Everolimus Genthon 10mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EVEROLIMUS

Available from:

Genthon BV Microweg 22, 6545 CM NIJMEGEN, Netherlands

ATC code:

L01EG02

INN (International Name):

EVEROLIMUS 10 mg/2ml

Pharmaceutical form:

TABLET

Composition:

EVEROLIMUS 10 mg/2ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2018-06-21

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVEROLIMUS GENTHON 2.5 MG TABLETS
EVEROLIMUS GENTHON 5 MG TABLETS
EVEROLIMUS GENTHON 10 MG TABLETS
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 Genthon is and what it is used for
2.
What you need to know before you take Everolimus Genthon
3.
How to take Everolimus Genthon
4.
Possible side effects
5.
How to store Everolimus Genthon
6.
Contents of the pack and other information
1
WHAT EVEROLIMUS GENTHON IS AND WHAT IT IS USED FOR
Everolimus
Genthon
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 Genthon
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.
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2
WHAT YOU NEED

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Everolimus Genthon 2.5 mg tablets
Everolimus Genthon 5 mg tablets
Everolimus Genthon 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Everolimus Genthon 2.5 mg tablets
Each tablet contains 2.5 mg everolimus.
Excipient with known effect
Each tablet contains 74.3 mg lactose
Everolimus Genthon 5 mg tablets
Each tablet contains 5 mg everolimus.
Excipient with known effect
Each tablet contains 148.5 mg lactose
Everolimus Genthon 10 mg tablets
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.
2.5 mg tablet: white to off white oval biconvex tablets (approximately
10 x 5 mm), debossed with E9VS on one
side and 2.5 on the other side.
5 mg tablet: white to off white oval and biconvex tablets
(approximately 13 x 6 mm), debossed with E9VS 5 on
one side.
10 mg tablet: white to off white oval and biconvex tablets
(approximately 16 x 8 mm), debossed with E9VS 10
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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Hormone receptor-positive advanced breast cancer
Everolimus Genthon 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 Genthon 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 Genthon is indicated for the treatment of unresectable or
metastatic, well-differentiated (Grade 1 or
Grade 2) non-functional neuroendocrine tumours of gastrointestinal or
lung origin in adults with progressive
disease (see sections 4.4 and 5.1).
Renal cell carcinoma