Lenalidomide Zentiva

Leaflet accompanying the packaging: patient information

Lenalidomide Zentiva, 5 mg, hard capsules

Lenalidomide Zentiva, 10 mg, hard capsules

Lenalidomide Zentiva, 15 mg, hard capsules

Lenalidomide Zentiva, 25 mg, hard capsules

Lenalidomide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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 as yours.
• 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 Zentiva and what is it used for
• 2. Important information before taking Lenalidomide Zentiva
• 3. How to take Lenalidomide Zentiva
• 4. Possible side effects
• 5. How to store Lenalidomide Zentiva
• 6. Contents of the pack and other information

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

Lenalidomide Zentiva contains the active substance lenalidomide and belongs to a group of medicines that affect the immune system.
Lenalidomide Zentiva is used in adults 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 divide uncontrollably. This can lead to bone and kidney damage.
In principle, multiple myeloma is incurable. However, it is possible to temporarily significantly alleviate or eliminate the symptoms of the disease. This condition is called "remission".
Newly diagnosed multiple myeloma - in patients after bone marrow transplantation
Lenalidomide Zentiva is used alone in maintenance treatment in patients who have achieved a suitable condition after bone marrow transplantation.
Newly diagnosed multiple myeloma - in patients who cannot undergo bone marrow transplantation
Lenalidomide Zentiva is taken with other medicines:

• with a chemotherapy medicine called "bortezomib",
• with an anti-inflammatory medicine called "dexamethasone",
• with a chemotherapy medicine called "melphalan",
• with a medicine that suppresses the immune system called "prednisone". The patient starts treatment by taking Lenalidomide Zentiva with additional medicines, and then continues treatment with Lenalidomide Zentiva alone. If the patient is 75 years old or older or has moderate or severe kidney function impairment, the doctor will perform thorough examinations before starting treatment. Multiple myeloma - in patients receiving previous treatment
  Lenalidomide Zentiva is taken with an anti-inflammatory medicine called "dexamethasone". Lenalidomide Zentiva may stop the worsening of multiple myeloma symptoms. 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. There are abnormal blood cells 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 Zentiva is used alone 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 an abnormality in bone marrow cells called "isolated cytogenetic abnormality del(5q)". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously used other treatments that have proven to be ineffective or insufficient.

Taking Lenalidomide Zentiva may lead to an increase in the number of healthy blood cells produced by the body, by limiting 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.
Follicular lymphoma (FL)
FL is a slow-growing malignant tumor 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 Zentiva is taken with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Zentiva works

The medicine works by affecting the immune system and directly attacking cancer cells. Its mechanism of action includes:

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

2. Important information before taking Lenalidomide Zentiva

Before starting treatment with Lenalidomide Zentiva, you should carefully read the leaflets of all medicinal products taken in combination with Lenalidomide Zentiva.

When not to take Lenalidomide Zentiva

• if the patient is pregnant or suspects that she may be pregnant or plans to become pregnant, as Lenalidomide Zentiva may harm the fetus (see "Pregnancy, breastfeeding, and contraception - information for women and men" in section 2);
• if the patient is of childbearing age, unless she follows all necessary methods to prevent pregnancy (see "Pregnancy, breastfeeding, and contraception - information for women and men" in section 2). If the patient is a woman of childbearing age, the doctor will note during each control visit that the necessary actions have been taken and will provide the patient with such confirmation.
• if the patient is allergic to lenalidomide or any of the excipients of this medicine (listed in section 6). If the patient suspects that they may be allergic, they should consult a doctor. If any of the above situations apply to the patient, they should not take Lenalidomide Zentiva. In case of doubts, the patient should consult a doctor.

Warnings and precautions

Before taking Lenalidomide Zentiva, the patient should discuss with their doctor or pharmacist if:

• the patient has had blood clots in the past - this means an increased risk of blood clots in veins and arteries during treatment;
• the patient has any symptoms of infection, such as cough or fever; the patient has or has had a viral infection in the past, especially viral hepatitis B, varicella-zoster virus, or HIV. In case of doubts, the patient should consult a doctor. Taking lenalidomide may cause the reactivation of viruses in previously infected patients, 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 function impairment - the doctor may adjust the dose of Lenalidomide Zentiva;
• the patient has had a heart attack, has had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• the patient has had an allergic reaction after taking thalidomide (another medicine used to treat multiple myeloma), such as a rash, itching, swelling, dizziness, or difficulty breathing;
• the patient has had a combination of any of the following symptoms in the past: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, elevated liver enzymes, elevated white blood cell count (eosinophilia), and swollen lymph nodes (severe skin reaction called "Drug Reaction with Eosinophilia and Systemic Symptoms", DRESS), see also section 4.

The patient should immediately tell their doctor or nurse if they experience any of the following at any time during or after treatment:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness of the arm or leg, change in gait or balance disturbances, persistent numbness, reduced sensation, or loss of sensation, memory loss, or disorientation, the patient should immediately tell their doctor or nurse. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML).
  If the patient has had such symptoms before treatment with lenalidomide, they should inform their doctor about any changes in these symptoms.

• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the feet or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Tests and examinations
Before starting Lenalidomide Zentiva and during treatment, the patient will undergo regular blood tests, as lenalidomide may cause a decrease in the number of blood cells that help fight infection (white blood cells) and those that help blood clot (platelets).
The doctor will order 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.
Patient with MDS taking Lenalidomide Zentiva
If the patient has myelodysplastic syndromes, there is an increased chance of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Zentiva affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that can better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Zentiva.
Patient with MCL taking Lenalidomide Zentiva
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

Patient with FL taking Lenalidomide Zentiva
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
• 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 may lead to a condition in which the tumor tissue breaks down, causing an abnormal increase in the levels of various chemicals in the blood and may lead to kidney failure (a condition called "tumor lysis syndrome").
The doctor may examine the patient's skin to check for changes, such as red spots or rash.
The doctor may change the dose of Lenalidomide Zentiva or stop treatment based on the results of the patient's blood tests and their overall condition. If the disease has been recently diagnosed, the doctor may also assess treatment considering the patient's age and other existing conditions.
Blood donation
Do not donate blood during treatment and for at least 7 days after its completion.

Children and adolescents

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

Elderly and patients with renal impairment

If the patient is 75 years old or older or has moderate or severe kidney function impairment, the doctor will perform thorough examinations before starting treatment.

Lenalidomide Zentiva and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as lenalidomide and some other medicines may interact with each other.
The patient should especially tell their doctor or nurse about taking any of the following medicines or products:

• certain contraceptives, such as oral contraceptives, as they may lose their effectiveness
• certain medicines for heart conditions, such as digoxin
• certain medicines for blood thinning, such as warfarin

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

Pregnancy
Information for women taking Lenalidomide Zentiva

• Do not take Lenalidomide Zentiva if you are pregnant, as it may harm the fetus.
• Women of childbearing age must not become pregnant while taking Lenalidomide Zentiva. Therefore, women of childbearing age must use effective methods of contraception (see below "Contraception").
• If you become pregnant while taking Lenalidomide Zentiva, you must stop treatment immediately and inform your doctor.

Information for men taking Lenalidomide Zentiva

• If your partner becomes pregnant, you should immediately inform your doctor. It is recommended that your partner consult a doctor.
• You must also use effective contraception methods (see below "Contraception").

Breastfeeding
Do not breastfeed while taking Lenalidomide Zentiva, as it is not known whether lenalidomide passes into breast milk.
Contraception
Information for women taking Lenalidomide Zentiva
Before starting treatment, you should ask your doctor if it is possible for you to become pregnant, even if you think it is unlikely.
If you are of childbearing age:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after the end of treatment), unless your doctor confirms that your fallopian tubes have been cut and blocked to prevent egg cells from reaching the uterus (tubal sterilization)
  AND

you must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and for at least 4 weeks after the end of treatment. Your doctor will recommend appropriate contraception methods.

Information for men taking Lenalidomide Zentiva
Lenalidomide is present in human semen. If your partner is pregnant or may become pregnant and is not using effective contraception, you must use condoms during treatment and for at least 7 days after the end of treatment. This also applies to men who have had a vasectomy. During treatment and for at least 7 days after the end of treatment, you must not donate semen.

Driving and using machines

If you experience dizziness, fatigue, drowsiness, a feeling of spinning, or blurred vision after taking Lenalidomide Zentiva, you should not drive or operate machinery.

Lenalidomide Zentiva contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Lenalidomide Zentiva

Lenalidomide Zentiva must be administered by medical personnel with experience in the treatment of multiple myeloma, MDS, MCL, or FL.

• If Lenalidomide Zentiva is used to treat multiple myeloma in patients who cannot undergo bone marrow transplantation or have received previous treatment, the medicine is taken with other medicines (see section 1 "What is Lenalidomide Zentiva and what is it used for").
• If Lenalidomide Zentiva is used to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS or MCL, the medicine is taken alone (as monotherapy).
• If Lenalidomide Zentiva is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
If you are taking Lenalidomide Zentiva with other medicines, you should read the leaflets of those medicines to get information about their use and effects.

Treatment cycle

Lenalidomide Zentiva is taken on specific days for 3 weeks (21 days).

• Each 21-day period is called a "treatment cycle".
• Depending on the day of the cycle, you will take one or more medicines. However, on some days, you will not take any medicines.
• After completing each 21-day cycle, you should start a new cycle lasting 21 days.
  OR
  Lenalidomide Zentiva is taken on specific days for 4 weeks (28 days).

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

How much Lenalidomide Zentiva to take

Before starting treatment, your doctor will inform you:

• how much Lenalidomide Zentiva to take;
• how many other medicines (if any) to take with Lenalidomide Zentiva;
• on which days of the cycle to take each of these medicines.

How and when to take Lenalidomide Zentiva

• The capsule should be swallowed whole, preferably with water.
• The capsule should not be broken, opened, or chewed. If the powder from a damaged Lenalidomide Zentiva capsule comes into contact with the skin, the skin should be washed 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, the hands should be washed thoroughly 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.
• The medicine should be taken on the designated days at approximately the same time.

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 on the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Zentiva

Lenalidomide Zentiva is taken in treatment cycles, each lasting 21 or 28 days (see above "Treatment cycle"). Treatment should be continued until the doctor recommends stopping it.

Taking more Lenalidomide Zentiva than recommended

If you have taken more capsules than you should, you should immediately consult your doctor.

Missing a dose of Lenalidomide Zentiva

If you forget to take Lenalidomide Zentiva at the usual time:

• and it has been less than 12 hours since then, you should take the capsule immediately,
• and it has been more than 12 hours since then, you should not take the missed capsule. The next dose of the medicine should be taken at the usual time the next day.

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

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Lenalidomide Zentiva and immediately consult your doctor - 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 can start as a rash in one area and spread to the entire body, accompanied by a significant loss of the 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), see also section 2.

You should immediately inform your doctor about any of the following serious side effects:

• fever, chills, sore throat, cough, mouth sores, or any other signs of infection (including blood infection - 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 may decrease the number of white blood cells that fight infection and the cells that help blood clot (platelets), which can lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide may also cause blood clots in the veins (thrombosis).

Other side effects

In a small number of patients, another type of cancer may develop, and it is possible that the risk of its development is higher when taking lenalidomide. Therefore, before prescribing this medicine, the doctor will carefully weigh the benefits and risks of treatment.
Very common(may affect more than 1 in 10 people)

• decrease in the number of red blood cells, which may 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 edema, including swelling of the hands and feet; ● weakness, fatigue ● fever 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 ● worsening of pain, increase in tumor size, 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 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 ● elevated liver enzyme values ● changes in blood proteins leading to blood vessel inflammation (vasculitis) ● elevated blood sugar levels (diabetes) ● low blood sugar levels ● headache ● nosebleeds ● dry skin ● depression, mood changes, sleep disturbances;

● cough ● low blood pressure ● general feeling of physical discomfort, malaise ● painful inflammatory condition of the mouth, dry mouth ● dehydration.
Common(may affect less than 1 in 10 people)

• breakdown of red blood cells (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 blood cells ● elevated levels of a protein indicating inflammation in the body ● skin darkening; skin discoloration due to bleeding under the skin, usually caused by bruising; swelling of blood-filled skin, bruising ● elevated uric acid levels in the blood ● skin rashes, redness of the skin, peeling, cracking, or flaking of the skin, hives ● itching, increased sweating, night sweats ● difficulty swallowing, sore throat, voice changes, or hoarseness
• nasal congestion ● passing much more or much less urine than normal or inability to control urination ● passing blood in urine ● shortness of breath, especially when lying down (which may be a sign of heart failure) ● erectile dysfunction
• stroke, fainting, dizziness (inner ear disorders causing a feeling of spinning), transient loss of consciousness
• chest pain radiating 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 phosphate or magnesium in the blood ● difficulty speaking ● liver damage ● balance disturbances, 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 ● falls that can lead to injury.

Uncommon(may affect less than 1 in 100 people)

• bleeding in the brain ● circulation problems ● loss of vision ● loss of libido ● passing large amounts of urine, accompanied by bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome) ● yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching of the skin, rash, pain, or swelling of the abdomen - may be symptoms of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colitis (inflammation of the colon) ● kidney cell damage (called tubular necrosis) ● changes in skin color, sensitivity to sunlight ● tumor lysis syndrome - metabolic complications 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, phosphate, uric acid, and low levels of calcium, leading to kidney function disorders, heart rhythm disturbances, seizures, and sometimes death ● elevated blood pressure in the blood vessels leading to the lungs (pulmonary hypertension)

Frequency not known(cannot be estimated from the 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 due to pneumonia ● breakdown of muscle tissue (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis), some of which occurred when lenalidomide was taken with a statin (a type of cholesterol-lowering medicine) ● a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis) ● breakdown of the stomach or intestine wall, which can lead to a serious infection. You should tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements. ● viral infections, including varicella-zoster virus (a viral disease that causes a painful rash with blisters) and hepatitis B virus reactivation (which can cause yellowing of the skin and eyes, dark urine, abdominal pain, fever, and nausea) ● transplant rejection (e.g., kidney, heart).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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 or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Zentiva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Do not use the medicine if it is damaged or if the packaging is broken.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Zentiva contains

Lenalidomide Zentiva 5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171)
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E172). Lenalidomide Zentiva 10 mg, hard capsules:
• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172)
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E172). Lenalidomide Zentiva, 15 mg, hard capsules:
• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132)
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E172). Lenalidomide Zentiva, 25 mg, hard capsules:
• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• Other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171)
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E172).

What Lenalidomide Zentiva looks like and contents of the pack

Lenalidomide Zentiva, 5 mg: hard capsule with a non-transparent white body and a non-transparent white cap, approximately 18.0 mm in length, with the imprint "L9NL" and "5".
Lenalidomide Zentiva, 10 mg: hard capsule with a non-transparent yellow body and a non-transparent green to light green cap, approximately 21.7 mm in length, with the imprint "L9NL" and "10".
Lenalidomide Zentiva, 15 mg: hard capsule with a non-transparent white body and a non-transparent blue to light blue cap, approximately 21.7 mm in length, with the imprint "L9NL" and "15".
Lenalidomide Zentiva, 25 mg: hard capsule with a non-transparent white body and a non-transparent white cap, approximately 21.7 mm in length, with the imprint "L9NL" and "25".
Lenalidomide Zentiva, hard capsules are available in cartons containing 7 or 21 capsules in OPA/Aluminum/PVC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer/Importer

Synthon Hispania S.L.
C/ Castelló 1, Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona, Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen, Netherlands
This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Lenalidomide Zentiva: Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Norway, Sweden, United Kingdom (Northern Ireland).
Lenalidomide Zentiva: France, Italy, Poland.
Lenalidomida Zentiva Portugal.