Sorafenib STADA 200 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SORAFENIBTOSYLAAT 274 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 200 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

INN (Algemene Internationale Benaming):

SORAFENIBTOSYLAAT 274 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 200 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-06-17

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB STADA 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is used to treat liver cancer
_(hepatocellular carcinoma)._
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.
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
DO NOT TAKE

-
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
TAKE SPECIAL CARE WITH
-
IF YOU EXPERIENCE THE FOLLOWING SYMPTOMS, CONTACT YOUR DOCTOR
IMMEDIATELY AS
THIS CAN BE A LIFE-THREATENING CONDITION:
NAUSEA, SHORTNESS OF BREATH, IRREGULAR
HEARTBEAT, MUSCULAR CRAMPS, SEIZURE, CLOUDING OF URINE AND TIREDNESS
. These may
be caused by a group of metabolic complications that can occur during
treatment of

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib STADA 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
is indicated for the treatment of hepatocellular
carcinoma (see section 5.1).
Renal cell carcinoma
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
treatment should be supervised by a physician
experienced in the use of anticancer
therapies.
Posology
The recommended dose of 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.
When dose reduction is necessary during the treatment of
hepatocellular carcinoma (HCC) and
advanced renal cell carcinoma (RCC), the dose should be
reduced to two tablets of
200 mg sorafenib once daily (see section 4.4).
_Paediatric population _
The safety and efficacy of 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 renal impai