Everolimus Zentiva 5 mg, tabletten

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

EVEROLIMUS 5 mg/stuk

Disponible depuis:

Zentiva a.s. U. Kabelovny 130 10237 PRAGUE (TSJECHIË)

Code ATC:

L01XE10

DCI (Dénomination commune internationale):

EVEROLIMUS 5 mg/stuk

forme pharmaceutique:

Tablet

Composition:

BUTYLHYDROXYTOLUEEN (E 321) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b)

Mode d'administration:

Oraal gebruik

Domaine thérapeutique:

Everolimus

Date de l'autorisation:

1900-01-01

Notice patient

04/2022 PRAC
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVEROLIMUS ZENTIVA 2,5 MG, TABLETTEN
EVEROLIMUS ZENTIVA 5 MG, TABLETTEN
EVEROLIMUS ZENTIVA 10 MG, TABLETTEN
everolimus
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 Everolimus Zentiva is and what it is used for
2.
What you need to know before you take Everolimus Zentiva
3.
How to take Everolimus Zentiva
4.
Possible side effects
5.
How to store Everolimus Zentiva
6.
Contents of the pack and other information
1.
WHAT EVEROLIMUS ZENTIVA IS AND WHAT IT IS USED FOR
Everolimus Zentiva is an anticancer medicine containing the active
substance everolimus.
Everolimus reduces the blood supply to the tumour and slows down the
growth and spread
of cancer cells.
Everolimus Zentiva is used to treat adult patients with:
•
hormone receptor-positive advanced breast cancer in postmenopausal
women, in whom
other treatments (so called “non-steroidal aromatase inhibitors”)
no longer keep
the disease under control. It is given together with a medicine called
exemestane,
a steroidal aromatase inhibitor, which is used for hormonal anticancer
therapy.
•
advanced tumours called neuroendocrine tumours that originate from the
stomach,
bowels, lung or pancreas. It is given if the tumours are inoperable
and do not
overproduce specific hormones or other related natural substances.
•
advanced kidney cancer (advanced renal cell carcinoma), where other
treatments (so-
called “VEGF-targeted therapy”) have not helped stop your disease.
2.
WHAT YOU NE

Résumé des caractéristiques du produit

10/2022 Renewal R/001
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Everolimus Zentiva 2,5 mg, tabletten
Everolimus Zentiva 5 mg, tabletten
Everolimus Zentiva 10 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Everolimus Zentiva 2,5 mg, tabletten
Each tablet contains 2.5 mg everolimus.
Excipient with known effect
Each tablet contains 74.3 mg lactose.
Everolimus Zentiva 5 mg, tabletten
Each tablet contains 5 mg everolimus.
Excipient with known effect
Each tablet contains 148.5 mg lactose.
Everolimus Zentiva 10 mg, tabletten
Each tablet contains 10 mg everolimus.
Excipient with known effect
Each tablet contains 297.0 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Everolimus Zentiva 2.5 mg tablets
White to off white oval biconvex tablets (approximately 10×5 mm),
debossed with E9VS
on one side and 2.5 on the other side.
Everolimus Zentiva 5 mg tablets
White to off white oval and biconvex tablets (approximately 13×6 mm),
debossed with E9VS
5 on one side.
Everolimus Zentiva 10 mg tablets
White to off white oval and biconvex tablets (approximately 16×8 mm),
debossed with E9VS
10 on one side.
10/2022 Renewal R/001
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone receptor-positive advanced breast cancer
Everolimus Zentiva is indicated for the treatment of hormone
receptor-positive, HER2/neu
negative advanced breast cancer, in combination with exemestane, in
postmenopausal women
without symptomatic visceral disease after recurrence or progression
following a non-
steroidal aromatase inhibitor.
Neuroendocrine tumours of pancreatic origin
Everolimus Zentiva is indicated for the treatment of unresectable or
metastatic, well-
or moderately-differentiated neuroendocrine tumours of pancreatic
origin in adults with
progressive disease.
Neuroendocrine tumours of gastrointestinal or lung origin
Everolimus Zentiva is indicated for the treatment of unresectable or
metastatic, well-
differentiated (Grade 1 or Grade 2) non-functional neuroendocrine