Zelorec

Capecitabine

Chemical

Oral

Dosage form :

Tablets

Doses :

500 mg

Short Description:

Zelorec contains the active substance capecitabine. Zelorec is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. Zelorec is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Product Introduction

What Zelorec is and what it is used for

Zelorec belongs to the group of medicines called “cytostatic medicines”, which stop the growth of cancer cells. Zelorec contains Capecitabine, which itself is not a cytostatic medicine. Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumor tissue than in normal tissue).

Zelorec is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Zelorec is used to prevent new occurrence of colon cancer after complete removal of the tumor by surgery.

Zelorec may be used either alone or in combination with other medicines.

What you need to know before you take Zelorec

Do not take Zelorec:

If you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
If you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
If you are pregnant or breast-feeding,
If you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia),
If you have severe liver or kidney problems,
If you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency).
If you are being treated now or have been treated in the last 4 weeks with brivudine, as part of herpes zoster (chickenpox or shingles) therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zelorec

If you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
If you have a family member who has partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
If you have liver or kidney diseases
If you have or had heart problems (for example an irregular heartbeat or pains to the chest, jaw and back brought on by physical effort and due to problems with the blood flow to the heart)
If you have brain diseases (for example, cancer that has spread to the brain, or nerve damage (neuropathy)
If you have calcium imbalances (seen in blood tests)
If you have diabetes
If you cannot keep food or water in your body because of severe nausea and vomiting
If you have diarrhea
If you are or become dehydrated
If you have imbalances of ions in your blood (electrolyte imbalances, seen in tests)
If you have a history of eye problems as you may need extra monitoring of your eyes
If you have sever e skin reactions

DPD deficiency: DPD deficiency is a genetic condition that is not usually associated with health problems unless you receive certain medicines. If you have DPD deficiency and take Zelorec, you are at an increased risk of severe side effects (listed under section 4 possible side effects). It is recommended to test you for DPD deficiency before start of treatment. If you have no activity of the enzyme, you should not take Zelorec. If you have a reduced enzyme activity (partial deficiency), your doctor might prescribe a reduced dose. If you have negative test results for DPD deficiency, severe and life-threatening side effects may still occur.

Children and adolescents

Zelorec is not indicated in children and adolescents. Do not give Zelorec to children and adolescents.

Other medicines and Zelorec

Before starting treatment, tell your doctor if you are taking, have recently taken, or might take any other medicines. This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.

Also, you need to be particularly careful if you are taking any of the following:

gout medicines (allopurinol),
blood-thinning medicines (coumarin, warfarin),
medicines for seizures or tremors (phenytoin),
interferon alpha,
radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
Medicines used to treat folic acid deficiency.
Zelorec with food and drinkYou should take Zelorec no later than 30 minutes after meals.Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Zelorec if you are pregnant or think you might be.

You must not breast-feed if you are taking Zelorec and for 2 weeks after the last dose. If you are a woman who could become pregnant, you should use effective contraception during treatment with Zelorec and for 6 months after the last dose.

If you are a male patient and your partner could become pregnant, you should use effective contraception during treatment with Zelorec and for 3 months after the last dose.

Driving and using machines

Zelorec may make you feel dizzy, nauseous or tired. It is therefore possible that Zelorec could affect your ability to drive a car or operate machines.

Zelorec contains anhydrous lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Zelorec

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Zelorec should only be prescribed by a doctor experienced in the use of anticancer medicines. Zelorec tablets should be swallowed whole with water and within 30 minutes of a meal.

Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Zelorec is based on your body surface area, this is calculated from your height and weight. The usual dose for adults is 1250 mg/m2 of body surface area taken two times daily (morning and evening).

For example: A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m2 and should take five tablets of 500 mg two times daily.

Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.

Take the tablets in the morning and evening as prescribed by your doctor.
Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water. Do not crush or cut tablets. If you cannot swallow Zelorec tablets whole, tell your doctor.
It is important that you take all your medicine as prescribed by your doctor.

Zelorec tablets are usually taken for 14 days followed by a 7-day rest period (when no tablets are taken). This 21-day period is one treatment cycle.

In combination with other medicines, the usual dose for adults may be less than 1250 mg/m2 of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).

If you take more Zelorec than you should

If you take more Zelorec than you should, contact your doctor as soon as possible before taking the next dose.

You might get the following side effects if you take a lot more capecitabine than you should; feeling or being sick, 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). Tell your doctor immediately if you experience any of these symptoms.

If you forget to take Zelorec

Do not take the missed dose at all. Do not take a double dose to make up for a forgotten dose. Instead, continue your regular dosing schedule and check with your doctor.

If you stop taking Zelorec

There are no side effects caused by stopping treatment with capecitabine. In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping capecitabine might require that your doctor adjusts your anticoagulant dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Zelorec immediately and contact your doctor if any of these symptoms occur:

Diarrhea: If you have, an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhea at night.
Vomiting: if you vomit more than once in a 24-hour time period.
Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
Stomatitis: if you have pain, redness, swelling or sores in your mouth and/or throat.
Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet.
Fever: if you have a temperature of 38°C or greater.
Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
Chest pain: if you experience pain localized to the center of the chest, especially if it occurs during exercise.
Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Angioedema: seek medical attention straight away if you notice any of the following symptoms – you may need urgent medical treatment: Swelling mainly of the face, lips, tongue or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of angioedema.

If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation. If these side effects continue, however, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

If severe stomatitis (sores in your mouth and/or throat), mucosal inflammation, diarrhea, neutropenia (increased risk for infections), or neurotoxicity occurred during the first cycle of treatment, a DPD deficiency may be involved (see section 2: Warning and precautions).

Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan.

In addition to the above, when Zelorec is used alone, very common side effects, which may affect more than 1 in 10 people are:

abdominal pain
rash, dry or itchy skin
tiredness
loss of appetite (anorexia)

How to store Zelorec

Keep this medicine out of the sight and reach of children.

Do not store above 30°C, store in the original package in order to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the blister and the outer carton.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Further information

What Zelorec contains

The active substance of this medicine is Capecitabine.

Each film-coated tablet of Zelorec 500 mg contains 500 mg Capecitabine.

The other ingredients are:

Tablet core: lactose anhydrous, croscarmellose sodium, hypromellose, microcrystalline cellulose, and magnesium stearate.
Tablet coating: Opadry pink, purified water.

What Zelorec looks like and contents of the pack

Zelorec 500 mg film-coated tablets are peach colored, oval shaped, biconvex, film-coated tablets.

Zelorec

Capecitabine

Category:

Chemical

Oral

Dosage form :

Tablets

Doses :

500 mg

Short Description:

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