Ecansya 150 mg film-coated tablets, Ecansya 300 mg film-coated tablets, Ecansya 500 mg film-coated tablets 
capecitabine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Ecansya is and what it is used for 
2. What you need to know before using Ecansya 
3. How to use Ecansya 
4. Possible side effects 
5. How to store Ecansya 
6. Contents of the packaging and other information 

1. What Ecansya is and what it is used for

Ecansya belongs to a group of medicines called “cytostatics”, which prevent the growth of cancer cells. Ecansya contains capecitabine, which is not in itself a cytostatic drug. Only after the body has absorbed capecitabine is it converted into an active anti-cancer drug (preferably in tumor tissue).

Ecansya is used to treat colon, rectal, gastric, or breast cancer. Ecansya is also used to prevent colon cancer from returning after a tumor has been removed.

Ecansya can be used either alone or in combination with other medicines.

2. What you need to know before using Ecansya

Do not use Ecansya

  • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You must tell your doctor if you know that you are allergic or hypersensitive to this medicine. if you have previously had severe reactions to fluoropyrimidine treatment (a group of anticancer medicines such as fluorouracil),
  • if you are pregnant or breastfeeding,
  • if you have severely low levels of white blood cells or platelets ( leukopenia, neutropenia, a or thrombocytopenia ),
  • if you have severe liver or kidney problems,
  • if you know that you are completely inactive by the enzyme a dihydropyridine dehydrogenase (DPD) (total DPD deficiency),
  • if you are being treated with, or within the last 4 weeks have been treated with brivudine to treat herpes zoster (chickenpox or shingles ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Ecansya

– if you know that the enzyme a dihydropyrimidine dehydrogenase (DPD) is partially inactive in you

– if the enzyme a dihydropyrimide dehydrogenase (DPD) is partially or completely inactive in someone in your family

– if you have liver or kidney disease

– if you have or have had heart problems such as irregular heartbeat or pain in the chest, jaw, or back caused by physical exertion and due to problems with blood flow to the heart

– if you have diseases of the brain (for example, cancer that has spread to the brain) or nerve damage ( neuropathy )

– if you have disturbed calcium balance (seen in blood tests)

– if you have diabetes

– if you can not keep food or water in your body due to severe nausea and vomiting

– if you have diarrhea

– if you are or become dehydrated

– if you have an imbalance of ions in the blood (imbalance of electrolyte is, seen in samples)

– if you have previously had eye problems, as you may need extra eye checks

– if you have a severe skin reaction

DPD deficiency :

DPD deficiency is a congenital condition that is not usually associated with health problems unless you use certain medications. If you have DPD deficiency and are taking Ecansya, you have an increased risk of serious side effects (listed in section 4 Possible side effects ). It is recommended that you be tested for DPD deficiency before starting treatment. If you have no enzyme activity, do not take Ecansya. If you have reduced enzyme activity ( partial deficiency), your doctor may prescribe a lower dose. Serious and life-threatening side effects can still occur even if your test result for DPD deficiency is negative.

Children and young people

Ecansya is not indicated for children and adolescents. Do not give Ecansya to children and adolescents.

Other medicines and Ecansya

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is very important, as taking more than one medicine at the same time may intensify or weaken the effect of the medicines.

You must not take brivudine (antiviral medicine used to treat shingles or chickenpox) while you are being treated with capecitabine (including during the rest period when you are not taking any capecitabine tablets).

If you have taken brivudine, you must wait at least 4 weeks after stopping brivudine before starting capecitabine treatment. See also section “Do not take Ecansya”.

You must also be especially careful if you take any of the following:

  • gout medication (allopurinol),
  • blood thinners (coumadin, warfarin ),
  • medicines for seizures or tremors ( phenytoin ),
  • interferon alfa,
  • radiation therapy and certain drugs used to treat cancer (folic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
  • drugs used to treat folic acid deficiency

Ecansya with food, drink, and alcohol

You should take the tablets within 30 minutes after the end of the meal.

Pregnancy and breastfeeding

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

You should not breast-feed while taking Ecansya and for 2 weeks after the last dose.

If you are a pregnant woman, you should use effective contraception during treatment with Ecansya and for a further 6 months after the last dose.

If you are a male patient and your female partner is fertile, you should use effective contraception during treatment with Ecansya and for a further 3 months after the last dose.

Driving and using machines

Ecansya may make you feel dizzy, nauseous, or tired after ingestion. It is therefore possible that Ecansya may affect your ability to drive or use machines.

Ecansya 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 use Ecansya

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Capecitabine should only be prescribed by a doctor who has experience in the use of anticancer medicines.

Your doctor will prescribe the right dose and dosage for you. The Ecansya dose is based on your body surface area. It is calculated based on your height and weight. The usual dose for adults is 1250 mg / m 2 body surface area twice a day (morning and evening). Two examples are given here: A person whose body weight is 64 kg and length is 1.64 m has a body surface area of ​​1.7 m 2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice a day. A person whose body weight is 80 kg and length is 1.80 m has a body surface area of ​​2.00 m 2 and should take 5 tablets of 500 mg twice a day.

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 at each dose.

  • Take the tablets morning and evening as prescribed by your doctor.
  • Take the tablets within 30 minutes after the end of the meal (breakfast and dinner) and swallow them whole with waterDo not crush or split the tablets. If you cannot swallow Ecansya tablets whole, talk to your healthcare provider.
  • You must take all the medicines prescribed by your doctor.

Ecansya tablets are normally taken for 14 days followed by a 7-day rest period (when no tablets are taken). This 21-day period is a treatment cycle.

In combination with other medicines, the normal dose for adults may be less than 1250 mg / m 2 body surface area, and you may need to take the tablets for a different period of time (eg every day without any rest period).

If you use more Ecansya than you should  

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

You can get the following side effects if you take much more capecitabine than you should: nausea and vomiting, diarrhea, inflammation or ulcers in the intestines or mouth, pain or bleeding from the intestines or stomach, or bone marrow depression (decrease in certain types of blood cells ). Tell your doctor immediately if you experience any of these symptoms.

If you forget to use Ecansya

Do not take the missed dose. Do not take a double dose to make up for a forgotten dose. Instead, continue with your prescribed dosage and talk to your doctor.

If you stop using Ecansya

There are no side effects caused by stopping capecitabine treatment. If you are taking coumarin anticoagulants (containing, for example, phenprocoumon), your doctor may need to adjust your dose of anticoagulants when you stop taking capecitabine.

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

  • Diarrhea: If you have an increase of more than 4 stools each day compared to your normal number of stools per day or diarrhea at night.
  • Vomiting: If you vomit more than once a day.
  • Nausea: If you lose your appetite and the amount of food you eat every day is much less than usual.
  • Stomatitis: If you have pain, redness, swelling, or sores in your mouth and/or throat.
  • Hand-foot syndrome: If you have pain, swelling, redness, or tingling in your hands and/or feet.
  • Fever: If you have a body temperature of 38 ºC or more.
  • Infection: If you have signs of infection caused by bacteria or viruses or other organisms.
  • Chest pain: If you feel pain from the middle of the chest, especially if it comes when you exercise.
  • Stevens-Johnson syndrome: if you have painful red or violet skin rashes that spread and blisters and/or other sores that begin to appear in the mucous membrane (eg mouth and lips), especially if you have previously been photosensitive, had an infection in the airways (t eg bronchitis ) and/or fever
  • DPD deficiency: if you have a known DPD deficiency, you are at increased risk of acute and early onset of poisoning and severe, life-threatening, or fatal side effects caused by Ecansya (eg stomatitis, mucositis, diarrhea, neutropenia, and neurotoxicity).

If these side effects are detected early, they may subside within 2 to 3 days after stopping treatment. If these side effects persist, contact your doctor immediately. Your doctor may advise you to start treatment again with a lower dose.

If severe stomatitis (sores in your mouth and/or throat), mucositis, diarrhea, neutropenia (increased risk of infections ), or neurotoxicity occurs during the first treatment cycle, this may be due to DPD deficiency (see section 2 Warnings and Precautions).

Skin reactions on hands and feet can lead to loss of fingerprints, which may affect your fingerprint identification.

In addition to what is mentioned above, when Ecansya is used alone, are very common side effects, which can affect more than 1 in 10 people:

– abdominal pain

skin rash, dry or itchy skin

– fatigue

– loss of appetite ( anorexia )

These side effects can be serious. Therefore, always contact your doctor immediately when you start to feel a side effect. Your doctor may advise you to reduce the dose one and/or to temporarily stop Ecansya treatment. In this way, the risk of the side effect continuing or worsening is reduced.

Other side effects are:

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

  • decreased number of white or red blood cells (seen in samples)
  • dehydration, weight loss
  • sleeplessness ( insomnia ), depression, headache, sleepiness, dizziness, abnormal sensation of the skin (numbness or tingling), taste perversion
  • eye irritation, increased tear volume, red eyes ( conjunctivitis )
  • inflammation of the veins ( thrombophlebitis )
  • shortness of breath, nosebleeds, cough, runny nose
  • cold sores or other herpes infection
  • infection in the lungs or respiratory tract (eg pneumonia or bronchitis )
  • bleeding from the intestine, constipation, pain in the upper abdomen, indigestion, increased gas in the stomach, dry mouth
  • skin rash, hair loss ( alopecia ), reddening of the skin, dry skin, itching, skin discoloration, skin detachment, skin inflammation, nail effects
  • joint, limb, chest, or back pain
  • fever, swelling of the extremities, feeling sick
  • problems with liver function (seen in blood tests) and increased amount of bilirubin in the blood (excreted by the liver)

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

  • Infection in the blood, urinary tract infection, infection of the skin, infection of the nose and throat, fungal infection (including infection of the mouth), influenza, gastrointestinal catarrh, dental disease,
  • lumps under the skin ( liposome )
  • decreased number of blood cells including platelets thinned the blood (seen in blood samples)
  • allergy
  • diabetes decreased potassium in the blood, malnutrition, elevated blood fats
  • confusion, panic attacks, depression, decreased libido
  • difficulty speaking impaired memory, loss of ability to coordinate movements, balance problems fainting, nerve damage ( neuropathy ), and emotional problems
  • blurred vision or double vision
  • dizziness, earache
  • irregular heartbeat and palpitations ( arrhythmias ), chest pain, and heart attack (infarction)
  • blood clots in the deep veins, high or low blood pressure, hot flashes, cold extremities, purple spots on the skin
  • blood clots in the veins of the lung ( pulmonary embolism), collapsing lung, coughing up blood, asthma, shortness of breath on exertion
  • intestinal obstruction, accumulation of fluid in the abdomen, inflammation of the small intestine, large intestine, stomach, or esophagus, pain in the lower abdomen, abdominal discomfort, heartburn (regurgitation of food from the stomach), bloody stools
  • jaundice (yellowing of the skin and eyes)
  • sores and blisters on the skin, skin reaction to sunlight, redness of the palms, swelling or pain in the face
  • swollen or stiff joints, skeletal pain, weakness, or stiffness in the muscles
  • renal fluid retention increased urinary frequency during the night, incontinence, blood in the urine, increased levels of creatinine in the blood (signs of renal dysfunction)
  • unusual vaginal bleeding
  • swelling ( edema ), chills, and stiffness.

Some of these side effects are more common when capecitabine is used with other medicines to treat cancer. Other side effects seen in these cases are as follows:

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

  • decreased amount of sodium, magnesium, or calcium in the blood, increased blood sugar
  • nerve pain
  • ringing or buzzing sounds in the ears ( tinnitus ), hearing loss
  • inflammation of the veins
  • hiccups, altered voice
  • pain or altered / abnormal sensation in the mouth, pain in the jaw
  • sweating, night sweats
  • muscle cramps
  • difficulty urinating, blood, or protein in the urine
  • bruising or reaction at the injection site (caused by medicines given as an injection at the same time )

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

  • narrowing or blocking of the lacrimal duct (lacrimal ductus stenosis)
  • liver failure
  • inflammation leading to dysfunction or blockage of 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 that causes eye pain and possibly vision problems,
  • inflammation of the skin that causes red scaly patches due to disease emanating from the immune system

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

  • severe skin reaction such as skin rash, sores, and blisters that may include sores in the mouth, nose, genitals, hands, feet, and eyes (red and swollen eyes)

5. How to store Ecansya

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 expiration date is the last day of the specified month.

For aluminum-aluminum blisters:

This medicine does not require any special storage instructions.

For PVC / PVdC aluminum blisters:

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is capecitabine. Each film-coated tablet contains 150 mg, 300 mg, or 500 mg of capecitabine.

– Other ingredients (excipients) are:

Tablet core

Anhydrous lactose, croscarmellose sodium, hypromellose (E-5), microcrystalline cellulose, magnesium stearate.

Film coating

Ecansya 150 mg film-coated tablets

Hypromellose (6cps), titanium dioxide (E 171), yellow iron oxide, red iron oxide (E 172), talc.

Ecansya 300 mg film-coated tablets

Hypromellose (6cps), titanium dioxide (E 171), talc.

Ecansya 500 mg film-coated tablets

Hypromellose (6cps), titanium dioxide (E 171), yellow iron oxide (E172), red iron oxide (E172), talc.

See section 2 “Ecansya contains lactose”.

What the medicine looks like and the contents of the pack

Ecansya 150 mg film-coated tablets are slightly peach-colored, oblong, biconvex tablets, 11.4 mm long and 5.3 mm wide, marked “150” on one side and smooth on the opposite side.

Ecansya 300 mg film-coated tablets are white to off-white, oblong, biconvex tablets, 14.6 mm long and 6.7 mm wide, marked “300” on one side and smooth on the opposite side.

Ecansya 500 mg film-coated tablets are peach-colored, oblong, biconvex tablets, 15.9 mm long and 8.4 mm wide, marked “500” on one side and smooth on the opposite side.

Ecansya is available as a blister (aluminum-aluminum or PVC / PVdC-aluminum) containing 30, 60, or 120 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow HA1 4HF, UK

Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Contact the representative of the marketing authorization holder to find out more about this medicine:

KRKA Sverige AB

Tel: + 46 (0) 8 643 67 66 (SE)

Muhammad Nadeem

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