Capecitabine Kern Pharma 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Capecitabine Kern Pharma 150 mg film-coated tablets EFG

Capecitabine Kern Pharma 300 mg film-coated tablets EFG

Capecitabine Kern Pharma 500 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Capecitabina Kern Pharma belongs to a group of medicines known as "cytostatic agents", which stop the growth of cancer cells. Capecitabina Kern Pharma contains the active substance capecitabine, which is not itself a cytostatic drug. It only becomes an anticancer medicine after being absorbed by the body, and this conversion occurs more in tumour tissue than in normal tissue.

Capecitabina Kern Pharma is used to treat colon, rectal, gastric, and breast cancer. In addition, Capecitabina Kern Pharma is used to help prevent the recurrence of colon cancer after complete surgical removal of the tumour.

Capecitabina Kern Pharma may 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 to any of the other ingredients of this medicine (listed in section 6). You must 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 anticancer 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 you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency),
• if you are being treated or have been treated within the last 4 weeks with brivudine as part of treatment for herpes zoster (shingles or herpes).

Warnings and precautions

Talk to your doctor before starting capecitabine

• if you have liver or kidney disease
• if you have or have had heart problems (for example, irregular heartbeat) or chest and back pain triggered by physical exertion due to problems with blood flow in the heart.
• if you have brain disorders (for example, cancer that has spread to the brain) or nerve damage (neuropathy)
• if you have calcium imbalance (seen in blood tests)
• if you have diabetes
• if you have diarrhea (see section 4)
• if you are dehydrated or become dehydrated
• if you have an imbalance of ions in your blood (electrolyte imbalance, see blood tests)
• if you have a history of eye problems, as you may require additional eye monitoring
• if you have a severe skin reaction
• if you know you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you are a relative of someone with partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)

DPD deficiency: DPD deficiency is a genetic condition that usually does not cause health problems unless you are being treated with certain medicines. If you have DPD deficiency and take capecitabine, you have a higher risk of experiencing serious adverse effects (listed in section 4, Possible side effects). It is recommended that you be tested for DPD deficiency before starting treatment. If you have no enzyme activity, you must not take capecitabine. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe a reduced dose. Even if the test results for DPD deficiency are negative, serious and potentially life-threatening adverse effects may still occur.

Children and adolescents

Capecitabine is not indicated for use in children and adolescents. Do not administer this medicine to children or adolescents.

Taking Capecitabine Kern Pharma with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is very important, as taking more than one medicine at the same time may 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),
• alpha interferon,
• radiotherapy and certain medicines used in cancer treatment (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Taking Capecitabine Kern Pharma with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take this medicine if you are pregnant or think you might be pregnant.

You must not breastfeed while taking this medicine and for two weeks after the last dose.

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

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

Driving and using machines

When taking capecitabine, you may feel dizzy, nauseous, or tired. Therefore, this medicine may affect your ability to drive vehicles or operate machinery.

Capecitabine Kern Pharma contains lactose

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

3. How to take Capecitabine Kern Pharma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, please consult your doctor or pharmacist again.

This medicine should only be prescribed by a physician experienced in the use of anticancer drugs.

Your doctor will prescribe the appropriate treatment schedule and dosage for you. The dose of capecitabine depends on your body surface area, which is calculated based on your height and weight. The usual dose for adults is 1,250 mg/m² of body surface area twice daily (morning and evening). Below are two examples: a person weighing 64 kg and measuring 1.64 m has a body surface area of 1.7 m² and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice daily. A person weighing 80 kg and measuring 1.80 m has a body surface area of 2.0 m² and should take 5 tablets of 500 mg twice daily.

Your doctor will tell you the exact dose you need to take, when to take it, and for how long you should continue treatment.

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 in the evening, as prescribed by your doctor.
• Take the tablets within 30 minutes after finishing breakfast or dinner, swallowing them whole with water.
• It is important that you take your medication exactly as prescribed by your doctor.

Capecitabine tablets are generally administered for 14 consecutive days, followed by a 7-day rest period (during which no tablets are taken). This 21-day period constitutes one treatment cycle.

When used in combination with other agents, the usual adult dose may be less than 1,250 mg/m² of body surface area, and you may be required to take the tablets for a different duration (e.g., daily without a rest period).

If you take more Capecitabine Kern Pharma than you should

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

You may experience the following adverse effects if you take much more capecitabine than recommended: dizziness, vomiting, diarrhea, intestinal or oral inflammation or ulcers, pain or bleeding in the intestine or stomach, or bone marrow suppression (reduction in certain types of blood cells).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine taken and the amount ingested.

If you forget to take Capecitabine Kern Pharma

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

If you stop treatment with Capecitabine Kern Pharma

Stopping treatment with capecitabine does not cause adverse effects.

However, if you are taking coumarin anticoagulants (e.g., containing acenocoumarol), discontinuation of this medicine may require your doctor to adjust your anticoagulant dose.

If you have any further 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 everyone experiences them.

STOP taking this medicine immediately and contact your doctor if any of the following symptoms occur:

• Diarrhea: if you have 4 or more additional bowel movements than your normal daily number, or if you have nocturnal diarrhea.
• Vomiting: if you vomit more than once within a 24-hour period.
• Nausea: if you lose your appetite and the amount of food you eat daily is much less than usual.
• Stomatitis: if you have pain, redness, swelling, or sores in the mouth and/or throat.
• Hand-foot skin reaction: if you have pain, swelling, redness, or tingling in the hands and/or feet.
• Infection: if you have a temperature of 38°C or higher.
• Chest pain: if you have pain located in the center of the chest, especially if it occurs during physical exertion.
• Stevens-Johnson syndrome: if you develop painful red or purple rashes that spread, blisters, and other lesions beginning to appear on mucous membranes (e.g., mouth and lips), particularly if you previously experienced light sensitivity, respiratory tract 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 affecting the face, lips, tongue, or throat making it difficult to swallow or breathe, itching, and rashes. These could be signs of angioedema.

If detected early, these adverse effects usually improve within 2 to 3 days after stopping treatment. However, if these adverse effects persist, contact your doctor immediately. Your doctor may advise restarting treatment at a lower dose.

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

The hand-foot skin reaction may lead to loss of fingerprint, which could affect your 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 reactions, dry skin, or itching,
• fatigue,
• loss of appetite (anorexia).

These adverse effects can be serious; therefore, always contact your doctor immediately when you start experiencing any adverse effect. Your doctor may advise reducing the dose and/or temporarily stopping treatment with capecitabine. This will help reduce the likelihood of the adverse effect continuing or becoming severe.

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people) include:

• decrease in white or red blood cell count (observed in blood tests),
• dehydration, weight loss,
• insomnia, depression,
• headache, drowsiness, dizziness, abnormal skin sensations (tingling or numbness), taste disturbances,
• eye irritation, increased tearing, eye redness (conjunctivitis),
• vein inflammation (thrombophlebitis),
• difficulty breathing, nosebleeds, cough, nasal discharge,
• cold sores or other herpes infections,
• lung or respiratory tract infections (e.g., pneumonia or bronchitis),
• intestinal bleeding, constipation, upper abdominal pain, indigestion, gas (increased flatulence), dry mouth,
• skin rashes, hair loss (alopecia), skin redness, dry skin, itching (pruritus), skin color changes, skin peeling, skin inflammation, nail disorders,
• joint or limb pain, chest or back pain,
• fever, swelling in limbs, feeling unwell,
• liver function problems (seen in blood tests) and increased blood bilirubin (excreted by the liver).

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

• blood infection, urinary tract infection, skin infection, nose and throat infections, fungal infections (including oral), flu, gastroenteritis, dental abscesses,
• skin inflammation (lipomas),
• reduction in blood cells including platelets, blood dilution (seen in blood tests),
• allergies,
• diabetes, low blood potassium, malnutrition, increased blood triglycerides,
• confusion, panic attacks, depression, decreased libido,
• difficulty speaking, memory problems, loss of motor coordination, balance disorders, fainting, nerve damage (neuropathy), and sensory problems,
• blurred or double vision,
• dizziness, ear pain,
• irregular heartbeat and palpitations (arrhythmias), chest pain, heart attack (infarction),
• formation of blood clots in deep veins, high or low blood pressure, hot flushes, cold extremities, purple spots on the skin,
• formation of 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, lower abdominal pain, abdominal discomfort, acid reflux (stomach contents regurgitating), blood in stools,
• jaundice (yellowing of the skin and eyes),
• skin ulcers and blisters, skin reaction to sunlight, redness of the palms, facial swelling or pain,
• joint swelling or stiffness, bone pain, muscle weakness or stiffness,
• fluid accumulation in the kidneys, increased frequency of urination at night, incontinence, blood in urine, elevated blood creatinine (a sign of kidney dysfunction),
• unusual vaginal bleeding,
• swelling (edema), chills, and stiffness.

Some of these adverse effects are more common when capecitabine is used together with other cancer treatments. Other adverse effects observed in this setting include:

Frequent adverse effects (may affect up to 1 in 10 people) include:

• decreased sodium, magnesium, or calcium in blood, increased blood sugar,
• neuropathic pain,
• ringing or buzzing in the ears (tinnitus), hearing loss,
• vein inflammation,
• hiccups, voice changes,
• mouth pain or altered/abnormal sensation, jaw pain,
• sweating, night sweats,
• muscle spasms,
• difficulty urinating, blood or protein in urine,
• bruising or injection site reactions (caused by co-administered injectable medicines).

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

• narrowing or blockage of the tear duct (lacrimal duct stenosis),
• liver failure,
• inflammation leading to dysfunction or obstruction of bile secretion (cholestatic hepatitis),
• specific changes in the electrocardiogram (prolongation of the QT interval),
• certain types of arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia),
• eye inflammation causing eye pain and possible vision problems,
• skin inflammation causing scaly red patches due to an autoimmune disease.

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

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Capecitabine Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Capecitabine Kern Pharma

• The active substance is capecitabine.

  • Each film-coated tablet of Capecitabine Kern Pharma 150 mg contains 150 mg of capecitabine.
  • Each film-coated tablet of Capecitabine Kern Pharma 300 mg contains 300 mg of capecitabine.
  • Each film-coated tablet of Capecitabine Kern Pharma 500 mg contains 500 mg of capecitabine.

• The other components for the 150 mg and 500 mg 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 300 mg dose are:

• Tablet core: anhydrous lactose, microcrystalline cellulose (E460), sodium croscarmellose, hypromellose, and magnesium stearate.

• Coating: talc, hypromellose, titanium dioxide (E171).

Appearance of the product and contents of the pack

Capecitabine Kern Pharma 150 mg:

Film-coated tablets, light peach-colored, oblong and biconvex.

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

Capecitabine Kern Pharma 300 mg:

• Film-coated tablets, white or almost white, oblong and biconvex, with the imprint “300” on one side and plain on the other.
• Supplied in blister packs (aluminum/aluminum or PVC/PVDC/aluminum) containing 60 film-coated tablets.

Capecitabine Kern Pharma 500 mg:

• Film-coated tablets, peach-colored, oblong and biconvex.
• Supplied 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

The last revision of this leaflet was in: April 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/