Lenalidomide Glenmark

Package Leaflet: Information for the Patient

Lenalidomide Glenmark, 2.5 mg, hard capsules
Lenalidomide Glenmark, 5 mg, hard capsules
Lenalidomide Glenmark, 10 mg, hard capsules
Lenalidomide Glenmark, 15 mg, hard capsules
Lenalidomide Glenmark, 25 mg, hard capsules
Lenalidomide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Lenalidomide Glenmark contains the active substance lenalidomide. This medicine belongs to a group of medicines that affect the immune system.
Lenalidomide Glenmark is used in adults to treat

• multiple myeloma
• myelodysplastic syndromes
• mantle cell lymphoma
• follicular lymphoma

Multiple Myeloma

Multiple myeloma is a type of cancer that affects a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and 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 eliminate the signs and symptoms of the disease. This condition is called "remission".
Newly diagnosed multiple myeloma - in patients after bone marrow transplantation
Lenalidomide Glenmark is used as monotherapy for maintenance treatment in patients who have recovered after transplantation.
Newly diagnosed multiple myeloma - in patients who cannot undergo bone marrow transplantation
Lenalidomide Glenmark is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib"
• a medicine with anti-inflammatory effects called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• a medicine with immunosuppressive effects called "prednisone".

The patient takes these medicines at the beginning of treatment, and then continues treatment using lenalidomide as monotherapy.
If the patient is 75 years old or older, or has moderate to severe kidney problems, the doctor will perform thorough examinations before starting treatment.
Multiple myeloma - in patients who have received previous treatment
Lenalidomide Glenmark is used in combination with another anti-inflammatory medicine called "dexamethasone".
Lenalidomide Glenmark 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 Glenmark is used as monotherapy in the treatment of adult patients with MDS, if all of the following conditions are met:

• the patient has a low number of red blood cells and needs regular blood transfusions ("transfusion-dependent anemia");
• the patient has an abnormality in bone marrow cells called "isolated cytogenetic abnormality with 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 Glenmark may lead to an increase in the number of healthy blood cells produced by the body, by limiting the number of abnormal cells.

• this may lead to a reduction in the number of blood transfusions required. It is possible that transfusions will no longer be needed.

Mantle Cell Lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphoid tissue). It affects a certain type of white blood cell called B lymphocytes or B cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B lymphocytes, resulting in their accumulation in lymphoid tissue, bone marrow, or blood.
Lenalidomide Glenmark is used as monotherapy in the treatment of adult patients who have previously been treated with other medicines.

Follicular Lymphoma

Follicular lymphoma is a slow-growing malignant cancer that affects B lymphocytes. It is a type of white blood cell that helps the body fight infections. In a patient with follicular lymphoma, too many B lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Glenmark is used in combination with another medicine called "rituximab" in the treatment of adult patients who have previously been treated for follicular lymphoma.

How Lenalidomide Glenmark works

Lenalidomide Glenmark works by affecting the immune system and directly attacking cancer cells. The medicine works in several ways:

• by inhibiting the growth of cancer cells,
• by inhibiting the formation of blood vessels in the tumor,
• by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Glenmark

Before starting treatment with Lenalidomide Glenmark, read the package leaflets of all medicinal products taken in combination with Lenalidomide Glenmark.

When not to take Lenalidomide Glenmark:

• If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because lenalidomide may be harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men").
• If the patient can become pregnant, unless all necessary contraceptive measures are taken (see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men"). If the patient can become pregnant, the doctor will always check when prescribing the medicine that all necessary measures have been taken and will inform the patient about 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 an allergy, they should ask their doctor for advice.

If any of the above situations apply to the patient, they should not take Lenalidomide Glenmark. In case of doubt, the patient should discuss this with their doctor.

Warnings and precautions

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

• the patient has a history of blood clots - the patient is at 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 a current or past viral infection, especially hepatitis B virus, varicella-zoster virus, HIV. If the patient is unsure, they should discuss this with their doctor. Taking Lenalidomide Glenmark may cause the reactivation of viruses in patients who have been infected in the past. This can lead to the recurrence of the disease in patients. The doctor will check if the patient has had hepatitis B in the past.
• the patient has kidney problems - the doctor may adjust the dose of Lenalidomide Glenmark
• the patient has had a heart attack, has ever had a blood clot, smokes, has high blood pressure, or high cholesterol levels
• the patient has had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
• the patient has had any of the following symptoms in the past: widespread rash, redness of the skin, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes - these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms (DRESS) or drug hypersensitivity syndrome (see also section 4 "Possible side effects").

If any of the above situations apply to the patient, they should discuss this with their doctor, pharmacist, or nurse before starting treatment.
If at any time during or after treatment the patient experiences:

• 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. 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 taking Lenalidomide Glenmark, they should tell their doctor about any changes in symptoms.
• shortness of breath, fatigue, dizziness, chest pain, or swelling of the feet or ankles. These may be symptoms of a severe disease called pulmonary hypertension (see section 4).

Tests and examinations
Before and during treatment with Lenalidomide Glenmark, the patient will have regular blood tests, as Lenalidomide Glenmark may cause a decrease in the number of blood cells that help fight infection (white blood cells) and help the blood to clot (platelets). The doctor will ask for a blood test:

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

Before starting treatment with lenalidomide and during treatment, the patient may undergo an assessment for circulation and breathing problems.
Patient with myelodysplastic syndromes taking Lenalidomide Glenmark
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 Glenmark affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests to assess the risk of acute myeloid leukemia during treatment with Lenalidomide Glenmark.
Patient with mantle cell lymphoma taking Lenalidomide Glenmark
The doctor will ask for a blood test:

• before treatment
• every week for the first 8 weeks (2 cycles) of treatment
• then every 2 weeks in cycles 3 and 4 (more information is provided in section 3 "Treatment cycle")
• then at the beginning of each cycle and
• at least once a month.

Patient with follicular lymphoma taking Lenalidomide Glenmark
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 in the 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 any skin changes, such as red spots or rash.
The doctor may change the dose of Lenalidomide Glenmark or stop treatment based on the results of the patient's blood tests and overall condition. If the disease has been recently diagnosed, the doctor may also assess the course of treatment, taking into account the patient's age and other diseases that may have occurred in the past.

Blood donation

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

Children and adolescents

Lenalidomide Glenmark 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 examinations before starting treatment.

Lenalidomide Glenmark and other medicines

The patient should tell their doctor or nurse about all medicines they are taking, or have recently taken. This is necessary because Lenalidomide Glenmark may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Glenmark.
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 medicines for heart conditions - such as digoxin
• certain medicines for blood thinning - such as warfarin.

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

Pregnancy
Women taking Lenalidomide Glenmark

• Lenalidomide Glenmark must not be taken if the patient is pregnant, as it may be harmful to the unborn child.
• A woman must not become pregnant while taking Lenalidomide Glenmark. For this reason, women of childbearing age must use effective contraception (see below "Contraception").
• If the patient becomes pregnant while taking Lenalidomide Glenmark, she must stop treatment immediately and inform her doctor.

Men taking Lenalidomide Glenmark

• If the partner of a man taking Lenalidomide Glenmark becomes pregnant, the man must inform his doctor immediately. The partner should seek the advice of a doctor.
• The man must also use effective contraception (see "Contraception").

Breastfeeding

Lenalidomide Glenmark must not be taken during breastfeeding, as it is not known whether the medicine passes into human milk.

Contraception

Women taking Lenalidomide Glenmark
Before starting treatment, the patient should ask their doctor if they can become pregnant, even if they think it is unlikely.
Women of childbearing age:

• a pregnancy test will be performed under the supervision of a doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), except for women who have had their fallopian tubes cut and sealed (tubal sterilization) AND
• the woman must use effective contraception 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 contraceptive methods to the patient.

Men taking Lenalidomide Glenmark
Lenalidomide is present in human semen. If the partner of a man taking Lenalidomide Glenmark is pregnant or may become pregnant and is not using effective contraception, the partner must use a condom during treatment and for at least 7 days after stopping treatment, including after vasectomy. During and for at least 7 days after stopping treatment, the patient must not donate semen.

Driving and using machines

The patient should not drive or use machines if they experience dizziness, fatigue, drowsiness, balance problems caused by dizziness, or blurred vision after taking Lenalidomide Glenmark.

Lenalidomide Glenmark contains lactose

If the patient has been told that they have an intolerance to some sugars, they should contact their doctor before taking the medicine.

Lenalidomide Glenmark contains sodium

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

3. How to take Lenalidomide Glenmark

Lenalidomide Glenmark must be administered by a healthcare professional who has experience in treating multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, or follicular lymphoma.

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

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.
If the patient is taking Lenalidomide Glenmark with other medicines, they should read the package leaflet of the other medicines to get information about their use and effects.

Treatment cycle

Lenalidomide Glenmark 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 21-day cycle. OR Lenalidomide Glenmark 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" of 28 days.

Recommended dose of Lenalidomide Glenmark

Before starting treatment, the doctor will inform the patient:

• what dose of Lenalidomide Glenmark they should take
• what dose of other medicines they should take in combination with Lenalidomide Glenmark, if other medicines are necessary
• on which days of the cycle to take each medicine.

How and when to take Lenalidomide Glenmark

• the capsule should be swallowed whole, preferably with water.
• do not break, open, or chew the capsules. If the powder from a damaged Lenalidomide Glenmark capsule comes into contact with the skin, it should be washed immediately with soap and water.
• healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of in accordance with local regulations. Then, the hands should be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister or capsule.
• the capsules can be taken with or without food.
• Lenalidomide Glenmark should be taken at approximately the same time every day, on the days when the medicine is scheduled.

Taking this medicine

To remove a 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 cause damage.

Duration of treatment with Lenalidomide Glenmark

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

Overdose of Lenalidomide Glenmark

If a higher dose of Lenalidomide Glenmark is taken than prescribed, the patient should inform their doctor immediately.

Missed dose of Lenalidomide Glenmark

If the patient forgets to take Lenalidomide Glenmark at the scheduled time and

• it has been less than 12 hours since then - the patient should take the capsule immediately.
• it has been more than 12 hours since then - the patient should not take the capsule. The next capsule should be taken at the scheduled time the next day.

If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

If any of the following serious side effects occur, the patient should stop taking Lenalidomide Glenmark and seek medical attention immediately - they may need urgent medical treatment:

• hives, rash, swelling of the eyelids, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis,
• severe allergic reaction, which may start as a rash in one area, spread to the whole body, and be accompanied by a high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes - these are symptoms of a severe skin reaction called DRESS or drug hypersensitivity syndrome (see also section 2),
• widespread rash, high body temperature, elevated liver enzymes, 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 inform their doctor immediately if they experience any of the following serious side effects:

• fever, chills, sore throat, cough, mouth ulcers, or any other signs of infection, including blood infections (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 levels of calcium in the blood.

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

Other side effects

Note that in a small number of patients, other types of cancer may occur, and it is possible that the risk may be higher during treatment with Lenalidomide Glenmark. Therefore, the treating doctor should carefully assess the benefits and risks of prescribing Lenalidomide Glenmark to the patient.
Very common side effects(may affect more than 1 in 10 people):

• decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness
• rash, itching
• muscle spasms, muscle weakness, pain in the muscles, 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
• numbness, tingling, or burning sensation of the skin, pain in the hands and feet, dizziness, tremors, decreased appetite, change in 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
• underactive thyroid function
• leg pain (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be a sign of blood clots in the lungs, called pulmonary embolism)
• 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 values
• changes in blood proteins, leading to vessel inflammation (vasculitis)
• high blood sugar levels (diabetes)
• low blood sugar levels
• headache
• nosebleeds
• dry skin
• depression, mood changes, sleep disturbances
• cough
• low blood pressure
• general feeling of physical discomfort, malaise
• painful mouth sores, dry mouth
• dehydration.

Common side effects(may affect up to 1 in 10 people)

• red blood cell breakdown (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 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
• high levels of uric acid in the blood
• rash, redness of the skin, peeling, cracking, or shedding of the skin, hives
• itching, increased sweating, night sweats
• difficulty swallowing, sore throat, voice problems, or voice changes
• runny nose (rhinitis)
• passing much more or much less urine than normal, or inability to control the timing of urination
• passing blood in the urine
• shortness of breath, especially when lying down (which may be a sign of heart failure)
• erectile dysfunction
• stroke, fainting, dizziness (balance problems caused by inner ear disorders), loss of consciousness
• chest pain radiating to the arms, neck, jaw, back, or abdomen, feeling of sweating and shortness of breath, nausea, or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• muscle weakness, lack of energy
• neck pain, chest pain
• chills
• joint swelling
• slowing or blocking of bile flow from the liver
• low levels of phosphate or magnesium in the blood
• speech difficulties
• liver damage
• balance problems, difficulty walking
• hearing loss, ringing in the ears (tinnitus)
• nerve pain, unpleasant abnormal sensations, especially in response to touch
• excessive iron in the body
• thirst
• confusion
• toothache
• fall, which may lead to injury.

Uncommon side effects(may affect up to 1 in 100 people)

• bleeding in the brain
• circulation problems
• vision loss
• loss of sex drive (libido)
• passing large amounts of urine, with accompanying bone pain and weakness, which may be a sign 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)
• kidney cell damage (tubular necrosis)
• skin color changes, sensitivity to sunlight
• breakdown of the stomach or intestine 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 varicella-zoster virus (a viral disease that causes a painful rash with blisters) and hepatitis B virus reactivation (which may cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting)
• organ transplant rejection.

Side effects with unknown frequency(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 rapid heart rate - these symptoms may occur in association with pancreatitis
• wheezing, shortness of breath, or dry cough, which may be due to lung inflammation
• muscle breakdown (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Glenmark was taken with a statin (a type of cholesterol-lowering medicine)
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis)
• breakdown of the stomach or intestine wall, which can lead to a 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 varicella-zoster virus (a viral disease that causes a painful rash with blisters) and hepatitis B virus reactivation (which may cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting)
• organ transplant rejection.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
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 this medicine.

5. How to store Lenalidomide Glenmark

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after the abbreviation: EXP. The expiry date refers to the last day of the month stated.
There are no special storage precautions.
Do not use this medicine if it is visible that it is damaged or if there are signs of tampering with 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 pack and other information

What Lenalidomide Glenmark contains

Lenalidomide Glenmark, 2.5 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 2.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132), iron oxide yellow (E 172).
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Lenalidomide Glenmark, 5 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• capsule shell: gelatin, titanium dioxide (E 171).
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Lenalidomide Glenmark, 10 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132), iron oxide yellow (E 172).
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Lenalidomide Glenmark, 15 mg, hard capsules

• The active substance is lenalidomide. One capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132).
• printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Lenalidomide Glenmark, 25 mg, hard capsules

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

What Lenalidomide Glenmark looks like and contents of the pack

Lenalidomide Glenmark, 2.5 mg, hard capsules are white, matte, with a green cap, approximately 14.3 mm in length, marked with the symbol "L9NL" and "2.5".
Lenalidomide Glenmark, 5 mg, hard capsules are white, matte, with a white cap, approximately 18.0 mm in length, marked with the symbol "L9NL" and "5".
Lenalidomide Glenmark, 10 mg, hard capsules are yellow, matte, with a green cap, approximately 21.7 mm in length, marked with the symbol "L9NL" and "10".
Lenalidomide Glenmark, 15 mg, hard capsules are white, matte, with a blue cap, approximately 21.7 mm in length, marked with the symbol "L9NL" and "15".
Lenalidomide Glenmark, 25 mg, hard capsules are white, matte, with a white cap, approximately 21.7 mm in length, marked with the symbol "L9NL" and "25".
Available pack sizes:
Lenalidomide Glenmark, 2.5 mg, 5 mg, 10 mg, 15 mg, 25 mg is available in a blister pack (OPA/Aluminum/PVC/Aluminum) containing 21 capsules in a cardboard box.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer

Synthon Hispania S.L.
Calle De Castelló 1
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM, Nijmegen
Netherlands

For more information, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o.
ul. Osmańska 14
02-823 Warsaw
Date of last revision of the leaflet:April 2023