Capecitabinum Glenmark

Package Leaflet: Information for the User

Capecitabinum Glenmark, 150 mg, film-coated tablets

Capecitabinum Glenmark, 500 mg, film-coated tablets

Capecitabinum

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 and other information

• 1. What is Capecitabinum Glenmark and what is it used for
• 2. Before you take Capecitabinum Glenmark
• 3. How to take Capecitabinum Glenmark
• 4. Possible side effects
• 5. How to store Capecitabinum Glenmark
• 6. Contents of the pack and other information

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

Capecitabinum Glenmark is a medicine that belongs to the group of "cytostatics" that inhibit the growth of cancer cells. Capecitabinum Glenmark contains capecitabine, which itself is not a cytostatic drug. Only after being absorbed by the patient's body does it turn into an active anti-cancer drug (more of this drug accumulates in tumor tissue than in healthy tissues). Capecitabinum Glenmark is used to treat colon, rectal, stomach, or breast cancer. Additionally, it is used to prevent colon cancer recurrences after complete surgical removal of the tumor. Capecitabinum Glenmark can be used alone or in combination with other medicines.

2. Before you take Capecitabinum Glenmark

When not to take Capecitabinum Glenmark:

• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). If you know you are allergic or hypersensitive to this medicine, you must inform your doctor immediately.
• if you have had severe reactions to previous treatment with fluoropyrimidine medicines (a group of anti-cancer medicines such as fluorouracil),
• if you are pregnant or breastfeeding,
• if you have a very low white blood cell or platelet count (leukopenia, neutropenia, or thrombocytopenia),
• if you have severe liver or kidney disease,
• if you have been found to have a complete lack of dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency),
• if you are currently being treated with or have been treated in the last 4 weeks with brivudine, used to treat chickenpox or shingles.

Warnings and precautions:

Before starting treatment with Capecitabinum Glenmark, you should discuss it with your doctor or pharmacist.

• if you have been diagnosed with a partial decrease in dihydropyrimidine dehydrogenase (DPD) enzyme activity,
• if a family member has a partial or complete deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme,
• if you have liver or kidney disease,
• if you have heart disease (e.g., irregular heartbeat or chest pain, jaw, and back pain worsening with physical exertion due to blood flow problems to the heart),
• if you have brain disease (e.g., tumor with brain metastases or nerve damage (neuropathy)),
• if you have been diagnosed with calcium level disorders (based on blood test results),
• if you have diabetes,
• if you are unable to absorb water or food due to severe nausea and vomiting,
• if you have diarrhea,
• if you are dehydrated or become dehydrated,
• if you have electrolyte imbalance disorders (electrolyte disorders, based on blood test results),
• if you have had eye problems in the past, as additional eye monitoring may be necessary,
• if you have severe skin reactions.

DPD deficiency:DPD deficiency is a genetic disorder that usually does not cause health problems until the patient receives certain medications. If you have a DPD deficiency and take Capecitabinum Glenmark, the risk of severe side effects (listed in section 4) increases. It is recommended to perform a test to check for DPD deficiency before starting treatment. If you have been found to have a complete lack of this enzyme activity, you should not be treated with Capecitabinum Glenmark. If the enzyme activity is reduced (partial enzyme deficiency), your doctor may prescribe a reduced dose of the medicine. Even if the DPD deficiency test result is negative, severe and life-threatening side effects can still occur.

Children and adolescents

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

Capecitabinum Glenmark and other medicines

Before starting treatment, tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is especially important because taking more than one medicine at the same time can enhance or weaken its effect.

Do not take brivudine (an antiviral medicine used to treat shingles or chickenpox) at the same time as Capecitabinum Glenmark treatment (including during treatment breaks without taking tablets).

If you have taken brivudine, you must wait at least 4 weeks after stopping brivudine before starting Capecitabinum Glenmark. See "When not to take Capecitabinum Glenmark" section.

You should also be careful if you are taking any of the following medicines:

• medicines used to treat gout (allopurinol),
• blood thinners (coumarin, warfarin),
• medicines used to treat epilepsy or seizures (phenytoin),
• interferon alpha,
• if you are undergoing radiotherapy and taking other anti-cancer medicines (folic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Capecitabinum Glenmark with food and drink

Capecitabinum Glenmark should be taken no later than 30 minutes after a meal.

Pregnancy and breastfeeding

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. Do not take Capecitabinum Glenmark if you are pregnant or think you may be pregnant. During treatment with Capecitabinum Glenmark and for 2 weeks after taking the last dose, do not breastfeed. Women who are able to become pregnant should use effective contraception during treatment with Capecitabinum Glenmark and for 6 months after taking the last dose. Men whose partners are able to become pregnant should use effective contraception during treatment with Capecitabinum Glenmark and for 3 months after taking the last dose.

Driving and using machines

Capecitabinum Glenmark may cause dizziness, nausea, or fatigue. Therefore, taking Capecitabinum Glenmark may affect your ability to drive or operate machinery.

Capecitabinum Glenmark contains lactose anhydrous

If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Capecitabinum Glenmark contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Capecitabinum Glenmark

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Capecitabinum Glenmark should only be prescribed by a doctor who has experience in the use of anti-cancer medicines. Your doctor will decide what dose you should take and how often you should take it. The dose of Capecitabinum Glenmark is usually based on your body surface area, which is calculated from your height and weight. The usual dose for adults is 1250 mg/m2 of body surface area, taken twice a day (morning and evening). Here are two examples: a person weighing 64 kg and 164 cm tall 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 180 cm tall has a body surface area of 2.00 m2, so they should take 5 tablets of 500 mg twice a day.

Your doctor will tell you how much to take, when to take it, and for how long 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 eveningas instructed by your doctor.
• Take the tablets whole, with waterwithin 30 minutes after finishing a meal(breakfast and dinner). Do not crush or cut the tablets. If you are unable to swallow Capecitabinum Glenmark tablets whole, tell your doctor.
• It is important to complete the entire treatment as instructed by your doctor.

Capecitabinum Glenmark tablets are usually taken for 14 days, followed by a 7-day break (when no tablets are taken). This 21-day period is one treatment cycle. When used in combination with other medicines, the usual dose for adults may be lower than 1250 mg/m2 of body surface area, and the duration of tablet taking may change (e.g., daily, without a break).

What to do if you take more Capecitabinum Glenmark than you should

If you take more Capecitabinum Glenmark than you should, contact your doctor immediately before taking the next dose. If you take much more medicine than prescribed, you may experience the following symptoms: nausea or vomiting, diarrhea, inflammation or ulceration of the intestines or mouth, abdominal or stomach pain or bleeding, or bone marrow suppression (reduced white blood cell count). Inform your doctor if you experience any of these symptoms.

What to do if you miss a dose of Capecitabinum Glenmark

Do not take a missed dose. Do not take a double dose to make up for a missed dose. Continue treatment as scheduled and contact your doctor.

What to do if you stop taking Capecitabinum Glenmark

There are no withdrawal symptoms when stopping capecitabine. If you are also taking anticoagulant medicines (containing, for example, phenprocoumon), stopping capecitabine may require a change in the dose of the anticoagulant medicine by your doctor. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You must STOPtaking Capecitabinum Glenmark and contact your doctor immediately if you experience any of the following symptoms:

• Diarrhea:if you have at least 4 additional bowel movements per day compared to your normal bowel habits or diarrhea at night.
• Vomiting:if vomiting occurs more frequently than once every 24 hours.
• Nausea:if you experience loss of appetite and significantly reduced food intake.
• Mouth inflammation:if you experience pain, redness, swelling, or ulcers in the mouth and (or) throat.
• Hand and foot skin reaction:if you experience pain, swelling, redness, or tingling of the hands and (or) feet.
• Fever:if you have a fever of 38°C or higher.
• Infections:if you experience symptoms of infection caused by bacteria, viruses, or other pathogens.
• Chest pain:if you experience pain in the middle of your chest, especially during physical exertion.
• Stevens-Johnson syndrome:if you experience painful redness or a spreading purple rash, along with blisters and (or) other skin lesions (e.g., in the mouth or on the lips), especially if you have had sensitivity to light, respiratory infections (e.g., bronchitis), and (or) fever .
• Angioedema:if you experience swelling, especially of the face, lips, tongue, or throat, which can cause difficulty swallowing or breathing, along with itching and rash. These can be symptoms of angioedema.

If these side effects are recognized early, they usually resolve within 2-3 days after stopping treatment. If side effects persist, contact your doctor immediately. Your doctor may recommend continuing treatment with a reduced dose. If you experience severe mouth inflammation (ulcers in the mouth and (or) throat), inflammation of the mucous membranes, diarrhea, neutropenia (increased risk of infection), or neurotoxicity during the first treatment cycle, it may be related to DPD deficiency (see section 2: "Warnings and precautions"). Hand and foot skin reactions can lead to loss of fingerprints (affecting fingerprint identification). Additionally, if Capecitabinum Glenmark is used as the only anti-cancer medicine, very common side effects (affecting more than 1 in 10 people) include:

• abdominal pain,
• skin rash, dryness, or itching,
• fatigue,
• loss of appetite (anorexia).

Side effects can worsen, so it is essential to always contact your doctor immediatelyif they occur. In such cases, your doctor may recommend reducing the dose and (or) temporarily stopping Capecitabinum Glenmark. This approach can help shorten the duration or severity of these symptoms. Other side effects: Common side effects (affecting up to 1 in 10 people) include:

• reduced white blood cell or red blood cell count (based on blood test results),
• dehydration, weight loss,
• insomnia, depression,
• headache, drowsiness, dizziness, abnormal sensations in the skin (numbness or tingling), taste changes,
• eye irritation, increased tearing, redness of the eyes (conjunctivitis),
• vein inflammation (thrombophlebitis),
• shortness of breath, nosebleeds, cough, runny nose,
• cold sores on the mouth (herpes) or other herpes infections,
• lung or respiratory tract infections (e.g., pneumonia or bronchitis),
• gastrointestinal bleeding, constipation, abdominal pain, indigestion, gas, dry mouth,
• skin rash, hair loss (alopecia), redness of the skin, dry skin, itching (pruritus), skin discoloration, skin peeling, skin inflammation, changes in nail appearance,
• joint or limb pain, chest or back pain,
• fever, swelling of limbs, general feeling of being unwell,
• liver function disorders (based on blood test results) and increased bilirubin levels in the blood.

Uncommon side effects (affecting up to 1 in 100 people) include:

• blood infections, urinary tract infections, skin infections, nose and throat infections, fungal infections (including oral thrush), flu, gastrointestinal upset,
• subcutaneous nodules (lipomas),
• reduced blood cell count, including platelets (based on blood test results), blood thinning,
• allergic reactions,
• diabetes, reduced potassium levels in the blood, malnutrition, increased triglyceride levels in the blood,
• disorientation, panic attacks, depressive mood, reduced libido,
• speech difficulties, memory impairment, lack of coordination, balance disorders, fainting, nerve damage (neuropathy), and sensory problems,
• blurred or double vision,
• vertigo, ear pain,
• irregular heartbeat and palpitations (heart rhythm disorders), chest pain, and heart attack,
• blood clots in deep veins, high or low blood pressure, hot flashes, cold limbs, purple spots on the skin,
• pulmonary embolism, lung collapse, coughing up blood, asthma, shortness of breath during exertion,
• intestinal obstruction, fluid accumulation in the abdomen, inflammation of the small or large intestine, stomach, or esophagus, lower abdominal pain, abdominal discomfort, heartburn (reflux), blood in stool,
• jaundice (yellowing of the skin and eyes),
• skin ulcers and blisters, skin reaction to sunlight, redness of the hands,
• swelling or stiffness of the joints, bone pain, muscle weakness or stiffness,
• fluid accumulation in the kidneys, increased urination at night, incontinence, blood in urine, increased creatinine levels in the blood (indicating kidney function disorder),
• abnormal vaginal bleeding,
• swelling, chills, and muscle stiffness.

Some of these side effects occur more frequently when capecitabine is used with other anti-cancer medicines. The following are other side effects that occur in these situations: Common side effects (affecting up to 1 in 10 people) include:

• reduced sodium, magnesium, or calcium levels in the blood, increased blood sugar levels,
• nerve pain,
• ringing or buzzing in the ears (tinnitus), hearing loss,
• vein inflammation,
• hiccups, voice changes,
• mouth or jaw pain,
• night sweats,
• muscle cramps,
• urination difficulties, blood or protein in urine,
• injection site reactions (caused by concurrently administered injections).

Rare side effects (affecting up to 1 in 1,000 people) include:

• narrowing or blockage of the tear duct (canaliculus stenosis),
• liver function disorders,
• inflammatory liver disease leading to bile flow disorders or bile duct obstruction (cholestatic hepatitis),
• certain heart rhythm disorders (including QT interval prolongation on an electrocardiogram),
• specific types of heart rhythm disorders (including atrial fibrillation, torsades de pointes, and bradycardia),
• inflammatory eye changes causing eye pain and potential vision disturbances,
• skin inflammation causing red, peeling lesions, associated with immune system disorders,
• angioedema (swelling, especially of the face, lips, tongue, or throat, with itching and rash).

Very rare side effects (affecting up to 1 in 10,000 people) include:

• severe skin reactions, such as skin rash, ulcers, and blisters, including blisters in the mouth, nose, genitals, hands, feet, and eyes (red and swollen eyes).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Capecitabinum Glenmark

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store in a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Capecitabinum Glenmark contains

The active substance is capecitabine. Each film-coated tablet contains 150 mg or 500 mg of capecitabine. The other ingredients are:

• Tablet core: lactose anhydrous (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).

What Capecitabinum Glenmark looks like and contents of the pack

Capecitabinum Glenmark 150 mg is a light pink, oblong, biconvex film-coated tablet, 11.5 mm in length and 5.5 mm in width, with "CAP" embossed on one side and "150" on the other. Capecitabinum Glenmark 500 mg is a dark pink, oblong, biconvex film-coated tablet, 16.0 mm in length and 8.5 mm in width, with "CAP" embossed on one side and "500" on the other. Capecitabinum Glenmark film-coated tablets are available in PVC/PVDC/Aluminum blisters. Available pack sizes: Capecitabinum Glenmark 150 mg: 60 film-coated tablets (6 blisters of 10 tablets) in a cardboard box. Capecitabinum Glenmark 500 mg: 120 film-coated tablets (12 blisters of 10 tablets) in a cardboard box.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o., Hvĕzdova 1716/2b, 140 78 Prague 4, Czech Republic

Importer

Glenmark Pharmaceuticals s.r.o., Fibichova 143, 566 17 Vysoké Mýto, Czech Republic; Apis labor GmbH, Resslstrasse 9, 9065 Ebenthal in Kärnten, Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Territory - Product name

DE - Capecitabin Glenmark 150 mg Filmtabletten, Capecitabin Glenmark 500 mg Filmtabletten

ES - Capecitabina Glenmark 150 mg comprimidos recubiertos con película EFG, Capecitabina Glenmark 500 mg comprimidos recubiertos con película EFG

DK - Capecitabin Zentiva 150 mg filmovertrukne tabletter, Capecitabin Zentiva 500 mg filmovertrukne tabletter

SE - Capecitabine Zentiva 150 mg filmdragerade tabletter, Capecitabine Zentiva 500 mg filmdragerade tabletter

NL - Capecitabine Glenmark 150 mg filmomhulde tabletten, Capecitabine Glenmark 500 mg filmomhulde tabletten

PL - Capecitabinum Glenmark

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o., ul. Dziekońskiego 3, 00-728 Warsaw; Tel: +48 22 35 12 500; Email: [email protected]

Date of last revision of the leaflet: