Nibix

Package leaflet: Information for the patient

Nibix, 100 mg, hard capsules
Imatinibum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Nibix is and what it is used for

Nibix is a medicine that contains 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.
Nibix is indicated for the treatment of adult patients and children with:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. Normally, white blood cells help the body fight infection. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
• Acute lymphoblastic leukaemia with the Philadelphia chromosome (Ph-positive ALL). Leukaemia is a cancer of white blood cells. Normally, white blood cells help the body fight infection. Acute lymphoblastic leukaemia is a type of leukaemia in which certain abnormal white blood cells (called lymphoblasts) begin to multiply uncontrollably. Nibix inhibits the growth of these cells.

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

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are blood disorders in which certain white blood cells begin to multiply uncontrollably. Nibix inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Nibix inhibits the growth of these cells in certain subtypes of these diseases.
• Gastrointestinal stromal tumours (GIST). 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. Nibix 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 Nibix works or why it has been prescribed,
please consult your doctor.

2. Important information before using Nibix

The medicine Nibix is prescribed to patients only by doctors experienced in the use of drugs administered in the treatment of haematological malignancies or solid tumours.
It is essential to strictly follow the doctor's instructions, even if they differ from the general information contained in this leaflet.
When not to use Nibix

• if the patient is allergic to imatinib or to any of the other components of this medicine (listed in section 6).

If this information applies to the patient, they should inform their doctor before taking Nibix.
If an allergy is suspected but not certain, medical advice should be sought.
Warnings and precautions
Before starting treatment with Nibix, discuss the following with the doctor:

• if the patient has or has ever had liver, kidney, or heart disease
• if the patient is taking levothyroxine after thyroid removal
• if the patient has ever had or may currently have hepatitis B virus infection; this is because Nibix 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 Nibix, contact the doctor immediately. These may be symptoms of a blood vessel disorder called thrombotic microangiopathy (TMA).

If any of the above points apply to the patient, they should inform their doctor before taking Nibix.
While taking Nibix, the patient may become more sensitive to sunlight. It is important to cover skin areas exposed to sunlight and to 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 Nibix. Nibix may cause fluid retention (severe fluid retention).
While taking Nibix, the patient's health status will be regularly evaluated by the doctor to monitor the effectiveness of treatment. Blood tests and body weight measurements will be performed regularly during treatment.
Children and adolescents
Nibix is also used in the treatment of children with CML. There is no experience with use in children with CML under 2 years of age. Experience with use in children with Ph-positive ALL is limited, and experience with use in children with MDS/MPD, DFSP, GIST, and HES/CEL is very limited.
In some children and adolescents taking Nibix, growth may be slower than normal. The doctor will monitor growth during regular visits.
Interaction of Nibix with other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, 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 Nibix when taken simultaneously. They may increase or decrease the effect of Nibix, leading to increased adverse reactions or making Nibix less effective. Nibix may similarly affect certain other medicines.
Inform the doctor if the patient is taking medicines to prevent blood clots.
Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
• Nibix is not recommended for pregnant women unless absolutely necessary, as it may harm the unborn child. The doctor will explain the potential risks associated with taking Nibix during pregnancy.
• Women who could become pregnant are advised to use an effective method of contraception during treatment with Nibix and for 15 days after stopping treatment.
• Breastfeeding must be avoided during treatment with Nibix and for 15 days after stopping treatment, as it may harm the infant.
• Patients concerned about fertility during treatment with Nibix should consult their doctor.

Driving and operating machinery
While taking Nibix, dizziness, somnolence, or visual disturbances may occur. In such cases, the patient should not drive or operate tools or machinery until they feel well again.
Nibix contains monohydrate lactose. If the patient has been diagnosed with an intolerance to certain sugars, they should inform their doctor before taking Nibix.

3. How to take Nibix

Your doctor has prescribed Nibix because of your serious condition. Nibix may help improve this
condition.
However, this medicine should always be taken exactly as recommended by your doctor or pharmacist. It is important to take the medicine for as long as your doctor or pharmacist has advised. If you have any doubts, consult your doctor or pharmacist.
Do not stop taking Nibix unless your doctor tells you to. 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 Nibix should be taken
Use in adult patients
Your doctor will determine the exact number of Nibix capsules to take.

• For treatment of CML: Depending on the patient's condition, the initial dose is usually 400 mg or 600 mg
• 400 mg taken as 4 capsules once daily,
• 600 mg taken as 6 capsules once daily.
• For treatment of GIST: The initial dose is 400 mg, taken as 4 capsules once daily.

In both CML and GIST treatment, your doctor may prescribe a higher or lower dose depending on your response to treatment. If the daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

• For treatment of Ph-positive ALL: The initial dose is 600 mg, taken as 6 capsules once daily.
• For treatment of MDS/MPD: The initial dose is 400 mg, taken as 4 capsules once daily.
• For treatment of HES/CEL: The initial dose is 100 mg, taken as one capsule once daily. Your doctor may decide to increase the dose to 400 mg (taken as 4 capsules once daily), depending on the patient's response to treatment.
• For treatment of DFSP: The daily dose is 800 mg (8 capsules), taken as 4 capsules in the morning and 4 capsules in the evening.

Use in children and adolescents
Your doctor will determine the number of Nibix capsules to give to the child. The dose of Nibix will depend on the child's condition, body weight, and height. The total daily dose in children must not exceed 800 mg in CML treatment and 600 mg in Ph-positive ALL treatment. 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 Nibix

• Nibix should be taken with food to protect the stomach during treatment.
• Capsules must be swallowed whole with a large glass of water. Do not open or crush the capsules unless you have difficulty swallowing them (including children).
• If you are unable to swallow the capsules, you may open them and dissolve the powder in a glass of non-carbonated water or apple juice.
• Women who are pregnant or who could become pregnant and who open capsules should handle the contents with care: avoid contact of the powder with skin and eyes, and do not inhale it. Hands should be washed immediately after opening the capsules.

How long to take Nibix
You should take Nibix every day for as long as your doctor advises.
Taking more than the recommended dose of Nibix
Patients who have accidentally taken too many capsules should immediately inform their doctor, as they may require medical attention. Take the medicine packaging with you.
Missing a dose of Nibix

• 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 not everyone will experience them.
They are usually mild to moderate.
Some adverse reactions may be serious. You should tell your doctor immediately if any of the
following adverse symptoms occur:
Very common ( may affect more than 1 in 10 people) or common (may affect less than 1 in 10
people):

• Rapid weight gain. Nibix may cause fluid retention in the body (severe fluid retention).
• Signs of infection, such as fever, severe chills, sore throat, and mouth ulcers. Nibix 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 affect less than 1 in 100 people) or rare (may affect less than 1 in
1,000 people):

• Chest pain, irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing, or pain when breathing (symptoms of lung problems).
• Feeling faint, 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, peeling of the skin, 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, stools, or urine, black stools (symptoms of gastrointestinal disorders).
• Significantly reduced urine output, feeling thirsty (symptoms of kidney problems).
• Nausea with diarrhoea 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 tired and breathless, and dark urine (symptoms of low red blood cell count).
• Eye pain or blurred vision, bleeding in the eyes.
• Bone or joint pain (symptoms of bone necrosis).
• Blisters on the skin or mucous membranes (symptoms of blistering diseases).
• 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 muscle 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 urine colour, muscle pain and weakness (symptoms of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, sudden 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 complaints 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 (cannot be estimated from available data):

• Co-occurrence of extensive, severe rash, nausea, fever, high number 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 thirsty, etc. (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection (liver infection) in patients who have 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 affect more than 1 in 10 people):

• Headache or fatigue.
• Nausea, vomiting, diarrhoea, indigestion.
• Rash.
• Muscle or joint cramps, muscle or bone pain, during or after discontinuation of Nibix.
• Swelling, such as ankle or eye area swelling.
• Weight gain. If any of the above symptoms worsen, you should inform your doctor.

Common (may affect less than 1 in 10 people):

• 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.
• Pain or swelling of the abdomen, bloating with passing wind, 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 flushes, chills, or night sweats. If any of the above symptoms worsen, you should inform your doctor.

Uncommon (may affect no more than 1 in 100 people):

• Painful red nodules on the skin, skin pain, redness of the skin (inflammation of subcutaneous fat tissue).
• Cough, watery nasal discharge or blocked nose, feeling of pressure or pain when pressing the area above the eyes or on both sides of the nose, nasal mucosal congestion, sneezing, sore throat, with or without headache (symptoms of upper respiratory tract infection).
• Severe headache felt as a pulsating pain or sensation of pulsation, often on one side of the head, frequently accompanied by nausea, vomiting, and sensitivity to light or sound (symptoms of migraine).
• Flu-like symptoms (influenza).
• Pain or burning sensation when passing urine, elevated body temperature, pain in the groin or pelvic area, red or brown urine colour, or cloudy urine (symptoms of urinary tract infection).
• Pain and swelling of joints (symptoms of joint pain).
• Persistent feeling of sadness and loss of interest, preventing the patient from performing daily activities (symptoms of depression).
• Feeling nervous or anxious with somatic symptoms such as rapid heartbeat, sweating, trembling, dry mouth (symptoms of anxiety).
• Drowsiness / excessive sleepiness.
• Tremor or muscle twitching.
• Memory disturbances.
• Irresistible urge to move legs (restless legs syndrome).
• Hearing noises (e.g. ringing, buzzing) in the ears not originating from outside (tinnitus).
• High blood pressure (hypertension).
• Belching.
• Inflammation of the lips.
• Difficulty swallowing.
• Increased sweating.
• Skin discolouration.
• Brittle nails.
• Red nodules or whiteheads forming around hair roots, which may cause pain, itching, or burning sensation (symptoms of folliculitis).
• 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 when passing urine, during sexual intercourse or ejaculation, blood in urine (symptoms of testicular swelling).
• Inability to achieve or maintain erection (erectile dysfunction).
• Heavy or irregular menstrual bleeding.
• Difficulty achieving/maintaining sexual arousal.
• Reduced libido.
• Nipple pain.
• General malaise.
• Viral infection, such as common cold.
• Lower back pain due to kidney disorders.
• Increased frequency of urination.
• Increased appetite.
• Pain or burning sensation in the upper abdomen and (or) chest (heartburn), nausea, vomiting, gastric acid reflux, feeling of fullness and bloating, black stools (symptoms of stomach ulcer).
• Joint and muscle stiffness.
• Abnormal laboratory test results. If any of the above symptoms worsen, you should inform your doctor.

Rare (may affect no more than 1 in 1,000 people):

• Confusion.
• Episode of convulsion (convulsions) and reduced consciousness (seizures).
• Nail discolouration.

Frequency not known (cannot be estimated from 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) 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 reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
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 marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Nibix

• Keep the 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 term "Expiry date (EXP):". The expiry date refers to the last day of the specified month.
• Do not store above 30°C.
• Do not use the medicine if the packaging is damaged or shows signs of having been opened.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the packaging and other information

What Nibix contains

• The active substance is imatinib (as mesilate). Each Nibix capsule contains 100 mg of imatinib (as mesilate).
• The other ingredients are: crospovidone type A, lactose monohydrate and magnesium stearate.
• The capsule shell contains gelatin, iron oxide yellow (E 172), titanium dioxide (E 171) and iron oxide red (E 172).

What Nibix looks like and contents of the pack
Nibix 100 mg, hard capsules are orange-colored, size "3" gelatin capsules. It is available in packs containing 30, 60, 100, 120 or 180 capsules. Not all pack sizes may be marketed in the country.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer/Importer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
UAB Norameda
Meistrų 8a, Vilnius LT-02189
Lithuania
Gedeon Richter Plc.
Gyömrői út 19-21., 1103, Budapest
Hungary
For additional information about this medicinal product, please contact the Marketing Authorisation Holder.
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Poland Nibix
Estonia Glipox
Hungary Nibix 100 mg kemény kapszula