Capecitabine Lek-am

Leaflet accompanying the packaging: patient information

Capecitabine LEK-AM, 500 mg, coated tablets

Capecitabine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Capecitabine LEK-AM and what is it used for
• 2. Important information before taking Capecitabine LEK-AM
• 3. How to take Capecitabine LEK-AM
• 4. Possible side effects
• 5. How to store Capecitabine LEK-AM
• 6. Contents of the packaging and other information

1. What is Capecitabine LEK-AM and what is it used for

Capecitabine LEK-AM is a medicine belonging to the group of "cytostatics" that inhibit the growth of cancer cells. Capecitabine LEK-AM contains 500 mg of capecitabine, which is not a cytostatic medicine itself. Only after being absorbed by the patient's body does it change into an active anti-cancer medicine (more of this compound accumulates in tumor tissue than in healthy tissues). Capecitabine LEK-AM is used to treat colon, rectal, stomach, and breast cancer. Additionally, it is used to prevent colon cancer recurrences after complete surgical removal of the tumor. Capecitabine LEK-AM may be used alone or in combination with other medicines.

2. Important information before taking Capecitabine LEK-AM

When not to take Capecitabine LEK-AM:

• if the patient is allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). The doctor should be informed immediately,
• if the patient has had severe reactions after previous treatment with fluoropyrimidine medicines (a group of anti-cancer medicines such as fluorouracil),
• if the patient is pregnant or breastfeeding,
• if the patient has a very low white blood cell or platelet count (leukopenia, neutropenia, thrombocytopenia),
• if the patient has severe liver or kidney disease,
• if the patient has no dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency),
• if the patient is currently being treated or has been treated in the last 4 weeks with brivudine for the treatment of chickenpox or shingles.

Warnings and precautions

Before starting treatment with Capecitabine LEK-AM, the patient should discuss the following with their doctor or pharmacist:

• if the patient has been diagnosed with partial deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme,
• if a family member of the patient has a partial or complete deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme,
• if the patient has liver or kidney disease,
• if the patient has heart problems (e.g., irregular heartbeat or chest pain, jaw, and back pain worsening during physical exertion due to blood flow problems to the heart),
• if the patient has brain disease, e.g., a tumor with brain metastases or nerve damage (neuropathy),
• if the patient has been diagnosed with calcium level disorders (see blood test results),
• if the patient has diabetes,
• if the patient is unable to absorb water or food due to severe nausea and vomiting,
• if the patient has diarrhea,
• if the patient is dehydrated or at risk of dehydration,
• if the patient has electrolyte disorders (abnormal blood test results),
• if the patient has a history of eye problems, as additional eye exams may be necessary,
• if the patient has severe skin reactions.

Dihydropyrimidine dehydrogenase (DPD) deficiency
DPD deficiency is a genetic disorder that usually does not cause any health problems until the patient takes certain medicines. If the patient has a DPD deficiency and takes Capecitabine LEK-AM, the risk of severe side effects (listed in section 4 - "Possible side effects") increases. It is recommended that the patient undergo a test to check for DPD deficiency before starting treatment. If the patient has no enzyme activity, they should not be treated with Capecitabine LEK-AM. If the enzyme activity is reduced (partial enzyme deficiency), the doctor may prescribe a reduced dose of the medicine. Even if the DPD deficiency test result is negative, severe and life-threatening side effects may still occur.

Children and adolescents

Capecitabine LEK-AM is not intended for use in children and adolescents. Do not give Capecitabine LEK-AM to children or adolescents.

Capecitabine LEK-AM and other medicines

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 their effects.

Do not take brivudine (an antiviral medicine used to treat shingles or chickenpox) at the same time as Capecitabine LEK-AM treatment (including periods of rest, without taking tablets).

If you have taken brivudine, you must wait at least 4 weeks after stopping brivudine before starting Capecitabine LEK-AM treatment. See "When not to take Capecitabine LEK-AM".

You should also be careful when taking any of the following medicines:

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

Taking Capecitabine LEK-AM with food, drink, and alcohol

Capecitabine LEK-AM 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 plan to have a child, consult your doctor or pharmacist before taking this medicine. Do not take Capecitabine LEK-AM if you are pregnant or think you may be pregnant. During treatment with Capecitabine LEK-AM and for 2 weeks after taking the last dose, do not breastfeed. Women who can become pregnant should use effective contraception during treatment with Capecitabine LEK-AM and for 6 months after taking the last dose. Men whose partners can become pregnant should use effective contraception during treatment with Capecitabine LEK-AM and for 3 months after taking the last dose.

Driving and using machines

Capecitabine LEK-AM may cause dizziness, nausea, or fatigue. Therefore, it may affect your ability to drive or operate machines.

Capecitabine LEK-AM contains anhydrous lactose

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Capecitabine LEK-AM

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. Capecitabine LEK-AM should only be prescribed by a doctor with experience in the use of anti-cancer medicines. The doctor will determine the dose and treatment schedule suitable for you. The dose of Capecitabine LEK-AM has been established based on body surface area. This 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 1.64 m 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 1.80 m tall has a body surface area of 2.00 m² and should take 5 tablets of 500 mg twice a day. Capecitabine LEK-AM is only available in a 500 mg dose. For doses that cannot be achieved with this medicine, other available medicines with the appropriate strength should be used.

The doctor will determine the dose to be taken, when, and for how long.

• Take the tablets in the morning and eveningas directed by your doctor.
• Take the tablets whole, with water, within 30 minutes after finishing a meal(breakfast and dinner). Do not crush or split the tablets. If you are unable to swallow Capecitabine LEK-AM tablets whole, tell your doctor.
• It is essential to complete the entire treatment as directed by your doctor.

Capecitabine LEK-AM tablets are usually taken for 14 days, followed by a 7-day rest period (when no tablets are taken). This 21-day period is called 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 intake may vary (e.g., daily, without rest).

Taking more Capecitabine LEK-AM than prescribed

If you have taken more Capecitabine LEK-AM than prescribed, contact your doctor immediately before taking the next dose. In this case, the patient may experience the following side effects: nausea or vomiting, diarrhea, inflammation or ulceration of the intestines or mouth, abdominal or stomach pain or bleeding, bone marrow depression (reduced white blood cell count). Inform your doctor if you experience any of these symptoms.

Missing a dose of Capecitabine LEK-AM

Do not take a missed dose. Do not take a double dose to make up for a missed dose. Continue treatment according to the prescribed schedule and consult your doctor.

Stopping Capecitabine LEK-AM treatment

There are no side effects associated with stopping Capecitabine LEK-AM treatment. If you are taking coumarin-type anticoagulant medicines (containing, for example, phenprocoumon), stopping Capecitabine LEK-AM treatment may require adjusting the dose of the anticoagulant medicine by your doctor. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Capecitabine LEK-AM can cause side effects, although not everybody gets them. STOP TAKINGCapecitabine LEK-AM and consult 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 movements or diarrhea at night.
• Vomiting: if vomiting occurs more frequently than once every 24 hours.
• Nausea: if you experience a loss of appetite, and the amount of food you eat per day is significantly less than usual.
• Mouth inflammation: if you experience pain, redness, swelling, or ulcers in your mouth and/or throat.
• Hand-foot syndrome: if you experience pain, swelling, and redness or tingling of the palms of your hands and/or soles of your feet.
• Fever: if you have a fever of 38°C or higher.
• Infection: if you experience symptoms of infection caused by bacteria, viruses, or other organisms.
• 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 purplish rash that spreads, and blisters and/or other skin lesions appear, especially if you have previously experienced sensitivity to light, respiratory infections (e.g., bronchitis), and/or fever.
• DPD deficiency: if you have been diagnosed with DPD deficiency, you are at increased risk of severe side effects, including those that can be life-threatening or fatal, caused by Capecitabine LEK-AM (e.g., mouth inflammation, inflammation of the mucous membranes, diarrhea, neutropenia, neurotoxicity).
• Angioedema: if you experience any of the following symptoms, seek medical help immediately, as you may need urgent treatment: swelling, mainly of the face, lips, tongue, or throat, difficulty swallowing or breathing, itching, and rash. These may be symptoms of angioedema.

Early detection of these side effects usually resolves within 2 to 3 days after stopping treatment. If side effects persist, consult your doctor immediately. The doctor may recommend continuing treatment with a reduced dose. Hand-foot syndrome can lead to the loss of fingerprints (fingerprints), which may affect patient identification during their collection. Additionally, when Capecitabine LEK-AM is used alone, the most common side effects that may affect more than 1 in 10 patients include:

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

Side effects can be very severe, so it is essential to always consult your doctor immediatelyif they occur. In this case, the doctor may recommend reducing the dose and/or temporarily stopping Capecitabine LEK-AM treatment. This usually allows for a shorter duration or severity of these symptoms. Other side effects

Frequent side effects (may affect up to 1 in 10 patients) include:

• reduced white blood cell or red blood cell count (detected in laboratory tests),
• dehydration, weight loss,
• insomnia, depression,
• headache, drowsiness, dizziness, abnormal skin sensations (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 lips (herpes) or other herpes infections,
• lung or respiratory tract infections (e.g., pneumonia or bronchitis),
• intestinal bleeding, constipation, abdominal pain, indigestion, excessive gas, dry mouth,
• skin rash, hair loss (alopecia), redness of the skin, dry skin, itching (pruritus), skin discoloration, skin loss, skin inflammation, nail disorders,
• joint or limb pain, chest or back pain,
• fever, limb swelling, general feeling of being unwell,
• liver function disorders (detected in blood tests) and increased bilirubin levels in the blood.

Less common side effects (may affect up to 1 in 100 patients) include:

• blood infections, urinary tract infections, skin infections, nose and throat infections, fungal infections (including oral thrush), flu, gastrointestinal upset,
• skin lumps (lipomas),
• reduced blood cell count, including platelets (detected in laboratory tests), blood thinning,
• allergic reactions,
• diabetes, reduced potassium levels in the blood, malnutrition, increased triglyceride levels in the blood,
• confusion, panic attacks, depressive mood, decreased libido,
• speech difficulties, memory impairment, coordination disorders, balance disorders, fainting, nerve damage (neuropathy), and sensory problems,
• blurred or double vision,
• dizziness, 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 (blood clots in the lungs), 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, abdominal pain, abdominal discomfort, heartburn (gastroesophageal reflux), blood in the stool,
• jaundice (yellowing of the skin and eyes),
• skin ulcers and blisters, skin reaction to sunlight, redness of the hands,
• joint or limb swelling, stiffness, muscle weakness or stiffness,
• fluid accumulation in the kidneys, increased urination at night, urinary incontinence, blood in the urine, increased creatinine levels in the blood (indicating kidney function disorders),
• abnormal vaginal bleeding,
• swelling, chills, and muscle stiffness.

Some of these side effects are more common when capecitabine is used with other medicines for cancer treatment. The following side effects may occur in this group of patients:

• reduced sodium, magnesium, or calcium levels in the blood, increased blood sugar levels,
• nerve pain,
• ringing or buzzing in the ears, hearing loss,
• vein inflammation,
• hiccups, voice changes,
• mouth or jaw pain, abnormal sensation in the mouth,
• sweating, night sweats,
• muscle cramps,
• urination difficulties, blood or protein in the urine,
• reaction at the injection site (caused by medicines given by injection at the same time).

Rare side effects (may affect up to 1 in 1,000 patients) include:

• narrowing or blockage of the tear ducts (narrowing of the lacrimal canal),
• liver failure,
• inflammation leading to bile secretion disorders or blockage of the bile ducts (cholestatic hepatitis),
• certain changes in the electrocardiogram (QT interval prolongation),
• specific types of heart rhythm disorders (including atrial fibrillation, torsades de pointes, and bradycardia),
• inflammatory eye changes causing eye pain and possible vision disturbances,
• skin inflammation causing red, scaly skin changes associated with immune system disorders,
• angioedema (swelling, mainly of the face, lips, tongue, or throat, itching, and rash).

Very rare side effects (may affect up to 1 in 10,000 patients) include:

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported 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 Capecitabine LEK-AM

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

6. Contents of the packaging and other information

What Capecitabine LEK-AM contains

• The active substance is capecitabine.
• The other ingredients are: Tablet core:hypromellose 5mPas, microcrystalline cellulose, sodium croscarmellose, anhydrous lactose, magnesium stearate; Opadry White Y-1-7000 coating:hypromellose 5mPas, titanium dioxide (E171), macrogol 400.

What Capecitabine LEK-AM looks like and contents of the pack

Capecitabine LEK-AM coated tablets are white or almost white, oval, and biconvex. Capecitabine LEK-AM, 500 mg, coated tablets are available in packs of: 30 coated tablets (3 blisters of 10 tablets) or 60 coated tablets (6 blisters of 10 tablets) or 120 coated tablets (12 blisters of 10 tablets).

Marketing authorization holder

MT Pharma - Healthcare Sp. z o. o., ul. Józefa Piłsudskiego 25, 16-500 Sejny, Poland, tel.: +48 603 400 858

Manufacturer

Przedsiębiorstwo Farmaceutyczne LEK-AM sp. z o.o., ul. Ostrzykowizna 14A, 05-170 Zakroczym

Date of last revision of the leaflet