Capecitabine Fair-Med 500mg film-coated tablets.

Land: Storbritannien

Språk: engelska

Källa: myHealthbox

Aktiva substanser:

capecitabine

Tillgänglig från:

Fair-Med Healthcare GmbH

ATC-kod:

L01BC06

INN (International namn):

capecitabine

Dos:

500mg

Läkemedelsform:

Film-coated tablets

Administreringssätt:

Oral use

Enheter i paketet:

120 film-coated tablets

Receptbelagda typ:

POM - Prescription Only Medicine

Tillverkad av:

Remedica Ltd

Terapeutisk grupp:

cytostatic (antimetabolite)

Terapeutiska indikationer:

Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer Capecitabine is indicated for the treatment of metastatic colorectal cancer Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen Capecitabine in combination with docetaxel 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.

Bemyndigande status:

Authorised

Tillstånd datum:

2015-03-02

Bipacksedel

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
_ _
 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. See section 4. 
_ _
WHAT IS IN THIS LEAFLET 
1. 
What  is and what it is used for 
2. 
What you need to know before you take  
3. 
How to  take  
4. 
Possible side effects 
5. 
How to store  
6. 
Contents of the pack and other information 

1. 
WHAT  IS AND WHAT IT IS USED FOR 

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

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

 may be used either alone or in combination with
other medicines. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE  

DO NOT TAKE : 
- 
if you are allergic to
capecitabine or any of the

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Capecitabine Fair-Med 500 mg film-coated tablets. 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 500 mg of capecitabine. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Film-coated tablet 

Peach, oblong capsule-shaped, film-coated tablets embossed
with “500” on one side. 
Of approximate dimensions 17.1 mm x 8.1 mm.  

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 platinum-based 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 
anthracycline-containing chemotherapy regimen or
for whom further anthracycline 
therapy is not indicated. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Capecitabine should only be prescribed by a
qualified physician experienced in the 
utilisation of anti-neoplastic medicinal products. Careful
monitoring during the first 
cycle of treatment is recommended for all patients. Treatment
should be discontinued 
if progressive disease or intolerable toxicity is observed.
Standard and reduced dose 
calculations according to body surface area for