Lenalidomide G.l.

Leaflet included in the packaging: patient information

Lenalidomide G.L., 5 mg, hard capsules
Lenalidomide G.L., 10 mg, hard capsules
Lenalidomide G.L., 15 mg, hard capsules
Lenalidomide G.L., 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific condition. 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 adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lenalidomide G.L. and what is it used for
• 2. Important information before taking Lenalidomide G.L.
• 3. How to take Lenalidomide G.L.
• 4. Possible side effects
• 5. How to store Lenalidomide G.L.
• 6. Contents of the packaging and other information

1. What is Lenalidomide G.L. and what is it used for

What is Lenalidomide G.L.

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

What is Lenalidomide G.L. used for

Lenalidomide G.L. 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". New diagnosed multiple myeloma — in patients after bone marrow transplantation In this indication, Lenalidomide G.L. is used without other medicines in maintenance treatment after achieving an appropriate condition after transplantation. New diagnosed multiple myeloma – in patients who are not eligible for bone marrow transplantation treatment Lenalidomide G.L. is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan" and
• a medicine that suppresses the activity of the immune system called "prednisone". The patient starts treatment with additional medicines and then continues with Lenalidomide G.L. 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 undergone previous treatment Lenalidomide G.L. is taken in combination with an anti-inflammatory medicine called "dexamethasone". Lenalidomide may slow down 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. 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 G.L. is used as monotherapy in the treatment of adult patients who have been diagnosed with MDS, provided that 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 an abnormality in bone marrow cells called "isolated cytogenetic abnormality in the form of 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 not sufficiently effective.

Taking Lenalidomide G.L. may lead to an increase in the number of healthy red 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 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 G.L. is used as monotherapy in the treatment of adult patients who have previously been treated with other medicines. Follicular lymphoma (ang. 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 G.L. is taken with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide G.L. works

Lenalidomide G.L. works by affecting the functioning of the immune system and directly attacking cancer cells. The medicine works in several 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 G.L.

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

When not to take Lenalidomide G.L.:

• If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant , as it is expected that Lenalidomide G.L. 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 she uses all required contraceptive measures (see "Contraception"). 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 consult a doctor.

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

Warnings and precautions

Before starting to take Lenalidomide G.L., you should discuss it with your doctor, pharmacist, or nurse if the patient:

• has had blood clots in the past - this means an increased risk of forming blood clots in veins and arteries during treatment;
• has symptoms of infection, such as cough or fever;
• has a current or past viral infection, especially chickenpox and shingles, hepatitis B, HIV. In case of doubts, you should consult a doctor. Treatment with Lenalidomide G.L. 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;
• has kidney disease - the doctor may adjust the dose of Lenalidomide G.L.;
• has had a heart attack (myocardial infarction), has had a blood clot, smokes, has high blood pressure, or has high cholesterol levels;
• has had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• has had a combination of any of the following symptoms in the past: widespread rash, redness of the skin, high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), enlarged lymph nodes - these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above applies to the patient, they should consult a doctor, pharmacist, or nurse. If at any time during or after treatment the patient experiences:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness of the arm or leg, change in gait or balance disturbances, persistent headache, decreased sensation or loss of sensation, memory loss or disorientation, they should immediately inform 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 G.L., they should inform their doctor about any changes.
• shortness of breath, fatigue, dizziness, chest pain, or swelling of the legs 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 G.L., the patient will undergo regular blood tests, as Lenalidomide G.L. 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 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 to detect circulation and breathing problems. Patients with MDS taking Lenalidomide G.L. If the patient has myelodysplastic syndromes, there is an increased risk of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide G.L. affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests to check for signs that can better predict the risk of acute myeloid leukemia during treatment with Lenalidomide G.L. Patients with MCL taking Lenalidomide G.L. 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 G.L. 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 can lead to a situation where the tumor tissue begins to die and causes an abnormal increase in the concentration of various substances in the blood, which can lead to kidney failure (a condition called tumor lysis syndrome). The doctor may perform a test to check for skin changes, such as red spots or rash. The doctor may change the dose of Lenalidomide G.L. or interrupt 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 the end of treatment, the patient should not donate blood.

Children and adolescents

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

Elderly and patients with kidney disease

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

Lenalidomide G.L. 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 G.L. may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide G.L. In particular, the patient should inform their doctor or nurse if they are taking:

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

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

Pregnancy

For women taking Lenalidomide G.L.

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

For men taking Lenalidomide G.L.

• If the partner of a man taking Lenalidomide G.L. becomes pregnant, she should immediately inform her doctor. The partner should consult a doctor.
• It is also necessary for men to use effective contraception (see "Contraception").

Breastfeeding

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

Contraception

Women taking Lenalidomide G.L.
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 the end of treatment), unless they have had their fallopian tubes removed or have been sterilized (tubal ligation) AND
• must use effective contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after the end of treatment. The doctor will recommend appropriate contraceptive methods.

Men taking Lenalidomide G.L.
Lenalidomide G.L. passes into human semen. If a woman is pregnant or may become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after 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, the patient should not donate semen.

Driving and using machines

The patient should not drive or operate machines if they experience dizziness, fatigue, drowsiness, or blurred vision after taking Lenalidomide G.L.

Lenalidomide G.L. contains lactose.

Lenalidomide G.L. contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Lenalidomide G.L.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is considered "sodium-free".

3. How to take Lenalidomide G.L.

Lenalidomide G.L. must be administered by medical personnel who have experience in the treatment of multiple myeloma, MDS, MCL, or FL.

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

Lenalidomide G.L. should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
If the patient is taking Lenalidomide G.L. with other medicines, they should read the leaflet included in the packaging of those medicines to obtain information about their use and action.

Treatment cycle

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

• Each 21-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, there may be days when the patient does not take any medicines.
• After completing each 21-day cycle, the patient should start a new 21-day cycle. OR Lenalidomide G.L. is taken on specific days during a period of four weeks (28 days).
• Each 28-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, there may be days when the patient does not take any medicines.
• After completing each 28-day cycle, the patient should start a new 28-day cycle.

Recommended dose of Lenalidomide G.L.

Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide G.L. they should take;
• how many other medicines they should take in combination with Lenalidomide G.L., if it is necessary to take other medicines;
• on which days of the cycle they should take which medicines.

How and when to take Lenalidomide G.L.

• The capsule should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. In case of contact with the powder from a damaged Lenalidomide G.L. capsule, 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 irritation, 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 women or those who suspect they may be pregnant should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Lenalidomide G.L. should be taken at approximately the same time every day, at the time when the medicine is scheduled to be taken.

Taking this medicine

To remove the capsule from the blister:

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

Duration of treatment with Lenalidomide G.L.

Lenalidomide G.L. is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor decides to stop the treatment.

Taking a higher dose of Lenalidomide G.L. than recommended

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

Missing a dose of Lenalidomide G.L.

If a dose of Lenalidomide G.L. is missed at the scheduled time and

• less than 12 hours have passed since then: the patient should take the capsule immediately;
• more than 12 hours have passed since then: 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 related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, the patient should stop taking Lenalidomide G.L. and immediately consult their doctor – immediate treatment may be necessary:

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

The patient should immediately inform their doctor about the occurrence of any of the following serious side effects:

• fever, chills, sore throat, cough, mouth ulcers, 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, which may be due to high calcium levels in the blood.

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

Other side effects

Note that in a small number of patients, Lenalidomide G.L. may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Lenalidomide G.L. Therefore, the treating doctor should carefully assess the benefits and risks of prescribing Lenalidomide G.L. 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;
• rash, itching;
• muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalized swelling, including swelling of the hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• tingling, burning sensation of the skin, pain in the arms or legs, dizziness, drowsiness,
• decreased appetite, changes in taste;
• increased pain, increased 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 symptom of thrombosis), chest pain, or shortness of breath (which may be symptoms of pulmonary embolism);
• all types of infections, including sinusitis, pneumonia, and upper respiratory tract infections;
• shortness of breath;
• blurred vision;
• cloudy vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver function tests;
• increased liver enzyme activity;
• changes in blood proteins, leading to vein 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 substances produced by the breakdown of red and abnormal red blood cells;
• increased levels of a protein that indicates inflammation in the body;
• skin discoloration; skin discoloration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• increased levels of uric acid in the blood;
• skin rashes, redness of the skin, peeling, shedding, or flaking of the skin, hives;
• flushing, sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or changes in voice;
• urinary incontinence or inability to control the timing of urination;
• blood in the urine;
• shortness of breath, especially when lying down (which may be a symptom of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), transient loss of consciousness;
• chest pain that radiates 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 down or blocking the flow of bile from the liver;
• low levels of phosphorus 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;
• fall that may 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);
• excessive urine production, 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, abdominal pain, or swelling - these may be symptoms of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis);
• kidney cell damage (tubular necrosis);
• skin color changes, sensitivity to sunlight;
• a syndrome of skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis);
• breakdown of the stomach or intestinal wall, which can lead to a 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 function;
• viral infections, including chickenpox and shingles, as well as 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).

Side effects with unknownfrequency (frequency 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, and fever - these symptoms may occur in association with pancreatitis;
• wheezing, shortness of breath, or dry cough, which may be due to 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 was taken with a statin (a type of medicine that lowers blood cholesterol levels);
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis);
• breakdown of the stomach or intestinal wall, which can lead to a 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 function;
• viral infections, including chickenpox and shingles, as well as 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction 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.
Reporting side effects can help gather more information on the safety of this medicine.

5. How to store Lenalidomide G.L.

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". The expiry date refers to the last day of the month stated.
There are no special precautions for storing the 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. Unused medicines should be returned to the pharmacy. This will help protect the environment.

6. Contents of the packaging and other information

What Lenalidomide G.L. contains

Lenalidomide G.L., 5 mg, hard capsules

• The active substance of the medicine is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: brilliant blue FCF (E 133), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
• printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

Lenalidomide G.L., 10 mg, hard capsules

• The active substance of the medicine is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: iron oxide black (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
• printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

Lenalidomide G.L., 15 mg, hard capsules

• The active substance of the medicine is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
• printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

Lenalidomide G.L., 25 mg, hard capsules

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

How the medicinal product Lenalidomide G.L. looks like and what the pack contains

Lenalidomide G.L., 5 mg, hard capsules
Dark green, opaque cap and flesh-colored, opaque body, capsule size 2,
18-19 mm, with black printing “LP” on the cap and “638” on the body.
Lenalidomide G.L., 10 mg, hard capsules
Intensively yellow, opaque cap and gray, opaque body, capsule size 0,
21-22 mm, with black printing “LP” on the cap and “639” on the body.
Lenalidomide G.L., 15 mg, hard capsules
Light brown, opaque cap and light gray, opaque body, capsule size 2,
18-19 mm, with black printing “LP” on the cap and “640” on the body.
Lenalidomide G.L., 25 mg, hard capsules
White, opaque cap and white, opaque body, capsule size 0, 21-22 mm,
with black printing “LP” on the cap and “642” on the body.
Carton box containing blisters of PVC/ACLAR/Aluminum foil with 7 capsules in each.
Packaging of 7 or 21 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

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 Industrial Estate,
San Gwann SGN 3000, Malta

To obtain further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warszawa, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: 09.04.2024