CAPECITABINE KERN PHARMA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Capecitabine Kern Pharma 150 mg film-coated tablets EFG

Capecitabine Kern Pharma 300mg film-coated tablets EFG

Capecitabine Kern Pharma 500mg film-coated tablets EFG

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

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Capecitabine Kern Pharma is and what it is used for
2. What you need to know before you take Capecitabine Kern Pharma
3. How to take Capecitabine Kern Pharma
4. Possible side effects
5. Storage of Capecitabine Kern Pharma
6. Contents of the pack and other information

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

Capecitabine Kern Pharma belongs to a group of medicines called “cytostatics” which stop the growth of cancer cells. Capecitabine Kern Pharma contains capecitabine, and by itself is not a cytostatic medicine. Only after being absorbed into the body does it change into an anti-cancer medicine (more in tumor tissue than in normal tissue).

Capecitabine Kern Pharma is used for the treatment of colon, rectal, stomach, or breast cancer. Additionally, Capecitabine Kern Pharma is used to prevent the return of colon cancer after the complete removal of the tumor through surgery.

Capecitabine Kern Pharma can be used alone or in combination with other medicines.

2. What you need to know before taking Capecitabine Kern Pharma

Do not take Capecitabine Kern Pharma

• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You should inform your doctor if you have any type of allergy or exaggerated reaction to this medicine.
• if you have previously had severe reactions to fluoropyrimidine treatment (a group of cancer medicines like 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 or kidney disease,
• if you know you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (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 chickenpox).

Warnings and precautions

Consult your doctor before starting to take capecitabine

• if you have liver or kidney disease
• if you have or have had heart problems (e.g. irregular heartbeat) or chest and back pain caused by physical exertion and due to problems with blood flow in the heart.
• if you have brain diseases (e.g. cancer that has spread to the brain or nerve damage (neuropathy))
• if you have a 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 an electrolyte imbalance in your blood (electrolyte imbalance, see blood tests)
• If you have a history of eye problems, as you will need additional monitoring of your eyes.
• If you have a severe skin reaction.
• if you know you have a partial deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you are a relative of a person with a partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)

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 capecitabine, you will have a higher risk of experiencing severe side effects (indicated in section 4, Possible side 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 capecitabine. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe a reduced dose. Although the results of the test for DPD deficiency are negative, severe and potentially fatal side effects may still occur.

Children and adolescents

Capecitabine is not indicated in children and adolescents. Do not give this medicine to children and adolescents.

Taking Capecitabine Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is very important, as taking more than one medicine at the same time can increase or decrease their effects.

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

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

Taking Capecitabine Kern Pharma with food and drinks

You should take this medicine within 30 minutes after finishing a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 this medicine if you are pregnant or think you may be pregnant.

You should not breastfeed while taking this medicine and for 2 weeks after the last dose.

If you are a woman who could become pregnant, you must use a reliable method of contraception during treatment with this medicine and for 6 months after the last dose.

If you are a male patient and your female partner could become pregnant, you must use a reliable method of contraception during treatment with this medicine and for 3 months after the last dose.

Driving and using machines

While taking capecitabine, you may feel dizzy, nauseous, or tired. Therefore, this medicine may affect your ability to drive or use machines.

Capecitabine Kern Pharma contains lactose

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

3. How to take Capecitabine Kern Pharma

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

This medicine should only be prescribed by a doctor with experience in the use of cancer medicines.

Your doctor will prescribe a treatment schedule and the correct dose for you. The dose of capecitabine 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 evening). 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 dose you need to take, when you should take it, and for how long you need to take it.

Your doctor may tell you to take a combination of 150 mg, 300 mg, and 500 mg tablets for each dose.

• Take the tablets in the morning and evening, as prescribed by your doctor
• Take the tablets within 30 minutes after finishing a meal and swallow them whole with water.
• It is important that you take all your medication as prescribed by your doctor.

Capecitabine tablets are usually taken for 14 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 (e.g. every day, without a rest period).

If you take more Capecitabine Kern Pharma than you should

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

You may have the following side effects if you take much more capecitabine than you should: feel dizzy or vomit, diarrhea, inflammation or ulceration of the intestine or mouth, pain or bleeding in the intestine or stomach, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Capecitabine Kern Pharma

Do not take a double dose to make up for forgotten doses. Instead, continue your usual dosing schedule and consult your doctor.

If you stop taking Capecitabine Kern Pharma

Stopping treatment with capecitabine does not produce side effects.

In case you are taking anticoagulant medicines (e.g. containing acenocoumarol), stopping treatment with this medicine may require your doctor to adjust the dose of the anticoagulant.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

STOPtaking this medicine immediately and contact your doctor if any of these symptoms appear:

• Diarrhea: if you have an increase of 4 or more bowel movements compared to your normal daily bowel movements 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 ulcers in the mouth and/or throat.
• Skin Reaction on Hands and Feet: if you have pain, swelling, and redness or tingling of 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 the 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 start to appear on the mucous membrane (e.g., mouth and lips), particularly if you have had previous 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 swallowing or breathing difficult, itching, and rashes. It could be a sign of angioedema.

If detected early, these adverse effects usually improve 2 or 3 days after treatment is interrupted. However, if these adverse effects continue, contact your doctor immediately. Your doctor may advise you to restart treatment with a lower dose.

If severe stomatitis (ulcers in the mouth and/or throat), mucosal inflammation, diarrhea, neutropenia (increased risk of infections), or neurotoxicity occur during the first treatment cycle, there may be a DPD deficiency (see section 2: Warnings and Precautions).

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

In addition to the above, when capecitabine is used alone, the most common adverse effects that may affect more than 1 in 10 people are:

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

These adverse effects can be serious; therefore, always contact your doctor immediatelywhen you start to feel an adverse effect. Your doctor may advise you to reduce the dose and/or temporarily stop treatment with capecitabine. This will help reduce the likelihood of the adverse effect continuing or becoming serious.

Other adverse effects are:

Adverse effects frequent(may affect up to 1 in 10 people) include:

• decrease in the number of white or red blood cells (observed in tests)
• dehydration, weight loss,
• sleeplessness (insomnia), depression,
• headache, drowsiness, dizziness, abnormal sensation in the skin (tingling or numbness), taste disorders,
• eye irritation, increased tearing, redness of the eyes (conjunctivitis)
• inflammation of the veins (thrombophlebitis),
• difficulty breathing, nosebleeds, cough, runny nose,
• herpes labialis or other herpes infections,
• infections of the lungs or respiratory tract (e.g., pneumonia or bronchitis),
• intestinal bleeding, constipation, pain in the upper abdomen, indigestion, gas (increased flatulence), dry mouth,
• skin rashes, hair loss (alopecia), redness of the skin, dry skin, itching (pruritus), skin color change, skin loss, skin inflammation, nail disorders,
• pain in the joints or limbs, chest, or back,
• fever, swelling in the limbs, feeling of discomfort
• liver function problems (seen in blood tests) and increased bilirubin in the blood (excreted by the liver).

Adverse effects infrequent(may affect up to 1 in 100 people) include:

• blood infection, urinary tract infection, skin infection, infections of the nose and throat, fungal infections (including those of the mouth), flu, gastroenteritis, dental abscesses.
• skin inflammation (lipomas),
• decrease in blood cells, including platelets, dilution in blood (seen in tests)
• allergies,
• diabetes, decrease in potassium in the blood, malnutrition, increase in triglycerides in the blood,
• confusion, panic attacks, depression, decreased libido,
• difficulty speaking, memory problems, loss of motor coordination, balance disorders, fainting, nerve damage (neuropathy), and sensitivity problems
• blurred or double vision,
• vertigo, ear pain.
• irregular heartbeats and palpitations (arrhythmias), chest pain, and heart attack (infarction),
• blood clots in deep veins, high or low blood pressure, hot flashes, cold limbs, purple spots on the skin
• blood clots in the pulmonary veins (pulmonary embolism), lung collapse, coughing up blood, asthma, exertional dyspnea,
• intestinal obstruction, fluid accumulation in the abdomen, inflammation of the small or large intestine, stomach, or esophagus, pain in the lower abdomen, abdominal discomfort, acid reflux (food regurgitation from the stomach), blood in the stool,
• jaundice (yellowing of the skin and eyes)
• skin ulcers and blisters, skin reaction to sunlight, redness of the palms, swelling, or pain in the face
• swelling of the joints or stiffness, bone pain, weakness, or muscle stiffness,
• fluid accumulation in the kidneys, increased frequency of urination at night, incontinence, blood in the urine, increased creatinine in the blood (sign of renal dysfunction)
• unusual vaginal bleeding
• swelling (edema), chills, and stiffness.

Some of these adverse effects are more frequent when capecitabine is used with other cancer medications. Other adverse effects observed in this setting are the following:

Adverse effects frequent(may affect up to 1 in 10 people) include:

• decrease in sodium, magnesium, or calcium in the blood, increase in blood sugar,
• neuropathic pain,
• ringing or buzzing in the ears (tinnitus), 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,

bruises or reactions at the injection site (caused by injectable medications at the same time)

Adverse effects rare(may affect up to 1 in 1,000 people) include:

• narrowing or obstruction of the tear duct (stenosis of the tear duct),
• liver failure,
• inflammation leading to dysfunction or obstruction of bile secretion (cholestatic hepatitis),
• specific changes in the electrocardiogram (QT interval prolongation),
• certain types of arrhythmias (including ventricular fibrillation, torsades de pointes, and bradycardia),
• eye inflammation causing eye pain and possible vision problems,

skin inflammation causing red scaly patches due to an immune system disease.

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

Adverse effects very rare(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 and swollen eyes).

Reporting Adverse Effects

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

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

5. Storage of Capecitabina Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Capecitabina Kern Pharma

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

• Tablet core: 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 300mg dose are:

• Tablet core: anhydrous lactose, microcrystalline cellulose (E460), sodium croscarmellose, hypromellose, and magnesium stearate.
• Coating: talc, hypromellose, titanium dioxide (E171),

Product Appearance and Package Contents

Capecitabina Kern Pharma 150mg:

They are film-coated tablets of light peach color, oblong, and biconvex.

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

Capecitabina Kern Pharma 300mg:

• They are film-coated tablets of white or almost white color, oblong, 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 500mg:

• They are film-coated tablets of peach color, oblong, and biconvex.
• They are presented in blister packs (aluminum/aluminum or PVC/PVDC/aluminum) containing 120 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This prospectus was last revised in: April 2021

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