Capecitabine Pharmacare 150 mg film-coated tablets

Negara: Malta

Bahasa: Inggris

Sumber: Malta Medicines Authority

Tersedia dari:

Pharmacare Premium Limited HHF 003 Halfar Industrial Estate Birzebbugia BBG 3000, Malta

Kode ATC:

L01BC06

INN (Nama Internasional):

CAPECITABINE 150 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

CAPECITABINE 150 mg

Jenis Resep:

POM

Area terapi:

ANTINEOPLASTIC AGENTS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2023-08-01

Selebaran informasi

CAPECITABINE PHARMACARE 150MG & 500MG
FILM-COATED TABLETS
Capecitabine 150mg and 500mg
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 Pharmacare is and what it is used for
2.
What you need to know before you take Capecitabine
Pharmacare
3.
How to take Capecitabine Pharmacare
4.
Possible side effects
5.
How to store Capecitabine Pharmacare
6.
Contents of the pack and other information
1.
WHAT CAPECITABINE PHARMACARE IS AND WHAT IT IS USED
FOR
Capecitabine Pharmacare belongs to a group of medicines
called "cytostatic medicines", which stop the growth of cancer
cells. Capecitabine Pharmacare 150 mg contains 150 mg of
Capecitabine and Capecitabine Pharmacare 500 mg contains
500 mg of capecitabine, which is not a cytostatic agent in
itself. Only after having been absorbed by the body is it
changed into an active anti-cancer medicine (more in tumor
tissue than in normal tissue).
Capecitabine Pharmacare is prescribed by doctors for the
treatment of colon, rectal, gastric or breast cancers.
Capecitabine Pharmacare may also be prescribed by doctors to
prevent recurrence of colon cancer after complete surgical
removal of the tumor. Capecitabine Pharmacare may be used
either alone or in combination with other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE
PHARMACARE
DO NOT TAKE CAPECITABINE PHARMACARE:
-
If you are allergic to capecitabine or any other ingredient of
this medicine (indicated in section 6). You must inform your
doctor if you know that you have an allergy or ov

Karakteristik produk

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1
of
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SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Pharmacare 150 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg capecitabine.
Excipients with known effect
Each film-coated tablet contains 7.64 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
(Pale) peach coloured, capsule shaped, biconvex, film-coated tablets,
debossed with “150” on one
side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitabine Pharmacare is indicated for the adjuvant treatment of
patients following surgery of stage III
(Dukes’ stage C) colon cancer (see section 5.1).
Capecitabine Pharmacare is indicated for the treatment of metastatic
colorectal cancer (see section 5.1).
Capecitabine Pharmacare is indicated for first-line treatment of
advanced gastric cancer in
combination with a platinum-based regimen (see section 5.1).
Capecitabine Pharmacare,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
Pharmacare 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 Pharmacare 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 doses of
Capecitabine Pharmacare of 1,250