Capecitabine Zentiva Italia: detailed information

Patient Information Leaflet

Capecitabine Zentiva Italia 150 mg film-coated tablets, 500 mg film-coated tablets

Generic medicine
Please read 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. Never give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Capecitabine Zentiva Italia is and what it is used for
What you need to know before taking Capecitabine Zentiva Italia
How to take Capecitabine Zentiva Italia
Possible side effects
How to store Capecitabine Zentiva Italia
Contents of the pack and other information

1. What Capecitabina Zentiva Italia is and what it is used for

Capecitabina Zentiva Italia belongs to a group of medicines called "cytostatic agents", which block the growth of tumour cells. Capecitabina Zentiva Italia contains 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).
Capecitabina Zentiva Italia is used to treat tumours of the colon, rectum, stomach or breast.
Additionally, Capecitabina Zentiva Italia is used to prevent recurrence of colon cancer after complete surgical removal of the tumour.
Capecitabina Zentiva Italia may be used alone or in combination with other medicines.

2. What you should know before taking Capecitabine Zentiva Italia

Do not take Capecitabine Zentiva Italia:

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 develop excessive reactions 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 (leukopenia, neutropenia or thrombocytopenia),
if you have severe liver or kidney problems,
if you know you lack dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency),
if you are currently being treated or have been treated within the last 4 weeks with brivudine for herpes zoster (shingles or chickenpox).

Warnings and precautions
Talk to your doctor or pharmacist before taking Capecitabine Zentiva Italia:

if you know you have a partial deficiency in dihydropyrimidine dehydrogenase (DPD) enzyme activity,
if you have a family member with partial or complete deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme,
if you have kidney or liver disease,
if you have had or currently have heart problems (e.g. irregular heartbeat or chest pain radiating to the jaw and vice versa, triggered by physical exertion and caused by impaired blood flow to the heart),
if you have brain disorders (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 take food or fluids due to severe nausea or vomiting,
if you have diarrhoea,
if you are or may become dehydrated,
if you have electrolyte imbalances in your blood (electrolyte disturbances, detectable in blood tests),
if you have had eye problems, as you may need further eye examinations,
if you develop a severe skin reaction.

Dihydropyrimidine dehydrogenase (DPD) deficiency: DPD deficiency is a genetic condition present at birth which generally does not cause health problems unless certain medicines are taken. If you have DPD deficiency and take Capecitabine Zentiva Italia, you are at higher risk of serious adverse effects (listed in section 4 “Possible side effects”). It is recommended to test for DPD deficiency before starting treatment. If there is no enzyme activity, Capecitabine Zentiva Italia must not be taken. If enzyme activity is reduced (partial deficiency), your doctor may prescribe a reduced dose. Even with negative test results for DPD deficiency, serious and potentially life-threatening adverse effects may still occur.

Children and adolescents
Capecitabine Zentiva Italia is not indicated for the treatment of children and adolescents. Do not administer Capecitabine Zentiva Italia to children and adolescents.

Other medicines and Capecitabine Zentiva Italia
Before starting treatment, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is extremely important, as taking multiple medicines together may enhance or reduce their effects.

You must not take brivudine (an antiviral medicine used to treat shingles or chickenpox) concomitantly with 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 Zentiva Italia”.

In addition, particular caution is required when taking the following medicines concomitantly:

medicines for gout (allopurinol),
anticoagulant medicines (coumarin, warfarin),
medicines used to treat seizures or tremors (phenytoin),
interferon alfa,
radiotherapy and certain anticancer medicines (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
medicines used to treat folic acid deficiency.

Capecitabine Zentiva Italia with food and drink:
You should take Capecitabine Zentiva Italia within 30 minutes after finishing a meal.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take Capecitabine Zentiva Italia if you are pregnant or think you might be pregnant.
You must not breastfeed during treatment with Capecitabine Zentiva Italia and for 2 months after the last dose.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with Capecitabine Zentiva Italia and for 6 months after the last dose.
If you are a male patient and your partner is a woman of childbearing potential, you must use effective contraception during treatment and for 3 months after the last dose of Capecitabine Zentiva Italia.

Driving and using machines
Capecitabine Zentiva Italia may cause dizziness, nausea or fatigue. Therefore, it may affect your ability to drive or use machinery.

Capecitabine Zentiva Italia contains anhydrous lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Capecitabine Zentiva Italia 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 Zentiva Italia

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Capecitabine Zentiva Italia must be prescribed only by a doctor experienced in the use of anticancer
medicines.
Your doctor will prescribe the dose and treatment schedule appropriate for you. The dose of Capecitabine
Zentiva Italia is based on your body surface area. This is calculated by considering your height and weight.
The usual dose for adults is 1,250 mg/m² of body surface area twice daily (in the morning and 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 you need to take, when to take it, and for how long you need to take it.
Your doctor may prescribe a combination of tablets of 150 mg and 500 mg 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 meals (breakfast and dinner) and swallow them whole with water. Do not crush or cut the tablets. If you are unable to swallow Capecitabine Zentiva Italia tablets whole, inform your doctor.
It is important to take all your medicines exactly as prescribed by your doctor.

Capecitabine Zentiva Italia tablets are generally taken for 14 days, followed by a 7-day rest period (during which
the tablets are not taken). These 21 days constitute one treatment cycle.
When used in combination with other medicines, the usual dose for adults may be less than 1,250 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 Zentiva Italia than you should
If you take more Capecitabine Zentiva Italia than prescribed, contact your doctor as soon as possible before
taking the next dose.
If you take an overdose of Capecitabine Zentiva Italia, you may experience the following adverse effects:
feeling unwell, diarrhoea, inflammation or ulceration of the intestine or mouth, pain or bleeding from the
intestine or stomach, bone marrow suppression (reduction in certain blood cells). If you experience any of
these symptoms, contact your doctor immediately.

If you forget to take Capecitabine Zentiva Italia
Do not take the missed dose. Do not take a double dose to make up for the forgotten dose. Instead, continue
with your regular dosing schedule and contact your doctor.

If you stop taking Capecitabine Zentiva Italia
Stopping treatment with capecitabine does not cause adverse effects. However, discontinuing capecitabine
while taking coumarin anticoagulants (e.g. containing phenprocoumon) may require your doctor to adjust the
dose of the anticoagulant.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking Capecitabina Zentiva Italia 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 than normal, or 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 each day is much less than normal.
Stomatitis: if you have pain, redness, swelling or ulcers in your mouth or throat.
Hand-foot syndrome: if you have pain, swelling or redness in your hands and/or feet.
Fever: if your body 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 in the centre of your chest, especially if it occurs during physical activity.
Stevens-Johnson syndrome: if you develop a painful red or purplish rash that spreads and blisters and/or other lesions appear on mucous membranes (e.g. mouth and lips), particularly if you previously experienced light sensitivity, respiratory tract infections (e.g. bronchitis) and/or fever.
Angioedema: seek immediate medical help if you notice any of the following symptoms – urgent medical treatment may be needed: swelling mainly of the face, lips, tongue or throat causing difficulty in swallowing or breathing, itching and skin rashes. This could be a sign of angioedema.

If detected early, these side effects usually improve within 2–3 days after stopping treatment. However, if they persist, contact your doctor immediately.
Your doctor may advise restarting treatment at a lower dose.
If severe stomatitis (sores in the mouth and/or throat), mucosal inflammation, diarrhoea, neutropenia (increased risk of infections) or neurotoxicity occur during the first treatment cycle, a DPD deficiency may be present (see section 2: Warnings and precautions).
Hand-foot syndrome may lead to loss of fingerprints, which could affect your identification using fingerprint readers.

In addition to those listed above, other very common side effects reported with Capecitabina Zentiva Italia used as monotherapy, affecting more than 1 in 10 people, are:

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

These side effects can become severe. Therefore, always contact your doctor immediately if you notice any side effect. Your doctor may instruct you to reduce the dose and/or temporarily stop treatment with Capecitabina Zentiva Italia. This will help reduce the likelihood of the side effect persisting or becoming severe.

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

decreased number of white or red blood cells in the blood (detected by blood tests)
dehydration, weight loss
sleep disturbance (insomnia), depression
headache, drowsiness, dizziness, abnormal skin sensations (numbness or tingling), taste disturbances
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, flatulence, dry mouth
skin rash, hair loss (alopecia), skin redness, dry skin, itching, skin discoloration, skin peeling, skin inflammation, nail changes
joint or limb (extremities), chest or back pain
fever, swelling of limbs, feeling unwell
liver function problems (detected by blood tests) and increased bilirubin in the blood (excreted via the liver)

Uncommon side 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), influenza, gastroenteritis, dental abscess
lumps under the skin (lipoma)
decreased blood cells including platelets, blood thinning (detected by blood tests)
allergy
diabetes, low blood potassium, malnutrition, increased blood triglycerides
confusion, panic attacks, mood depression, reduced libido
difficulty speaking, memory impairment, loss of coordination, balance problems, fainting, nerve damage (neuropathy) and sensory disturbances
blurred or double vision
vertigo, 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 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 disorders, heartburn (food reflux from stomach), blood in stools
jaundice (yellowing of 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 kidneys, increased frequency of urination at night, incontinence, blood in urine, increased blood creatinine (sign of kidney dysfunction)
unusual vaginal bleeding
swelling (oedema), chills and rigidity

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

decreased sodium, magnesium and calcium in the blood, increased blood sugar
nerve pain
ringing or noise in the ears (tinnitus), hearing loss
inflammation of veins
hiccups, voice changes
pain or altered/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 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, torsades de pointes, and bradycardia)
eye inflammation causing eye pain and possibly vision problems
skin inflammation causing red, scaly patches due to an immune system disorder
angioedema (swelling mainly of the face, lips, tongue or throat, itching and skin rashes)

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

severe skin reactions such as rash, ulceration and blistering, which may lead to 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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Capecitabine Zentiva Italia

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Capecitabina Zentiva Italia contains

The active substance is capecitabine. Each film-coated tablet contains 150 mg or 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), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Capecitabina Zentiva Italia and package contents
Film-coated, biconvex, light pink, capsule-shaped tablets, 11.5 mm long and 5.5 mm wide, imprinted with "CAP" on one side and "150" on the other.
Film-coated, biconvex, dark pink, capsule-shaped tablets, 16.0 mm long and 8.5 mm wide, imprinted with "CAP" on one side and "500" on the other.
Capecitabina Zentiva Italia film-coated tablets are available in transparent PVC/PVDC – Aluminium blisters.
Pack sizes:
Capecitabina Zentiva Italia 150 mg film-coated tablets:
blister: 60 film-coated tablets (6 blisters of 10 tablets each)
Capecitabina Zentiva Italia 500 mg film-coated tablets:
blister: 120 film-coated tablets (12 blisters of 10 tablets each)

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy
Manufacturer:
apis labor GmbH
Resslstraße 9,
Ebenthal in Kärnten, 9065
Austria