GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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

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 & SCHEDULE:

CAUTION: Cytotoxic Agent: To be supplied against the prescription of a Cancer Specialist/Hospital only.
It is dangerous to take this preparation of Cancer Specialist/Hospital only.
SCHEDULE H PRESCRIPTION DRUG – CAUTION: Not to be sold by retail without the prescription of a Registered Medical Prescriber (Oncologist only).
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 light and moisture, at a temperature not exceeding 30°C.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
KEEP TIGHTLY CLOSED.
DOSAGE: As directed by the Oncologist.

Capecitabine Tablets IP 500mg Technical Specification

Product Name:Capecitabine Tablets IP 500mg
Brand Name:Xlotabin
Strength:150mg, 500mg
Dosage Form:Film-coated tablets
Packing:10s, 60s, 120s
Route of Administration:For Oral Use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
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 in a cool & dry place. Store protected from light and moisture, at a temperature not exceeding 30°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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

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 & SCHEDULE:

CAUTION: Cytotoxic Agent: To be supplied against the prescription of a Cancer Specialist/Hospital only.
It is dangerous to take this preparation of Cancer Specialist/Hospital only.
SCHEDULE H PRESCRIPTION DRUG – CAUTION: Not to be sold by retail without the prescription of a Registered Medical Prescriber (Oncologist only).
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 light and moisture, at a temperature not exceeding 30°C.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
KEEP TIGHTLY CLOSED.

DOSAGE: As directed by the Oncologist.