IMATINIB FARMALIDER 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Imatinib Farmalider 400 mg Hard Capsules 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 or pharmacist.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Imatinib Farmalider is a treatment 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.

In adult patients, Imatinib Farmalider is used to treat the more advanced stage of the disease (blast crisis). In children and adolescents, imatinib may be used in different stages of the disease (accelerated phase, chronic phase, and blast crisis).

Imatinib Farmalider is also a treatment for adults for:

• 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 Farmalider inhibits the growth of these cells.

• Mycloproliferative or myelodysplastic syndromes (MDS/MPD). These are a group of diseases of the blood in which some blood cells start to grow out of control. Imatinib Farmalider inhibits the growth of these cells in a certain subtype of these diseases.

• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are diseases of the blood in which some blood cells (called eosinophils) start to grow out of control. Imatinib Farmalider inhibits the growth of these cells in a certain subtype of these diseases.

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

For the rest of this leaflet, these abbreviations will be used when referring to these diseases.

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

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

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

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

Do not take Imatinib Farmalider:

• 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 Farmalider.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Imatinib Farmalider:

• 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 while taking Imatinib Farmalider you get bruising, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of blood vessel damage called thrombotic microangiopathy (TMA).
• if you have ever had or might currently have a hepatitis B virus infection. This is because Imatinib Farmalider could cause the hepatitis B virus to become active again, which can be fatal in some cases. Your doctor should check carefully for signs of this infection before starting treatment.

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

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

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

Using Imatinib Farmalider with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 Farmalider when taken together. They may increase or decrease the effect of Imatinib Farmalider, leading to an increased risk of side effects or making Imatinib Farmalider less effective. Imatinib Farmalider 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, consult your doctor or pharmacist before using this medicine.

Imatinib Farmalider is not recommended during pregnancy unless clearly necessary, as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Farmalider during pregnancy.

Women who could become pregnant are advised to use an effective method of contraception during treatment.

Do not breastfeed while taking Imatinib Farmalider.

Patients who are concerned about their fertility while taking Imatinib Farmalider should consult 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.

Imatinib Farmalider contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Imatinib Farmalider

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

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. It is important to do this for the time your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist again.

Do not stop taking Imatinib Farmalider 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

Adult use

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

• If you are being treated for CML:

The usual starting dose is 600 mg, taken as 1 capsule of 400 mg and 2 capsules of 100 mg oncea day.

Your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg (2 capsules), take 1 capsule in the morning and 1 capsule in the evening.

• If you are being treated for Ph+ ALL:

The starting dose is 600 mg, taken as 1 capsule of 400 mg and 2 capsules of 100 mg oncea day.

• If you are being treated for MDS/MPD:

The starting dose is 400 mg, which is 1 capsule oncea day.

• If you are being treated for HES/CEL:

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

• If you are being treated for DFSP:

The dose is 800 mg a day (2 capsules), which is 1 capsule in the morning and 1 capsule in the evening.

Use in children and adolescents

Your doctor will tell you how many capsules of Imatinib Farmalider to give to the child. The amount of Imatinib Farmalider given will depend on the child's situation, body weight, and height.

The total daily dose in children and adolescents should not exceed 800 mg. 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 Farmalider

• Take Imatinib Farmalider with food. This will help protect you from stomach problems when taking Imatinib Farmalider.
• 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 a woman who could become pregnant and are trying 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 Farmalider

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

If you take more Imatinib Farmalider 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.

If you forget to take Imatinib Farmalider

• 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 your 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 or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Very Common Adverse Effects(may affect more than 1 in 10 people) or Common(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 may reduce the number of white blood cells in your blood, so you may suffer from infections more easily.
• Bleeding or bruising unexpectedly (when you have not suffered any injury).

Uncommon Adverse Effects(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, with difficulty breathing or painful breathing (signs of lung problems).
• Feeling of dizziness, dizziness, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark-colored urine, yellowish skin or eyes (signs of liver problems).
• Rash, skin redness, 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 of thirst (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 problems in the nervous system, such as bleeding or swelling in the skull/brain).
• Pale skin, feeling of fatigue, 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 hip or difficulty walking.
• Numbness or feeling of 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, reddish-brown urine, pain, or weakness in the muscles (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling of dizziness 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 discomfort associated with abnormal laboratory test results (e.g., high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).
• Painful red lumps on the skin, skin pain, skin redness (inflammation of the fatty tissue under the skin).

Unknown(frequency cannot be estimated from the available data):

• Combination of extensive intense rash, feeling of discomfort, fever, high levels of certain white blood cells, or yellowish skin or eyes (signs of jaundice) with difficulty breathing, chest pain, severely decreased urine production, and feeling of thirst, 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 suffer from any of the above alterations, inform your doctor immediately.

Other Adverse Effects May Include:

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

• Headache or feeling of fatigue
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the joints, muscles, or bones.
• Swelling such as swollen ankles or eyes.
• Weight gain.

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

Common Adverse Effects(may affect up to 1 in 10 people)

• Anorexia, weight loss, or altered sense of taste.
• Feeling of fatigue or weakness.
• 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.
• Weakness 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.

Unknown Frequency(cannot be estimated from the available data):

• Redness and/or swelling of the palms of the hands and the soles of the feet, which may be accompanied by a tingling sensation and burning pain.
• Delayed growth in children and adolescents.

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

Reporting Adverse Effects

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

5. Storage of Imatinib Farmalider

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Imatinib Farmalider

• The active ingredient is imatinib mesylate. Each capsule contains 400 mg of imatinib (as mesylate).
• The other components are: Capsule content: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shell is composed of gelatin, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), and titanium dioxide (E171).

Appearance of the Product and Package Contents

Imatinib Farmalider 400 mg capsules are caramel-colored. They contain a white or almost white powder.

They are presented in packages containing 30 capsules.

Marketing Authorization Holder

Farmalider S.A.

C/Aragoneses, 15

28108 Alcobendas (Madrid)

Spain

Manufacturer

Adamed Pharma, S.A.

ul. Marszalka Józefa Pilsudskiego 5 Str.

95-200 Pabianice,

Poland

or

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Prospectus: June 2022

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/.