IMATINIB GRINDEKS 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Imatinib Grindeks 100 mg hard capsules EFG

Imatinib

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.

• If you experience side effects, talk to your doctor, pharmacist, or nurse, even if they are listed in this leaflet.

Contents of the pack

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

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

Imatinib Grindeks is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases described below. These include some types of cancer.

Imatinibis a treatment for adults and children for:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of the white blood cells. These white blood cells normally help the body to fight infections. Chronic myeloid leukaemia is a type of leukaemia in which some 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 the white blood cells. These white blood cells normally help the body to fight infections. Acute lymphoblastic leukaemia is a type of leukaemia in which some abnormal white blood cells (called lymphoblasts) start to grow out of control. Imatinib inhibits the growth of these cells.

Imatinibis also a treatment for adults for:

• 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, these abbreviations are used when referring to these diseases.

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

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

Imatinib will only be prescribed by a doctor who has experience in medicines to treat blood cell cancer or solid tumours.

Follow carefully all instructions given by your doctor, even if they are different from the general information contained in this leaflet.

Do not take Imatinib Grindeks:

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

Warnings and precautions

Talk to your doctor before taking Imatinib Grindeks:

• if you have or have had liver, kidney, or heart problems.
• if you are taking a medicine that contains levothyroxine because you have had your thyroid gland removed.
• if you have ever had or could currently have a hepatitis B infection.

• This is because Imatinib could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.

If any of these apply to you, tell your doctor before takingImatinib.

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

During treatment withImatinib, tell your doctor immediatelyif you gain weight very quickly. Imatinib can cause water retention in the body (severe fluid retention).

While taking Imatinib, your doctor will regularly check if the medicine is working. You will also have regular blood tests and be weighed regularly.

Children and adolescents

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

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

Other medicines and Imatinib Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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, leading to an increased risk of side effects or making Imatinib Grindeks less effective. Imatinib may have the same effect on other medicines.

Tell your doctor if you are taking 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 discuss with you the potential risks of taking Imatinib during pregnancy.
  • Women who could become pregnant are advised to use an effective method of contraception during treatment and for 15 days after finishing treatment.
  • Do not breastfeed while taking Imatinib Grindeks and for 15 days after finishing 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

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

3. How to take Imatinib Grindeks

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 do this for as long as your doctor or pharmacist tells you. If you are unsure, ask your doctor or pharmacist again.

Do not stop taking Imatinib unless your doctor tells you to. If you cannot take the medicine as your doctor has prescribed or think you no longer need it, contact your doctor immediately.

How much to take and when

Adults

Your doctor will tell you exactly how many Imatinib Grindeks capsules to take.

• If you are being treated for CML:

The usual starting dose is either 400 mg or 600 mg:

• 400 mgtaken in 4 capsules once a day.
• 600 mgtaken in 6 capsules once a day.

• If you are being treated for GIST:

The starting dose is 400 mg, which is 4 capsules 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 (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

• If you are being treated for Ph+ ALL:

The starting dose is 600 mg, which is 6 capsules once a day.

• If you are being treated for MDS/MPD:

The starting dose is 400 mg, which is 4 capsules once a day.

• If you are being treated for HES/CEL:

The starting dose is 100 mg, which is 1 capsule once a day. Your doctor may decide to increase the dose to 400 mg, which is 4 capsules once a day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800 mg a day (8 capsules), which is 4 capsules in the morning and 4 capsules in the evening.

Children and adolescents

Your doctor will tell you how many Imatinib capsules to give to the child. The amount of Imatinib given will depend on the child's condition, body weight, and height. The total daily dose in children should not exceed 800 mg in CML and 600 mg in Ph+ ALL. The treatment can be given to the child once a day or, alternatively, the dose can be divided into two doses (half in the morning and half in the evening).

When and how to take Imatinib Grindeks

• TakeImatinibwith food. This will help protect you from stomach problems when taking Imatinib.
• Swallow the capsules with a large glass of water. Do not open or crush the capsules unless you have difficulty swallowing them (for example, in children).
• If you are unable to swallow the capsules, you can open them and pour the powder into a glass of water or apple juice.
• If you are a pregnant woman or could become pregnant and try to open the capsules, you should handle the contents with care to avoid skin contact and eye irritation or inhalation. You should wash your hands immediately after opening the capsules.

How long to take Imatinib Grindeks

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

If you take more Imatinib Grindeks than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Imatinib Grindeks

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose.
• Then continue with the normal schedule.
• 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

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

Some adverse effects can be serious. Inform your doctor immediately if you suffer from any of the following:

Very Common(may affect more than 1 in 10 patients) or Common(may affect up to 1 in 10 patients):

• 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 may reduce the number of white blood cells in your blood, so you may get infections more easily.
• Bleeding or bruising unexpectedly (when you have not had any injury).

Uncommon(may affect up to 1 in 100 patients) or Rare(may affect up to 1 in 1,000 patients):

• Chest pain, irregular heartbeat (signs of heart problems).
• Cough, difficulty breathing, or painful breathing (signs of lung problems).
• Feeling dizzy, lightheaded, or fainting (signs of low blood pressure).
• Nausea, loss of appetite, dark-colored urine, yellow skin, or eyes (signs of liver problems).
• Rash, redness of the skin, with blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin spots, itching, burning sensation, rash with pus (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in urine output, feeling thirsty (signs of kidney problems).
• Nausea, with diarrhea and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis in the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).
• Pale skin, feeling tired, and difficulty breathing, dark-colored urine (signs of low red blood cell count in the blood).
• Pain in the eyes or vision disorders, bleeding in the eyes.
• Pain in the bones or joints (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numbness or feeling cold in the feet and toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and muscle spasms, with an abnormal heartbeat (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, dark-colored urine, pain, or weakness in the muscles (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems in the ovaries or uterus).
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with 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 the available data):

• Combination of a widespread rash, feeling unwell, fever, high levels of certain blood cells, or yellow skin and eyes (signs of jaundice) with difficulty breathing, chest pain, severely decreased urine output, and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection).

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

Other adverse effects may include:

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

• Headache or feeling tired
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the joints, muscles, or bones, during treatment with Imatinib or when stopping treatment.
• Swelling such as swollen ankles or eyes.
• Weight gain.

If any of these affect you significantly, inform your doctor.

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

• Lack of appetite, weight loss, or altered sense of taste.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Tearing of the eyes with itching, redness, and swelling (conjunctivitis), or watery eyes or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, flatulence, heartburn, or constipation.
• Itching.
• Weakening or unusual hair loss.
• Numbness of the hands or feet.
• Ulcers in the mouth.
• Pain in the joints with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats.

If any of these affect you significantly, consult 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, secretion, or blockage in the nose, feeling of heaviness or pain when pressing the area around the eyes or 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).
• Pain and swelling of the joints (signs of arthralgia).
• A constant feeling of sadness and loss of interest, which disrupts your ability to lead a normal life (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as palpitations, sweating, tremors, dry mouth (signs of anxiety).
• Drowsiness or excessive sleepiness.
• Tremors or involuntary movements (tremor).
• Memory impairment.
• 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.
• Discoloration of the skin.
• Brittle nails.
• Reddish bumps or pimples 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).
• Difficulty getting or maintaining an erection (erectile dysfunction).
• Heavy or irregular menstrual periods. Difficulty achieving/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 a 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 bloating, black stools (signs of stomach ulcer).
• Stiffness in the joints or muscles.
• Abnormal laboratory test results.

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

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

• Confusion.
• Discoloration of the nails.

Frequency Not Known(cannot be estimated from the 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 pain.
• Painful skin lesions and/or blisters.
• Delayed growth in children and adolescents.

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

Reporting of Adverse Effects

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

5. Storage of Imatinib Grindeks

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

Do not use this medicine after the expiration date stated on the carton after EXP. 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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. 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 Grindeks

• The active ingredient is imatinib (in the form of mesilate). Each Imatinib Grindeks capsule contains imatinib mesilate, equivalent to 100 mg of imatinib.
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, crospovidone, talc, magnesium stearate.

Hard gelatin capsule (body and cap): titanium dioxide (E-171), red iron oxide (E-172), yellow iron oxide (E-172), gelatin.

Appearance and Package Contents

Imatinib Grindeks 100 mg capsules are hard gelatin capsules, orange-brown in color, and 19 mm in length, containing a white-yellowish or yellowish-brown powder.

The capsules are packaged in PVC/PVDC/aluminum blisters.

Each blister contains 10 capsules.

Package sizes: 60 or 120 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS. Krustpils iela 53, Riga, LV-1057, Latvia. Tel: +371 67083205. Fax: +371 67083505. Email: [email protected].

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain.

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria: Imatinib Grindeks 100 mg Hartkapseln.

Belgium: Imatinib Grindeks 100 mg hard capsules.

Czech Republic: Imatinib Grindeks.

Estonia: Imatinib Grindeks.

France: Imatinib Grindeks 100 mg, gélule.

Hungary: Imatinib Grindeks 100 mg kemény kapszula.

Latvia: Imatinib Grindeks 100 mg cietas kapsulas.

Lithuania: Imatinib Grindeks 100 mg kietosios kapsulės.

Romania: Imatinib Grindeks 100 mg capsule.

Slovakia: Imatinib Grindeks 100 mg tvrdé kapsuly.

Spain: Imatinib Grindeks 100 mg cápsulas duras EFG.

Sweden: Imatinib Grindeks 100 mg hårda kapslar.

United Kingdom: Imatinib Grindeks 100 mg hard Capsules (Northern Ireland).

Date of the Last Revision of this Leaflet:01/2023.

Other Sources of Information

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