Capecitabine Pharmacare tablets film-coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

capecitabine

제공처:

Pharmacare Premium Limited

ATC 코드:

L01BC06

INN (국제 이름):

capecitabine

복용량:

500mg

약제 형태:

tablets film-coated

패키지 단위:

(120/12x10/) in blister

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2021-10-08

환자 정보 전단

CAPECITABINE PHARMACARE 500MG FILM-
COATED TABLETS
Capecitabine 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 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 tumour 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 tumour. 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 over-reaction
to this medicine;
-
If you previously have had severe reactions to
fl

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Pharmacare 500 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg capecitabine.
Excipients with known effect
Each film-coated tablet contains 25.470 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach coloured, oblong shaped, biconvex, film coated tablets, debossed
with ‘500’ 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 mg/m² and 1,000