Label: information for the patient

Pomalidomida Sandoz 1 mg hard capsules EFG

Pomalidomida Sandoz 2 mg hard capsules EFG

Pomalidomida Sandoz 3 mg hard capsules EFG

Pomalidomida Sandoz 4 mg hard capsules EFG

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section 4.

Pomalidomida Sandoz

Pomalidomida Sandoz contains the active ingredient “pomalidomida”. This medicine is related to talidomida and belongs to a group of medicines that affect the immune system (the body's natural defenses).

What is Pomalidomida Sandoz used for

Pomalidomida is used to treat adults with a type of cancer called “multiple myeloma”.

Pomalidomida is used with:

• Other two medicinescalled “bortezomib” (a type of chemotherapy medicine) and “dexametasona” (an anti-inflammatory medicine) in people who have received at least one other treatment, including lenalidomida.

or

• Another medicine called“dexametasona” in people who have experienced a worsening of their multiple myeloma, despite havingreceivedat least two other types of treatments, including the medicines lenalidomida and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called “plasmatic cells”). These cells grow uncontrollably and accumulate in the bone marrow, damaging the bones and kidneys.

Multiple myeloma generally does not have a cure. However, treatment can reduce the symptoms and signsofthe disease or make them disappear for a period of time. When this occurs, it is referred to as “response”.

How Pomalidomida Sandoz works

Pomalidomida acts in several ways:

• It stops the development of multiple myeloma cells;
• It stimulates the immune system to attack the cancer cells;
• It stops the formation of blood vessels that feed the cancer cells.

Benefit of using pomalidomida with bortezomib and dexametasona

If pomalidomida is used with bortezomib and dexametasona in people who have received at least one other treatment, the progression of multiple myeloma can be stopped:

• Generally, the combination of pomalidomida with bortezomib and dexametasona prevented the recurrence of multiple myeloma for a period of up to 11 months compared to the 7 months observed in patients who took only bortezomib and dexametasona.

Benefit of using pomalidomida with dexametasona

If pomalidomida is usedwithdexametasona in people who have received at least two other treatments, it can stop the progression of multiple myeloma:

Generally, the combination of pomalidomida and dexametasona prevented the recurrence of multiple myeloma for a period of up to 4 months compared to the 2 months observed in patients who took dexametasona only.

Do not take Pomalidomida Sandoz:

• if you are pregnant, think you may be pregnant, or intend to become pregnant, as pomalidomida is expected to be harmful to the fetus.Pomalidomida is expected to be harmful to the fetus.. (Men and women taking this medication should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below),
• if you can become pregnant, unless you are taking all necessary measures to prevent pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If you can become pregnant, your doctor will note on each prescription that all necessary measures have been taken and will provide you with this confirmation,
• if you are allergic to pomalidomida or any of the other components of this medication (listed in section 6). If you think you may be allergic, consult your doctor.

If you are unsure whether any of these situations described applies to you, consult your doctor, pharmacist or nurse before taking pomalidomida.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Pomalidomida Sandoz if:

• you have ever had blood clots in the past. During treatment with pomalidomida, you have a higher risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reduce your pomalidomida dose to have fewer chances of developing blood clots,
• you have ever had an allergic reaction, such as skin rash, itching, swelling, dizziness or respiratory problems while taking related medications called “thalidomide” or “lenalidomide”,
• you have had a heart attack, have heart failure, have difficulty breathing or, if you are a smoker,havehigh blood pressure or high cholesterol levels,
• you have a high total tumor burden in the body, including the bone marrow. This could lead to adiseasein which tumors break down and produce unusual levels of chemicals in the blood that, in turn, can cause kidney failure. You may also experience irregular heartbeats. This disease is called tumor lysis syndrome,
• you suffer or have suffered neuropathy (nerve damage that causes tingling or pain in your feet or hands),
• you have or have had a hepatitis B virus infection. Treatment with pomalidomida can reactivate the hepatitis B virus in patients who are carriers of the virus, leading to the reappearance of the infection. Your doctor should check if you have ever had a hepatitis B virus infection,
• youexperienceor have experienced in the past a combination of any of the following symptoms: facial or generalized rash, skin redness, high fever, flu-like symptoms, enlarged lymph nodes (symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, or DRESS syndrome or Stevens-Johnson syndrome). See also section 4 “Possible side effects”).

It is essential to note that patients with multiple myeloma treated with pomalidomida may develop other types of cancer, so your doctor should carefully evaluate the benefits and risks of prescribing this medication.

At any time during or after treatment, inform your doctor or nurse immediately if: you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss orconfusion. All of these can be symptoms of a severe and potentially life-threatening brain disease called multifocal progressive leukoencephalopathy (MPL). If you had any of these symptoms before starting treatment with pomalidomida, inform your doctor if you notice any change in these symptoms.

After treatment, you must return all unused capsules to the pharmacist.

Pregnancy, contraception and breastfeeding: information for men and women

You must follow the following instructions collected in the Pomalidomida Pregnancy Prevention Program.

Men and women taking pomalidomida should not conceive or become pregnant.

The reason is that pomalidomida is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medication.

Women

Do not take pomalidomida if you are pregnant, think you may be pregnant, or intend to become pregnant. The reason is that this medication is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is a possibility that you may become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you mustuseeffective contraceptive methods from at least 4 weeks before starting treatment, during the entire time you are taking the treatment and until at least 4 weeks after finishing it. Your doctor will advise you on the most suitable contraceptive methods,
• each time your doctor prescribes a prescription, they will ensure that you have understood the necessary measures to prevent pregnancy,
• your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment and at least 4 weeks after finishing treatment.

If, despite preventive measures, you become pregnant:

• you must stop treatment immediately and inform your doctor immediately.

Breastfeeding

The passage of pomalidomida into human breast milk is unknown. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you can continue or must stop breastfeeding.

Men

Pomalidomida passes into human semen.

• If your partner is pregnant or can become pregnant, you must use condoms during the entire time you are taking the treatment and until 7 days after finishing it.
• If your partner becomes pregnant while you are taking pomalidomida, inform your doctor immediately. Your partner should also inform their doctor immediately.

You must not donate semen or sperm during treatment and until 7 days after finishing it.

Blood donation and blood tests

You must not donate blood during treatment and until 7 days after finishing it.

Before starting treatment with pomalidomida and during treatment, you will have periodic blood tests. This is because your medication can cause a decrease in the number of white blood cells that help fight infections and the number of platelets that help stop bleeding.

Yourdoctorwill ask you to have a blood test:

• before treatment,
• every week during the first 8 weeks of treatment,
• at least once a month while you continue to take pomalidomida.

Your doctor may adjust the dose of pomalidomida or stop your treatment, depending on the results of these tests. Your doctor may also adjust the dose or stop this medication due to your overall health status.

Children and adolescents

Pomalidomida is not recommended for use in children and adolescents under 18 years of age.

Other medications and Pomalidomida Sandoz

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medication. This is because pomalidomida can affect how other medications work. Additionally, some medications can affect how pomalidomida works.

In particular, inform your doctor, pharmacist or nurse before taking pomalidomida if you are taking any of the following medications:

• some antifungals such as ketoconazole,
• some antibiotics (e.g., ciprofloxacin, enoxacin),
• some antidepressants such as fluvoxamine.

Driving and using machines

Some people experience fatigue, dizziness, confusion or decreased alertness while taking pomalidomida. If this happens to you, do not drive or use tools or machinery.

Pomalidomida Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Pomalidomidemust be administered by a doctor with experience in the treatment of multiple myeloma.

Followexactlythe medication administration instructions indicated by your doctor. If in doubt, consult your doctor, pharmacist or nurse.

When to take pomalidomide with other medications

Pomalidomide in combination with bortezomib and dexamethasone

• Consult the prospectus attached to bortezomib and dexamethasone for additional information on their use and effects.
• Pomalidomide, bortezomib and dexamethasone are taken in cycles of treatment.
• Each cycle lasts 21 days (3 weeks).
• Observe the following chart to see what you should take each day of the 3-week cycle:

-Each day observe the chart and identify the correct day to see what medications you should take.

-Some days you will take all three medications, other days you will take only 1 or 2 medications, and other days you will take none of them.

POM: Pomalidomide;BOR: Bortezomib;DEX: Dexamethasone

Aftercompletingeach 3-week cycle, start a new one.

Pomalidomide only with dexamethasone

Consult the prospectus attached to dexamethasone for additional information on its use and effects.

• Pomalidomide and dexamethasone are taken in cycles of treatment. Each cycle lasts 28 days (4 weeks).
• Observe the following chart to see what you should take each day of the 4-week cycle:

• Each day observe the chart and identify the correct day to see what medications you should take.
• Some days you will take both medications, other days you will take only 1 medication, and other days you will take none of them.

POM: Pomalidomide;DEX: Dexamethasone

• Aftercompleting each 4-week cycle, start a new one.

How much pomalidomide to take with other medications

Pomalidomide with bortezomib and dexamethasone

• The recommended initial dose of pomalidomide is 4 mg per day.
• The initial dose of bortezomib will be calculated by your doctor based on your height and weight (1.3 mg/m2 of body surface area).
• The recommended initial dose of dexamethasone is 20 mg per day. However, if you are over 75 years old, the recommended initial dose is 10 mg per day.

Pomalidomide only with dexamethasone

• The recommended dose of pomalidomide is 4 mg once a day.
• The recommended initial dose of dexamethasone is 40 mg per day. However, if you are over 75 years old, the recommended initial dose is 20 mg per day.

Your doctor may need to reduce the dose of pomalidomide, bortezomib or dexamethasone, or interrupt one or more of these medications based on your blood test results and overall condition, if you are taking other medications (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience adverse effects (especially skin rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will closely monitor your condition while you are taking this medication.

How to take Pomalidomide Sandoz

• Do not break, open or chew the capsules. If the powder from a broken capsule comes into contact with your skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister pack or capsule. After handling the blister pack or capsule, carefully remove the gloves, place them in a plastic bag and dispose of them according to local requirements. Then, wash your hands thoroughly with water and soap. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• You can take the capsules with or without food.
• Take the capsules at approximately the same time each day.

To remove the capsule from the blister pack, press only one end of the capsule to push it through the foil.Do not press in the center of the capsule as it may break.

Your doctor will advise you on how and when to take pomalidomide if you have kidney problems and are receiving treatment with dialysis.

Duration of treatment with Pomalidomide Sandoz

You should continue the treatment cycles until your doctor tells you to stop.

What to do if you take too much Pomalidomide Sandoz

If you take more pomalidomide than you should, inform your doctor or go to the hospital immediately. Bring the medication packaging with you.

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

What to do if you forget to take Pomalidomide Sandoz

If you forget to take pomalidomide on the day you should, take the next capsule the next day at the usual time.

Do not take a double dose to make up for the missed dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

If you experience any of the following severe side effects, stop taking pomalidomida and seek medical attention immediately, as you may need emergency medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a decrease in white blood cells that fight infection),
• Bleeding or bruising without apparent cause, including nosebleeds and gastrointestinal or stomach bleeding (due to effects on blood cells called platelets),
• Fast breathing, rapid pulse, fever, and chills, reduced or absent urination, nausea, and vomiting, confusion, and loss of consciousness (due to a blood infection called sepsis or septic shock),
• Severe, persistent, or bloody diarrhea (possibly accompanied by stomach pain or fever) caused by the bacteria Clostridium difficile,
• Chest or leg pain and swelling, especially in the lower leg or calf (produced by blood clots),
• Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots),
• Swelling of the face, lips, tongue, and throat, which can cause difficulty breathing (due to severe allergic reactions called angioedema and anaphylaxis),
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in skin appearance or skin bumps. If you notice changes in skin appearance while taking pomalidomida, report it to your doctor as soon as possible,
• Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, abdominal pain on the right side, fever, nausea, or discomfort. Inform your doctor immediately if you notice any of these symptoms,

Inform your doctor immediately if you notice any of these symptoms,

• Generalized rash, high body temperature, enlarged lymph nodes, and effects on other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomida if you experience these symptoms and contact your doctor or seek medical attention immediately. See section 2.

If you experience any of the following severe side effects,stop taking pomalidomida and seek medical attention immediately, as you may need emergency medical treatment.

Other side effects

Side effectsvery common(may affect more than 1 in 10 people):

• Difficulty breathing (dyspnea),
• Pneumonia and bronchitis,
• Infections of the nose, sinuses, and throat caused by bacteria or viruses,
• Flu-like symptoms,
• Low red blood cell count, which can cause anemia leading to fatigue and weakness,
• Low potassium levels in the blood (hypokalemia), which can cause weakness, muscle cramps, and pains, palpitations, numbness or tingling, shortness of breath, and mood changes,
• High blood sugar levels,
• Irregular and rapid heartbeat (atrial fibrillation),
• Loss of appetite,
• Constipation, diarrhea, or nausea,
• Vomiting,
• Abdominal pain,
• Lack of energy,
• Difficulty falling or staying asleep,
• Dizziness, tremors,
• Muscle spasms, muscle weakness,
• Bone pain, back pain,
• Numbness, tingling, or prickling sensation in the skin, hand or foot pain (peripheral sensory neuropathy),
• Generalized swelling, including swelling of arms and legs,
• Rashes,
• Urinary tract infections, which can cause a burning sensation while urinating or the need to urinate more frequently.

Side effectscommon(may affect up to 1 in 10 people):

• Falling,
• Internal bleeding in the brain,
• Reduced ability to move or feel (sensibility) in the hands, feet, and legs due to neurological damage (peripheral sensory-motor neuropathy),
• Numbness, tingling, or prickling sensation in the skin (paresthesia),
• Sensation of spinning, which makes it difficult to stand and move normally,
• Swelling caused by fluid retention,
• Hives (urticaria)
• Itching skin,
• Herpes zoster,
• Heart attack (chest pain that radiates to the arms, neck, and jaw),
• Sensation of sweating and difficulty breathing, sensation of nausea or vomiting),
• Chest pain, chest infection,
• Increased blood pressure,
• Simultaneous reduction in the number of red and white blood cells and platelets (pancytopenia), which makes you more prone to bleeding and bruising. You may feel tired and weak, and have difficulty breathing. You will also be more susceptible to infections,
• Decreased lymphocyte count (a type of white blood cell) often caused by an infection (lymphopenia),
• Low magnesium levels in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, and irritability, and can cause low calcium levels in the blood (hypocalcemia), which can cause numbness or tingling in the hands, feet, or lips, muscle cramps, muscle weakness, drowsiness, confusion,
• Low phosphate levels in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion,
• High calcium levels in the blood (hypercalcemia) that can slow down reflexes and cause skeletal muscle weakness,
• High potassium levels in the blood that can cause abnormal heart rhythm,
• Low sodium levels in the blood that can cause fatigue and confusion, muscle contractions, seizures, or coma,
• High uric acid levels in the blood, which can cause a type of arthritis called gout,
• Low blood pressure, which can cause dizziness or fainting,
• Mouth or tongue pain,
• Change in taste,
• Swollen abdomen,
• Feeling confused,
• Feeling down (depressed mood),
• Loss of consciousness, fainting,
• Eye cloudiness (cataract),
• Kidney damage,
• Inability to urinate,
• Abnormal liver function test results,
• Pelvic pain,
• Weight loss.

Side effectsinfrequent(may affect up to 1 in 100 people):

• Stroke,
• Liver inflammation (hepatitis) that can cause skin itching, yellowing of the skin and eyes (jaundice), light-colored stools, dark-colored urine, and abdominal pain,
• The breakdown of tumor cells results in the release of toxic compounds into the bloodstream (tumor lysis syndrome). It can lead to kidney problems,
• Underactive thyroid gland, which can cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain,

Side effects ofunknown frequency(cannot be estimated from available data):

• Rejection of solid organ transplants (such as heart or liver).

Reporting 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 System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack and the boxafter “CAD/EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe visible signs of deterioration or signs of improper handling of the medication.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pomalidomida Sandoz

• The active ingredient is pomalidomide.
• The other excipients are microcrystalline cellulose (E460), maltodextrin, and stearic acid and sodium fumarate.

Pomalidomida Sandoz 1 mg hard capsules:

• Each capsule contains 1 mg of pomalidomide.
• The other excipients are:
• Capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and white ink.
• Printing ink: shellac lacquer, titanium dioxide (E171), propylene glycol.

Pomalidomida Sandoz 2 mg hard capsules:

• Each capsule contains 2 mg of pomalidomide.
• The other excipients are:

• Capsule coating: gelatin, titanium dioxide (E 171), yellow iron oxide (E172), red iron oxide (E172), and white ink.
• Printing ink: shellac lacquer, titanium dioxide (E171), propylene glycol.

Pomalidomida Sandoz 3 mg hard capsules:

• Each capsule contains 3 mg of pomalidomide.
• The other excipients are:

• Capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132), and white ink.

• Printing ink: shellac lacquer, titanium dioxide (E171), propylene glycol.

Pomalidomida Sandoz 4 mg hard capsules:

• Each capsule contains 4 mg of pomalidomide.
• The other excipients are:

• Capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132), and white ink.
• Printing ink: shellac lacquer, titanium dioxide (E171), propylene glycol.

Appearance of the product and contents of the package

Pomalidomida Sandoz 1 mg hard capsules:

Hard gelatin capsule, with yellow body and red cap, marked with “PLM 1” printed axially rectified with white ink on the body.

Pomalidomida Sandoz 2 mg hard capsules:

Hard gelatin capsule, with orange body and red cap, marked with “PLM 2” printed axially rectified with white ink on the body.

Pomalidomida Sandoz 3 mg hard capsules:

Hard gelatin capsule, with turquoise body and red cap, marked with “PLM 3” printed axially rectified with white ink on the body.

Pomalidomida Sandoz 4 mg hard capsules:

Hard gelatin capsule, with dark blue body and red cap, marked with “PLM 4” printed axially rectified with white ink on the body.

Packaging sizes:

Pomalidomida Sandoz is packaged in blisters or perforated single-dose blisters. Each package contains 14, 21, 14x1, 21x1 capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Synthon B.V.

Microweg 22

6545 CM

Nijmegen

Netherlands

or

Synthon Hispania, S.L.

C/ Castelló, nº 1

Sant Boi de Llobregat

08830 Barcelona

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Alle 1

39179 Barleben

Germany

Last revision date of this leaflet:June 2024.

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/