DASATINIB 20 mg Film-Coated Tablets

Зміст інструкції

1. 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
   1. What is Dasatinib Accord Healthcare 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. Package Contents and Other Information

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

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 could 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 Dasatinib Accord Healthcare is and what it is 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. How to store Dasatinib Accord Healthcare
• 6. Contents of the pack and other information

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

Dasatinib Accord Healthcare contains the active substance dasatinib. This medicine is used
for the treatment of chronic myeloid leukemia (CML) in adults, adolescents and children
at least 1 year of age. Leukemia is a cancer of the white blood cells. White blood cells normally
help the body fight infections. In individuals with CML, white blood cells
called granulocytes begin to grow out of control. Dasatinib Accord Healthcare inhibits the
growth of these leukemic cells.
Dasatinib Accord Healthcare is also used for the treatment of acute lymphoblastic
leukemia (ALL) with Philadelphia chromosome positive (Ph+) in adults, adolescents and children
at least 1 year of age and CML in lymphoid blast phase in adults who have not
benefited from previous therapies. In individuals with ALL, white blood cells called lymphocytes
multiply too quickly and live too long. Dasatinib Accord Healthcare inhibits the
growth of these leukemic cells.
If you have any questions about how Dasatinib Accord Healthcare works or why it has been
prescribed to you, ask your doctor.

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

Do not take Dasatinib Accord Healthcare
if you are allergicto dasatinib or to any of the other ingredients of this medicine
(listed in section 6)

If you think you may be allergic, ask your doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dasatinib Accord Healthcare
if you are taking medicines that thin the bloodor prevent blood clots (see "Other
medicines and Dasatinib Accord Healthcare")
if you have liver or heart problems, or have had them
if you start to experience difficulty breathing, chest pain or coughwhile taking Dasatinib
Accord Healthcare: this could be a symptom of fluid retention in the lungs or in the
chest (which may be more common in patients aged 65 years or older) or could
be due to changes in the blood vessels that supply the lungs
if you have ever had or may have an ongoing hepatitis B infection. This is because Dasatinib
Accord Healthcare may cause hepatitis B to become active again, which can be
fatal in some cases. Patients will be carefully examined by the doctor for signs of this infection
before starting treatment.
if you develop bruising, bleeding, fever, fatigue and confusion while taking
Dasatinib Accord Healthcare, contact your doctor. This may be a sign of blood vessel damage known as thrombotic microangiopathy (TMA).
The doctor will need to regularly monitor your condition to check that 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 one year of age. Experience with the use of Dasatinib
Accord Healthcare in this age group is limited. Bone growth and development of children who
are taking Dasatinib Accord Healthcare will be carefully monitored.

Other medicines and Dasatinib Accord Healthcare
Tell your doctorif you are taking, have recently taken or might take any other
medicines.
Dasatinib Accord Healthcare is mainly broken down by the liver. Some medicines can
interfere with the effect of Dasatinib Accord Healthcare when taken at the same time as
Dasatinib Accord Healthcare.

These 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 the production of acid in the
stomach
St John's wort - a herbal remedy available without a prescription
used to treat depressionand other conditions (also
known as Hypericum perforatum)

Do not takemedicines that neutralize stomach acid (antacidssuch as aluminium hydroxide
or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib
Accord Healthcare.
Tell your doctorif you are taking medicines that thin the bloodor prevent blood clots.

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

Pregnancy and breastfeeding
If you are pregnantor suspect you may be pregnant, tell your doctor immediately.

Dasatinib Accord Healthcare should not be used during pregnancyunless it is absolutely
necessary. Your doctor will discuss the potential risks of taking Dasatinib Accord
Healthcare during pregnancy with you.
Both men and women taking Dasatinib Accord Healthcare will be recommended to use effective
contraception during treatment.

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

Driving and using machines
If you experience side effects such as dizziness and blurred vision, be particularly
careful when driving and using machines.

Dasatinib Accord Healthcare contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

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

3. How to take Dasatinib Accord Healthcare

Dasatinib Accord Healthcare will only be prescribed to you by a doctor experienced in the treatment of
leukemia. Take this medicine following the doctor's instructions exactly. If you have
any doubts, consult your doctor or pharmacist. Dasatinib Accord Healthcare is prescribed for adults and
children aged 1 year or older.

The recommended initial dose in adult patients with chronic myeloid leukemia (CML) in the
chronic phase is 100 mg once daily.
The recommended initial dose in adult patients with chronic myeloid leukemia (CML) in the accelerated
phase or blast phase, or with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) is 140 mg once daily.
The dosage in children with CML in the chronic phase or Ph+ ALL is based on body weight.
Dasatinib Accord Healthcare is administered orally once daily in the form of Dasatinib
Accord Healthcare tablets or dasatinib oral suspension powder. Dasatinib Accord Healthcare
tablets are not recommended for patients weighing less than 10 kg. In patients weighing less than 10
kg and in patients who are 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 between them.
The doctor will decide the correct formulation and dose based on weight, any side effects and the
response to treatment. The initial dose of Dasatinib Accord Healthcare for children is calculated
based on body weight, as indicated below:

Body weight (kg)Daily dose (mg)
10 to <20 kg 40 mg
20 to <30 kg 60 mg
30 to <45 kg 70 mg
at least 45 kg 100 mg
There is no recommended dose of Dasatinib Accord Healthcare for children under 1 year of age.
Depending on how you respond 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 of different strengths.

How to take Dasatinib Accord Healthcare
Take the tablets at the same time each day.Swallow the tablets whole without
crushing, dividing or chewingthem. Do not take dissolved tablets. You cannot be sure of
receiving the correct dose if you crush, divide, chew or disperse the tablets. The tablets of
Dasatinib Accord Healthcare can be taken with or without food.

Special precautions for handling Dasatinib Accord Healthcare
It is unlikely that Dasatinib Accord Healthcare tablets will break. If this should happen,
people other than the patient should wear gloves when handling Dasatinib Accord Healthcare.

How long to take Dasatinib Accord Healthcare
Take Dasatinib Accord Healthcare daily as long as your doctor does not tell you to stop. Make
sure you take Dasatinib Accord Healthcare for the entire time it has been prescribed for.

If you take more Dasatinib Accord Healthcare than you should
If you have accidentally taken too many tablets, contact immediatelyyour doctor. You may
need medical assistance.

If you forget to take Dasatinib Accord Healthcare
Do not take a double dose to make up for a missed tablet. Take the next
dose scheduled at the usual time.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following can all be symptoms of serious side effects:
if you have chest pain, difficulty breathing, cough and fainting
if you experience unexpected bleeding or bruisingwithout injury
if you find blood in your vomit, stools or urine, or your stools are black
if you experience signs of infectionsuch 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 immediatelyif 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

Problems of the digestive system:diarrhea, feeling or being 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 pain
(stomach pain)

Laboratory and instrumental tests may show:low platelet count, low
white blood cell count (neutropenia), anemia, fluid in the lungs (effusion)

Common side effects (may affect up to 1 in 10 people)
Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), infections
of the upper respiratory tract, serious blood and tissue infections (including uncommon
cases with fatal outcomes)

Heart and lungs: palpitations, irregular heartbeat, congestive heart failure,
weakened myocardium, high blood pressure, increased pressure in the lungs, cough

Problems of the digestive system:loss of appetite, changes in taste, bloating or
distension of the abdomen, inflammation of the colon, constipation, heartburn,
mouth ulcers, weight gain, weight loss, gastritis

Skin, hair, eyes, general:skin tingling, itching, dry skin, acne, skin inflammation, persistent noise in the ears, hair loss, excessive sweating,
eye problems (including blurred vision and visual disturbances), dry eyes,
bruising, depression, insomnia, hot flushes, dizziness, contusion (bruise), anorexia, drowsiness,
generalized edema

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, high uric acid
levels in the blood

Uncommon side effects (may affect up to 1 in 100 people)
Heart and lungs:heart attack (including fatal ones), inflammation of the
covering (fibrous sac) surrounding the heart, irregular heartbeat, chest pain
due to lack of blood flow to the heart (angina), low blood pressure,
narrowing of the airways that can cause difficulty breathing, asthma, increased
blood pressure in the arteries (blood vessels) of the lungs

Problems of the digestive system:inflammation of the pancreas, peptic ulcer, inflammation
of the esophagus, bloated abdomen, tear in the skin of the anal canal, difficulty
swallowing, inflammation of the gallbladder, blockage of the bile ducts, gastro-esophageal reflux
(a condition where acids and other stomach 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, inflammation of the eyes 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,
sensitivity to light, impaired vision, increased tearing of the
eyes, changes in skin color, 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, frequent urination, breast enlargement in
men, menstrual disorder, general weakness and malaise, decreased thyroid function, loss
of balance while walking, osteonecrosis (a disease due to reduced blood flow
to the bones, which can cause bone loss and bone death), arthritis, swelling of the skin
everywhere in the body

Pain:inflammation of the veins that can cause redness, sensitivity and swelling,
tendon inflammation

Brain:memory loss

Laboratory and instrumental tests may show:abnormal blood test results and possible impairment of kidney function caused by products of tumor lysis
destroyed (tumor lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes
(a type of white blood cells) in the blood, high levels of cholesterol in the blood, swollen lymph nodes,
cerebral hemorrhage, irregularity of the heart's electrical activity, enlarged heart,
liver inflammation, protein in the urine, increased creatine phosphokinase (an enzyme
found mainly in the heart, brain and skeletal muscles), increased troponin
(an enzyme found mainly in the heart and skeletal muscles), increased gamma-
glutamyltransferase (an enzyme found mainly 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 set of conditions resulting from blockage of blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (cessation of blood flow from
the heart), coronary heart disease (of the heart), inflammation of the tissue lining the heart and
lungs, blood clots, blood clots in the lungs

Problems of the digestive system:loss of vital nutrients from the digestive tract, such
as proteins, intestinal obstruction, anal fistula (an abnormal fissure from the anus to the skin
around the anus), impaired kidney function, diabetes

Skin, hair, eyes, general:seizures, inflammation of the optic nerve that can cause
partial or complete vision loss, blue-purple patches on the skin, abnormally increased thyroid function, inflammation of the thyroid gland, ataxia (a
condition associated with lack of muscle coordination), difficulty walking, spontaneous abortion, inflammation of the blood vessels of the skin, fibrosis of the skin

Brain:stroke, temporary episode of neurological dysfunction caused by loss of blood flow,
facial nerve paralysis, dementia

Immune system: severe allergic reaction

Musculoskeletal and connective tissue: delay in the fusion of the rounded ends that
form the joints (epiphyses); slowed or delayed growth

Other side effects reported with unknown frequency (cannot be defined based on
available data):
pneumonia
bleeding in the stomach or intestines that can cause death
recurrence (reactivation) of hepatitis B infection if you have had hepatitis B in the past (an
infection of the liver)
a reaction with fever, blisters on the skin and ulceration of the mucous membranes
kidney disease with symptoms including edema and abnormal laboratory results
such as the presence of protein in the urine and low levels of protein in the blood
Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased
red blood cell count, decreased platelets and formation of blood clots
The doctor will monitor some of these effects during treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported 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 which is stated on the blister or the package after
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 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 Dasatinib Accord Healthcare contains
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).

Description of the appearance of Dasatinib Accord Healthcare and package contents
Dasatinib Accord Healthcare 20 mg: the film-coated tablet is from white to almost
white, biconvex, approximately 5.5 mm in diameter, round in shape, with "IV1" imprinted on one side and smooth on the
other side.
Dasatinib Accord Healthcare 50 mg: the film-coated tablet is from white to almost
white, biconvex, approximately 10.70 x 5.70 mm, oval in shape, with "IV2" imprinted on one side and smooth
on the other side.
Dasatinib Accord Healthcare 70 mg: the film-coated tablet is from white to almost
white, biconvex, approximately 8.7 mm in diameter, round in shape, with "IV3" imprinted on one side and smooth on the
other side.
Dasatinib Accord Healthcare 80 mg: the film-coated tablet is from white to almost
white, biconvex, approximately 10.20 x 9.95 mm, triangular in shape, with "IV4" imprinted on one side and
smooth on the other side.
Dasatinib Accord Healthcare 100 mg: the film-coated tablet is from white to almost
white, biconvex, approximately 14.70 x 7.10 mm, oval in shape, with "IV5" imprinted on one side and smooth
on the other side.
The film-coated tablet is from white to almost white,
biconvex, approximately 10.9 mm in diameter, round in shape, with "IV6" imprinted on one side and smooth on the other side.
Dasatinib Accord Healthcare 20 mg and 50 mg film-coated tablets are available in packs
containing 56 or 60 film-coated tablets in blisters, and in packs 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 packs containing
56 or 60 film-coated tablets in blisters, and in packs 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 packs
containing 30 or 56 film-coated tablets in blisters, and in packs 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 packs
containing 30 or 56 film-coated tablets, and in packs containing 30 x 1 or 56 x 1 film-coated tablets
in unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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
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/ .