LENALIDOMIDE MYLAN 5 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Lenalidomide Mylan 2.5 mg hard capsules EFG

Lenalidomide Mylan 5 mg hard capsules EFG

Lenalidomide Mylan 7.5 mg hard capsules EFG

Lenalidomide Mylan 10 mg hard capsules EFG

Lenalidomide Mylan 15 mg hard capsules EFG

Lenalidomide Mylan 20 mg hard capsules EFG

Lenalidomide Mylan 25 mg hard capsules EFG

lenalidomide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Lenalidomide Mylan is and what it is used for
2. What you need to know before you take Lenalidomide Mylan
3. How to take Lenalidomide Mylan
4. Possible side effects
5. Storage of Lenalidomide Mylan
6. Pack contents and further information

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

Lenalidomide Mylan contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect how the immune system works.

Lenalidomide Mylan is used in adults to:

• Multple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma

Multple myeloma

Multple myeloma is a type of cancer that affects a specific type of white blood cell called plasma cells. These cells accumulate in the bone marrow and multiply out of control. This can damage the bones and kidneys.

Multple myeloma usually has no cure. However, the signs and symptoms can be greatly reduced or may disappear for a period of time. This is called “remission”.

Newly diagnosed multple myeloma: in patients who have undergone a bone marrow transplant

Lenalidomide Mylan is used as maintenance treatment after recovering from a bone marrow transplant.

Newly diagnosed multple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomide Mylan is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”;
• an anti-inflammatory called “dexamethasone”;
• a chemotherapy medicine called “melphalan” and
• an immunosuppressant called “prednisone”.

You will take these medicines at the start of treatment and then continue to take Lenalidomide Mylan on its own.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Multple myeloma: in patients previously treated

Lenalidomide Mylan is taken with an anti-inflammatory called “dexamethasone”.

Lenalidomide Mylan can delay the worsening of multple myeloma signs and symptoms. It has also been shown to delay the return of multple myeloma after treatment.

Myelodysplastic syndromes (MDS)

MDS are a group of many different blood and bone marrow disorders. The blood cells become abnormal and do not work properly. Patients may experience a variety of signs and symptoms including low red blood cell count (anemia), the need for blood transfusions, and an increased risk of infection.

Lenalidomide Mylan is used to treat adult patients diagnosed with MDS, when all of the following apply:

• you need regular blood transfusions to treat low red blood cell counts (“transfusion-dependent anemia”);
• you have a bone marrow cell abnormality called “isolated deletion 5q cytogenetic abnormality”. This means your body does not produce enough healthy blood cells;
• other treatments you have used before are not suitable or have not worked well enough.

Lenalidomide Mylan can increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

• this may reduce the number of blood transfusions you need. You may not need transfusions at all.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymph tissue). It affects a type of white blood cell called “B lymphocytes” or B cells. MCL is a disease in which B cells grow out of control and accumulate in the lymph tissue, bone marrow, or blood.

Lenalidomide Mylan is used on its own to treat adult patients who have previously received other treatments.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infection. When someone has FL, they may have too many of these B lymphocytes in their blood, bone marrow, lymph nodes, and spleen.

Lenalidomide Mylan is used with another medicine called “rituximab” to treat adult patients who have previously received treatment for follicular lymphoma.

How Lenalidomide Mylan works

Lenalidomide Mylan works by affecting the immune system and directly attacking the cancer. It works in several ways:

• it stops the growth of cancer cells;
• it stops the growth of blood vessels in the cancer;
• it stimulates part of the immune system to attack the cancer cells.

2. What you need to know before you take Lenalidomide Mylan

You must read the summary of product characteristics of all medicines you are going to take in combination with Lenalidomide Mylan before starting treatment with Lenalidomide Mylan.

Do not take Lenalidomide Mylan

• if you are pregnant, think you may be pregnant or plan to become pregnant, as Lenalidomide Mylan is expected to be harmful to the fetus(see section 2, “Pregnancy, breastfeeding, and contraception: information for women and men”);
• if you can become pregnant, unless you use effective contraception (see section 2, “Pregnancy, breastfeeding, and contraception: information for women and men”). If you can become pregnant, your doctor will confirm that all necessary measures have been taken and provide you with this confirmation;
• if you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor.

If any of these conditions apply to you, do not take Lenalidomide Mylan. If in doubt, talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Lenalidomide Mylan if:

• you have ever had blood clots; during treatment, you have a higher risk of getting blood clots in your veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have had a viral infection, especially hepatitis B, varicella-zoster, or HIV. If in doubt, talk to your doctor. Treatment with Lenalidomide Mylan may cause the virus to become active again in patients who carry the virus. This can lead to the infection coming back. Your doctor will check if you have ever had a hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of Lenalidomide Mylan;
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure, or high cholesterol levels;
• you have had an allergic reaction while using thalidomide (another medicine used to treat multple myeloma), such as a skin rash, itching, swelling, dizziness, or breathing problems;
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome).

If any of these conditions apply to you, tell your doctor, pharmacist, or nurse before starting treatment.

At any time during or after treatment, tell your doctor or nurse immediately if you:

• have blurred vision, loss of vision, or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk, or balance problems, numbness, decreased sensitivity, or loss of sensitivity, memory loss, or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with lenalidomide, tell your doctor if you notice any change in these symptoms.

• have shortness of breath, tiredness, dizziness, chest pain, faster heartbeat, or swelling in your legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting treatment with Lenalidomide Mylan and during treatment, you will have regular blood tests. This is because Lenalidomide Mylan can cause a decrease in the blood cells that help fight infections (white blood cells) and those that help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

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

You may be evaluated for signs of heart and lung problems before and during treatment with lenalidomide.

For patients with MDS taking Lenalidomide Mylan

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). Additionally, it is not known how lenalidomide affects the chances of developing AML. Your doctor may therefore perform tests to detect signs that may predict a higher chance of developing AML during treatment with Lenalidomide Mylan.

For patients with MCL taking Lenalidomide Mylan

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 8 weeks (2 cycles) of treatment;
• then every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information);
• after that, at the start of each cycle;
• at least once a month.

For patients with FL taking Lenalidomide Mylan

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 3 weeks (1 cycle) of treatment;
• then every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).
• after that, at the start of each cycle and;
• at least every month.

Your doctor may check if you have a high total tumor burden in your body, including the bone marrow. This could lead to a condition in which the tumors break down and produce unusual levels of chemicals in the blood that can cause kidney failure (this condition is called “tumor lysis syndrome”).

Your doctor may examine you to check for changes in your skin, such as red spots or skin rash.

Your doctor may adjust your dose of Lenalidomide Mylan or interrupt your treatment, depending on your blood test results and your overall condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and any other conditions you may have.

Blood donation

You must not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide Mylan is not recommended for use in children and adolescents under 18 years.

Elderly and patients with kidney problems

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Other medicines and Lenalidomide Mylan

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

This is because Lenalidomide Mylan can affect how other medicines work. Additionally, some medicines can affect how Lenalidomide Mylan works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working;
• some medicines used for heart problems, such as digoxin;
• some medicines used to thin the blood, such as warfarin.

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

Pregnancy

Women taking Lenalidomide Mylan

• Do not take Lenalidomide Mylan if you are pregnant, as it is expected to be harmful to the fetus.
• Do not become pregnant while taking Lenalidomide Mylan. You must use effective contraception if there is a possibility you may become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomide Mylan, stop treatment and tell your doctor immediately.

Men taking Lenalidomide Mylan

• If your partner becomes pregnant while you are taking Lenalidomide Mylan, tell your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective contraception (see “Contraception”).

Breastfeeding

Do not breastfeed while taking Lenalidomide Mylan, as it is not known if lenalidomide passes into breast milk.

Contraception

For women taking Lenalidomide Mylan

Before starting treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment, and for at least 4 weeks after the end of treatment) unless you have had your fallopian tubes blocked (tubal ligation);

And

• you must use effective contraception from at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after the end of treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking Lenalidomide Mylan

Lenalidomide Mylan passes into human semen. If your partner is pregnant or may become pregnant and is not using any effective contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, drowsy, have vertigo, or blurred vision after taking Lenalidomide Mylan.

Lenalidomide Mylan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule: it is essentially “sodium-free”.

3. How to take Lenalidomida Mylan

Lenalidomida Mylan should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, MCL, or FL.

• When Lenalidomida Mylan is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have undergone other treatments before, it is taken with other medications (see section 1 "What Lenalidomida Mylan is used for").
• When Lenalidomida Mylan is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant or to treat patients with MDS or MCL, it is taken alone.
• When Lenalidomida Mylan is used for the treatment of follicular lymphoma, it is taken with another medication called "rituximab".

Follow the administration instructions of Lenalidomida Mylan indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist.

If you are taking Lenalidomida Mylan with other medications, you should consult the package insert of those other medications for additional information on their use and effects.

Treatment cycle

Lenalidomida Mylan is taken on certain days during a period of 3 weeks (21 days).

• A "treatment cycle" consists of 21 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each 21-day cycle, you must start a new "cycle" for the next 21 days.

Or

Lenalidomida Mylan is taken on certain days during a period of 4 weeks (28 days).

• A "treatment cycle" consists of 28 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each 28-day cycle, you must start a new "cycle" for the next 28 days.

How much Lenalidomida Mylan to take

Before starting treatment, your doctor will indicate:

• what amount of Lenalidomida Mylan you should take;
• what amount of other medications you should take with Lenalidomida Mylan, if applicable;
• which days of the treatment cycle you should take each medication.

How and when to take Lenalidomida Mylan

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. In case the powder of a broken Lenalidomida Mylan capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic bag, and dispose of them according to local requirements. Then, they should wash their hands well with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister or capsule.
• The capsules can be taken with or without food.
• You should take Lenalidomida Mylan approximately at the same time on scheduled days.

Taking this medication

To remove the capsule from the blister:

• Press only one end of the capsule so that it comes out through the foil.

• Do not press the center of the capsule as it may break.

Duration of treatment with Lenalidomida Mylan

Lenalidomida Mylan is taken in treatment cycles, each cycle lasting 21 or 28 days (see "Treatment cycle" above). You should continue the treatment cycles until your doctor tells you to stop the treatment.

If you take more Lenalidomida Mylan than you should

If you take more Lenalidomida Mylan than prescribed, inform your doctor immediately.

If you forget to take Lenalidomida Mylan

If you forget to take Lenalidomida Mylan at your usual time and:

• less than 12 hours have passed: take the capsule immediately;
• more than 12 hours have passed: do not take the capsule. Take the next capsule the next day at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Lenalidomida Mylan can cause side effects, although not all people experience them.

If you experience any of the following serious side effects, stop treatment with Lenalidomida Mylan and see a doctor immediately, as you may need urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth, or face, difficulty breathing or itching, which can be symptoms of severe allergic reactions called angioedema and anaphylactic reaction.
• A severe allergic reaction that can start as a rash in one area but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Consult your doctor immediately if you notice any of the following serious side effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other symptoms of infection, including in the bloodstream (sepsis).
• Bleeding (bleeding) or bruising (bruising) not due to an injury.
• Chest pain (thoracic) or leg pain.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue that may be due to high calcium levels in the blood.

Lenalidomida Mylan may reduce the number of white blood cells that fight infections and also the cells in the blood that help the blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising.

Lenalidomida Mylan can also cause blood clots in the veins (thrombosis).

Other side effects

It is important to note that a small number of patients may develop other types of cancer, and this risk may increase with treatment with Lenalidomida Mylan. Therefore, your doctor should carefully evaluate the benefits and risks when prescribing Lenalidomida Mylan.

Very common(may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which can cause anemia, leading to fatigue and weakness.
• Skin rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, pain in the limbs.
• Generalized swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills.
• Numbness, tingling, or a prickling sensation on the skin, pain in the hands or feet, dizziness, tremors.
• Decreased appetite, changes in taste.
• Increased pain, tumor size, or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn.
• Low levels of potassium, calcium, or sodium in the blood.
• Underactive thyroid function.
• Pain in the legs (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism).
• Infections of all kinds, including sinusitis, pneumonia, and upper respiratory tract infections.
• Difficulty breathing.
• Blurred vision.
• Eye opacity (cataracts).
• Kidney problems, including kidney dysfunction or inability to maintain normal kidney function.
• Abnormal liver function test results.
• High liver function test results.
• Changes in a blood protein that can cause swelling of the arteries (vasculitis).
• High blood sugar levels (diabetes).
• Low blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, mood changes, difficulty sleeping.
• Cough.
• Low blood pressure.
• A vague feeling of discomfort in the body, feeling unwell.
• Painful inflammation of the mouth, dry mouth.
• Dehydration.

Common(may affect up to 1 in 10 people):

• Destruction of red blood cells (hemolytic anemia).
• Certain types of skin tumors.
• Bleeding from the gums, stomach, or intestines.
• Increased blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance released after normal or abnormal destruction of red blood cells.
• Increased levels of a protein that indicates inflammation in the body.
• Darkening of skin color; change in skin color due to internal bleeding, usually caused by bruising; skin inflammation caused by blood accumulation; bruising.
• High levels of uric acid in the blood.
• Skin rashes, redness of the skin, cracked skin, peeling, or flaking of the skin, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Rhinorrhea.
• Strong increase or decrease in urine output compared to usual or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
• Difficulty having an erection.
• Stroke, fainting, vertigo (inner ear disorder that causes a sensation of spinning), temporary loss of consciousness.
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, nausea, or vomiting, which can be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Cervical pain, chest pain.
• Chills.
• Swollen joints.
• Slowed or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Balance disturbance, difficulty moving.
• Hearing loss, ringing in the ears (tinnitus).
• Nerve pain, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Falling that can cause injuries.

Uncommon(may affect up to 1 in 100 people):

• Bleeding inside the skull.
• Circulatory problems.
• Increased blood pressure in the blood vessels that supply the lungs (pulmonary hypertension).
• Loss of vision.
• Loss of sexual desire (libido).
• Excretion of large amounts of urine with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome).
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching of the skin, rash, pain, or swelling of the stomach; these can be symptoms of liver damage (liver failure).
• Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (called colitis or typhlitis).
• Kidney cell damage (called tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying tumor cells and can include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.

Frequency not known(cannot be estimated from available data):

• Sudden, mild, or severe pain in the upper abdomen and/or back that lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms can be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) have been observed, which can lead to kidney problems (rhabdomyolysis), some of them when lenalidomide is administered with a statin (a type of medication to lower cholesterol).
• A disease that affects the skin, produced by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Rupture of the stomach or intestine wall. This can lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package insert. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lenalidomida Mylan

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date shown on the blister and carton after "EXP". The expiration date is the last day of the month indicated.
• Do not store above 30°C.
• Do not use this medication if you notice visible signs of deterioration or evidence of tampering.
• Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition of Lenalidomide Mylan

Lenalidomide Mylan 2.5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:

? Capsule content: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate.

? Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and indigo carmine (E132).

? Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Lenalidomide Mylan 5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:

? Capsule content: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate.

? Capsule shell: titanium dioxide (E171), gelatin.

? Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Lenalidomide Mylan 7.5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:

? Capsule content: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate.

? Capsule shell: yellow iron oxide (E172), titanium dioxide (E172), gelatin.

? Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Mylan 10 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:

? Capsule content: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate.

? Capsule shell: gelatin, titanium dioxide (E171), black iron oxide, and yellow iron oxide (E172), indigo carmine (E132).

? Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Mylan 15 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:

? Capsule content: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate.

? Capsule shell: titanium dioxide (E171), gelatin.

? Printing ink: shellac, propylene glycol (E1520), red iron oxide (E172), and simethicone.

Lenalidomide Mylan 20 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:

? Capsule content: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate.

? Capsule shell: yellow iron oxide (E172), titanium dioxide, indigo carmine (E132), gelatin.

? Printing ink: shellac, propylene glycol (E1520), red iron oxide (E172), and simethicone.

Lenalidomide Mylan 25 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:

? Capsule content: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate.

? Capsule shell: titanium dioxide (E171), gelatin.

? Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Appearance and packaging of the product

The hard capsules of Lenalidomide Mylan 2.5 mg are green and white, size 4, 14 mm, and are marked with “MYLAN/LL 2.5 mg”.

The hard capsules of Lenalidomide Mylan 5 mg are white, size 2, 18 mm, and are marked with “MYLAN/LL 5 mg”.

The hard capsules of Lenalidomide Mylan 7.5 mg are light gray and white, size 2, 18 mm, and are marked with “MYLAN/LL 7.5 mg”.

The hard capsules of Lenalidomide Mylan 10 mg are green and light gray, size 0, 22 mm, and are marked with “MYLAN/LL 10 mg”.

The hard capsules of Lenalidomide Mylan 15 mg are white, size 0, 22 mm, and are marked with “MYLAN/LL 15 mg”.

The hard capsules of Lenalidomide Mylan 20 mg are green and white, size 0, 22 mm, and are marked with “MYLAN/LL 20 mg”.

The hard capsules of Lenalidomide Mylan 25 mg are white, size 0, 22 mm, and are marked with “MYLAN/LL 25 mg”.

The hard capsules Lenalidomide Mylan 2.5 mg, 7.5 mg, 10 mg, 20 mg, and 25 mg are supplied in blisters containing 7 hard capsules.

The hard capsules Lenalidomide Mylan 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, and 25 mg are supplied in blisters containing 21 hard capsules and in perforated blisters containing 7 x 1 or 21 x 1 hard capsules.

Only some pack sizes may be marketed.

Marketing authorization holder

Mylan Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate

Dublin 13,

Ireland

Manufacturer

McDermott Laboratories Ltd trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe, Hessen, 61352,

Germany

Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Hungary

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Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.