Dasatinib Sandoz

Leaflet accompanying the packaging: patient information

Dasatinib Sandoz, 20 mg, film-coated tablets

Dasatinib

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

• 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 those not listed in this leaflet, please tell your 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 normally help the body fight infection. In people with chronic myeloid leukemia, the number of white blood cells increases in an uncontrolled way. 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 failed. 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 you are allergic to dasatinib or 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

Before taking (or while taking) Dasatinib Sandoz, discuss 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 retention in the lungs or chest (which may affect people aged 65 or older more often), 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 any symptoms of this infection.
• while taking Dasatinib Sandoz, you experience bruising, bleeding, fever, fatigue, and confusion. Contact your doctor, as these may be signs 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

Tell your doctorabout all medicines you are taking or have recently taken, as well as any medicines you plan to take. Dasatinib is mainly broken down in the liver. Some medicines taken at the same time may interfere with its effects.

Medicines that 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) - a herbal medicine available without a prescription, used to treat depressionand other conditions.

Do not takemedicines that reduce stomach acid (such as those containing aluminum hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after takingDasatinib Sandoz.
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, tell your doctor immediately.

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

Driving and using machines

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

Dasatinib Sandoz contains lactose and sodium

If you have been told that you have an intolerance to some sugars, tell your doctor before taking this 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 exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. The medicine is taken by 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 with Philadelphia chromosome-positive acute lymphoblastic leukemia is 140 mg once daily.

The dosage for children with chronic phase CML or with Philadelphia chromosome-positive acute lymphoblastic leukemia 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 formulation (i.e., tablets and powder for oral suspension), the dose may need to be changed, so do not change one formulation to another. Your doctor will determine the appropriate formulation and dose for you 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 the use of Dasatinib Sandoz in children under 1 year of age. Depending on the response to treatment, your 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 your doctor tells you to stop. Make sure you take the medicine for as long as your doctor has told you.

Taking more Dasatinib Sandoz than prescribed

If you accidentally take too many tablets, contact your 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 questions about taking 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.

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 skin and (or) mucous membranes If you notice any of these symptoms, contact your 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, 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 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 have been fatal)
• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakening of the heart muscle, high blood pressure in the lungs, cough

Uncommon side effects (may affect up to 1 in 100 people)

• Heart and lungs:heart attack (including cases that have been fatal), inflammation of the sac (fibrous bag) surrounding the heart, irregular heart rhythm, 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) in the lungs
• Digestive disorders:pancreatitis, stomach ulcer, esophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastroesophageal reflux disease (a condition in which acid and stomach contents back up into the esophagus)
• Skin, hair, eyes, general symptoms:allergic reaction, including the development of painful, red lumps on the skin (erythema nodosum), restlessness, confusion, mood changes, decreased sex drive, fainting, tremors, eye inflammation causing redness or pain, skin disease characterized by the presence of sensitive, red, blistering skin with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, blurred vision, increased tearing, skin discoloration, inflammation of the fatty tissue under the skin, skin ulcers, blistering skin, nail disorders, hair disorders, hand-foot syndrome, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, hypothyroidism, balance disorders while walking, bone death (a disease in which there is a reduced blood supply to the bone, resulting in bone tissue loss and death), joint inflammation, skin swelling at any site
• Pain:vein inflammation that can cause redness, tenderness, and swelling, tendon inflammation
• Brain:memory loss
• Test results:abnormal blood test results and possible kidney function disorders due to tumor breakdown products (tumor lysis syndrome), low albumin levels in the blood, low lymphocyte count (a type of white blood cell) in the blood, high cholesterol levels in the blood, lymph node swelling, brain bleeding, irregular heart rhythm, heart muscle enlargement, liver inflammation, protein in the urine, increased creatine kinase activity (an enzyme mainly found in the heart, brain, and skeletal muscles), increased troponin levels (a protein mainly found in heart and skeletal muscles), increased gamma-glutamyltransferase activity (an enzyme mainly found in the liver), milky fluid around the lungs (chylous effusion)

Rare side effects (may affect up to 1 in 1000 people)

• Heart and lungs:enlargement of the right heart chamber, heart muscle inflammation, a condition characterized by blockage of blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (stop of heart function), coronary artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
• Digestive disorders:loss 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 function disorders, diabetes

Unknown frequency side effects (cannot be estimated from the available data)

• lung inflammation
• stomach or intestinal bleeding that can be fatal
• reactivation (relapse) of viral hepatitis B in patients who have had it before
• a reaction characterized by fever, blistering skin, and mucous membrane ulcers
• 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, your doctor will monitor you for some of these side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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 this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle, blister, and carton after 'EXP'. The expiry date refers to the last day of that month. There are no special storage instructions 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. 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 20 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 6.1 mm, with "20" engraved 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 60 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 this medicine and its authorized names in 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
Company logo