Sprycel

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dasatinib

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

L01EA02

INN (International Name):

dasatinib (anhydrous)

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Therapeutic indications:

Sprycel is indicated for the treatment of paediatric patients with:newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib.newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.Sprycel is indicated for the treatment of adult patients with:newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase;chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate;Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.Sprycel is indicated for the treatment of paediatric patients with:newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

Product summary:

Revision: 41

Authorization status:

Authorised

Authorization date:

2006-11-20

Patient Information leaflet

106
B. PACKAGE LEAFLET
107
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.

Keep this leaflet. 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 pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects , talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SPRYCEL 20 mg film-coated tablets
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 27 mg of lactose monohydrate.
SPRYCEL 50 mg film-coated tablets
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 67.5 mg of lactose monohydrate.
SPRYCEL 70 mg film-coated tablets
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 94.5 mg of lactose monohydrate.
SPRYCEL 80 mg film-coated tablets
Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 108 mg of lactose monohydrate.
SPRYCEL 100 mg film-coated tablets
Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 135.0 mg of lactose monohydrate.
SPRYCEL 140 mg film-coated tablets
Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 189 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
3
SPRYCEL 20 mg film-coated tablets
White to off-white, biconvex, round film-coated tablet with "BMS"
debossed on one side and "527" on
the other side.
SPRYCEL 50 mg film-coated tablets
White to off-white, biconvex, oval film-coated tablet with "BMS"
debossed on one side and "528" on
the other side.
SPRYCEL 70 mg film-coated tablets
White to off-white, biconvex, round film-coated tablet with "BMS"
debossed on one side and "524" on
the other side.