Leaflet: information for the user

Capecitabina Kern Pharma 150 mg film-coated tablets

Capecitabina Kern Pharma 300mg film-coated tablets

Capecitabina Kern Pharma 500mg film-coated tablets

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 you, 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.

1. What isCapecitabina Kern Pharma and what it is used for

2. What you need to know before starting to takeCapecitabina Kern Pharma

3. How to takeCapecitabina Kern Pharma

4. Possible side effects

5. Storage ofCapecitabina Kern Pharma

6. Contents of the pack and additional information

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

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

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

Do not take Capecitabina Kern Pharma

• 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 excessive reaction to this medication.
• if you have previously experienced severe reactions to treatment with fluoropirimidina (a group of cancer medications 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 diseases or kidney problems,
• if you know that you have no activity of the dihydropirimidina deshidrogenasa (DPD) enzyme (complete DPD deficiency),
• if you are being treated or have been treated in the last 4 weeks with brivudina as part of the treatment for herpes zoster (shingles or herpes).

Warnings and precautions

Consult your doctor before starting to take capecitabina

• if you have liver or kidney diseases
• 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 heart blood flow problems.
• 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 you have diarrhea (see section 4)
• if you are dehydrated or become dehydrated.
• if you have blood ion imbalance (electrolyte imbalance, see blood tests)
• if you have a history of eye problems, as you will need additional eye monitoring.
• if you have a severe skin reaction.
• if you know that you have a partial deficiency of the dihydropirimidina deshidrogenasa (DPD) enzyme activity
• if you are a relative of a person with partial or complete deficiency of the dihydropirimidina deshidrogenasa (DPD) enzyme activity

DPD Deficiency: DPD deficiency is a genetic condition that is not usually related to health problems, unless you are being treated with certain medications. If you have a DPD deficiency and take capecitabina, 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. 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 is not indicated for children and adolescents. Do not administer this medication to children and adolescents.

Capecitabina Kern Pharma with other medications

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:

•gout medications (alopurinol),

•blood thinners (cumarina, warfarina),

•seizure or tremor medications (phenytoin),

•interferon alfa

•radiation therapy and certain cancer medications (folic acid, oxaliplatino, bevacizumab, cisplatino, irinotecán).

•medications used to treat folate deficiency.

Capecitabina Kern Pharma with food and drinks

You should take this medication before or 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 medication.

You should not take this medication if you are pregnant or think you may be.

You should not breastfeed your baby while taking this medication and for two weeks after the last dose.

If you are a woman who may become pregnant, you should use an effective contraceptive method during treatment with this medication and for six 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 this medication and for three months after the last dose.

Driving and using machines

When taking capecitabina, you may feel dizzy, nauseous, or tired. Therefore, this medication may affect your ability to drive vehicles or use machinery.

Capecitabina Kern Pharma contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him 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.

This medication should be prescribed only 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/m2 of body surface area twice a day (morning and night). Here are two examples: a person whose weight is 64 kg and measures 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 whose weight is 80 kg and measures 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 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 of 150 mg, 300 mg, and 500 mg for each dose.

• Take the tablets in the morning and at night, as prescribed by your doctor
• Take the tablets before 30 minutes have passed after finishing breakfast or dinner and swallow them whole with water.
• 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 agents, the usual dose in adults may be less than 1,250 mg/m2 of body surface area, and it may be necessary to take the tablets for a different period of time (for example, every day, without a rest period).

If you take more Capecitabina Kern Pharma 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 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).

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

If you forgot to take Capecitabina Kern Pharma

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

If you interrupt treatment with Capecitabina Kern Pharma

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

In the case of taking anticoagulant coumarins (containing, for example, acenocoumarol), the end of treatment with this medication 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, this medicine can cause side effects, although not everyone will experience them.

STOP taking this medicine 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 nighttime 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.
• Infection:if you have a temperature of 38°C or higher.
• 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.
• 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 early, these side effects usually improve within 2 or 3 days after stopping treatment. However, if these side effects continue, contact your doctor immediately. Your doctor may advise you to restart treatment with a lower dose.

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

Hand and foot rash 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 doctor immediatelywhen you start experiencing a side effect. Your doctor may advise you to reduce the dose and/or temporarily stop treatment with capecitabina. 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 skin sensation (tingling or numbness), taste alterations,

− eye irritation, increased tearing, conjunctivitis (redness of the eyes)

− venous inflammation (thrombophlebitis),

− difficulty breathing, nasal bleeding, cough, nasal discharge,

− herpes labialis or other herpes infections,

− respiratory or bronchial infections (e.g., pneumonia or bronchitis),

− intestinal hemorrhage, constipation, upper abdominal pain, indigestion, gas (flatulence), dry mouth,

− skin rashes, hair loss (alopecia), skin redness, dry skin, itching (pruritus), skin color changes, skin loss, skin inflammation, nail disorders,

− joint or limb pain, chest or back pain,

− fever, swelling in the extremities, feeling unwell

− liver function problems (seen in blood tests) and increased bilirubin in the blood (excreted by the liver).

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

− blood infection, urinary tract infection, skin infection, nasal and throat infections, fungal infections (including those in the mouth), flu, gastroenteritis, dental abscesses.

− skin inflammation (lipomas),

− decrease in blood cells, including platelets, dilution in 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, motor coordination loss, balance disorders, fainting, nerve damage (neuropathy), and sensitivity problems

− blurred vision or double vision,

− vertigo, ear pain.

− irregular heartbeats 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, exertional dyspnea,

− intestinal obstruction, abdominal fluid accumulation, small intestine or large intestine inflammation, stomach or esophagus inflammation, lower abdominal pain, abdominal discomfort, acid reflux (gastroesophageal reflux disease), bloody stools,

− jaundice (yellowing of the skin and eyes)

− skin ulcers and blisters, skin reaction to sunlight, hand redness, swelling, or pain in the face

− joint swelling or stiffness, bone pain, muscle weakness or stiffness,

− kidney fluid accumulation, increased 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 as follows:

Side effectsfrequent(can 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), hearing loss,

− venous inflammation,

− hoarseness, voice changes,

− pain or abnormal sensation in the mouth, jaw pain,

− sweating, night sweats,

− muscle spasms,

− difficulty urinating, blood or protein in the urine,

− injection site reactions (caused by the injection medications at the same time)

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

− nasolacrimal duct obstruction,

− liver failure,

− inflammation that leads to liver dysfunction or bile duct obstruction (hepatitis colestásica),

− specific changes in the electrocardiogram (prolongation of the QT interval),

− certain types of arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia),

− eye inflammation that causes eye pain and potential vision problems,

− skin inflammation that causes red, scaly patches due to an autoimmune disease.

− angioedema (swelling mainly of the face, lips, tongue, or throat, itching, and rashes)

Side effectsvery rare(can 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).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Composition of Capecitabina Kern Pharma

• The active ingredient is capecitabina.
• • Each film-coated tablet of Capecitabina Kern Pharma 150mg contains 150 mg of capecitabina.
  • Each film-coated tablet of Capecitabina Kern Pharma 300mg contains 300 mg of capecitabina.
  • Each film-coated tablet of Capecitabina Kern Pharma 500mg contains 500 mg of capecitabina.
• The other components for the 150 mg and 500 mg doses are:

• Core of the tablet: anhydrous lactose, microcrystalline cellulose (E460), sodium croscarmellose, hypromellose, and magnesium stearate.
• Coating: talc, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

• The other components for the 300 mg dose are:

• Core of the tablet: anhydrous lactose, microcrystalline cellulose (E460), sodium croscarmellose, hypromellose, and magnesium stearate.
• Coating: talc, hypromellose, dióxido de titanio (E171),

Appearance of the product and contents of the package

Capecitabina Kern Pharma 150 mg:

Are film-coated tablets of light orange color, oblong and biconvex.

They are presented in blister packs (aluminum/aluminum or PVC/PVDC/aluminum) containing 60 film-coated tablets.

Capecitabina Kern Pharma 300 mg:

− Are film-coated tablets of white or almost white color, oblong and biconvex, with the mark “300” on one side and smooth on the other.

− They are presented in blister packs (aluminum/aluminum or PVC/PVDC/aluminum) containing 60 film-coated tablets.

Capecitabina Kern Pharma 500 mg:

− Are film-coated tablets of orange color, oblong and biconvex.

− They are presented in blister packs (aluminum/aluminum or PVC/PVDC/aluminum) containing 120 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review of this prospectus was in: April 2021

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