Product Information for the User

Capecitabina Accord 150 mg Film-Coated Tablets

Capecitabina Accord 300 mg Film-Coated Tablets

Capecitabina Accord 500 mg Film-Coated Tablets

Capecitabina

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Capecitabina Accord belongs to the group of medications known as “chemotherapeutic agents”, which halt the growth of cancerous cells. Capecitabina Accord contains capecitabina and by itself is not a chemotherapeutic agent. It only transforms into an active anti-cancer medication after being absorbed by the body, more so in tumor tissue than in normal tissue.

Capecitabina Accord is used for the treatment of colon cancer, rectal cancer, gastric cancer, or breast cancer. Additionally, Capecitabina Accord is used to prevent the reappearance of colon cancer after the complete removal of the tumor through surgical operation.

Capecitabina Accord can be used alone or in combination with other medications.

Do not take Capecitabina Accord

• if you are allergic to capecitabina or any of the other components of this medication (listed in section 6). Inform your doctor if you have any type of allergy or exaggerated reaction to this medication,
• if you have previously experienced severe reactions to fluoropyrimidine therapy (a group of anticancer medications such as fluorouracil).
• if you are pregnant or breastfeeding,
• if you have extremely low levels of white blood cells or platelets in your blood (leucopenia, neutropenia, or thrombocytopenia),
• if you have liver disease or severe kidney problems,

• if you know that you do not have any activity of the dihydropyrimidine dehydrogenase (DPD) enzyme (complete DPD deficiency)
• if you are being treated or have been treated in the last 4 weeks with brivudine as part of the treatment for herpes zoster (shingles or herpes).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Capecitabina Accord, if:

• you know that you have a partial deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme activity.
• you are a relative of a person with partial or complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
• you have liver or kidney problems
• you have or have had heart problems (e.g. irregular heartbeat) or chest, jaw, and back pain due to physical exertion and circulation problems
• you have brain diseases (e.g. cancer that has spread to the brain or nerve damage (neuropathy))
• you have calcium imbalance (seen in blood tests)
• you have diabetes
• due to severe nausea and vomiting, you are unable to retain food or water in your body
• you have diarrhea
• you are or will be dehydrated
• you have electrolyte imbalance in your blood (electrolyte imbalance, seen in blood tests)
• you have a history of eye problems, as you may need additional eye monitoring
• you have a severe skin reaction.

Dihydropyrimidine dehydrogenase (DPD) deficiency: DPD deficiency is a genetic condition that is not usually related to health problems, unless you are taking certain medications. If you have a DPD deficiency and take Capecitabina Accord, you will have a higher risk of experiencing severe adverse effects (listed in section 4, Possible adverse effects). It is recommended that you undergo a test to detect DPD deficiency before starting treatment. If you have no enzyme activity, you should not take Capecitabina Accord. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe a reduced dose. Although the test results for DPD deficiency are negative, severe and potentially fatal adverse effects may still occur.

Children and adolescents

Capecitabina Accord is not indicated for children and adolescents. Do not give Capecitabina Accord to children and adolescents.

Use of Capecitabina Accord with other medications

Before starting treatment, inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is very important, as taking multiple medications at the same time may potentiate or weaken their effects.

You also need to be very careful if you are taking any of the following medications:

• medications for gout (allopurinol),
• medications to reduce blood clotting (warfarin, coumarin),
• medications for seizures or tremors (phenytoin)
• a medication to treat cancer (interferon alpha)
• radiation therapy and certain medications used to treat cancer (folinic acid, oxaliplatin, and bevacizumab, cisplatin, irinotecan).

Use of Capecitabina Accord with food and drinks

You should take Capecitabina Accord before or 30 minutes after eating.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not take Capecitabina Accord if you are pregnant or think you may be pregnant.

You should not breastfeed your baby while taking Capecitabina Accord and for 2 weeks after the last dose.

If you are a woman who may become pregnant, you should use an effective contraceptive method during treatment with Capecitabina Accord and for 6 months after the last dose.

If you are a male patient and your female partner may become pregnant, you should use an effective contraceptive method during treatment with Capecitabina Accord and for 3 months after the last dose.

Driving and operating machinery

When taking Capecitabina Accord, you may feel dizzy, nauseous, or tired. Therefore, Capecitabina Accord may affect your ability to drive vehicles or operate machinery. Do not drive if you feel dizzy, nauseous, or tired after taking this medication.

Capecitabina Accord contains lactose

If your doctor has told you that you have intolerance to some sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Capecitabina Accord should only be prescribed by a doctor experienced in the use of anticancer medications.

Your doctor will prescribe a treatment schedule and correct dose for you. The dose of Capecitabina Accord depends on your body surface area. This is calculated by measuring your height and weight. The usual dose for adults is 1,250 mg/m2of body surface area twice a day (morning and night). Here are two examples: a person weighing 64 kg and measuring 1.64 m has a body surface area of 1.7 m2, so they should take 4 tablets of 500 mg and 1 tablet of 150 mg twice a day. A person weighing 80 kg and measuring 1.80 m has a body surface area of 2.00 m2, so they should take 5 tablets of 500 mg twice a day.

Your doctor will tell you how much dose you need to take, when to take it, and for how long you need to take it.

Your doctor may instruct you to take a combination of tablets of150 mgand500 mgfor each dose.

• Take the tabletsin the morning and at night, as prescribed by your doctor.
• Take the tabletswithin 30 minutes after finishing breakfast or dinner and swallow them whole with water. Do not crush or cut the tablets. If you cannot swallow the Capecitabina Accord tablets whole, talk to your doctor or pharmacist.
• It is essential that you take all your medication as prescribed by your doctor.

Capecitabina Accord tablets are usually taken for 14 consecutive days followed by a 7-day break (during which no tablets are taken). This 21-day period is a treatment cycle.

In combination with other medications, the usual dose in adults may be less than 1,250 mg/m2of body surface area, and it may be necessary to take the tablets for a different period of time (for example, every day, without a break).

If you take more Capecitabina Accord than you should:

If you take more Capecitabina Accord than you should, contact your doctor as soon as possible before taking the next dose.

You may experience the following adverse effects if you take too much capecitabina: dizziness or vomiting, diarrhea, intestinal or oral inflammation or ulcers, abdominal or intestinal pain or bleeding, or bone marrow depression (reduction of certain types of blood cells). Inform your doctor immediately if you experience any of these symptoms.

If you forgot to take Capecitabina Accord:

Do nottake the missed dose. Do not take a double dose to make up for the missed dose. Instead, continue your regular dosing schedule and consult your doctor.

If you interrupt the treatment with Capecitabina Accord:

The end of treatment with capecitabina does not produce adverse effects.

If you are taking coumarin anticoagulants (such as phenprocoumon), the end of treatment with capecitabina may require your doctor to adjust the dose of the anticoagulant.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Capecitabina Accord can cause side effects, although not everyone will experience them.

STOPtaking Capecitabina Accord immediately and contact your doctor ifyou experience any of the following symptoms:

• Diarrea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements per day or have nocturnal diarrhea.
• Vómito: if you vomit more than once in a 24-hour period.
• Náuseas: if you lose your appetite and the amount of food you eat each day is much less than usual.
• Estomatitis: if you have pain, redness, swelling, or sores in your mouth and/or throat.
• Reacción cutánea en las manos y pies: if you have pain, swelling, and redness or tingling in your hands and/or feet.
• Fiebre:if you have a temperature of 38°C or higher.
• Infección: if you have signs of infection caused by bacteria or viruses, or other organisms.
• Dolor torácico:if you have localized pain in the center of the chest, especially if it occurs while exercising.
• Síndrome de Steven-Johnson:if you have painful red or purple rashes that spread and blisters and other lesions that begin to appear on the mucous membrane (e.g., mouth and lips), particularly if you have had sensitivity to light, respiratory infections (e.g., bronchitis), and/or fever.
• Deficiencia de DPD:if you have a known deficiency of DPD, you have a higher risk of early onset of toxicity and severe adverse reactions, potentially life-threatening or fatal, caused by Capecitabina Accord (e.g., stomatitis, mucosal inflammation, diarrhea, neutropenia, and neurotoxicity).
• Angioedema: Seek immediate medical attention if you notice any of the following symptoms, you may need urgent medical treatment: swelling mainly of the face, lips, tongue, or throat that makes it difficult to swallow or breathe, itching, and rashes. This could be a sign of angioedema.

Detected in time, these side effects usually improve within 2 to 3 days of stopping the medication.

However, if these side effects continue, contact your doctor immediately.

Your doctor may advise you to resume treatment with a lower dose.

If severe stomatitis (mouth sores and/or throat sores), mucosal inflammation, diarrhea, neutropenia (increased risk of infections), or neurotoxicity occurs during the first cycle of treatment, it is possible that there is a DPD deficiency (see section 2: Warnings and precautions).

The skin reaction on the hands and feet can lead to loss of fingerprints, which can affect your identification through fingerprint analysis.

In addition to the above, when capecitabina is used alone, the most common side effects that can affect more than 1 in 10 people are:

• abdominal pain
• skin rash, dry skin, or itching
• fatigue
• loss of appetite (anorexia).

These side effects can be severe; therefore,contact your doctorimmediatelywhen you start experiencing a side effect. Your doctor may advise you toreduce the dose and/or temporarily stop treatment with Capecitabina Accord. This will help reduce the likelihood of the side effect continuing or becoming severe.

Other side effects are:

Side effectsfrequent(can affect up to 1 in 10 people) include:

• decrease in the number of white or red blood cells (observed in blood tests),
• dehydration, weight loss
• insomnia, depression
• headache, drowsiness, dizziness, abnormal sensation in the skin (tingling or numbness), taste alterations
• eye irritation, increased tearing, redness of the eyes (conjunctivitis)
• inflammation of the veins (thrombophlebitis)
• difficulty breathing, nasal bleeding, cough, nasal discharge
• herpes labial or other herpes infections
• respiratory infections or respiratory system infections (e.g., pneumonia or bronchitis)
• intestinal hemorrhage, constipation, upper abdominal pain, indigestion, gas (flatulence), dry mouth
• skin rash, mild hair loss (alopecia), redness of the skin, dry skin, itching (pruritus), skin color change, skin loss, skin inflammation, nail disorders
• tingling or numbness sensation in the skin
• joint or limb pain, chest or back pain
• fever, swelling in the limbs, feeling unwell
• liver function problems (seen in blood tests) and increased bilirubin in the blood (excreted by the liver)

Side effects uncommon (can affect up to 1 in 100 people) include:

• blood infection, urinary tract infection, skin infection, nasal and throat infections, fungal infections (including oral), flu, gastroenteritis, dental abscess
• lipoma (bumps under the skin)
• decrease in blood cells, including platelets, anemia (seen in blood tests)
• allergy
• diabetes, decrease in potassium in the blood, malnutrition, increase in triglycerides in the blood
• confusion, panic attacks, depression, reduced libido
• difficulty speaking, altered memory, loss of coordination of movements, balance disorders, fainting, nerve damage (neuropathy), and sensitivity problems
• blurred or double vision
• vertigo, ear pain
• irregular heartbeat and palpitations (arrhythmias), chest pain, and heart attack (myocardial infarction)
• deep vein thrombosis, high or low blood pressure, hot flashes, cold extremities, purple spots on the skin
• pulmonary embolism, pulmonary atelectasis, coughing up blood, asthma, difficulty breathing during exercise
• intestinal obstruction, accumulation of fluid in the abdomen, inflammation of the small or large intestine, stomach, or esophagus, lower abdominal pain, abdominal discomfort, acid reflux (food regurgitation from the stomach), blood in the stool
• jaundice (yellow skin and eyes)
• skin ulcers and blisters, skin reaction to sunlight, redness of the palms, swelling or pain in the face
• swelling or numbness in the joints, bone pain, muscle weakness or stiffness
• fluid accumulation in the kidneys, increased frequency of nighttime urination, incontinence, blood in the urine, increased creatinine in the blood (sign of kidney dysfunction)
• unusual vaginal bleeding
• swelling (edema), chills, and stiffness

Some of these side effects are more common when capecitabina is used with other cancer treatment medications. Other side effects observed in this setting are:

Side effects frequent (can affect up to 1 in 10 people) include:

• decrease in sodium, magnesium, or calcium in the blood, increased glucose
• nerve pain
• ringing in the ears (tinnitus), hearing loss
• venous inflammation
• hoarseness, voice change
• pain or altered 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 medications administered by injection at the same time)

Side effects rare (can affect up to 1 in 1,000 people) include:

• nasolacrimal duct obstruction (nasolacrimal duct stenosis)
• liver insufficiency
• inflammation that leads to dysfunction or obstruction of bile secretion (hepatitis colestásica)
• specific changes in the electrocardiogram (prolongation of QT)
• specific types of arrhythmias (including ventricular fibrillation, torsades de pointes, and bradycardia)
• inflammation of the eyes that causes eye pain and potential vision problems
• inflammation of the skin that causes red, scaly patches due to an autoimmune disease
• angioedema (inflammation mainly of the face, lip, tongue, or throat, itching, and rashes)

Side effects very rare (can affect up to 1 in 10,000 people), are:

• severe skin reactions such as skin rashes, ulcers, and blisters that may involve mouth, nose, genitals, hands, feet, and eyes (red, swollen eyes)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAnexo V.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date indicated on the packaging after CAD.

For aluminum/aluminum blister

This medication does not require any special storage conditions.

PVC/PVDC/aluminum (single-dose perforated blister)

Do not store above 30°C

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Capecitabina Accord

• The active ingredient is capecitabina

Each film-coated tablet contains 150 mg of capecitabina.

Each film-coated tablet contains 300 mg of capecitabina.

Each film-coated tablet contains 500 mg of capecitabina.

• The other components are:

Core tablet: anhydrous lactose, sodium croscarmellose, hypromellose, microcrystalline cellulose, magnesium stearate.

Coating of the tablet (for 150 mg): hypromellose, titanium dioxide (E171), yellow iron oxide and red iron oxide (E172), talc.

Coating of the tablet (for 300 mg): hypromellose, titanium dioxide (E171), talc.

Coating of the tablet (for 500 mg): hypromellose, titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc.

Appearance of the product and contents of the package

Capecitabina Accord 150 mg are film-coated tablets of light peach color, oblong, biconvex shape, 11.4 mm in length and 5.3 mm in width, with the mark “150” on one side and smooth on the other.

Capecitabina Accord 300 mg are film-coated tablets of white to bone color, oblong, biconvex shape, 14.6 mm in length and 6.7 mm in width, with the mark “300” on one side and smooth on the other.

Capecitabina Accord 500 mg are film-coated tablets of peach color, oblong, biconvex shape, 15.9 mm in length and 8.4 mm in width, with the mark “500” on one side and smooth on the other.

Capecitabina Accord is available in a blister pack containing 30, 60, or 120 film-coated tablets or in perforated blister packs containing 30 x 1, 60 x 1, or 120 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

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

Edifici Est 6th floor,

08039 Barcelona,

Spain

Responsible for Manufacturing

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex HA1 4HF

United Kingdom

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Last review date of this leaflet

The detailed information on this medicine is available on the European Medicines Agency websitehttp://www.ema.europa.eu.