Meaxin

Leaflet accompanying the packaging: patient information

Meaxin, 100 mg, coated tablets

Imatinib

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Meaxin and what is it used for
• 2. Important information before taking Meaxin
• 3. How to take Meaxin
• 4. Possible side effects
• 5. How to store Meaxin
• 6. Package contents and other information

1. What is Meaxin and what is it used for

Meaxin is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.

Meaxin is indicated for the treatment of adult patients and children with:

• Chronic myeloid leukemia (CML) -English Chronic Myeloid Leukaemia). Leukemia is a cancer that originates from white blood cells. White blood cells usually help the body fight infections. Chronic myeloid leukemia is a type of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
• Acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph-positive ALL)- English Philadelphia chromosome positive acute lymphoblastic leukaemia). Leukemia is a cancer that originates from white blood cells. Usually, white blood cells help the body fight infections. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to multiply uncontrollably. Meaxin inhibits the growth of these cells.

Meaxin is also indicated for the treatment of adult patients with:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD)- English Myelodysplastic/myeloproliferate diseases). These are blood diseases in which certain white blood cells begin to multiply uncontrollably. Meaxin inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES)- English Hypereosinophilic Syndrome) and (or) chronic eosinophilic leukemia (CEL)- English Chronic Eosinophilic Leukemia). These are blood diseases in which certain blood cells (called eosinophils) begin to multiply uncontrollably.

in an uncontrolled manner. Meaxin inhibits the growth of these cells in certain subtypes of these diseases.

• Gastrointestinal stromal tumors (GIST)- English Gastrointestinal Stromal Tumours). GIST is a stomach and intestinal tumor. It occurs as a result of uncontrolled growth of connective tissue cells of these organs.
• Dermatofibrosarcoma protuberans (DFSP)- English dermatofibrosarcoma protuberans). DFSP is a skin and subcutaneous tissue tumor, in which certain cells begin to multiply uncontrollably. Meaxin inhibits the growth of these cells.

In the rest of the leaflet, abbreviations of the disease names mentioned above will be used.
In case of any questions about the mechanism of action and justification of the administration of Meaxin,
you should consult your doctor.

2. Important information before taking Meaxin

Meaxin is prescribed to patients only by doctors with experience in the use of medicines used in the treatment of blood cancers or solid tumors.
You should strictly follow the doctor's recommendations, even if they differ from the general information contained in this leaflet.

When not to take Meaxin

• if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6). If this information applies to you, you should tell your doctor before taking the medicine

Meaxin.

In case of suspected allergy, but uncertainty, you should consult your doctor.

Warnings and precautions

Before starting Meaxin, you should discuss with your doctor:

• if you have or have had liver, kidney, or heart disease,
• if you are taking levothyroxine after thyroid removal,
• if you have had or may have a hepatitis B virus infection; this is because Meaxin may cause reactivation of hepatitis B virus infection, which can be fatal in some cases; patients will be closely monitored by their doctor to detect signs of this infection before starting treatment,
• if you experience bruising, bleeding, fever, fatigue, and disorientation while taking Meaxin, you should contact your doctor. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA). If any of the above points apply to you, you should tell your doctor before taking the medicine.

While taking Meaxin, you may become more sensitive to the sun. It is essential to cover exposed skin areas and use sunscreen with a high sun protection factor (SPF). These precautions should also be taken by children.
You should immediately tell your doctor if you experience a very rapid weight gain during Meaxin treatment. Meaxin may cause water retention in the body (severe fluid retention).
During Meaxin treatment, your health will be regularly evaluated by your doctor to determine if the treatment is effective. Blood tests and weight measurements will be regularly performed while taking this medicine.

Children and adolescents

Meaxin is also used to treat children with CML. There is no experience with the use of Meaxin in children with CML under the age of 2. Experience with the use of Meaxin in children with Ph-positive ALL is limited, and experience with the use of Meaxin in children with MDS/MPD, DFSP, GIST, and HES/CEL is very limited.
In some children and adolescents taking Meaxin, growth may be slower than normal. Your doctor will monitor growth during regular visits.

Meaxin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may affect the action of Meaxin if taken at the same time. They may enhance or weaken the action of Meaxin, which can lead to increased side effects or make Meaxin less effective. Similarly, Meaxin may affect certain other medicines.
You should tell your doctor if you are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

• Meaxin is not recommended for pregnant women unless absolutely necessary, as it may harm the baby. Your doctor will discuss the possible risks that may occur during Meaxin treatment during pregnancy.
• Women who may become pregnant should use effective contraception during Meaxin treatment and for 15 days after the end of treatment.
• You should not breastfeed while taking Meaxin and for 15 days after the end of treatment, as it may harm the baby.
• Patient interested in the impact of Meaxin on fertility during its use should consult their doctor.

Driving and using machines

While taking Meaxin, you may experience dizziness or drowsiness, or vision disturbances. In this case, you should not drive or operate any tools or machines until you feel better.

Meaxin contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Meaxin

Your doctor has prescribed Meaxin because of your serious condition. Meaxin may help improve your condition.
However, this medicine should always be taken according to your doctor's or pharmacist's recommendations. It is essential to take the medicine for as long as your doctor or pharmacist recommends. If you have any doubts, you should consult your doctor or pharmacist.
You should not stop taking Meaxin unless your doctor recommends it.
If you cannot take the prescribed medicine or think you no longer need it, you should immediately contact your doctor.

What dose of Meaxin to take

Adult patients

Your doctor will determine the exact number of Meaxin tablets you should take.

In the case of CML treatment:

Depending on your condition, the initial dose is usually 400 mg or 600 mg:

• 400 mgtaken as 4 tablets of 100 mg oncea day.
• 600 mgtaken as 6 tablets of 100 mg oncea day.

In the case of GIST treatment:

The initial dose is 400 mg, taken as:

• 4 tablets oncea day.

In the case of CML and GIST treatment, your doctor may prescribe a higher or lower dose depending on the response to treatment. If the daily dose is 800 mg (8 tablets), you should take:

• 4 tablets in the morning and 4 tablets in the evening.

In the case of Ph-positive ALL treatment:

The initial dose is 600 mg, taken as:

• 6 tablets oncea day.

In the case of MDS/MPD treatment:

The initial dose is 400 mg, taken as:

• 4 tablets oncea day.

In the case of HES/CEL treatment:

The initial dose is 100 mg, taken as 1 tablet of 100 mg oncea day.
Depending on your response to treatment, your doctor may decide to increase the dose to 400 mg taken as 4 tablets oncea day.

In the case of DFSP treatment:

The daily dose is 800 mg (8 tablets) taken as:

• 4 tablets in the morning and 4 tablets in the evening.

Children and adolescents

Your doctor will determine the number of tablets to give to the child. The dose of the medicine will depend on the child's condition, weight, and height. The total daily dose in children should not exceed 800 mg in CML treatment and 600 mg in Ph-positive ALL treatment. The dose can be given to the child once a day or divided into two doses (half the dose in the morning and half the dose in the evening).

When and how to take Meaxin

• Meaxin should be taken with foodto protect the stomach during Meaxin treatment.
• Tablets should be swallowed whole, with a large glass of water.

Patient who are unable to swallow tablets may dissolve them in a glass of non-carbonated water or apple juice.

• About 50 ml of liquid should be used for one 100 mg tablet.
• Mix with a spoon until the tablets are completely dissolved.
• After dissolving the tablets, the entire contents of the glass should be drunk immediately. Residues of the dissolved tablets may remain in the glass.

How long to take Meaxin

You should take Meaxin every day for as long as your doctor recommends.

Taking a higher dose of Meaxin than recommended

Patient who have taken too many tablets by mistake should immediatelytell their doctor, as they may need medical attention. You should take the medicine packaging with you.

Missing a dose of Meaxin

If you forget to take a dose, you should take it as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose.
Then continue with your regular dosing schedule.
You should not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Meaxin can cause side effects, although not everybody gets them.
They are usually mild to moderate.

Some side effects can be serious. You should immediately tell your doctor if you experience any of the following side effects.

Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):

• Rapid weight gain. Meaxin may cause water retention in the body (severe fluid retention).
• Infection symptoms, such as fever, severe chills, sore throat, and mouth ulcers. Meaxin may decrease the number of white blood cells in the blood, which can increase the risk of infection.
• Unexpected bleeding or bruising (even without injury).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1000 people):

• Chest pain, irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing, or chest pain during breathing (symptoms of lung problems).
• Feeling of emptiness in the head, dizziness, or fainting (symptoms of low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (symptoms of liver problems).
• Rash, redness of the skin with blisters on the lips, eyes, skin, or mouth, peeling of the skin, fever, bulging red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin problems).

Swollen stomach, blood in vomit, stool, or urine, black stools (symptoms of stomach and intestine disorders).

• Significantly reduced urine output, feeling of thirst (symptoms of kidney problems).
• Nausea with diarrhea and vomiting, stomach pain, or fever (symptoms of intestinal problems).
• Severe headache, weakness, or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (symptoms of nervous system problems, such as bleeding or swelling in the skull/brain).
• Pale skin, feeling of tiredness, and shortness of breath, and dark urine (symptoms of red blood cell deficiency).
• Eye pain or vision disturbances, bleeding in the eyes.
• Bone or joint pain (symptoms of osteonecrosis).
• Blisters on the skin or mucous membranes (symptoms of pemphigus).
• Numbness or feeling of cold in the fingers and toes (symptoms of Raynaud's syndrome).
• Sudden swelling and redness of the skin (symptoms of skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and cramps with irregular heartbeat (symptoms of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, reddish-brown urine, pain, and weakness (symptoms of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with unexpected vaginal bleeding, dizziness, or fainting due to low blood pressure (symptoms of ovarian or uterine problems).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and (or) joint problems with abnormal laboratory test results (e.g., high potassium, uric acid, and calcium levels, and low phosphorus levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Frequency not known (frequency cannot be estimated from the available data):

• Co-occurrence of widespread, severe rash, nausea, fever, high levels of certain white blood cells, or yellowing of the skin or eyes (symptoms of allergic reaction related to treatment) with shortness of breath, chest pain/discomfort, significantly reduced urine output, and feeling of thirst, etc. (symptoms of anaphylaxis).
• Chronic kidney failure.
• Reactivation (recurrence) of hepatitis B virus infection (liver infection) in patients who have had the disease in the past.

If you experience any of the above side effects, you should immediately tell your doctor.

Other side effects may include:

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

• Headache or fatigue.
• Nausea, vomiting, diarrhea, indigestion.
• Rash.
• Muscle or joint cramps, muscle or bone pain, during or after Meaxin treatment.
• Swelling, such as swelling of the ankles or eyes.
• Weight gain.

If any of the above side effects worsen, you should tell your doctor.

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

• Lack of appetite, weight loss, or taste disturbances.
• Dizziness or weakness.
• Sleep disturbances (insomnia).
• Eye discharge with itching, redness, and swelling, excessive tearing, and blurred vision (conjunctivitis).
• Nosebleeds.
• Abdominal pain or swelling, gas, bloating, heartburn, or constipation.
• Itching.
• Excessive hair loss or thinning.
• Numbness of hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats.

If any of the above side effects worsen, you should tell your doctor.

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

• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of subcutaneous tissue).
• Cough, runny nose, or shortness of breath, feeling of heaviness or pain when pressing on the area above the eyes or on the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (symptoms of upper respiratory tract infection).
• Severe headache felt as a pulsating pain or a feeling of pulsation, usually on one side of the head, often accompanied by nausea, vomiting, and sensitivity to light or sound (symptoms of migraine).
• Flu-like symptoms (flu).
• Pain or burning sensation when urinating, elevated body temperature, pain in the groin or pelvis, red or brown urine (symptoms of urinary tract infection).
• Joint pain or swelling (symptoms of arthralgia).
• Continuous feeling of sadness and loss of interest, which prevents performing normal activities (symptoms of depression).
• Feeling of anxiety and worry along with physical symptoms, such as palpitations, sweating, trembling, dry mouth (symptoms of anxiety).
• Drowsiness/excessive sleepiness.
• Trembling or shaky movements (tremor).
• Memory disturbances.
• Overwhelming urge to move legs (restless legs syndrome).
• Ringing or other sounds in the ears (e.g., ringing, buzzing), which have no external source (tinnitus).
• High blood pressure (hypertension).
• Belching.
• Stomatitis.
• Difficulty swallowing.
• Increased sweating.
• Discoloration of the skin.
• Brittle nails.
• Red lumps or white-gray pustules around hair follicles, possibly with pain, itching, or burning sensation (symptoms of folliculitis, also called hair follicle inflammation).
• Skin rash with peeling skin (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull pain and (or) feeling of heaviness in the testicles or groin, pain when urinating, pain during sexual intercourse or ejaculation, blood in the urine (symptoms of testicular swelling).
• Difficulty achieving or maintaining an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving or maintaining sexual arousal.
• Decreased sexual desire.
• Breast pain.
• General malaise.
• Viral infection, such as a cold.
• Lower back pain due to kidney problems.
• Increased frequency of urination.
• Increased appetite.
• Pain or burning sensation in the upper abdomen and (or) chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness, and bloating, black stools (symptoms of stomach ulcer disease).
• Stiffness of joints and muscles.
• Abnormal laboratory test results. If any of the above side effects worsen, you should tell your doctor.

Rare (may affect up to 1 in 1000 people):

• Disorientation.
• Seizure (seizures) and decreased consciousness (seizures)
• Discoloration of nails.

Frequency not known (frequency cannot be estimated from the available data):

• Redness or swelling of the palms and soles, which may be accompanied by tingling and burning pain.
• Skin changes with pain and (or) blistering.
• Slowed growth in children and adolescents.

If any of the above side effects worsen, you should tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Meaxin

The medicine should be stored out of sight and reach of children.
You should not take this medicine after the expiration date stated on the carton and blister pack after the abbreviation "EXP". The expiration date refers to the last day of the month stated.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Meaxin contains

• The active substance of the medicine is imatinib. Each coated tablet contains 100 mg of imatinib (in the form of imatinib mesylate).
• The other ingredients are: lactose monohydrate, cornstarch, hydroxypropyl cellulose, microcrystalline cellulose, crospovidone (type A), colloidal silicon dioxide, magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, iron oxide red (E 172), and iron oxide yellow (E 172) in the tablet coating. See section 2 "Meaxin contains lactose".

What Meaxin looks like and what the package contains

Meaxin, 100 mg: the coated tablets are orange-brown, round (11 mm in diameter), slightly convex on both sides with a beveled edge and a dividing line on one side. The tablet can be divided into equal doses.
Meaxin, 100 mg is available in packages of 20, 30, 60, 90, 120, and 180 coated tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
KRKA – FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
Date of last revision of the leaflet:24.05.2024