Lonsurf
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-09-2023
Produktets egenskaber
(SPC)
11-09-2023
Offentlige vurderingsrapport
(PAR)
11-09-2023
Aktiv bestanddel:
trifluridine, tipiracil hydrochloride
Tilgængelig fra:
Les Laboratoires Servier
ATC-kode:
L01BC59
INN (International Name):
trifluridine, tipiracil
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Colorectal Neoplasms
Terapeutiske indikationer:
Colorectal cancerLonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti EGFR agentsGastric cancerLonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
Produkt oversigt:
Revision: 9
Autorisation status:
Authorised
Autorisation dato:
2016-04-25
Indlægsseddel
38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LONSURF 15 MG/6.14 MG FILM-COATED TABLETS
LONSURF 20 MG/8.19 MG FILM-COATED TABLETS
trifluridine/tipiracil
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 experience 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 Lonsurf
is and what it is used for
2.
What you need to know before you take Lonsurf
3.
How to take Lonsurf
4.
Possible side effects
5.
How to store Lonsurf
6.
Contents of the pack and other information
1.
WHAT LONSURF IS AND WHAT IT IS USED FOR
Lonsurf is a type of cancer chemotherapy which belongs to the group of
medicines called "cytostatic
antimetabolite medicines".
Lonsurf contains two different active substances: trifluridine and
tipiracil.
•
Trifluridine stops the growth of cancer cells.
•
Tipiracil stops the trifluridine from being broken down by the body,
helping trifluridine to work
longer.
Lonsurf is used to treat adults with colon or rectal cancer -
sometimes called ‘colorectal’ cancer and
stomach cancer (including cancer of the junction between the
oesophagus and the stomach).
•
It is used when the cancer has spread to other parts of the body
(metastases).
•
It is used when other treatments have not worked - or when other
treatments are not suitable for
you.
Lonsurf may be given in combination with bevacizumab. It is important
that you also read the package
leaflet of bevacizumab. If you have any questions about this medicine,
ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LONSURF
DO NOT TAKE LONSURF
•
if you are al
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lonsurf 15 mg/6.14 mg film-coated tablets
Lonsurf 20 mg/8.19 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lonsurf 15 mg/6.14 mg film-coated tablets
Each film-coated tablet contains 15 mg trifluridine and 6.14 mg
tipiracil (as hydrochloride).
_Excipient with known effect _
Eac`h film-coated tablet contains 90.735 mg of lactose monohydrate.
Lonsurf 20 mg/8.19 mg film-coated tablets
Each film-coated tablet contains 20 mg trifluridine and 8.19 mg
tipiracil (as hydrochloride).
_Excipient with known effect _
Each film-coated tablet contains 120.980 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Lonsurf 15 mg/6.14 mg film-coated tablets
The tablet is a white, biconvex, round, film-coated tablet, with a
diameter of 7.1 mm and a thickness
of 2.7 mm, imprinted with ‘15’ on one side, and ‘102’ and
’15 mg’ on the other side, in grey ink.
Lonsurf 20 mg/8.19 mg film-coated tablets
The tablet is a pale red, biconvex, round, film-coated tablet, with a
diameter of 7.6 mm and a thickness
of 3.2 mm, imprinted with ‘20’ on one side, and ‘102’ and
‘20 mg’ on the other side, in grey ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Colorectal cancer
Lonsurf is indicated in combination with bevacizumab for the treatment
of adult patients with
metastatic colorectal cancer (CRC) who have received two prior
anticancer treatment regimens
including fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapies, anti-VEGF agents,
and/or anti-EGFR agents.
Lonsurf is indicated as monotherapy for the treatment of adult
patients with metastatic colorectal
cancer who have been previously treated with, or are not considered
candidates for, available therapies
including fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapies, anti-VEGF agents, and
anti-EGFR agents.
Gastric cancer
Lonsurf is indicated as monotherapy for t
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