IMATINIB QILU 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Imatinib Qilu 100 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Imatinib Qilu and what is it used for
2. What you need to know before you take Imatinib Qilu
3. How to take Imatinib Qilu
4. Possible side effects
5. Storage of Imatinib Qilu
6. Contents of the pack and other information

1. What is Imatinib Qilu and what is it used for

Imatinib Qilu 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 some types of cancer.

Imatinib Qilu is a treatment for adults and children with:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white blood cells normally help the body to fight infection. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) start to grow out of control.

• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of white blood cells. These white blood cells normally help the body to fight infection. Acute lymphoblastic leukaemia is a type of leukaemia in which certain abnormal white blood cells (called lymphoblasts) start to grow out of control. Imatinib inhibits the growth of these white blood cells.

Imatinib Qilu is also a treatment for adults with:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start to grow out of control. Imatinib inhibits the growth of these cells in a certain subtype of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (called eosinophils) start to grow out of control. Imatinib inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and intestine. It originates from uncontrolled cell growth of the supporting tissues of these organs.

• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which some cells start to grow out of control. Imatinib inhibits the growth of these cells.

In the rest of this leaflet, we will use abbreviations when we talk about these diseases.

If you have any questions about how imatinib works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Imatinib Qilu

Imatinib Qilu is only prescribed by doctors who have experience in medicines for treating blood cancers or solid tumours.

Follow your doctor's instructions carefully, even if they differ from the general information in this leaflet.

Do not take Imatinib Qilu:

• if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor and do not take Imatinib Qilu.

If you think you may be allergic but are not sure, talk to your doctor.

Warnings and precautions

Talk to your doctor before you start taking Imatinib Qilu:

• If you have or have ever had liver, kidney, or heart problems.
• If you are taking the medicine levothyroxine because you have had your thyroid removed.
• If you have or could have a hepatitis B virus infection. This is because imatinib may cause hepatitis B to become active again, which can be life-threatening in some cases. Your doctor will carefully examine you for signs of this infection before starting treatment.
• If while taking Imatinib Qilu you get bruises, bleeding, fever, fatigue, and

confusion, please contact your doctor. This could be a sign of blood vessel damage called thrombotic microangiopathy (TMA).

If any of the above apply to you, tell your doctor before taking Imatinib Qilu.

You may be more sensitive to the sun while taking Imatinib Qilu. It is important that you cover the skin that is exposed to the sun and use a high protection sunscreen. These precautions also apply to children.

Tell your doctor immediately if you gain weight very quickly while taking imatinib.Imatinib Qilu may cause your body to retain water (severe fluid retention).

While taking imatinib, your doctor will regularly check if the medicine is working. Your doctor will also do regular blood tests and weight checks.

Children and adolescents

Imatinib Qilu is also a treatment for children with CML. There is no experience in children with CML under 2 years of age. There is limited experience in children with Ph+ ALL and very limited experience in children with MDS/MPD, DFSP, GIST, and HES/CEL.

Some children and adolescents who take imatinib may have slower than normal growth. The doctor will check growth during regular visits.

Taking Imatinib Qilu with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may interfere with the effect of imatinib when taken together. They may increase or decrease the effect of imatinib, producing more side effects or making imatinib less effective. Imatinib may do the same to other medicines.

Tell your doctor if you are using medicines that prevent blood clots from forming.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.
• Imatinib is not recommended during pregnancy unless clearly necessary, as it may harm your baby. Your doctor will explain the possible risks of taking imatinib during pregnancy.
• Women who are able to become pregnant should use effective contraceptive methods during treatment and for 15 days after stopping treatment.
• Do not breastfeed during treatment with imatinib and for 15 days after stopping treatment, as it may harm your baby.
• Patients who are concerned about their fertility while taking imatinib should discuss this with their doctor.

Driving and using machines

While taking this medicine, you may feel dizzy or drowsy or have blurred vision. If this happens, do not drive or use tools or machines until you feel better.

3. How to take Imatinib Qilu

Your doctor has prescribed imatinib because you have a serious disease. Imatinib can help you fight this disease.

However, follow your doctor's or pharmacist's instructions exactly. It is important that you take it for as long as your doctor or pharmacist tells you to. If you are unsure, ask your doctor or pharmacist.

Do not stop taking imatinib unless your doctor tells you to. If you cannot take the medicine as instructed by your doctor or think you no longer need it, talk to your doctor immediately.

How much Imatinib Qilu to take

Adults

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

• If you are being treated for CML:

Depending on your situation, the usual starting dose is 400mgor 600mgonce a day.

• If you are being treated for GIST:

The starting dose is 400 mg, taken as 4 tablets once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg, you should take 400 mg in the morning and 400 mg in the evening.

• If you are being treated for Ph+ ALL:

The starting dose is 600mgonce a day.

• If you are being treated for MDS/MPD:

The starting dose is 400mgonce a day.

• If you are being treated for HES/CEL:

The starting dose is 100mgonce a day.

Your doctor may decide to increase the dose to 400mg, taken as 4 tablets once a day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800mga day, taken as 400 mg in the morning and 400 mg in the evening.

The 400 mg dose can be taken as 1 tablet of 400 mg or 4 tablets of 100 mg.

The 600 mg dose can be taken as 1 tablet of 400 mg and 2 tablets of 100 mg or as 1 tablet of 400 mg plus half a tablet of 400 mg.

Children and adolescents

Your doctor will tell you how many imatinib tablets to give to your child. The amount of imatinib given will depend on the disease, weight, and height of your child. The daily dose in children should not exceed 800 mg in cases of CML and 600 mg in cases of Ph+ ALL. The treatment can be given to your child as a single dose once a day or, alternatively, divided into two doses (half in the morning and half in the evening).

The tablet can be divided into equal doses.

When and how to take imatinib

• Take imatinib with a meal.This will help protect you from stomach problems when taking imatinib.
• Swallow the tablets whole with a large glass of water.

If you are not able to swallow the tablets, you can dissolve them in a glass of still water or apple juice:

• Use about 50 ml for each 100 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.
• Drink the whole contents of the glass immediately. There may be some leftover tablet parts in the glass.

How long to take Imatinib Qilu

Keep taking imatinib every day for as long as your doctor tells you to.

If you take more Imatinib Qilu than you should

If you accidentally take too many tablets, talk to your doctor immediately. You may need medical attention. Take the medicine pack with you.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediatelyor call the Toxicology Information Service, telephone 915 620 420, stating the medicine and the amount taken.

If you forget to take Imatinib Qilu

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

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

4. Possible Adverse Effects

Empty section

Like all medicines, this medicine can cause side effects, although not all people suffer from them. They are usually mild to moderate.

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

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

• Rapid weight gain. Imatinib may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, or ulcers in the mouth. Imatinib can reduce the number of white blood cells, so you may be more likely to get infections.
• Unexpected bleeding or bruising (when no injury has occurred).

Uncommon(may affect up to 1 in 100 people) or rare(may affect up to 1 in 1,000 people):

• Chest pain, irregular heartbeat (signs of heart problems).
• Cough, difficulty breathing, or pain when breathing (signs of lung problems).
• Feeling of dizziness, dizziness, or fainting (signs of low blood pressure).
• Nausea, loss of appetite, dark urine, yellowing of the skin or eyes (signs of liver problems).
• Rash, redness of the skin with blisters on the lips, eyes, skin, or mouth, skin peeling, fever, purple or red bumps on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Severe abdominal pain, blood in vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Greatly reduced urine production, feeling of thirst (signs of kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis of the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems, such as brain or skull bleeding or swelling).
• Pale skin, feeling of tiredness, and shortness of breath, and dark urine (signs of low red blood cell count).
• Eye pain or vision loss, eye bleeding.
• Bone or joint pain (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numbness or coldness in the hands and feet (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Hearing problems.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, brown or red urine, pain, or weakness in the muscles (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, unexpected vaginal bleeding, feeling of dizziness or fainting due to low blood pressure (signs of problems in the ovaries or uterus).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness, or joint discomfort associated with abnormal 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 estimated from available data):

• Combination of severe generalized rash, nausea, fever, high levels of certain white blood cells, or yellowing of the skin or eyes (signs of jaundice) with shortness of breath, chest pain or discomfort, greatly reduced urine production, and feeling of thirst, etc. (signs of a treatment-related allergic reaction).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B infection when previously having hepatitis B (a liver infection).

If you experience any of the above effects, inform your doctor immediately.

Other side effects may be:

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

• Headache or feeling of tiredness.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in bones, muscles, or joints, during treatment with imatinib or after stopping imatinib.
• Swelling, for example, around the ankles or swollen eyes.
• Weight gain.

If you experience any of these effects intensely, inform your doctor.

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

• Loss of appetite, weight loss, or altered sense of taste.
• Feeling of dizziness or weakness.
• Difficulty sleeping (insomnia).
• Eye discharge with itching, redness, and swelling (conjunctivitis), tearing, or blurred vision.
• Nosebleeds.
• Abdominal pain or swelling, flatulence, heartburn, or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the 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 you experience any of these effects intensely, inform your doctor.

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

• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue under the skin).
• Cough, discharge, or blockage in the nose, feeling of heaviness or pain when pressing the area around the eyes or the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing pain or a throbbing sensation, usually on one side of the head, and often accompanied by nausea, vomiting, and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms (influenza).
• Pain or burning sensation when urinating, fever, pain in the groin or pelvis, cloudy or reddish-brown urine (signs of urinary tract infection).
• Joint pain and swelling (signs of arthralgia).
• A constant feeling of sadness and loss of interest, which disrupts daily life (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
• Drowsiness or excessive sleepiness.
• Tremors or involuntary movements (tremor).
• Memory problems.
• Need to constantly move the legs (restless legs syndrome).
• Hearing noises (e.g., ringing, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Skin discoloration.
• Brittle nails.
• Red or reddish bumps around the hair root, possibly with pain, itching, or burning sensation (signs of folliculitis).
• Skin rash with peeling or skin shedding (exfoliative dermatitis).
• Breast growth (can occur in men or women).
• Dull pain and/or feeling of heaviness in the testicles or lower abdomen, pain when urinating, having sex, or ejaculating, blood in the urine (signs of testicular edema).
• Inability to have or maintain an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving or maintaining sexual arousal.
• Decreased sexual desire.
• Nipple pain.
• General feeling of discomfort (general discomfort).
• Viral infections such as cold sores.
• Lower back pain due to kidney disorder.
• 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 swelling, black stools (signs of stomach ulcer).
• Stiffness in the joints or muscles.
• Abnormal laboratory test results.

If any of these affect you importantly, consult your doctor.

Rare(may affect up to 1 in 1,000 patients):

• Confusion.
• Episode of spasms and decreased level of consciousness (seizures).
• Discoloration of the nails.

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

• Redness and/or swelling of the palms of the hands and soles of the feet, which may be accompanied by a tingling sensation and burning.
• Painful skin lesions and/or blisters.
• Slowed growth in children and adolescents.

If you experience any of these effects intensely, inform your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Imatinib Qilu

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

Do not use this medicine after the expiration date stated on the carton. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Imatinib Qilu

• The active ingredient is imatinib mesilate. Each Imatinib Qilu tablet contains 100 mg of imatinib (in the form of mesilate).
• The other ingredients are microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, and anhydrous colloidal silica.
• The tablet coating is composed of red iron oxide (E-172), yellow iron oxide (E-172), macrogol, talc, and hypromellose.

Appearance of the product and package contents

Imatinib Qilu 100 mg film-coated tablets are round, biconvex, film-coated tablets, brown in color, scored on one side, and with the inscription «51» on the other.

They are available in packs of 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

QILU PHARMA SPAIN S.L.,

Paseo de la Castellana 40,

8th floor, Madrid-28046,

Spain

Manufacturer

KYMOS, S.L.,

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès,

08290-Barcelona,

Spain

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/