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

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Dasatinib Mylan is and what it is used for 
2. What you need to know before you take Dasatinib Mylan 
3. How to take Dasatinib Mylan 
4. Possible side effects 
5. How to store Dasatinib Mylan 
6. Contents of the packaging and other information 

What Dasatinib Mylan is and what it is used for

Dasatinib Mylan contains the active substance dasatinib. This medicine is used to treat Philadelphia chromosome-positive (Ph +) acute lymphocytic leukemia (ALL) in adults who have not responded to previous treatment, as well as in adolescents and children at least 1 year old. Leukemia is a cancer of white blood cells. The white blood cells usually help the body fight infection. ALL is a form of leukemia in which the white blood cells called lymphocytes are formed too fast and live for

long. Dasatinib Mylan inhibits the growth of these leukemic cells.

Ask your doctor if you are wondering how Dasatinib Mylan works or why this medicine has been prescribed for you.

Dasatinib contained in Dasatinib Mylan may also be approved for the treatment of other conditions not mentioned in this product information.

Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Dasatinib Mylan

Do not take Dasatinib Mylan

  • 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, ask your doctor for advice.

Warnings and cautions

Talk to your doctor or pharmacist before using Dasatinib Mylan.

  • if you are being treated with medicines that are blood thinners or prevent blood clots (see “Other medicines and Dasatinib Mylan”)
  • if you have a liver or heart disease, or if you have had one
  • if you experience difficulty breathing, chest pain, or coughing while taking Dasatinib Mylan. It may be a sign of fluid accumulation in the lungs or chest (which may occur more often in patients 65 years of age or older) or may be due to changes in the blood vessels that supply the lungs
  • if you have ever had or may have a hepatitis B infection. The reason for this is that Dasatinib Mylan can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment.
  • Contact your doctor if you experience bruising, bleeding, fever, tiredness, and confusion while taking Dasatinib Mylan. This can be a sign of damage to blood vessels, so-called thrombotic microangiopathy (TMA).

You will be checked regularly by your doctor to determine if Dasatinib Mylan has the desired effect. You will also have regular blood tests when taking Dasatinib Mylan.

Children and young people

Do not give this medicine to children under 1 year of age. Experience with Dasatinib Mylan in this age group is limited. Skeletal bone growth and development will be monitored in children treated with Dasatinib Mylan.

Other medicines and Dasatinib Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Dasatinib Mylan is mainly processed in the liver. Some medicines may affect the effect of Dasatinib Mylan when used at the same time.

The following medicines should not be used concomitantly with Dasatinib Mylan:

  • ketoconazole, itraconazole – these are medicines for fungal diseases
  • erythromycin, clarithromycin, telithromycin – these are antibiotics
  • ritonavir – this is a medicine for viral diseases
  • phenytoin, carbamazepine, phenobarbital – these are for the treatment of epilepsy
  • rifampicin – this is for the treatment of tuberculosis
  • famotidine, omeprazole – these are drugs that inhibit gastric acid production
  • St. John’s wort – (traditional) herbal medicine used to treat mild depression and mild anxiety (also known as Hypericum perforatum ).

Do not use medicines that neutralize stomach acid (antacids such as aluminum hydroxide or magnesium hydroxide ) from 2 hours before to 2 hours after taking Dasatinib Mylan.

Tell your doctor if you are taking medicines that are blood thinners or prevent blood clots.

Dasatinib Mylan with food and drink

Do not take Dasatinib Mylan with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, tell your doctor immediately. Dasatinib Mylan should not be used during pregnancy unless clearly necessary. Your doctor will discuss the possible risks of taking Dasatinib Mylan during pregnancy.

Both women and men will be advised to use effective contraception during treatment with Dasatinib Mylan.

Tell your doctor if you are breast-feeding. Breast-feeding should be discontinued if you are being treated with Dasatinib Mylan.

Driving and using machines

If you experience side effects such as dizziness and blurred vision, take special care when driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dasatinib Mylan contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.

How to take Dasatinib Mylan

Dasatinib Mylan will only be prescribed to you by a doctor who has experience in the treatment of leukemia. Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dasatinib Mylan is prescribed for adults and children over 1 year of age.

The recommended starting dose for adult patients with Ph + ALL is 140 mg once daily.

Dosage one for children with Ph + ALL is based on body weight. Dasatinib is taken orally once a day either as tablets or as a powder for oral suspension. Dasatinib tablets are not recommended for patients weighing less than 10 kg. Powders for oral suspension should be used in patients weighing less than 10 kg and in patients unable to swallow tablets. A dose change may be needed when switching between the formulations (tablets or powder for oral suspension ), so do not switch from one formulation to another. Your doctor will determine the correct dose based on your weight, any side effects, and your response to the treatment. The starting dose of Dasatinib Mylan for children is calculated based on body weight as follows:

Bodyweight (kg) a Daily dose (mg)
10 – under 20 kg 40 mg
20 – under 30 kg 60 mg
30 – under 45 kg 70 mg
45 kg and over 100 mg

Tablets are not recommended for patients weighing less than 10 kg; powder for oral suspension should be used in these patients.

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

Depending on how you respond to treatment, your doctor may recommend a higher or lower dose. The treatment can also be temporarily stopped. For higher or lower dosages, it may be necessary to combine tablets of different strengths.

How to take Dasatinib Mylan

Take the tablets at the same time each day. Swallow the tablets whole. Do not crush, divide or chew them. Do not slurry the tablets. You can not be sure that you will get the right dose if you crush, divide, chew or slurry the tablets. Dasatinib Mylan tablets can be taken with or without food.

Special instructions for handling Dasatinib Mylan

Dasatinib Mylan tablets are unlikely to rupture. Should this nevertheless occur, persons other than the patient should wear gloves when handling Dasatinib Mylan.

How long to take Dasatinib Mylan

Take Dasatinib Mylan every day until your doctor tells you to stop. Make sure you take Dasatinib Mylan for as long as it is prescribed.

If you take more Dasatinib Mylan then you should

Contact your doctor immediately if you have accidentally taken too many tablets. You may need medical attention.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Dasatinib Mylan

Do not take a double dose to make up for a forgotten dose . Take the next dose as usual according to prescription one.

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

4. Possible side effects

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

The following may be signs of serious side effects are :

  • if you have chest pain, difficulty breathing, cough, fainting
  • if you experience unexpected bleeding or bruising without being injured
  • if you notice blood in the vomit, stool, or urine, or if the stool is black
  • if you get signs of infection , e.g. fever or severe chills
  • if you get a fever, pain in the mouth or throat, blisters or peeling of the skin and / or mucous membranes

Contact your doctor immediately if you notice any of the above.

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

  • Infection (including infection caused by bacteria, viruses and fungi).
  • Heart and lungs: shortness of breath.
  • Digestive problems: diarrhea, nausea, vomiting.
  • Skin, hair, eyes, general symptoms: rash, fever, swelling of the face, hands and feet, headache, fatigue or weakness, bleeding.
  • Pain: muscle aches (during or after treatment), abdominal pain (abdomen).
  • Tests may show: 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 , herpes virus infection (including cytomegalovirus – CMV ), upper respiratory tract infection, severe infection of the blood or tissues(including rare fatal cases).
  • Heart and lungs: palpitations, irregular heartbeat, heart failure , impaired heart function, high blood pressure, high blood pressure in the lungs, cough.
  • Digestive problems: appetite disturbances, taste disturbances, flatulence or distended abdomen, inflammation of the colon, constipation, heartburn, cold sores, weight gain, weight loss, inflammation of the stomach.
  • Skin, hair, eyes, general symptoms: skin tingling, itching , dry skin, acne , inflammation of the skin, persistent noise in the ears, hair loss, excessive sweating, vision problems (including blurred vision and vision change), dry eyes, bruising, depression, insomnia, hemorrhage, dizziness, bruising, anorexia (loss of appetite), drowsiness, generalized edema .
  • Pain: joint pain, muscle weakness, chest pain, pain around hands and feet, chills, stiffness in muscles and joints, muscle cramps.
  • Tests may show: fluid around the heart, fluid in the lungs, irregular heartbeat, febrile neutropenia, bleeding in the gastrointestinal tract, high levels of uric acidin the blood.

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

  • Heart and lungs: heart attack (sometimes fatal), inflammation of the pericardium, irregular heartbeat, chest pain due to reduced blood supply to the heart (angina), low blood pressure , constriction of the airways, which can cause breathing difficulties, asthma , increased blood pressure in the pulmonary artery s (blood vessels).
  • Digestive problems: inflammation of the pancreas, stomach ulcers , inflammationof the esophagus, swollen stomach (abdomen), ulcers in the rectum mucosa , difficulty swallowing, inflammation of the gallbladder, blocking the bile ducts, gastroesophageal reflux disease (a condition in which acid and other stomach contents come back up into the throat ).
  • Skin, hair, eyes, general symptoms: allergic reaction including soreness, lumpy blush (anxiety), anxiety, confusion, mood swings, decreased sexual desire, fainting, tremors, inflammation of the eye that can cause redness and pain, a skin disease characterized by sore, red , sharply demarcated and raised skin spots with rapid onset of fever and elevated white blood cell count ( neutrophil dermatosis ), hearing loss, photosensitivity, visual impairment, increased tear flow, altered skin color, inflammation of the skin adipose tissue, wounds on the skin, blistering on the skin, nail problems , hand-foot syndrome, kidney failure, affected urination frequency, breast enlargement in men, menstrual disorders, general weakness and discomfort, low thyroid function, balance problems when walking, osteonecrosis (a condition where skeletal bones die and collapse due to impaired blood supply), joint inflammation, preferably swelling of the body.
  • Pain: inflammation of the blood vessels that can cause redness, tenderness and swelling, tendinitis (tenditis).
  • Brain: memory loss.
  • Tests may show: abnormal blood levels and possibly impaired kidney function caused by residues of the decaying tumor (tumor lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell ) in the blood, high cholesterol levels, swollen lymph nodes , bleeding in the brain, irregularities in the electrical impulses to the heart, enlarged heart, inflammationof the liver, protein in the urine, elevated levels of creatinine phosphokinase (an enzyme found mainly in the heart, brain and skeletal muscles), elevated levels of troponin (an enzymefound mainly in the heart and skeletal muscles), elevated gamma-glutamyltransferase (an enzyme found mainly in the liver).

Rare side effects (may affect up to 1 in 1,000 people)

  • Heart and lungs: enlarged upper ventricles, myocarditis, the combined effect of various conditions that block the blood supply to the heart ( acute heart syndrome), cardiac arrest (blockage of blood flow from the heart), coronary heart disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots the lungs.
  • Digestive problems: decreased absorption of important nutrients, such as protein, from the gastrointestinal tract, intestinal knots, anal fistula (an abnormal opening from the anus to the skin around the anus), impaired kidney function, diabetes .
  • Skin, hair, eyes, general symptoms: convulsions, inflammation of the optic nervewhich can cause complete or partial loss of vision, blue-violet spots on the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (a condition associated with lack of muscular coordination), difficulty walking , miscarriage, inflammation of the blood vessels of the skin, skin fibrosis.
  • Brain: stroke , temporary events of disturbed function of the nervous system caused by decreased blood flow, facial paralysis, dementia.
  • Immune system: severe allergic reaction .
  • Muscles, bones and connective tissue: delayed interconnection of the bone ends that form joints (epiphyses); slower or delayed growth.

Other reported side effects are not known (affects an unknown number of users)

  • Inflammatory changes in the lungs.
  • Bleeding in the stomach or intestines that can lead to death.
  • Recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection).
  • A reaction with fever, blisters on the skin and sores on the mucous membranes.
  • Kidney disease with symptoms including edema and abnormal laboratory test results such as protein in the urine and low protein content in the blood.
  • Damage to blood vessels, so-called thrombotic microangiopathy (TMA), including decreased number of red blood cells , decreased number of platelets and blood clot formation.

Your doctor will check if you have any of these side effects during your treatment.

5. How to store Dasatinib Mylan

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 can label, blister or carton after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg of dasatinib.
  • Other ingredients are:Tablet core : lactose monohydrate; cellulose, microcrystalline; croscarmellose sodium, hydroxypropylcellulose; magnesium stearate.Film coating : lactose monohydrate; hypromellos; titanium dioxide (E171); triacetin. (see section 2 “Dasatinib Mylan contains lactose and sodium”)

What the medicine looks like and contents of the pack

Dasatinib Mylan 20 mg: the film-coated tablet is white to off-white, biconvex, round with a diameter of about 5.6 mm, with “D7SB” embossed on one side and “20” on the other side.

Dasatinib Mylan 50 mg: the film-coated tablet is white to off-white, biconvex, oval with a length of about 11.0 mm and a width of about 6.0 mm, with “D7SB” embossed on one side and “50” on the other. side.

Dasatinib Mylan 70 mg: the film-coated tablet is white to off-white, biconvex, round with a diameter of about 9.1 mm, with “D7SB” embossed on one side and “70” on the other side.

Dasatinib Mylan 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with a length of about 10.4 mm and a width of about 10.6 mm, with “D7SB” embossed on one side and “80” on the other. side

Dasatinib Mylan 100 mg: the film-coated tablet is white to off-white, biconvex, oval with a length of about 15.1 mm and a width of about 7.1 mm, with “D7SB” embossed on one side and “100” on the other. side.

Dasatinib Mylan 140 mg: the film-coated tablet is white to off-white, biconvex, round with a diameter of about 11.7 mm, with “D7SB” embossed on one side and “140” on the other side.

Dasatinib Mylan 20 mg, 50 mg and 70 mg film-coated tablets are supplied in cartons containing 56 or 60 film-coated tablets in blister packs, or in cartons containing 56 x 1 or 60 x 1 film-coated tablets in single-dose blisters. They are also available in cans containing 60 film-coated tablets.

Dasatinib Mylan 80 mg, 100 mg and 140 mg film-coated tablets are supplied in cartons containing 30 film-coated tablets in blister packs, or in cartons containing 30 x 1 film-coated tablets in single-dose blisters. They are also available in cans containing 30 film-coated tablets.

Not all pack sizes may be marketed.

Manufacturer

Synthon Hispania, SL

Calle Castelló 1

Polygono las Salinas

08830 Sant Boi de Llobregat

Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Muhammad Nadeem

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