Prospecto:Information for the User

Capecitabina Glenmark 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 your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

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

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

Do not take Capecitabina Glenmark:

• if you are allergic to capecitabina or any of the other ingredients of this medicine (listed in section 6). Inform your doctor if you have any type of allergy or exaggerated 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 (chickenpox or herpes).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• if you know that you have a partial deficiency of activity of the dihydropyrimidine dehydrogenase (DPD) enzyme,
• if you have a family member who has a partial or complete deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme,
• if you have liver or kidney disease,
• if you have or have had heart problems, for example, an 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 become dehydrated,
• if you have electrolyte imbalance in the blood (electrolyte imbalance, 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.

DPD Deficiency

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, you have a higher risk of 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, do not take Capecitabina Glenmark. 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, severe or potentially fatal adverse effects may occur.

Children and adolescents

Capecitabina is not indicated in children and adolescents. Do not administer Capecitabina to children and adolescents.

Use of Capecitabina Glenmark with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.This is very important, as taking more than one medicine at a time may potentiate 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 to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Taking Capecitabina Glenmark with food and drinks

You should take this medicine before eating or within 30 minutes after eating.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine. Do not take this medicine if you are pregnant or think you may be.

Do not breastfeed your baby while taking this medicine and for 2 weeks after the last dose.

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

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

Driving and operating machines

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

Capecitabina Glenmark contains lactose anhydrous

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

Capecitabina Glenmark contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 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 exactly as prescribed by your doctor or pharmacist.Consult your doctor or pharmacist in case of doubt.

Capecitabina should only be prescribed by a doctor with experience in the use of cancer medications.

Your doctor will prescribe a treatment schedule and correct dose for you. The dose of capecitabina 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 2.0 m2, so they should take 5 tablets of 500 mg twice a day.

Your doctor will tell you how much 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.

• Take the tablets in the morning and at night, as prescribed by your doctor.
• Take the tablets within 30 minutes after finishing breakfast or dinner and swallow them whole with water. Do not crush or divide the tablets. If you cannot swallow the Capecitabina Glenmark tablets whole, tell your healthcare professional.
• It is essential that you take all your medication as prescribed by your doctor.

Capecitabina tablets are usually administered for 14 consecutive days followed by a 7-day rest period (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 you may need to take the tablets for a different period of time (e.g., every day, without a rest period).

If you take more Capecitabina Glenmark than you should

If you take more capecitabina 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 more capecitabina than you should: feeling unwell, diarrhea, inflammation or ulcers in the stomach or mouth, abdominal or stomach pain or bleeding, or bone marrow depression (decrease in certain types of blood cells). Inform your doctor immediately if you experience any of these symptoms.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Capecitabina Glenmark

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 Glenmark

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

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

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

STOP taking Capecitabina Glenmark immediately and contact your doctor if you experience any of the following symptoms:

• 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 significantly less than usual.
• Stomatitis: if you have pain, redness, swelling, or sores in your mouth and/or throat.
• Hand and foot reaction: 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), particularly if you have had sensitivity to light, respiratory infections (e.g., bronchitis), and/or fever.
• 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.

Detected early, these side effects usually improve within 2 to 3 days of stopping treatment. However, if these side effects continue, contact your doctor immediately. Your doctor may advise you to resume 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 deficiency of DPD (see Section 2: Warnings and precautions).

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

Aside from the above, when this medicine is used alone, the very common side effects that can affect more than 1 in 10 people are:

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

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

Other side effects are:

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

• decrease in the number of white or red blood cells (see blood tests)
• dehydration, weight loss
• insomnia, depression
• headache, drowsiness, dizziness, strange 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 labialis or infections by other herpes
• respiratory or airway infections (e.g., pneumonia or bronchitis)
• intestinal hemorrhage, constipation, upper abdominal pain, indigestion, gas (flatulence), dry mouth
• hives on the skin, hair loss (alopecia), redness of the skin, dry skin, itching (pruritus), skin color change, skin loss, skin inflammation, nail disorders
• joint pain, pain in the extremities, chest, or back
• fever, swelling of the extremities, feeling unwell
• liver function problems (seen in blood tests) and increased bilirubin in the blood (excreted by the liver)

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

• blood infection, urinary tract infection, skin infection, nasal and throat infection, fungal infections (including those in the mouth), flu, gastroenteritis, dental abscesses
• skin inflammation (lipomas)
• decrease in white 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 sensory 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
• pulmonary 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 (reflux of food from the stomach), 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
• swelling of the joints or stiffness, bone pain, muscle weakness or stiffness
• fluid accumulation in the kidneys, 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

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

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

• decrease in sodium, magnesium, or calcium in the blood, increased blood sugar
• neuropathic pain
• tinnitus or ringing in the ears, hearing loss
• inflammation of the veins
• 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 reactions at the injection site (caused by medications administered by injection at the same time)

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

• nasolacrimal duct obstruction or narrowing
• liver failure
• inflammation leading to liver dysfunction or obstruction in bile secretion (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 (can affect up to 1 in 10,000 people) include:

• 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)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the blister packafter CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofpackaging and unusedmedicines. In this way, you will help protect the environment.

Composition of Capecitabina Glenmark

The active ingredient is capecitabina. Each film-coated tablet contains 500 mg of capecitabina.

The other components are:

• Core tablet: anhydrous lactose (see section 2), microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate.
• Film coating: hypromellose, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and content of the container

Film-coated tablet, dark pink, capsule-shaped, biconvex, 16.0 mm in length and 8.5 mm in width, with the mark “CAP” on one side and “500” on the other.

Capecitabina Glenmark film-coated tablets are available in PVC/PVdC/aluminum blisters in transparent containers.

Container sizes:

Blister container: 120 film-coated tablets (12 blisters of 10 film-coated tablets)

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible manufacturer:

Apis labor GmbH

Resslstraße 9,

Ebenthal in Kärnten, 9065,

Austria.

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

DenmarkCapecitabin Zentiva 500 mg filmovertukne tabletter

GermanyCapecitabin Glenmark 500 mg Filmtabletten

SpainCapecitabina Glenmark 500 mg comprimidos recubiertos con película EFG

SwedenCapecitabin Zentiva 500 mg filmdragerade tabletter

Last review date of thisleaflet: May 2021.

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)