Meaxin

Package leaflet: Information for the patient

Meaxin, 400 mg, film-coated tablets
imatinibum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Meaxin is and what it is used for
2. Important information before taking Meaxin
3. How to take Meaxin
4. Possible side effects
5. How to store Meaxin
6. Contents of the pack and other information

1. What Meaxin is and what it is used for

Meaxin is a medicine containing the active substance called 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 adults and children with:

• Chronic myeloid leukaemia (CML – Chronic Myeloid Leukaemia). Leukaemia is a cancer originating from white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
• Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph-positive ALL – Philadelphia chromosome positive acute lymphoblastic leukaemia). Leukaemia is a cancer originating from white blood cells. Normally, white blood cells help the body fight infections. Acute lymphoblastic leukaemia is a type of leukaemia 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 adults with:

• Myelodysplastic/myeloproliferative syndromes (MDS/MPD – Myelodysplastic/myeloproliferative diseases). These are blood disorders 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) and/or chronic eosinophilic leukaemia (CEL – Chronic Eosinophilic Leukaemia). These are blood disorders in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Meaxin inhibits the growth of these cells in certain subtypes of these diseases.
• Gastrointestinal stromal tumours (GIST – Gastrointestinal Stromal Tumours). GIST is a tumour of the stomach and intestines. It arises due to uncontrolled growth of connective tissue cells in these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the skin and subcutaneous tissues in which certain cells begin to multiply uncontrollably. Meaxin inhibits the growth of these cells.

In the remainder of this leaflet, the abbreviated names of the diseases listed above will be used.
If you have any questions about how Meaxin works or why it has been prescribed, please consult your doctor.

2. Important information before using Meaxin

Meaxin is prescribed to patients only by physicians experienced in the use of drugs administered in the treatment of hematological malignancies or solid tumors.
It is essential to strictly follow the doctor's instructions, even if they differ from the general information provided in this leaflet.
When not to use Meaxin

• if the patient is allergic to imatinib or any of the other ingredients of this medicine (listed in section 6). If this applies to the patient, inform the doctor before taking Meaxin.

If an allergy is suspected but not certain, medical advice should be sought.
Warnings and precautions
Before starting treatment with Meaxin, discuss the following with your doctor:

• if the patient has or has ever had liver, kidney, or heart disease,
• if the patient is taking levothyroxine following thyroid removal,
• if the patient has ever had or may currently have hepatitis B virus infection; this is because Meaxin may cause reactivation of hepatitis B virus, which in some cases may be fatal; patients will be closely monitored by the doctor for signs of this infection before starting treatment,
• if the patient develops bruising, bleeding, fever, fatigue, or confusion while taking Meaxin, contact the doctor immediately. These symptoms may indicate a blood vessel disorder called thrombotic microangiopathy (TMA). If any of the above points apply to the patient, inform the doctor before the patient takes Meaxin.

While taking Meaxin, the patient may become more sensitive to sunlight. It is important to cover sun-exposed skin areas and use sunscreen products with a high sun protection factor (SPF). These precautions should also be applied to children.
Inform the doctor immediately if rapid weight gain occurs during treatment with Meaxin. Meaxin may cause fluid retention (severe fluid retention).
While taking Meaxin, the patient's health status will be regularly evaluated by the doctor to monitor treatment effectiveness. Blood tests and body weight measurements will be performed regularly during treatment with this medicine.
Children and adolescents
Meaxin is also used in the treatment of children with CML. There is no experience with use in children under 2 years of age with CML. Experience with use in children with Ph-positive ALL is limited, and experience 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. The doctor will monitor growth during regular visits.
Meaxin and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription (such as paracetamol) and herbal medicines (such as St. John's wort). Some medicines may affect the action of Meaxin when taken concurrently. They may increase or decrease the effect of Meaxin, leading to increased adverse reactions or reducing the effectiveness of Meaxin. Meaxin may similarly affect certain other medicines.
Inform the doctor if the patient is taking medicines used to prevent blood clots.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

• Meaxin is not recommended for pregnant women unless absolutely necessary, as it may harm the unborn child. The doctor will discuss potential risks associated with taking Meaxin during pregnancy.
• Women of childbearing potential are advised to use effective contraception during treatment with Meaxin and for 15 days after stopping treatment.
• Breastfeeding must be avoided during treatment with Meaxin and for 15 days after stopping treatment, as it may harm the infant.
• Patients concerned about the effects of Meaxin on fertility should consult their doctor.

Driving and operating machinery
Dizziness, drowsiness, or visual disturbances may occur while taking Meaxin. In such cases, patients should not drive or operate tools or machinery until they feel well again.
Meaxin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to take Meaxin

Your doctor has prescribed Meaxin because of your serious condition. Meaxin may help improve
this condition.
However, this medicine should always be taken exactly as prescribed by your doctor or pharmacist. It is important to take the medicine for as long as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor or pharmacist.
Do not stop taking Meaxin unless your doctor tells you to do so.
If you are unable to take the prescribed medicine or think you no longer need it, you should contact your doctor immediately.

What dose of Meaxin should be taken?
Use in adult patients
Your doctor will determine the exact number of Meaxin tablets to take.

For the treatment of CML:
Depending on the patient's condition, the initial dose is usually 400 mg or 600 mg:

• 400 mg taken as 1 tablet of 400 mg strength once daily.
• 600 mg taken as 1 tablet of 400 mg strength and 2 tablets of 100 mg strength, once daily.

For the treatment of GIST:
The initial dose is 400 mg, taken as:

• 1 tablet once daily.

In the treatment of CML and GIST, your doctor may prescribe a higher or lower dose depending on your response to treatment. If the daily dose is 800 mg (2 tablets), you should take:

• 1 tablet in the morning and 1 tablet in the evening.

For the treatment of Ph-positive ALL:
The initial dose is 600 mg, taken as:

• 1 tablet of 400 mg strength and 2 tablets of 100 mg strength, once daily.

For the treatment of MDS/MPD:
The initial dose is 400 mg, taken as:

• 1 tablet once daily.

For the treatment of HES/CEL:
The initial dose is 100 mg, taken as 1 tablet of 100 mg strength once daily.
Depending on the patient's response to treatment, your doctor may decide to increase the dose to 400 mg taken as 1 tablet once daily.

For the treatment of DFSP:
The daily dose is 800 mg (2 tablets), taken as:

• 1 tablet in the morning and 1 tablet in the evening.

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

When and how to take Meaxin

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

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

• Use approximately 200 ml of liquid per 400 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.
• After dissolving, drink the entire contents of the glass immediately. Traces of dissolved tablets may remain in the glass.

How long to take Meaxin
You should take Meaxin every day for as long as your doctor has instructed.

Taking more Meaxin than prescribed
Patients who have accidentally taken too many tablets should immediately inform their doctor, as they may require medical attention. Bring the medicine packaging with you.

Missed dose of Meaxin
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Then continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
They are usually mild to moderate.
Some adverse reactions may be serious. You should immediately inform your doctor
if any of the following adverse symptoms occur.
Very common (may occur in more than 1 in 10 patients) or common (may occur in
no more than 1 in 10 patients):

• Rapid weight gain. Meaxin may cause fluid retention in the body (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, and mouth ulcers. Meaxin may reduce the number of white blood cells in the blood, which may increase susceptibility to infection.
• Unexpected bleeding or bruising (despite no injury).

Uncommon (may occur in no more than 1 in 100 patients) or rare (may occur in
no more than 1 in 1000 patients):

• Chest pain, irregular heartbeat (symptoms of heart problems).

• Cough, difficulty breathing, or pain when 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, around the eyes, on the skin, or in the mouth, skin peeling, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin problems).

• Severe abdominal pain, presence of blood in vomit, stool, or urine, black stools (symptoms of stomach and intestinal disorders).

• Significantly reduced urine output, feeling of thirst (symptoms of kidney problems).

• Nausea with diarrhea and vomiting, abdominal 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 within the skull/brain).

• Pale skin, feeling of fatigue and shortness of breath, and dark urine (symptoms of red blood cell deficiency).

• Eye pain or blurred vision, bleeding in the eyes.

• Bone or joint pain (symptoms of osteonecrosis).

• Blisters on the skin or mucous membranes (symptoms of blistering).

• Numbness or cold sensation in fingers and toes (symptoms of Raynaud's syndrome).

• Sudden swelling and redness of the skin (symptoms of skin infection called connective tissue inflammation).

• Hearing difficulties.

• Muscle weakness and cramps with irregular heartbeat (symptoms of changes in potassium levels in the patient's blood).

• Bruising.

• Stomach pain with nausea.

• Muscle cramps with fever, red-brown discoloration of urine, muscle pain and weakness (symptoms of muscle problems).

• Pelvic pain, sometimes with nausea and vomiting, 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 discomfort accompanied by abnormal laboratory test results (e.g. high levels of potassium, uric acid, and calcium, and low levels of phosphorus in the blood).

• Blood clots in small blood vessels (thrombotic microangiopathy).

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

• Co-occurrence of extensive, severe rash, nausea, fever, high count of certain white blood cells, or yellowing of the skin or eyes (jaundice symptoms) with shortness of breath, chest pain/discomfort, significantly reduced urine output, and feeling of thirst, etc. (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection (liver infection) in patients who previously had this disease.

If any of the above adverse symptoms occur, you should immediately inform your doctor.
Other adverse reactions may include:
Very common (may occur in more than 1 in 10 patients):

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

If any of the above symptoms worsen, you should inform your doctor.
Common (may occur in no more than 1 in 10 patients):

• Loss of appetite, weight loss, or taste disturbances.
• Dizziness or weakness.
• Sleep difficulties (insomnia).
• Eye discharge with itching, redness, and swelling (conjunctivitis), excessive tearing, or blurred vision.
• Nosebleeds.
• Abdominal pain or swelling, bloating with passing gas, 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 symptoms worsen, you should inform your doctor.
Uncommon (may occur in no more than 1 in 100 patients):

• Painful red nodules on the skin, skin pain, redness of the skin (inflammation of subcutaneous fat tissue).
• Cough, nasal congestion or runny nose, feeling of heaviness or pain upon pressing the area above the eyes or sides of the nose, nasal obstruction, sneezing, sore throat, with or without headache (symptoms of upper respiratory tract infection).
• Severe headache felt as pulsating pain or sensation 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 (influenza-like illness).
• Pain or burning sensation during urination, elevated body temperature, pain in the groin or pelvis, red or brown discoloration or cloudy urine (symptoms of urinary tract infection).
• Joint pain and swelling (arthralgia symptoms).
• Persistent feeling of sadness and loss of interest, preventing normal daily activities (symptoms of depression).
• Feeling of anxiety and worry with physical symptoms such as rapid heartbeat, sweating, trembling, dry mouth (symptoms of anxiety).
• Drowsiness / sleepiness / excessive sleepiness.
• Tremor or shaky movements (tremor).
• Memory disturbances.
• Overwhelming urge to move legs (restless legs syndrome).
• Ringing in the ears (e.g. ringing, buzzing) without external source (tinnitus).
• High blood pressure (hypertension).
• Gurgling / belching.
• Inflammation of the lips.
• Difficulty swallowing.
• Increased sweating.
• Skin discoloration.
• Brittle nails.
• Red nodules or white-yellow pustules around hair follicles, possibly with pain, itching, or burning sensation (symptoms of folliculitis, also known as follicular inflammation).
• Skin rash with skin peeling (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull pain and (or) feeling of heaviness in testicles or lower abdomen, pain during urination, pain during urination, sexual intercourse, or ejaculation, blood in urine (symptoms of testicular swelling).
• Inability to achieve or maintain erection (erectile dysfunction).
• Heavy or irregular menstruation.
• Difficulty achieving/maintaining sexual arousal.
• Reduced sexual desire.
• Breast pain.
• General malaise (malaise).
• Viral infection, e.g. cold.
• Lower back pain due to impaired kidney function.
• 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 gastric ulcer disease).
• Joint and muscle stiffness.
• Abnormal laboratory test results. If any of the above symptoms worsen, you should inform your doctor.

Rare (may occur in no more than 1 in 1000 patients):

• Disorientation.
• Episode of seizure (seizures) and decreased consciousness (convulsions).
• Nail discoloration.

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

• Redness or swelling of the palms and soles, possibly accompanied by tingling and burning pain.
• Skin changes with pain and (or) blister formation.
• Slowed growth in children and adolescents.

If any of the above symptoms worsen, you should inform your doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Meaxin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following the abbreviation "EXP". The expiry date refers to the last day of the stated month. The batch number is indicated on the carton and blister pack following the abbreviation "Lot".
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Meaxin contains

• The active substance is imatinib. Each coated tablet contains 400 mg of imatinib (as imatinib mesilate).
• The other ingredients are: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, 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 contents of the pack
Meaxin 400 mg: the coated tablets are orange-brown, oval-shaped (measuring 22 mm x 9 mm), biconvex.
Meaxin 400 mg is available in packs of 10, 30, 60 and 90 coated tablets in blister packs, contained in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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