150 mg and 500 mg film-coated tablets
capecitabine
What Capecitabine STADA is and what it is used for
Capecitabine Stada belongs to a group of medicines called ‘cytostatics’, which prevent the growth of cancer cells. Capecitabine Stada contains capecitabine, which in itself is not a cytostatic drug. Only after the body has absorbed capecitabine is it converted into an active anti-cancer drug (preferably in tumor tissue).
Capecitabine Stada is used to treat colon, rectal, gastric, or breast cancer. Capecitabine Stada is also used to prevent colon cancer from returning after a tumour has been removed.
Capecitabine Stada can be used either alone or in combination with other medicines.
Capecitabine contained in Capecitabine Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you use Capecitabine STADA
Do not use Capecitabine STADA
- if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You must tell your doctor if you know that you are allergic or hypersensitive to this medicine
- if you have previously had severe reactions to fluoropyrimidine treatment (a group of anticancer medicines such as fluorouracil)
- if you are pregnant or breastfeeding
- if you have severely low levels of white blood cells or platelets ( leukopenia, neutropenia or thrombocytopenia )
- if you have severe liver or kidney problems
- if you know that you are completely devoid of enzyme activity and dihydropyridine dehydrogenase (DPD)
- if you are being treated with, or within the last 4 weeks have been treated with brivudine to treat herpes zoster (chickenpox or shingles ).
Warnings and cautions
Talk to your doctor or pharmacist before taking Capecitabin Stada
- if you know that enzyme et dihydropyrimidine dehydrogenase (DPD) is partially inactive in you
- if the enzyme a dihydropyridine dehydrogenase (DPD) is partially or completely inactive in someone in your family
- if you have liver or kidney disease
- or has or has had
- if you have brain diseases (for example, cancer that has spread to the brain or nerve damage (neuropathy))
- if you have disturbed calcium balance (seen in blood tests)
- if you have diabetes
- if you can not keep food or water in your body due to severe nausea and vomiting
- if you have diarrhea
- if you are or become dehydrated
- if you have an imbalance of ions in the blood (imbalance of electrolyte is, seen in samples)
- if you have previously had eye problems, as you may need extra eye checks
- if you have a severe skin reaction.
DPD deficiency
DPD deficiency is a congenital condition that is not usually associated with health problems unless you use certain medications. If you have DPD deficiency and are taking Capecitabine Stada, you have an increased risk of serious side effects (listed in section 4 Possible side effects ). It is recommended that you be tested for DPD deficiency before starting treatment. If you have no enzyme activity, do not take Capecitabine Stada. If you have reduced enzyme activity ( partial deficiency), your doctor may prescribe a lower dose. Serious and life-threatening side effects can still occur even if your test result for DPD deficiency is negative.
Children and young people
Capecitabine Stada is not indicated for use in children and adolescents. Do not give Capecitabine Stada to children and adolescents.
Other medicines and Capecitabine STADA
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is very important, as taking more than one medicine at the same time may intensify or weaken the effect of the medicines.
You must not take brivudine (antiviral medicine used to treat shingles or chickenpox) while you are being treated with capecitabine (including during the rest period when you are not taking any capecitabine tablets).
If you have taken brivudine, you must wait at least 4 weeks after stopping brivudine before starting capecitabine treatment. See also section “Do not take Capecitabine Stada”.
You must also be especially careful if you are taking medicines for any of the following:
- gout (allopurinol)
- blood-thinning drugs (coumarin, warfarin )
- medicines for seizures or tremors ( phenytoin )
- interferon-alpha
- radiation therapy and certain drugs used to treat cancer (folic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan)
- drugs used to treat folic acid deficiency.
Capecitabine STADA with food, drink, and alcohol
You should take the tablets within 30 minutes after the end of the meal.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Capecitabine Stada if you are or think you may be pregnant. You should not breast-feed while taking Capecitabin Stada.
Driving and using machines
The treatment may make you feel dizzy, nauseous, or tired after ingestion. It is therefore possible that Capecitabin Stada may affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Capecitabine STADA contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. next to “sodium-free”.
How to use Capecitabine STADA
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Capecitabine Stada should only be prescribed by a doctor who has experience in the use of anticancer medicines.
Your doctor will prescribe the right dose and dosage for you. Capecitabine Stada doses based on your body surface area. It is calculated from your height and weight. The usual dose for adults is 1250 mg / m 2 body surface area twice a day (morning and evening).
Two examples are given here: A person whose body weight is 64 kg and length is 1.64 m has a body surface area of 1.7 m 2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice a day. A person whose body weight is 80 kg and length is 1.80 m has a body surface area of 2.00 m 2 and should take 5 tablets of 500 mg twice a day.
Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Your doctor may want you to take a combination of 150 mg and 500 mg tablets at each dose.
- Take the tablets morning and evening as prescribed by your doctor.
- Take the tablets within 30 minutes after the end of the meal (breakfast and dinner) and swallow them whole with water.
- It is important that you take all the medicines prescribed by your doctor.
Capecitabine tablets are normally taken for 14 days followed by a 7-day rest period (when no tablets are taken). This 21-day period is a treatment cycle.
In combination with other medicines, the normal dose for adults may be less than 1250 mg / m 2 body surface area, and you may need to take the tablets for a different period of time (eg every day without any rest period).
If you use more Capecitabine STADA than you should
If you take more Capecitabine Stada than you should, contact your doctor as soon as possible before taking the next dose .
You can get the following side effects if you take much more capecitabine than you should: nausea and vomiting, diarrhea, inflammation or ulcers in the intestines or mouth, pain or bleeding from the intestines or stomach or bone marrow depression (decrease in certain types of blood cells ). Tell your doctor immediately if you experience any of these symptoms.
If you forget to use Capecitabine STADA
Do not take the missed dose one or double the next dose. Instead, continue with your prescribed dosage and talk to your doctor.
If you stop using Capecitabine STADA
There are no side effects caused by stopping capecitabine treatment. If you are taking coumarin anticoagulants (containing, for example, phenprocoumon), your doctor may require you to adjust your dose of anticoagulants when you stop taking capecitabine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Additional side effects in children and adolescents
Like all medicines, this medicine can cause side effects , although not everybody gets them.
STOP taking Capecitabine Stada immediately and contact your doctor if any of these symptoms occur:
- Diarrhea: If you have an increase of more than 4 stools each day compared to your normal number of stools per day or diarrhea at night.
- Vomiting: If you vomit more than once a day.
- Nausea: If you lose your appetite and the amount of food you eat every day is much less than usual.
- Stomatitis: If you have pain, redness , swelling or sores in your mouth and / or throat.
- Hand-foot syndrome: If you have pain, swelling and redness or tingling in your hands and / or feet.
- Fever: If you have a body temperature of 38ºC or more.
- Infection: if you have signs of infection caused by bacteria or viruses or other organisms.
- Chest pain: If you feel pain from the middle of the chest, especially if it comes when you exercise.
- Stevens-Johnson syndrome: if you have painful red or purple skin rash that spreads and blisters and / or other wounds that are starting to appear in the mucous membrane (eg, mouth and lips), especially if you have been sensitized before, had infection of the respiratory tract (eg bronchitis ) and / or fever.
- DPD deficiency: if you have a known DPD deficiency, you are at increased risk of acute and early onset of poisoning and severe, life-threatening or fatal side effects caused by Capecitabine Stada (eg stomatitis , mucositis, diarrhea, neutropenia, and neurotoxicity) ).
If these side effects are detected early, they may subside within 2 to 3 days after stopping treatment. If these side effects persist, contact your doctor immediately. Your doctor may advise you to start treatment again with a lower dose.
If severe stomatitis (sores in your mouth and / or throat), mucositis, diarrhea, neutropenia (increased risk of infections ) or neurotoxicity occur during the first treatment cycle, this may be due to DPD deficiency (see section 2 Warnings and precautions).
Skin reactions on hands and feet can lead to loss of fingerprints, which may affect your fingerprint identification.
In addition to what is mentioned above, when Capecitabin Stada is used alone, very common side effects, which may occur in more than 1 in 10 users:
- abdominal pain
- skin rash, dry or itchy skin
- fatigue
- loss of appetite ( anorexia ).
These side effects can be serious. Therefore, always contact your doctor immediately when you start to feel a side effect. Your doctor may advise you to reduce the dose one and/or temporarily discontinue Capecitabine Stada treatment. In this way, the risk of the side effect continuing or worsening is reduced.
Other side effects are:
Common side effects (may affect up to 1 in 10 people) include:
- decreased number of white or red blood cells (seen in samples)
- dehydration, weight loss,
- insomnia ( insomnia ), depression,
- headache, drowsiness, dizziness, abnormal feeling in the skin (numbness or tingling), taste changes,
- eye irritation increased tearing, red eyes ( conjunctivitis ),
- inflammation of the veins ( thrombophlebitis ),
- shortness of breath, nosebleeds, cough, runny nose,
- cold sores or other herpes infection,
- infection in the lungs or respiratory tract (eg pneumonia or bronchitis ),
- intestinal bleeding, constipation, upper abdominal pain, digestive problems, increased gas in the stomach, dry mouth,
- skin rash, hair loss ( alopecia ), skin redness, dry skin, itching, skin discoloration, skin peeling, skin inflammation, nail effects,
- joint, limb, chest or back pain,
- fever, swelling of the extremities, malaise,
- problems with liver function (seen in blood samples) and increased amount of bilirubin in the blood (excreted by the liver).
Uncommon side effects (may affect up to 1 in 100 people) include:
- infection of the blood, urinary tract infection, infection of the skin, infection of the nose and throat, fungal infections (including infection of the mouth), influenza, gastroenteritis, dental disease,
- lumps under the skin (lipoma),
- decreased number of blood cells including platelets thinned blood (seen in samples),
- allergy,
- diabetes decreased potassium in the blood, malnutrition, elevated blood fats,
- confusion, panic attacks, depression, decreased libido,
- difficulty speaking, impaired memory, loss of ability to coordinate movements, balance problems, fainting, nerve damage ( neuropathy ) and emotional problems,
- blurred vision or double vision,
- dizziness, earache,
- irregular heartbeat and palpitations ( arrhythmia ), chest pain and heart attack (infarction),
- blood clots in the deep veins, high or low blood pressure, hot flashes, cold extremities, purple spots on the skin,
- blood clots in the veins of the lungs ( pulmonary embolism), collapsing lung, coughing up blood, asthma, shortness of breath on exertion,
- intestinal obstruction, accumulation of fluid in the abdomen, inflammation of the small intestine, large intestine, stomach, or esophagus, pain in the lower abdomen, abdominal discomfort, heartburn (regurgitation of food from the stomach), bloody stools,
- jaundice (yellowing of the skin and eyes),
- sores and blisters on the skin, skin reaction to sunlight, redness of the palms, swelling or pain in the face,
- swollen or stiff joints, skeletal pain, weakness or stiffness in the muscles,
- accumulation of fluid in the kidneys, urinating more often at night, incontinence, blood in the urine, increased creatinine in the blood (signs of impaired kidney function),
- unusual bleeding from the vagina,
- swelling ( edema ), chills and stiffness.
Some of these side effects are more common when capecitabine is used with other medicines to treat cancer. Other side effects seen in these cases are as follows:
Common side effects (may affect up to 1 in 10 people) include:
- decreased amount of sodium, magnesium, or calcium in the blood, increased blood sugar,
- nerve pain,
- ringing or buzzing in the ears ( tinnitus ), hearing loss,
- inflammation of the veins,
- hiccups, altered voice,
- pain or altered / abnormal sensation in the mouth, pain in the jaw,
- sweating, night sweats,
- muscle cramps,
- difficulty urinating, blood or protein in the urine,
- bruising or reaction at the injection site (caused by medicines given as an injection at the same time ).
Rare side effects (may affect up to 1 in 1,000 people) include:
- narrowing or blocking of the lacrimal duct (lacrimal ductus stenosis),
- liver failure,
- inflammation leading to dysfunction or blockage of bile secretion (cholestatic hepatitis ),
- specific changes in the electrocardiogram ( QT prolongation),
- certain types of arrhythmia (including ventricular fibrillation, torsade de points, and bradycardia ),
- eye inflammation that causes eye pain and possibly vision problems,
- inflammation of the skin that causes red scaly patches due to disease emanating from the immune system.
Very rare side effects (may affect up to 1 in 10,000 people) include:
- severe skin reaction such as rash, sores and blisters that may include sores in the mouth, nose, genitals, hands, feet and eyes (red and swollen eyes).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Capecitabin STADA
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via 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 packaging and other information
Content declaration
Capecitabine Stada 150 mg film-coated tablets:
The active substance is capecitabine (150 mg / film-coated tablet)
Capecitabine Stada 500 mg film-coated tablets:
The active substance is capecitabine (500 mg / film-coated tablet)
Other ingredients (excipients) are
Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), yellow and red iron oxide (E172), talc
What the medicine looks like and contents of the pack
Capecitabine Stada 150 mg film-coated tablets:
Slightly peach-colored, oblong shape, biconvex, film-coated tablet with ‘150’ imprinted on one side and smooth on the other side.
Capecitabine Stada 150 film-coated tablets pack contains: 60, 120, 180 or 240 film-coated tablets.
Capecitabine Stada 500 mg film-coated tablets:
Slightly peach-colored, oblong shape, biconvex, film-coated tablet with ‘500’ imprinted on one side and smooth on the other side.
Capecitabine Stada 500 film-coated tablets pack contains: 60, 120, 180 or 240 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADApharm GmbH
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic Aps
Marielundvej 46 A
2730 Herlev
Denmark