CAPECITABINE NORMON 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Capecitabine Normon 500 mg film-coated tablets EFG

capecitabine

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience 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 Normon is and what it is used for
2. What you need to know before you take Capecitabine Normon
3. How to take Capecitabine Normon
4. Possible side effects

5 Storage of Capecitabine Normon

1. Contents of the pack and other information

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

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

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

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

2. What you need to know before you take Capecitabine Normon

Do not take Capecitabine Normon

• 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 experienced severe reactions to treatment with fluoropyrimidine (a group of anti-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 (chickenpox or shingles).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Capecitabine Normon

• if you know you have a partial deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you have a family member with a partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you have liver or kidney problems
• if you have heart problems, for example, an irregular heartbeat or chest and back pain caused by physical exertion 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 a 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 an electrolyte imbalance in your blood (electrolyte imbalance, see blood tests)
• if you have a history of eye problems, as you will need extra monitoring of your eyes
• 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 Capecitabine Normon, you 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 Normon. 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 or potentially life-threatening side effects may still occur.

Children and adolescents

Capecitabine Normon is not indicated in children and adolescents. Do not administer Capecitabine Normon to children and adolescents.

Other medicines and Capecitabine Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is very important, as taking more than one medicine at the same time can 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 (coumarin, warfarin),
• medicines for seizures or tremors (phenytoin),
• interferon alpha,
• radiation therapy and certain medicines used for cancer treatment (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Taking Capecitabine Normonwith foodand drinks

You should take Capecitabine Normon within 30 minutes after finishing a meal.

Pregnancy,breastfeeding,and fertility

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 must not take Capecitabine Normon if you are pregnant or think you may be pregnant. You must not breastfeed if you are taking Capecitabine Normon and for 2 weeks after the last dose.

If you are a woman who could become pregnant, you must use a highly effective method of birth control during treatment with Capecitabine Normon 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 highly effective method of birth control during treatment with Capecitabine Normon and for 3 months after the last dose.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

While taking Capecitabine Normon, you may feel dizzy, nauseous, or tired. Therefore, Capecitabine Normon may affect your ability to drive or use machines.

Capecitabine Normon contains lactose and sodium

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

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

3. How to take Capecitabine Normon

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.

Capecitabine should only be prescribed by a doctor with experience in the use of anti-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 1250 mg/m2 of body surface area twice a day (morning and evening). We provide 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 instruct you to take a combination of 150 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. Do not crush or divide the tablets. If you cannot swallow the tablets whole, tell your healthcare professional.
• It is important that you take all your medication as prescribed by your doctor.

The tablets are usually given 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 medicines, the usual dose in adults may be less than 1250 mg/m2 of body surface area, and it may be necessary to take the tablets for a different period (for example, every day, without a rest period).

If you take more Capecitabine Normon than you should

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

You may experience the following side effects if you take more capecitabine 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 (reduction of certain types of blood cells).

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

If you forget to take Capecitabine Normon

Do not take the forgotten dose. 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 Normon

Stopping treatment with capecitabine does not produce side effects. If you are taking anticoagulant medicines containing coumarin (e.g., acenocoumarol), stopping treatment with capecitabine may require your doctor to adjust the dose of the anticoagulant.

If you have any further questions on 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 Capecitabina Normon 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 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 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.
• 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 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 sensitivity to light, respiratory system infections (e.g., bronchitis), and/or fever before.
• Angioedema: seek medical attention immediately 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 in time, these adverse effects usually improve 2 or 3 days after treatment is discontinued. However, if these adverse effects continue, contact your doctor immediately. Your doctor may advise you to restart treatment with a lower dose.

If you experience severe stomatitis (irritation in the mouth and/or throat), mucosal inflammation, diarrhea, neutropenia (increased risk of infections), or neurotoxicity during the first treatment cycle, you may have 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 your identification through fingerprint analysis.

In addition to the above, when Capecitabina Normon is used alone, very frequent adverse effects that can affect more than 1 in 10 people are:

• abdominal pain
• rash, dry or itchy skin
• 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 discontinue treatment with Capecitabina Normon. This will help reduce the likelihood of the adverse effect continuing or becoming serious.

Other adverse effects are:

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

• decrease in the number of white or red blood cells (seen in blood tests)
• dehydration, weight loss
• insomnia, depression
• headache, drowsiness, dizziness, strange 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 infections with other herpes
• lung or respiratory tract infections (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), change in skin color, skin loss, skin inflammation, nail disorders
• joint pain, or pain in the extremities, chest, or back
• fever, swelling of the extremities, feeling of discomfort
• liver function problems (seen in blood tests) and increased bilirubin in the blood (excreted by the liver)

Infrequent adverse effects (can affect up to 1 in 100 people) include:

• blood infection, urinary tract infection, skin infection, infection 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 of 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 disorders, fainting, nerve damage (neuropathy), and sensation problems
• blurred or double vision
• vertigo, ear pain
• irregular heartbeats and palpitations (arrhythmias), chest pain, and heart attack (myocardial infarction)
• formation of blood clots in deep veins, high or low blood pressure, hot flashes, 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, pain in the lower abdomen, abdominal discomfort, acid reflux, 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 or stiffness of the joints, 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

Rare adverse effects (can 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 that causes eye pain and possible vision problems
• skin inflammation that causes red scaly patches due to an immune system disease
• Angioedema (swelling mainly of the face, lips, tongue, or throat, itching, and rashes)

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

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

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

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

• decreased sodium, magnesium, or calcium in the blood, increased blood sugar
• neuropathic pain
• ringing or buzzing in the ears (tinnitus), hearing loss
• inflammation of the veins
• hoarseness, change in voice
• 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 medications administered by injection at the same time)

Reporting Adverse Effects

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

5. Storage of Capecitabina Normon

Keep this medicine out of the sight and reach of children.

Do not store at a temperature above 30°C.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

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

Marketing Authorization Holder and 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 under the following names:

Spain: Capecitabina Normon 500 mg film-coated tablets EFG

Portugal: Capecitabina Normon 500 mg film-coated tablets

Date of the Last Revision of this Leaflet:October 2021

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