100 mg film-coated tablets
imatinib

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 can harm them, even if they show signs of illness similar to yours.

– 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. See section 4.

In this leaflet:
1. What Imatinib Mylan is and what it is used for
2. What you need to know before taking Imatinib Mylan
3. How to take Imatinib Mylan
4. Possible side effects
5. How to store Imatinib Mylan
6. Contents of the packaging and other information

What Imatinib Mylan is and what it is used for

Imantinib Mylan is a medicine that contains an active substance called imatinib. The drug acts by inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.

Imatinib Mylan is a treatment for adults and children for:

  • Chronic myeloid leukemia (CML).   Leukemia is a cancer of the white blood cells . These white blood cells usually help the body fight infection . Chronic myeloid leukemia is a form of leukemia in which certain abnormal white blood cells (so-called myeloid cells) begin to grow out of control.
  • Philadelphia chromosome-positive acute lymphoblastic leukemia ( Ph- positive ALL). Leukemia is a cancer of the white blood cells . These white blood cells normally help the body fight infection . Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal, immature white blood cells (so-called lymphoblasts ) begin to grow out of control. Imatinib Mylan inhibits the growth of these cells.

Imatinib Mylan is also a treatment for adults for:

  • Myelodysplastic / myeloproliferative disorders (MDS / MPD). These are a group of blood diseases in which certain blood cells begin to grow out of control. Imatinib Mylan inhibits the growth of these cells in a certain subset of these diseases. 
  • Hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukemia (CEL). These are blood diseases in which certain blood cells (so-called eosinophils ) begin to grow out of control. Imatinib Mylan inhibits the growth of these cells in a certain subset of these diseases.
  • Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which certain cells begin to grow out of control. Imatinib Mylan inhibits the growth of these cells.

In the rest of this leaflet, abbreviations will be used when talking about these diseases.

Ask your doctor if you have any questions about how Imatinib Mylan works or why this medicine has been prescribed for you.

Imantinib contained in Imantinib Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Imatinib Mylan

Do not use Imatinib Mylan

Imatinib Mylan will only be prescribed to you by a doctor with medical experience in treating different types of blood cancers or solid tumors. 

Follow all of your doctor’s instructions carefully, although these may differ from the general information in this leaflet.

Do not take Imatinib Mylan

  • if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).If this applies to you, do not take Imatinib Mylan without telling your doctor .

If you think you may be allergic but are not sure, ask your doctor for further advice.

Warnings and cautions

Talk to your doctor before taking Imatinib Mylan.

  • if you have or have had a liver, kidney or heart disease.
  • if you are taking the medicine levothyroxine because your thyroid has been removed.
  • if you have ever had or may now have a hepatitis B infection . The reason for this is that Imatinib Mylan can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their physician for signs of this infection before starting treatment.
  • if you get bruises, bleeding, fever, get very tired and confused when taking imatinib, contact your doctor. This may be a sign of an injury to the blood vessels called thrombotic microangiopathy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Mylan.

You may become more sensitive to the sun while taking Imatinib Mylan. It is important to cover exposed areas of the skin and use sunscreen with a high sun protection factor (SPF). These precautions also apply to children.

When taking Imatinib Mylan, tell your doctor immediately if you gain weight quickly. Imatinib Mylan may cause your body to bind fluid (severe fluid retention ).

When you take Imatinib Mylan, your doctor will regularly check that the medicine is working. You will also be given blood samples and weighed regularly.

Children and young people

Imatinib Mylan is also a treatment for children with CML. There is no experience from children with CML under 2 years. There is limited experience from children with Ph-positive ALL and very limited experience from children with MDS / MPD, DFSP, and HES / CEL.

Some children and adolescents taking Imatinib Mylan may grow more slowly than usual. Your doctor will regularly check your growth.

Other medicines and Imatinib Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription (eg paracetamol ) and herbal medicines (eg St. John’s wort ). Some medicines may affect the effect of Imatinib Mylan when taken together. They may increase or decrease the effect of Imatinib Mylan and either leads to more side effects or make Imatinib Mylan less effective. Imatinib Mylan can do the same for some other medicines.

Tell your doctor if you are taking medicines that prevent the formation of blood clots.

Pregnancy, breastfeeding and fertility

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
  • Imatinib Mylan is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss the possible risks of taking Imatinib Mylan during pregnancy.
  • Women who may become pregnant are advised to use effective contraception during treatment.
  • Do not breast-feed during treatment with Imatinib Mylan.
  • Patients who are concerned about their fertility when taking Imatinib Mylan are advised to consult their doctor.

Driving and using machines

You may feel dizzy or tired or have blurred vision when using this medicine. If this happens, do not drive or use any tools or machines until you feel well again.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Imatinib Mylan

Your doctor has prescribed Imatinib Mylan because you are suffering from a serious illness. Imatinib Mylan can help you fight this condition.

Always take this medicine exactly as your doctor or pharmacist has told you. It is important that you do this as long as your doctor or pharmacist tells you to. Ask your doctor or pharmacist if you are unsure.

Do not stop taking Imatinib Mylan unless your doctor tells you to. If you can not take the medicine according to your doctor’s prescription or if you feel that you do not need it anymore, contact your doctor immediately.

How much Imatinib Mylan to take?

Use for adults

Your doctor will tell you exactly how many Imatinib Mylan tablets to take.

If you are being treated for KML:

Depending on your condition, the usual starting dose is either 400 mg or 600 mg:

  • 400 mg taken as 4 tablets once a day,
  • 600 mg taken as 6 tablets once a day.

Your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.

– If you are being treated for Ph-positive ALL: The
the starting dose is 600 mg taken as 6 tablets once a day.

– If you are being treated for MDS / MPD: The
the starting dose is 400 mg taken as 4 tablets once a day.

– If you are being treated for HES / CEL: The
starting dose is 100 mg taken as a tablet once a day. Your doctor may decide to increase the dose to one to 400 mg taken as 4 tablets once a day, depending on how you respond to the treatment.

– If you are being treated for DFSP:
Dose one is 800 mg per day (8 tablets) taken as 4 tablets in the morning and 4 tablets in the evening.

Use for children and adolescents

Your doctor will tell you how many Imatinib Mylan tablets to give to your child. The amount of Imatinib Mylan given depends on your baby’s condition, body weight, and height. The total dose for children should not exceed 800 mg for CML and 600 mg for Ph-positive ALL. The treatment can either be given to your child as a single dose or alternatively the daily dose can be given on two different occasions (half in the morning and a half in the evening).

When and how to take Imatinib Mylan

  • Take Imatinib Mylan with a meal. It helps to protect against stomach problems when you take Imatinib Mylan.
  • Swallow the tablets whole with a large glass of water.

If you can not swallow the tablets, you can slurry them in a glass of non-carbonated water or apple juice.

  • Take about 50 ml for each 100 mg tablet.
  • Stir with a spoon until the tablets have completely dissolved.
  • Once the tablet has dissolved, immediately drink the entire contents of the glass. Residues of the dissolved tablets may remain in the glass.

How long to take Imatinib Mylan?

Continue to take Imatinib Mylan every day for as long as your doctor tells you to.

If you take more Imatinib Mylan than you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice. You may need medical attention. Take the medicine pack with you. Symptoms of an overdose include nausea, vomiting, diarrhea, rash, redness of the skin, fatigue, uncontrollable movements, muscle aches, abdominal pain, headache, decreased appetite, weakness and high body temperature.

If you forget to take Imatinib Mylan

  • If you forget to take a dose , take it as soon as you remember. However, skip the missed dose if it is soon time to take the next dose .
  • Then continue with your normal schedule.
  • Do not take a double dose to make up for a forgotten dose .

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. They are usually of mild to moderate severity.

Some side effects can be serious. Tell your doctor immediately if you get any of the following:

Very common (may affect more than 1 user in 10)

  • Changes in the number of blood cells that can cause signs of infection such as fever, chills, sore throat or sore mouth (changes in the number of white blood cells ), pale skin, tiredness and shortness of breath and dark urine (low number of red blood cells ), bleeding and bruising which lasts longer than normal or occurs for no known reason, when you have not injured yourself (changes in the number of platelets ).
  • Rapid weight gain. Imatinib Mylan can cause your body to bind water (severe fluid retention ).

Uncommon (may affect up to 1 in 100 people)

  • Fever with chills, rapid heartbeat, rapid breathing and / or confusion (signs of sepsis, severe reaction to an infection )
  • Chest pain (which may radiate to the arms), irregular heartbeat, shortness of breath, swelling in the feet or ankles due to accumulation of fluid (signs of heart problems).
  • Cough, difficulty breathing or painful breathing (signs of lung problems).
  • Nausea, with decreased appetite, dark urine, yellowing of the skin or eyes (signs of liver problems).
  • Skin rash, redness with blisters on lips, eyes, skin or mouth, flaking of the skin, fever, raised red or purple skin areas, itching , burning sensation, rash with small blisters (signs of skin problems).
  • Severe abdominal pain, vomiting or stool blood, black stools (signs of gastrointestinal disease).
  • Severe decreased urine output, thirst, dehydration, nausea, loss of appetite, weakness, fatigue, headache, general malaise (signs of kidney disease).
  • Severe headache, weakness or paralysis of the legs or face, difficulty speaking, sudden unconsciousness (signs of nervous system problems such as bleeding or swelling of the skull / brain).
  • Eye pain or impaired vision. Bleeding in the eyes.
  • Sudden swelling and redness of the skin (signs of a skin infection called cellulite ).
  • Impaired hearing.
  • Muscle weakness and muscle cramps with abnormal heart rhythm (signs that indicate changes in the amount of potassium in your blood).
  • Severe pain in the upper abdomen, often with nausea and vomiting
  • Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and / or joint problems associated with abnormal laboratory values ​​(eg high potassium , uric acid and calcium levels in the blood and low phosphorus levels in the blood).

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

  • Muscle cramps, with fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems)
  • Nausea with diarrhea and vomiting, persistent constipation, abdominal pain or fever (signs of intestinal problems)
  • Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, dizziness or fainting due to low blood pressure (signs of ovarian or uterine problems).
  • Blood clots in small blood vessels (thrombotic microangiopathy).

Has been reported (occurs in unknown number of users)

  • Pain in the hips or difficulty walking
  • Slow growth in children and adolescents 
  • Chronic renal failure
  • Severe allergic reaction with rash, itching or hives , swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing.
  • Sudden severe headache, loss of vision, loss of coordination, slurred speech, shortness of breath, chest pain, numbness, heat or swelling in the arms or legs (signs of a blockage in a blood vessel caused by a blood clot).
  • Allergic reaction that may affect the skin or other parts of the body such as the liver or blood cells (DRESS syndrome). Symptoms include rash, fever, enlarged lymph nodes for a long time, yellow skin or yellow whites of the eyes, unusual bruising or bleeding, unexplained muscle aches, frequent infections .
  • Recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection).

Tell your doctor immediately if you get any of the above.

Other side effects may include:

Very common (may affect more than 1 user in 10):

  • Headache or fatigue.
  • Nausea, vomiting, diarrhea or indigestion.
  • Rash.
  • Muscle cramps or pain in joints, muscles or bones during treatment with Imatinib Mylan or after stopping Imatinib Mylan.
  • Swelling around joints or swollen eyes.
  • Weight gain.

Tell your doctor if any of these affect you seriously.

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

  • Decreased appetite, weight loss or taste disorders.
  • Dizziness or weakness.
  • Sleep problems ( insomnia ).
  • Runny eyes with itching , redness and swelling (conjunctivitis), watery eyes or blurred vision.
  • Nosebleed.
  • Abdominal pain or distended abdomen, flatulence, heartburn, constipation.
  • Itching .
  • Unexpectedly heavy hair loss or thinning of the hair.
  • Numbness or tingling in the hands and feet.
  • Joint pain with swelling.
  • Dry mouth , dry skin or dry eyes.
  • Decreased or increased sensitivity of the skin.
  • Increased photosensitivity in the skin.
  • Hot flashes, chills or night sweats.
  • Increased levels of liver enzymes detected in blood tests.

Tell your doctor if any of these affect you seriously.

Uncommon (may affect up to 1 in 100 people)

  • Depression, anxiety.
  • Memory problem.
  • General malaise.
  • High blood pressure .
  • Feeling dizzy, dizzy or fainting (signs of low blood pressure ).
  • Somnolence.
  • Restless legs, tremors .
  • Pain in the lower back, which radiates to the leg (sciatica).
  • Scams ( vertigo ).
  • Ringing in the ears.
  • Increased sweating.
  • Increased appetite.
  • Cracked fingernails or toenails.
  • Discoloration of the skin.
  • Skin rash, often with pain and blisters ( shingles ).
  • Numb or cold toes and fingers (signs of Raynaud’s syndrome).
  • Pain, discomfort when swallowing or difficulty swallowing.
  • Sore mouth, dry or chapped lips, sores in the mouth.
  • Cold sores.
  • Belching.
  • Stiff joints or muscles.
  • Frequent urination, pain when urinating, cloudy urine or blood in the urine.
  • Abundant or irregular menstruation.
  • Enlarged breasts (even in men), pain in the nipple.
  • Swollen lymph nodes in the neck, armpits or groin
  • Swelling of the scrotum.
  • Sexual problems, including difficulty maintaining or achieving an erection in men and decreased sexual desire.
  • Changes in the levels of certain chemicals in the blood that show how the body works and that are detected in blood tests.

Tell your doctor if any of these affect you seriously.

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

  • Confusion.
  • Cramps.
  • Color changes on nails.

Tell your doctor if any of these affect you seriously.

Has been reported (occurs in unknown number of users):

  • Redness and / or swelling in the palms and soles of the feet which may be accompanied by a stinging sensation or burning pain.
  • Painful changes in the skin with or without blisters.

Tell your doctor if any of these affect you seriously.

Reporting of side effects

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

5. How to store Imatinib Mylan

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. The expiration date is the last day of the specified month.

No special storage instructions.

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 imatinib mesylate. Each tablet contains imatinib mesylate equivalent to 100 mg imatinib.
  • The other ingredients are microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463), povidone (E1201), crospovidone (Type A) (E1202), anhydrous colloidal silica, magnesium stearate (E572)
  • The film coating contains hypromellose (E464), macrogol 400, talc (E553b), red iron oxide (E172), yellow iron oxide (E172)

What the medicine looks like and contents of the pack

Imatinib Mylan 100 mg is a dark yellow to brownish orange, round film-coated tablet with a score line on one side and the label “100” on the other side. The tablet can be divided into two equal doses .

The packs contain 20, 60, 60×1, 120 or 180 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer

Remedica Ltd

Acharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

Muhammad Nadeem

Leave a Reply