Everolimus Dr. Reddy's Tablets 2.5mg

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Disponibil de la:

Reddy Pharma Iberia S.A. Avinguda De Josep Tarradellas 38 Barcelona, 08029, Spain

Codul ATC:

L01EG02

INN (nume internaţional):

EVEROLIMUS 2.5 mg

Forma farmaceutică:

TABLET

Compoziție:

EVEROLIMUS 2.5 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2023-01-16

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Everolimus Dr. Reddy’s Tablets 2.5 mg
Everolimus Dr. Reddy’s Tablets 5 mg
Everolimus Dr. Reddy’s Tablets 10 mg
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 Dr. Reddy’s Tablets is and what it is used for
2.
What you need to know before you take Everolimus Dr. Reddy's tablets
3.
How to take Everolimus Dr. Reddy's tablets
4.
Possible side effects
5.
How to store Everolimus Dr. Reddy's tablets
6.
Contents of the pack and other information
1.
WHAT EVEROLIMUS DR. REDDY’S TABLETS IS AND WHAT IT IS USED FOR
Everolimus Dr. Reddy’s Tablets 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 Dr. Reddy’s Tablets 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-call

Caracteristicilor produsului

1
1.
NAME OF THE MEDICINAL PRODUCT
Everolimus Dr. Reddy's Tablets 2.5mg
Everolimus Dr. Reddy's Tablets 5 mg
Everolimus Dr. Reddy's Tablets 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Everolimus Dr. Reddy's Tablets 2.5mg
Each tablet contains 2.5 mg everolimus.
Excipient with known effect
Each tablet contains 74.3 mg lactose
Everolimus Dr. Reddy's Tablets 5 mg
Each tablet contains 5 mg everolimus.
Excipient with known effect
Each tablet contains 148.5 mg lactose
Everolimus Dr. Reddy's Tablets 10 mg
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
Hormone receptor-positive advanced breast cancer
[product name] 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.
2
Neuroendocrine tumours of pancreatic origin
[product name] 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
[product name] 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
[product na