Capecitabine Normon 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Capecitabine Normon 150 mg film-coated tablets EFG

capecitabine

Read the entire 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 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.

Contents of the leaflet

1. What Capecitabine Normon is and what it is used for
2. What you need to know before taking Capecitabine Normon
3. How to take Capecitabine Normon
4. Possible side effects

5 Storage of Capecitabine 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, but is not itself a cytostatic medicine. Only after being absorbed by the body does it transform into an active anticancer medicine (with greater effect in tumour tissue than in 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 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 or pharmacist before starting Capecitabine Normon

• if you know you have partial deficiency 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 impaired 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 (detected in blood tests)
• if you have diabetes
• if nausea and vomiting prevent you from retaining food or fluids
• if you have diarrhea
• if you are dehydrated or become dehydrated
• if you have an imbalance of ions in your blood (electrolyte imbalance, detectable 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 have a higher risk of experiencing serious 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 must not take Capecitabine Normon. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe a lower 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is very important because taking multiple medicines at the same time may increase or reduce 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 Capecitabina Normon with food and drinks

You should take Capecitabina Normon within 30 minutes after eating a meal.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. You must not take Capecitabina Normon if you are pregnant or think you might be pregnant. You must not breast-feed 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 using 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; this is essentially “sodium-free”.

3. How to take Capecitabine Normon

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

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

Your doctor will prescribe the appropriate treatment schedule and dosage for you. The dose of capecitabine is based on your body surface area, which is calculated using your height and weight. The usual adult dose is 1250 mg/m² of body surface area, taken 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 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 medications, the usual adult dose may be less than 1250 mg/m² of body surface area, and you may need to take the tablets for a different duration (e.g., every day without a rest period).

If you take more Capecitabine Normon than you should

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

You may experience the following adverse effects if you take an overdose of capecitabine: feeling unwell, diarrhea, inflammation 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 experiences 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 usual daily number, or have nighttime diarrhea.
• Vomiting: if you vomit more than once within a 24-hour period.
• Nausea: if you lose your appetite and your daily food intake 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 had 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 advise restarting 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 DPD deficiency (see Section 2: Warnings and precautions).

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

In addition to the above, when Capecitabine Normon is used alone, very common adverse effects affecting 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 immediately when you start experiencing any adverse effect. Your doctor may advise reducing the dose and/or temporarily stopping treatment with Capecitabine Normon. 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:

• decreased number of white or red blood cells (seen in blood tests)
• dehydration, weight loss
• sleep disturbances (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, nose and throat infection, fungal infections (including oral), flu, gastroenteritis, dental abscesses
• skin inflammation (lipomas)
• decreased blood cells including platelets, blood dilution (seen in blood tests)
• allergic reactions
• 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
• 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 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, increased blood creatinine (a sign of kidney dysfunction)
• unusual vaginal bleeding
• swelling (edema), chills, and rigidity

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 impaired or obstructed 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 disorder
• 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).

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

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

• decreased blood sodium, magnesium, or calcium levels, increased blood sugar
• neuropathic pain
• ringing or buzzing in the ears (tinnitus), hearing loss
• vein inflammation
• hiccups, voice changes
• pain or altered/abnormal sensation in the mouth, jaw pain
• sweating, night sweats
• muscle spasms
• difficulty urinating, blood or protein in the 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 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 containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. 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 150 mg of capecitabine.
• The other components (excipients) are:
  • Tablet core: anhydrous lactose, sodium croscarmellose (E468), hypromellose (E464), microcrystalline cellulose (E460), magnesium stearate.
  • Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), yellow and red iron oxides (E172), talc, polyethylene glycol/macrogol.

Appearance of the product and contents of the pack

Capecitabine Normon are film-coated tablets. The tablets are light peach-coloured, oblong-shaped tablets. Each pack contains 60 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 Member States of the European Economic Area under the following names:

Spain: Capecitabine Normon 150 mg film-coated tablets EFG

Portugal: Capecitabine Normon 150 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 for Medicines and Health Products (AEMPS) www.aemps.gob.es