Dasatinib Sandoz

Leaflet attached to the packaging: patient information

Dasatinib Sandoz, 80 mg, film-coated tablets

Dasatinib

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Dasatinib Sandoz contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukemia (CML) in adults, adolescents, and children aged 1 year and older. Leukemia is a cancer of white blood cells - cells in the blood that usually help the body fight infections. In people with chronic myeloid leukemia, the number of white blood cells increases uncontrollably. Dasatinib Sandoz inhibits the development of these leukemic cells. Dasatinib Sandoz is also used to treat acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph+) and lymphoblastic blast crisis in CML in adults, adolescents, and children aged 1 year and older, in whom previous treatment has been ineffective. In people with acute lymphoblastic leukemia, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Sandoz inhibits the development of these leukemic cells. If you have any questions about how Dasatinib Sandoz works or why it has been prescribed for you, you should consult your doctor.

2. Important information before taking Dasatinib Sandoz

When not to take Dasatinib Sandoz

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

If you suspect that you may be allergic, you should consult your doctor.

Warnings and precautions

Before taking (or while taking) Dasatinib Sandoz, you should discuss it with your doctor or pharmacist if:

• you are taking medicines to thin your blood or prevent blood clots (see "Dasatinib Sandoz and other medicines");
• you have liver or heart problems or have had them in the past;
• you experience difficulty breathing, chest pain or cough while taking dasatinib;

chest pain or cough: these may be symptoms of fluid accumulation in the lungs or chest cavity (which may affect people aged 65 or older more frequently), or symptoms caused by changes in the blood vessels that supply blood to the lungs

• you have ever had or may currently have viral hepatitis B (dasatinib may cause reactivation of viral hepatitis B, which in some cases can be fatal). Before starting treatment, your doctor will carefully check if you have symptoms of this infection.
• while taking Dasatinib Sandoz, you experience bruising, bleeding, fever, fatigue, and confusion. You should contact your doctor, as these may be symptoms of blood vessel damage, known as thrombotic microangiopathy.

Your doctor will regularly check your condition to assess whether dasatinib is having the desired effect. While taking Dasatinib Sandoz, you will also have blood tests.

Children and adolescents

This medicine must not be given to children under 1 year of age. Experience with dasatinib in this age group is limited. In children treated with dasatinib, bone growth and development should be carefully monitored.

Dasatinib Sandoz and other medicines

You should tell your doctorabout all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Dasatinib is mainly converted in the liver. Some medicines taken at the same time may interfere with its effect.

The following medicines must not be taken with Dasatinib Sandoz:

• ketokonazole, itraconazole - antifungal medicines
• erythromycin, clarithromycin, telithromycin - antibiotics
• ritonavir - antiviral medicine
• phenytoin, carbamazepine, phenobarbital - medicines used to treat epilepsy
• rifampicin - a medicine used to treat tuberculosis
• famotidine, omeprazole - medicines that reduce stomach acid secretion
• St. John's Wort ( Hypericum perforatum) - a herbal medicine available without a prescription, used to treat depressionand other conditions.

Do not takemedicines that reduce stomach acid (such as medicines containing aluminum hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after takingDasatinib Sandoz.You should tell your doctorif you are taking blood-thinning medicinesor medicines to prevent blood clots.

Dasatinib Sandoz with food and drink

Do not take Dasatinib Sandoz with grapefruit or grapefruit juice.

Pregnancy and breastfeeding If you are pregnant or think you may be pregnant, you should tell your doctor immediately.

Dasatinib Sandoz must not be taken during pregnancyunless it is absolutely necessary. Your doctor will discuss with you the possible risks associated with taking dasatinib during pregnancy. Both men and women taking Dasatinib Sandoz are advised to use effective contraception during treatment. If you are breastfeeding, you should tell your doctor.While taking Dasatinib Sandoz, you should not breastfeed.

Driving and using machines

If you experience side effects such as dizziness and blurred vision, you should be careful when driving or operating machinery.

Dasatinib Sandoz contains lactose and sodium:

If you have been diagnosed with an intolerance to some sugars, you should tell your doctor before taking the medicine. This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Dasatinib Sandoz

Dasatinib Sandoz is prescribed only by a doctor with experience in treating leukemia. This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist. The medicine is used in adults and children aged 1 year and older.

The recommended initial dose for adult patients with chronic phase CML is 100 mg once daily.

The recommended initial dose for adult patients with accelerated phase or blast crisis CML or Philadelphia chromosome-positive acute lymphoblastic leukemia is 140 mg once daily.

Dosing in children with chronic phase CML or Philadelphia chromosome-positive acute lymphoblastic leukemia is based on body surface area.

The medicine is taken orally once daily. It is not recommended to use Dasatinib Sandoz tablets in patients with a body weight below 10 kg. For patients with a body weight below 10 kg and patients who cannot swallow tablets, a powder for oral suspension may be available. When changing the form of the medicine (i.e., tablets and powder for oral suspension), the dose may change, so you should not change one form of the medicine to another. Your doctor will determine the appropriate form of the medicine and its dose based on your body weight, side effects, and response to treatment. The initial dose of Dasatinib Sandoz is calculated based on body weight as follows: It is not recommended to administer tablets to patients with a body weight below 10 kg; for these patients, a powder for oral suspension may be available. There are no recommendations for dosing Dasatinib Sandoz in children under 1 year of age. Depending on the patient's response to treatment, the doctor may recommend taking a higher or lower dose, or even temporarily stopping treatment. To take higher or lower doses, it may be necessary to use a combination of tablets of different strengths.

Tablets may be available in calendar packs. These are blisters with the days of the week marked. Arrows indicate the next tablet to be taken according to the prescribed treatment schedule.

How to take Dasatinib Sandoz Tablets should be taken daily at the same time. Tablets should be swallowed whole, without

crushing, breaking, or chewing.You should not take a crushed tablet. If a tablet is crushed, broken, chewed, or crushed, you cannot be sure that you have taken the correct dose of the medicine. Dasatinib Sandoz can be taken with or without food.

Special instructions for handling Dasatinib Sandoz

Breaking Dasatinib Sandoz tablets is unlikely, but if it happens, people other than the patient should wear disposable gloves when handling the tablets.

How long to take Dasatinib Sandoz

Dasatinib Sandoz should be taken daily until your doctor tells you to stop. You should make sure that you take the medicine for as long as your doctor has prescribed.

Taking more than the recommended dose of Dasatinib Sandoz

If you accidentally take too many tablets, you should immediatelyconsult your doctor. Medical attention may be necessary.

Missing a dose of Dasatinib Sandoz

You should not take a double dose to make up for a missed tablet. The next dose of the medicine should be taken at the usual time. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Symptoms that may indicate a serious side effect:

• chest pain, difficulty breathing, cough, and fainting
• unexpected bleeding or bruisingwithout previous injury
• blood in vomit, stool, or urine, black stools
• infection symptoms, such as fever, severe chills
• fever, mouth or throat pain, blistering or peeling of the skin and (or) mucous membranes If you notice any of these symptoms, you should immediately contact your doctor.

Very common side effects (may affect more than 1 in 10 people)

• Infections(including bacterial, viral, and fungal infections)
• Heart and lungs: shortness of breath
• Digestive disorders:diarrhea, 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
• Test results:low platelet count, low white blood cell count (neutropenia), anemia, fluid accumulation around the lungs

Common side effects (may affect up to 1 in 10 people)

• Infections: pneumonia, viral infection (including cytomegalovirus - CMV), upper respiratory tract infection, severe blood or tissue infection (including rare cases that were fatal)

severe infection of the blood or tissues, which can be life-threatening

• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakening of the heart muscle, high blood pressure in the lungs, cough
• Digestive disorders:loss of appetite, taste disorders, bloating or abdominal distension, colitis, constipation, heartburn, mouth ulcers, weight gain, weight loss, stomach inflammation
• Skin, hair, eyes, general symptoms:tingling of the skin, itching, dry skin, acne, skin inflammation, ringing in the ears, hair loss, excessive sweating, vision disturbances (including double vision and vision disturbances), dry eyes, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling
• Pain:joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle stiffness and joint stiffness, muscle cramps
• Test results:fluid accumulation around the heart, fluid accumulation in the lungs, heart rhythm disturbances, 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 enlargement, heart muscle inflammation, a condition that occurs when the blood flow to the heart is blocked (acute coronary syndrome), cardiac arrest (when the heart stops pumping blood), ischemic heart disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
• Digestive disorders:malabsorption of nutrients from the digestive tract, intestinal obstruction, anal fistula (an abnormal passage between the anus and the skin surrounding it), kidney problems, diabetes
• Skin, hair, eyes, general symptoms:seizures, optic nerve inflammation, which can cause total or partial loss of vision, purple spots on the skin, excessive thyroid function, thyroid inflammation, ataxia (a condition related to lack of muscle coordination), difficulty walking, miscarriage, blood vessel inflammation, skin scarring
• Pain:vein inflammation, which can cause redness, tenderness, and swelling, tendon inflammation
• Brain:stroke, a temporary episode of neurological disturbances due to lack of blood flow, facial nerve paralysis, dementia
• Immune system:severe allergic reaction
• Musculoskeletal and connective tissue disorders:delayed closure of the growth plates in bones, which form joints; slowed or delayed growth

Other reported side effects include ( frequency not known - cannot be estimated from the available data):

• pneumonia
• stomach or intestinal bleeding, which can be fatal
• reactivation of viral hepatitis B in patients who have had it before
• a reaction that occurs with fever, blistering of the skin, and ulcers of the mucous membranes
• kidney disease with symptoms including swelling and abnormal test results, such as protein in the urine and low protein levels in the blood.
• blood vessel damage known as thrombotic microangiopathy, including low red blood cell count, low platelet count, and blood clots.

While taking the medicine, your doctor will monitor you for some of these side effects.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dasatinib Sandoz

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the bottle, blister, and carton after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dasatinib Sandoz contains

• The active substance is dasatinib. Each film-coated tablet contains 80 mg of dasatinib.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate Coating:polyvinyl alcohol, titanium dioxide (E 171), talc, glycerol monostearate, sodium lauryl sulfate.

What Dasatinib Sandoz looks like and contents of the pack

White or almost white, biconvex, triangular film-coated tablets with dimensions 10.3 mm x 10.0 mm, with "80" embossed on one side and smooth on the other side. The film-coated tablets are packaged in a single-dose blister pack with aluminum/OPA/aluminum/PVC foil and placed in a cardboard box. Pack sizes: The cardboard box contains 30 x 1 film-coated tablets in single-dose blisters.

Marketing authorization holder

Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Remedica Ltd. Aharnon Street, Limassol Industrial Estate 3056 Limassol, Cyprus

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, you should contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00

Date of last revision of the leaflet: 06/2023

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