Dasatinib Sandoz

Leaflet accompanying the packaging: patient information

Dasatinib Sandoz, 140 mg, film-coated tablets

Dasatinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, 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 those not listed in this leaflet, they should inform 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 above. 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 leukemia cells. Dasatinib Sandoz is also used to treat acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph+) and lymphoblastic blast crisis of CML in adults, adolescents, and children aged 1 year and above, 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 leukemia cells. If you have any questions about how Dasatinib Sandoz works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Dasatinib Sandoz

When not to take Dasatinib Sandoz

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

If it is suspected that the patient may be allergic, consult a doctor.

Warnings and precautions

Before taking (or during) Dasatinib Sandoz, discuss with your doctor or pharmacist if:

• the patient is taking blood thinning medicinesor medicines to prevent blood clots (see "Dasatinib Sandoz and other medicines");
• the patient has liver or heart problems or has had them in the past;
• the patient experiences breathing difficulties, chest pain or cough

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 blood vessels supplying blood to the lungs

• the patient has 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, the doctor will carefully check if the patient has symptoms of this infection.
• while taking Dasatinib Sandoz, the patient experiences bruising, bleeding, fever, fatigue, and confusion. Contact a doctor, as these may be symptoms of blood vessel damage, known as thrombotic microangiopathy.

The doctor will regularly monitor the patient's condition to assess whether dasatinib is having the desired effect. While taking Dasatinib Sandoz, the patient 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

Tell your doctorabout all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Dasatinib is mainly broken down 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 - medicine used to treat tuberculosis
• famotidine, omeprazole - medicines that reduce stomach acid
• St. John's Wort ( Hypericum perforatum) - herbal medicine available without prescription, used to treat depressionand other conditions.

Do not takemedicines that reduce stomach acid (such as medicines containing aluminum or magnesium hydroxide) within 2 hours before or 2 hours after takingDasatinib Sandoz.Tell your doctorif the patient is 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 the patient is pregnant or thinks she may be pregnant, she should

tell her doctor immediately.Dasatinib Sandoz must not be taken during pregnancy, unless it is absolutely necessary. The doctor will discuss with the patient the possible risk associated with taking dasatinib during pregnancy. Both men and women taking Dasatinib Sandoz are advised to use effective contraception during treatment. If a woman is breastfeeding, she should tell her doctor.While taking Dasatinib Sandoz, do not breastfeed.

Driving and using machines

If the patient experiences side effects such as dizziness and blurred vision, they should be careful when driving or operating machinery.

Dasatinib Sandoz contains lactose and sodium

If the patient has been told that they have an intolerance to some sugars, they should tell their doctor before taking the medicine. This medicine contains less than 1 mmol (23 mg) of sodium per dose, 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 exactly as prescribed by the doctor. If you have any doubts, consult a doctor or pharmacist. The medicine is used in adults and children aged 1 year and above.

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 Ph+ ALL is 140 mg once daily.

The dosage for children with CML in chronic phase or Ph+ ALL is based on body weight.

The medicine is taken orally once daily. It is not recommended to take 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 do not change one form of the medicine to another. The doctor will determine the appropriate form and dose of the medicine for the patient based on 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. No dosing recommendations have been established for children under 1 year of age. Depending on the patient's response to treatment, the doctor may recommend a higher or lower dose, or even a temporary interruption of 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 every day at the same time. Tablets should be swallowed whole, without

crushing, breaking, or chewing.Do not take a crushed tablet. If a tablet is crushed, broken, chewed, or crushed, it cannot be guaranteed that the correct dose of the medicine has been taken. Dasatinib Sandoz can be taken with or without food.

Special instructions for handling Dasatinib Sandoz

Breaking a Dasatinib Sandoz tablet 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 every day until the doctor recommends stopping the medicine. Make sure the medicine is taken for as long as the doctor has prescribed.

Taking a higher dose of Dasatinib Sandoz than recommended

If too many tablets are taken by mistake, contact a doctor immediately.Medical attention may be necessary.

Missing a dose of Dasatinib Sandoz

Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time. If you have any further doubts about taking this medicine, consult a 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, breathing difficulties, 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 skin and (or) mucous membranes If you notice any of these symptoms, contact a doctor immediately.

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, facial swelling, hand and foot swelling, 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 around the lungs

Common side effects (may affect less than 1 in 10 people)

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

severe blood or tissue infection (including rare cases that have been fatal), upper respiratory tract infection, viral infection (including cytomegalovirus - CMV), pneumonia

• 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, gastritis
• 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), anorexia, somnolence, generalized edema
• Pain:joint pain, muscle weakness, chest pain, hand and foot pain, chills, muscle stiffness and joint stiffness, muscle cramps
• Test results:fluid around the heart, fluid in the lungs, heart rhythm disorders, febrile neutropenia, gastrointestinal bleeding, high uric acid levels in the blood

Uncommon side effects (may affect less than 1 in 100 people)

• Heart and lungs:enlargement of the right heart chamber, heart muscle inflammation, acute coronary syndrome (a condition caused by blockage of blood flow to the heart muscle), cardiac arrest (stop of blood flow from the heart), ischemic heart disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs

blood clots in the lungs, blood clots, inflammation of the tissue covering the heart and lungs, cardiac arrest (stop of blood flow from the heart), acute coronary syndrome (a condition caused by blockage of blood flow to the heart muscle), heart muscle inflammation, enlargement of the right heart chamber

• Digestive disorders:malabsorption of nutrients from the digestive tract, such as protein, intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and the surrounding skin), kidney dysfunction, diabetes
• Skin, hair, eye, general symptoms:seizures, optic neuritis (which can cause total or partial loss of vision), presence of blue-purple spots on the skin, abnormal overactivity of the thyroid gland, thyroid inflammation, ataxia (a condition related to lack of muscle coordination), difficulty walking, miscarriage, skin vessel inflammation, skin fibrosis
• Brain:stroke, transient neurological disorders 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 the bones (epiphyses), which form the joints; slowing or delay of bone growth

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

• pneumonia
• stomach or intestinal bleeding, which can be fatal
• reactivation (relapse) of viral hepatitis B in patients who have had this infection in the past
• a reaction characterized by 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.

During treatment with the medicine, the doctor will monitor the occurrence of some of these side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, 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

Keep the medicine out of the 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 storage. Medicines should not be disposed of via wastewater or household waste. 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 140 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, round film-coated tablets with a diameter of 11.8 mm, with "140" embossed on one side and smooth on the other. 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, 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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