Capecitabine . 500 mg. 120 coated table TEVA 

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

2 . What you should know before taking Capecitabine Teva
Do not take Capecitabine Teva:
if you are allergic to capecitabine or to any of the other ingredients of this medicine (listed in Section 6) . You should tell your doctor if you know you are allergic 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 or kidney problems ;
if you have a known deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), involved in the metabolism of uracil and thymine ;
Now if you are treated or have been treated for the last 4 weeks with brivudine sorivudine or similar classes of substances as part of the treatment of herpes zoster infection ( chickenpox or shingles ) .
Warnings and Precautions
Tell your doctor or pharmacist before taking Capecitabine Teva:
if you have liver or kidney disease ;
if you have or have had heart problems (eg, irregular heartbeat or chest pain, jaw and back caused by physical effort and due to problems with blood flow to the heart) ;
if you have a brain disease (eg, cancer that has spread to the brain or nerve damage ( neuropathy) ) ;
if you have impaired balance of calcium ( blood test ) ;
if you have diabetes ;
if you have diarrhea ;
if you are dehydrated ( dehydrated ) ;
if you have impaired levels of ions in the blood ( electrolyte disturbances observed in the studies ) .
Deficiency of DPD: DPD deficiency is a rare condition that is present at birth and usually not associated with health problems unless you take certain medicines. If you have an unrecognized deficiency of DPD and taking capecitabine may experience 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 is not indicated in children and adolescents. Do not give capecitabine children and adolescents.

Other medicines and Capecitabine Teva
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 cautious if you are taking any of these medicines:
for the treatment of gout ( allopurinol) ;
blood-thinning drugs ( coumarin , warfarin ) ;
some antiviral medicines ( sorivudine and brivudine ) ;
medicines for seizures or tremors ( phenytoin) ;
interferon alpha ;
radiation and certain drugs used for treatment of cancer ( folinic acid , oxaliplatin, bevacizumab ) .
Capecitabine Teva with food and drink alcohol
You should take Capecitabine Teva no later than 30 minutes after a meal.

Pregnancy and lactation
Before the start of treatment you should tell your doctor if you are pregnant, think you may be pregnant or planning a pregnancy . You should not take Capecitabine Teva if you are pregnant or think you may be pregnant . You should not breastfeed while taking Capecitabine Teva. Before taking this medication you should consult with your doctor or pharmacist.

Driving and using machines
Capecitabine Teva can cause dizziness , nausea, or fatigue. It is therefore possible Capecitabine Teva affect your ability to drive or operate machinery.

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

3 . How to take Capecitabine Teva
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Capecitabine should only be prescribed by a physician experienced in the use of anticancer drugs.
Capecitabine Teva 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 . The dose of Capecitabine Teva is determined depending on the surface of your body. Calculated taking into account the height and weight . The usual adult dose is 1250 mg/m2 body surface area taken twice daily (morning and evening). Here are two examples: a person weighing 64 kg and a height of 1,64 m surface area of 1,7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice daily. Person weighing 80 kg and a height of 1,80 m surface area of 2,00 m2 and should take 5 tablets of 500 mg twice daily.
Capecitabine Teva tablets are usually taken for 14 days followed by 7 days rest period ( no tablets ) . This 21 - day period of one treatment cycle .
In combination with other drugs , the usual dose for adults may be less than 1250 mg/m2 body surface area 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 should take , when to take and how long you should take it.

Your doctor may suggest a combination of tablets of 150 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 all medications as prescribed by your doctor.
If you take more dose Capecitabine Teva
If you take more than the dose of capecitabine , call your doctor as soon as possible before you take your next dose.
You may experience the following side effects: nausea or vomiting , diarrhea , inflammation or ulceration of the gut or mouth , pain or bleeding from the stomach or small intestine , or bone marrow suppression (reduction of certain types of blood cells). If you get any of these symptoms , call your doctor immediately .

If you forget to take Capecitabine Teva
Do not take the missed dose at all and do not take a double dose. Instead resume your usual regimen of medication and consult your doctor.

If you stop taking Capecitabine Teva
No side effects caused by stopping treatment with capecitabine. If you are using coumarin anticoagulants ( containing eg . Phenprocoumon ) , stopping the use of capecitabine may require dose adjustment of the 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 Teva immediately and contact your doctor if any of these symptoms :
Diarrhea : if you have 4 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 the 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 stopping treatment. If these side effects continue , contact your doctor. Your doctor may advise you to resume treatment at a lower dose.

When capecitabine is used alone , the very common side effects which may affect more than 1 in 10 people :
abdominal pain;
rash, dry or itchy skin ;
fatigue ;
loss of appetite ( anorexia ) .
These side effects can become severe ; it is important always when a side effect immediately contact your doctor . Your doctor may instruct you to reduce the dose and / or temporarily stop your treatment with Capecitabine Teva. This will help reduce the likelihood that the side effect continues or becomes severe.

Other side effects are:
Common side effects (may affect up to 1 in 10 people ) include:
decrease in white blood cells or red blood cells (seen in studies) ;
dehydration, loss of body weight;
insomnia , depression ;
headache, drowsiness , dizziness, abnormal sensation of the skin ( tingling or numbness ), changes in taste ;
inflammation of the veins ( thrombophlebitis) ;
shortness of breath, nosebleeds cough , runny nose ;
Herpes on the lips and other herpes infections ;
infections of the lungs or respiratory system ( such as pneumonia and bronchitis ) ;
bleeding from the bowel , constipation , pain in the upper abdomen , indigestion , flatulence, dry mouth ;
skin rash , hair loss ( alopecia ), redness of the skin , dry skin, itching ( pruritus) , discoloration of the skin , loss of fur , skin , nail disorder ;
joint pain, chest or back;
fever, swelling of the legs , malaise ;
problems with liver function (seen in blood tests ) and elevated bilirubin levels ( secreted 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 the mouth), influenza , gastroenteritis , tooth abscesses ;
lumps under the skin ( lipoma ) ;
reduction of blood cells, including platelets , blood thinners (observed in studies ) ;
allergy ;
diabetes, decrease in blood potassium , malnutrition , increased blood triglycerides ;
state of confusion, panic attacks , depressed mood , decreased libido ;
difficulty speaking , memory impairment , loss of motor coordination , balance disorder , seizures, nerve damage ( neuropathy) and problems with sensation ( feeling ) ;
blurred vision or double vision ;
dizziness, ear pain ;
irregular heartbeat and heartbeat ( arrhythmia) , chest pain and heart attack ( infarction) ;
blood clots in the deep veins , high or low blood pressure , hot flushes, cold extremities, purple spots on the skin;
blood clots in the veins of the lung ( pulmonary embolism ) , collapsed lung , coughing up 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 , abdominal discomfort , heartburn ( reflux of food from the stomach) , blood in the stool ;
jaundice ( yellowing of the skin or eyes ) ;
ulcers and skin blistering , skin reaction to sunlight , sore hands, swelling or pain in the face ;
joint swelling or stiffness , bone pain , muscle weakness or stiffness ;
collection of fluid in the kidneys, increased frequency of urination at night, incontinence , blood in urine , increased blood creatinine levels ( a sign of impaired renal function);
abnormal vaginal bleeding ;
swelling ( edema) , chills and fever .
Some of these adverse effects are more common when capecitabine is used with other drugs to treat cancer .

Other adverse reactions observed under these conditions are the following:
Common side effects (may affect up to 1 in 10 people ) include:
reduction of sodium, magnesium or calcium in the blood , blood sugar ;
neuralgic pain;
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 at the same time by injection) .
Very rare ( may affect up to 1 in 10 000) side effects include:
narrowing or blockage of the tear duct ( lacrimal duct stenosis ) ;
liver failure ;
inflammation leading to dysfunction or obstruction of bile secretion ( cholestatic hepatitis) ;
specific changes in the electrocardiogram ( QT prolongation ) ;
some types of arrhythmia (including ventricular fibrillation , torsade de pointes and bradycardia) .
If you are concerned about these or other unexpected effects, talk to your doctor.
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.

5 . How to store Capecitabine Teva
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after " EXP" and "EXP". The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Store in the original package to protect from moisture.
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.

6 . Contents of the pack and other information
What does Capecitabine Teva
The active substance is capecitabine. Each tablet contains 500 mg capecitabine.

Other ingredients are:
Tablet core : lactose , microcrystalline cellulose , hypromellose , croscarmellose sodium, magnesium stearate.
Tablet coating : macrogol , hypromellose , titanium dioxide ( E171 ), iron oxide yellow (E172 ), iron oxide red (E172) .

Capecitabine Teva looks like and contents of the pack
Capecitabine Teva 500 mg are oblong , biconvex, film-coated tablets svetlopraskoveni marked " C" on one side of the tablet and "500 " on the other side.
The tablets are blister containing 120 tablets. Each pack contains 12 blisters of 10 tablets.