Everolimus 5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Everolimus

Disponibil de la:

Accord-UK Ltd

Codul ATC:

L01EG02

INN (nume internaţional):

Everolimus

Dozare:

5mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 08010500; GTIN: 5055565748091

Prospect

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EVEROLIMUS 10MG TABLETS PIL - UK
Black
Profile
BBBB1586
RH
09-06-21
152x440
9pt
Synthon ES
10-06-21
01
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified) 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

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Everolimus 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg everolimus.
Excipient with known effect
Each tablet contains 148.5 mg lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
5 mg tablet: white to off white oval and biconvex tablets
(approximately 13 x 6 mm),
debossed with E9VS 5 on one side
4.1
THERAPEUTIC INDICATIONS
Hormone receptor-positive advanced breast cancer
Everolimus Tablets are 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 Tablets are 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 Tablets are 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 Tablets are 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 Tablets should be initiated and supervised
by a physician
experienced in the use of anticancer therapies.
Posology
For the different dose regimens Everolimus Tablets are 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 toxicity
occurs.
If a dose is missed, the patient should n