BINODA 500mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CAPECITABINE

Available from:

ALFRED E. TIEFEMBACHER (GmbH &Co. KG) Van-der-Smissen-Straße 1, 22767 Hamburg, Germany

ATC code:

L01BC06

INN (International Name):

CAPECITABINE 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CAPECITABINE 500 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-04-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

BINODA150 MG FILM-COATED TABLETS 
 BINODA 500 MG FILM-COATED TABLETS 
capecitabine 

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. 

WHAT IS IN THIS LEAFLET: 
1. 
What BINODA is and what it is used for 
2. 
What you need to know before you take BINODA 
3. 
How to take BINODA 
4. 
Possible side effects 
5. 
How to store BINODA 
6. 
Contents of pack and other information 

1. WHAT BINODA IS AND WHAT IT IS USED FOR 

BINODA belongs to the group of medicines called "cytostatic agents",
which stop the growth of cancer cells. 
BINODA contains 150 mg/500 mg capecitabine, which itself is not a
cytostatic agent. Only after being 
absorbed by the body is it changed into an active anti-cancer
agent (more in tumour tissue than in normal 
tissue). 

BINODA is prescribed by doctors for the treatment of colon, rectal,
gastric, or breast cancers. 
Furthermore, BINODA is prescribed by doctors to prevent new
occurrence of colon cancer after complete 
removal of the tumour by surgery. 

BINODA may be used either alone or in combination with other
agents. 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BINODA 

DO NOT TAKE BINODA: 
- 
if you are allergic to capecitabine, flourouracil or any of the
other ingredients of this medicine (listed 
in section 6). 
- 
You must inform your doctor if you know that you have an
allergy or over-reaction to BINODA or 
to flouropyrimidin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

BINODA 150 mg film-coated tablets. 
BINODA 500 mg film-coated tablets. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

[For 150 mg strength:] 
Each film-coated tablet contains 150 mg capecitabine. 

Excipient with known effect: 12.3 mg lactose monohydrate. 

[For 500 mg strength:] 
Each film-coated tablet contains 500 mg capecitabine. 

Excipient with known effect: 41 mg lactose monohydrate. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Film-coated tablet 

[For 150 mg strength:] 
Pink coloured, capsule shaped, biconvex, film coated tablets
(approx. 11.1 mm x 5.6 mm), debossed with 
“150”on one side and plain on other side. 

[For 500 mg strength:] 
Pink coloured, capsule shaped, biconvex, film coated tablets
(approx. 17.1 mm x 8.1 mm), debossed with 
“500’ on one side and plain on other side. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Capecitabine is indicated for the adjuvant treatment of patients
following surgery of stage III (Dukes’ stage 
C) colon cancer (see section 5.1). 

Capecitabine is indicated for the treatment of metastatic
colorectal cancer (see section 5.1). 

Capecitabine is indicated for first-line treatment of advanced
gastric cancer in combination with a 
platinumbased regimen (see section 5.1). 

Capecitabine in combination with docetaxel (see section 5.1) is
indicated for the treatment of patients with 
locally advanced or metastatic breast cancer after failure of
cytotoxic chemotherapy. Previous therapy should 
have included an anthracycline. Capecitabine is also indicated
as monotherapy for the treatment of patients 
with locally advanced or metastatic breast cancer after failure of
taxanes and an anthracyclinecontaining 
chemotherapy regimen or for whom further anthracycline therapy is
not indicated. 
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