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XELODA Tablet 300
2014-02-18 12:26:38 À´Ô´: ×÷Õß: ¡¾´ó ÖРС¡¿ ä¯ÀÀ:584´Î ÆÀÂÛ:0Ìõ
Manufacturer's name : Chugai Pharmaceutical Co., Ltd. 610470009
Revised: 09/2011
 
Brand name : XELODA Tablet 300
¡¡Active ingredient: Capecitabine
¡¡Dosage form: white tablet (major axis: approx. 13.4 mm, minor axis: approx. 7.1 mm, thickness: approx. 4.8 mm)
¡¡Printings on wrapping: NR450 ¥¼¥í©`¥À300

Effects of this medicine

This medicine is metabolized by enzymes which abound in malignant tumors, acts on the tumors effectively, and interferes with growth of the tumors.
It is usually used for treatment of inoperable or recurrent breast cancer, for postoperative adjuvant chemotherapy for colon cancer, for treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection, and for treatment of advanced or recurrent gastric cancer which is not amenable to curative resection.

Before using this medicine, tell your doctor/pharmacist

  • If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
    If you had been receiving treatment with combined ingredient of tegafur, gimeracil and oteracil potassium within the last 7 days.
    If you have renal or hepatic disorder, myelosuppression, or gastrointestinal ulcer/bleeding.
    If you have ever had a coronary artery disease.
  • If you are pregnant or breastfeeding.
  • If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)

Dosage regimen (proper use of this medicine)

  • Your dosage regimen is:(order of your doctor)
  •  
  • General dosage regimen: For treatment of inoperable or recurrent breast cancer: Take the medicine according to the following regimen A or B.
    -Regimen A: According to the body surface area, take 3 to 5 tablets (900 to 1,500 mg of the active ingredient) at a time, twice a day, within 30 minutes after breakfast and dinner. "Take the medicine for consecutive 21 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist.
    -Regimen B: According to the body surface area, take 5 to 8 tablets (1,500 to 2,400 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist.
    For postoperative adjuvant chemotherapy for colon cancer: According to the body surface area, take 5 to 8 tablets (1,500 to 2,400 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist.
    For treatment of advanced or recurrent colorectal cancer, which is not amenable to curative resection: It is used along with other anti-malignant tumor medicines. According to the body surface area, take 4 to 7 tablets (1,200 to 2,100 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist.
    For treatment of advanced or recurrent gastric cancer, which is not amenable to curative resection: It is used along with a platinum-based regimen. According to the body surface area, take 4 to 7 tablets (1,200 to 2,100 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist.
  • Missed dose: Skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
  • Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. The medicine may cause serious nausea, vomiting, diarrhea, mucositis, gastrointestinal stimulus or bleeding, or myelosuppression.
  • Others: Do not stop taking the medicine without the instructions of your doctor.

Precautions while using this medicine

  • The medicine may decrease the immune system, and is likely to cause infections such as cold. Take enough care, such as to avoid being in crowd, to wash the hands and to gargle after returning home.
  • Avoid breastfeeding.
  •  

Side effects of this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: hand-foot syndrome, nausea, loss of appetite, diarrhea, stomatitis, peripheral sensory neuropathy, fatigue, pigmentation disorder, etc.Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
  • lassitude, thirst, hyperventilation, shaky hands and fingers, decreased urinary volume, faint consciousness, impaired mind/judgment[dehydration]
  • sensitivity or insensitivity, redness and swelling, pain, skin strip, blister, skin sore on the palms of the hands and/or the soles of the feet[hand-foot syndrome]
  • lassitude, swollen body, cold sweat, dizziness, easy breathing in upright position, breathlessness, shortness of breath, palpitation, palpitation when moving, chest pain, anginal pain, chest pressured/constrictive feeling, strong chest oppressive feeling, sense of being compressed strongly on the chest suddenly, faint[cardiac disorder]
  • lassitude, yellowness in the skin and/or the white of the eyes, itch, dark or brown urine, loss of appetite, nausea, vomiting[hepatic disorder, jaundice]
  • headache, swollen face/eyelids, decreased urinary volume[renal disorder]
  • lassitude, fever, gum/nose bleeding, shortness of breath, blue spot, prolonged bleeding, bleeding tendency[myelosuppression]
  • mucosa irritation in the mouth[stomatitis]
  • dry cough, breathlessness, shortness of breath, fever[interstitial pneumonia]
  • severe abdominal pain, diarrhea, bloody stool, fever, feeling sick at the stomach, nausea, vomiting, enlarged feeling of abdomen[serious enteritis (hemorrhagic/ischemic/necrotizing enteritis, etc.)]
  • memory loss, lightheadedness, absent-mindedness, difficulty memorizing, difficulty speaking, loss of consciousness, convulsion[serious psychoneurotic disorder (leukoencephalopathy, etc.)]
  • paralysis/numbness of the limbs, difficulty speaking, chest pain, breathing difficulty, sudden pain/swelling in one leg, back pain[thrombosis]
  • lassitude, loss of appetite, high fever, fever, red rash with dropsical swelling in the center, red rash, inflamed eye and eyelid, conjunctival sore, severe stomatitis, lip/intraoral sore, pain in the genitalia[mucocutaneous ocular syndrome (Stevens-Johnson syndrome)]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.

Storage and other information

  • Keep out of the reach of children. Store at room temperature (1 to 30¡æ), away from direct sunlight and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist how to discard.
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency. 
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