150 mg, 300 mg, 500 mg film-coated tablets 
capecitabine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Capecitabine Accord is and what it is used for 
2. What you need to know before you take Capecitabine Accord 
3. How to take Capecitabine Accord 
4. Possible side effects 
5. How to store Capecitabine Accord 
6. Contents of the packaging and other information 

What Capecitabine Accord is and what it is used for

Capecitabine Accord belongs to a group of medicines called ‘cytostatics’, which inhibit the growth of cancer cells. Capecitabine Accord 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 agent (preferably in tumor tissue).

Capecitabine Accord is used to treat colon, rectal, gastric or breast cancer.

Capecitabine Accord is also used to prevent colon cancer from coming back after a tumor has been removed.

Capecitabine Accord can be used either alone or in combination with other medicines.

What you need to know before taking Capecitabine Accord

Do not take Capecitabine Accord:

  • 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 in your blood ( leukopenia , neutropenia or thrombocytopenia ),
  • if you have severe liver or kidney problems,
  • if you know that the enzyme a dihydropyrimidine dehydrogenase (DPD) is completely inactive in you,
  • 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 Capecitabine Accord

  • if you know that enzyme et dihydropyrimidine dehydrogenase (DPD) is partially inactive in you
  • if you have liver or kidney disease
  • if you have or have had heart problems (eg irregular heartbeat) or pain in the chest, jaw and back, which occur during physical exertion and are due to problems with the blood flow to the heart
  • if you have brain diseases (eg cancer that has spread to the brain) or nerve damage ( neuropathy )
  • if you have disturbed calcium balance (seen with blood test)
  • 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 have or experience dehydration
  • if you have an imbalance of ions in the blood (electrolyte imbalance, seen with blood tests)
  • 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 rare congenital condition that is not usually associated with health problems unless you are given certain medications. If you have an unknown DPD deficiency and are taking Capecitabine Accord, you have an increased risk of early and rapidly occurring severe forms of side effects listed in section 4. Possible side effects . Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effectsnot listed in this leaflet (see section 4. Any side effects ).

Children and young people

Capecitabine Accord is not indicated for use in children and adolescents. Do not give Capecitabine Accord to 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 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 (an 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 Accord”.

You need to be especially careful if you take any of the following:

  • gout medication (allopurinol),
  • blood-thinning drugs (coumarin, warfarin ),
  • medicines for seizures or tremors ( phenytoin ),
  • a drug to treat cancer ( interferon alfa),
  • radiation therapy and certain drugs used to treat cancer ( folic acid , oxaliplatin, bevacizumab, cisplatin, irinotecan),
  • drugs used to treat folic acid deficiency.

Capecitabine Accord with food and drink

You should take Capecitabine Accord within 30 minutes of finishing your meal.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, 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 Accord if you are or think you may be pregnant. 
You should not breast-feed if you are taking Capecitabine Accord and for 2 weeks after the last dose .

If you are a pregnant woman, you should use effective contraception during treatment with Capecitabine Accord and for a further 6 months after the last dose .

If you are a male patient and your female partner is fertile , you should use effective contraception during treatment with Capecitabine Accord and for a further 3 months after the last dose of a

Driving and using machines

Capecitabine Accord may make you feel dizzy, nauseous or tired. It is therefore possible that Capecitabine Accord may affect your ability to drive or use machines. Do not drive if you feel dizzy, nauseous or tired after taking this medicine

Capecitabine Accord contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Capecitabine Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Capecitabine Accord 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. Dose one of Capecitabine Accord is based on your body surface area. It is calculated based on 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 waterDo not crush or split the tablets. If you can not swallow Capecitabine Accord tablets whole, talk to your healthcare provider.
  • It is important that you take all medicines according to your doctor’s prescription.

Capecitabine Accord 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 take more Capecitabine Accord than you should

If you take more Capecitabine Accord then 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 or vomiting, diarrhea, inflammation or ulceration of the stomach 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 take Capecitabine Accord

Do not take the missed dose. Do not take a double dose to make up for a forgotten dose. Instead, continue with your prescribed dosage and talk to your doctor.

If you stop taking Capecitabine Accord

There are no side effects caused by stopping Capecitabine Accord treatment. If you are taking coumarin anticoagulants (which contain, for example, phenprocoumon), your doctor may require you to adjust your dose of anticoagulants when you stop taking Capecitabine Accord.

If you have any further questions on the use of this product, 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 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 in 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, redness, or tingling in your hands and/or feet.
  • Fever: if you have a body temperature of 38 ºC 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 violet skin rashes that spread and blisters and/or other sores that begin to appear in the mucous membrane (eg mouth and lips), especially if you have previously been photosensitive, had an infection in the airways (t 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 Accord (eg stomatitis, mucositis, diarrhea, neutropenia 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.

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 capecitabine is used alone, very common side effects, which occur in more than 1 in 10 individuals:

  • 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 to discontinue Capecitabine Accord treatment temporarily. 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 tear volume, 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 ), reddening of the skin, 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, gastrointestinal catarrh, 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 injectionat the same time ).

Rare side effects (may affect up to 1 in 1,000 people) include:

  • narrowing or blocking of the lacrimal duct (lacrimalis ductus stenosis),
  • liver failure,
  • inflammation leading to dysfunction or blockage of bile secretion (cholestatic hepatitis ),
  • specific changes in electrocardiogram ( QT – prolongation),
  • certain types of arrhythmia (including ventricular fibrillation , torsade de pointesand 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 Capecitabine Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. and on blisters after EXP.

For aluminum-aluminum blisters

No special storage instructions.

For PVC / PVdC aluminum blisters (perforated unit dose blisters) Do not store above 
30 ° C.

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

  • The active substance is capecitabine
    • Each film-coated tablet contains 150 mg of capecitabine
    • Each film-coated tablet contains 300 mg of capecitabine
    • Each film-coated tablet contains 500 mg of capecitabine
  • Other ingredients are:
    • Tablet core: anhydrous lactose , croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
    • Tablet coating (for 150 mg): hypromellose, titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc.
    • Tablet coating (for 300 mg): hypromellose, titanium dioxide (E171), talc.
    • Tablet coating (for 500 mg): hypromellose, titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc.

What the medicine looks like and contents of the pack

Capecitabine Accord 150 mg film-coated tablets are peach-colored, oblong, biconvex, film-coated tablets 11.4 mm long and 5.3 mm wide, curved with ‘150’ on one side and smooth on the other side.

Capecitabine Accord 300 mg film-coated tablets are white to off-white, oblong, biconvex, film-coated tablets 14.6 mm long and 6.7 mm wide, curved with ‘300’ on one side and smooth on the other.

Capecitabine Accord 500 mg film-coated tablets are peach-colored, oblong, biconvex, film-coated tablets with a length of 15.9 mm and a width of 8.4 mm, curved with ‘500’ on one side and smooth on the other side.

Capecitabine Accord is available in blister packs containing 30, 60 or 120 film-coated tablets or in perforated unit dose blister packs containing 30 x 1, 60 x 1 or 120 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare SLU

World Trade Center, Moll de Barcelona, ​​s / n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road, Harrow HA1 4HF, UK

Pharmadox HeaIthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000, Malta

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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