Dasatinib Synthon 100mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DASATINIB

Available from:

Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands

ATC code:

L01EA02

INN (International Name):

DASATINIB 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DASATINIB 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-05-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DASATINIB SYNTHON 20 MG FILM-COATED TABLETS
DASATINIB SYNTHON 50 MG FILM-COATED TABLETS
DASATINIB SYNTHON 70 MG FILM-COATED TABLETS
DASATINIB SYNTHON 80 MG FILM-COATED TABLETS
DASATINIB SYNTHON 100 MG FILM-COATED TABLETS
DASATINIB SYNTHON 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 Dasatinib Synthon is and what it is used for
2.
What you need to know before you take Dasatinib Synthon
3.
How to take Dasatinib Synthon
4.
Possible side effects
5.
How to store Dasatinib Synthon
6.
Contents of the pack and other information
1
WHAT DASATINIB SYNTHON IS AND WHAT IT IS USED FOR
Dasatinib Synthon 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.
Dasatinib Synthon inhibits the growth of these leukaemic cells.
Dasatinib Synthon 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. Dasatinib
Synthon inhibits the growth of these leukaemic cells.
If you h

Summary of Product characteristics

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1.3.1
Summary of Product Characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
Dasatinib Synthon 20 mg film-coated tablets
Dasatinib Synthon 50 mg film-coated tablets
Dasatinib Synthon 70 mg film-coated tablets
Dasatinib Synthon 80 mg film-coated tablets
Dasatinib Synthon 100 mg film-coated tablets
Dasatinib Synthon 140 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dasatinib Synthon 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of dasatinib.
Excipient(s) with known effect
Each film-coated tablet contains 28 mg of lactose monohydrate.
Dasatinib Synthon 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of dasatinib.
Excipient(s) with known effect
Each film-coated tablet contains 69 mg of lactose monohydrate.
Dasatinib Synthon 70 mg film-coated tablets
Each film-coated tablet contains 70 mg of dasatinib.
Excipient(s) with known effect
Each film-coated tablet contains 97 mg of lactose monohydrate.
Dasatinib Synthon 80 mg film-coated tablets
Each film-coated tablet contains 80 mg of dasatinib.
Excipient(s) with known effect
Each film-coated tablet contains 111 mg of lactose monohydrate.
Dasatinib Synthon 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of dasatinib.
Excipient(s) with known effect
Each film-coated tablet contains 138 mg of lactose monohydrate.
Dasatinib Synthon 140 mg film-coated tablets
Each film-coated tablet contains 140 mg of dasatinib.
Excipient(s) with known effect
Each film-coated tablet contains 194 mg of lactose monohydrate.
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For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Dasatinib Synthon 20 mg film-coated tablets
White to off-white, biconvex, round film-coated tablet with a diameter
of approximately 5.6
mm, with “D7SB” debossed on one side and “20” on the other
side.
Dasatinib Synthon 50 mg film-coated tablets
White to off-white, biconvex, oval film-coated tablet with a length of
approximately 11.0 mm
and a width of approximately 6