Prospecto:Information for the User

Capecitabina Normon 500 mg Film-Coated Tablets

capecitabina

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospectus. See section 4.

1.What is Capecitabina Normon and what it is used for

2.What you need to knowbeforestarting totake Capecitabina Normon

3.How to take Capecitabina Normon

4.Possible adverse effects

5Storage of Capecitabina Normon

6.Contents of the pack and additional information

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

Capecitabinais used for the treatment of colon cancer, rectal cancer, gastric cancer, or breast cancer. Additionally, it is used to prevent the reappearance of colon cancer after complete tumor removal through surgery.

Capecitabinacan be used alone or in combination with other medications.

Do not take Capecitabina Normon

• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). Inform your doctor if you have any type of allergy or severe reaction to this medicine,
• if you have previously experienced severe reactions to treatment with fluoropyrimidines (a group of cancer medicines such as fluorouracil),
• if you are pregnant or breastfeeding,
• if you have very low levels of white blood cells or platelets in your blood (leucopenia, neutropenia, or thrombocytopenia),
• if you have severe liver disease or 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 Normon

• if you know that you have a partial deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme activity,
• if you have a family member who has a partial or complete deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme activity,
• if you have liver or kidney problems,
• if you have heart problems, for example, irregular heartbeat or chest and back pain caused by physical effort and due to problems with blood flow to the heart,
• if you have brain diseases (for example, cancer that has spread to the brain, or nerve damage (neuropathy)),
• if you have calcium imbalance (see blood tests),
• if you have diabetes,
• if due to nausea and vomiting you are unable to retain food or water in your body,
• if you have diarrhea,
• if you are dehydrated or at risk of dehydration,
• if you have electrolyte imbalance in the blood (see blood tests),
• if you have a history of eye problems, as you will need extra eye follow-up,
• if you have a severe skin reaction.

Dihydropyrimidine dehydrogenase (DPD) deficiency

The DPD deficiency is a genetic condition that is not usually related to health problems, unless you are being treated with certain medicines. If you have a DPD deficiency and take Capecitabina Normon, you 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 do not have enzyme activity, you should not take Capecitabina Normon. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe a reduced dose. Although the results of the DPD deficiency test are negative, you may still experience severe or potentially fatal adverse effects.

Children and adolescents

Capecitabina Normon is not indicated for children and adolescents. Do not administer Capecitabina Normon to children and adolescents.

Other medicines and Capecitabina Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

This is very important, as taking more than one medicine at a time may enhance or weaken their effects.

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

• medicines for gout (allopurinol),
• medicines to reduce blood clotting (warfarin, coumarin),
• medicines for seizures or tremors (phenytoin),
• interferon alpha,
• radiation therapy and certain medicines used for cancer treatment (folic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folate deficiency.

Taking Capecitabina Normon with food and drinks

You should take Capecitabina Normon before eating, within 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 taking this medicine.You should not take Capecitabina Normon if you are pregnant or think you may be pregnant. Do not breastfeed your baby while taking Capecitabina Normon 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 Normon 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 Normon and for 3 months after the last dose.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

When taking Capecitabina Normon, you may feel dizzy, nauseous, or tired. Therefore, Capecitabina Normon may affect your ability to drive vehicles or operate machines.

Capecitabina Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be administered only under the guidance of a doctor with experience in the use of cancer medications.

Your doctor will prescribe a treatment schedule and correct dosage for you. The dosage of capecitabina depends on your body surface area. This is calculated by measuring your height and weight. The usual dosage for adults is 1250 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 2.0 m2, so they should take 5 tablets of 500 mg twice a day.

Your doctor will tell you what dosage 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 150 mg and 500 mg tablets for each dose.

The tablets are usually administered 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 dosage in adults may be less than 1250 mg/m2of body surface area, and it may be necessary to take the tablets for a different period of time (e.g., every day, without a break).

If you take more Capecitabina Normon than you should

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

You may experience the following adverse effects if you take more capecitabina than you should: feeling unwell, diarrhea, inflammation or ulcers in the stomach or mouth, pain or bleeding in the intestine or stomach, or bone marrow depression (decrease in certain types of blood cells).

Inform your doctor immediately if you experience any of these symptoms.

If you forgot to take Capecitabina Normon

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

If you interrupt treatment with Capecitabina Normon

Stopping treatment with capecitabina does not produce adverse effects. If you are taking anticoagulant medications (such as acenocoumarol), stopping treatment with capecitabina may require your doctor to adjust the dosage of the anticoagulant.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking CapecitabinaNormonimmediately and contact your doctor if any of the following symptoms appear:

• Diarrhea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements per day or have nocturnal diarrhea.
• 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 your mouth and/or throat.
• Hand and foot rash: if you have pain, swelling, and redness or tingling in your hands and/or feet.
• Fever:if you have a temperature of 38°C or higher.
• Infection: if you have signs of infection caused by bacteria or viruses or other organisms.
• Chest pain:if you have localized pain in the center of your chest, especially if it occurs while exercising.
• Steven-Johnson syndrome: if you have painful, red, or purple rashes that spread and blisters and other lesions that appear on mucous membranes (e.g., mouth and lips), especially if you have had sensitivity to light, respiratory infections (e.g., bronchitis), and/or fever before.
• 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. It could be a sign of angioedema.

If detected in time, these side effects usually improve within 2-3 days after stopping treatment. However, if these side effects continue, contact your doctor immediately. Your doctor may instruct you to restart treatment with a lower dose.

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

The hand and foot rash can lead to fingerprint loss, which can affect your identification through fingerprint analysis.

In addition to the above, when CapecitabinaNormonis used alone, the very common side effects that may affect more than 1 in 10 people are:

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

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

Other side effects are:

Common side effects (may affect up to 1 in 10 people) include:

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

Uncommon side effects (may affect up to 1 in 100 people) include:

• blood infection, urinary tract infection, skin infection, nasal and throat infection, fungal infections (including oral infections), flu, gastroenteritis, dental abscesses
• skin inflammation (lipomas)
• decrease in blood cells, including platelets, dilution of the blood (seen in blood tests)
• allergies
• diabetes, decreased potassium in the blood, malnutrition, increased triglycerides in the blood
• confusion, panic attacks, depression, decreased libido
• difficulty speaking, memory problems, loss of motor coordination, balance disorder, fainting, nerve damage (neuropathy), and sensation 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 skin patches
• lung embolism, pulmonary collapse, coughing up blood, asthma, shortness of breath
• intestinal obstruction, abdominal fluid accumulation, inflammation of the small or large intestine, stomach, or esophagus, lower abdominal pain, abdominal discomfort, acid reflux (gastroesophageal reflux disease), bloody stools
• jaundice (yellowing of the skin and eyes)
• skin ulcers and blisters, sun reaction, redness of the palms, swelling or pain in the face
• joint swelling or stiffness, bone pain, muscle weakness or stiffness
• kidney fluid accumulation, increased frequency of urination at night, incontinence, blood in the urine, increased creatinine in the blood (sign of kidney dysfunction)
• unusual vaginal bleeding
• swelling (edema), chills, and stiffness

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

• nasolacrimal duct stenosis or obstruction.
• hepatic failure.
• inflammation leading to liver dysfunction or obstruction (hepatitis colestásica).
• specific changes in the electrocardiogram (prolongation of the QT interval).
• specific types of arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia).
• eye inflammation causing eye pain and possible vision problems.
• skin inflammation causing red, scaly patches due to an autoimmune disease.
• Angioedema (swelling mainly of the face, lips, tongue, or throat, itching, and rashes)

Very rare side effects (may affect up to 1 in 10,000 people) are:

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

Some of these side effects are more frequent when capecitabina is used with other cancer medications. Other side effects observed are:

Common side effects (may affect up to 1 in 10 people) include:

• decrease in sodium, magnesium, or calcium in the blood, increased blood sugar
• neuropathic pain
• tinnitus (ringing in the ears) or hearing loss
• phlebitis (inflammation of the veins)
• hoarseness, voice change
• mouth or jaw pain
• sweating, night sweats
• muscle spasms
• difficulty urinating, blood or protein in the urine
• bruising or reactions at the injection site (caused by medications administered by injection at the same time)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do notstoreata temperatureabove30ºC.

Do notusethismedicationaftertheexpiration datethatappearsonthecontainerandonthelabelafterCAD.Theexpiration dateisthelastdayofthemonthindicated.

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Capecitabina Normon

• The active ingredient is capecitabine. Each film-coated tablet contains 500 mg of capecitabine.
• The other components (excipients) are:
• • Tablet core: anhydrous lactose, sodium croscarmellose (E468), hypromellose (E464), microcrystalline cellulose (E460), magnesium stearate.
  • Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), yellow, red, and black iron oxide (E172), talc, and polyethylene glycol/macrogol.

Appearance of the product and contents of the packaging

Capecitabina Normon are film-coated tablets. The tablets are orange in color and oblong in shape. Each package contains 120 film-coated tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Capecitabina Normon 500 mg film-coated tablets EFG

Portugal: Capecitabina Normon 500 mg film-coated tablets

Last review date of this prospectus: October 2021

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es