GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Capecitabine Tablets USP 150mg (Xlotabin)
(B) Capecitabine Tablets USP 500mg (Xlotabin)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Capecitabine Tablets USP 150mg
Each film-coated tablet contains:
Capecitabine USP ……………….150mg
Excipients…………………………….q.s.
Colours: Red Oxide of Iron and Titanium Dioxide USP

B) Capecitabine Tablets USP 500mg
Each film-coated tablet contains:
Capecitabine USP ……………….500mg
Excipients…………………………….q.s.
Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Capecitabine is used to help treat patients with Dukes' C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
Cytotoxic Agent: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a Cancer Specialist only.
Potent cytotoxic agent handle with great care. Use only after reading the direction on pack insert.
Aluminium – Aluminium blister The medicinal product does not require any special storage condition PVC/PVdc-aluminium blister.
WARNING: NOT FOR SALE WITHOUT PRESCRIPTION PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.
Swallow capecitabine tablets whole with water within 30 minutes of a meal.
Do not crush or cut capecitabine tablets.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
KEEP TIGHTLY CLOSED.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
HUMAN PRESCRIPTION DRUG.
Dosage: As directed by the Oncologist.

Capecitabine Tablets USP 500mg Technical Specification

Product Name:Capecitabine Tablets USP 500mg
Brand Name:Xlotabin
Strength:150mg, 500mg
Dosage Form:Film-coated tablets
Packing:10s, 30s, 100s Blisters
30 Tab Bottle, 60 Tab Bottle, 120 Tab Bottle
Route of Administration:For Oral Use Only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Capecitabine is used to help treat patients with Dukes’ C colon cancer after having surgery. This medicine is also used to treat metastatic colorectal cancer.
Storage:Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Capecitabine Tablets USP 150mg (Xlotabin)
  • Capecitabine Tablets USP 500mg (Xlotabin)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Capecitabine Tablets USP 150mg
    Each film-coated tablet contains:
    Capecitabine USP ……………….150mg
    Excipients…………………………….q.s.
    Colours: Red Oxide of Iron and Titanium Dioxide USP
  • Capecitabine Tablets USP 500mg
    Each film-coated tablet contains:

    Capecitabine USP ……………….500mg
    Excipients…………………………….q.s.
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Capecitabine is used to help treat patients with Dukes’ C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
Cytotoxic Agent: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a Cancer Specialist only.
Potent cytotoxic agent handle with great care. Use only after reading the direction on pack insert.
Aluminium – Aluminium blister The medicinal product does not require any special storage condition PVC/PVdc-aluminium blister.

WARNING: NOT FOR SALE WITHOUT PRESCRIPTION
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.
Swallow capecitabine tablets whole with water within 30 minutes of a meal.
Do not crush or cut capecitabine tablets.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
KEEP TIGHTLY CLOSED.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
HUMAN PRESCRIPTION DRUG.

Dosage: As directed by the Oncologist.