Capecitabine Glenmark 500 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Capecitabine Glenmark 500 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 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.

Contents of the leaflet

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

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

Capecitabine belongs to a group of medicines known as "cytostatic agents", which stop the growth of cancer cells. This medicine contains capecitabine, which is not itself a cytostatic agent. Only after being absorbed by the body is it converted into an active anticancer drug (with greater conversion in tumour tissue than in normal tissue).

Capecitabine is used to treat colon, rectal, gastric, and breast cancer. In addition, this medicine is used to help 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 to take Capecitabine Glenmark

Do not take Capecitabine Glenmark:

• 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 to take this medicine

• 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 disease
• if you have or have had heart problems, for example, 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 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 are unable to retain food or fluids due to nausea and vomiting
• if you have diarrhoea
• 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 will need 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 being treated with certain medicines. If you have DPD deficiency and take capecitabine, you have a higher risk of 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 Glenmark. If you have reduced enzyme activity (partial deficiency), your doctor may prescribe you a lower dose. Even if the test for DPD deficiency is negative, serious or potentially life-threatening adverse effects may still occur.

Children and adolescents

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

Taking Capecitabine Glenmark with other medicines

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 must not take brivudine (an antiviral medicine used to treat herpes zoster or shingles) at the same time as receiving treatment with capecitabine (including any rest period when you are not taking capecitabine tablets).

If you have taken brivudine, you must wait at least 4 weeks after finishing brivudine before starting capecitabine. See also section “Do not take Capecitabine Glenmark”.

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 to treat cancer (leucovorin, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Taking Capecitabine Glenmark 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.

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

If you are a woman who could become pregnant, you should use an effective method of contraception during treatment with Capecitabine Glenmark and for 6 months after the last dose.

If you are a male patient and your female partner could become pregnant, you should use an effective method of contraception during treatment with Capecitabine Glenmark and for 3 months after the last dose.

Driving and using machines

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

Capecitabine Glenmark contains anhydrous lactose

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

Capecitabine Glenmark contains sodium

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

3. How to take Capecitabine Glenmark

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

Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.

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 by measuring your height and weight. The usual adult dose is 1,250 mg/m² 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 therefore 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 therefore 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 are unable to swallow Capecitabine Glenmark tablets whole, inform your healthcare professional.
• 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 medicines, the usual adult dose may be less than 1,250 mg/m² 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 Glenmark 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 too much capecitabine: feeling unwell, diarrhoea, 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.

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

If you forget to take Capecitabine Glenmark

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

If you stop taking Capecitabine Glenmark

Stopping treatment with capecitabine does not cause adverse effects. However, if you are taking coumarin anticoagulants (e.g. containing acenocoumarol), discontinuation of capecitabine treatment 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 will experience them.

STOP taking Capecitabine Glenmark immediately and contact your doctor if you experience any of the following symptoms:

• Diarrhea: if you have 4 or more additional bowel movements per day compared to your normal daily bowel movements, 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 your daily food intake is much lower 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 localized 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 starting to appear on mucous membranes (e.g., mouth and lips), particularly if you previously had photosensitivity, 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 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 deficiency in DPD (see Section 2: Warnings and precautions).

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

In addition to the above, when this medicine is used alone, very common adverse effects that 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 if you start experiencing any adverse effect. Your doctor may advise reducing the dose and/or temporarily stopping treatment with this medicine. This will help reduce the likelihood of the adverse effect continuing or becoming severe.

Other adverse effects are:

Common adverse effects (may 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
• 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 problems (seen in blood tests) and increased bilirubin in blood (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 in the mouth), flu, gastroenteritis, dental abscesses
• skin inflammation (lipomas)
• decrease 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
• vertigo, 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 limbs, 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 stools
• 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 nighttime urination, incontinence, blood in urine, increased 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 in combination with other cancer treatments. Other observed adverse effects are:

Common 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
• inflammation of veins
• hiccups, voice changes
• pain or abnormal sensations 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)

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, talk to your doctor, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Capecitabine Glenmark

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

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

Store below 25°C.

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 are unsure, please ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Capecitabine Glenmark

The active substance is capecitabine. Each film-coated tablet contains 500 mg of capecitabine.

The other components are:

• Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate.
• Tablet coating: hypromellose, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the container

Dark pink, capsule-shaped, biconvex film-coated tablet, 16.0 mm in length and 8.5 mm in width, marked with “CAP” on one side and “500” on the other.

Capecitabine Glenmark film-coated tablets are available in PVC/PVdC/aluminum blisters in transparent packaging.

Pack sizes:

Blister pack: 120 film-coated tablets (12 blisters containing 10 tablets each)

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Apis labor GmbH

Resslstraße 9

Ebenthal in Kärnten, 9065

Austria.

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Denmark Capecitabin Zentiva 500 mg film-coated tablets

Germany Capecitabin Glenmark 500 mg Filmtabletten

Spain Capecitabina Glenmark 500 mg comprimidos recubiertos con película EFG

Sweden Capecitabin Zentiva 500 mg filmdragerade tabletter

Date of the most recent review of this package leaflet: May 2022.

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