Capecitabine Fair-Med 150mg film-coated tablets.

Pays: Royaume-Uni

Langue: anglais

Source: myHealthbox

Ingrédients actifs:

capecitabine

Disponible depuis:

Fair-Med Healthcare GmbH

Code ATC:

L01BC06

DCI (Dénomination commune internationale):

capecitabine

Dosage:

150mg

forme pharmaceutique:

Film-coated tablets

Mode d'administration:

Oral use

Unités en paquet:

60 film-coated tablets

Type d'ordonnance:

POM - Prescription Only Medicine

Fabriqué par:

Remedica Ltd

Groupe thérapeutique:

cytostatic (antimetabolite)

indications thérapeutiques:

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.

Statut de autorisation:

Authorised

Date de l'autorisation:

2015-03-02

Notice patient

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
_ _
CAPECITABINE 150 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 Capecitabine is and what it is used for 
2. 
What you need to know before you take Capecitabine 
3. 
How to  take Capecitabine 
4. 
Possible side effects 
5. 
How to store Capecitabine 
6. 
Contents of the pack and other information 

1. 
WHAT CAPECITABINE IS AND WHAT IT IS USED FOR 

Capecitabine belongs to the group
of medicines called "cytostatic medicines", which stop the 
growth of cancer cells. Capecitabine contains 150
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). 

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

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

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE 

DO NOT TAKE CAPECITABINE: 
- 
if you are allergic to
capecitabine or any of the other ingredients of this medicine 

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Capecitabine Fair-Med 150 mg film-coated tablets. 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 150 mg of capecitabine. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Film-coated tablet 

Light-peach oval film-coated tablets embossed with “150” on one
side. Of 
approximate dimensions 11.4 mm x 5.9 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 starting dos