DASATINIB SANDOZ

Package leaflet: Information for the patient

Dasatinib Sandoz, 80 mg, film-coated tablets
Dasatinibum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Dasatinib Sandoz is and what it is used for
2. What you need to know 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 Dasatinib Sandoz is and what it is 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 at least 1 year. Leukemia is a cancer of the white blood cells – blood cells that normally help the body fight infections. In people with chronic myeloid leukemia, the number of white blood cells increases uncontrollably. Dasatinib Sandoz inhibits the growth of these leukemic cells.

Dasatinib Sandoz is also used to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and lymphoblastic blast crisis phase of CML in adults, adolescents, and children aged at least 1 year, in whom prior therapy has failed. In people with acute lymphoblastic leukemia, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Sandoz inhibits the growth of these leukemic cells.

If you have any questions about how Dasatinib Sandoz works or why it has been prescribed for you, please consult your doctor.

2. Important information before using Dasatinib Sandoz

When not to use Dasatinib Sandoz

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

If you suspect that the patient may be allergic, consult a doctor.
Warnings and precautions
Before taking (or while using) Dasatinib Sandoz, discuss with the doctor or pharmacist if:

• the patient is taking medicines to thin the blood or prevent blood clots (see "Dasatinib Sandoz and other medicines");
• the patient has or has had liver or heart problems;
• the patient experiences difficulty breathing, chest pain or cough during treatment with dasatinib: these may be symptoms of fluid retention in the lungs or chest cavity (which may occur more frequently in patients aged 65 years or older), or symptoms caused by changes in blood vessels supplying blood to the lungs;
• the patient has ever had or may currently have hepatitis B virus infection (dasatinib may cause reactivation of hepatitis B virus, which in some cases may lead to death). Before starting treatment, the doctor will carefully check whether the patient shows signs of this infection;
• the patient develops bruising, bleeding, fever, fatigue or confusion during treatment with Dasatinib Sandoz. Contact the doctor immediately, 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 undergo regular blood tests.
Children and adolescents
This medicine must not be given to children under 1 year of age. Experience with the use of dasatinib in this age group is limited. In children treated with dasatinib, bone growth and development should be closely monitored.
Dasatinib Sandoz and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Dasatinib is mainly metabolized in the liver. Some concomitant medicines may interfere with its action.
The following medicines should not be taken together with Dasatinib Sandoz:

• ketoconazole, itraconazole – antifungal medicines
• erythromycin, clarithromycin, telithromycin – antibiotics
• ritonavir – antiviral medicine
• phenytoin, carbamazepine, phenobarbital – medicines used in the treatment of epilepsy
• rifampicin – medicine used in the treatment of tuberculosis
• famotidine, omeprazole – medicines that reduce stomach acid secretion
• St. John's wort (Hypericum perforatum) – herbal medicine available without prescription, used in the treatment of depression and other conditions.

Do not take medicines that neutralize stomach acid (such as those containing aluminium hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib Sandoz.
Tell the doctor if the patient is taking medicines that thin the blood or 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 suspects she may be pregnant, she should inform the doctor immediately. Dasatinib Sandoz must not be used during pregnancy, unless absolutely necessary. The doctor will discuss with the patient the potential risks associated with using 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 inform the doctor. Breastfeeding must not be continued while taking Dasatinib Sandoz.
Driving and using machines
If the patient experiences adverse effects such as dizziness or blurred vision, particular caution should be exercised when driving or operating machinery.
Dasatinib Sandoz contains lactose and sodium:
If the patient has previously been diagnosed with intolerance to certain sugars, inform the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Dasatinib Sandoz

Dasatinib Sandoz is prescribed only by a physician experienced in the treatment of leukemia. This medicine must always be taken exactly as directed by the physician. In case of doubts, consult the physician or pharmacist. The medicine is used in adults and in children aged at least 1 year.
The recommended initial dose for adult patients with chronic phase chronic myeloid leukemia is 100 mg once daily.
The recommended initial dose for adult patients with accelerated phase or blast phase chronic myeloid leukemia, or with Philadelphia chromosome-positive acute lymphoblastic leukemia, is 140 mg once daily.
Dosing in children with chronic phase chronic myeloid leukemia or with Philadelphia chromosome-positive acute lymphoblastic leukemia is based on body weight.
The medicine is administered orally once daily. Use of Dasatinib Sandoz tablets is not recommended in patients weighing less than 10 kg. For patients weighing less than 10 kg and for patients who cannot swallow tablets, an oral suspension powder may be available. When switching between formulations (i.e., tablets and oral suspension powder), the dose may change; therefore, one formulation should not be substituted for the other.
The physician determines the appropriate formulation and dose for the patient based on body weight, adverse reactions, and response to treatment. The initial dose of Dasatinib Sandoz according to body weight is provided below:

It is not recommended to administer tablets to patients with body weight below 10 kg; for these patients, an oral suspension powder may be available.
Dosage recommendations for Dasatinib Sandoz in children under 1 year of age have not been established.
Depending on the patient's response to treatment, the doctor may recommend taking a higher or lower dose, or even temporarily interrupting treatment. To achieve higher or lower doses, it may be necessary to use a combination of tablets with different strengths.
Tablets may be available in calendar packs. These are blister packs labeled with days of the week. 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 must be swallowed whole, without
crushing, breaking, or chewing. Do not take a crushed tablet. If a tablet is crushed, broken, chewed, or fragmented, it cannot be ensured that the correct dose of the medicine has been taken. Dasatinib Sandoz can be taken with food or independently of meals.
Special instructions for handling Dasatinib Sandoz tablets
Breaking Dasatinib Sandoz tablets is unlikely, but if it occurs, individuals 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 the doctor advises stopping the treatment. Ensure that the medicine is taken for as long as directed by the doctor.
Taking more than the recommended dose of Dasatinib Sandoz
If too many tablets are accidentally taken, seek medical advice immediately. Medical assistance may be required.
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 concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Symptoms which may indicate a serious adverse reaction:

• chest pain, difficulty breathing, cough and fainting
• unexpected bleeding or bruising without prior injury
• presence of blood in vomit, faeces or urine, tarry stools
• signs of infection, such as fever, severe chills
• fever, mouth or throat pain, development of blisters or peeling of the skin and (or) mucous membranes
  If any of the symptoms listed above occur, immediately contact a doctor.

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

• Infections (including bacterial, viral and fungal infections)
• Heart and lungs: 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 of fatigue or weakness, bleeding
• Pain: muscle pain (during treatment or after its completion), abdominal pain
• Test results: low platelet count, low white blood cell count (neutropenia), anaemia, presence of fluid around the lungs

Common adverse reactions (may affect less than 1 in 10 people)

• Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV),
  upper respiratory tract infection, 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 in the lungs, cough

• Gastrointestinal disorders: loss of appetite, taste disturbances, bloating or abdominal distension, inflammation of the large intestine, constipation, heartburn, mouth ulcers, weight gain, weight loss, inflammation of the gastric mucosa

• Skin, hair, eyes, general symptoms: skin tingling, itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, vision disturbances (including double vision and visual disturbances), dry eyes, bruising, depression, insomnia, sudden flushing of the skin, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling

• Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle and joint stiffness, muscle cramps

• Test results: presence of fluid around the heart, presence of fluid in the lungs, heart rhythm disturbances, neutropenic fever, gastrointestinal bleeding, high blood uric acid levels

Uncommon adverse reactions (may affect less than 1 in 100 people)

• Heart and lungs: heart attack (including fatal cases), inflammation of the lining (fibrous sac) around the heart, irregular heart function, chest pain due to lack of blood supply to the heart (angina pectoris), low blood pressure, narrowing of the airways which may cause breathing difficulties, asthma, increased blood pressure in the arteries (blood vessels) in the lungs
• Gastrointestinal disorders: pancreatitis, peptic ulcer, oesophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, obstruction of bile ducts, gastro-oesophageal reflux (a condition in which acid and stomach contents flow back from the stomach into the oesophagus)
• Skin, hair, eyes, general symptoms: allergic reaction, including formation of tender, red nodules on the skin (erythema nodosum), restlessness, confusion, mood changes, decreased libido, fainting, tremor, eye inflammation causing redness or pain, skin disease characterized by the presence of tender, red blisters with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, worsening vision, increased tearing, skin pigmentation disorders, inflammation of subcutaneous fat tissue, skin ulceration, blistering of the skin, nail disorders, hair disorders, hand-foot syndrome, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, hypothyroidism, balance disturbances while walking, bone necrosis (a condition in which reduced blood supply to the bone causes loss of bone tissue and its death), joint inflammation, localized skin swelling
• Pain: vein inflammation which may cause redness, tenderness and swelling, tendon inflammation
• Brain: memory loss
• Test results: abnormal blood test results and possible kidney function disturbances caused by tumor breakdown products (tumor lysis syndrome), low blood albumin levels, low lymphocyte count (a type of white blood cell) in blood, high blood cholesterol levels, swollen lymph nodes, bleeding within the brain, irregular electrical activity of the heart, enlargement of the heart muscle, liver inflammation, presence of protein in urine, increased creatine kinase activity (an enzyme mainly present in the heart, brain and skeletal muscles), increased troponin levels (a protein mainly present in cardiac and skeletal muscle), increased gamma-glutamyl transferase activity (an enzyme mainly present in the liver), milky-appearing fluid around the lungs (chylous effusion)

Rare adverse reactions (may affect less than 1 in 1000 people)

• Heart and lungs: enlargement of the right ventricle of the heart, myocarditis, syndrome of symptoms caused by blocked blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (cessation of blood flow from the heart), ischemic heart disease,
  inflammation of the tissue covering the heart and lungs, blood clot formation, presence of blood clots
  in the lungs

• Gastrointestinal disorders: loss of nutrients from the gastrointestinal tract, such as protein, intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and surrounding skin), kidney function disorders, diabetes

• Skin, hair, eye, general symptoms: seizures, optic neuritis which may cause complete or partial loss of vision, presence of blue-purple spots on the skin, abnormal overactivity of the thyroid gland, thyroid inflammation, ataxia (a condition associated with lack of muscular coordination), difficulty walking, miscarriage, skin vasculitis, skin fibrosis

• Brain: stroke, transient episode of neurological disturbances due to lack of blood flow, facial nerve paralysis, dementia

• Immune system: severe allergic reaction

• Musculoskeletal and connective tissue: delayed healing of rounded ends of bones forming joints (epiphyses); slowed or delayed growth

Other reported adverse reactions (frequency unknown – cannot be estimated based on available data):

• pneumonia
• bleeding from the stomach or intestines, which may lead to death
• recurrence (reactivation) of hepatitis B virus infection in patients with a past history of such infection
• reaction with fever, blistering of the skin and mucosal ulceration
• kidney disease with symptoms including swelling and abnormal diagnostic test results, such as presence of protein in urine and low blood protein levels
• blood vessel damage known as thrombotic microangiopathy, including reduced number of red blood cells, reduced platelet count and blood clot formation

During treatment with this medicine, your doctor will monitor for some of these adverse reactions.
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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 stated on the bottle, blister pack,
and cardboard box after "EXP". The expiry date refers to the last day of the stated month.
There are no special requirements for storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Dasatinib Sandoz contains

• The active substance is dasatinib. Each coated tablet contains 80 mg of dasatinib.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, 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 measuring
10.3 mm x 10.0 mm, with the imprint "80" on one side and smooth on the other side.
Film-coated tablets are packed in single-dose blisters made of Aluminium/OPA/Aluminium/PVC
and placed in a cardboard box.
Pack sizes:
Cardboard box containing 30 x 1 film-coated tablet in single-dose blisters.
Marketing Authorisation 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
For further information about the medicine and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
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