Lenalidomide Grindeks

Leaflet attached to the packaging: patient information

Lenalidomide Grindeks, 2.5 mg, hard capsules

Lenalidomide Grindeks, 5 mg, hard capsules Lenalidomide Grindeks, 7.5 mg, hard capsules

Lenalidomide Grindeks, 10 mg, hard capsules

Lenalidomide Grindeks, 15 mg, hard capsules

Lenalidomide Grindeks, 20 mg, hard capsules

Lenalidomide Grindeks, 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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Grindeks and what is it used for
• 2. Important information before taking Lenalidomide Grindeks
• 3. How to take Lenalidomide Grindeks
• 4. Possible side effects
• 5. How to store Lenalidomide Grindeks
• 6. Package contents and other information

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

What is Lenalidomide Grindeks

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

What is Lenalidomide Grindeks used for

Lenalidomide Grindeks is used in adults to treat:

• multiple myeloma,
• 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 divide uncontrollably. This can lead to bone and kidney damage. In principle, multiple myeloma is incurable. However, it is possible to temporarily significantly alleviate or eliminate the signs and symptoms of the disease. We call this "remission". New diagnosed multiple myeloma - in patients after bone marrow transplantation Lenalidomide Grindeks is used alone in maintenance treatment in patients who have achieved a satisfactory condition after bone marrow transplantation. New diagnosed multiple myeloma - in patients who cannot undergo bone marrow transplantation Lenalidomide Grindeks 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 medicine called 'prednisone'. The patient starts treatment by taking Lenalidomide Grindeks with additional medicines and then continues treatment with Lenalidomide Grindeks alone.

• with a medicine used in chemotherapy called 'bortezomib';
• with an anti-inflammatory medicine called 'dexamethasone';
• with a medicine used in chemotherapy called 'melphalan'; and
• with an immunosuppressant medicine called 'prednisone'. The patient starts treatment by taking Lenalidomide Grindeks with additional medicines and then continues treatment with Lenalidomide Grindeks alone.

If the patient is 75 years old or older or has moderate or severe kidney function impairment, the doctor will perform thorough examinations before starting treatment. Multiple myeloma - in patients who have undergone previous treatment Lenalidomide Grindeks is taken with an anti-inflammatory medicine called 'dexamethasone'. Lenalidomide Grindeks may stop the progression of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment. Follicular lymphoma (FL)Follicular lymphoma (FL) is a slow-growing malignant tumor that attacks B lymphocytes. It is a type of white blood cell that helps the body fight infections. In a patient with FL, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen. Lenalidomide Grindeks is taken with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Grindeks works

Lenalidomide Grindeks works by affecting the body's immune system and directly attacking cancer cells. Its mechanism of action includes:

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

2. Important information before taking Lenalidomide Grindeks

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

Lenalidomide Grindeks.

When not to take Lenalidomide Grindeks

• if the patient is pregnant or suspects she may be pregnant or plans to become pregnant, as Lenalidomide Grindeks may be harmful to the unborn child(see "Pregnancy, breastfeeding and contraception - information for women and men" in section 2);
• if the patient may become pregnant, unless she uses all required pregnancy prevention measures (see "Pregnancy, breastfeeding and contraception - information for women and men" in section 2). If the patient may become pregnant, the doctor will note during each control visit that the necessary measures have been taken and will ensure that the patient is aware of this;
• if the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If the patient suspects they may be allergic, they should ask their doctor for advice;

If any of the above situations apply to the patient, they should not take Lenalidomide Grindeks. In case of doubts, they should consult a doctor.

Warnings and precautions

Before starting Lenalidomide Grindeks, the patient should discuss with their doctor, pharmacist, or nurse if:

• the patient has had blood clots in the past, as they have an increased risk of developing blood clots in the veins and arteries during treatment;
• the patient has any symptoms of infection, such as cough or fever;
• the patient has or has had a viral infection in the past, especially: viral hepatitis B, varicella-zoster virus infection, HIV. In case of doubts, the patient should consult a doctor. Taking Lenalidomide Grindeks may cause the virus to reactivate, leading to a recurrence of the infection. The doctor should check if the patient has had hepatitis B in the past;
• the patient has kidney function impairment - the doctor may adjust the dose of Lenalidomide Grindeks;
• the patient has had a heart attack, has had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• the patient has had an allergic reaction after taking thalidomide (another medicine used to treat multiple myeloma), such as a rash, itching, swelling, dizziness, or difficulty breathing;
• the patient has had a combination of any of the following symptoms in the past: 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 rash 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 tell their doctor, pharmacist, or nurse before starting treatment.

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

• blurred vision, loss of vision, or double vision, difficulty speaking, weakness in the arms or legs, change in walking or balance problems, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation. All these symptoms may be signs of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If the patient has experienced any of these symptoms before starting lenalidomide treatment, 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 starting Lenalidomide Grindeks and during treatment, the patient will undergo regular blood tests, as this medicine may cause a decrease in the number of blood cells that fight infection (white blood cells) and those that help blood clot (platelets). The doctor will order blood tests:

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

Before starting lenalidomide treatment and during treatment, the patient may undergo an assessment for circulation and breathing problems. Patients with FL taking Lenalidomide Grindeks The doctor will ask for blood tests:

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

The doctor may perform a test to check if the patient has a large amount of tumor tissue in the body, including in the bone marrow. This can lead to a condition in which the tumor tissue begins to die, causing an abnormal increase in the levels of various substances in the blood and potentially leading to kidney failure (a condition called "tumor lysis syndrome"). The doctor may examine the patient to check for skin changes, such as red spots or rash. The doctor may adjust the dose of Lenalidomide Grindeks or interrupt treatment based on the patient's blood test results and overall condition. If the disease has been recently diagnosed, the doctor may also assess treatment considering the patient's age and other past conditions.

Blood donation

The patient should not donate blood during treatment and for at least 7 days after its completion.

Children and adolescents

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

Elderly and patients with kidney function impairment

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

Lenalidomide Grindeks 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 Grindeks may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Grindeks. In particular, the patient should tell their doctor or nurse if they are taking any of the following medicines:

• certain medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working;
• certain medicines used for heart conditions, 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 Grindeks

• Lenalidomide Grindeks should not be taken if the patient is pregnant, as it is expected to be harmful to the unborn child;
• Female patients should not become pregnant while taking Lenalidomide Grindeks. Therefore, women who can become pregnant must use effective pregnancy prevention methods (see "Contraception"). If the patient becomes pregnant while taking Lenalidomide Grindeks, she should stop treatment immediately and inform her doctor.

For men taking Lenalidomide Grindeks

• If the partner of a male patient taking Lenalidomide Grindeks becomes pregnant, the patient should immediately inform their doctor. It is recommended that the partner consult a doctor.
• The patient should also use effective contraception methods (see below - "Contraception").

Breastfeeding

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

Contraception

Women taking Lenalidomide Grindeks Before starting treatment, the patient should ask her doctor if it is possible for her to become pregnant, even if she thinks it is unlikely. If the patient can become pregnant:

• she will have pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment completion), unless the doctor confirms that her fallopian tubes have been cut and blocked to prevent egg cells from reaching the uterus (tubal sterilization) AND
• she must use effective pregnancy prevention methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment completion. The doctor will recommend appropriate contraception methods. Men taking Lenalidomide Grindeks Lenalidomide Grindeks is present in human semen. If the patient's partner is pregnant or may become pregnant and is not using effective contraception, the patient must use condoms during treatment and for at least 7 days after its completion, even if they have had a vasectomy.

Driving and using machines

If the patient experiences dizziness, fatigue, drowsiness, balance problems due to dizziness, or blurred vision after taking Lenalidomide Grindeks, they should not drive or operate machines.

Lenalidomide Grindeks contains lactose

Lenalidomide Grindeks contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Lenalidomide Grindeks contains sodium

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

3. How to take Lenalidomide Grindeks

Lenalidomide Grindeks must be administered by medical personnel with experience in treating multiple myeloma or FL.

• If Lenalidomide Grindeks is used to treat multiple myeloma in patients who cannot undergo bone marrow transplantation or have received previous treatment, the medicine is taken with other medicines (see section 1 "What is Lenalidomide Grindeks used for"). If Lenalidomide Grindeks is used to treat multiple myeloma in patients after bone marrow transplantation, the medicine is taken alone. If Lenalidomide Grindeks is used to treat follicular lymphoma, it is taken with another medicine called "rituximab". This medicine 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 Grindeks with other medicines, they should read the leaflets of those medicines to obtain information about their use and action.

Treatment cycle

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

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

How much Lenalidomide Grindeks to take

Before starting treatment, the doctor will inform the patient:

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

How and when to take Lenalidomide Grindeks

• The capsule should be swallowed whole, preferably with water.
• The capsule should not be broken, opened, or chewed. In case of contact with the powder from a damaged Lenalidomide Grindeks capsule, the skin should be washed immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene 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 Grindeks should be taken on the designated days at approximately the same time.

Taking this medicine

To remove a capsule from the blister:

• the capsule should be pressed only from one side and pushed through the foil;
• the center of the capsule should not be pressed, as this may cause damage.

Duration of treatment with Lenalidomide Grindeks

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

Taking a higher dose of Lenalidomide Grindeks than recommended

If the patient has taken a higher dose of Lenalidomide Grindeks than prescribed, they should immediately inform their doctor.

Missing a dose of Lenalidomide Grindeks

If the patient has forgotten to take Lenalidomide Grindeks at the scheduled time and:

• less than 12 hours have passed since then - they should take the capsule immediately;
• more than 12 hours have passed since then - they 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 Grindeks can cause side effects, although not everybody gets them. If any of the following serious side effects occur, the patient should stop taking Lenalidomide Grindeks and immediately consult their doctor - they may need urgent treatment:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis;
• severe allergic reaction that can start as a rash in one area and spread to the whole body, accompanied by a high fever, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome);
• widespread rash, high fever, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen 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 any of the following serious side effects:

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

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

Other side effects

It should be noted that in a small number of patients, Lenalidomide Grindeks may cause the development of other types of cancer, and it is possible that the risk of this increases with treatment with Lenalidomide Grindeks. Therefore, before prescribing Lenalidomide Grindeks, the doctor should carefully weigh the benefits and risks of treatment. Very commonside effects (may occur in more than 1 in 10 people):

• decrease in red blood cells, which can cause anemia leading to fatigue and weakness;
• rash, itching;
• muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalized swelling, including swelling of the hands and feet;
• weakness, fatigue;
• fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• numbness, tingling, or burning sensation of the skin, pain in the hands or feet, dizziness, tremors;
• decreased appetite, altered taste;
• 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 sign of thrombosis), chest pain, or shortness of breath (which may be symptoms of a 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 test results;
• elevated liver enzyme activity;
• changes in blood proteins, leading to swelling of the blood vessels (vasculitis);
• high blood sugar levels (diabetes);
• low blood sugar levels;
• headache;
• dry skin;
• depression, mood changes, difficulty sleeping;
• cough;
• drop in blood pressure;
• feeling of general 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 heartbeat;
• increased levels of substances due to normal and abnormal breakdown of red blood cells;
• increased levels of a protein indicating inflammation in the body;
• skin darkening, skin discoloration due to bleeding under the skin, usually caused by bruising, skin swelling filled with blood, bruising;
• high levels of uric acid in the blood;
• skin rashes, redness, peeling, or shedding of the skin, hives;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• runny nose;
• production of large amounts of urine or inability to control urination;
• presence of blood in the urine;
• shortness of breath, especially when lying down (which may be a sign of heart failure);
• difficulty achieving an erection;
• stroke, fainting, dizziness (inner ear disorders causing a feeling of spinning), transient loss of consciousness;
• chest pain radiating to the arms, neck, jaw, back, or abdomen, feeling of sweating and shortness of breath, nausea, or vomiting, which may be symptoms of a heart attack (myocardial infarction);
• muscle weakness, lack of energy;
• neck pain, chest pain;
• chills;
• joint swelling;
• slowing or blocking of bile flow from the liver;
• low levels of phosphorus or magnesium in the blood;
• difficulty speaking;
• liver damage;
• balance disorders, difficulty walking;
• deafness;
• ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excess iron in the body;
• thirst;
• confusion;
• toothache;
• fall that can lead to injury;

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

• bleeding in the brain;
• circulation disorders;
• vision loss;
• loss of sex drive (libido);
• production of large amounts of urine with accompanying bone pain and weakness, which may be symptoms of kidney function disorders (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stool, dark urine, itching, rash, pain, or swelling of the abdomen - these may be symptoms of liver damage (liver function disorders);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis);
• kidney cell damage (tubular necrosis);
• skin color changes, sensitivity to sunlight;
• tumor lysis syndrome - a metabolic complication that can occur during cancer treatment, and sometimes even without treatment. This complication is caused by the products of dying cancer cells and can include changes in blood chemistry; high levels of potassium, phosphorus, uric acid, and low calcium levels, leading to kidney function disorders, irregular heartbeat, seizures, and sometimes death;
• high blood pressure in the blood vessels leading to the lungs (pulmonary hypertension);

Unknown frequencyside effects (frequency cannot be estimated from available data):

• sudden or mild but worsening abdominal pain and back pain that persists for several days and may be accompanied by nausea, vomiting, fever, and rapid heartbeat. These symptoms may be caused by pancreatitis.;
• wheezing, shortness of breath, or dry cough, which may be caused by inflammation of the lung tissue.;
• rare cases of muscle breakdown (muscle pain, weakness, or swelling) have been observed, which can lead to kidney function disorders (rhabdomyolysis), some of which occurred when Lenalidomide Grindeks was administered with a statin (a type of cholesterol-lowering medicine).;
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).;
• rupture of the stomach or intestine wall, which can lead to a severe infection. The patient should tell their doctor if they experience severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.;
• viral infections, including varicella-zoster virus infection (a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B virus infection (which can cause yellowing of the skin and eyes, dark urine, abdominal pain, fever, nausea, or vomiting).;
• rejection of a transplanted solid organ (such as kidneys, heart).;

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: 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 Grindeks

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the blister and carton after 'Expiry date (EXP)'. The expiry date refers to the last day of the month stated.
• There are no special storage instructions for the medicine.
• The medicine should not be used if signs of damage or evidence of packaging security breaches are visible.
• 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. Package contents and other information

What Lenalidomide Grindeks contains

Lenalidomide Grindeks, 2.5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 2.5 mg of lenalidomide.

The other ingredients are:

• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E 171), Brilliant Blue FCF - FD&C Blue 1 (E 133), and yellow iron oxide (E 172)
• printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonia solution (E 527)

Lenalidomide Grindeks, 5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 5 mg of lenalidomide.

The other ingredients are:

• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• capsule shell: gelatin and titanium dioxide (E 171)
• printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonia solution (E 527)

Lenalidomide Grindeks, 7.5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 7.5 mg of lenalidomide.

The other ingredients are:

• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E 171), and yellow iron oxide (E 172)
• printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonia solution (E 527)

Lenalidomide Grindeks, 10 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 10 mg of lenalidomide.

The other ingredients are:

• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E 171), Brilliant Blue FCF - FD&C Blue 1 (E 133), and yellow iron oxide (E 172)
• printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonia solution (E 527)

Lenalidomide Grindeks, 15 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 15 mg of lenalidomide.

The other ingredients are:

• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E 171), and Brilliant Blue FCF - FD&C Blue 1 (E 133)
• printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonia solution (E 527)

Lenalidomide Grindeks, 20 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 20 mg of lenalidomide.

The other ingredients are:

• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: gelatin, titanium dioxide (E 171), Brilliant Blue FCF - FD&C Blue 1 (E 133), and yellow iron oxide (E 172)
• printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonia solution (E 527)

Lenalidomide Grindeks, 25 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains lenalidomide with ammonium chloride equivalent to 25 mg of lenalidomide.

The other ingredients are:

• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• capsule shell: gelatin and titanium dioxide (E 171)
• printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), and concentrated ammonia solution (E 527)

What Lenalidomide Grindeks looks like and contents of the pack

Lenalidomide Grindeks, 2.5 mg, hard capsules are light green/white capsules, size 4, marked with "L2.5". Lenalidomide Grindeks, 5 mg, hard capsules are white capsules, size 4, marked with "L5". Lenalidomide Grindeks, 7.5 mg, hard capsules are light yellow/white capsules, size 3, marked with "L7.5". Lenalidomide Grindeks, 10 mg, hard capsules are light green/light yellow capsules, size 2, marked with "L10". Lenalidomide Grindeks, 15 mg, hard capsules are blue/white capsules, size 1, marked with "L15". Lenalidomide Grindeks, 20 mg, hard capsules are light green/blue capsules, size 0, marked with "L20". Lenalidomide Grindeks, 25 mg, hard capsules are white capsules, size 0, marked with "L25". The capsules are provided in packs containing 7, 21 capsules in a carton. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS Krustpils iela 53, Riga, LV-1057, Latvia Tel.: +371 67083205 Fax: +370 67083505

This medicine is authorized in the Member States of the European Economic Area

Economically and in the United Kingdom (Northern Ireland) under the following names:

Netherlands:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg, hard capsules
Lithuania:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg solid capsules
Lithuania:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg solid capsules
Estonia, Poland,
Czech Republic:
Lenalidomide Grindeks
Hungary:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg hard capsules
Slovakia:
Lenalidomide Grindeks 2.5 mg hard capsules
Lenalidomide Grindeks 5 mg hard capsules
Lenalidomide Grindeks 7.5 mg hard capsules
Lenalidomide Grindeks 10 mg hard capsules
Lenalidomide Grindeks 15 mg hard capsules
Lenalidomide Grindeks 20 mg hard capsules
Lenalidomide Grindeks 25 mg hard capsules
Slovenia:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20
mg, 25 mg hard capsules
Bulgaria:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg hard capsules
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg,
20 mg, 25 mg hard capsules
Romania:
Lenalidomide Grindeks 2.5 mg capsule
Lenalidomide Grindeks 5 mg capsule
Lenalidomide Grindeks 7.5 mg capsule
Lenalidomide Grindeks 10 mg capsule
Lenalidomide Grindeks 15 mg capsule
Lenalidomide Grindeks 20 mg capsule
Lenalidomide Grindeks 25 mg capsule
Croatia:
Lenalidomide Grindeks 2.5 mg hard capsules
Lenalidomide Grindeks 5 mg hard capsules
Lenalidomide Grindeks 7.5 mg hard capsules
Lenalidomide Grindeks 10 mg hard capsules
Lenalidomide Grindeks 15 mg hard capsules
Lenalidomide Grindeks 20 mg hard capsules
Lenalidomide Grindeks 25 mg hard capsules
Austria:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Belgium:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Cyprus:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Denmark:
Lenalidomide Grindeks
Finland:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
France:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Germany:
Lenalidomide Ethypharm 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Greece:
Lenalidomide Grindeks 2.5 mg hard capsules
Lenalidomide Grindeks 5 mg hard capsules
Lenalidomide Grindeks 7.5 mg hard capsules
Lenalidomide Grindeks 10 mg hard capsules
Lenalidomide Grindeks 15 mg hard capsules
Lenalidomide Grindeks 20 mg hard capsules
Lenalidomide Grindeks 25 mg hard capsules
Iceland:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Ireland:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Italy:
Lenalidomide Grindeks
Malta:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Norway:
Lenalidomide Grindeks
Portugal:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Spain:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Sweden:
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
United Kingdom
(Northern Ireland):
Lenalidomide Grindeks 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 25 mg hard capsules
Date of last update of the leaflet:05/2022