Dasatinib Stada 50 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dasatinib Stada 50 mg film-coated tablets EFG
Dasatinib Stada 70 mg film-coated tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Dasatinib Stada is and what it is used for
- What you need to know before taking Dasatinib Stada
- How to take Dasatinib Stada
- Possible adverse effects
- How to store Dasatinib Stada
- Contents of the pack and other information
1. What Dasatinib Stada is and what it is used for
Dasatinib Stada 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 inhibits the growth of these leukaemic cells.
Dasatinib 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 chronic myeloid leukaemia in adults who have not benefited from prior treatments. In patients with ALL, a type of white blood cells called lymphocytes multiply too rapidly and live too long. Dasatinib inhibits the growth of these leukaemic cells.
If you have any questions about how dasatinib works or why this medicine has been prescribed for you, consult your doctor.
2. What you need to know before taking Dasatinib Stada
Do not take Dasatinib Stada
??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 dasatinib.
??if you are taking medicines to thin the blood or prevent blood clots (see Use of dasatinib with other medicines)
??if you have or have had any liver or heart problems
??if you start experiencing 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 might currently have, an infection with hepatitis B virus. This is because dasatinib could cause hepatitis B to become active again, which may be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment.
??if you experience bruising, bleeding, fever, fatigue, and confusion while taking dasatinib, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
Your doctor will monitor your condition regularly to check that dasatinib is having the desired effect. You will also have periodic blood tests while receiving dasatinib.
Children and adolescents
Do not give this medicine to children under one 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.
Other medicines and Dasatinib Stada
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 Stada:
??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 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.
Inform your doctor if you are taking medicines to thin the blood or prevent blood clots.
Taking Dasatinib Stada 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 should not be used during pregnancy unless clearly necessary. Your doctor will inform you of the potential risks of taking dasatinib during pregnancy.
Men and women are advised to use effective contraception during treatment with dasatinib.
If you are breastfeeding, inform your doctor. You must stop breastfeeding while taking dasatinib.
Driving and using machines
Exercise particular caution when driving or operating machinery if you experience adverse effects such as dizziness or blurred vision.
Dasatinib Stada contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Dasatinib Stada
Dasatinib will only be prescribed by a doctor experienced in the treatment of leukemia. Always follow exactly the dosing instructions provided by your doctor. If you are unsure, 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 CML 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 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 is required when switching between formulations (i.e., tablets and oral suspension powder); therefore, do not switch from one formulation to the other without specific medical instruction.
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 Tablets are not recommended 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 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 Stada
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. It cannot be ensured that you will receive the correct dose if the tablets are crushed, cut, chewed, or dispersed. Dasatinib tablets may be taken with or without food.
Special handling instructions for Dasatinib Stada
It is unlikely that dasatinib tablets will break, but if they do, individuals other than the patient should wear gloves when handling dasatinib.
How long to take Dasatinib Stada
Take dasatinib daily until your doctor instructs you to stop treatment. Make sure you take dasatinib for the prescribed duration.
If you take more Dasatinib Stada 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, indicating the medication and the amount ingested.
If you forget to take Dasatinib Stada
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 the use of 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 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, or burning or peeling of the skin and/or mucous membranes
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, fatigue 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: changes in appetite, changes in taste, 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, stiffness of muscles and joints, muscle spasm
??Laboratory tests: fluid around the heart, fluid in the lungs, heart arrhythmias, febrile neutropenia, deficiency in all blood cells, 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 heart rhythm, 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 returning to 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, skin color changes, inflammation of fat tissue under the skin, skin ulcer, skin blisters, nail changes, hair changes, changes in hands and feet, kidney failure, increased urination frequency, breast enlargement in men, menstrual disorders, general weakness and malaise, low thyroid function, loss of balance while walking, osteonecrosis (a condition where blood supply to bones is reduced, potentially causing bone loss and death), arthritis, skin swelling anywhere on the body
??Pain: vein inflammation that may cause redness, tenderness, and swelling, tendon inflammation
??Brain: memory loss
??Additional tests: abnormal blood test results and possible kidney failure caused by waste products from dying tumor cells (tumor lysis syndrome), low blood albumin levels, low lymphocyte count (a type of white blood cell) in the blood, elevated blood cholesterol levels, swollen lymph nodes, brain hemorrhage, irregularities in the heart's electrical activity, enlarged heart, liver inflammation, protein in urine, elevated creatine phosphokinase (an enzyme found mainly in the heart, brain, and skeletal muscles), increased troponin (an enzyme found mainly in the heart and skeletal muscle), elevated gamma-glutamyl transferase (an enzyme found mainly in the liver), milky-appearing fluid around the lungs (chylous 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 blockage of blood supply to the heart muscle (acute coronary syndrome), heart attack (interruption of blood supply to the heart), coronary artery disease (heart disease), 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 the digestive system, intestinal obstruction, anal fistula (abnormal opening from the anus to the surrounding skin), kidney function failure, 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, thyroid gland inflammation, ataxia (associated with loss of muscle coordination), difficulty walking, miscarriage, inflammation of blood vessel skin, skin 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, which 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, skin blisters, 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), including 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Stada
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 outer packaging, after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dasatinib Stada
- The active substance is dasatinib. Each film-coated tablet contains 50 mg or 70 mg of dasatinib.
- The other components are:
Tablet core: lactose monohydrate (200); microcrystalline cellulose (101 and 102); sodium croscarmellose; hydroxypropylcellulose (MW 80,000); magnesium stearate.
Film coating: lactose monohydrate; hypromellose (15 mPas); titanium dioxide (E171); triacetin.
(See section 2 "Dasatinib Stada contains lactose and sodium").
Appearance of the product and contents of the pack
Dasatinib Stada 50 mg: film-coated tablet, white to off-white, biconvex, oval-shaped, approximately 11.0 mm in length and 6.0 mm in width, with "D7SB" engraved on one side and "50" on the other.
Dasatinib Stada 70 mg: film-coated tablet, white to off-white, biconvex, round, approximately 9.1 mm in diameter, with "D7SB" engraved on one side and "70" on the other.
Dasatinib Stada 50 mg is available in packs containing 56 or 60 tablets in blister packs, or in packs containing 56 x 1 or 60 x 1 tablets in unit-dose blisters. It is also available in bottles containing 60 tablets.
Dasatinib Stada 70 mg is available in packs containing 56 or 60 tablets in blister packs, or in packs containing 56 x 1 or 60 x 1 tablets in unit-dose blisters. It is also available in bottles containing 60 tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio STADA, S.L.
C/Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
Synthon Hispania, S.L.
C/Castelló, 1
08830 Sant Boi de Llobregat
Barcelona
Spain
or
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Dasatinib Heumann 50 mg Filmtabletten
Dasatinib Heumann 70 mg Filmtabletten
Spain Dasatinib Stada 50 mg film-coated tablets EFG
Dasatinib Stada 70 mg film-coated tablets EFG
Estonia Dasatinib Norameda
Finland Dasatinib Avansor 50 mg tabletti, kalvopäällysteinen / tablett, filmdragerad
Greece ASATINIB/FARAN
Hungary Dasatinib Onkogen 50 mg filmtabletta
Dasatinib Onkogen 70 mg filmtabletta
Latvia Dasatinib Norameda 50 mg apvalkotas tabletes
Dasatinib Norameda 70 mg apvalkotas tabletes
Lithuania Dasatinib Norameda 50 mg plevele dengtos tabletes
Dasatinib Norameda 50 mg plevele dengtos tabletes
Netherlands Dasatinib Synthon 50 mg, filmomhulde tabletten
Dasatinib Synthon 70 mg, filmomhulde tabletten
Sweden Dasatinib Avansor 50 mg tablett, filmdragerad
Date of the most recent review of this leaflet: November 2023.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/