Xeloda 150mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Capecitabine

Available from:

Roche Products Ltd

ATC code:

L01BC06

INN (International Name):

Capecitabine

Dosage:

150mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010300; GTIN: 5000471004991

Patient Information leaflet

1
uk-mt-pil-xeloda-clean-180316-150-500-tabs
PACKAGE LEAFLET: INFORMATION FOR THE USER
XELODA 150 MG FILM-COATED TABLETS
XELODA 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 Xeloda is and what it is used for
2.
What you need to know before you take Xeloda
3.
How to take Xeloda
4.
Possible side effects
5.
How to store Xeloda
6.
Contents of the pack and other information
1.
WHAT XELODA IS AND WHAT IT IS USED FOR
Xeloda belongs to the group of medicines called "cytostatic
medicines", which stop the growth of
cancer cells. Xeloda contains 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).
Xeloda is used in the treatment of colon, rectal, gastric, or breast
cancers.
Furthermore, Xeloda is used to prevent new occurrence of colon cancer
after complete removal of the
tumour by surgery.
Xeloda may be used either alone or in combination with other
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XELODA
DO NOT TAKE XELODA:

if you are allergic to capecitabine 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 this medicine,

if you previously have had severe reactions to fluoropyrimidine
therapy (a group of anticancer
medicines such as fluorouracil),

if you are pregnant orbreast-feeding,

if you ha

Summary of Product characteristics

OBJECT 1
XELODA 150MG AND 500MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Apr-2018 | Roche
Products Limited
1. Name of the medicinal product
Xeloda 150 mg film-coated tablets.
Xeloda 500 mg film-coated tablets.
2. Qualitative and quantitative composition
Xeloda 150 mg film-coated tablets
Each film-coated tablet contains 150 mg capecitabine.
Xeloda 500 mg film-coated tablets
Each film-coated tablet contains 500 mg capecitabine
Excipient(s) with known effect
_Xeloda 150 mg film-coated tablets _
Each 150 mg film-coated tablet contains 15.6 mg anhydrous lactose.
_Xeloda 500 mg film-coated tablets_
Each 500 mg film-coated tablet contains 52 mg anhydrous lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Xeloda 150 mg film-coated tablets
The film-coated tablets are light peach tablets of biconvex, oblong
shape with the marking '150' on the
one side and 'Xeloda' on the other side
Xeloda 500 mg film-caoted tablets
The film-coated tablets are peach tablets of biconvex, oblong shape
with the marking '500' on the one side
and 'Xeloda' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Xeloda is indicated for the treatment of:
-for the adjuvant treatment of patients following surgery of stage III
(Dukes' stage C) colon cancer (see
section 5.1).
- metastatic colorectal cancer (see section 5.1).
- first-line treatment of advanced gastric cancer in combination with
a platinum-based regimen (see
section 5.1).
- in combination with docetaxel (see section 5.1) for the treatment of
patients with locally advanced or
metastatic breast cancer after failure of cytotoxic chemotherapy.
Previous therapy should have included
an anthracycline.
- 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
Xeloda should only be prescribed