Prospect: information for the patient

Pomalidomida Teva 1 mg hard capsules

Pomalidomida Teva 2 mg hard capsules

Pomalidomida Teva 3 mg hard capsules

Pomalidomida Teva 4 mg hard capsules

pomalidomida

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

• Keep this prospect, 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 other people 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 prospect. See section 4.

Pomalidomida Teva

Pomalidomida Teva 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 Teva used for

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

Pomalidomida Teva 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.

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• Another medicinecalled “dexametasona” in people who have experienced a worsening of their myeloma, despite having received at 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 signs of the disease or make them disappear for a period of time. When this occurs, it is referred to as “response”.

How Pomalidomida Teva works

Pomalidomida Teva acts in several ways:

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

Benefit of using Pomalidomida Teva with bortezomib and dexametasona

If Pomalidomida Teva 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 Teva 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 taking only bortezomib and dexametasona.

Benefit of using Pomalidomida Teva with dexametasona

If Pomalidomida Teva is used with dexametasona in people who have received at least two other treatments, the progression of multiple myeloma can be stopped:

• Generally, the combination of Pomalidomida Teva and dexametasona prevented the recurrence of multiple myeloma for a period of up to 4 months compared to the 2 months observed in patients taking dexametasona only.

Do not take Pomalidomida Teva:

• if you are pregnant, think you may be pregnant or intend to become pregnant, as Pomalidomida Teva 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 apply to you, consult your doctor, pharmacist or nurse before starting to take Pomalidomida Teva.

Warnings and precautions

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

• you have ever had blood clots in the past. During treatment with Pomalidomida Teva, 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 Teva 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, have high blood pressure or high cholesterol levels;
• you have a high total tumor burden in the body, including the bone marrow. This could lead to a disease in which tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may 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 hepatitis B virus infection. Treatment with Pomalidomida Teva may reactivate the hepatitis B virus in patients who are carriers of the virus, leading to the reappearance of the infection (recurrence). Your doctor should check if you have ever had a hepatitis B virus infection;
• you experience or 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 [by its English acronym] or drug hypersensitivity syndrome, toxic epidermal necrolysis [NET] or Stevens-Johnson syndrome [SSJ]. 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, immediately inform your doctor or nurse if: you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. All of these may be symptoms of a severe and potentially fatal brain disease called multifocal progressive leukoencephalopathy (LMP). If you had any of these symptoms before starting treatment with Pomalidomida Teva, inform your doctor if you notice any change in these symptoms.

At the end of 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 as part of the Pomalidomida Teva Pregnancy Prevention Program. Men and women taking Pomalidomida Teva 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 Teva 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 must use effective 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 be taken 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 Teva 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 Teva 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 Teva, 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 Teva and during treatment, you will have periodic blood tests. This is because your medication may cause a decrease in the number of white blood cells that help fight infections and in the number of platelets that help stop bleeding.

Your doctor will 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 Teva.

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

Children and adolescents

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

Other medications and Pomalidomida Teva

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 Teva may affect how other medications work. In addition, some medications may affect how Pomalidomida Teva works.

Particularly, inform your doctor, pharmacist or nurse before taking Pomalidomida Teva 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 Teva. If this happens to you, do not drive or use tools or machinery.

Pomalidomida Teva contains sodium

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

Pomalidomida Teva contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Pomalidomida Teva contains Brilliant Blue FCF (E133)

This medication contains the Brilliant Blue FCF (E133) dye, which may cause allergic reactions.

Pomalidomide Teva should be administered by a doctor with experience in the treatment of multiple myeloma.

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

When to take Pomalidomide Teva with other medications

Pomalidomide Teva in combination with bortezomib and dexamethasone

• Consult the prospectus attached to bortezomib and dexamethasone for additional information on their use and effects.
• Pomalidomide Teva, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).
• Observe the following chart to consult what to 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 3 medications, other days you will take only 1 or 2 medications, and other days none of them.

POM:Pomalidomide Teva;BOR:bortezomib;DEX:dexamethasone

• After completing each 3-week cycle, start a new one.

Pomalidomide Teva only with dexamethasone

• Consult the prospectus attached to dexamethasone for additional information on its use and effects.
• Pomalidomide Teva and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Observe the following chart to consult what to 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 none of them.

POM:Pomalidomide Teva;DEX:dexamethasone

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

How much Pomalidomide Teva to take with other medications

Pomalidomide Teva with bortezomib and dexamethasone

• The recommended initial dose of Pomalidomide Teva is 4 mg per day.
• The recommended 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 Teva only with dexamethasone

• The recommended dose of Pomalidomide Teva 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 Teva, 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 receive this medication.

How to take Pomalidomide Teva

• 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. Afterward, they should carefully remove the gloves to avoid skin exposure, place them in a plastic bag, and dispose of them according to local requirements. Then, they should wash their hands thoroughly with water and soap. Pregnant women or those 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.
• You should take the capsules approximately at the same time each day.

To remove the capsule from the blister pack, press only one end of the capsule to allow it to come out 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 Teva if you have kidney problems and are receiving dialysis treatment.

Duration of treatment with Pomalidomide Teva

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

If you take more Pomalidomide Teva than you should

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

If you forget to take Pomalidomide Teva

If you forget to take Pomalidomide Teva on the day you should, take the next capsule the next day at the usual time. Do not take more capsules to make up for the missed dose of Pomalidomide Teva the previous day.

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 Teva 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 the 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 bacteriaClostridium 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 Teva, inform your doctor as soon as possible.
• Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea, or discomfort. 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 Teva and seek medical attention immediately, as you may need emergency medical treatment.

Other side effects

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

• Difficulty breathing (dyspnea).
• Pneumonia and bronchitis.
• Nasal, sinus, and throat infections 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, tremor.
• 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.
• Skin rashes.
• Urinary tract infections, which can cause a burning sensation while urinating or the need to urinate more frequently.

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

• Falling.
• Internal bleeding in the skull.
• Reduced ability to move or feel (sensitivity) in the hands, feet, and legs due to neurological damage (peripheral sensory-motor neuropathy).
• Numbness, itching, or tingling in the skin (paresthesia).
• Sensation of dizziness, 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, sweating, difficulty breathing, nausea, or vomiting).
• Chest pain, chest infection.
• High blood pressure.
• Simultaneous reduction in the number of red and white blood cells and platelets (pancytopenia) that 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, tingling, or prickling sensation in the hands, feet, or lips, muscle cramps, muscle weakness, drowsiness, confusion.
• Low phosphate levels in the blood (hypophosphatemia), which can cause muscle weakness, irritability, or confusion.
• High calcium levels in the blood (hypercalcemia), which can slow down reflexes and cause skeletal muscle weakness.
• High potassium levels in the blood, which can cause abnormal heart rhythm.
• Low sodium levels in the blood, which 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.
• Oral pain or dryness.
• Changes in the taste of things.
• Swollen abdomen.
• Confusion.
• Feeling down (depressed mood).
• Loss of consciousness, fainting.
• Eye opacity (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal liver function test results.
• Pelvic pain.
• Weight loss.

Uncommon(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). This can lead to kidney problems.
• Underactive thyroid gland, which can cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain.

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

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

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 thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and the box after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use Pomalidomida Teva 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. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Pomalidomide Teva Composition

• The active ingredient is pomalidomide
• The other components are lactose monohydrate, crospovidone, povidone, sodium lauryl sulfate, and sodium stearyl fumarate

Pomalidomide Teva 1 mg Hard Capsules

• Each capsule contains 1 mg of pomalidomide
• The capsule shell contains: Brilliant Blue FCF (E133), titanium dioxide (E171), gelatin, and yellow iron oxide (E172)
• The ink used for printing contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525)

Pomalidomide Teva 2 mg Hard Capsules

• Each capsule contains 2 mg of pomalidomide
• The capsule shell contains: Brilliant Blue FCF (E133), titanium dioxide (E171), gelatin, yellow iron oxide (E172), and red iron oxide (E172)
• The ink used for printing contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525)

Pomalidomide Teva 3 mg Hard Capsules

• Each capsule contains 3 mg of pomalidomide
• The capsule shell contains: Brilliant Blue FCF (E133), titanium dioxide (E171), gelatin, and yellow iron oxide (E172)
• The ink used for printing contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525)

Pomalidomide Teva 4 mg Hard Capsules

• Each capsule contains 4 mg of pomalidomide
• The capsule shell contains: Brilliant Blue FCF (E133), titanium dioxide (E171), and gelatin
• The ink used for printing contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525)

Appearance of the product and contents of the pack

Pomalidomide Teva 1 mg Hard Capsules: Hard gelatin capsule of approximately 14 mm with opaque blue cap and opaque yellow body with the inscription “T” on the cap and “1” on the body.

Pomalidomide Teva 2 mg Hard Capsules: Hard gelatin capsule of approximately 18 mm with opaque blue cap and opaque orange body with the inscription “T” on the cap and “2” on the body.

Pomalidomide Teva 3 mg Hard Capsules: Hard gelatin capsule of approximately 18 mm with opaque blue cap and opaque green body with the inscription “T” on the cap and “3” on the body.

Pomalidomide Teva 4 mg Hard Capsules: Hard gelatin capsule of approximately 18 mm with opaque blue cap and opaque light blue body with the inscription “T” on the cap and “4” on the body.

Each pack contains 14, 14 x 1, 21, 21 x 1, 63, and 63 x 1 capsules. Some pack sizes may not be marketed.

Marketing Authorisation Holder

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Responsible Person

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600, Bulgaria

Merckle GmbH

Graf-Arco-Str. 3

89079 Ulm, Germany

Actavis Group PTC ehf.

Dalshraun 1

IS-220 Hafnarfjordur, Iceland

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics: