Capecitabine Normon 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Capecitabina 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Contents of this leaflet

1. What Capecitabina Normon is and what it is used for
2. What you need to know before taking Capecitabina Normon
3. How to take Capecitabina Normon
4. Possible side effects
5. How to store Capecitabina Normon
6. 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 known as "cytostatic agents", which stop the growth of cancer cells. Capecitabine Normon contains capecitabine, which is not itself a cytostatic drug. It only becomes an active anticancer medicine after being absorbed by the body, and this conversion occurs preferentially in tumour tissue compared to normal tissue.

Capecitabine is used to treat colon, rectal, gastric, and breast cancer. It is also used to prevent the recurrence of colon cancer after complete surgical removal of the tumour.

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

2. What you need to know before starting Capecitabine Normon

Do not take Capecitabine Normon

• 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 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 within the last 4 weeks with brivudine as part of treatment for herpes zoster (shingles or herpes).

Warnings and precautions

Talk to your doctor or pharmacist before starting Capecitabine Normon

• if you know you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you have a family member who has partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you have liver or kidney problems
• if you have or have had heart problems, for example, an irregular heartbeat or chest and back pain triggered by physical exertion and due to problems with blood flow to the heart
• if you have brain disorders (e.g., 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 are unable to retain food or water due to nausea and vomiting
• if you have diarrhea
• if you are dehydrated or become dehydrated
• if you have an imbalance of ions in your blood (electrolyte imbalance, seen in blood tests)
• if you have a history of eye problems, as you may require additional eye monitoring
• if you experience a severe skin reaction.

DPD deficiency

DPD deficiency is a genetic condition that usually does not cause health problems unless you are taking certain medicines. If you have DPD deficiency and take Capecitabine Normon, you are at higher risk of experiencing serious adverse effects (listed 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 must not take Capecitabine Normon. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe a reduced dose. Even if the test result for DPD deficiency is negative, serious or potentially life-threatening adverse effects may still occur.

Children and adolescents

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

Other medicines and Capecitabine Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Taking Capecitabina Normon with food and drinks

You should take Capecitabina Normon within 30 minutes after eating.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. You must not take Capecitabina Normon if you are pregnant or suspect you might be pregnant. You must not breastfeed while taking Capecitabina Normon and for 2 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 Capecitabina 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 an effective method of contraception during treatment with Capecitabina Normon and for 3 months after the last dose.

Consult your doctor or pharmacist before using this medicine.

Driving and use of machines

While taking Capecitabina Normon, you may feel dizzy, nauseous or tired. Therefore, Capecitabina Normon may affect your ability to drive or operate machinery.

Capecitabina Normon contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; i.e., essentially "sodium-free".

3. How to take Capecitabine Normon

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Capecitabine should only be prescribed by a physician experienced in the use of anticancer medications.

Your doctor will prescribe a treatment schedule and the correct dose for you. The dose of capecitabine depends on your body surface area, which is calculated by measuring your height and weight. The usual dose for adults is 1250 mg/m² of body surface area twice daily (in the 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 inform you of the 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 150 mg and 500 mg tablets 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. Do not crush or divide the tablets. If you cannot swallow the tablets whole, inform your healthcare professional.
• It is important that you take your medication exactly as prescribed by your doctor.

The tablets are generally taken 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 medicines, the usual adult dose may be less than 1250 mg/m² of body surface area, and it may be necessary for you to take the tablets for a different duration (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 adverse effects if you take more capecitabine than prescribed: feeling unwell, diarrhea, swelling or ulceration in the stomach or mouth, pain or bleeding in the intestine or stomach, or bone marrow suppression (reduction in certain types of blood cells).

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

If you forget to take Capecitabine Normon

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

If you stop treatment with Capecitabine Normon

Stopping treatment with capecitabine does not cause adverse effects. If you are taking coumarin anticoagulants (containing, for example, acenocoumarol), discontinuation of capecitabine treatment may require your doctor to adjust the dose of the anticoagulant.

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 will experience them.

STOP taking Capecitabine Normon 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 bowel movements, or 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 your mouth and/or throat.
• Hand-foot skin reaction: if you have pain, swelling, redness, or tingling in your hands and/or feet.
• Fever: if your temperature is 38°C or higher.
• Infection: if you have signs of infection caused by bacteria, viruses, or other organisms.
• Chest pain: if you have pain located in the center of your chest, especially if it occurs during physical activity.
• Stevens-Johnson syndrome: if you develop painful red or purple rashes that spread, blisters, and other lesions starting in the 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; urgent medical treatment may be required: swelling mainly affecting the face, lips, tongue, or throat making swallowing or breathing difficult, 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 instruct you to restart treatment at a lower dose.

If you experience severe stomatitis (irritation of the mouth and/or throat), mucosal inflammation, diarrhea, neutropenia (increased risk of infections), or neurotoxicity during the first treatment cycle, you may have a deficiency in DPD (see Section 2: Warnings and precautions).

The hand-foot skin reaction may lead to loss of fingerprint, which could affect identification via fingerprint analysis.

In addition to the above, when Capecitabine Normon is used alone, very common adverse effects (which may affect more than 1 in 10 people) include:

• abdominal pain
• rash, dry or itchy skin
• 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 you to reduce the dose and/or temporarily discontinue treatment with Capecitabine Normon. This will help reduce the likelihood of the adverse effect continuing or becoming severe.

Other adverse effects are:

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

• decrease in white or red blood cell counts (seen in blood tests)
• dehydration, weight loss
• sleeplessness (insomnia), depression
• headache, drowsiness, dizziness, skin sensations (tingling or numbness), taste disturbances
• eye irritation, increased tearing, eye redness (conjunctivitis)
• inflammation of veins (thrombophlebitis)
• difficulty breathing, nosebleeds, cough, runny nose
• cold sores or infections caused by other herpes viruses
• 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, limb, chest, or back pain
• fever, swelling of limbs, feeling unwell
• liver function abnormalities (seen in blood tests) and increased blood bilirubin levels (excreted by the liver)

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

• blood infection, urinary tract infection, skin infection, nasal and throat infection, 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 disturbances
• blurred or double vision
• vertigo, ear pain
• irregular heartbeat and palpitations (arrhythmias), chest pain, heart attack (myocardial 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 (food regurgitation from the stomach), blood in 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
• 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, increased blood creatinine (a sign of kidney dysfunction)
• unusual vaginal bleeding
• swelling (edema), chills, and stiffness

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, which may involve ulcers in the mouth, nose, genitals, hands, feet, and eyes (red and swollen eyes).

Some of these adverse effects are more common when capecitabine is used in combination with other cancer treatments. Other observed adverse effects 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
• inflammation of veins
• hiccups, voice changes
• pain or abnormal sensation in the mouth, jaw pain
• sweating, night sweats
• muscle spasms
• difficulty urinating, blood or protein in urine
• bruising or injection site reactions (caused by concomitantly administered injectable medicines)

Reporting of adverse effects

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

5. Storage of Capecitabine Normon

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Capecitabine Normon

• The active substance 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 oxides (E172), talc, and polyethylene glycol/macrogol.

Appearance of the product and contents of the pack

Capecitabine Normon are film-coated tablets. The tablets are oblong-shaped and peach-colored. Each pack contains 120 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

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

Spain: Capecitabine Normon 500 mg film-coated tablets EFG

Portugal: Capecitabine Normon 500 mg film-coated tablets

Date of the most recent review of this leaflet: October 2021

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