Capecitabine 500mg.120 tablets
Capecitabine 500mg.120 tablets
What Capecitabine Sandoz and what it is used
Capecitabine Sandoz to a group of medicines called "cytostatic agents", which stop the growth of cancer cells. Sandoz contains capecitabine capecitabine, which itself is not chemotherapy. Once absorbed by the body, it is converted into an active anti-cancer drug (more in tumor tissue than in normal tissue).
Capecitabine Sandoz is used for treating cancer of the colon, rectum, stomach and breast. Furthermore, Capecitabine Sandoz is prescribed by doctors to prevent new occurrence of colon cancer after complete removal by surgery.
Sandoz Capecitabine may be used alone or in combination with other drugs.
2 What you should know before taking Capecitabine Sandoz
Do not take Sandoz Capecitabine:
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 have an allergy or over-reaction to this medicine;
if you have had severe reactions to drugs fluoropiramidinovi (a group of anticancer drugs, eg. fluorouracil);
if you are pregnant or breast-feeding;
if you have severely reduced levels of white blood cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia);
if you have liver or kidney problems;
if it is known to have a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), which is 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 substances as part of the treatment of infection with herpes zoster (chickenpox or shingles).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Capecitabine Sandoz if:
have liver or KIDNEY DISEASE;
have or have had heart problems (eg. irregular heartbeat or chest pain, jaw or back to effort and due to problems with blood flow to the heart);
have a disease of the brain (eg. cancer that has spread to the brain or nerve damage (NEUROPATHY);
have impaired calcium levels (seen in blood tests);
you are dehydrated;
have altered levels of ions in the blood (electrolyte imbalance observed in studies).
Deficiency of DPD: DPD deficiency is a rare condition that is present at birth and usually not associated with health problems, unless you are taking certain medications. If you have an unrecognized deficiency of DPD and taking Capecitabine Sandoz may experience side effects severe, described in section 4 "Possible side effects". Contact your doctor immediately if you are concerned about any side effects or if you notice any side effects not listed in this leaflet (see. Section 4 "Possible side effects").
Children and adolescents
Capecitabine Sandoz is not indicated in children and adolescents. Capecitabine Sandoz should not be used in children and adolescents.
Other medicines and Capecitabine Sandoz
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:
medicines for gout (allopurinol);
blood-thinning drugs (coumarin, warfarin);
some antiviral medicines (sorivudine and brivudine);
medicines for seizures or tremors (phenytoin);
radiotherapy and other drugs for the treatment of cancer (folinic acid, oxaliplatin, bevacizumab).
Capecitabine Sandoz with food and drink
You should take Capecitabine Sandoz no later than 30 minutes after a meal.
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. You should not take Capecitabine Sandoz if you are pregnant or think you may be pregnant. You should not breastfeed if you are taking capecitabine Sandoz.
Driving and using machines
Capecitabine Sandoz may cause dizziness, nausea, or fatigue. Therefore Capecitabine Sandoz could affect your ability to drive or operate machinery.
Capecitabine Sandoz contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult before taking this medicine.
3 How to take Capecitabine Sandoz
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Capecitabine Sandoz must only be prescribed by a physician experienced in the use of anticancer drugs.
Capecitabine Sandoz 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. Capecitabine dose of Sandoz is determined by the surface of your body. Calculated using height and weight. The usual dose for adults is 1250 mg / m2 body surface, taken twice daily (morning and evening). Here are two examples: a person weighing 64 kg, 1,64 m height and body surface area of 1,7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice daily. A person weighing 80 kg and a height of 1,80 m has a body surface area of 2,00 m2 and should take 5 tablets of 500 mg twice daily.
Sandoz tablets Capecitabine is usually taken for 14 days followed by 7 days rest period (when tablets are taken). This 21 day period is one treatment cycle.
In combination with other agents, the usual dosage for adults may be less than 1250 mg / m2 body surface area, and it may be necessary to take the tablets for various periods of time (e. 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 of the medicine as prescribed by your doctor.
If you take more than the dose of capecitabine Sandoz
If you take more than the dose of capecitabine Sandoz should contact your doctor as soon as possible before you take your next dose. You may get these side effects if you take more than the required dose capecitabine: nausea or vomiting, diarrhea, inflammation or ulceration of the gut or mouth, pain or bleeding in the intestines or stomach, bone marrow depression (reduction of certain blood cells ). Tell your doctor immediately if you experience these symptoms.
If you forget to take Capecitabine Sandoz
Do not take the missed dose at all and do not take a double dose. Instead, continue your regular schedule for taking the medicine and consult your doctor.
If you stop taking capecitabine Sandoz
There are no side effects caused by stopping treatment with capecitabine Sandoz. If you are using coumarin anticoagulants (containing eg. Phenprocoumon), stopping the Sandoz Capecitabine may require dose adjustment of anticoagulant by your doctor.
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 Sandoz immediately and call your doctor if you develop any of the following symptoms:
Diarrhea: if you have 4 or more bowel movement every day than usual or diarrhea during the night;
Vomiting: if you vomit more than once within 24 hours;
Nausea: if you lose your appetite and amount of food you take every day is much less than usual;
Stomatitis: if you have pain, redness, swelling or sores in the mouth;
Skin reaction "hand-foot": if you have pain, swelling and redness of the hands and / or feet;
Fever or Infection: if you have a temperature over 38 ° C or other signs of infection;
Chest pain: if you get pain in the middle of the chest, especially if it occurs during exercise.
If found 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 restart treatment with a lower dose.
In addition to the above side effects when capecitabine Sandoz is used alone, very common side effects which may affect more than 1 in 10 people are:
rash, dry or ITCHY SKIN;
decreased appetite (anorexia).
These side effects can become severe; it is therefore important to always immediately contact your doctor if adverse reactions occur. Your doctor may advise you to reduce the dose and / or temporarily discontinue treatment with capecitabine Sandoz. This will reduce the likelihood of side effects continue or become severe.
Other side effects are:
Common side effects (may affect less than 1 in 10 people) include:
reduce the number of white or red blood cells (seen in studies);
dehydration, weight loss;
difficulty sleeping (insomnia), depression;
headache, drowsiness, dizziness, abnormal sensations in the skin (numbness or tingling), 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;
infections of the lungs or respiratory system (eg. pneumonia or bronchitis);
bleeding in the intestines, 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 joints or limbs, 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);
diabetes, decreased potassium levels, malnutrition, increased blood triglycerides;
state of confusion, panic attacks, depressed mood, decreased libido;
difficulty speaking, memory impairment, loss of coordination of movements, balance disorder, seizures, nerve damage (NEUROPATHY) and sensory problems;
blurred vision or double vision;
dizziness, ear pain;
irregular heartbeat and palpitations (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 lung (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, abdominal discomfort, HEARTBURN (regurgitation of food from the stomach), blood in the stool;
jaundice (yellowing of the skin or eyes);
ulcers and skin blistering, skin reaction to sunlight, red hands, swelling or pain in the face;
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);
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 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 high blood sugar;
ringing or noise in the ears (TINNITUS), hearing loss;
inflammation of a vein;
hiccups, change in voice;
pain or altered / abnormal sensation in the mouth, pain in the jaw;
sweating, night sweats;
difficulty urinating, blood or protein in the urine;
reaction or bruising at the injection site (caused by drugs administered 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);
inflammation leading to dysfunction or obstruction of bile secretion (cholestatic hepatitis);
specific changes in the electrocardiogram (QT prolongation);
certain types of arrhythmia (including ventricular fibrillation, torsade de pointes and bradycardia).
If you are concerned about these or other (s) unexpected (s) reaction (s), 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 Sandoz
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" The expiry date refers to the last day of that month.
Do not store above 30 ° 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.
6 Package Contents and more information
What does Capecitabine Sandoz
The active substance is capecitabine (capecitabine). Each tablet Capecitabine Sandoz 500 mg contains 500 mg capecitabine.
Other ingredients are:
Tablet core: lactose monohydrate, hypromellose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Film-coating: hypromellose, talc, titanium dioxide (E171), red iron oxide (E172)
Capecitabine Sandoz looks like and contents of pack
Sandoz capecitabine 500 mg tablets
Pink tablet in the shape of an irregular ellipse (8,4 x 16,0 mm), with "500" on one side.
Capecitabine Sandoz is packaged in blister packs of PVC / PVDC (250/120 ?m) - Al (20 ?m) film in cartons containing 28, 30, 50, 56, 60, 80, 84, 90, 100, 110, 112, 120 and 180 tablets.