicine
phenytoin, carbamazepine, phenobarbital – which are treatments for epilepsy
rifampicin – which is a treatment for tuberculosis
famotidine, omeprazole – which are medicines that block acid production in the stomach
St. John’s wort – a herbal preparation available without prescription, used for the treatment of depression and other conditions (also known as Hypericum perforatum)

Do not take medicines that neutralize stomach acid (antacids such as aluminium hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib Accord Healthcare.

Tell your doctor if you are taking medicines that thin the blood or prevent clotting.

Dasatinib Accord Healthcare with food and drink
Do not take Dasatinib with grapefruit or grapefruit juice.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor immediately.
Dasatinib Accord Healthcare must not be used during pregnancy unless strictly necessary. Your doctor will discuss with you the potential risks of taking Dasatinib Accord Healthcare during pregnancy.
Both men and women taking Dasatinib Accord Healthcare will be advised to use an effective method of contraception during treatment.

If you are breastfeeding, inform your doctor. Breastfeeding must be discontinued during treatment with Dasatinib Accord Healthcare.

Driving and using machines
If you experience side effects such as dizziness or blurred vision, take special care when driving or operating machinery.

Dasatinib Accord Healthcare contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Dasatinib Accord Healthcare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Dasatinib Accord Healthcare

Dasatinib Accord Healthcare will only be prescribed by a doctor experienced in the treatment of
leukaemia. Always take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist. Dasatinib Accord Healthcare is prescribed for adults and
children aged at least 1 year.
The recommended starting dose in adult patients with chronic phase chronic myeloid leukaemia (CML) is 100 mg once daily.
The recommended starting dose in adult patients with accelerated phase or blast phase CML, or with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL), is 140 mg once daily.
The dosage for children with chronic phase CML or Ph+ ALL is based on body weight.
Dasatinib Accord Healthcare is administered orally once daily as either Dasatinib Accord Healthcare tablets or dasatinib oral suspension powder. Dasatinib Accord Healthcare tablets are not recommended for patients weighing less than 10 kg. For patients weighing less than 10 kg and for patients unable to swallow tablets, the oral suspension powder should be used. When switching between formulations (i.e., between tablets and oral suspension powder), there may be a change in dose; therefore, do not switch from one formulation to the other on your own.
Your doctor will determine the appropriate formulation and dose based on body weight, any side effects, and response to treatment. The initial dose of Dasatinib Accord Healthcare for children is calculated according to body weight, as shown below:
Body weight (kg) Daily dose (mg)
from 10 to <20 kg 40 mg
from 20 to <30 kg 60 mg
from 30 to <45 kg 70 mg
≥45 kg 100 mg
There is no recommended dose of Dasatinib Accord Healthcare for children under 1 year of age.
Depending on your response to treatment, your doctor may recommend a higher or lower dose, or even a brief interruption of treatment. For higher or lower doses, you may need to take combinations of tablets with different strengths.

How to take Dasatinib Accord Healthcare
Take the tablets at the same time each day. Swallow the tablets whole without
crushing, splitting, or chewing them. Do not take dissolved tablets. If you crush, split, chew, or disperse the tablets, you cannot be certain of receiving the correct dose. Dasatinib Accord Healthcare tablets may be taken with or without food.

Special handling precautions for Dasatinib Accord Healthcare
It is unlikely that Dasatinib Accord Healthcare tablets will break. However, if this occurs, individuals other than the patient must wear gloves when handling Dasatinib Accord Healthcare.

How long to take Dasatinib Accord Healthcare
Take Dasatinib Accord Healthcare daily until your doctor tells you to stop. Make sure you take Dasatinib Accord Healthcare for the entire duration prescribed.

If you take more Dasatinib Accord Healthcare than you should
If you have accidentally taken 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 missed tablet. Take the next scheduled dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following may all be symptoms of serious side effects:
if you have chest pain, difficulty breathing, cough or fainting
if you experience unexpected bleeding or bruising without injury
if you find blood in your vomit, faeces or urine, or your faeces are black
if you develop signs of infection such as fever, severe chills
if you experience fever, mouth or throat pain, blisters or peeling of the skin and/or mucous membranes
Contact your doctor immediately if you notice any of the above effects.

Very common side effects (may affect more than 1 in 10 people)
Infections (includes bacterial, viral and fungal infections)
Heart and lungs: shortness of breath
Gastrointestinal problems: diarrhoea, feeling unwell (nausea, vomiting)
Skin, hair, eyes, general: rash, fever, swelling of the face, hands and feet, headache, feeling tired or weak, bleeding
Pain: muscle pain (during or after stopping treatment), abdominal (stomach) pain
Laboratory and instrumental tests may show: low platelet count, low white blood cell count (neutropenia), anaemia, fluid in the lungs (effusion)

Common side effects (may affect up to 1 in 10 people)
Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infections, severe blood and tissue infections (including uncommon cases with fatal outcomes)
Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, myocardial weakness, high blood pressure, increased pressure in the lungs, cough
Gastrointestinal problems: loss of appetite, altered taste, bloating or swelling of the abdomen (abdominal distension), inflammation of the colon, constipation, heartburn, mouth ulceration, weight gain, weight loss, gastritis
Skin, hair, eyes, general: tingling of the skin, itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, eye disorders (including blurred vision and visual disturbances), dry eyes, bruising, depression, insomnia, hot flushes, dizziness, contusion (bruise), anorexia, somnolence, generalized oedema
Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle and joint stiffness, muscle spasm
Laboratory and instrumental tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, gastrointestinal bleeding, elevated blood uric acid levels

Uncommon side effects (may affect up to 1 in 100 people)
Heart and lungs: heart attack (including fatal outcome), inflammation of the sac (fibrous sac) surrounding the heart, irregular heartbeat, chest pain due to reduced blood flow to the heart (angina), low blood pressure, narrowing of the airways which may cause breathing difficulties, asthma, increased blood pressure in the pulmonary arteries (blood vessels) of the lungs
Gastrointestinal problems: pancreatitis, peptic ulcer, oesophagitis, bloated abdomen, tear in the skin of the anal canal, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastro-oesophageal reflux (a condition where stomach acids and other contents rise into the throat)
Skin, hair, eyes, general: allergic reactions including sensitivity, red nodules on the skin (erythema nodosum), anxiety, confusion, mood swings, decreased sexual desire, fainting, tremors, eye inflammation causing redness or pain, a skin disease characterized by sensitivity, redness, well-defined patches with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, impaired vision, increased eye tearing, skin pigmentation disorders, inflammation of the fatty tissue under the skin, skin ulcers, blisters on the skin, nail disorders, hair and hair disorders, hand-foot syndrome, kidney failure, increased frequency of urination, breast enlargement in men, menstrual disorder, general weakness and malaise, reduced thyroid function, loss of balance while walking, osteonecrosis (a disease due to reduced blood flow to the bones, which may lead to bone loss and bone death), arthritis, skin swelling anywhere on the body
Pain: inflammation of veins which may cause redness, tenderness and swelling, tendon inflammation
Brain: memory loss
Laboratory and instrumental tests may show: abnormal blood test results and possible impairment of kidney function due to products from the breakdown of destroyed tumour (tumour lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cells) in the blood, high cholesterol levels in the blood, swollen lymph nodes, cerebral haemorrhage, irregularities in the heart's electrical activity, heart enlargement, liver inflammation, protein in the urine, increased creatine phosphokinase (an enzyme mainly found in the heart, brain and skeletal muscles), increased troponin (an enzyme mainly found in the heart and skeletal muscles), increased gamma-glutamyltransferase (an enzyme mainly found in the liver), milky-looking fluid around the lungs (chylothorax)

Rare side effects (may affect up to 1 in 1,000 people)
Heart and lungs: enlargement of the right ventricle of the heart, inflammation of the heart muscle, a group of conditions resulting from blocked blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (cessation of blood flow from the heart), coronary heart disease, inflammation of the tissue lining the heart and lungs, blood clots, blood clots in the lungs
Gastrointestinal problems: loss of vital nutrients from the digestive tract, such as proteins, intestinal obstruction, anal fistula (an abnormal crack from the anus to the surrounding skin), impaired kidney function, diabetes
Skin, hair, eyes, general: seizures, optic nerve inflammation which may cause partial or complete vision loss, blue-purple patches on the skin, abnormally increased thyroid function, thyroid gland inflammation, ataxia (a condition associated with lack of muscle coordination), difficulty walking, miscarriage, inflammation of blood vessels in the skin, skin fibrosis
Brain: stroke, transient episode of neurological dysfunction caused by loss of blood flow, facial nerve paralysis, dementia
Immune system: severe allergic reaction
Musculoskeletal and connective tissue: delayed fusion of the rounded ends forming the joints (epiphyses); slowed or delayed growth

Other side effects reported with unknown frequency (cannot be estimated from the available data):
pneumonia
bleeding in the stomach or intestines which may cause death
reactivation (recurrence) of hepatitis B infection if you have previously had hepatitis B (a liver infection)
a reaction with fever, blisters on the skin and mucosal ulceration
kidney disease with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low blood protein levels
Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets and blood clot formation

Your doctor will monitor some of these side effects during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dasatinib Accord Healthcare

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton, following
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage precautions.
Do not dispose of medicines via 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 Dasatinib Accord Healthcare contains
The active substance 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 components are:
tablet core: monohydrate lactose, 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).

Description of the appearance of Dasatinib Accord Healthcare and package contents
Dasatinib Accord Healthcare 20 mg: the film-coated tablet is white to almost white, biconvex, approximately 5.5 mm in diameter, round in shape, with "IV1" engraved on one side and smooth on the other side.
Dasatinib Accord Healthcare 50 mg: the film-coated tablet is white to almost white, biconvex, approximately 10.70 x 5.70 mm, oval in shape, with "IV2" engraved on one side and smooth on the other side.
Dasatinib Accord Healthcare 70 mg: the film-coated tablet is white to almost white, biconvex, approximately 8.7 mm in diameter, round in shape, with "IV3" engraved on one side and smooth on the other side.
Dasatinib Accord Healthcare 80 mg: the film-coated tablet is white to almost white, biconvex, approximately 10.20 x 9.95 mm, triangular in shape, with "IV4" engraved on one side and smooth on the other side.
Dasatinib Accord Healthcare 100 mg: the film-coated tablet is white to almost white, biconvex, approximately 14.70 x 7.10 mm, oval in shape, with "IV5" engraved on one side and smooth on the other side.
Dasatinib Accord Healthcare 140 mg: the film-coated tablet is white to almost white, biconvex, approximately 10.9 mm in diameter, round in shape, with "IV6" engraved on one side and smooth on the other side.

Dasatinib Accord Healthcare 20 mg and 50 mg film-coated tablets are available in cartons containing 56 or 60 film-coated tablets in blisters, and in cartons containing 56 x 1 or 60 x 1 film-coated tablets in unit-dose divisible blisters.
Dasatinib Accord Healthcare 70 mg film-coated tablets are available in cartons containing 56 or 60 film-coated tablets in blisters, and in cartons containing 56 x 1 or 60 x 1 film-coated tablets in unit-dose divisible blisters.
Dasatinib Accord Healthcare 80 mg and 140 mg film-coated tablets are available in cartons containing 30 or 56 film-coated tablets in blisters, and in cartons containing 30 x 1 or 56 x 1 film-coated tablets in unit-dose divisible blisters.
Dasatinib Accord Healthcare 100 mg film-coated tablets are available in cartons containing 30 or 56 film-coated tablets, and in cartons containing 30 x 1 or 56 x 1 film-coated tablets in unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
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
The Netherlands
Pharmadox Healthcare Limited
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ .