Axitinib Synthon 1 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands

ATC code:

L01EK01

INN (International Name):

AXITINIB 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AXITINIB 1 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-02-02

Patient Information leaflet

M1.3.1_03.ATI.tab.001.06.MT.5475.01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AXITINIB SYNTHON 1 MG FILM-COATED TABLETS
AXITINIB SYNTHON 3 MG FILM-COATED TABLETS
AXITINIB SYNTHON 5 MG FILM-COATED TABLETS
AXITINIB SYNTHON 7 MG FILM-COATED TABLETS
axitinib
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Axitinib Synthon is and what it is used for
2.
What you need to know before you take Axitinib Synthon
3.
How to take Axitinib Synthon
4.
Possible side effects
5.
How to store Axitinib Synthon
6.
Contents of the pack and other information
1
WHAT AXITINIB SYNTHON IS AND WHAT IT IS USED FOR
Axitinib Synthon is a medicine containing the active substance
axitinib. Axitinib reduces the blood supply to the
tumour and slows down the growth of cancer.
Axitinib Synthon is indicated for the treatment of advanced kidney
cancer (advanced renal cell carcinoma) in
adults, when another medicine (called sunitinib or a cytokine) is no
longer stopping disease from progressing.
If you have any questions about how this medicine works or why this
medicine has been prescribed for you, ask
your doctor.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXITINIB SYNTHON
DO NOT TAKE AXITINIB SYNTHON
:
If you are allergic to axitinib or any of the other ingredients of
this medicine (listed in section 6). If you think
you may be allergic, ask your doctor for advice.
M1.3.1_03.ATI.tab.001.06.MT.5475.01
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE TAKING AXITINIB SYNTHON
-
IF YOU HAVE HIGH BLOOD PRESSURE.

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Axitinib Synthon 1 mg film-coated tablets
Axitinib Synthon 3 mg film-coated tablets
Axitinib Synthon 5 mg film-coated tablets
Axitinib Synthon 7 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Axitinib Synthon 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of axitinib.
Axitinib Synthon 3 mg film-coated tablets
Each film-coated tablet contains 3 mg of axitinib.
Axitinib Synthon 5 mg film-coated tablets
Each film-coated tablet contains 5 mg of axitinib.
Axitinib Synthon 7 mg film-coated tablets
Each film-coated tablet contains 7 mg of axitinib.
Excipient(s) with known effect
Axitinib Synthon 1 mg film-coated tablets
Each film-coated tablet contains 33 mg of lactose monohydrate.
Axitinib Synthon 3 mg film-coated tablets
Each film-coated tablet contains 99 mg of lactose monohydrate.
Axitinib Synthon 5 mg film-coated tablets
Each film-coated tablet contains 166 mg of lactose monohydrate.
Axitinib Synthon 7 mg film-coated tablets
Each film-coated tablet contains 232 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Axitinib Synthon 1 mg film-coated tablets
Red colour, round biconvex coated tablet, approximately 6 mm diameter
and debossed with “A7TI” on one
side and “1” on the other.
Axitinib Synthon 3 mg film-coated tablets
Red colour, oval biconvex coated tablet, approximately 12 mm long by 7
mm wide and debossed with “A7TI” on
one side and “3” on the other.
Axitinib Synthon 5 mg film-coated tablets
Red colour, oval biconvex coated tablet, approximately 15 mm long by 8
mm wide and debossed with “A7TI”
on one side and “5” on the other.
Axitinib Synthon 7 mg film-coated tablets
Red colour, oval biconvex coated tablet, approximately 17 mm long by 9
mm wide and debossed with “A7TI”
on one side and “7” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Axitinib Synthon is indicated for the treatment of adult patients with
advanced r