Capecitabine Sandoz capecitabine 150mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

capecitabine, Quantity: 150 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Capecitabine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; hypromellose; croscarmellose sodium; titanium dioxide; purified talc; magnesium stearate; iron oxide red

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Colon Cancer,CAPECITABINE SANDOZ is indicated for the adjuvant treatment of patients with Dukes' stage C and high-risk stage B, colon cancer, either as monotherapy or in combination with oxaliplatin.,Colorectal Cancer,CAPECITABINE SANDOZ is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,Oesophagogastric Cancer,CAPECITABINE SANDOZ is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,Breast Cancer,CAPECITABINE SANDOZ is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,CAPECITABINE SANDOZ in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Product summary:

Visual Identification: light pink-coloured, modified oval shaped film-coated tablet with debossment "150" on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-01-31

Patient Information leaflet

CAPECITABINE SANDOZ
®
FILM-COATED TABLETS
1
CAPECITABINE
SANDOZ
®
_Capecitabine tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CAPECITABINE
SANDOZ tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
CAPECITABINE SANDOZ tablets
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CAPECITABINE
SANDOZ IS USED FOR
CAPECITABINE SANDOZ contains
the active ingredient capecitabine.
CAPECITABINE SANDOZ belongs
to a group of medicines called anti-
neoplastic agents. Within this group,
CAPECITABINE SANDOZ belongs
to a class of medicines called
fluoropyrimidine analogues.
CAPECITABINE SANDOZ is used
to treat cancer of the bowel and
rectum (colorectal), breast and
stomach and food pipe (oesophagus).
It may be prescribed alone or in
combination with other medicines
used to treat cancer, such as
chemotherapy medicines.
The medicine contained in
CAPECITABINE SANDOZ tablets,
capecitabine, is converted by the
liver and cancer cells to another
medicine called 5-fluorouracil (also
called 5-FU).
It is 5-FU that acts to kill or stop the
growth of cancer cells.
Your doctor may have prescribed
CAPECITABINE SANDOZ for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY CAPECITABINE
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor's prescription.
CAPECITABINE SANDOZ is not
addictive.
BEFORE YOU TAKE
CAPECITABINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CAPECITABINE
SANDOZ IF:
1.
YOU HAVE HAD AN ALLERGY TO
•
CAPECITABINE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
•
5-FLUOROURACIL (ALSO CALLED 5-
FU), A MEDICINE USED TO TREAT
CANCER
•
OTHER FLUOROPYRIMIDINE
MEDICINES
Some of the sympto

Summary of Product characteristics

190426-capecitabine-sandoz-pi
Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION
CAPECITABINE SANDOZ
® (CAPECITABINE)
TABLETS
1
NAME OF THE MEDICINE
Capecitabine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Capecitabine Sandoz 150 mg film coated tablet contains 150 mg
capecitabine.
Each Capecitabine Sandoz 500 mg film coated tablet contains 500 mg
capecitabine.
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Capecitabine Sandoz 150 mg tablets are light pink coloured, modified
oval shaped film-coated
tablets with ‘150 mg’ marked on one side.
Capecitabine Sandoz 500 mg tablets are pink coloured, modified oval
shaped film-coated
tablets with ‘500 mg’ marked on one side.
_Not all strengths may be marketed in Australia. _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_COLON CANCER _
Capecitabine Sandoz is indicated for the adjuvant treatment of
patients with Dukes' stage C
and high-risk stage B, colon cancer, either as monotherapy or in
combination with oxaliplatin.
_COLORECTAL CANCER _
Capecitabine Sandoz is indicated for the treatment of patients with
advanced or metastatic
colorectal cancer.
_OESOPHAGOGASTRIC CANCER _
Capecitabine Sandoz is indicated for the first-line treatment of
patients with advanced
oesophagogastric cancer in combination with a platinum-based regimen.
_BREAST CANCER _
Capecitabine Sandoz is indicated for the treatment of patients with
locally advanced or
metastatic breast cancer after failure of taxanes and an anthracycline
containing chemotherapy
regimen unless therapy with these and other standard agents are
clinically contraindicated.
Capecitabine Sandoz in combination with docetaxel is indicated for the
treatment of patients
with locally advanced or metastatic breast cancer after failure of
prior anthracycline containing
chemotherapy.
190426-capecitabine-sandoz-pi
Page 2 of 31
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_STANDARD DOSAGE _
Capecitabine Sandoz tablets should be swallow