20 mg, 50 mg, 70 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.

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

What Dasatinib Sandoz is and what it is used for

Dasatinib Sandoz contains the active substance dasatinib. This medicine is used to treat Philadelphia-positive (Ph +) acute lymphocytic leukemia (ALL) in adults who have not responded to previous treatment. ALL is a form of leukemia in which the white blood cells called lymphocytes are formed too fast and live too long. Dasatinib Sandoz inhibits the growth of these leukemic cells.

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

Dasatinib contained in Dasatinib Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Dasatinib Sandoz

Do not 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, ask your doctor for advice.

Warnings and cautions

Talk to your doctor or pharmacist before taking Dasatinib Sandoz

  • if you are being treated with medicines that are blood thinners or prevent blood clots (see “Other medicines and Dasatinib Sandoz”)
  • if you have a liver or heart disease, or if you have had one
  • if you experience difficulty breathing, chest pain, or cough while taking Dasatinib Sandoz. 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 Sandoz 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.

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

Children and young people

Dasatinib Sandoz is not recommended for patients under 18 years of age. Experience with Dasatinib Sandoz in this age group is limited.

Other medicines and Dasatinib Sandoz

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

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

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

  • ketoconazole, itraconazole – these are medicines for fungal diseases
  • erythromycin, clarithromycin, telithromycin – these are antibiotics
  • ritonavir – this is a medicine for viral diseases
  • dexamethasone – this is a corticosteroid
  • 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 – an over-the-counter herbal remedy 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 Sandoz.

Tell your doctor if you are taking medicines that are blood thinners or 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 immediatelyDasatinib Sandoz should not be used during pregnancy unless clearly necessary. Your doctor will discuss the possible risks of taking Dasatinib Sandoz during pregnancy.

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

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

Driving and using machines

If you experience side effects such as dizziness and blurred vision, take special care when driving or using machines. It is not known whether Dasatinib Sandoz affects the ability to drive or use 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 Sandoz contains

Dasatinib Sandoz contains lactose

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

Dasatinib Sandoz contains sodium

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

How to take Dasatinib Sandoz

Dasatinib Sandoz 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 Sandoz is prescribed for adults.

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

Take the tablets at the same time each day.

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.

The tablets may be packaged in calendar blisters. These are blisters that show the days of the week.

How to take Dasatinib Sandoz

Swallow the tablets whole. Do not crush them. They can be taken with or without food.

Special instructions for handling Dasatinib Sandoz

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

How long to take Dasatinib Sandoz

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

If you take more Dasatinib Sandoz then you should

If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poisons Information Center for risk assessment and advice. You may need medical attention.

If you forget to take Dasatinib Sandoz

Do not take a double dose to make up for a forgotten tablet. 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:

  • 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, sore mouth or throat, blisters, or flaking 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 user in 10 )

  • Infection s (including infection s 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, 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 )

  • Infection s: pneumonia, herpes virus infection (including cytomegalovirus[CMV]), upper respiratory infection, a serious infection in the blood or tissue you (including uncommonly fatal)
  • Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, disturbed heart function, high blood pressure, high blood pressure in the lungs, cough
  • Indigestion: appetite disturbances, taste disturbances, bloated or distended abdomen, inflammation of the colon, constipation, heartburn, cold sores, weight gain, weight loss, inflammation of the stomach
  • Skin, hair, eyes, general: 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, 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 acid in 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)
  • Indigestion: inflammation of the pancreas, stomach ulcers, inflammation of the esophagus, swollen stomach (abdomen), ulcers in the anal canal mucosa, difficulty swallowing, inflammation of the gallbladder, blockage of the bile ducts, gastroesophageal reflux (a condition in which acid and other stomach contents return to the throat)
  • Skin, hair, eyes, general: allergic reaction including soreness, lumpy blush (anxiety), anxiety, confusion, mood swings, decreased sexual drive, fainting, tremors, inflammation of the eye that may cause redness and pain, a skin disease characterized by sore, red and sharply demarcated skin patches 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 adipose tissue of the skin, ulcers on the skin, blistering of the skin, nail problems, hair problems foot syndrome, kidney failure, frequent urination, 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, any swelling of the body
  • Pain: inflammation of the blood vessels that can cause redness, tenderness and swelling, tendinitis ( tendinitis )
  • 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 in the blood, swelling lymph nodes, bleeding in the brain, irregularity in the electrical impulses to the heart, enlarged heart, inflammation of the liver, protein in the urine, elevated levels of creatine phosphokinase (an enzyme found mostly in the heart, brain, and skeletal muscle), elevated levels of troponin (the enzyme found 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 coronary 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
  • Indigestion: decreased absorption of important nutrients, such as protein, from the gastrointestinal tract, intestinal obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impaired kidney function, diabetes
  • Skin, hair, eyes, general: seizures, inflammation of optic nerve which may cause a 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 the disturbed function of the nervous system caused by decreased blood flow, facial paralysis, dementia.

Other reported side effects ( no known frequency ) include:

  • Pneumonia
  • Bleeding in the stomach or intestines 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.

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

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

No special storage instructions.

Medicines 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, 100 mg or 140 mg of dasatinib.
  • Other ingredients are:

Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see section 2 “What you need to know before you take Dasatinib Sandoz”), croscarmellose sodium, hydroxypropyl cellulose (E463), magnesium stearate (E470b).

Film coating : poly (vinyl alcohol) (E1203), titanium dioxide (E171), talc (E553b), glyceryl monostearate (E471), sodium lauryl sulfate.

What the medicine looks like and contents of the pack

Dasatinib Sandoz 20 mg, 50 mg, 70 mg film-coated tablets

Aluminum-OPA / Alu / PVC blisters (calendar blisters or perforated single-dose blisters).

Jar of high-density polyethylene (HDPE) with child-resistant polypropylene closure and a plastic container (HDPE) containing silica gel.

Carton containing 56 film-coated tablets in 4 calendar blisters containing 14 film-coated tablets each.

Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters.

Carton containing 60 film-coated tablets in a jar.

Dasatinib Sandoz 100 mg, 140 mg film-coated tablets

Aluminum-OPA / Alu / PVC blisters (perforated unit dose blisters).

Jar of high-density polyethylene (HDPE) with child-resistant polypropylene closure and a plastic container (HDPE) containing silica gel.

Carton containing 30 x 1 film-coated tablets in perforated unit dose blisters.

Carton containing 30 film-coated tablets in a jar.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol

3056 Cyprus

Muhammad Nadeem

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