Dasatinib stada

Package leaflet: Information for the user

Dasatinib Stada, 20 mg, coated tablets
Dasatinib Stada, 50 mg, coated tablets
Dasatinib Stada, 70 mg, coated tablets
Dasatinib Stada, 80 mg, coated tablets
Dasatinib Stada, 100 mg, coated tablets
Dasatinib Stada, 140 mg, coated tablets
Dasatinibum
Please read this leaflet carefully before 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Dasatinib Stada is and what it is used for

Dasatinib Stada contains the active substance dasatinib. This medicine is used to treat chronic
myeloid leukaemia (CML) in adults, adolescents and children aged at least 1 year. Leukaemia is a
cancer of the white blood cells. Normally, white blood cells help the body fight infections. In people
with CML, white blood cells called granulocytes grow uncontrollably. Dasatinib Stada helps to inhibit
the growth of these leukaemia cells.
Dasatinib Stada is also used to treat Philadelphia chromosome-positive (Ph+) acute lymphoblastic
leukaemia (ALL) in adults, adolescents and children aged at least 1 year, as well as for the treatment
of the lymphoblastic phase of blast crisis CML in adults who have not responded to prior therapy. In
patients with acute lymphoblastic leukaemia, white blood cells called lymphocytes multiply too quickly
and live too long. Dasatinib Stada inhibits the growth of these leukaemia cells.
If you have any questions about how Dasatinib Stada works or why this medicine has been prescribed
for you, please consult your doctor.

2. Important information before using Dasatinib Stada

When not to use Dasatinib Stada

• if the patient is allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6). Consult a doctor if allergy is suspected.

Warnings and precautions
Before starting treatment with Dasatinib Stada, discuss this with your doctor or pharmacist.

• if the patient is taking blood-thinning medicines or medicines that prevent blood clots (see section "Dasatinib Stada with other medicines");
• if the patient has previously or currently has liver or heart function disorders;
• if the patient develops difficulty breathing, chest pain or cough while taking dasatinib: these may be symptoms of fluid buildup in the lungs or chest cavity (which may occur more frequently in patients aged 65 years and older) or caused by changes in blood vessels supplying blood to the lungs;
• if the patient has ever been diagnosed with hepatitis B virus infection or currently suspects such infection, because dasatinib may reactivate hepatitis B, in some cases leading to death. Before starting treatment, the doctor will carefully check whether the patient has this infection;
• if bruising, bleeding, fever, fatigue or confusion occur during treatment with Dasatinib Stada, contact the doctor immediately. These may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).

During treatment, the doctor will perform periodic health checks to assess whether dasatinib is producing the intended effect. Regular blood tests will also be performed during treatment with Dasatinib Stada.

Children and adolescents
This medicine should not be used in children under 1 year of age. Data on the use of dasatinib in this age group are limited. Growth and development should be closely monitored in children receiving Dasatinib Stada.

Dasatinib Stada with other medicines
Tell your doctor about all medicines currently used, recently used, or planned for use.

Dasatinib is mainly metabolized in the liver. Certain medicines may affect the action of dasatinib when used concomitantly.

Do not use the following medicines with dasatinib:

• ketoconazole, itraconazole – these are antifungal medicines;
• erythromycin, clarithromycin, telithromycin – these are antibiotics;
• ritonavir – this is an antiviral medicine;
• phenytoin, carbamazepine, phenobarbital – these are medicines used in the treatment of epilepsy;
• rifampicin – this is a medicine used in the treatment of tuberculosis;
• famotidine, omeprazole – these are medicines that block gastric acid secretion;
• St. John's wort – herbal medicines available without prescription, used in the treatment of depression and other conditions (also known as Hypericum perforatum).

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

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

Taking Dasatinib Stada with food and drink
Do not take dasatinib with grapefruit or grapefruit juice.

Pregnancy and breastfeeding
Patients who are pregnant or suspect they may have become pregnant should immediately inform their doctor. Dasatinib should not be used during pregnancy unless absolutely necessary. The doctor will discuss with the patient the potential risks of taking dasatinib during pregnancy.

Both men and women should use effective contraception during treatment with dasatinib.

Inform your doctor if you are breastfeeding. Breastfeeding must not be performed while taking dasatinib.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, particular caution should be exercised when driving or operating machinery.

Dasatinib Stada contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Dasatinib Stada contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Dasatinib Stada

Dasatinib Stada may only be prescribed by a physician experienced in the treatment of
leukemia. This medicine must always be taken exactly as directed by the physician. If in doubt,
consult the physician or pharmacist. Dasatinib Stada is prescribed to adults, adolescents, and children aged at least 1 year.
The recommended initial dose of Dasatinib Stada for adult patients in the chronic phase of CML is
100 mg once daily.
The recommended initial dose of Dasatinib Stada for adult patients in the accelerated phase or
blast phase of CML, or with Ph+ ALL, is 140 mg once daily.
Dosing in children with chronic phase CML or Ph+ ALL is based on body weight.
Dasatinib is administered orally once daily in the form of tablets or oral suspension powder. The use of Dasatinib Stada tablets is not recommended in patients with body weight less than 10 kg. In patients with body weight less than 10 kg and in patients unable to swallow tablets, the oral suspension powder should be used. When switching between formulations (i.e. tablets and oral suspension powder), a dose adjustment may be necessary; therefore, one formulation should not be changed to the other without medical advice.
Based on the patient's body weight, adverse effects, and response to treatment, the physician will determine the appropriate formulation and dose. The initial dose of Dasatinib Stada in children is calculated according to body weight as shown below:
Body weight (kg) Daily dose (mg)
10 to less than 20 kg 40 mg
20 to less than 30 kg 60 mg
30 to less than 45 kg 70 mg
at least 45 kg 100 mg
The use of tablets is not recommended in patients with body weight less than 10 kg; in these patients, the oral suspension powder should be used.
There are no dosage recommendations for Dasatinib Stada in children under 1 year of age.
Depending on the response to treatment, the physician may decide to increase or reduce the dose, or even temporarily interrupt treatment. To achieve higher or lower doses, it may be necessary to use several tablets of different strengths.
How to use Dasatinib Stada
Tablets should be taken daily at the same time. Tablets must be swallowed whole. They must not be
crushed, cut, or chewed. Do not take fragmented tablets. If tablets are crushed, cut, chewed, or otherwise fragmented, there is no guarantee that the patient will receive the correct dose. Dasatinib Stada may be taken with or without food.
Special handling instructions for Dasatinib Stada
It is unlikely that Dasatinib Stada tablets will be damaged. However, if this occurs, individuals other than the patient who come into contact with Dasatinib Stada should wear protective gloves.
How long to use Dasatinib Stada
Dasatinib Stada should be taken daily until the physician decides that treatment should be discontinued. Ensure that Dasatinib Stada is taken for as long as recommended by the physician.
Overdose of Dasatinib Stada
If a patient accidentally takes more tablets than recommended, the physician must be informed immediately, as the patient may require medical attention.
Missed dose of Dasatinib Stada
Do not take a double dose to make up for a missed tablet. Take the next scheduled dose at the usual time.
If there are any further questions about the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
All of the symptoms listed below may indicate serious adverse reactions:

• if chest pain, difficulty breathing, cough, or fainting occur;
• if unexpected bleeding or bruising occurs without prior injury;
• if blood is present in vomit, stool, or urine, or if the stool is black in colour;
• if signs of infection such as fever or severe chills occur;
• if fever, mouth or throat pain, development of blisters, or peeling of the skin and/or mucous membranes occur. You should contact your doctor immediately if any of the above symptoms occur.

Very common adverse reactions ( may affect more than 1 in 10 people )

• Infections (including bacterial, viral, and fungal infections)
• Heart and lung disorders: shortness of breath
• Gastrointestinal disorders: diarrhoea, nausea, or vomiting
• Skin, hair, eyes, general symptoms: skin rash, fever, swelling of the face, hands, and feet, headache, feeling tired or weak, bleeding
• Pain: muscle pain (during or after treatment), abdominal pain
• Additional tests may show: low platelet count, low white blood cell count (neutropenia), anaemia, fluid around the lungs

Common adverse reactions ( may affect up to 1 in 10 people )

• Infections: pneumonia, herpes virus infection (including cytomegalovirus (CMV) infection), upper respiratory tract infections, severe blood or tissue infection (including uncommon cases resulting in death)
• Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weakening of the heart muscle, high blood pressure, increased blood pressure in the lungs, cough
• Gastrointestinal disorders: loss of appetite, taste disturbances, bloated or enlarged abdomen, inflammation of the large intestine, constipation, heartburn, mouth ulcers, weight gain, weight loss, stomach inflammation
• Skin, hair, eyes, general symptoms: tingling, skin itching, dry skin, acne, skin inflammation, persistent ringing in the ears (tinnitus), hair loss, excessive sweating, vision disturbances (including blurred or impaired vision), dry eyes, bruising, depression, insomnia, sudden flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalised swelling
• Pain: joint pain, muscle weakness, chest pain, pain in arms and legs, chills, muscle and joint stiffness, muscle cramps
• Additional tests may show: fluid around the heart, fluid in the lungs, heart rhythm disturbances, decreased white blood cell count (neutropia) with fever, gastrointestinal bleeding, high levels of uric acid in the blood

Uncommon adverse reactions ( may affect up to 1 in 100 people )

• Heart and lungs: heart attack (including fatal cases), inflammation of the lining (fibrous sac) around the heart, irregular heartbeat, chest pain due to reduced blood flow to the heart (angina), low blood pressure, narrowing of the airways causing breathing difficulties, asthma, increased blood pressure in the arteries (blood vessels) of the lungs
• Gastrointestinal disorders: pancreatitis, peptic ulcer disease, oesophagitis, abdominal swelling, anal fissures, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastro-oesophageal reflux (a condition in which acid and other stomach contents flow back into the throat)
• Skin, hair, eyes, general symptoms: allergic reactions, including tenderness on pressure, red skin nodules (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremor, eye inflammation causing redness or pain, skin disease characterised by tenderness, redness, and appearance of distinct erythematous patches with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, visual disturbances, excessive tearing of the eyes, skin colour changes, inflammation of the subcutaneous fat tissue, skin ulceration, blistering of the skin, nail disorders, hair disorders, disorders of hands and feet, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, reduced thyroid function, loss of balance while walking, bone necrosis (a disease characterised by reduced blood flow to the bone, which may lead to loss of bone tissue and bone death), joint inflammation, skin swelling anywhere on the body
• Pain: vein inflammation (phlebitis), which may cause redness, pain, and swelling; tendon inflammation (tendinitis)
• Brain: memory loss
• Additional tests may show: abnormal blood test results and possible kidney dysfunction due to remnants of dying tumour cells (tumour lysis syndrome), low blood albumin levels, low lymphocyte count (a type of white blood cell), high blood cholesterol levels, swollen lymph nodes, brain haemorrhage, abnormalities in the heart's electrical activity, enlarged heart, liver inflammation, protein in the urine, increased creatine phosphokinase activity (an enzyme mainly present in the heart, brain, and skeletal muscles), increased troponin activity (an enzyme mainly present in the heart and skeletal muscles), increased gamma-glutamyl transferase activity (an enzyme mainly present in the liver), milky fluid around the lungs (chylothorax)

Rare adverse reactions ( 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 (myocarditis), syndrome of symptoms due to blocked blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (cessation of the heart's pumping action), coronary artery disease (heart), inflammation of the tissue covering the heart and lungs, blood clots, pulmonary embolism (blood clots in the lungs)
• Gastrointestinal disorders: loss of essential nutrients from the gastrointestinal tract such as proteins, intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and the skin around the anus), kidney dysfunction, diabetes
• Skin, hair, eyes, general symptoms: seizures, optic neuritis (which may cause complete or partial vision loss), blue-violet skin spots, abnormally high thyroid function, thyroid inflammation, ataxia (a condition associated with lack of muscular coordination), difficulty walking, miscarriage, cutaneous vasculitis (inflammation of blood vessels in the skin), skin fibrosis
• Brain: stroke, transient neurological deficits due to impaired blood flow, facial nerve paralysis, dementia
• Immune system: severe allergic reaction
• Musculoskeletal and connective tissue system: delayed healing of rounded ends of bones forming joints (epiphyses); slowed or delayed growth

Other observed adverse reactions with unknown frequency (frequency cannot be estimated from the available data ):

• Pneumonitis (lung inflammation)
• Bleeding in the stomach or intestines, which may lead to death
• Reactivation of hepatitis B virus infection in patients who have previously had this disease
• Reaction with fever, skin blisters, and mucosal ulceration
• Kidney disease with symptoms including swelling 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 reduced number of red blood cells, reduced platelet count, and blood clot formation

During treatment, your doctor will monitor for the occurrence of the adverse reactions listed above.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dasatinib Stada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle,
blister pack, or carton after "EXP". The expiry date refers to the last day of the stated month.
The abbreviation "Lot" on the label of the bottle, blister pack, or carton means "Batch number".
There are no special storage requirements for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Dasatinib Stada contains

• The active substance is dasatinib. Each coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg of dasatinib.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate (see section 2 "Important information before taking Dasatinib Stada"); sodium croscarmellose, hydroxypropylcellulose, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, glyceryl monostearate, sodium lauryl sulfate.

What Dasatinib Stada looks like and contents of the pack
Dasatinib Stada 20 mg: The coated tablet is white or almost white, biconvex, round,
with an embossed mark "20" on one side and smooth on the other side, with a diameter of 6.1 mm.
Dasatinib Stada 50 mg: The coated tablet is white or almost white, biconvex, oval,
with an embossed mark "50" on one side and smooth on the other side, with dimensions of
10.9 mm x 5.8 mm.
Dasatinib Stada 70 mg: The coated tablet is white or almost white, biconvex, round,
with an embossed mark "70" on one side and smooth on the other side, with a diameter of 8.9 mm.
Dasatinib Stada 80 mg: The coated tablet is white or almost white, biconvex, triangular,
with an embossed mark "80" on one side and smooth on the other side, with dimensions of
10.3 mm x 10.0 mm.
Dasatinib Stada 100 mg: The coated tablet is white or almost white, biconvex, oval,
with an embossed mark "100" on one side and smooth on the other side, with dimensions of
14.8 mm x 7.2 mm.
Dasatinib Stada 140 mg: The coated tablet is white or almost white, biconvex, round,
with an embossed mark "140" on one side and smooth on the other side, with a diameter of 11.8 mm.

Dasatinib Stada, 20 mg, 50 mg, 70 mg, coated tablets
Aluminium/OPA/Aluminium/PVC foil blisters (perforated blisters divisible into single doses).
Aluminium/OPA/Aluminium/PVC foil blisters.
High-density polyethylene (HDPE) bottles with child-resistant closure made of polypropylene and a plastic container (HDPE) containing a desiccant (silica gel).
Cardboard box containing 60 x 1 or 100 x 1 coated tablets in perforated blisters divisible into single doses.
Cardboard box containing 60 or 100 coated tablets in blisters.
Cardboard box containing a bottle with 60 coated tablets.

Dasatinib Stada, 80 mg, 100 mg, 140 mg, coated tablets
Aluminium/OPA/Aluminium/PVC foil blisters (perforated blisters divisible into single doses).
Aluminium/OPA/Aluminium/PVC foil blisters.
High-density polyethylene (HDPE) bottles with child-resistant closure made of polypropylene and a plastic container (HDPE) containing a desiccant (silica gel).
Cardboard box containing 30 x 1, 60 x 1 or 100 x 1 coated tablets in perforated blisters divisible into single doses.
Cardboard box containing 30, 60 or 100 coated tablets in blisters.
Cardboard box containing a bottle with 30 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Dasatinib EG 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, filmomhulde tabletten
Germany Dasatinib AL 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, Filmtabletten
Denmark Dasatinib STADA
Finland Dasatinib STADA 20, 50, 70, 80, 100, 140 mg kalvopäällysteiset tabletit
Italy Dasatinib EG
Luxembourg Dasatinib EG 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg comprimé pelliculé
The Netherlands Dasatinib CF 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, filmomhulde tabletten
Poland Dasatinib Stada
Sweden Dasatinib STADA 20, 50, 70, 80, 100, 140 mg filmdragerade tabletter