CAPECITABINE MYLAN

Package leaflet: Information for the patient

Capecitabine Mylan 150 mg film-coated tablets, 500 mg film-coated tablets

Generic medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Capecitabine Mylan belongs to a group of medicines called "cytostatic agents", which block the growth of tumour cells. Capecitabine Mylan contains 150 mg of capecitabine, which in itself is not a cytostatic medicine. Only after being absorbed by the body is it converted into an active anticancer medicine (to a greater extent in tumour tissues than in normal tissues).
Capecitabine Mylan belongs to a group of medicines called "cytostatic agents", which block the growth of tumour cells. Capecitabine Mylan contains 500 mg of capecitabine, which in itself is not a cytostatic medicine. Only after being absorbed by the body is it converted into an active anticancer medicine (to a greater extent in tumour tissues than in normal tissues).
Capecitabine Mylan is used in the treatment of cancers of the colon, rectum, stomach, or breast. Additionally, Capecitabine Mylan is used to prevent the recurrence of colon cancer after complete surgical removal of the tumour.
Capecitabine Mylan may be used alone or in combination with other medicines.

2. What you need to know before taking Capecitabine Mylan

Do not take Capecitabine Mylan:

• 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 know you are allergic or have had an excessive reaction to this medicine,
• if you have previously had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
• if you are pregnant or breastfeeding,
• if you have extremely low levels of white blood cells or platelets in your blood (leucopenia, neutropenia or thrombocytopenia),
• if you have severe liver or kidney problems,
• if you know you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD),
• if you are currently being treated or have been treated in the last 4 weeks with brivudine for the treatment of herpes zoster (shingles or varicella).

Warnings and precautions
Talk to your doctor or pharmacist before taking Capecitabine Mylan

• if you know you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you have kidney or liver disease
• if you have had or have heart problems (for example, irregular heartbeat or chest pain radiating to the jaw and vice versa, caused by physical exertion and due to problems with blood flow to the heart)
• if you have brain diseases (e.g. a tumour that has spread to the brain) or nerve damage (neuropathy)
• if you have imbalances in calcium levels (detectable in blood tests)
• if you have diabetes
• if you are unable to retain food or water due to severe nausea and vomiting
• if you have diarrhoea
• if you are or may become dehydrated
• if you have electrolyte imbalances in the blood (electrolyte imbalances, detectable in blood tests)
• if you have had eye problems, as you may need additional eye monitoring
• if you develop a severe skin reaction.

Dihydropyrimidine dehydrogenase (DPD) deficiency: DPD deficiency is a rare inherited condition present at birth that is generally not associated with health problems unless certain medicines are taken. If you have an unknown DPD deficiency and take capecitabine, you are more likely to experience severe and sudden adverse effects listed in section 4 Possible side effects. Inform your doctor immediately if any of the side effects concern you or if you notice any side effect not listed in this leaflet (see section 4 Possible side effects).

Children and adolescents
Capecitabine Mylan is not indicated for use in children and adolescents. Do not administer Capecitabine Mylan to children and adolescents.

Other medicines and Capecitabine Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is extremely important, as taking several medicines together may increase or reduce their effects.

Do not take brivudine (an antiviral medicine used to treat shingles or varicella) at the same time as capecitabine treatment (including during treatment breaks when no capecitabine tablets are taken).
If you have taken brivudine, you must wait at least 4 weeks after stopping it before starting capecitabine therapy. See also section “Do not take Capecitabine Mylan”.

Particular caution is also required when taking the following medicines concomitantly:

• medicines for gout (allopurinol),
• medicines that thin the blood (coumarins, warfarin),
• medicines for the treatment of seizures or tremor (phenytoin),
• alpha interferon,
• radiotherapy and certain anticancer medicines (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Capecitabine Mylan with food
You must take Capecitabine Mylan no more than 30 minutes after meals (see section 3 (reported below)).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take Capecitabine Mylan if you are pregnant or suspect you are pregnant. You must not breastfeed during treatment with Capecitabine Mylan.

Driving and using machines
Capecitabine may cause dizziness, nausea or fatigue. Therefore, Capecitabine Mylan may affect your ability to drive or operate machinery.

Capecitabine Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Capecitabine Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your
doctor or pharmacist.
Capecitabine Mylan should only be prescribed by a doctor experienced in the use of anticancer medicines.
Your doctor will determine the dose and treatment schedule appropriate for you. The dose of Capecitabine
Mylan is based on body surface area, which is calculated according to your height and weight. The
recommended dose for adults is 1250 mg/m² of body surface area, taken twice daily (in the morning and in the
evening).
Two examples are provided: a person weighing 64 kg and 1.64 m tall 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 1.80 m tall
has a body surface area of 2.00 m² and should take 5 tablets of 500 mg twice daily.
Your doctor will tell you which dose to take, when to take it, and for how long you need to take it.
Your doctor may prescribe 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 the end of meals (after breakfast and dinner) and swallow them whole with water.
• It is important that you take this medicine exactly as instructed by your doctor.

Capecitabine Mylan tablets are generally taken for 14 days, followed by a 7-day rest period (during which no
tablets are taken). These 21 days constitute one treatment cycle.
When used in combination with other medicines, the recommended dose for adults may be lower than 1250
mg/m² of body surface area, and you may need to take the tablets for a different duration (for example, every
day, without any rest period).

If you take more Capecitabine Mylan than you should
If you take more Capecitabine Mylan than prescribed, contact your doctor as soon as possible before taking
your next dose.
If you take too much Capecitabine Mylan, you may experience the following side effects: nausea or vomiting,
diarrhea, inflammation or ulceration of the intestine or mouth, pain or bleeding from the intestine or stomach,
or bone marrow suppression (reduction in certain types of blood cells). If you experience any of these
symptoms, contact your doctor immediately.

If you forget to take Capecitabine Mylan
Do not take the missed dose. Do not take a double dose to make up for a forgotten dose. Instead, continue
taking the medicine as prescribed and consult your doctor.

If you stop taking Capecitabine Mylan
Stopping treatment with capecitabine does not cause adverse effects. However, if you are taking coumarin
anticoagulants (e.g. phenprocoumon), stopping capecitabine may require your doctor to adjust your
anticoagulant dose.

If you have any questions about how to use 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.
STOP taking Capecitabine Mylan immediately and contact your doctor if you experience any of the
following symptoms:

• Diarrhoea: if you have 4 or more additional bowel movements per day compared to your usual bowel movements, or if you have nocturnal diarrhoea.
• Vomiting: if you vomit more than once within 24 hours.
• Nausea: if you lose your appetite and the amount of food you eat in a day is much lower than normal.
• Stomatitis: if you have pain, redness, swelling or ulcers in your mouth.
• 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 show signs of infection caused by bacteria, viruses or other organisms.
• Chest pain: if you feel pain located in the centre of your chest, especially if it occurs during physical exercise.
• Stevens-Johnson syndrome: if you develop a painful red or purplish rash that spreads and forms blisters and/or 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.

If detected early, these side effects usually improve within 2–3 days after stopping treatment. If side effects persist, contact your doctor immediately.
Your doctor may advise you to restart treatment at a lower dose.
Skin reactions on hands and feet may lead to loss of fingerprints, which could affect your identification through fingerprint scanning.

In addition to those listed above, when Capecitabine Mylan is used alone, very common side effects (affecting more than 1 in 10 people) are:

• abdominal pain
• skin rash, dry or itchy skin
• fatigue
• loss of appetite (anorexia)

These side effects may become severe; therefore, it is important that you always contact your doctor immediately when you notice any side effect. Your doctor may instruct you to reduce the dose and/or temporarily stop treatment with Capecitabine Mylan. This will help reduce the likelihood that the side effect persists or becomes more severe.

Other side effects are:
Common side effects (may affect up to 1 in 10 people) include:

• decrease in the number of white or red blood cells in the blood (observed in laboratory tests),
• dehydration, weight loss,
• sleep disturbances (insomnia), depression,
• headache, drowsiness, dizziness, abnormal skin sensations (numbness or tingling), altered taste,
• eye irritation, increased tearing, eye redness (conjunctivitis),
• inflammation of veins (thrombophlebitis),
• shortness of breath, nosebleeds, cough, runny nose,
• cold sores or other herpes infections,
• lung or respiratory tract infections (e.g. pneumonia or bronchitis),
• intestinal bleeding, constipation, upper abdominal pain, indigestion, excess gas, dry mouth,
• skin rash, hair loss (alopecia), skin redness, dry skin, itching, skin discoloration, skin loss, skin inflammation, nail disorders,
• joint pain, or pain in limbs (extremities), chest or back,
• fever, swelling of limbs, feeling unwell,
• problems with liver function (detected in blood tests), and increased bilirubin in the blood (excreted through the liver).

Uncommon side effects (may affect less than 1 in 100 people) include:

• blood infection, urinary tract infection, skin infection, nose and throat infection, fungal infections (including in the mouth), influenza, gastroenteritis, dental abscess,
• soft swellings under the skin (lipoma),
• decrease in blood cells including platelets, blood thinning (observed in laboratory tests),
• allergy,
• diabetes, low blood potassium, malnutrition, increased blood triglycerides,
• confusion, panic attacks, low mood, reduced libido,
• difficulty speaking, memory impairment, loss of coordination, balance problems, fainting, nerve damage (neuropathy) and sensory problems,
• blurred or double vision,
• dizziness, ear pain,
• irregular heartbeat and palpitations (arrhythmia), chest pain and heart attack (infarction),
• blood clots in deep veins, high or low blood pressure, hot flushes, coldness in limbs (extremities), purplish spots on the skin,
• blood clots in the lung veins (pulmonary embolism), lung collapse, coughing up blood, asthma, shortness of breath on exertion,
• intestinal obstruction, fluid accumulation in the abdomen, inflammation of the small or large intestine, stomach or oesophagus, lower abdominal pain, abdominal discomfort, heartburn (reflux of food from the stomach), blood in stools,
• jaundice (yellowing of the skin and eyes),
• skin ulcers and blisters, skin reaction to sunlight, redness of 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 (oedema), chills and stiffness.

Some of these side effects are common when capecitabine is used together with other anticancer medicines. Other side effects observed in this context are:
Common side effects (may affect up to 1 in 10 people) include:

• decreased sodium, magnesium or calcium in the blood, increased blood sugar,
• nerve pain,
• ringing or buzzing in the ears (tinnitus), hearing loss,
• inflammation of veins,
• hiccups, voice changes,
• pain or altered sensation 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 side 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 blocked 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 pain and potential vision problems,
• skin inflammation leading to red, scaly patches due to an immune system disorder.

Very rare side effects (may affect up to 1 in 10,000 people) include:
severe skin reactions such as rash, ulceration and blistering, which may involve ulcers in the mouth, nose, genitals, hands, feet and eyes (eye redness and swelling).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Capecitabine Mylan

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 carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Capecitabine Mylan contains
Capecitabine Mylan 150 mg film-coated tablets

• The active substance is capecitabine. Each film-coated tablet contains 150 mg of capecitabine.

Capecitabine Mylan 500 mg film-coated tablets

• The active substance is capecitabine. Each film-coated tablet contains 500 mg of capecitabine.
• The other ingredients are:
• Tablet core: croscarmellose sodium, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide (E171), talc, macrogol 400, red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Capecitabine Mylan and package contents
Capecitabine Mylan 150 mg film-coated tablets
Light peach-coloured, oval, film-coated tablets marked with "150" on one side. Approximate dimensions: 11.4 mm x 5.9 mm.
Capecitabine Mylan 150 mg film-coated tablets are available in various pack sizes:
Blister packs containing 60 film-coated tablets.
Unit dose divisible blister packs containing 60x1 film-coated tablets.

Capecitabine Mylan 500 mg film-coated tablets
Peach-coloured, capsule-shaped, oblong, film-coated tablets marked with "500" on one side. Approximate dimensions: 17.1 mm x 8.1 mm.
Capecitabine Mylan 500 mg film-coated tablets are available in various pack sizes:
Blister packs containing 120 film-coated tablets.
Unit dose divisible blister packs containing 120x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Remedica LTD
Aharnon Street
Limassol Industrial Estate, 3056 Limassol
Cyprus

This medicinal product is authorized in the European Economic Area countries under the following names:
Czech Republic: Capecitabine Mylan 150 mg, potahované tablety
Capecitabine Mylan 500 mg, potahované tablety
France: Capecitabine Mylan 150mg, 500mg Comprimé pelliculé
Greece: Capecitabine Mylan 150 mg, επικαλυμμένα με λεπτό υμένιο δισκίο
Capecitabine Mylan 500 mg, επικαλυμμένα με λεπτό υμένιο δισκίο
Italy: Capecitabina Mylan 150mg, 500mg
Netherlands: Capecitabine Mylan 150 mg, filmomhulde tabletten
Capecitabine Mylan 500 mg, filmomhulde tabletten
United Kingdom: Capecitabine Mylan 150mg, 500mg Film-coated Tablets