Lenalidomide Gedeon Rihter

Leaflet accompanying the packaging: information for the user

Lenalidomide Gedeon Richter, 2.5 mg, hard capsules

Lenalidomide Gedeon Richter, 5 mg, hard capsules

Lenalidomide Gedeon Richter, 7.5 mg, hard capsules

Lenalidomide Gedeon Richter, 10 mg, hard capsules

Lenalidomide Gedeon Richter, 15 mg, hard capsules

Lenalidomide Gedeon Richter, 20 mg, hard capsules

Lenalidomide Gedeon Richter, 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 that you can read it again if you need to.
• In case of 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.
• 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 Gedeon Richter and what is it used for
• 2. Important information before taking Lenalidomide Gedeon Richter
• 3. How to take Lenalidomide Gedeon Richter
• 4. Possible side effects
• 5. How to store Lenalidomide Gedeon Richter
• 6. Contents of the pack and other information

1. What is Lenalidomide Gedeon Richter and what is it used for

What is Lenalidomide Gedeon Richter

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

What is Lenalidomide Gedeon Richter used for

Lenalidomide Gedeon Richter 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".
Newly diagnosed multiple myeloma in patients after bone marrow transplantation
In this indication, Lenalidomide Gedeon Richter is used alone as maintenance therapy after achieving a suitable state after bone marrow transplantation.
Newly diagnosed multiple myeloma - in patients who are not eligible for bone marrow transplantation treatment.
Lenalidomide Gedeon Richter is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib"
• an anti-inflammatory medicine called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• an immunosuppressant called "prednisone". The patient starts treatment with additional medicines and then continues with Lenalidomide Gedeon Richter 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 Gedeon Richter is taken in combination with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Gedeon Richter 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 Gedeon Richter is used alone to treat adult patients who have been diagnosed with MDS, if all of the following conditions are met:

• the patient needs regular blood transfusions due to a low number of red blood cells ("transfusion-dependent anemia");
• the patient has a genetic abnormality in bone marrow cells called "isolated cytogenetic deletion 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 Gedeon Richter 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 Gedeon Richter is used alone to treat adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)

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 Gedeon Richter is taken with another medicine called "rituximab" to treat adult patients with previously treated follicular lymphoma.

How Lenalidomide Gedeon Richter works

Lenalidomide Gedeon Richter works by affecting the functioning of 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 Gedeon Richter

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

When not to take Lenalidomide Gedeon Richter:

as it is expected that Lenalidomide Gedeon Richter is harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men").

If any of these points apply to you, do not take Lenalidomide Gedeon Richter. In case of doubts, consult your doctor.

Warnings and precautions

Before starting Lenalidomide Gedeon Richter, you should discuss it with your doctor, pharmacist, or nurse if you:

• have had blood clots in the past - this means an increased risk of forming blood clots in veins and arteries during treatment
• have any symptoms of infection, such as cough or fever
• have a current or past viral infection, especially hepatitis B, chickenpox, and shingles (Varicella Zoster). If in doubt, consult your doctor. Treatment with Lenalidomide Gedeon Richter may cause the reactivation of viruses in previously infected patients, leading to the recurrence of the infection. Your doctor will check if you have had hepatitis B in the past.
• have kidney problems - your doctor may adjust the dose of Lenalidomide Gedeon Richter
• have had a heart attack, have ever had a blood clot, if you smoke, have high blood pressure, or high cholesterol levels
• have had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
• have had a combination of any of the following symptoms in the past: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, 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 apply to you, consult your doctor, pharmacist, or nurse before starting treatment.
At any time during or after treatment, you should immediately inform your doctor or nurse if you experience:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness in the arm or leg, change in gait, or balance disturbances, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have had such symptoms before starting treatment with lenalidomide, you should inform your doctor about any changes in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, rapid heart rate, 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 and during treatment with Lenalidomide Gedeon Richter, you will have regular blood tests, as Lenalidomide Gedeon Richter may cause a decrease in the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets).
Your doctor will call you 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, you may undergo an assessment for circulation and breathing problems.
Patients with MDS taking Lenalidomide Gedeon Richter
If you have myelodysplastic syndromes, there is an increased likelihood of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Gedeon Richter affects the likelihood of developing acute myeloid leukemia. Therefore, your doctor may perform tests and check for signs that will help better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Gedeon Richter.
Patients with MCL taking Lenalidomide Gedeon Richter
Your doctor will ask you to have 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 Gedeon Richter
Your doctor will ask you to have 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.

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

Blood donation

During and for at least 7 days after stopping treatment, you must not donate blood.

Children and adolescents

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

Elderly and patients with kidney problems

If you are 75 years old or older, or have moderate to severe kidney problems, your doctor will perform thorough tests before starting treatment.

Lenalidomide Gedeon Richter and other medicines

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

• certain contraceptives, such as oral contraceptives, as they may stop working,
• certain medicines used for heart problems - such as digoxin,
• certain medicines used to thin the blood - such as warfarin.

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

Pregnancy

For women taking Lenalidomide Gedeon Richter

• Do not take Lenalidomide Gedeon Richter if you are pregnant, as it is expected to be harmful to the unborn child.
• Women should not become pregnant while taking Lenalidomide Gedeon Richter. Therefore, women who may become pregnant must use effective contraception methods (see "Contraception").
• If you become pregnant while taking Lenalidomide Gedeon Richter, you must stop treatment immediately and inform your doctor.

For men taking Lenalidomide Gedeon Richter

• If your partner becomes pregnant while you are taking Lenalidomide Gedeon Richter, she should immediately inform her doctor. Your partner should consult a doctor.
• Men should also use effective contraception methods (see "Contraception").

Breastfeeding

Do not breastfeed while taking Lenalidomide Gedeon Richter, as it is not known whether Lenalidomide Gedeon Richter passes into human milk.

Contraception

Women taking Lenalidomide Gedeon Richter
Before starting treatment, you should 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 you have had your fallopian tubes cut and sealed to prevent eggs from reaching the uterus (sterilization by 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. Your doctor will recommend the appropriate contraception methods.

Men taking Lenalidomide Gedeon Richter
Lenalidomide Gedeon Richter is present in human sperm. 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 and for at least 7 days after stopping treatment, you must not donate sperm or semen.

Driving and using machines

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

Lenalidomide Gedeon Richter contains lactose, tartrazine, orange yellow, and allura red.

Lenalidomide Gedeon Richter contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Lenalidomide Gedeon Richter.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is "sodium-free".
[ Dose 2.5 mg]
Lenalidomide Gedeon Richter contains allura red (E 129), which may cause allergic reactions.
[ Dose 5 mg and 7.5 mg]
Lenalidomide Gedeon Richter contains orange yellow (E 110), which may cause allergic reactions.
[ Dose 10 mg]
Lenalidomide Gedeon Richter contains tartrazine (E 102), orange yellow (E110), and allura red (E129), which may cause allergic reactions.
[ Dose 15 mg]
Lenalidomide Gedeon Richter contains tartrazine (E 102) and allura red (E 129), which may cause allergic reactions.
[ Dose 20 mg]
Lenalidomide Gedeon Richter contains allura red (E 129), which may cause allergic reactions.

3. How to take Lenalidomide Gedeon Richter

Lenalidomide Gedeon Richter must be administered by medical personnel who have experience in treating multiple myeloma, myelodysplastic syndromes (MDS), mantle cell lymphoma (MCL), or follicular lymphoma (FL).

• In the case of using Lenalidomide Gedeon Richter to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received previous treatment, the medicine is used in combination with other medicines (see section 1 "What is Lenalidomide Gedeon Richter used for").
• In the case of using Lenalidomide Gedeon Richter to treat multiple myeloma in patients after bone marrow transplantation, the medicine is used alone as maintenance therapy.
• When Lenalidomide Gedeon Richter is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Lenalidomide Gedeon Richter should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
If you are taking Lenalidomide Gedeon Richter with other medicines, you should read the leaflet accompanying their packaging to get information about their use and action.

Treatment cycle

Lenalidomide Gedeon Richter is taken on specific days during a 3-week period (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 Gedeon Richter is taken on specific days during a 4-week period (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.

Recommended dose of Lenalidomide Gedeon Richter

Before starting treatment, your doctor will inform you:

• how much Lenalidomide Gedeon Richter you should take
• how many other medicines you should take in combination with Lenalidomide Gedeon Richter, if it is necessary to take other medicines
• on which days of the cycle to take which medicines.

How and when to take Lenalidomide Gedeon Richter

• swallow the capsule whole, preferably with water.
• do not break, open, or chew the capsules. If the powder from a damaged Lenalidomide Gedeon Richter capsule comes into contact with your 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 Gedeon Richter should be taken at approximately the same time every day when it is scheduled.

Taking this medicine

To remove the capsule from the blister:

• press the capsule only on 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 Gedeon Richter

Lenalidomide Gedeon Richter is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). You should continue the treatment cycles until your doctor advises you to stop them.

Taking a higher dose of Lenalidomide Gedeon Richter than recommended

If you take a higher dose of Lenalidomide Gedeon Richter than prescribed, you should immediately inform your doctor.

Missing a dose of Lenalidomide Gedeon Richter

If you miss a dose of Lenalidomide Gedeon Richter at the scheduled time and

• it has been less than 12 hours since then: you should take the capsule immediately.
• it has been more than 12 hours since then: do not take the capsule. Take the next capsule at the scheduled time the next day.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Lenalidomide Gedeon Richter 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 anaphylactic reaction.
• 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 body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms (DRESS) or "drug hypersensitivity syndrome") (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 symptoms of infection, including blood infections (sepsis)
• Bleeding or bruising without injury
• Chest pain or leg pain
• Shortness of breath
• Bone pain, muscle weakness, feeling of confusion, or fatigue that may be due to high calcium levels in the blood.

Lenalidomide Gedeon Richter 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 Gedeon Richter may also cause the formation of blood clots in the veins (thrombosis).

Other side effects

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

• Decreased number of red blood cells, which may cause anemia leading to fatigue and weakness
• Rashes, itching
• Muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain
• General 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 arms or legs, 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, calcium, or sodium in the blood
• Abnormal thyroid function
• Leg pain (which may be a symptom of thrombosis), chest pain, or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism)
• All types of infections, including sinus infections, lung infections, 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 values
• 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 inflammation of the mouth, dry mouth
• Dehydration.

Commonside effects (may affect up to 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 heart rhythm
• Increased levels of a substance produced by the breakdown of red and abnormal red blood cells
• Increased levels of a protein indicating inflammation in the body
• Darkening of the skin; discoloration of the skin due to bleeding under its surface, usually caused by bruising; swelling of the skin filled with blood, bruising
• Increased uric acid levels in the blood
• Rashes, skin redness, peeling, or flaking of the skin
• Excessive sweating, night sweats
• Difficulty swallowing, sore throat, voice problems, or voice changes
• Rhinitis (runny nose)
• Passing much more or much less urine than normal, or inability to control the timing of urination
• Passing blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty getting an erection
• Stroke, fainting, dizziness (inner ear disturbances causing a feeling that everything around is spinning), loss of consciousness
• Chest pain radiating to the arms, neck, jaw, or back, or a 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 the flow of bile from the liver,
• Low levels of phosphates or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disturbances, difficulty walking
• Hearing loss, tinnitus (ringing in the ears)
• Nerve pain, unpleasant abnormal sensations, especially in response to touch
• Excessive iron in the body
• Thirst
• Feeling of confusion
• Toothache
• Falling, which can 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)
• Passing large amounts of urine, with accompanying 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, rash, pain, or swelling of the abdomen - these may be symptoms of liver damage (liver failure)
• Abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis or proctitis)
• Kidney cell damage (tubular necrosis)
• Skin color changes, sensitivity to sunlight
• Tumor lysis syndrome - a complication of metabolism 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 leading to the lungs (pulmonary hypertension).

Side effects with unknownfrequency (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 heart rate - these symptoms may occur in association with pancreatitis.
• Wheezing, shortness of breath, or dry cough, which may be caused by lung inflammation.
• Observed 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 Gedeon Richter was administered with a statin (a type of cholesterol-lowering medicine).

Lenalidomide Gedeon Richter

• 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 very severe infection. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.
• Viral infections, including chickenpox and shingles (a viral disease that causes a painful rash with blisters) 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, you should tell your doctor or pharmacist. 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
Phone: +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 Gedeon Richter

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" or Expiry Date (EXP). The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice any damage or signs of opening of 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. Contents of the pack and other information

What contains the medicinal product Lenalidomide Gedeon Richter

Lenalidomide Gedeon Richter, 2.5 mg, hard capsules

• The active substance of the medicinal product is lenalidomide. Each hard capsule contains 2.5 mg of lenalidomide.
• Other ingredients are:
• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: brilliant blue (E 133), erythrosine (E 127), allura red (E 129) (see section 2), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
• Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 5 mg, hard capsules

• The active substance of the medicinal product is lenalidomide. Each hard capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: brilliant blue (E 133), orange yellow (E 110) (see section 2), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
• Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 7.5 mg, hard capsules

• The active substance of the medicinal product is lenalidomide. Each hard capsule contains 7.5 mg of lenalidomide.
• Other ingredients are:
• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: brilliant blue (E 133), erythrosine (E 127), orange yellow (E 110) (see section 2), titanium dioxide (E 171), and gelatin
• Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 10 mg, hard capsules

• The active substance of the medicinal product is lenalidomide. Each hard capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: brilliant blue (E 133), allura red (E 129) (see section 2), tartrazine (E 102) (see section 2), orange yellow (E 110) (see section
• 2), titanium dioxide (E 171), and gelatin
• Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 15 mg, hard capsules

• The active substance of the medicinal product is lenalidomide. Each hard capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: brilliant blue (E 133), allura red (E 129) (see section 2), tartrazine (E 102) (see section 2), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
• Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 20 mg, hard capsules

• The active substance of the medicinal product is lenalidomide. Each hard capsule contains 20 mg of lenalidomide.
• Other ingredients are:
• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: brilliant blue (E 133), allura red (E 129) (see section 2), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin
• Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

Lenalidomide Gedeon Richter, 25 mg, hard capsules

• The active substance of the medicinal product is lenalidomide. Each hard capsule contains 25 mg of lenalidomide.
• Other ingredients are:
• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: titanium dioxide (E 171) and gelatin
• Printing ink: shellac, propylene glycol, ammonia, iron oxide black (E 172), and potassium hydroxide

What Lenalidomide Gedeon Richter looks like and what the pack contains

Lenalidomide Gedeon Richter, 2.5 mg, hard capsules have a dark blue opaque cap and a light orange opaque body, capsule size 4, 14-15 mm, with black printing "LP" on the cap and "637" on the body.
Lenalidomide Gedeon Richter, 5 mg, hard capsules have a green opaque cap and a light brown opaque body, capsule size 2, 18-19 mm, with black printing "LP" on the cap and "638" on the body.
Lenalidomide Gedeon Richter, 7.5 mg, hard capsules have a purple opaque cap and a pink opaque body, capsule size 1, 19-20 mm, with black printing "LP" on the cap and "643" on the body.
Lenalidomide Gedeon Richter, 10 mg, hard capsules have a yellow opaque cap and a grey opaque body, capsule size 0, 21-22 mm, with black printing "LP" on the cap and "639" on the body.
Lenalidomide Gedeon Richter, 15 mg, hard capsules have a brown opaque cap and a grey opaque body, capsule size 2, 18-19 mm, with black printing "LP" on the cap and "640" on the body.
Lenalidomide Gedeon Richter, 20 mg, hard capsules have a dark red opaque cap and a light grey opaque body, capsule size 1, 19-20 mm, with black printing "LP" on the cap and "641" on the body.
Lenalidomide Gedeon Richter, 25 mg, hard capsules have a white opaque cap and a white opaque body, capsule size 0, 21-22 mm, with black printing "LP" on the cap and "642" on the body.
A cardboard box containing a blister pack of polyvinyl chloride (PVC) / ACLAR / Aluminium foil, each containing 7 hard capsules.
Lenalidomide Gedeon Richter, 2.5 mg and 5 mg
Pack size: 7 or 21 capsules. Not all pack sizes may be marketed.
Lenalidomide Gedeon Richter, 7.5 mg, 20 mg, and 25 mg
Pack size: 21 capsules.
Lenalidomide Gedeon Richter, 10 mg and 15 mg
Pack size: 21 capsules.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

Manufacturer/Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Adalvo Ltd.
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000, Malta

This medicinal product is authorised in the Member States of the European

Economic Area under the following names:

Iceland
Lenalidomide Gedeon Richter
Czech Republic
Lenalidomide Gedeon Richter
Poland Lenalidomide Gedeon Richter

Date of last revision of the leaflet: March 2023