Everolimus 2.5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Everolimus

Disponibil de la:

A A H Pharmaceuticals Ltd

Codul ATC:

L01EG02

INN (nume internaţional):

Everolimus

Dozare:

2.5mg

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

Prospect

Common Technical Document
Everolimus, 2.5, 5, 10 mg
Tablets
M1.3.1_03.EVS.tab.001.03.Core
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVEROLIMUS 2.5MG, 5MG AND 10MG TABLETS
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 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, bowel, lung or
pancreas. It is given if the tumours are inoperable and do not
overproduce specific hormones or other
related natural substances.
Everolimus whi

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Everolimus Sandoz 2.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg everolimus.
Excipient(s) with known effect
Each tablet contains 74 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to slightly yellow, elongated tablets approximately 10.1 x 4.1
mm with a
bevelled edge and no score, engraved with “LCL” on one side and
“NVR” on
the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neuroendocrine tumours of pancreatic origin
Everolimus is indicated for the treatment of unresectable or
metastatic, well-
or moderately-differentiated neuroendocrine tumours of pancreatic
origin in
adults with progressive disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Everolimus should be initiated and supervised by a
physician
experienced in the use of anticancer therapies.
_ _
Posology
For the different dose regimens Everolimus 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
toxicity
occurs.
If a dose is missed, the patient should not take an additional dose,
but take the
next prescribed dose as usual.
_Dose adjustment due to adverse reactions _
Management of severe and/or intolerable suspected adverse reactions
may
require dose reduction and/or temporary interruption of Everolimus
therapy.
For adverse reactions of Grade 1, dose adjustment is usually not
required. If
dose reduction is required, the recommended dose is 5 mg daily and
must not
be lower than 5 mg daily.
Table 1 summarises the dose adjustment recommendations for specific
adverse
reactions (see also section 4.4).
TABLE 1
EVEROLIMUS DOSE ADJUSTMENT RECOMMENDATIONS
ADVERSE REACTION
SEVERITY
1
EVEROLIMUS DOSE ADJUSTMENT
Grade 2
Consider
interruption
of
therapy
until
symptoms
improve to
Grade
≤
1.
Re-initiate treatment at 5 mg daily.
Discontinue treatm