iMeds.se

Capecitabine Mylan

Package leaflet: Information for the patient


Capecitabine Mylan 150mg film-coated tablets

Capecitabine Mylan 500 mg film-coated tablets

capecitabine


Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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 Mylan is and what it is used for

2. What you need to know before you take 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 the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Mylan contains 150 mg 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 Mylan belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Mylan contains 500 mg 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 Mylan is used in the treatment of colon, rectal, gastric, or breast cancers.

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


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


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


Do not take Capecitabine Mylan:

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 nursing,

if you have severely low levels of white cells or platelets in the blood (leucopenia, 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)

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


Warnings and precautions

Talk to your doctor or pharmacist before taking Capecitabine Mylan:

if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)

if you have liver or kidney diseases

if you have or had heart problems (for example an irregular heartbeat 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 rare condition present at birth that is not usually associated with health problems unless you receive certain medicines. If you have an unrecognised DPD deficiency and take capecitabine, you may be more likely to experience sudden and severe forms of the side effects listed under section 4 ‘Possible side effects’. Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 ‘Possible side effects’).


Children and adolescents

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


Other medicines and Capecitabine Mylan

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

medicines used to treat folic acid deficiency.


Capecitabine Mylan with food

You should take Capecitabine Mylan no later than 30 minutes after meals (see section 3 (below)).


Pregnancy and breast-feeding

Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. You must not take Capecitabine Mylan if you are pregnant or think you might be. You must not breast-feed if you are taking Capecitabine Mylan.


Ask your doctor or pharmacist for advice before taking this medicine.


Driving and using machines

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


3. How to take Capecitabine Mylan


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


Capecitabine Mylan tablets should be swallowed whole with water and within 30 minutes of a meal.


Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Capecitabine Mylan is based on your body surface area. This is calculated from your height and weight. The recommended dose for adults is 1250 mg/m2of 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 m2and 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.


Capecitabine Mylan 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 recommended dose for adults may be less than 1250 mg/m2of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).


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 mgand 500 mgtablets for each dose.


If you take more Capecitabine Mylan than you should

If you take more Capecitabine Mylan 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 Mylan

Do nottake 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 Mylan

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.


STOPtaking Capecitabine Mylan immediately and contact your doctor if any of these symptoms occur:

Diarrhoea: if you have an increase of 4 or more bowelmovements 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, viruses or other organisms.

Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.

Steven-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.


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.


In addition to the above, when Capecitabine Mylan is used alone, very common side effects, which may affect more than 1 person in 10 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 Mylan. This will help reduce the likelihood that the side effect continues or becomes severe.


Other side effects are:


Commonside effects (may affect up to 1 in 10 people) include:

sleeplessness (insomnia), depression

headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes

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


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

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

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:


Commonsideeffects(mayaffectupto1in10people)include:


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

narrowing or blockage of tear duct (lacrimal duct stenosis)


Veryraresideeffects(mayaffectupto1in10,000people)include:

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, pharmacistor nurse.This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via [To be completed nationally]. 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 30C.


Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.


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 Mylan contains


Capecitabine Mylan 150 mg film-coated tablets:

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


Capecitabine Mylan 500 mg film-coated tablets:

The active substance is capecitabine. Each film-coated tablet contains 500 mg capecitabine.


The other ingredients are:

  • Tablet core: Croscarmellose sodium, microcrystalline cellulose, hypromellose, silica, colloidal anhydrous, magnesium stearate,

  • Tablet coating: Hypromellose, titanium dioxide (E171), talc, macrogol 400, red iron oxide (E172), yellow iron oxide (E172)


What Capecitabine Mylan looks like and contents of the pack


Capecitabine Mylan 150 mg film-coated tablets:

Light-peach oval film-coated tablets marked with “150” on one side. Of approximate dimensions 11.4 mm x 5.9 mm.


Capecitabine Mylan 150 mg film-coated tablets are available in different pack sizes:


Blister packs of 60 film-coated tablets.


Unit dose blister packs of 60x1 film-coated tablets.


Capecitabine Mylan 500 mg film-coated tablets:

Peach, oblong capsule-shaped, film-coated tablets marked with “500” on one side. Of approximate dimensions 17.1 mm x 8.1 mm.


Capecitabine Mylan 500 mg film-coated tablets are available in different pack sizes:


Blister packs of 120 film-coated tablets


Unit dose blister packs of 120x1 film-coated tablets


Not all pack sizes/types may be marketed.


Marketing Authorisation Holder


[To be completed nationally]


Manufacturer

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


This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: Capecitabine Mylan 150 mg, filmomhulde tabletten, comprimés pelliculés / Filmtabletten

Capecitabine Mylan 500 mg, filmomhulde tabletten, comprimés pelliculés / Filmtabletten

Czech Republic: Capecitabine Mylan 150 mg, potahované tablety

Capecitabine Mylan 500 mg, potahované tablety

France: CAPECITABINE MYLAN 150 mg, comprimé pelliculé

CAPECITABINE MYLAN 500 mg, comprimé pelliculé

Germany: Capecitabin Mylan 150 mg Filmtabletten

Capecitabin Mylan 500 mg Filmtabletten

Greece: Capecitabine Mylan 150 mg, επικαλυμμένα με λεπτό υμένιο δισκίο

Capecitabine Mylan 500 mg, επικαλυμμένα με λεπτό υμένιο δισκίο

Italy: Capecitabina Mylan 150mg

Capecitabina Mylan 500mg

The Netherlands: Capecitabine Mylan 150 mg, filmomhulde tabletten

Capecitabine Mylan 500 mg, filmomhulde tabletten

Spain: Capecitabina MYLAN 150 mg comprimidos recubiertos con película EFG

Capecitabina MYLAN 500 mg comprimidos recubiertos con película EFG

Sweden: Capecitabine Mylan, 150mg filmdragerad tablett

Capecitabine Mylan, 500mg filmdragerad tablet

UK: Capecitabine Mylan 150mg Film-coated Tablets

Capecitabine Mylan 500mg Film-coated Tablets

This leaflet was last revised in 2016-10-19