Everolimus 5mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Everolimus

Dostupné s:

A A H Pharmaceuticals Ltd

ATC kód:

L01EG02

INN (Mezinárodní Name):

Everolimus

Dávkování:

5mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 08010500

Informace pro uživatele

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Details
EVEROLIMUS 2.5MG AND 5MG TABLETS PIL - UK
Black
BBBA6289
NM
19/09/2019
19/11/2019
NM
200x320
9pt
Synthon
19/09/2019
03/10/2019
2
Version 2
01.11.2017 EVEROLIMUS 2.5MG, 5MG AND 10MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.
•
The full name of this medicine is Everolimus 2.5mg, 5mg and 10mg
Tablets but
within this leaflet it will be referred to as Everolimus Tablets.
WHAT IS IN THIS LEAFLET
1 WHAT EVEROLIMUS TABLETS ARE AND WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVEROLIMUS TABLETS
3
HOW TO TAKE EVEROLIMUS TABLETS
4 POSSIBLE SIDE EFFECTS
5
HOW TO STORE EVEROLIMUS TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT EVEROLIMUS TABLETS ARE AND WHAT THEY ARE USED FOR
Everolimus Tablets are 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 Tablets are used to treat adult patien

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Everolimus Ethypharm 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg everolimus.
Excipient with known effect:
Each tablet contains 149 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white oblong tablet, 12.5 x 5.0 mm engraved with a
“E” on one side and
with a “5” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hormone receptor-positive advanced breast cancer _
Everolimus Ethypharm 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 Ethypharm 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 Ethypharm 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 _
Everolimus Ethypharm is indicated for the treatment of patients with
advanced renal
cell carcinoma, whose disease has progressed on or after treatment
with VEGF-
targeted therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Everolimus Ethypharm should be initiated and supervised
by a
physician experienced in the use of anticancer therapies.
POSOLOGY
For the different dose regimens Everolimus Ethypharm is available as
2.5 mg, 5 mg
and 10 mg tablets.
The recommended dose is 10 mg everolimus once daily. Treatment should
continue
as long as clinical benefit is observed or until unacceptable to