Active ingredient
- dasatinib monohydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/06/363/002, EU/1/06/363/011, EU/1/06/363/015, EU/1/06/363/001, EU/1/06/363/012, EU/1/06/363/014, EU/1/06/363/004, EU/1/06/363/005, EU/1/06/363/010, EU/1/06/363/013, EU/1/06/363/007, EU/1/06/363/008.
Sprycel 20mg 50mg 80mg 100mg 140mg Film Coated Tablets
Package leaflet: Information for the user
SPRYCEL 20 mg film-coated tablets
SPRYCEL 50 mg film-coated tablets
SPRYCEL 70 mg film-coated tablets
SPRYCEL 80 mg film-coated tablets
SPRYCEL 100 mg film-coated tablets
SPRYCEL 140 mg film-coated tablets
dasatinib
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What SPRYCEL is and what it is used for
2. What you need to know before you take SPRYCEL
3. How to take SPRYCEL
4. Possible side effects
5. How to store SPRYCEL
6. Contents of the pack and other information
1. What SPRYCEL is and what it is used for
SPRYCEL 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 cancer of white blood cells. These white cells usually help the body to fight infection. In people with CML, white cells called granulocytes start growing out of control. SPRYCEL inhibits the growth of these leukaemic cells.
SPRYCEL 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 CML in adults who are not benefiting from prior therapies. In people with ALL, white cells called lymphocytes multiply too quickly and live too long. SPRYCEL inhibits the growth of these leukaemic cells.
If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take SPRYCEL
Do not take SPRYCEL
If you could be allergic, ask your doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist before using SPRYCEL
Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect. You will also have blood tests regularly while you are taking SPRYCEL.
Children and adolescents
Do not give this medicine to children younger than one year of age. There is limited experience with the use of SPRYCEL in this age group. Bone growth and development will be closely monitored in children taking SPRYCEL.
Other medicines and SPRYCEL
Tell your doctor if you are taking, have recently taken or might take any other medicines.
SPRYCEL is mainly handled by the liver. Certain medicines may interfere with the effect of SPRYCEL when taken together.
These medicines are not to be used with SPRYCEL:
Do not take medicines that neutralise stomach acids (antacids such as aluminium hydroxide or magnesium hydroxide) in the 2 hours before or 2 hours after taking SPRYCEL.
Tell your doctor if you are taking medicines to thin the blood or prevent clots.
SPRYCEL with food and drink
Do not take SPRYCEL with grapefruit or grapefruit juice.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor immediately. SPRYCEL is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy.
Both men and women taking SPRYCEL will be advised to use effective contraception during treatment.
If you are breast-feeding, tell your doctor. You should stop breast-feeding while you are taking SPRYCEL.
Driving and using machines
Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.
SPRYCEL contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take SPRYCEL
SPRYCEL will only be prescribed to you by a doctor with experience in treating leukaemia. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. SPRYCEL is prescribed for adults and children at least 1 year of age.
The starting dose recommended for adult patients with chronic phase CML is 100 mg once a day.
The starting dose recommended for adult patients with accelerated or blast crisis CML or Ph+ ALL is 140 mg once a day.
Dosing for children with chronic phase CML or Ph+ ALL is on the basis of body weight.
SPRYCEL is administered orally once daily in the form of either SPRYCEL tablets or SPRYCEL powder for oral suspension. SPRYCEL tablets are not recommended for patients weighing less than 10 kg. The powder for oral suspension should be used for patients weighing less than 10 kg and patients who cannot swallow tablets. A change in dose may occur when switching between formulations (i.e., tablets and powder for oral suspension), so you should not switch from one to the other.
Your doctor will decide the right formulation and dose based on your weight, any side effects and response to treatment. The starting dose of SPRYCEL for children is calculated by body weight as shown below:
Body Weight (kg)a Daily Dose (mg)
10 to less than 20 kg 40 mg
20 to less than 30 kg 60 mg
30 to less than 45 kg 70 mg
at least 45 kg 100 mg
a The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
There is no dose recommendation for SPRYCEL with children under 1 year of age.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose, or even stopping treatment briefly. For higher or lower doses, you may need to take combinations of the different tablet strengths.
The tablets may come in packs with calendar blisters. These are blisters showing the days of the week. There are arrows to show the next tablet to be taken according to your treatment schedule.
How to take SPRYCEL
Take your tablets at the same time every day. Swallow the tablets whole. Do not crush, cut or chew them. Do not take dispersed tablets. You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets. SPRYCEL tablets can be taken with or without a meal.
Special handling instructions for SPRYCEL
It is unlikely that the SPRYCEL tablets will get broken. But if they do, persons other than the patient should use gloves when handling SPRYCEL.
How long to take SPRYCEL
Take SPRYCEL daily until your doctor tells you to stop. Make sure you take SPRYCEL for as long as it is prescribed.
If you take more SPRYCEL than you should
If you have accidentally taken too many tablets, talk to your doctor immediately. You may require medical attention.
If you forget to take SPRYCEL
Do not take a double dose to make up for a forgotten tablet. Take the next scheduled dose at the regular time.
If you have any further questions on 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 everybody gets them.
Contact your doctor immediately if you notice any of the above.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Other side effects that have been reported with frequency not known (cannot be estimated from the available data)
Your doctor will check for some of these effects during your treatment.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Ireland
Malta
United Kingdom
Yellow Card Scheme
Website: at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store SPRYCEL
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 bottle label, blister or 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What SPRYCEL contains
What SPRYCEL looks like and contents of the pack
SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side.
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side.
SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with “BMS 80” debossed on one side and “855” on the other side.
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS 140” debossed on one side and “857” on the other side.
SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each, and in cartons containing 60 x 1 film-coated tablets in perforated unit dose blisters. They are also available in bottles with child-resistant closure containing 60 film-coated tablets. Each carton contains one bottle.
SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablets in perforated unit dose blisters. They are also available in bottles with child-resistant closure containing 30 film-coated tablets. Each carton contains one bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, UK
+44 (0) 800 731 1736