Capecitabine Medac - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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.

What is in this leaflet

• 1. What Capecitabine medac is and what it is used for

• 2. What you need to know before you take Capecitabine medac

• 3. How to take Capecitabine medac

• 4. Possible side effects

• 5. How to store Capecitabine medac

• 6. Contents of the pack and other information

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

Capecitabine medac belongs to the group of medicines called „cytostatic medicines“, which stop the growth of cancer cells. Capecitabine medac contains capecitabine, which itself is not a cytostatic medicine. Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).

Capecitabine medac is used in the treatment of colon, rectal, gastric, or breast cancers.

Furthermore, Capecitabine medac is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.

Capecitabine medac may be used either alone or in combination with other medicines.

2. What you need to know before you take Capecitabine medac

Do not take Capecitabine medac

• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
• if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
• if you are pregnant or breast-feeding,
• if you have severely low levels of white cells or platelets in the blood (leukopenia, neutropenia or thrombocytopenia),
• if you have severe liver or kidney problems,
• if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD defiency),

if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Capecitabine medac

• if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD),
• if you have a family member who has partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD),
• if you have liver or kidney diseases,
• if you have or had heart problems (for example an irregular heart beat or pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart),
• if you have brain diseases (for example cancer that has spread to the brain) or nerve damage (neuropathy),
• if you have calcium imbalances (seen in blood tests),
• if you have diabetes,
• if you cannot keep food or water in your body because of severe nausea and vomiting,
• if you have diarrhoea,
• if you are or become dehydrated,
• if you have imbalances of ions in your blood (electrolyte imbalances, seen in tests),
• if you have a history of eye problems as you may need extra monitoring of your eyes,
• if you have a severe skin reaction.

DPD deficiency

DPD deficiency is a genetic condition that is not usually associated with health problems unless you receive certain medicines. If you have DPD deficiency and take Capecitabine medac, you are at an increased risk of severe side effects (listed under section 4 Possible side effects). It is recommended to test you for DPD deficiency before start of treatment. If you have no activity of the enzyme you should not take Capecitabine medac. If you have a reduced enzyme activity (partial deficiency) your doctor might prescribe a reduced dose. If you have negative test results for DPD deficiency, severe and life-threatening side effects may still occur.

Children and adolescents

Capecitabine medac is not indicated in children and adolescents. Do not give Capecitabine medac to children and adolescents.

Other medicines and Capecitabine medac

Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.

You must not take brivudine (an anti-viral medicine for the treatment of shingles or chickenpox) at the same time as capecitabine treatment (including during any rest periods when you are not taking any capecitabine tablets).

If you have taken brivudine you must wait for at least 4 weeks after stopping brivudine before starting to take capecitabine. See also section “Do not take Capecitabine medac”.

Also, you need to be particularly careful if you are taking any of the following:

• gout medicines (allopurinol)
• blood-thinning medicines (coumarin, warfarin)
• medicines for seizures or tremors (phenytoin)
• interferon alpha
• radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan)
• medicines used to treat folic acid deficiency

Capecitabine medac with food and drink

You should take Capecitabine medac no later than 30 minutes after meals.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.You must not take Capecitabine medac if you are pregnant or think you might be.

You must not breast-feed if you are taking Capecitabine medac and for 2 weeks after the last dose. If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine medac and for 6 months after the last dose.

If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with Capecitabine medac and for 3 months after the last dose.

Driving and using machines

Capecitabine medac may make you feel dizzy, nauseous or tired. It is therefore possible that Capecitabine medac could affect your ability to drive a car or operate machines.

Capecitabine medac contains lactose

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

Capecitabine medac contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Capecitabine medac

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Capecitabine medac should only be prescribed by a doctor experienced in the use of anticancer medicines.

Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Capecitabine medac is based on your body surface area. This is calculated from your height and weight. The usual dose for adults is 1,250 mg/m2 of body surface area taken two times daily (morning and evening). Two examples are provided here: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily. A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m2 and should take 5 tablets of 500 mg two times daily.

Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.

• Your doctor may want you to take a combination of 150 mg, 300 mg and 500 mg tablets for each dose. Take the tablets in the morning and evening as prescribed by your doctor.
• Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow

whole with water. Do not crush or cut tablets. If you cannot swallow Capecitabine medac tablets whole, tell your healthcare provider.

• It is important that you take all your medicine as prescribed by your doctor.

Capecitabine medac tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken). This 21 day period is one treatment cycle.

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 over a different time period (e.g. every day, with no rest period).

If you take more Capecitabine medac than you should

If you take more Capecitabine medac than you should, contact your doctor as soon as possible before taking the next dose.

You might get the following side effects if you take a lot more capecitabine than you should: feeling, or being sick, diarrhoea, inflammation or ulceration of the gut or mouth, pain or bleeding from the intestine or stomach, or bone marrow depression (reduction in certain kinds of blood cells). Tell your doctor immediately if you experience any of these symptoms.

If you forget to take Capecitabine medac

Do not take the missed dose at all. Do not take a double dose to make up for a forgotten dose. Instead, continue your regular dosing schedule and check with your doctor.

If you stop taking Capecitabine medac

There are no side effects caused by stopping treatment with capecitabine. In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping capecitabine might require that your doctor adjusts your anticoagulant dose.

If you have any further questions on the use of 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 medac immediately and contact your doctor if any of these symptoms occur:

• Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night.
• Vomiting: if you vomit more than once in a 24-hour time period.
• Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
• Stomatitis: if you have pain, redness, swelling or sores in your mouth and or throat.
• Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or

feet.

• Fever: if you have a temperature of 38 °C or greater.
• Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
• Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
• Stevens-Johnson syndrome: if you experience painful red or purplish rash that spreads and

blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.

• Angioedema: Seek medical attention straight away if you notice any of the following symptoms – you may need urgent medical treatment: swelling mainly of the face, lips, tongue or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of angioedema.

If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation. If these side effects continue, however, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

If severe stomatitis (sores in your mouth and/or throat), mucosal inflammation, diarrhoea, neutropenia (increased risk for infections), or neurotoxicity occurs during the first cycle of treatment a DPD deficiency may be involved (please see Section 2: Warning and precautions).

Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan.

In addition to the above, when Capecitabine medac is used alone, very common side effects which may affect more than 1 in 10 people are:

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

These side effects can become severe; therefore, it is important that you always contact your doctor immediately when you start to experience a side effect. Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Capecitabine medac. This will help reduce the likelihood that the side effect continues or becomes severe.

Other side effects are:

Common (may affect up to 1 in 10 people):

• decreases in the number of white blood cells or red blood cells (seen in tests)
• dehydration, weight loss
• sleeplessness (insomnia), depression
• headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes
• eye irritation, increased tears, eye redness (conjunctivitis)
• inflammation of the veins (thrombophlebitis)
• shortness of breath, nose bleeds, cough, runny nose
• cold sores or other herpes infections
• infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
• bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth
• skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration, skin loss, skin inflammation, nail disorder
• pain in the joints or in the limbs (extremities), chest or back
• fever, swelling in the limbs, feeling ill
• problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)

Uncommon (may affect up to 1 in 100 people):

• blood infection, urinary tract infection, infection of the skin, infections in the nose and throat, fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess
• lumps under the skin (lipoma)
• decreases in blood cells including platelets, thinning of blood (seen in tests)
• allergy
• diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides
• confusional state, panic attacks, depressed mood, decreased libido
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder, fainting, nerve damage (neuropathy) and problems with sensation
• blurred or double vision
• vertigo, ear pain
• irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
• blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities), purple spots on the skin
• blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood, asthma, shortness of breath on exertion
• bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn (reflux of food from the stomach), blood in the stool
• jaundice (yellowing of skin and eyes)
• skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face
• joint swelling or stiffness, bone pain, muscle weakness or stiffness
• fluid collection in the kidneys, increased frequency of urination during the night, incontinence, blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
• unusual bleeding from the vagina
• swelling (oedema), chills and rigors

Some of these side effects are more common when capecitabine is used with other medicines for the treatment of cancer. Other side-effects seen in this setting are the following:

Common (may affect up to 1 in 10 people):

• decrease in blood sodium, magnesium or calcium, increase in blood sugar
• nerve pain
• ringing or buzzing in the ears (tinnitus), loss of hearing
• vein inflammation
• hiccups, change in voice
• pain or altered/abnormal sensation in the mouth, pain in the jaw
• sweating, night sweats
• muscle spasm
• difficulty in urination, blood or protein in the urine
• bruising or reaction at the injection site (caused by medicines given by injection at the same time)

Rare (may affect up to 1 in 1,000 people):

• angioedema (swelling mainly of the face, lip, tongue or throat, itching and rashes)
• narrowing or blockage of tear duct (lacrimal duct stenosis)
• liver failure
• inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
• specific changes in the electrocardiogram (QT prolongation)
• certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
• eye inflammation causing eye pain and possibly eyesight problems
• inflammation of the skin causing red scaly patches due to an immune system illness

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

• severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Capecitabine medac

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 and blister after EXP. The expiry date refers to the last day of that month.

For Aluminium-aluminium blisters:

This medicine does not require any special storage conditions.

For PVC/PVdC-aluminium blisters:

Do not store above 30 °C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Capecitabine medac contains

• The active substance is capecitabine.

Each 150 mg film-coated tablet contains 150 mg capecitabine

Each 300 mg film-coated tablet contains 300 mg capecitabine

Each 500 mg film-coated tablet contains 500 mg capecitabine

• The other ingredients are:

What Capecitabine medac looks like and contents of the pack

Capecitabine medac 150 mg film-coated tablets

Light peach coloured, oblong shaped, biconvex tablet, debossed with ‘150’ on the one side and plain on the other side.

Capecitabine medac 300 mg film-coated tablets

White to off-white, oblong shaped, biconvex tablet, debossed with ‘300’ on the one side and plain on the other side.

Capecitabine medac 500 mg film-coated tablets

Peach coloured, oblong shaped, biconvex tablet, debossed with ‘500’ on the one side and plain on the other side.

Capecitabine medac is available in blisters (Aluminium-Aluminium or PVC/PVdC-Aluminium). Each pack contains 28, 30, 56, 60, 84, 112, or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

medac

Gesellschaft für klinische

Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Manufacturer

Pharmacare Premium Ltd

HHF 003, Hal Far Industrial Estate Birzebbugia

BBG 3000, Malta

LABORATORI FUNDACIO DAU

C/ C, 12–14 Pol. Ind. Zona Franca, Barcelona

08040 Barcelona

Spain

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

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