Sorafenib Mylan 200 mg, filmomhulde tabletten

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

SORAFENIBTOSYLAAT SAMENSTELLING overeenkomend met ; SORAFENIB

Dostupné s:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

INN (Mezinárodní Name):

SORAFENIBTOSYLAAT COMPOSITION corresponding to ; SORAFENIB

Léková forma:

Filmomhulde tablet

Složení:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171)

Podání:

Oraal gebruik

Datum autorizace:

2020-06-27

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB MYLAN 200 MG FILMOMHULDE TABLETTEN
sorafenib
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 Sorafenib Mylan is and what it is used for
2.
What you need to know before you take Sorafenib Mylan
3.
How to take Sorafenib Mylan
4.
Possible side effects
5.
How to store Sorafenib Mylan
6.
Contents of the pack and other information
1.
WHAT SORAFENIB MYLAN IS AND WHAT IT IS USED FOR
Sorafenib Mylan is used to treat liver cancer
_(hepatocellular carcinoma)._
Sorafenib Mylan is also used to treat kidney cancer
_(advanced renal cell carcinoma)_
at an advanced
stage when standard therapy has not helped to stop your disease or is
considered unsuitable.
Sorafenib Mylan is a so-called
_multikinase inhibitor_
. It works by slowing down the rate of growth of
cancer cells and cutting off the blood supply that keeps cancer cells
growing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SORAFENIB MYLAN
DO NOT TAKE
SORAFENIB MYLAN
-
IF YOU ARE ALLERGIC
to sorafenib or any of the other ingredients of this medicine (listed
in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Sorafenib Mylan
TAKE SPECIAL CARE WITH SORAFENIB MYLAN
-
IF YOU EXPERIENCE SKIN PROBLEMS.
Sorafenib Mylan can cause rashes and skin reactions,
especially on the hands and feet. These can usually be treated by your
doctor. If not, your doctor
may interrupt treatment or stop it altogether.
-
IF YOU HAVE HIGH BLOOD PRESSURE.
Sorafenib Mylan can raise blood pressure, and

Charakteristika produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib Mylan 200 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red-brown, round, biconvex film-coated tablets, debossed with
“200” on one side and plain
on the other side with a diameter of tablet 12.0 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hepatocellular carcinoma
Sorafenib Mylan is indicated for the treatment of hepatocellular
carcinoma (see section 5.1).
Renal cell carcinoma
Sorafenib Mylan is indicated for the treatment of patients with
advanced renal cell carcinoma
who have failed prior interferon-alpha or interleukin-2 based therapy
or are considered
unsuitable for such therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sorafenib Mylan treatment should be supervised by a physician
experienced in the use of
anticancer therapies.
Posology
The recommended dose of Sorafenib Mylan in adults is 400 mg sorafenib
(two tablets of 200
mg) twice daily (equivalent to a total daily dose of 800 mg).
Treatment should continue as long as clinical benefit is observed or
until unacceptable toxicity
occurs.
Posology adjustments
Management of suspected adverse drug reactions may require temporary
interruption or dose
reduction of sorafenib therapy.
2
When dose reduction is necessary during the treatment of
hepatocellular carcinoma (HCC)
and advanced renal cell carcinoma (RCC), the Sorafenib Mylan dose
should be reduced to two
tablets of 200 mg sorafenib once daily (see section 4.4).
_Paediatric population _
The safety and efficacy of Sorafenib Mylan in children and adolescents
aged < 18 years have
not yet been established. No data are available.
_Elderly population _
No dose adjustment is required in the elderly (patients above 65 years
of age).
_Renal impairment _
No dose adjustment is required in patients with mild, moderate or
severe r