Dasatinib Teva 70 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dasatinib Teva 20 mg film-coated tablets EFG
Dasatinib Teva 50 mg film-coated tablets EFG
Dasatinib Teva 70 mg film-coated tablets EFG
Dasatinib Teva 100 mg film-coated tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Dasatinib Teva is and what it is used for
- What you need to know before taking Dasatinib Teva
- How to take Dasatinib Teva
- Possible side effects
- How to store Dasatinib Teva
- Contents of the pack and other information
1. What Dasatinib Teva is and what it is used for
Dasatinib Teva contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age. Leukaemia is a type of cancer of the white blood cells. These white blood cells normally help the body fight infections. In patients with CML, a type of white blood cells called granulocytes begin to multiply uncontrollably. Dasatinib Teva inhibits the growth of these leukaemic cells.
Dasatinib Teva is also used to treat Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age, and lymphoid blast phase CML in adults who have not benefited from previous treatments. In patients with ALL, a type of white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Teva inhibits the growth of these leukaemic cells.
If you have any questions about how Dasatinib Teva works or why you have been prescribed this medicine, consult your doctor.
2. What you need to know before taking Dasatinib Teva
Do not take dasatinib
- 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 starting to take dasatinib
- if you are taking medicines to thin the blood or prevent blood clots (see “Taking Dasatinib Teva with other medicines”)
- if you have or have had any liver or heart problems
- if you start to have difficulty breathing, chest pain, or cough while taking dasatinib: this may be a sign of fluid retention in the lungs or chest (which may be more common in patients aged 65 years or older) or due to changes in the blood vessels supplying the lungs
- if you have ever had or may currently have an infection with the hepatitis B virus. This is because dasatinib could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.
- if you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
Your doctor will monitor your condition periodically to check that dasatinib is having the desired effect. You will also have regular blood tests while taking dasatinib.
Children and adolescents
Do not give this medicine to children under 1 year of age. Experience with the use of dasatinib in this age group is limited. In children taking dasatinib, growth and bone development should be closely monitored.
Taking Dasatinib Teva with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Dasatinib is mainly metabolized by the liver. Some medicines may interfere with the effect of dasatinib when taken together.
The following medicines must not be used during treatment with Dasatinib Teva:
- ketoconazole, itraconazole – antifungal medicines
- erythromycin, clarithromycin, telithromycin – antibiotics
- ritonavir – an antiviral medicine
- phenytoin, carbamazepine, phenobarbital – treatments for epilepsy
- rifampicin – a treatment for tuberculosis
- famotidine, omeprazole – medicines that block stomach acid secretion
- St. John’s wort – a herbal medicine available without prescription 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/magnesium hydroxide) within 2 hours before or 2 hours after taking dasatinib.
Tell your doctor if you are taking medicines to thin the blood or prevent blood clots.
Taking Dasatinib Teva with food and drinks
Do not take dasatinib with grapefruit or grapefruit juice.
Pregnancy and breastfeeding
If you are pregnant or think you may be pregnant, inform your doctor immediately. Dasatinib must not be used during pregnancy unless clearly necessary. Your doctor will inform you of the potential risks of taking dasatinib during pregnancy.
Effective contraception is recommended for both men and women during treatment with dasatinib.
If you are breastfeeding, inform your doctor. You must stop breastfeeding while taking dasatinib.
Driving and using machines
Exercise caution when driving or operating machinery if you experience side effects such as dizziness or blurred vision.
Dasatinib Teva contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Dasatinib Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.
3. How to take Dasatinib Teva
Dasatinib will only be prescribed by a physician experienced in the treatment of leukemia. Always follow exactly the dosing instructions given by your doctor. If in doubt, consult your doctor or pharmacist again. Dasatinib is prescribed for adults and children at least 1 year of age.
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 phase CML, or Ph+ ALL, is 140 mg once daily.
Dosing schedule for children with chronic phase CML or Ph+ ALL based on body weight. Dasatinib is administered orally once daily, either as dasatinib tablets or as oral suspension powder. Dasatinib tablets are not recommended for patients weighing less than 10 kg. The oral suspension powder should be used in patients weighing less than 10 kg and in patients who cannot swallow tablets. A dose adjustment may be required when switching between formulations (i.e., tablets and oral suspension powder); therefore, do not switch from one formulation to the other without medical advice.
Your doctor will determine the correct formulation and dose based on your body weight, side effects, and response to treatment. In children, the starting dose of dasatinib is calculated according to body weight as shown below:
Body weight (kg)a | Daily dose (mg) |
From 10 to less than 20 kg | 40 mg |
From 20 to less than 30 kg | 60 mg |
From 30 to less than 45 kg | 70 mg |
At least 45 kg | 100 mg |
a Do not recommend the tablets for patients weighing less than 10 kg; the oral suspension powder should be used in these patients.
There is no dosage recommendation for dasatinib in children under 1 year of age.
Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose, or may even temporarily interrupt treatment. To take higher or lower doses, you may need to take combinations of tablets of different strengths.
How to take Dasatinib Teva
Take the tablets at the same time each day. Swallow the tablets whole. Do not crush, cut, or chew them. Do not take dissolved tablets. You cannot be sure of receiving the correct dose if you crush, cut, chew, or disperse the tablets. The tablets may be taken with or without food.
Special handling instructions for Dasatinib Teva
It is unlikely that dasatinib tablets will break, but if they do break, individuals other than the patient should wear gloves when handling dasatinib.
How long to take Dasatinib Teva
Take dasatinib daily until your doctor instructs you to stop treatment. Make sure to take dasatinib for the prescribed duration.
If you take more Dasatinib Teva than you should
If you accidentally take too many tablets, consult your doctor immediately. You may require medical attention.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested. It is recommended to bring the package leaflet and medicine container to the healthcare professional.
If you forget to take Dasatinib Teva
Do not take a double dose to make up for missed doses. Take the next scheduled dose at the usual time.
If you have any further questions about using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following may be signs of serious adverse effects:
- if you have chest pain, difficulty breathing, cough, or fainting
- if you have unexpected bleeding or bruising without injury
- if you notice blood in your vomit, stools, or urine, or have black stools
- if you develop signs of infection , such as fever, severe chills
- if you have fever, mouth or throat pain, burning sensation, or skin and/or mucous membrane peeling
Contact your doctor immediately if you notice any of the above.
Very common adverse effects (may affect more than 1 in 10 people)
- Infections (caused by bacteria, viruses, and fungi)
- Heart and lungs : difficulty breathing
- Digestive problems : diarrhea, feeling unwell (nausea, vomiting)
- Skin, hair, eyes, general : skin rash, fever, swelling of the face, hands, and feet, headache, tiredness or weakness, bleeding
- Pain : muscle pain (during or after stopping treatment), abdominal pain
- Laboratory tests : low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs
Common adverse effects (may affect up to 1 in 10 people)
- Infections : pneumonia, herpes virus infection (including cytomegalovirus – CMV), upper respiratory tract infection, severe blood or tissue infection (including rare cases with fatal outcomes)
- Heart and lungs : palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, high blood pressure in the lungs, cough
- Digestive problems : appetite changes, taste disturbances, abdominal distension or bloating, inflammation of the colon, constipation, esophageal reflux, mouth ulcers, weight loss, weight gain, gastritis
- Skin, hair, eyes, general : tingling of the skin, itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, visual disturbances (including blurred or distorted vision), dry eyes, bruising, depression, insomnia, hot flushes, dizziness, contusions (bruises), anorexia, drowsiness, generalized edema
- Pain : joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle and joint stiffness, muscle spasm
- Laboratory tests : fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, gastrointestinal bleeding, elevated blood uric acid levels
Uncommon adverse effects (may affect up to 1 in 100 people)
- Heart and lungs: heart attack (including fatal outcome), inflammation of the membrane surrounding the heart (fibrous sac), irregular heartbeat, chest pain due to reduced blood supply to the heart (angina), low blood pressure, narrowing of the airways that could cause breathing difficulties, asthma, high blood pressure in the arteries (blood vessels) leading to the lungs
- Digestive problems: inflammation of the pancreas, peptic ulcer, inflammation of the digestive tract, abdominal swelling, anal skin tear, difficulty swallowing, inflammation of the gallbladder, blockage of bile ducts, gastroesophageal reflux (stomach acid and other contents flowing back into the throat)
- Skin, hair, eyes, general: allergic reactions including sensitivity, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, low sex drive, fainting, tremor, eye inflammation that may cause redness or pain, skin disease characterized by sensitivity, redness, well-defined spots with sudden onset of fever and elevated white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, visual disturbance, increased eye tearing, changes in skin color, inflammation of fatty tissue under the skin, skin ulcer, blisters on the skin, nail changes, hair changes, changes in hands and feet, kidney failure, frequent urination, breast enlargement in men, menstrual disturbances, general weakness and malaise, low thyroid function, loss of balance while walking, osteonecrosis (a condition where blood supply to bones is reduced, possibly leading to bone loss and death), arthritis, skin swelling anywhere on the body
- Pain: inflammation of veins that may cause redness, tenderness, and swelling, tendon inflammation
- Brain: memory loss
- Laboratory tests: abnormal blood test results and possibly kidney failure caused by tumor waste products during recovery (tumor lysis syndrome), low blood albumin levels, low lymphocyte levels (a type of white blood cell) in blood, elevated blood cholesterol levels, swollen lymph nodes, brain hemorrhage, irregular electrical activity of the heart, enlarged heart, liver inflammation, protein in urine, elevated creatine phosphokinase (an enzyme mainly found in the heart, brain, and skeletal muscles), increased troponin (an enzyme mainly found in the heart and skeletal muscle), elevated gamma-glutamyl transferase (an enzyme mainly found in the liver), milky-appearing fluid around the lungs (chylous pleural effusion).
Rare adverse effects (may affect up to 1 in 1,000 people)
- Heart and lungs: dilation of the right ventricle of the heart, inflammation of the heart muscle, a set of symptoms caused by blocked blood supply to the heart muscle (acute coronary syndrome), heart attack (interruption of blood supply to the heart), coronary artery disease (of the heart), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
- Digestive problems: loss of vital nutrients such as proteins from your digestive system, intestinal obstruction, anal fistula (abnormal opening from the anus to the surrounding skin), impaired kidney function, diabetes
- Skin, hair, eyes, general: seizure, inflammation of the optic nerve that may cause complete or partial vision loss, bluish to purplish spots on the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (associated with loss of muscle coordination), difficulty walking, miscarriage, inflammation of blood vessel skin, cutaneous fibrosis
- Brain: stroke, transient episode of neurological dysfunction caused by loss of blood flow, facial nerve paralysis, dementia
- Immune system: severe allergic reactions
- Connective tissue and musculoskeletal system: delayed fusion of the rounded ends forming joints (epiphyses); slow or delayed growth
Other adverse effects reported with unknown frequency (cannot be estimated from available data)
- Inflammation of the lungs
- Bleeding in the stomach or intestine that may be fatal
- Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection)
- Reaction with fever, blisters on the skin, and mucosal ulceration
- Kidney disorders with symptoms such as edema and abnormal laboratory test results such as protein in urine and low blood protein levels
- Damage to blood vessels known as thrombotic microangiopathy (TMA), which includes reduced red blood cell count, reduced platelets, and blood clot formation.
Your doctor will monitor you for any of these effects during your treatment.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist , even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dasatinib Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle, blister pack, or carton, following EXP. The expiry date refers to the last day of the month indicated.
Blister pack: Store in the original packaging to protect from moisture. This medicine does not require any special storage temperature.
Bottle: Store in the original packaging to protect from moisture. Keep the bottle tightly closed. This medicine does not require any special storage temperature.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dasatinib Teva
- The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, or 100 mg of dasatinib (as monohydrate).
- The other components are:
- Tablet core: lactose monohydrate (see section 2 “Dasatinib Teva contains lactose”), microcrystalline cellulose (E460(i)), hydroxypropylcellulose (E463), sodium croscarmellose, magnesium stearate
- Film coating: hypromellose, titanium dioxide (E171), triacetin (E1518)
Appearance of the product and contents of the pack
Dasatinib Teva 20 mg: round film-coated tablet, white to off-white in colour, bevelled edges, with “20” engraved on one side of the tablet, approximately 5.6 mm in diameter.
Dasatinib Teva 50 mg: oval film-coated tablet, white to off-white in colour, bevelled edges, with “50” engraved on one side of the tablet, approximately 10.8 x 5.8 mm in size.
Dasatinib Teva 70 mg: round film-coated tablet, white to off-white in colour, bevelled edges, with “70” engraved on one side of the tablet, approximately 8.8 mm in diameter.
Dasatinib Teva 100 mg: oval film-coated tablet, white to off-white in colour, bevelled edges, with “100” engraved on one side of the tablet, approximately 14.8 x 7.2 mm in size.
Dasatinib Teva 20 mg, 50 mg, and 70 mg film-coated tablets are available in packs containing 30 and 60 film-coated tablets in blister packs, or packs containing 56 and 60 film-coated tablets in perforated unit-dose blisters. They are also available in bottles with child-resistant closures and silica gel desiccant containing 60 film-coated tablets. Each carton contains one bottle.
Dasatinib Teva 100 mg film-coated tablets are available in packs containing 30 film-coated tablets in blister packs or packs containing 30 film-coated tablets in perforated unit-dose blisters. They are also available in bottles with child-resistant closures and silica gel desiccant containing 30 film-coated tablets. Each carton contains one bottle.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5,
2031GA Haarlem
The Netherlands
Manufacturer
Merckle GmbH
Ludwig-Merckle-Strasse 3,
89143 Blaubeuren
Germany
or
PLIVA Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid (Spain)
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Dasatinib-ratiopharm 20 mg, 50 mg, 70 mg, 80 mg, 100 mg Film tablets
Spain Dasatinib Teva 20 mg, 50 mg, 70 mg and 100 mg film-coated tablets EFG
Norway Dasatinib Teva Pharma B.V.
Date of the most recent review of this leaflet: May 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)