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INTRODUCTION

CAPECITAPER 500MG TABLET contains capecitabine, which belongs to the group of medicines called antineoplastic agents. It is used in the management of abnormal growth of cells present in the colon, rectal, gastric, and breast regions. It may be used either alone or in combination with other medicines.

CAPECITAPER 500MG TABLET is not recommended for use if you have severe liver or kidney disease. CAPECITAPER 500MG TABLET should be used with caution in patients with liver disease, kidney disease, heart problems, brain disease or nerve damage, diabetes, or a history of eye problems. Consult your doctor before taking this medicine.

CAPECITAPER 500MG TABLET is not recommended for use by pregnant or breastfeeding women. Consult your doctor before taking this medicine.

CAPECITAPER 500MG TABLET is not recommended for use by children and adolescents. Consult your doctor before taking this medicine.

The most common side effects of taking CAPECITAPER 500MG TABLET are abdominal pain, rash, dry or itchy skin, tiredness, and loss of appetite. Consult your doctor if any of these symptoms worsen.

USES OF CAPECITAPER 500MG TABLET

  • It inhibits the abnormal growth of cells present in the colon, rectal, gastric, and breast regions.

HOW CAPECITAPER 500MG TABLET WORKS

CAPECITAPER 500MG TABLET is an antimetabolite that works by stopping the abnormal growth of cells. Thus, it helps manage the conditions associated with it.

DIRECTIONS FOR USE

Take CAPECITAPER 500MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Take the medicine within 30 minutes after the end of a meal.

Your doctor will decide the correct dose and duration of CAPECITAPER 500MG TABLET for you depending upon your age, body surface area, and disease condition. Do not stop taking CAPECITAPER 500MG TABLET unless your doctor has told you to.

SIDE EFFECTS OF CAPECITAPER 500MG TABLET

COMMON

  • abdominal pain
  • rash, dry, or itchy skin
  • tiredness
  • loss of appetite
  • dehydration and weight loss
  • sleeplessness (insomnia), depression
  • headache, sleepiness, and dizziness
  • tingling sensations or numbness in the skin
  • changes in taste
  • increased tears, irritation in the eye, and redness of the eyes (conjunctivitis)
  • inflammation of the veins (thrombophlebitis)
  • shortness of breath, bleeding from the nose, cough, or runny nose
  • cold sores or other herpes infections
  • infections of the lungs or respiratory system (pneumonia or bronchitis)
  • bleeding from the gut, constipation, pain in the upper abdomen, indigestion, excess wind
  • dry mouth
  • skin problems (rash, reddening, dry skin, itching, skin discoloration, skin loss)
  • inflammation, nail disorder, hair loss (alopecia)
  • painful joints or limbs (hands and legs), chest, or back
  • fever, swelling in the limbs, feeling ill
  • nerve pain
  • ringing or buzzing in the ears (tinnitus), loss of hearing
  • hiccups, change in voice
  • pain or altered or abnormal sensation in the mouth; pain in the jaw; sweating; night sweats
  • muscle spasm
  • difficulty in urinating, blood, or protein in the urine
  • bruising or reaction at the injection site

UNCOMMON

  • blood infection, urinary tract infection, infection of the skin, infections in the nose and throat, fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess
  • lumps under the skin (lipoma)
  • allergy
  • diabetes
  • malnutrition
  • confusional state, panic attacks, and a depressed mood
  • decreased libido
  • difficulty speaking
  • impaired memory
  • loss of movement coordination, balance problems
  • fainting
  • nerve damage and altered sensation
  • blurred or double vision
  • vertigo, pain in the ear
  • irregular and fast heartbeat (arrhythmias), chest pain, and heart attack
  • blood clots in the deep veins
  • high or low blood pressure
  • hot flushes
  • cold limbs (hands or feet)
  • purple spots on the skin
  • respiratory problems such as blood clots in the veins in the lung (pulmonary embolism), collapsed lungs, coughing up blood, asthma, and shortness of breath on exertion
  • gastrointestinal problems (bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach, or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn, blood in the stool)
  • jaundice (yellowing of the skin and eyes)
  • ulcer and blister on skin, skin reaction with sunlight, reddening of palms, swelling or pain of the face
  • joint swelling or stiffness of joints, bone pain, weakness, or stiffness of muscles
  • fluid collection in the kidneys, an increase in the frequency of urination during the night, and incontinence (loss of bladder control)
  • unusual bleeding from the vagina
  • swelling (oedema)
  • chills and rigors

RARE

  • narrowing or blockage of the tear duct (lacrimal duct stenosis)
  • liver failure, inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
  • specific changes in the electrocardiogram (QT prolongation)
  • certain types of arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia)
  • eye inflammation causing eye pain and possibly eyesight problems
  • inflammation of the skin causing red, scaly patches due to an immune system illness

Stop taking CAPECITAPER 500MG TABLET and contact your doctor immediately if you experience any of the following side effects:

  • diarrhoea
  • nausea and vomiting
  • stomatitis (redness, pain, swelling, or sores in the mouth or throat)
  • hand-and-foot skin reaction (pain, swelling, redness, or tingling of hands and/or feet)
  • fever
  • infection
  • chest pain
  • Steven Johnson syndrome (painful red or purplish rash that spreads and blisters or other lesions begin to appear in the mouth and lips), especially if you had before light sensitivity, infections of the respiratory system (Ex. bronchitis), and/or fever
  • angioedema (swelling of the lips, face, throat, or tongue causing difficulty swallowing or breathing, itchiness, and rashes)

HOW TO MANAGE SIDE EFFECTS

Bloating

Eat smaller and more frequent meals. Eat and drink slowly, and exercise regularly. If the flatulence does not improve, contact your doctor.

Constipation

Eat plenty of fiber-rich foods, such as fresh fruits, vegetables, and cereals, and drink plenty of water. Exercise more regularly. Contact your doctor if constipation persists.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Contact your doctor if the dizziness does not improve.

Headache

Rest and relax. Drink plenty of fluids, such as water or ORS (Oral Rehydrating Solution), and apply a pain-relieving balm to the head if necessary. Contact your doctor if the headache does not improve.

Stomach Pain

Try to rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heat pad on your stomach. If the stomach pain does not improve, contact your doctor.

WARNING & PRECAUTIONS

PREGNANCY
Contraindicated

CAPECITAPER 500MG TABLET is not recommended for use by pregnant women. Women of childbearing potential should use effective contraception during management with CAPECITAPER 500MG TABLET and for 6 months after the last dose.

If you are a male patient and your female partner could become pregnant, you should use effective contraception during management with CAPECITAPER 500MG TABLET and for 3 months after the last dose. Consult your doctor before taking CAPECITAPER 500MG TABLET.

BREASTFEEDING
Contraindicated

CAPECITAPER 500MG TABLET is not recommended for use in breastfeeding women, and do not breastfeed for 2 weeks after the last dose of CAPECITAPER 500MG TABLET. Consult your doctor before taking it.

DRIVING AND USING MACHINES
Use with Caution

Do not drive or operate any machines if you feel dizzy, nauseous, or tired after taking CAPECITAPER 500MG TABLET.

KIDNEY
Consult your doctor

CAPECITAPER 500MG TABLET is not recommended for use in patients with severe kidney disease. Consult your doctor before taking it.

CAPECITAPER 500MG TABLET should be used with caution in patients with kidney disease. Consult your doctor before taking CAPECITAPER 500MG TABLET.

LIVER
Consult your doctor

CAPECITAPER 500MG TABLET is not recommended for use in patients with severe liver disease. Consult your doctor before taking it.

CAPECITAPER 500MG TABLET should be used with caution in patients with liver disease. Consult your doctor before taking it.

ALLERGY
Use with Caution

Do not take CAPECITAPER 500MG TABLET if you are allergic to Capecitabine or any of the other ingredients in this medicine.

HEART DISEASE
Use with Caution

CAPECITAPER 500MG TABLET should be used with caution in patients with heart problems (Ex. an irregular heartbeat or chest pain radiating to the jaw and back brought on by physical effort and due to problems with the blood flow to the heart). Consult your doctor before taking CAPECITAPER 500MG TABLET.

USE IN PEDIATRICS
Contraindicated

CAPECITAPER 500MG TABLET is not recommended for use in children and adolescents. Consult your doctor before taking CAPECITAPER 500MG TABLET.

OTHERS

CAPECITAPER 500MG TABLET is not recommended for use if you:

  • previously had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil)
  • have severely low levels of white cells or platelets in the blood (leukopenia, neutropenia, or thrombocytopenia)
  • have complete DPD deficiency (do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
  • are being treated now or have been treated in the last 4 weeks for herpes zoster (chickenpox or shingles) with brivudine

Before taking CAPECITAPER 500MG TABLET, inform your doctor if you:

  • have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
  • have a family member who has a partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
  • have a brain disease (Ex. cancer that has spread to the brain) or nerve damage (neuropathy)
  • have a calcium imbalance or other electrolyte imbalances
  • have diabetes
  • cannot keep food or water in your body because of severe nausea and vomiting
  • have a history of eye problems
  • have diarrhea
  • are dehydrated
  • have a severe skin reaction
  • have intolerance to lactose or other sugars

INTERACTIONS

A. Drug-Drug Interactions:

  • medicine used in the management of shingles and chickenpox (Ex. brivudine)
  • medicines used in the management of gout (Ex. allopurinol)
  • blood-thinning medicines Ex. coumarin, warfarin (medicines used to manage blood clots
  • medicines used in the management of seizures or tremors (Ex. phenytoin)
  • interferon alpha (used in the management of hepatitis B, C, lymphoma, and other cancers)
  • radiotherapy and certain medicines used to manage cancer (Ex. folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan, and fluorouracil)
  • medicines used to manage folic acid deficiency Ex. levomefolic acid

Overdosage:

If you or anyone else accidentally takes too much of CAPECITAPER 500MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are nausea, vomiting, diarrhea, inflammation or ulceration of the gut or mouth, pain or bleeding from the intestine or stomach, or bone marrow depression (reduction in certain kinds of blood cells).

SYNOPSIS

Drug :   Capecitabine
Pharmacological Category :   Nucleoside metabolic inhibitor
Therapeutic Indication :   Inhibits the abnormal growth of cells present in the colon, rectal, gastric and breast regions
Dosage Forms :   Tablet

MORE INFORMATION

  • Keep CAPECITAPER 500MG TABLET out of reach of children
  • Store below 30°C

FAQs ABOUT CAPECITAPER 500MG TABLET

Q: What should I inform my doctor before starting with CAPECITAPER 500MG TABLET?

A: Before starting the management with CAPECITAPER 500MG TABLET, you should inform your doctor if you have kidney, liver, or heart disease, diarrhea, dehydration, nausea and vomiting, brain disease (Ex. cancer that has spread to the brain or nerve damage (neuropathy), diabetes, a history of eye problems, or severe skin reactions.

Q: What if I forget to take a dose of CAPECITAPER 500MG TABLET?

A: If you have missed a dose, take it as soon as you remember it. Do not take a double dose to compensate for the missed dose of CAPECITAPER 500MG TABLET. Continue taking the medicine as per your schedule. Talk to your doctor.

Q: Is CAPECITAPER 500MG TABLET a form of chemotherapy?

A: Yes. CAPECITAPER 500MG TABLET is an oral chemotherapy medicine that is used in the management of abnormal growth of cells present in the colon, rectal, gastric, and breast regions. Your doctor will decide the correct management plan for you.

Q: How long do I have to take CAPECITAPER 500MG TABLET?

A: Your doctor will decide the correct dose of CAPECITAPER 500MG TABLET and number of cycles for you depending upon your body weight, age, and disease condition. CAPECITAPER 500MG TABLET are usually taken for 14 days, followed by a 7-day rest period. This 21-day period is one management cycle. In some cases, you will advise taking CAPECITAPER 500MG TABLET every day while using it in combination with other medicines.

Q: Can I stop taking CAPECITAPER 500MG TABLET if I feel better?

A: No. You should not stop taking CAPECITAPER 500MG TABLET or change the dose until and unless your doctor asks you to. You will be at high risk of getting back the symptoms and dangerous tumour growth. Talk to your doctor.

Q: Can CAPECITAPER 500MG TABLET cause eye problems?

A: Prior to starting management with CAPECITAPER 500MG TABLET, you should inform your doctor if you have a history of eye problems. While you are managing with CAPECITAPER 500MG TABLET, you may need monitoring of your eyes. Talk to your doctor before taking CAPECITAPER 500MG TABLET.

Q: Does CAPECITAPER 500MG TABLET shrink tumours?

A: No, CAPECITAPER 500MG TABLET does not shrink tumours. CAPECITAPER 500MG TABLET contains capecitabine, which works by stopping or reducing the abnormal growth of cells, which is called cytostatic activity. Only after being absorbed by the body is it changed into an active anti-neoplastic medicine (more in tumour tissue than in normal tissue). Therefore, it stops tumour growth and spreading without causing them to shrink.

Q: Does CAPECITAPER 500MG TABLET cause hair loss?

A: Yes, the most common side effect of CAPECITAPER 500MG TABLET is hair loss. Before your management, prepare in advance for changes in your hair. Talk to your doctor about what to expect. Use head coverings such as a wig or scarf. Try to add iron and protein-rich foods like green leafy vegetables and beans to snacks and meals.

Q: Can I take double doses together to cure my condition soon?

A: No, do not take more CAPECITAPER 500MG TABLET than the normal recommended dose as it may cause overdosage of CAPECITAPER 500MG TABLET, leading to harmful side effects such as diarrhea, inflammation of the gut or mouth, pain or bleeding in the stomach or bone marrow, depression (reduction in blood cells), nausea, and vomiting.

REFERENCES

1. KD. Tripathi. Chemotherapy of Neoplastic Diseases. Essentials of medical pharmacology. Seventh edition. 2013. Page – 864.

2. Sedat Tatar, Can E. Yalcin, Billur Sezgin, Ayse Y. Tas, Orkun Muftuoglu, Selahattin Ozmen. Capecitabine-Induced Bilateral Ectropion: A Rare Ocular Manifestation Requiring Surgical Intervention. National Institute of Health NLM, National Centre for Biotechnology Information. PubMed Central. 2018 Oct-Dec. [Accessed on 18th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371725/

3. Walko CM, Lindley C. Capecitabine: a review. National Institute of Health NLM, National Centre for Biotechnology Information. PubMed.gov. January 2005. [Accessed on 18th June 2022] https://pubmed.ncbi.nlm.nih.gov/15763604/

4. Glenmark Pharmaceuticals s.r.o. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 18th June 2022] https://www.medicines.org.uk/emc/files/pil.9938.pdf

5. Hawke’s Bay District Health Board. Capecitabine. March 2018. [Accessed on 18th June 2022] https://hawkesbay.health.nz/assets/Patient-Medication-Information/Capecitabine-PIL-Booklet.pdf

6. Drug bank. Capecitabine. [Accessed on 18th June 2022] https://go.drugbank.com/drugs/DB01101

USEFUL DIAGNOSTIC TESTS

  • Complete blood count
  • Circulating tumour test (CTC)
  • Tumour Markers
  • Liver function test

AUTHOR DETAILS

Written By Dr. N. Sai Swaroop, Pharm.D
Last updated on 21 Nov 2023 | 05:35 PM(IST)

PRODUCT DETAILS
    Net Qty
    1 N
    Shelf Life
    720
    Item Weight
    10 g
    Ingredient
    Capecitabine 500 mg
    Hsn Code
    30049099
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