Capecitabine 500 mg. 120 tablets ACCORD

What Capecitabine Accord and what it is used
Capecitabine Accord belongs to a group of medicines called "cytostatic drugs" that stop the growth of cancer cells. Capecitabine Accord contains capecitabine, which itself is not a cytostatic drug. Only after being absorbed by the body, it is converted into an active anti-cancer drug (more in tumor tissue than in normal tissue).
Capecitabine Accord is used for treating cancer of the colon, rectum, stomach cancer, or breast cancer.
Furthermore, Capecitabine Accord is used to prevent new occurrence of colon cancer after complete removal of the tumor by surgery.
Capecitabine Accord can be used alone or in combination with other medicines.

2 WHAT YOU SHOULD KNOW BEFORE YOU TAKE CAPECITABINE ACCORD
Do not take Capecitabine Accord:
if you are allergic to capecitabine or to any of the other ingredients of this medicine (listed in Section 6). You must tell your doctor if you know that you have an allergy or over-reaction to this medicine;
if you have had severe reactions to treatment with fluoropyrimidine (a group of anticancer drugs such as fluorouracil);
if you are pregnant or breast-feeding;
if you have very low levels of white blood cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia);
if you have severe liver problems or kidney problems;
if you know that you have a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), involved in the metabolism of uracil and thymine;
if you are taking now or have been treated in the last 4 weeks with brivudine sorivudine or similar classes of substance as part of the treatment of herpes zoster (chickenpox or shingles).
Warnings and Precautions
Talk to your doctor before taking Capecitabine Accord, if:
have liver or kidney disease;
have or have had heart problems (eg, irregular heartbeat), or pain in the chest, jaw and back caused by physical effort and due to problems with blood flow to the heart;
have brain diseases (such as cancer that has spread to the brain) or nerve damage (neuropathy);
you have abnormal calcium balance (seen in blood tests);
have diabetes;
have diarrhea;
have too few or too many ions in the blood (electrolyte imbalance observed in the study);
you are dehydrated or hydrated;
have an imbalance of ions in the blood (electrolyte imbalance observed in the study);
have a history of eye problems, as you will need extra monitoring of your eyes.
Deficiency of DPD: DPD deficiency is a rare condition that is present at birth and is usually not associated with health problems, unless you are taking certain medications. If you have an unrecognized deficiency of DPD and taking Capecitabine Accord, you may get side effects listed in section 4 severe. Contact your doctor immediately if you are concerned about any of the effects or if you notice any side effects not listed in this leaflet (see section 4 "Possible side effects").

Children and adolescents
Capecitabine Accord is not indicated in children and adolescents. Do not give Capecitabine Accord of children and adolescents.

Other medicines and Capecitabine Accord
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines. This is extremely important as taking more than one medicine at the same time can strengthen or weaken the effect of the drugs.
You should be especially careful if you are taking any of the following:
drugs for gout (allopurinol);
medicines for blood clotting (coumarin, warfarin);
some antiviral medicines (sorivudine and brivudine);
medicines for seizures or tremors (phenytoin);
interferon alfa;
radiotherapy and certain drugs used for treatment of cancer (folinic acid, oxaliplatin, bevacizumab).
Capecitabine Accord with food, beverages and alcohol
You should take Capecitabine Accord no later than 30 minutes after a meal.

Pregnancy, lactation and fertility
Before starting treatment, you must tell your doctor if you are pregnant, think you may be pregnant or intend to become pregnant.
You should not take Capecitabine Accord, if you are pregnant or think you may be pregnant.
You should not breastfeed if you are taking Capecitabine Accord.
Ask your doctor or pharmacist before taking this medicine.

Driving and using machines
Capecitabine Accord may feel dizzy, nauseous or tired. It is therefore possible Capecitabine Accord affect your ability to drive or operate machinery. Do not drive if you feel dizzy, nauseous or tired after taking this medicine.

Capecitabine Accord contains lactose
This medicine contains lactose. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 HOW TO TAKE CAPECITABINE ACCORD
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Capecitabine Accord should only be prescribed by a physician experienced in the use of anticancer drugs.
Capecitabine Accord tablets should be swallowed whole with water within 30 minutes after a meal.
Your doctor will prescribe a dose and treatment regimen that is right for you. Dose of Capecitabine Accord is based on your body surface. It is calculated from your height and weight. The usual dose for adults is 1250 mg / m2 body surface area taken twice daily (morning and evening). Here we give two examples: a person whose body weight is 64 kg and height - 1,64 m, has a body surface 1,7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice daily. A person whose body weight is 80 kg and height - 1,80 m, has a body surface 2,00 m2 and should take 5 tablets of 500 mg twice daily.
Capecitabine Accord tablets are usually taken for 14 days followed by a 7-day rest period (during which not a tablet). This 21-day period is one treatment cycle.
In combination with other drugs, the usual dose for adults may be less than 1250 mg / m2 body surface, and may need to take the tablets for different periods of time (eg. Every day without rest period).
Your doctor will tell you what dose you need to take, when and how long you should take it.

Your doctor may ask you to take a combination of tablets of 150 mg, 300 mg and 500 mg per dose.
Take the tablets in the morning and evening as prescribed by your doctor;
Take the tablets within 30 minutes after a meal (breakfast and dinner);
It is important to take your medicine as prescribed by your doctor.
If you take more than the amount of Capecitabine Accord
If you take more than the amount of Capecitabine Accord, contact your doctor before taking the next dose.
You can get these side effects if you take a lot more capecitabine than you have nausea or vomiting, diarrhea, inflammation or ulceration of the gut or mouth, pain or bleeding from the stomach or intestines, or bone marrow suppression (reduction in the number of certain types of blood cells). Tell your doctor immediately if you experience any of these symptoms.

If you forget to take Capecitabine Accord
Do not take the missed dose at all and do not double the next dose. Instead, continue your regular dosing schedule and check with your doctor.

If you stop taking Capecitabine Accord
There are no side effects caused by stopping treatment with capecitabine. If you are using coumarin anticoagulants (phenprocoumon containing) after stopping capecitabine may be necessary for your doctor to adjust the dose of anticoagulant.

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

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

STOP taking Capecitabine Accord immediately and contact your doctor if any of these symptoms:
Diarrhea: if you have four or more bowel movements per day than usual or diarrhea during the night;
Vomiting: if you vomit more than once in a 24 hour period;
Nausea: if you lose your appetite and amount of food you eat each day is much less than usual;
Stomatitis: if you have pain, redness, swelling or sores in the mouth and / or throat;
Skin reaction "hand and foot": if you have pain, swelling, redness or tingling of the hands and / or feet;
Fever, if you have a temperature of 38 ° C or higher;
Infection: if signs of infection caused by bacteria or viruses, or other microorganisms;
Chest pain: if you have pain localized to the center of the chest, especially during physical exertion.
If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation. If these side effects continue, immediately contact your doctor. Your doctor may advise you to resume treatment at a lower dose.

In addition to the above, when capecitabine is used alone, the most common side effects which may affect more than 1 in 10 people are:
rash, dry or itchy skin;
fatigue;
loss of appetite (anorexia).
These side effects can become severe; it is therefore important to always immediately contact your doctor when you experience a side effect. Your doctor may advise you to reduce the dose and / or temporarily discontinue treatment with Capecitabine Accord. This will reduce the likelihood of side effects continue or become severe.

Other side effects are:
Common side effects (may affect up to 1 in 10 people) include:
reduction in the number of white blood cells or red blood cells (observed in study);
dehydration, weight loss;
difficulty sleeping (insomnia), depression;
headache, drowsiness, dizziness, abnormal sensation of the skin (numbness or tingling), change in taste;
eye irritation, watery eyes, redness of the eye (conjunctivitis);
inflammation of the veins (thrombophlebitis);
shortness of breath, nosebleeds, cough, runny nose;
cold sores or other herpes infections;
infections of the lungs or respiratory system (eg. pneumonia or bronchitis);
bleeding from the bowel, constipation, pain in the upper abdomen, indigestion, excessive flatulence, dry mouth;
skin rash, hair loss (alopecia), redness of the skin, dry skin, itching (pruritus), discoloration of the skin, peeling skin, skin, nail disorder;
pain in joints or limbs, chest or back;
fever, swelling of the limbs, malaise;
liver dysfunction (detected by blood tests) and elevated bilirubin (excreted by the liver).
Uncommon side effects (may affect up to 1 in 100 people) include:
blood infection, urinary tract infection, skin infection, infections of the nose and throat, fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess;
lumps under the skin (lipoma);
reducing the number of blood cells, including platelets, blood thinners (seen in studies);
allergy;
diabetes, decreased potassium levels, malnutrition, increased blood triglycerides;
state of confusion, panic attacks, depressed mood, decreased libido;
difficulty speaking, impaired memory, loss of motor coordination, balance disorder, seizures, nerve damage (neuropathy) and problems with sensation;
blurred or double vision;
dizziness, earache;
irregular heartbeat and palpitations (arrhythmia), chest pain and heart attack (infarction);
blood clots in deep veins, high or low blood pressure, hot flushes, cold extremities, purple spots on the skin;
blood clots in the deep veins in the lungs (pulmonary embolism), collapsed lung, coughing of blood, asthma, shortness of breath on exertion;
bowel obstruction, fluid accumulation in the abdomen, inflammation of the small or large intestine, stomach or esophagus, pain in the lower abdomen, stomach discomfort, heartburn (reflux of food from the stomach), blood in the stool;
jaundice (yellowing of the skin or eyes);
skin ulcers and blisters, skin reaction to sunlight, red hands, swelling or pain of the person;
joint swelling or stiffness, bone pain, muscle weakness or stiffness;
collection of fluid in the kidneys, frequent urination at night, urinary incontinence, blood in urine, increased blood creatinine (signs of renal dysfunction);
unusual bleeding from the vagina;
swelling (edema), chills and fever.
Some of these side effects are more common when capecitabine is used with other drugs to treat cancer.

Other side effects observed in this situation are as follows:
Common side effects (may affect up to 1 in 10 people) include:
reducing the sodium, magnesium or calcium in the blood, increase in blood glucose;
pain along the nerve;
ringing or buzzing in the ears (tinnitus), hearing loss;
inflammation of a vein;
hiccups, change in voice;
pain or altered / abnormal sensation in the mouth, jaw pain;
sweating, night sweats;
muscle spasms;
difficulty urinating, blood or protein in the urine;
bruising or reaction at the site of injection (caused by medicines, administered by injection at the same time).
Very rare (may affect up to 1 in 10,000 people) side effects include:
narrowing or blockage of the tear duct (lacrimal duct stenosis);
liver failure;
inflammation, which results in impairment of the function or obstruction of the bile (cholestatic hepatitis);
specific electrocardiogram changes (prolongation of QT-interval);
certain types of arrhythmias (including ventricular fibrillation, torsade de pointes and bradycardia);
inflammation of the eye, causing eye pain and possible vision problems;
inflammation of the skin, leading to the appearance of red scaly patches due to a disease of the immune system.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet. You may also report side effects directly through the national reporting system referred to in Annex V. As reported side effects, you can do your bit to get more information on the safety of this medicine.

5 How to store Capecitabine Accord
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP / EXP".

Aluminum-aluminum blisters:
This medicinal product does not require any special storage conditions.

For PVC / PVdC-aluminum blisters:
Do not store above 3 ° C.

Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.