Dasatinib Sandoz

Patient Information Leaflet

Dasatinib Sandoz 20 mg film-coated tablets, 50 mg film-coated tablets, 70 mg film-coated tablets, 80 mg film-coated tablets, 100 mg film-coated tablets, 140 mg film-coated tablets

dasatinib
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine as 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 give it to others, even if they have the
same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your
doctor or pharmacist. See section 4.
Contents of this 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 for the
treatment of chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age.
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 begin to grow uncontrollably. Dasatinib Sandoz
inhibits the growth of these leukaemic cells.
Dasatinib Sandoz is also used for the treatment of Philadelphia chromosome-positive (Ph+) acute
lymphoblastic leukaemia (ALL) and lymphoid blast phase CML in adults, adolescents and children at
least 1 year of age who have not benefited from previous therapies. In individuals with ALL, white blood
cells called lymphocytes multiply very rapidly and live much longer than normal. Dasatinib Sandoz
inhibits the growth of these leukaemic cells.
If you have any questions about how Dasatinib Sandoz works or why it has been prescribed for you,
please consult your doctor.

2. What you need to know before taking Dasatinib Sandoz

Do not take Dasatinib Sandoz
if you are allergic to dasatinib or to 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
Talk to your doctor or pharmacist before taking Dasatinib Sandoz if:

• you are taking medicines that thin the blood or prevent blood clots (see "Other
  medicines and Dasatinib Sandoz")
• you have or have had liver or heart problems
• you start experiencing breathing difficulties, chest pain, or cough while taking dasatinib:
  this could be a sign of fluid retention in the lungs or chest (which may be more common in patients aged 65 years or older) or could be due to changes in the blood vessels supplying the lungs
• you have ever had or may currently have a hepatitis B infection. This is because
  dasatinib could cause reactivation of hepatitis B, which in some cases can be fatal.
  Patients will be closely monitored by their doctor for signs of this infection before starting treatment
• you develop bruising, bleeding, fever, fatigue, or confusion while taking Dasatinib Sandoz, contact your doctor immediately. These may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will need to regularly monitor your clinical condition to ensure dasatinib is having the desired effect. Additionally, you will have regular blood tests while taking Dasatinib Sandoz.

Children and adolescents
Do not give this medicine to children under one year of age. Experience with dasatinib in this age group is limited. Bone growth and development in children taking dasatinib will be closely monitored.

Other medicines and Dasatinib Sandoz
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Dasatinib is mainly metabolized by the liver. Some medicines can interfere with the effect of dasatinib when taken at the same time.

The following medicines must not be used with dasatinib:
ketoconazole, itraconazole – which are antifungal medicines
erythromycin, clarithromycin, telithromycin – which are antibiotics
ritonavir – which is an antiviral medicine
phenytoin, carbamazepine, phenobarbital – which are treatments for epilepsy
rifampicin – which is a treatment for tuberculosis
famotidine, omeprazole – which are medicines that block acid production in the
stomach
St. John’s wort – an over-the-counter herbal preparation used for the treatment of depression and other conditions (also known as Hypericum perforatum)

Do not take medicines that neutralize stomach acid (antacids 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 clots.

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

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor immediately.
Dasatinib must not be used during pregnancy unless absolutely necessary. Your doctor will discuss with you the potential risks of taking dasatinib during pregnancy.
Both men and women taking dasatinib should use an effective method of contraception during treatment.
If you are breastfeeding, inform your doctor. Breastfeeding must be discontinued during treatment with dasatinib.

Driving and use of machines
If you experience side effects such as dizziness or blurred vision, exercise particular caution when driving or operating machinery.

Dasatinib Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Dasatinib Sandoz

Dasatinib Sandoz will only be prescribed by a doctor experienced in the treatment of leukemia. Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Dasatinib Sandoz is prescribed for adults and children aged at least 1 year.

The recommended starting dose for adult patients with chronic myeloid leukemia (CML) in the chronic phase is 100 mg once daily.
The recommended starting dose for adult patients with chronic myeloid leukemia (CML) in the accelerated phase or blast phase, or with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is 140 mg once daily.
The dosage for children with chronic phase CML or Ph+ ALL is based on body weight.

Dasatinib Sandoz is administered orally once daily. Dasatinib Sandoz tablets are not recommended for patients weighing less than 10 kg. The oral suspension powder may be available for patients with a body weight below 10 kg and for patients unable to swallow tablets. A dose adjustment may be required when switching between the two formulations (e.g., tablets and oral suspension powder); therefore, do not switch from one formulation to the other on your own.

Your doctor will determine the appropriate formulation and dose based on body weight, any side effects, and response to treatment. The initial dose of Dasatinib Sandoz for children is calculated according to body weight, as shown below:

Body weight (kg) Daily dose (mg)
From 10 to < 20 kg 40 mg
From 20 to < 30 kg 60 mg
From 30 to < 45 kg 70 mg
At least 45 kg 100 mg

There is no recommended dose of Dasatinib Sandoz for children under 1 year of age.

Depending on your response to treatment, your doctor may recommend a higher or lower dose, or even a brief interruption of treatment. For higher or lower doses, you may need to take combinations of tablets with different strengths.

The tablets may be supplied in calendar blister packs. These are blister packs indicating the days of the week. Arrows indicate the next tablet to take according to your treatment schedule.

How to take Dasatinib Sandoz
Take your tablets at the same time each day. Swallow the tablets whole. Do not crush, split, or chew them. Do not take dissolved tablets. Crushing, splitting, chewing, or dispersing the tablets may result in an incorrect dose. Dasatinib Sandoz can be taken with or without food.

Special precautions for handling Dasatinib Sandoz
It is unlikely that Dasatinib Sandoz tablets will break. If this should happen, individuals other than the patient must wear gloves when handling Dasatinib Sandoz.

How long to take Dasatinib Sandoz
Take Dasatinib Sandoz daily for as long as your doctor instructs you to continue. Make sure you take Dasatinib Sandoz for the entire prescribed duration.

If you take more Dasatinib Sandoz than you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may require medical assistance.

If you forget to take Dasatinib Sandoz
Do not take a double dose to make up for the missed tablet. Take the next scheduled dose at the usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following may all be symptoms of serious side effects:
if you have chest pain, difficulty breathing, cough, or fainting
if you experience unexpected bleeding or bruising without injury
if you find blood in your vomit, stools, or urine, or if your stools are black
if you develop signs of infection such as fever, severe chills
if you have fever, mouth or throat pain, blisters or peeling of the skin and/or mucous membranes
Contact your doctor immediately if you notice any of the above effects.

Very common side effects (may affect more than 1 in 10 people)
Infections (includes bacterial, viral, and fungal infections)
Heart and lungs: shortness of breath
Digestive system problems: diarrhoea, feeling unwell (nausea, vomiting)
Skin, hair, eyes, general: rash, fever, swelling of the face, hands, and feet, headache, feeling tired or weak, bleeding
Pain: muscle pain (during or after treatment interruption), abdominal (stomach) pain
Laboratory and instrumental tests may show: low platelet count, low white blood cell count (neutropenia), anaemia, fluid in the lungs

Common side effects (may affect up to 1 in 10 people)
Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infections, severe blood and tissue infections (including uncommon cases with fatal outcomes)
Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, myocardial weakness, high blood pressure, increased blood pressure in the lungs, cough
Digestive system problems: loss of appetite, altered taste, bloating or swelling of the abdomen, inflammation of the colon, constipation, heartburn, mouth ulceration, weight gain, weight loss, gastritis
Skin, hair, eyes, general: skin tingling, itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, eye disorders (including blurred vision and vision disturbances), dry eyes, bruising, depression, insomnia, hot flushes, dizziness, contusion (bruise), anorexia, drowsiness, generalized oedema
Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle and joint stiffness, muscle spasm
Laboratory and instrumental tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, gastrointestinal bleeding, elevated levels of uric acid in the blood

Uncommon side effects (may affect up to 1 in 100 people)
Heart and lungs: heart attack (including fatal cases), inflammation of the fibrous sac surrounding the heart (pericarditis), 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 pulmonary arteries (blood vessels) of the lungs
Digestive system problems: pancreatitis, peptic ulcer, oesophagitis, bloated abdomen, anal fissure (tear in the skin of the anal canal), difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastro-oesophageal reflux (a condition where stomach acids and other contents flow back into the throat)
Skin, hair, eyes, general: allergic reactions including sensitivity, red skin nodules (erythema nodosum), anxiety, confusion, mood swings, decreased sexual desire, fainting, tremors, eye inflammation causing redness or pain, a skin disease characterized by sensitivity, redness, well-defined patches with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, visual impairment, increased eye tearing, skin pigmentation disorders, inflammation of subcutaneous fat tissue, skin ulcers, skin blisters, nail disorders, hair and hair disorders, hand-foot syndrome, renal failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and malaise, reduced thyroid function, loss of balance while walking, osteonecrosis (a disease caused by reduced blood supply to bones, which may lead to bone loss and bone death), arthritis, skin swelling anywhere on the body
Pain: vein inflammation causing redness, tenderness, and swelling (phlebitis), tendon inflammation (tendinitis)
Brain: memory loss
Laboratory and instrumental tests may show: abnormal blood test results and possible kidney function impairment due to tumour lysis products (tumour lysis syndrome), low albumin levels in blood, low lymphocyte levels (a type of white blood cells) in blood, high cholesterol levels in blood, swollen lymph nodes, cerebral haemorrhage, irregular heart electrical activity, heart enlargement, liver inflammation, protein in urine, increased creatine phosphokinase (an enzyme mainly found in the heart, brain, and skeletal muscles), elevated troponin (an enzyme mainly found in the heart and skeletal muscles), increased gamma-glutamyl transferase (an enzyme mainly found in the liver), milky fluid around the lungs (chylothorax)

Rare side effects (may affect up to 1 in 1,000 people)
Heart and lungs: right ventricular enlargement of the heart, inflammation of the heart muscle (myocarditis), a set of conditions resulting from blocked blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (cessation of blood flow from the heart), coronary artery disease (of the heart), inflammation of the tissue lining the heart and lungs, blood clots, blood clots in the lungs (pulmonary embolism)
Digestive system problems: loss of vital nutrients from the digestive tract such as proteins, intestinal obstruction, anal fistula (an abnormal passage from the anus to the surrounding skin), reduced kidney function, diabetes
Skin, hair, eyes, general: seizures, optic nerve inflammation which may cause partial or complete vision loss, blue-violet skin patches, abnormally increased thyroid function, thyroid gland inflammation, ataxia (a condition associated with lack of muscular coordination), difficulty walking, spontaneous abortion, inflammation of blood vessels in the skin, skin fibrosis
Brain: stroke, transient neurological episode caused by loss of blood flow, facial nerve paralysis, dementia
Immune system: severe allergic reaction
Musculoskeletal and connective tissue: delayed fusion of the rounded ends forming the joints (epiphyses); slowed or delayed growth

Other side effects reported with unknown frequency (cannot be estimated from the available data)
pneumonia
bleeding in the stomach or intestines which may cause death
reactivation (recurrence) of hepatitis B infection if you have had hepatitis B in the past (a liver infection)
a reaction with fever, skin blisters, and mucosal ulceration
kidney disease with symptoms including oedema and abnormal laboratory test results such as protein in urine and low protein levels in blood
damage to blood vessels known as thrombotic microangiopathy (TMA), including reduced red blood cell count, reduced platelet count, and formation of blood clots

Your doctor will monitor some of these side effects during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 stated on the vial label, on the blister pack and on the
carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dasatinib Sandoz contains
The active substance is dasatinib. Each film-coated tablet contains 20 mg of dasatinib.
Each film-coated tablet contains 50 mg of dasatinib.
Each film-coated tablet contains 70 mg of dasatinib.
Each film-coated tablet contains 80 mg of dasatinib.
Each film-coated tablet contains 100 mg of dasatinib.
Each film-coated tablet contains 140 mg of dasatinib.

The other components are:
Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see
section 2 "What you need to know before taking Dasatinib Sandoz"); sodium croscarmellose,
hydroxypropylcellulose (E463), magnesium stearate (E470b).
Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b),
glycerol monostearate (E471), sodium lauryl sulfate.

Description of the appearance of Dasatinib Sandoz and contents of the pack
20 mg film-coated tablets
Film-coated tablet, white to almost white, biconvex, round, with "20" engraved on one side and smooth on the other, with a diameter of 6.1 mm.

50 mg film-coated tablets
Film-coated tablet, white to almost white, biconvex, oval, with "50" engraved on one side and smooth on the other, with dimensions 10.9 mm x 5.8 mm.

70 mg film-coated tablets
Film-coated tablet, white to almost white, biconvex, round, with "70" engraved on one side and smooth on the other, with a diameter of 8.9 mm.

80 mg film-coated tablets
Film-coated tablet, white to almost white, biconvex, triangular-shaped, with "80" engraved on one side and smooth on the other, with dimensions 10.3 mm x 10.0 mm.

100 mg film-coated tablets
Film-coated tablet, white to almost white, biconvex, oval, with "100" engraved on one side and smooth on the other, with dimensions 14.8 mm x 7.2 mm.

140 mg film-coated tablets
Film-coated tablet, white to almost white, biconvex, round, with "140" engraved on one side and smooth on the other, with a diameter of 11.8 mm.

The tablets are packaged in aluminium-OPA/aluminium/PVC blisters (calendar blister or unit-dose divisible blister) or in HDPE bottles with a polypropylene child-resistant cap and a plastic container (HDPE) containing silica gel, all placed in a cardboard box.

Pack sizes:
20 mg, 50 mg, 70 mg film-coated tablets:
Box containing 12 film-coated tablets in 1 calendar blister.
Box containing 56 film-coated tablets in 4 calendar blisters (14 film-coated tablets each).
Box containing 12 x 1 and 60 x 1 film-coated tablets in unit-dose divisible blister.
Box containing 1 HDPE bottle with 60 film-coated tablets.

80 mg, 100 mg, 140 mg film-coated tablets:
Box containing 10 film-coated tablets in 1 calendar blister.
Box containing 10 x 1 and 30 x 1 film-coated tablets in unit-dose divisible blister.
Box containing 1 HDPE bottle with 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

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

This medicinal product is authorized in the European Economic Area (EEA) and the United Kingdom (Northern Ireland) under the following names:
Belgium Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 100 mg filmomhulde tabletten
Bulgaria Dasatinib Sandoz 20 mg, 50 mg, 100 mg, 140 mg филмирани таблетки
Cyprus Dasatinib PharOS 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg
επικαλλυμένα με λεπτό υμένιο δισκία
Finland Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 100 mg, 140 mg kalvopäällysteiset tabletit
France DASATINIB SANDOZ 20 mg, 50 mg, 70 mg, 100 mg, 140 mg comprimé pelliculé
Germany Dasatinib Hexal 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg Filmtabletten
Italy Dasatinib Sandoz
Latvia Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg apvalkotās tabletes
Lithuania Dasatinib PharOS 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg plėvele dengtos tabletės
Netherlands Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, filmomhulde tabletten
Poland Dasatinib Sandoz
Portugal Dasatinib PharOS 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg
United Kingdom Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg Film-coated Tablets
Slovakia Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 100 mg
Romania Dasatinib PharOS 20 mg, 50 mg, 70 mg, 100 mg comprimate filmate
Slovenia Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg filmsko obložene tablete
Sweden Dasatinib Sandoz 20 mg, 50 mg, 70 mg, 100 mg, 140 mg filmdragerade tabletter
Hungary Dazatinib Sandoz 20 mg, 50 mg, 70 mg, 100 mg, 140 mg filmtabletta