Lenalidomide Teva

Leaflet accompanying the packaging: patient information

Lenalidomide Teva, 5 mg, hard capsules

Lenalidomide Teva, 10 mg, hard capsules

Lenalidomide Teva, 15 mg, hard capsules

Lenalidomide Teva, 25 mg, hard capsules

Lenalidomide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lenalidomide Teva and what is it used for
• 2. Important information before taking Lenalidomide Teva
• 3. How to take Lenalidomide Teva
• 4. Possible side effects
• 5. How to store Lenalidomide Teva
• 6. Package contents and other information

1. What is Lenalidomide Teva and what is it used for

What is Lenalidomide Teva

Lenalidomide Teva contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the immune system.

What is Lenalidomide Teva used for

Lenalidomide Teva is used in adult patients to treat:

• multiple myeloma,
• myelodysplastic syndromes,
• mantle cell lymphoma,
• follicular lymphoma.

Multiple myeloma

Multiple myeloma is a type of cancer that affects a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and undergo uncontrolled divisions. This can lead to bone and kidney damage. In principle, multiple myeloma is incurable. However, it is possible to temporarily significantly alleviate or remove the signs and symptoms of the disease. We call this "remission". New diagnosis of multiple myeloma - in patients after bone marrow transplantation In this indication, Lenalidomide Teva is used without other medicines in maintenance treatment after achieving a suitable condition after transplantation. New diagnosis of multiple myeloma - in patients who are not eligible for bone marrow transplantation treatment Lenalidomide Teva is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan" and
• a medicine that suppresses the immune system called "prednisone". The patient starts treatment with additional medicines and then continues with Lenalidomide Teva alone.

If the patient is 75 years old or older, or has moderate to severe kidney problems, the doctor will perform thorough tests before starting treatment. Multiple myeloma - in patients who have received previous treatment Lenalidomide Teva is taken in combination with an anti-inflammatory medicine called "dexamethasone". Lenalidomide Teva may stop the progression of multiple myeloma symptoms and signs. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow diseases. Abnormal blood cells are present that do not function properly. Patients may experience various subjective and objective symptoms, including a low number of red blood cells (anemia), the need for blood transfusions, and the risk of infection. Lenalidomide Teva is used as monotherapy in the treatment of adult patients with MDS, if all of the following conditions are met:

• the patient has a low number of red blood cells and needs regular blood transfusions ("transfusion-dependent anemia");
• the patient has a cytogenetic abnormality in bone marrow cells called "isolated deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously received other treatments that have proven to be ineffective or insufficient.

Taking Lenalidomide Teva may lead to an increase in the number of healthy blood cells produced by the body, by reducing the number of abnormal cells:

• this may lead to a reduction in the number of blood transfusions required. It is possible that transfusions will no longer be needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphoid tissue). It affects a certain type of white blood cell called B lymphocytes or B cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B lymphocytes, resulting in their accumulation in lymphoid tissue, bone marrow, or blood. Lenalidomide Teva is used as monotherapy in the treatment of adult patients who have previously received other medicines.

Follicular lymphoma (FL)

Follicular lymphoma (FL) is a slow-growing malignant cancer that affects B lymphocytes. It is a type of white blood cell that helps the body fight infections. In patients with FL, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen. Lenalidomide Teva is taken with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Teva works

Lenalidomide Teva works by affecting the immune system and directly attacking cancer cells. The medicine works in several different ways:

• by inhibiting the growth of cancer cells;
• by inhibiting the growth of blood vessels in the tumor;
• by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Teva

Before starting treatment with Lenalidomide Teva, read the leaflets of all medicines taken in combination with Lenalidomide Teva.

When not to take Lenalidomide Teva:

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, as Lenalidomide Teva is expected to be harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men");
• if the patient may become pregnant, unless all required contraceptive measures are taken (see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men"). If the patient may become pregnant, the doctor will always make a note when prescribing the medicine that the necessary measures have been taken and will inform the patient about it;
• if the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). In case of suspected allergy, consult a doctor.

If any of these points apply to the patient, they should not take Lenalidomide Teva. In case of doubts, consult a doctor.

Warnings and precautions

Before starting Lenalidomide Teva, discuss with your doctor, pharmacist, or nurse if:

• the patient has a history of blood clots - this means an increased risk of forming blood clots in veins and arteries during treatment;
• the patient has any signs of infection, such as cough or fever;
• the patient currently has or has had a viral infection, especially chickenpox and shingles, hepatitis B, HIV infection. In case of doubts, consult a doctor. Treatment with Lenalidomide Teva may cause the reactivation of viruses in patients who have been infected in the past, leading to the recurrence of the infection. The doctor will check if the patient has had hepatitis B in the past;
• the patient has kidney problems - the doctor may adjust the dose of Lenalidomide Teva;
• the patient has had a heart attack, has ever had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• the patient has had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• the patient has had a combination of any of the following symptoms in the past: widespread rash, redness of the skin, high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes
• these are symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above points apply to the patient, they should consult a doctor, pharmacist, or nurse. If any of the above points apply to the patient, they should inform their doctor, pharmacist, or nurse.

Tests and examinations

Before and during treatment with Lenalidomide Teva, the patient will have regular blood tests, as Lenalidomide Teva may cause a decrease in the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets). The doctor will call the patient for blood tests:

• before treatment,
• every week for the first 8 weeks of treatment,
• then at least once a month.

Before starting treatment with lenalidomide and during treatment, the patient may undergo an assessment for circulation and breathing problems. Patients with MDS taking Lenalidomide Teva If the patient has myelodysplastic syndromes, there is an increased risk of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Teva affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that will help better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Teva. Patients with MCL taking Lenalidomide Teva The doctor will ask for a blood test:

• before treatment,
• every week for the first 8 weeks (2 cycles) of treatment,
• then every 2 weeks in cycles 3 and 4 (more information is provided in section 3 "Treatment cycle"),
• then at the beginning of each cycle and
• at least once a month.

Patients with FL taking Lenalidomide Teva The doctor will ask for a blood test:

• before treatment,
• every week for the first 3 weeks (1 cycle) of treatment,
• then every 2 weeks in cycles 2 to 4 (more information is provided in section 3 "Treatment cycle"),
• then at the beginning of each cycle and
• at least once a month.

The doctor may perform a test to check if the patient has a large amount of tumor tissue in the body, including in the bone marrow. This can lead to a situation where the tumor tissue starts to die and causes abnormal growth of various substances in the blood, which can lead to kidney failure (a condition called tumor lysis syndrome). The doctor may perform a test to check for skin changes, such as red spots or rash. The doctor may change the dose of Lenalidomide Teva or stop treatment based on the results of the patient's blood tests and overall condition. If the disease is newly diagnosed, the doctor may also assess treatment based on the patient's age and other conditions that may have occurred in the past.

Blood donation

During treatment and for at least 7 days after stopping treatment, the patient should not donate blood.

Children and adolescents

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

Elderly and patients with kidney problems

If the patient is 75 years old or older, or has moderate to severe kidney problems, the doctor will perform thorough tests before starting treatment.

Lenalidomide Teva and other medicines

Tell your doctor or nurse about all medicines you are taking now or have taken recently. This is necessary because Lenalidomide Teva may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Teva. In particular, inform your doctor or nurse if you are taking:

• certain birth control pills, such as oral contraceptives, as they may stop working;
• certain medicines for heart problems - such as digoxin;
• certain medicines for blood thinning - such as warfarin.

Pregnancy, breastfeeding, and contraception - information for women and men

Pregnancy

For women taking Lenalidomide Teva

• Lenalidomide Teva should not be taken if the patient is pregnant, as it is expected to be harmful to the unborn child.
• The patient should not become pregnant while taking Lenalidomide Teva. Therefore, women who may become pregnant must use effective contraception (see "Contraception").
• If the patient becomes pregnant while taking Lenalidomide Teva, she should stop treatment immediately and inform her doctor.

For men taking Lenalidomide Teva

• If the partner of a man taking Lenalidomide Teva becomes pregnant, she should inform her doctor immediately. The partner should consult a doctor.
• Men should also use effective contraception (see "Contraception").

Breastfeeding

Breastfeeding should not be done while taking Lenalidomide Teva, as it is not known whether Lenalidomide Teva passes into human milk.

Contraception

Women taking Lenalidomide Teva Before starting treatment, ask your doctor about the possibility of becoming pregnant, even if you think it is unlikely. Women who may become pregnant:

• will have pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless the patient has had her fallopian tubes cut and sealed (tubal ligation) AND
• must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. The doctor will recommend the appropriate contraception methods to the patient.

Men taking Lenalidomide Teva Lenalidomide Teva passes into human semen. If a woman is pregnant or may become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after stopping treatment. This also applies to men who have had a vasectomy. During treatment and for at least 7 days after stopping treatment, the patient should not donate semen.

Driving and using machines

Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, balance problems, or blurred vision after taking Lenalidomide Teva.

Lenalidomide Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Lenalidomide Teva

Lenalidomide Teva must be administered by a qualified medical professional who has experience in treating multiple myeloma, MDS, MCL, or FL.

• When Lenalidomide Teva is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received previous treatment, the medicine is taken with other medicines (see section 1 "What is Lenalidomide Teva used for").
• When Lenalidomide Teva is used to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS or MCL, the medicine is taken as monotherapy.
• When Lenalidomide Teva is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Lenalidomide Teva should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. If you are taking Lenalidomide Teva with other medicines, you should read the leaflet that comes with their packaging to get information about their use and effects.

Treatment cycle

Lenalidomide Teva is taken on specific days during a period of three weeks (21 days).

• Each 21-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 21-day cycle, the patient should start a new 21-day cycle. OR

Lenalidomide Teva is taken on specific days during a period of four weeks (28 days).

• Each 28-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 28-day cycle, the patient should start a new 28-day cycle.

Recommended dose of Lenalidomide Teva

Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide Teva to take;
• how many other medicines to take in combination with Lenalidomide Teva, if other medicines are necessary;
• on which days of the cycle to take which medicines.

How and when to take Lenalidomide Teva

• The capsule should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Lenalidomide Teva capsule comes into contact with the skin, wash the skin immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of in accordance with local regulations. Then, wash your hands with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Lenalidomide Teva should be taken at approximately the same time every day when the product is scheduled to be administered.

Taking this medicine

To remove the capsule from the blister:

• press the capsule only from one side and push it through the foil;
• do not press the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Teva

Lenalidomide Teva is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor stops the treatment.

Taking a higher dose of Lenalidomide Teva than recommended

If a higher dose of Lenalidomide Teva than prescribed is taken, the doctor should be informed immediately.

Missing a dose of Lenalidomide Teva

If a dose of Lenalidomide Teva is missed at the scheduled time and

• less than 12 hours have passed since then: the capsule should be taken immediately;
• more than 12 hours have passed since then: the capsule should not be taken. The next capsule should be taken at the scheduled time the next day.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lenalidomide Teva can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, stop taking Lenalidomide Teva and consult your doctor immediately - you may need urgent medical attention:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis;
• a severe allergic reaction that starts as a rash in one area and spreads to the entire body, accompanied by a significant loss of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or "drug hypersensitivity syndrome"). See also section 2.

Inform your doctor immediately if you experience any of the following serious side effects:

• fever, chills, sore throat, cough, mouth sores, or any other signs of infection (including blood infections (sepsis));
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion, or fatigue that may be due to high calcium levels in the blood.

Lenalidomide Teva may decrease the number of white blood cells that fight infection and the number of blood cells that help blood clot (platelets), which can lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide Teva may also cause the formation of blood clots in the veins (thrombosis).

Other side effects

Note that in a small number of patients, Lenalidomide Teva may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Lenalidomide Teva. Therefore, the treating doctor should carefully assess the benefits and risks when prescribing Lenalidomide Teva to a patient. Very commonside effects (may affect more than 1 in 10 people):

• decrease in the number of red blood cells, which can cause anemia leading to fatigue and weakness;
• rash, itching;
• muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;

generalized swelling, including swelling of the hands and feet;

• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• numbness, tingling, or burning sensation of the skin, pain in the hands or feet, dizziness, tremors;
• decreased appetite, altered taste;
• increased pain, tumor growth, or redness around the tumor;
• weight loss;
• constipation, diarrhea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium or calcium and/or sodium in the blood;
• abnormal thyroid function;
• leg pain (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be a sign of blood clots in the lungs, called pulmonary embolism);
• all types of infections, including sinusitis, pneumonia, and upper respiratory tract infections;
• shortness of breath;
• blurred vision;
• blurred vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver test results;
• increased liver enzyme activity;
• changes in blood proteins, leading to blood vessel inflammation (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of physical discomfort, malaise;
• painful mouth ulcers, dry mouth;
• dehydration.

Commonside effects (may affect up to 1 in 10 people):

• red blood cell breakdown (hemolytic anemia);
• certain types of skin tumors;
• bleeding from the gums, stomach, or intestines;
• high blood pressure, slow, fast, or irregular heartbeat;
• increased levels of a substance produced by the breakdown of red and abnormal red blood cells;
• increased levels of a protein that indicates inflammation in the body;
• skin discoloration; skin discoloration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• increased uric acid levels in the blood;
• skin rashes, redness of the skin, peeling, cracking, or shedding of the skin, hives;
• increased sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• urinary problems, including excessive or reduced urination, or inability to control urination;
• blood in the urine;
• shortness of breath, especially when lying down (which may be a sign of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (inner ear disorders that cause a feeling of spinning), loss of consciousness;
• chest pain that spreads to the arms, neck, jaw, back, or abdomen, feeling of sweating and shortness of breath, nausea, or vomiting, which may be symptoms of a heart attack (myocardial infarction);
• muscle weakness, lack of energy;
• neck pain, chest pain;
• chills;
• joint swelling;
• slowing or blocking of bile flow from the liver;
• low levels of phosphates or magnesium in the blood;
• speech difficulties;
• liver damage;
• balance problems, difficulty walking;
• hearing loss, ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excessive iron in the body;
• thirst;
• confusion;
• toothache;
• fall that may lead to injury.

Uncommonside effects (may affect up to 1 in 100 people):

• bleeding in the brain;
• circulation problems;
• vision loss;
• loss of sex drive (libido);
• excessive urination, accompanied by bone pain and weakness, which may be a sign of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, rash, pain, or swelling of the abdomen - may be signs of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be signs of colon inflammation (colitis or proctitis);
• kidney cell damage (tubular necrosis);
• skin color changes, sensitivity to sunlight;
• tumor lysis syndrome - a metabolic complication that can occur during cancer treatment, as well as sometimes without treatment. These complications are caused by the breakdown products of dying cancer cells and can include: changes in blood chemistry; high levels of potassium, phosphorus, uric acid, and low levels of calcium, leading to kidney function disorders, heart rhythm disturbances, seizures, and sometimes death;
• high blood pressure in the blood vessels that lead to the lungs (pulmonary hypertension).

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

• sudden or gradual, but worsening, pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever, and rapid heartbeat - these symptoms may occur in association with pancreatitis;
• wheezing, shortness of breath, or dry cough, which may be caused by lung inflammation;
• rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Teva was taken with a statin (a type of cholesterol-lowering medicine);
• a skin disease caused by inflammation of small blood vessels, characterized by joint pain and fever (leukocytoclastic vasculitis);
• rupture of the stomach or intestine wall, which can lead to a severe infection. Tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function;
• viral infections, including chickenpox and shingles, and reactivation of hepatitis B virus (which can cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting);
• rejection of a transplanted organ (e.g., kidney, heart).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products. Al. Jerozolimskie 181C, 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Teva

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiration date stated on the blister and carton after: "EXP" or Expiration Date (EXP). The expiration date refers to the last day of the month. There are no special storage instructions for this medicine. Do not use this medicine if you notice any damage or signs of opening the packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Lenalidomide Teva contains

• The active substance of Lenalidomide Teva is lenalidomide. Each capsule contains lenalidomide hydrochloride monohydrate, micronized, in an amount equivalent to 5 mg, 10 mg, 15 mg, 25 mg of lenalidomide.
• Other ingredients are:
• capsule contents: silicon dioxide, anhydrous, microcrystalline cellulose, type 301, croscarmellose sodium, type A, talc,
• capsule shell: Lenalidomide Teva, 5 mg: gelatin, titanium dioxide (E171)

Lenalidomide Teva, 10 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine FD&C (E132) Lenalidomide Teva, 15 mg: gelatin, titanium dioxide (E171), indigo carmine FD&C (E132) Lenalidomide Teva, 25 mg: gelatin, titanium dioxide (E171) Ink for printing: shellac, propylene glycol (E1520), black iron oxide (E172), potassium hydroxide, and ammonium hydroxide, concentrated (E527).

What Lenalidomide Teva looks like and contents of the pack

Lenalidomide Teva, 5 mg, hard capsules, are non-transparent hard gelatin capsules, size "4" (approximately 14.3 mm in length), with black printing "5" on a white body, with a white cap, containing powder or compressed powder in a color from white to light yellow or beige. Lenalidomide Teva, 10 mg, hard capsules, are non-transparent hard gelatin capsules, size "2" (approximately 18 mm in length), with black printing "10" on an ivory-colored body, with a green cap, containing powder or compressed powder in a color from white to light yellow or beige. Lenalidomide Teva, 15 mg, hard capsules, are non-transparent hard gelatin capsules, size "1" (approximately 19.4 mm in length), with black printing "15" on a white body, with a blue cap, containing powder or compressed powder in a color from white to light yellow or beige. Lenalidomide Teva, 25 mg, hard capsules, are non-transparent hard gelatin capsules, size "0" (approximately 21.7 mm in length), with black printing "25" on a white body, with a white cap, containing powder or compressed powder in a color from white to light yellow or beige. Pack sizesLenalidomide Teva, 5 mg, 10 mg, 15 mg, is available in blisters containing 7, 21, or 63 hard capsules, and in single-dose blisters containing 7 x 1, 21 x 1, or 63 x 1 hard capsules. Lenalidomide Teva, 25 mg, is available in blisters containing 21 or 63 hard capsules, and in single-dose blisters containing 21 x 1 or 63 x 1 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V. Swensweg 5 2031 GA Haarlem Netherlands

Manufacturer

Pliva Hrvatska d.o.o. Prilaz baruna Filipovića 25 10000, Zagreb, Croatia Merckle GmbH, Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany Teva Operations Poland Sp. z o.o. ul. Mogilska 80 31-546 Kraków

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

Greece Lenalidomide/Teva Poland Lenalidomide Teva Romania Lenalidomidă TEVA 5 mg, 10 mg, 15 mg, 20 mg, capsule

For more information about this medicine, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warszawa tel. (22) 345 93 00 Date of last revision of the leaflet:February 2024