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 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 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 attacks 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 in 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 in the treatment of adult patients who have been diagnosed 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 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 attacks 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 in the treatment of adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing malignant cancer that attacks 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" in the treatment of 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:

• if the patient is pregnant, suspects pregnancy, or plans to become pregnant, 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 the patient may become pregnant, unless all required contraceptive measures are used (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, you should ask your doctor for advice.

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

Warnings and precautions

Before starting treatment with Lenalidomide Gedeon Richter, the patient should discuss it with their doctor, pharmacist, or nurse if:

• they have had blood clots in the past - this means an increased risk of forming blood clots in veins and arteries during treatment
• they have any symptoms of infection, such as cough or fever
• they have a current or past viral infection, especially hepatitis B, chickenpox, and shingles (Varicella Zoster). In case of doubts, they should consult a doctor. Treatment with Lenalidomide Gedeon Richter 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.
• they have kidney problems - the doctor may adjust the dose of Lenalidomide Gedeon Richter
• they have had a heart attack, have had a blood clot, smoke, have high blood pressure, or high cholesterol levels
• they have had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
• they 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 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 apply to the patient, they should consult a doctor, pharmacist, or nurse before starting treatment.
At any time during or after treatment, the patient should immediately inform their doctor or nurse if they 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 the patient has had such symptoms before starting treatment with lenalidomide, they should inform their 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, the patient will undergo 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).
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 Gedeon Richter
If the patient has 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, the doctor may perform tests and check for signs that can better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Gedeon Richter.
Patients with MCL taking Lenalidomide Gedeon Richter
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 Gedeon Richter
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 bone marrow. This may 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 if the patient has developed skin changes, such as red spots or rash.
The doctor may change the dose of Lenalidomide Gedeon Richter 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 Gedeon Richter 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 Gedeon Richter and other medicines

The patient should tell their doctor or nurse about all medicines they are currently 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, the patient should inform their doctor or nurse if they are taking:

• certain contraceptive medicines, 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

• Lenalidomide Gedeon Richter should not be taken if the patient is pregnant, as it is expected to be harmful to the unborn child.
• A woman should not become pregnant while taking Lenalidomide Gedeon Richter. Therefore, women who may become pregnant must use effective contraception (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Gedeon Richter, they should stop treatment immediately and inform their doctor.

For men taking Lenalidomide Gedeon Richter

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

Breastfeeding

Breastfeeding should not be done 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, the patient should ask their doctor about the possibility of becoming pregnant, even if they 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 they have had their fallopian tubes cut and tied (sterilization) OR
• 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.

Men taking Lenalidomide Gedeon Richter
Lenalidomide Gedeon Richter passes into 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 treatment and for at least 7 days after stopping treatment, the patient should not donate semen or sperm.

Driving and using machines

The patient should not drive or operate machinery if they experience dizziness, fatigue, drowsiness, balance disturbances caused by dizziness, 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 the patient has been diagnosed with intolerance to some sugars, they should contact their 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 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.
• 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 the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
If the patient is taking Lenalidomide Gedeon Richter with other medicines, they should read the leaflet accompanying the packaging of those medicines to obtain 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, 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 "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, 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 "cycle" lasting 28 days.

Recommended dose of Lenalidomide Gedeon Richter

Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide Gedeon Richter to take
• how many other medicines to take in combination with Lenalidomide Gedeon Richter, if other medicines need to be taken
• on which days of the cycle to take which medicines.

How and when to take Lenalidomide Gedeon Richter

• the capsule should be swallowed 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 the skin, the skin should be washed immediately with soap and water.
• healthcare professionals, caregivers, and family members should wear single-use 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.
• Lenalidomide Gedeon Richter should be taken at approximately the same time every day, on the day when it is scheduled to be taken.

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"). The patient should continue the treatment cycles until the doctor recommends stopping them.

Taking a higher dose of Lenalidomide Gedeon Richter than recommended

In case of taking a higher dose of Lenalidomide Gedeon Richter than prescribed, the patient should immediately inform their doctor.

Missing a dose of Lenalidomide Gedeon Richter

If a dose of Lenalidomide Gedeon Richter is missed and

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

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following serious side effects occur, the patient should stop taking Lenalidomide Gedeon Richter and immediately consult their doctor - immediate treatment may be necessary:

• 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 significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• A widespread rash, high body temperature, elevated liver enzyme activity, 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).

The patient should immediately inform their 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, the treating doctor should carefully assess the benefits and risks of prescribing Lenalidomide Gedeon Richter to the patient.
Very commonside effects (may occur in more than 1 in 10 people):

• Decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness
• Rashes, itching
• Muscle spasms, muscle weakness, pain in muscles, 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
• Feeling of numbness, tingling, or burning 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, 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 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 inflammation of the mouth, dry mouth
• Dehydration.

Commonside effects (may occur in 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 blood cells
• Increased levels of a protein that indicates inflammation in the body
• Darkening of the skin; discoloration of the skin due to bleeding under the skin, usually caused by bruising; swelling of the skin filled with blood, bruising
• Increased levels of uric acid in the blood
• Rashes, skin redness, peeling, cracking, or flaking of the skin, hives
• Excessive sweating, night sweats
• Difficulty swallowing, sore throat, voice problems, or voice changes
• Rhinitis (runny nose)
• Passing large or small amounts of urine, 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 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 the flow of bile from the liver
• Low levels of phosphates or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disturbances, difficulty walking
• Deafness, 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 that can lead to injury

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

• Bleeding in the brain
• Circulation problems
• Vision loss
• Loss of sex drive (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, 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)
• 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, 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 unknownfrequency (frequency cannot be estimated from available data):

• Sudden or mild 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.
• 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. The patient should tell their doctor if they experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.
• Viral infections, including shingles (a viral disease that causes a painful rash with blisters) and recurrence of hepatitis B virus infection (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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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
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, more information can be collected on the safety of the medicine.

5. How to store Lenalidomide Gedeon Richter

The medicine should be stored in a place that is 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 the medicine.
Do not use this medicine if the packaging is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 the medicinal product Lenalidomide Gedeon Richter contains

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 package leaflet: March 2023