Capecitabine 150 Mg Film-Coated Tablets
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1. What Capecitabine Tablets are and what they are used for
Package leaflet: Information forthe user
Capecitabine 150 mg film-coated Tablets
capecitabine
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
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pharmacist.
on to others. It may harm them, even if their signs of illness are the same as yours.
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This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Capecitabine Tablets are and what they are used for
2. What you need to know before you take Capecitabine Tablets
3. How to take Capecitabine Tablets
4. Possible side effects
5. How to store Capecitabine Tablets
6. Contents of the pack and other information
Capecitabine Tablets belong to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Tablets contain 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 Tablets are used in the treatmentofcolon, rectal, gastric, or breast cancers.
Furthermore, Capecitabine Tablets are used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Capecitabine Tablets may be used eitheralone or in combination with other medicines.
2. What you need to know before you take Capecitabine Tablets
Do not take Capecitabine Tablets:
ingredients of this medicine (listed in section 6). You must inform your doctor if you know that you have an allergy or overreaction 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 (leucopenia, neutropenia or thrombocytopenia),
• if you have severe liver or kidney problems,
• if you know that you do not have any activity for 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 Tablets
• 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. Ifyou have an unrecognised DPD deficiency and take Capecitabine Tablets, you are at an increased risk of acute early-onset of 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 Tablets are not indicated in children and adolescents. Do not give Capecitabine Tablets to children and adolescents.
Other medicines and Capecitabine Tablets
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 orweaken the effect ofthe medicines. You need to be particularly careful if you are taking any of the following:
gout medicines (allopurinol), blood-thinning medicines (coumarin, warfarin), certain anti-viral medicines (sorivudine and brivudine), medicines for seizures or tremors (phenytoin), interferon alpha, or
radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
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Capecitabine Tablets with food, drink and alcohol
You should take Capecitabine Tablets 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 Tablets if you are pregnant or think you might be.
You must not breast-feed if you are taking Capecitabine Tablets. Driving and using machines
Capecitabine Tablets may make you feel dizzy, nauseous or tired. It is therefore possible that Capecitabine Tablets could affect your ability to drive a car or operate machines.
Capecitabine Tablets 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.
3. How to take Capecitabine Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.
Capecitabine Tablets should only be prescribed by a doctor experienced in the use of anticancer medicines. Capecitabine Tablets should be swallowed whole with water and within 30 minutes ofa meal.
Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Capecitabine Tablets is based on your body surface area. This is calculated from your height and weight. The usual 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 m2and should take 5 tablets of 500 mg two times daily.
Capecitabine Tablets are usually taken for 14 days followed bya7 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 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 mg and 500 mg tablets for each dose.
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doctor.
(breakfast and dinner), your doctor.
Ifyou take more Capecitabine Tablets than you should
Ifyou take more Capecitabine Tablets 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.
Ifyou forget to take Capecitabine Tablets
Do not take the missed dose at all and do not double the next one. Instead, continue your regular dosing schedule and check with your doctor.
Ifyou stop taking Capecitabine Tablets
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 Tablets immediately and contact your doctor if any of these symptoms occur:
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movements compared to your normal bowel movements each day or any diarrhoea at night.
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• 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-footskin-reaction: ifyou 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.
• Chestpain: 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/orfever.
• DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, orfatal adverse reactions caused by capecitabine (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
If caught early, these side effects usually improve within 2to3 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.
Hand and foot skin-reaction can lead to loss offingerprint, which could impact your identification by fingerprint scan.
In addition to the above, when Capecitabine Tablets are 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 Tablets. This will help reduce the likelihood that the side effect continues or becomes severe.
Other side effects are:
Common side effects (may affect upto1in10 people) include:
• decreases in the number ofwhite 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 side effects (may affect up to 1 in 100 people) include:
• blood infection, urinary tract infection, infection ofthe 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 lowerabdomen, abdominal discomfort, heartburn (reflux offood 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 ofthe 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 ofthese 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 side effects (may affect uptol in10 people) include:
• decrease in blood sodium, magnesium orcalcium, increase in blood sugar,
• nerve pain,
• ringing or buzzing in the ears (tinnitus), loss of hearing,
• vein inflammation,
• hiccups, change in voice,
• pain oraltered/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 side effects (may affect up to 1 in 1,000 people) include:
• 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 side effects (may affect up to 1 in 10,000 people) include:
• severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers ofthe mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes).
Reporting ofside effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Capecitabine Tablets
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 outer carton and label after EXP.
The expiry date refers to the last day of that month.
There are no special storage requirements for this medicinal product.
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 Tablets contain
150mg capecitabine.
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Tablet core: lactose monohydrate, microcrystalline cellulose (E460), hypromellose, crosscarmellose sodium, magnesium stearate (E572).
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide red NF (E172).
What Capecitabine Tablets look like and contents ofthe pack
Capecitabine Tablets are pink coloured, capsule shaped, biconvex, film-coated tablets, debossed with "150"on one side and plain on the other side.
Capecitabine Tablets are supplied in blister packs of30, 60 & 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough
LE11 5GW
UK
This leaflet was last revised in September 2016.
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