Read all of this leaflet carefully before you start taking this medicine.

– Save this leaflet, you may need to read about it.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you personally. You should not pass it on 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.

In this leaflet you will find information about: 
1. What is Capecitabine medac and what is it used for? 
2. Before you use Capecitabine medac 
3. How to use Capecitabine medac 
4. Possible side effects 
5. Storage of Capecitabine medac

What does Capecitabine medac contain?

The active substance is capecitabine.

Each 150 mg film-coated tablet contains 150 mg of capecitabine

Each 300 mg film-coated tablet contains 300 mg of capecitabine

Each 500 mg film-coated tablet contains 500 mg of capecitabine

Other ingredients are:

Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.

Tablet coating (for 150 mg): hypromellose, titanium dioxide (E 171), yellow iron oxide, red iron oxide (E 172), talc

Tablet coating (for 300 mg): hypromellose, titanium dioxide (E 171), talc

Tablet coating (for 500 mg): hypromellose, titanium dioxide (E 171), yellow iron oxide, red iron oxide (E 172), talc

Marketing Authorisation Holder

medac

Society for clinical

Special preparations mbH

Theaterstr. 6

22880 Wedel

Germany

Manufacturer

Pharmacare Premium Ltd,

HHF 003, Hal Far Industrial Estate Birzebbugia

BBG 3000, Malta

1. WHAT IS CAPECITABINE MEDAC AND WHAT IS IT USED FOR?

The appearance of the drug:

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

What is Capecitabine medac used for?

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

Capecitabine medac is used to treating colon, rectal, gastric, or breast cancer. Capecitabine medac is also used to prevent the recurrence of colon cancer after a tumor has been removed.

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

2. BEFORE YOU USE CAPECITABINE MEDAC

Do not use 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 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 anti-cancer drugs such as fluorouracil),

• if you are pregnant or breast-feeding,

• 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 that the enzyme a dihydropyridine dehydrogenase (DPD) is completely inactive in you,

• if you have been treated with, or within the last 4 weeks have been treated with brivudine, sorivudine, or similar substances for the treatment of herpes zoster (chickenpox or shingles ).

Take special care with Capecitabine medac:

Warnings and cautions

Talk to your doctor or pharmacist before taking Capecitabine medac

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

• if you have liver or kidney disease

• if you have or have had heart problems (eg irregular heartbeat or pain in the chest jaw and back, which occurs during physical exertion and is due to problems with blood flow to the heart)

• if you have brain diseases (eg cancer that has spread to the brain) or nerve damage ( neuropathy )

• if you have disturbed calcium balance (seen with a blood test)

• if you have diabetes

• if you cannot keep food or water in your body due to severe nausea and vomiting

• if you have diarrhea

• if you have or experience dehydration

• if you have an imbalance of ions in the blood (electrolyte imbalance, seen with blood tests)

• 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 rare congenital condition that is not usually associated with health problems unless you are given certain medications. If you have an unknown DPD deficiency and are taking Capecitabine medac, you may be at increased risk for early and rapid onset severe side effects listed in section 4 Possible side effects. Contact your doctor immediately if you are worried about any of the side effects or if you notice any additional side effects not listed in this leaflet (see section 4 Possible side effects ).

Taking Capecitabine medac with food and drink:

You should take Capecitabine medac within 30 minutes of finishing your meal.

Children

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

Pregnancy

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 should not take Capecitabine medac if you are or think you may be pregnant.

You should not breast-feed if you are taking Capecitabine medac.

Breast-feeding

See under Pregnancy

Driving and using machines:

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

Use of other medicines:

Before starting treatment, 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 need to be especially careful if you take any of the following:

• medicines for gout (allopurinol),

• blood thinners (coumadin, warfarin ),

• certain antiviral drugs (sorivudine and brivudine),

• medicines for seizures or tremors ( phenytoin ),

• interferon-alpha,

• radiation therapy and certain medicines used to treat cancer ( folic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),

• medicines used to treat folic acid deficiency.

3. HOW TO USE CAPECITABINE MEDAC

Dosage instructions

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 water.
  • It is important that you take all the medicines prescribed by your doctor.

Capecitabine medac 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 / m² 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 Capecitabine medac than you should:

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

If you forget to take Capecitabine medac:

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

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:

  • 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 in 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 Capecitabine medac (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.

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

In addition to the above, when Capecitabine medac has used alone, very common side effects, which occur in 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. It is therefore important that you always contact your doctor immediately when you start to feel a side effect. Your doctor may tell you to reduce the dose and/or temporarily stop taking Capecitabine medac. In this way, the risk of the side effect continuing or worsening is reduced.

Common: may affect up to 1 in 10 people

  • Reduction in the number of white blood cells or red blood cells (seen with blood tests)
  • Dehydration, weight loss
  • Insomnia, depression
  • Headache, drowsiness, dizziness, abnormal sensation in the skin (numbness or tingling), taste changes
  • Eye irritation, increased tear flow, red eyes ( conjunctivitis )
  • Inflammation of the veins ( thrombophlebitis )
  • Shortness of breath, nosebleeds, cough, runny nose
  • Cold sores or other herpes infections
  • Infection in the lungs or respiratory tract (for example pneumonia or bronchitis )
  • Bleeding from the stomach, constipation, upper abdominal pain, indigestion, increased flatulence, dry mouth
  • Skin rash, hair loss ( alopecia ), reddening of the skin, dry skin, itching ( pruritus ), discoloration of the skin, skin loss, skin inflammation, nail problems
  • Pain in the joints or in the arms and legs ( extremities ), chest or back
  • Fever, swelling in arms or legs, feeling sick
  • Problems with liver function (seen with blood tests) and increased bilirubin in the blood (excreted from the liver)

Uncommon: may affect up to 1 in 100 people

  • Blood infection, urinary tract infection, infection of the skin, infection of the nose and throat, fungal infections (including those in the mouth), influenza, gastroenteritis (summer sickness), warts in the teeth
  • Lumps under the skin (lipoma)
  • Decreased number of blood cells, including platelets, blood thinning (seen with blood tests)
  • Allergy
  • Diabetes , decreased potassium in the blood, malnutrition, increased triglycerides in the blood
  • Confusion, panic attacks, depression, decreased sex drive
  • Speech difficulties, impaired memory, impaired coordination of movements, balance problems, fainting, nerve damage ( neuropathy ), and problems with feeling
  • 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 arms and / or legs ( extremities ), violet spots on the skin
  • Blood clots in the veins of the lung ( pulmonary embolism ), collapsed lung, coughing up blood, asthma, shortness of breath on exertion
  • Blockages of the intestines, accumulation of fluid in the abdomen, inflammation of the small intestine or large intestine, stomach or esophagus, pain in the lower abdomen, discomfort in the stomach, heartburn (regurgitation of food from the stomach), blood in the stool
  • Jaundice (skin and eyes turn yellow)
  • Sores and blisters on the skin, skin reactions when exposed to the skin in sunlight, flushing palms, swelling or pain in the face
  • Swelling or stiffness in the joints, pain in the skeleton, muscle weakness or stiffness
  • Accumulation of fluid in the kidneys increased frequency of urination at night, incontinence, blood in the urine, increase in creatinine in the blood (signs of poor kidney function)
  • Unusual vaginal bleeding
  • Swelling ( edema ), chills, or stiffness

Some of these side effects are more common when capecitabine is used with other medicines to treat cancer. Other side effects that appear in this context are the following:

Common:  may affect up to 1 in 10 people

  • The decrease in sodium, magnesium, or calcium in the blood, increase in blood sugar
  • Nerve pain
  • Ringing or buzzing in the ears ( tinnitus ), hearing loss
  • Venous inflammation
  • Hiccups, voice changes
  • Pain or altered / abnormal sensation in the mouth, pain in the jaw
  • Sweating, night sweats
  • Muscle spasms
  • Difficulty urinating, blood or protein in the urine
  • Bruising or reaction at the injection site (caused by drugs being injected at the same time)

Rare:  may affect up to 1 in 1000 people

  • narrowing or blockage of the tear duct (tear duct stenosis)
  • liver failure
  • inflammation leading to impaired function or blockage of bile secretion (cholestatic hepatitis )
  • specific changes in ECG ( QT prolongation)
  • certain types of arrhythmias (including ventricular fibrillation, torsade de Pointes and bradycardia )
  • eye inflammation that causes pain in the eyes and possibly vision problems
  • inflammation of the skin that causes red scaly patches due to disease emanating from the immune system

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

  • 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)

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

Website: The Medical Products Agency

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. STORAGE OF CAPECITABINE MEDAC

Keep this medicine out of the sight and reach of children.

<For aluminum-aluminum blisters:>

No 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.

Muhammad Nadeem

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