Xeloda. 150 mg. 60 tablets

What is Xeloda and what it is used?
Xeloda belongs to the group of medicines called " cytostatic drugs ", which stop the growth of cancer cells. Xeloda contains 150 mg capecitabine, which in itself is not a cytostatic drug. Only after being absorbed into the body, it becomes an active anticancer drug (more in tumor tissue than in normal tissue).
Xeloda is used for treating cancer of the colon, rectum, stomach cancer , or breast cancer .
Furthermore, Xeloda is used to prevent the recurrence of colon cancer after complete removal of the tumor by surgery.
Xeloda may be used alone or in combination with other medicines.

2 . What you should know before taking Xeloda

Do not take Xeloda:
• 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 or kidney problems
• if you have a known deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), involved in the metabolism of uracil and thymine, or
• if you are taking now or have 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 or pharmacist before taking Xeloda
• 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 brain diseases (such as cancer that has spread to the brain or nerve damage ( neuropathy) )
• if you have altered levels of calcium in the blood ( seen in blood tests )
• if you have diabetes
• if you have diarrhea
• if you are dehydrated
• if you have altered levels of ions in the blood ( electrolyte imbalance observed in studies )
• if you 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 usually not associated with health problems unless you take certain medicines. If you have an unrecognized deficiency of DPD and taking Xeloda, 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
Xeloda is not indicated in children and adolescents. Xeloda Do not give to children and adolescents . Other medicines and Xeloda
Before starting treatment , tell your doctor or pharmacist if you are taking, have recently taken or 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 drugs. You should be especially careful if you are taking any of the following :
• medicines for gout ( allopurinol )
• medicines for blood clotting ( coumarin , warfarin )
• some antiviral medicines ( sorivudine and brivudine )
• medicines for seizures or tremors ( phenytoin )
• interferon alpha or
• radiation and certain drugs used for treatment of cancer ( folinic acid , oxaliplatin, bevacizumab ) .

Xeloda with food, drinks and alcohol
Should not take Xeloda no later than 30 minutes after a meal. Pregnancy and lactation
Before starting treatment , you should tell your doctor if you are pregnant, think you may be pregnant or planning a pregnancy . You should not take Xeloda, if you are pregnant or think you may be pregnant. You should not breastfeed if you are taking Xeloda. Ask your doctor or pharmacist before taking this medicine
Driving and using machines
Xeloda may cause feelings of dizziness , nausea, or fatigue. It is therefore possible that Xeloda can affect your ability to drive or operate machinery.

Xeloda contains anhydrous lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 . How to take Xeloda?
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Xeloda should only be prescribed by a physician experienced in the use of anticancer drugs.
Xeloda tablets should be swallowed whole with water within 30 minutes after eating.
Your doctor will prescribe a dose and treatment regimen that is right for you . Dose of Xeloda is based on your body surface. It is calculated from your height and weight. The usual adult dose is 1250 mg/m2 of body surface area twice daily (morning and evening). Here we give two examples : a person whose body weight is 64 kg and height - 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. A person whose body weight is 80 kg and height - 1,80 m, surface area of 2,00 m2 and should take 5 tablets of 500 mg twice daily.
Xeloda tablets are usually taken for 14 days followed by a 7 day rest period ( during which no tablets ) . This 21-day period constitutes one cycle of treatment .
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 , with no rest period) .
Your doctor will tell you what dose you need to take, when and how long you need to take it .
Your doctor may ask you to take 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 your medicine as prescribed by your doctor.
If you take more than the dose of Xeloda
If you take more dose Xeloda, contact your doctor as soon as possible before taking the next dose .
If you take more than the dose of capecitabine 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 intestines , or bone marrow suppression (reduction of certain types of blood cells ) . Tell your doctor immediately if you experience any of these symptoms .

If you forget to take Xeloda
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 Xeloda
There are no side effects caused by stopping treatment with capecitabine. If you are using coumarin anticoagulants ( containing eg . Phenprocoumon ), 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 Xeloda immediately and contact your doctor if any of these symptoms :
• Diarrhea : if you increase the number of bowel movements with 4 or more a day than usual or diarrhea at 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-foot ": if you have pain , swelling, redness or tingling of the hands and / or feet .
• High temperature : 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 found 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.
In addition to the above, when Xeloda is used alone , very common side effects which may affect more than 1 in 10 people :
• abdominal pain
• rash, dry or itchy skin
• tiredness
• decreased appetite (anorexia )
These side effects can become severe , it is therefore important to always immediately contact your doctor if you get side effects . Your doctor may advise you to reduce the dose and / or temporarily discontinue treatment with Xeloda. 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:
• reduce the number of white or red blood cells ( seen in studies)
• dehydration, weight loss,
• sleeplessness ( insomnia) , depression,
• headache, drowsiness , dizziness, abnormal sensation of the skin ( tingling or numbness ), changes in taste ,
• eye irritation , increased lacrimation , redness of the eye ( conjunctivitis )
• inflammation of the veins ( thrombophlebitis )
• shortness of breath, nosebleeds , cough , runny nose,
• cold sores or other herpes infections ,
• infection of the lungs or respiratory system (e.g., pneumonia or 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 ,
• pain in the joints or limbs , chest or back ,
• fever, leg swelling , discomfort,
• 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:
• a 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 , thin the blood (seen in studies) , allergy, diabetes, decrease in blood potassium , malnutrition , increased triglyceride levels , confusion , panic attacks , depressed mood, decreased libido, difficulty speaking , memory loss coordination of movements , balance disorder , seizures, nerve damage ( neuropathy) and problems with sensation ( sense of touch ) , blurred vision or double vision , dizziness, ear pain , irregular heartbeat and heartbeat ( arrhythmia) , chest pain and heart stroke ( stroke ) , 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 ( return of food from the stomach) , blood in stools , jaundice ( yellowing of the skin and eyes) , skin ulcers and blisters , skin reaction to sunlight , sore hands, swelling or facial pain , swelling or stiffness , bone pain , muscle weakness or stiffness, fluid collection kidney , increased frequency of urination at night, incontinence , blood in urine , increased blood creatinine levels ( a sign of renal dysfunction ) , 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:
• reducing sodium, magnesium or calcium in the blood , high blood sugar
• neuralgic pain
• ringing or noise in the ears ( tinnitus) , hearing loss ,
• inflammation of the 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 injection site (caused by drugs used at the same time by injection)

Very rare side effects (may affect up to 1 in 10 000 people ) include
• narrowing or blockage of the tear duct ( lacrimal duct stenosis )
• hepatic failure
• inflammation leading to dysfunction or obstruction of bile secretion ( cholestatic hepatitis )
• specific electrocardiogram changes ( QT prolongation )
• some types of arrhythmia (including ventricular fibrillation , torsade de pointes and bradycardia )
• inflammation of the eye, causing eye pain and possible vision problems
• inflammation of the skin , which leads to appearance of red scaly patches due to disease of the immune system .

Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all of this leaflet affect you . You can also report side effects directly through the national system of notification 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 Xeloda?
Keep out of reach of children. Do not store above 30 ° C.
Do not use this medicine after the expiry date stated on the carton and label after " EXP " and " EXP " . Expiry date refers to the last day of that month.
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 . Package Contents and more information
What does Xeloda?
• The active substance is capecitabine (150 mg per tablet ) .
• The other ingredients are:
• Core: anhydrous lactose , croscarmellose sodium, hypromellose , microcrystalline cellulose , magnesium stearate.
• Tablet coating : hypromellose , titanium dioxide (E171), yellow and red iron oxide (E172), talc.
Xeloda looks like and contents of the pack ?
Peach film-coated tablet of biconvex , oblong shape marked "150" on one side and "Xeloda" on the other.
One pack Xeloda 150 mg film-coated tablet contains 60 tablets ( 6 blisters of 10 tablets).