Capecitabine glenmark

Package leaflet: Information for the user

Capecitabinum Glenmark, 150 mg, film-coated tablets
Capecitabinum Glenmark, 500 mg, film-coated tablets
Capecitabinum
Please 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of the leaflet

1. What Capecitabinum Glenmark is and what it is used for
2. What you need to know before taking 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 Capecitabinum Glenmark is and what it is used for

Capecitabinum Glenmark is a medicine belonging to a group called "cytostatic agents", which inhibit the growth of cancer cells. Capecitabinum Glenmark contains capecitabine, which is not itself a cytostatic drug. Only after being absorbed by the patient's body is it converted into an active anticancer agent (more of this drug accumulates in tumour tissue than in healthy tissues).
Capecitabinum Glenmark is used in the treatment of colon, rectal, gastric or breast cancer.
Additionally, it is also used to prevent recurrence of colon cancer after complete surgical removal of the tumour.
Capecitabinum Glenmark may be used as a single agent or in combination with other medicines.

2. Important information before using Capecitabinum Glenmark

When not to use Capecitabinum Glenmark:

• if the patient is allergic to capecitabine or to any of the other ingredients of this medicine (listed in section 6). If the patient knows they have an allergy or hypersensitivity to this medicine, they must inform their doctor immediately.
• if the patient has previously experienced severe reactions to fluoropyrimidine drugs (a group of anticancer medicines such as fluorouracil),
• if the patient is pregnant or breastfeeding,
• if the patient has very low levels of white blood cells or platelets (leukopenia, neutropenia, or thrombocytopenia),
• if the patient has severe liver or kidney disease,
• if the patient lacks activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency),
• if the patient is currently being treated or has been treated within the last 4 weeks with brivudine, used to treat shingles or chickenpox.

Warnings and precautions:
Before starting treatment with Capecitabinum Glenmark, discuss this with your doctor or
pharmacist.

• if the patient has been diagnosed with partial reduction in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD),
• if a family member of the patient has partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD),
• if the patient has liver or kidney disease,
• if the patient has or has had heart disease (e.g. irregular heartbeat or chest pain radiating to the jaw and back, worsening with physical exertion due to reduced blood flow to the heart),
• if the patient has brain disease (e.g. brain metastases or nerve damage [neuropathy]),
• if the patient has been diagnosed with calcium imbalance (detected by blood laboratory tests),
• if the patient has diabetes,
• if the patient is unable to retain fluids or food due to severe nausea and vomiting,
• if the patient has diarrhea,
• if the patient is dehydrated or becomes dehydrated,
• if the patient has electrolyte imbalance (electrolyte disturbances, detected by blood laboratory tests),
• if the patient has previously had eye problems, as additional eye monitoring may be required,
• if the patient has severe skin reactions.

Dihydropyrimidine dehydrogenase (DPD) deficiency: DPD deficiency is a genetic condition which
usually does not cause health problems until the patient receives certain medications. If
the patient has DPD deficiency and takes Capecitabinum Glenmark, the risk of severe
adverse reactions (listed in section 4. Possible side effects) increases.
It is recommended to test the patient for DPD deficiency before starting treatment.
If the patient is found to have no activity of this enzyme, Capecitabinum Glenmark should not be used.
If enzyme activity is reduced (partial enzyme deficiency), the doctor may prescribe a reduced dose.
Even if the DPD deficiency test result is negative, severe and life-threatening adverse reactions may 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 the patient is currently taking,
has recently taken, or plans to take. This is particularly important because taking more than one
medicine at the same time may enhance or weaken its effect.

Do not take brivudine (an antiviral medicine used to treat shingles or chickenpox) at the same time as
capecitabine treatment (including during treatment breaks when tablets are not taken).

If the patient has taken brivudine, they must wait at least 4 weeks after stopping brivudine before starting
capecitabine. See section "When not to take Capecitabinum Glenmark".

Special caution is also required if the patient is taking any of the following medicines:

• medicines used to treat gout (allopurinol),
• anticoagulants (warfarin, coumarins),
• medicines used to treat epilepsy or seizures (phenytoin),
• interferon alfa,
• if the patient is undergoing radiotherapy and taking other anticancer 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine. Do not take
Capecitabinum Glenmark if the patient is pregnant or suspects she may be pregnant.

During treatment with Capecitabinum Glenmark and for 2 weeks after the last dose, breastfeeding must not be performed.

Female patients of childbearing potential should use effective contraception during treatment with Capecitabinum Glenmark and for 6 months after the last dose.

Male patients whose partners are of childbearing potential should use effective contraception during treatment with Capecitabinum Glenmark and for 3 months after the last dose.

Driving and operating machinery
Capecitabinum Glenmark may cause dizziness, nausea, or fatigue. Therefore, using Capecitabinum Glenmark may impair the ability to drive or operate machinery.

Capecitabinum Glenmark contains anhydrous lactose
If the doctor has previously diagnosed the patient with intolerance to certain sugars, the patient should
consult their doctor before taking this medicine.

Capecitabinum Glenmark contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Capecitabinum Glenmark

This medicine should always be used exactly as your doctor or pharmacist has advised. If in doubt,
please consult your doctor or pharmacist.
Capecitabinum Glenmark should be prescribed only by a doctor experienced in the use of anticancer
medicines.
Your treating doctor will determine the dose and treatment regimen appropriate for the individual
patient. The dose of Capecitabinum Glenmark is based on the patient's body surface area, which is
calculated from height and weight. The usual dose for adults is 1250 mg/m² of body surface area,
administered twice daily (in the morning and evening). Below are two examples: a person weighing
64 kg and 164 cm tall has a body surface area of 1.7 m², and therefore should take 4 tablets of 500 mg
and 1 tablet of 150 mg twice daily. A person weighing 80 kg and 180 cm tall has a body surface area
of 2.00 m², and therefore should take 5 tablets of 500 mg twice daily.
Your doctor will specify the dose to be taken, when to take it, and how long the treatment should
continue.
Your doctor may prescribe a combination of tablets containing 150 mg and 500 mg of the medicine
for each dose.

• Take the tablets in the morning and evening, exactly as prescribed by your doctor.
• Swallow the tablets whole with water, within 30 minutes after finishing a meal (breakfast and
  dinner). Do not crush or split the tablets. If a patient is unable to swallow Capecitabinum Glenmark
  tablets whole, they should inform their doctor.
• It is important that the entire course of treatment is followed exactly as directed by your doctor.

Capecitabinum Glenmark tablets are usually taken for 14 days, followed by a 7-day break (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 lower than 1250 mg/m²,
and the dosing schedule may differ (e.g., daily without interruption).

Taking more Capecitabinum Glenmark than prescribed
If you take more Capecitabinum Glenmark than prescribed, contact your treating doctor as soon as
possible before taking the next dose.
If a significantly higher dose than recommended is taken, the following symptoms may occur:
nausea or vomiting, diarrhoea, inflammation or ulceration of the intestine or mouth, abdominal pain
or gastrointestinal bleeding, or bone marrow suppression (reduction in certain types of blood cells).
Inform your treating doctor if any of these symptoms occur.

Missing 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 according to the prescribed schedule and contact your treating doctor.

Stopping Capecitabinum Glenmark
There are no withdrawal symptoms associated with stopping capecitabine. However, if anticoagulant
medicines (e.g. containing phenprocoumon) are being taken concurrently, discontinuation of
capecitabine may require your treating doctor to adjust the dose of the anticoagulant.

If you have any further questions about the use of this medicine, please consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should IMMEDIATELY DISCONTINUE the use of Capecitabinum Glenmark and contact your
doctor if any of the following symptoms occur:

• Diarrhoea: if there are at least 4 additional bowel movements per day compared to normal frequency, or if nocturnal diarrhoea occurs.
• Vomiting: if vomiting occurs more than once every 24 hours.
• Nausea: if appetite loss occurs and the amount of food consumed daily is significantly less than usual.
• Mucositis (inflammation of the mouth): if pain, redness, swelling or ulceration occurs in the mouth and/or throat.
• Hand-foot syndrome (palmar-plantar erythrodysesthesia): if pain, swelling, redness or tingling occurs in the hands and/or feet.
• Fever: if body temperature reaches 38°C or higher.
• Infections: if symptoms of infection caused by bacteria, viruses or other pathogens occur.
• Chest pain: if pain occurs in the central part of the chest, especially during physical exertion.
• Stevens-Johnson syndrome: if painful redness or purple rash appears and spreads, blisters form, and/or other mucosal lesions appear (e.g. in the mouth or on the lips), particularly if the patient previously experienced photosensitivity, respiratory tract infections (e.g. bronchitis) and/or fever.
• Angioedema: if any of the following symptoms occur, seek immediate medical help, as urgent treatment may be required: swelling, particularly of the face, lips, tongue or throat, making swallowing or breathing difficult, itching and rash. These may be symptoms of angioedema.

If these adverse reactions are recognised early, they usually resolve within 2–3 days after stopping treatment.
If adverse reactions persist longer, contact your doctor immediately. The doctor may recommend continuing treatment at a reduced dose.
If severe mucositis (ulceration in the mouth and/or throat), mucosal inflammation, diarrhoea, neutropenia (increased risk of infections) or neurotoxicity occur during the first treatment cycle, this may be related to DPD deficiency (see section 2: "Warnings and precautions").
Skin reactions on the hands and feet may lead to loss of dermatoglyphics (fingerprint loss), which may affect patient identification when fingerprints are collected.

Additionally, when Capecitabinum Glenmark is used as the sole anticancer agent, very common adverse reactions (affecting more than 1 in 10 people) include:

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

Adverse reactions may become significantly more severe; therefore, it is important to always contact your doctor immediately when they appear. In such cases, the doctor may recommend reducing the dose and/or temporarily interrupting treatment with Capecitabinum Glenmark. This approach helps shorten the duration or reduce the severity of these symptoms.

Other adverse reactions:
Common adverse reactions (occurring in up to 1 in 10 people) include:

• decreased number of white blood cells or red blood cells (detected in blood laboratory tests),
• dehydration, weight loss,
• insomnia, depression,
• headache, drowsiness, dizziness, abnormal skin sensations (tingling or numbness), taste disturbances,
• eye irritation, increased tearing, eye redness (conjunctivitis),
• vein inflammation (venous thromboembolic disease),
• shortness of breath, nosebleeds, cough, nasal congestion,
• cold sores (herpes labialis) or other herpes infections,
• lung or respiratory tract infections (e.g. pneumonia or bronchitis),
• gastrointestinal bleeding, constipation, epigastric pain, indigestion, excessive flatulence, dry mouth,
• skin rash, hair loss (alopecia), skin redness, dry skin, itching (pruritus), skin discoloration, skin peeling, dermatitis, nail appearance changes,
• joint or limb pain, chest or back pain,
• fever, limb swelling, general malaise.

Uncommon adverse reactions (occurring in up to 1 in 100 people) include:

• blood infections, urinary tract infections, skin infections, nose and throat infections, fungal infections (including in the oral cavity), influenza, gastroenteritis, dental abscess,
• subcutaneous nodules (lipomas),
• decreased blood cell count, including platelets, blood thinning (detected in blood laboratory tests),
• hypersensitivity,
• diabetes, decreased potassium levels in blood, malnutrition, increased blood triglyceride levels,
• disorientation, panic attacks, depressive mood, decreased 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 (arrhythmias), chest pain and myocardial infarction,
• deep vein thrombosis, high or low blood pressure, hot flushes, cold extremities, purple skin spots,
• pulmonary embolism (blood clots in lung arteries), lung collapse, coughing up blood, asthma, exertional dyspnoea,
• intestinal obstruction, fluid accumulation in the abdominal cavity, inflammation of the small or large intestine, stomach or oesophagus, lower abdominal pain, abdominal discomfort, heartburn (reflux of stomach contents), blood in stool,
• jaundice (yellowing of skin and eyes),
• skin ulcers and blisters, photosensitivity reaction, redness of hands, facial swelling or pain,
• joint swelling or stiffness, bone pain, muscle weakness or stiffness,
• fluid accumulation in kidneys, increased frequency of nocturnal urination, urinary incontinence, blood in urine, increased blood creatinine levels (a sign of impaired kidney function),
• abnormal vaginal bleeding,
• oedema, chills and muscle stiffness.

Some of these adverse reactions occur more frequently when capecitabine is used in combination with other anticancer medicines. The following are additional adverse reactions observed under these conditions:
Common adverse reactions (occurring in up to 1 in 10 people) include:

• decreased blood sodium, magnesium or calcium levels, increased blood glucose levels,
• nerve pain,
• ringing or buzzing (tinnitus), hearing loss,
• vein inflammation,
• hiccups, voice changes,
• pain or altered/abnormal sensation in the mouth, jaw pain,
• sweating, night sweats,
• muscle cramps,
• difficulty urinating, presence of blood or protein in urine,
• bruising or reaction at the injection site (caused by concomitant injectable medicines).

Rare adverse reactions (occurring in up to 1 in 1,000 people) include:

• narrowing or blockage of the tear drainage duct (nasolacrimal duct stenosis),
• liver function disorders,
• inflammation leading to impaired bile secretion or obstruction of bile ducts (cholestatic hepatitis),
• specific changes in electrocardiogram (ECG) findings – QT interval prolongation,
• certain types of cardiac arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia),
• inflammatory eye conditions causing eye pain and possible vision disturbances,
• skin inflammation causing red, scaly lesions associated with autoimmune disease,
• angioedema (swelling, particularly of the face, lips, tongue or throat, itching and rash).

Very rare adverse reactions (occurring in up to 1 in 10,000 people) include:

• severe skin reactions such as skin rash, ulceration and blistering, including blisters in the mouth, nose, genital organs, hands, feet and eyes (red and swollen eyes).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Capecitabinum Glenmark

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after:
EXP = Expiry date or on the blister after: EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Capecitabinum Glenmark contains
The active substance is capecitabine. Each coated tablet contains 150 mg or 500 mg of
capecitabine.
The other ingredients are:

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

What Capecitabinum Glenmark looks like and contents of the pack
Capecitabinum Glenmark 150 mg are light pink, oblong, biconvex coated tablets, 11.5 mm in length and 5.5 mm in width, with the imprint "CAP" on one side and "150" on the other.
Capecitabinum Glenmark 500 mg are dark pink, oblong, biconvex coated tablets, 16.0 mm in length and 8.5 mm in width, with the imprint "CAP" on one side and "500" on the other.
Capecitabinum Glenmark, coated tablets, are available in PVC/PVDC/Aluminium blisters.
Pack sizes available:
Capecitabinum Glenmark 150 mg: 60 coated tablets (6 blisters of 10 tablets) in a cardboard carton.
Capecitabinum Glenmark 500 mg: 120 coated tablets (12 blisters of 10 tablets) in a cardboard carton.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 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 medicinal product is authorised 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 medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekonińskiego 3
00-728 Warsaw
Tel: +48 22 35 12 500
Email: [email protected]