Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
capecitabine, Quantity: 150 mg
Sandoz Pty Ltd
Capecitabine
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; hypromellose; croscarmellose sodium; titanium dioxide; purified talc; magnesium stearate; iron oxide red
Oral
60 tablets
(S4) Prescription Only Medicine
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.
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
Licence status A
2014-01-31
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 Read the complete document
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 Read the complete document