Lenalidomide Mylan

Package leaflet: Information for the user

Lenalidomide Mylan 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

lenalidomide
Please read all of this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Lenalidomide Mylan is and what it is used for
2. What you need to know before taking Lenalidomide Mylan
3. How to take Lenalidomide Mylan
4. Possible side effects
5. How to store Lenalidomide Mylan
6. Contents of the pack and other 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 the way the immune system works.
Lenalidomide Mylan is used in adults for:

• 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 cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This can damage the bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be greatly reduced or disappear for a certain period. This outcome is called a "response".
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplant
Lenalidomide Mylan is used alone as maintenance therapy in patients who have adequately recovered after bone marrow transplantation.
Newly diagnosed multiple myeloma: in patients who cannot undergo bone marrow transplantation
Lenalidomide Mylan is taken with other medicines, which may include:

• a chemotherapy medicine called "bortezomib"
• an anti-inflammatory medicine called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• an immunosuppressive medicine called "prednisone".
  You will take these other medicines at the beginning of treatment and then continue taking Lenalidomide Mylan alone.

If you are aged 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.
Multiple myeloma: in previously treated patients
Lenalidomide Mylan is taken together with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Mylan can stop the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
MDS are a group of different blood and bone marrow disorders. Blood cells become abnormal and do not function properly. Patients may experience various signs and symptoms, including a low number of red blood cells (anaemia), the need for blood transfusions and an increased risk of infection.
Lenalidomide Mylan alone is used to treat adult patients diagnosed with MDS who meet all of the following conditions:

• if they require regular blood transfusions to treat low levels of red blood cells ("transfusion-dependent anaemia")
• if they have an abnormality in bone marrow cells called "isolated 5q cytogenetic abnormality". This means that their body does not produce enough healthy blood cells
• if previous treatments used have not been suitable or have not been effective enough.

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

• this may reduce the number of blood transfusions required. It may become unnecessary to have any transfusions.

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cells called B-lymphocytes, or B-cells. In MCL, B-lymphocytes grow uncontrollably and accumulate in lymphatic tissue, bone marrow or blood.
Lenalidomide Mylan is used alone to treat adult patients previously treated with other medicines.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer affecting B-lymphocytes, a type of white blood cells that help the body fight infections. In FL, an excessive number of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes and spleen.
Lenalidomide Mylan is taken together with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Mylan works
Lenalidomide Mylan works on the body's immune system and directly on the tumour in several ways:

• by stopping the development of tumour cells
• by stopping the growth of blood vessels that supply blood to tumour cells
• by stimulating part of the immune system to attack tumour cells.

2. What you should know before taking Lenalidomide Mylan

Before starting treatment with Lenalidomide Mylan, you must read the package leaflet of
all the medicines you are required to take in combination with Lenalidomide Mylan.
Do not take Lenalidomide Mylan

• If you are pregnant, think you might be pregnant, or are planning a pregnancy, because Lenalidomide Mylan is expected to be harmful to the unborn baby (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men').
• If there is any possibility you may become pregnant unless you follow all necessary measures to avoid pregnancy (see section 2 'Pregnancy, breastfeeding and contraception – information for women and men'). If there is any possibility you may become pregnant, your doctor will record and confirm at each prescription that the necessary measures to avoid pregnancy have been taken.
• 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, consult your doctor.

If any of these conditions apply to you, do not take Lenalidomide Mylan. If you have any doubts, consult your
doctor.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Lenalidomide Mylan if:

• you have previously had episodes of blood clots, as the risk of developing blood clots in veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, or HIV. If in doubt, consult your doctor. Treatment with Lenalidomide Mylan may cause reactivation of the virus in patients who carry the virus, leading to recurrence of the infection. Your doctor must check whether you have previously had hepatitis B infection
• you have kidney problems – your doctor may adjust the dose of Lenalidomide Mylan
• you have had a heart attack, blood clots, or if you smoke, have high blood pressure, or high cholesterol levels
• you have previously had an allergic reaction during treatment with thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
• you have previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), or swollen lymph nodes; these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome (see also section 4 “Possible side effects”).

If any of these conditions apply to you, inform your doctor, pharmacist, or nurse before starting
treatment.
At any time during or after treatment, inform your doctor or nurse immediately if you experience

• blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, changes in walking or balance problems, persistent numbness, decreased sensation, or loss of sensation, memory loss or confusion. These may be symptoms of a serious brain condition that can be fatal, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomide, inform your doctor of any changes in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and monitoring
Before and during treatment with Lenalidomide Mylan, you will undergo regular blood tests.
This is because Lenalidomide Mylan may cause a reduction in blood cells that protect you from infections (white blood cells) and those that help blood clot (platelets).
Your doctor will ask you to have blood tests:

• before starting treatment
• weekly for the first 8 weeks of treatment
• then at least once a month thereafter.

You may be evaluated for signs of cardiopulmonary problems before and during treatment with lenalidomide.
For patients with MDS taking Lenalidomide Mylan
If you have MDS, you have a higher risk of developing a more advanced disease called acute myeloid leukemia (AML). Furthermore, the role of lenalidomide in the risk of developing AML is not known. Your doctor may request certain tests to monitor signs that could more accurately predict your risk of developing AML during treatment with Lenalidomide Mylan.
For patients with MCL taking Lenalidomide Mylan
Your doctor will ask you to have blood tests:

• before starting treatment
• weekly for the first 8 weeks (2 cycles) of treatment
• then every 2 weeks during cycles 3 and 4 (for further information see section 3 "Treatment cycle")
• subsequently at the beginning of each cycle and
• at least once a month.

For patients with FL taking Lenalidomide Mylan
Your doctor will ask you to have blood tests:

• before starting treatment
• weekly for the first 3 weeks (1 cycle) of treatment
• then every 2 weeks during cycles 2 to 4 (for further information see section 3 “Treatment cycle”)
• subsequently at the beginning of each cycle and
• at least once a month.

Your doctor may check whether you have a high tumour burden throughout the body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, potentially leading to kidney failure (this condition is called “tumour lysis syndrome”).
Your doctor may monitor for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Mylan or stop treatment depending on the results of blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also consider your age and any other pre-existing conditions when evaluating treatment.
Blood donation
You must not donate blood during treatment with lenalidomide and for at least 7 days after treatment ends.
Children and adolescents
The use of Lenalidomide Mylan is not recommended in children and adolescents under 18 years of age.
Elderly and patients with kidney problems
If you are aged 75 years or older, or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.
Other medicines and Lenalidomide Mylan
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Lenalidomide Mylan may affect the action of other medicines and other medicines may affect the action of Lenalidomide Mylan.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

• certain medicines used to prevent pregnancy, such as oral contraceptives, as they may become less effective
• certain medicines used for heart problems, such as digoxin
• certain medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Lenalidomide Mylan

• You must not take Lenalidomide Mylan if you are pregnant, as this medicine is expected to be harmful to the unborn baby.
• During treatment with Lenalidomide Mylan, you must not become pregnant. If there is any possibility of becoming pregnant, you must use effective contraceptive methods (see the section “Contraception”).
• If you become pregnant during treatment with Lenalidomide Mylan, you must stop treatment immediately and inform your doctor.

For men taking Lenalidomide Mylan

• If your partner becomes pregnant while you are taking Lenalidomide Mylan, inform your doctor immediately. It is also recommended that your partner contacts her doctor.
• In addition, you must use effective contraceptive methods (see the section “Contraception”).

Breastfeeding
You must not breastfeed while taking Lenalidomide Mylan, as it is not known whether this medicine passes into breast milk.
Contraception
For women taking Lenalidomide Mylan
Before starting treatment, ask your doctor whether there is any possibility you could become pregnant, even if you think it is unlikely.
If there is any possibility you could become pregnant

• you will need to undergo pregnancy testing under your doctor's supervision (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless it has been confirmed that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (sterilisation by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will provide you with full instructions on appropriate contraceptive methods.

For men taking Lenalidomide Mylan
Lenalidomide Mylan passes into human seminal fluid. If there is any possibility that your partner is pregnant or could become pregnant and she is not using effective contraception, you must use condoms during treatment and for at least 7 days after treatment ends, even if you have had a vasectomy. You must not donate semen or sperm during treatment with lenalidomide and for at least 7 days after treatment ends.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo, or blurred vision after taking Lenalidomide Mylan.
Lenalidomide Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule. This means the medicine is essentially “sodium-free”.

3. How to take Lenalidomide Mylan

Lenalidomide Mylan must be prescribed and managed by healthcare professionals experienced in the treatment of multiple myeloma, MDS, MCL, or FL.

• When Lenalidomide Mylan is used for the treatment of multiple myeloma in patients who cannot undergo bone marrow transplantation or who have previously received other treatments, it is taken in combination with other medicines (see section 1 “What Lenalidomide Mylan is and what it is used for”).
• When Lenalidomide Mylan is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation or for the treatment of patients with MDS or MCL, it is taken alone.
• When Lenalidomide Mylan is used to treat follicular lymphoma, it is taken in combination with another medicine called "rituximab".

Always take Lenalidomide Mylan exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you are taking Lenalidomide Mylan in combination with other medicines, refer to the package leaflet of those medicines for further information on their use and side effects.

Treatment cycle
Lenalidomide Mylan is taken on certain days within a 3-week period (21 days).

• Each 21-day period is called a "treatment cycle".
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 21-day cycle, you must start a new "cycle" within the following 21 days. OR

Lenalidomide Mylan is taken on certain days within a 4-week period (28 days).

• Each 28-day period is called a "treatment cycle".
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 28-day cycle, you must start a new "cycle" within the following 28 days.

Dose of Lenalidomide Mylan to be taken
Before starting treatment, your doctor will inform you:

• of the dose of Lenalidomide Mylan to be taken
• of the dose of any other medicines to be taken in combination with Lenalidomide Mylan, if prescribed
• on which days of the treatment cycle to take each medicine.

How and when to take Lenalidomide Mylan

• Swallow the capsules whole, preferably with water.
• Do not crush, open, or chew the capsules. If the powder from a broken Lenalidomide Mylan capsule comes into contact with your skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare providers, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be removed carefully to avoid skin exposure, placed in a sealed polyethylene bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• The capsules may be taken with or without food.
• You must take Lenalidomide Mylan on the scheduled days at approximately the same time each day.

How to take this medicine
To remove the capsule from the blister:

press on one side of the capsule, pushing it through the aluminium foil

do not press in the center of the capsule, as this may cause it to break.

Duration of treatment with Lenalidomide Mylan
Lenalidomide Mylan is taken in treatment cycles, each lasting 21 or 28 days (see above “Treatment cycle”). You must continue the treatment cycles until your doctor tells you to stop.

If you take more Lenalidomide Mylan than you should
If you have taken more Lenalidomide Mylan than prescribed, inform your doctor immediately.

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

• less than 12 hours have passed: take your capsule immediately
• more than 12 hours have passed: do not take the missed capsule; instead, take the next capsule at the usual time the following day.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop taking Lenalidomide Mylan and contact your doctor immediately if you experience any
of the following serious adverse reactions – urgent medical treatment may be required:

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

Contact your doctor immediately if you experience any of the following adverse reactions:

• Fever, chills, sore throat, cough, mouth ulcers or any other sign of infection, including infection in the bloodstream (sepsis)
• Bleeding or bruising without injury
• Chest or leg pain
• Shortness of breath
• Bone pain, muscle weakness, confusion or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomide Mylan may reduce the number of white blood cells that fight infections and also the number of blood cells involved in blood clotting (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Mylan may also cause blood clots in the veins (thrombosis).
Other adverse reactions
It is important to note that a small number of patients may develop other types of cancer, and this risk may potentially increase with treatment with Lenalidomide Mylan. Therefore, your doctor must carefully evaluate the benefits and risks before prescribing Lenalidomide Mylan.
Adverse reactions very common (may affect more than 1 in 10 people):

• Decrease in red blood cells (anaemia), which may cause fatigue and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain
• Generalised swelling, including swelling of arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
• Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor
• Loss of appetite, altered taste
• Increase in pain, size of tumour or redness around tumour
• Loss of body weight
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium and/or sodium in the blood
• Underactive thyroid gland
• Leg pain (which may be a symptom of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, known as pulmonary embolism)
• Any type of infection, including infections of the sinuses around the nose, lungs and upper respiratory tract
• Shortness of breath
• Blurred vision
• Clouding of the lens of the eye (cataract)
• Kidney problems, including impaired kidney function or inability of the kidneys to maintain normal function
• Abnormal liver function test results
• Increased liver function test results
• Changes in a protein in the blood that may cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of discomfort, malaise
• Inflammation of the mouth, dry mouth
• Dehydration

Adverse reactions common (may affect up to 1 in 10 people):

• Destruction of red blood cells in the blood (haemolytic anaemia)
• Certain types of skin tumours
• Bleeding from gums, stomach or intestine
• Increased blood pressure, slow, fast or irregular heartbeat
• Increase in a substance resulting from normal and abnormal breakdown of red blood cells
• Increase in a protein indicating inflammation in the body
• Darkening of the skin, skin discolouration due to bleeding under the skin, typically caused by bruising, skin swelling due to blood, bruising
• Increased uric acid in the blood
• Skin rashes, redness of the skin, skin cracking, peeling or flaking, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, voice quality problems or voice changes
• Runny nose
• Urinating much more or less than usual or inability to control the urge to urinate
• Presence of blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (a problem of the inner ear causing a sensation of spinning), temporary loss of consciousness
• Chest pain radiating to arms, neck, jaw, back or stomach, sweating and breathlessness, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Swelling of joints
• Slowing or blockage of bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disorders, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, altered sensation, especially touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which may lead to injury

Adverse reactions uncommon (may affect up to 1 in 100 people):

• Bleeding within the skull
• Circulatory problems
• Loss of vision
• Loss of sexual desire (libido)
• Excessive urination with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, stomach pain or swelling. These may be symptoms of liver damage (hepatic failure).
• Stomach pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called renal tubular necrosis)
• Changes in skin colour, sensitivity to sunlight
• Tumour lysis syndrome: metabolic complications that may occur during anticancer treatment and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include changes in blood parameters with high levels of potassium, phosphate and uric acid, and low calcium levels, leading to changes in kidney function and heart rhythm, seizures and, in some cases, death.
• Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

Adverse reactions with frequency not known (frequency cannot be estimated from the available data):

• Sudden or mild but worsening pain in the upper abdomen and/or back, persisting for several days, possibly accompanied by nausea, vomiting, fever and rapid pulse; these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some occurring when lenalidomide is administered with a statin (a type of cholesterol-lowering medicine).
• A skin disease caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
• Deterioration of the stomach or intestinal wall, which may lead to severe infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, nausea or feeling unwell).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system mentioned in Annex V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Mylan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and the outer carton after "Exp.". The expiry date refers to the last day of that month.
• Do not store above 30 °C.
• Do not use this medicine if you notice damaged packaging or signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Return unused medicines to the pharmacist. This will help protect the environment.

6. Package contents and other information

What Lenalidomide Mylan contains
Lenalidomide Mylan 2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other components are:
  • capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate
  • capsule coating: 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 substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other components are:
  • capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate
  • capsule coating: 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 substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other components are:
  • capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate
  • capsule coating: yellow iron oxide (E172), titanium dioxide (E171), gelatin
  • printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Mylan 10 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other components are:
  • capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate
  • capsule coating: gelatin, titanium dioxide (E171), black iron oxide, 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 substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other components are:
  • capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate
  • capsule coating: titanium dioxide (E171), gelatin
  • printing ink: shellac, propylene glycol (E1520), red iron oxide (E172), and simethicone.

Lenalidomide Mylan 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other components are:
  • capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate
  • capsule coating: 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 substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other components are:
  • capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate
  • capsule coating: titanium dioxide (E171), gelatin
  • printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Description of the appearance of Lenalidomide Mylan and contents of the pack
Lenalidomide Mylan 2.5 mg hard capsules are green and white, size 4, 14 mm, marked “MYLAN/LL 2.5”.
Lenalidomide Mylan 5 mg hard capsules are white, size 2, 18 mm, marked “MYLAN/LL 5”.
Lenalidomide Mylan 7.5 mg hard capsules are light grey and white, size 2, 18 mm, marked “MYLAN/LL7.5”.
Lenalidomide Mylan 10 mg hard capsules are green and light grey, size 0, 22 mm, marked “MYLAN/LL 10”.
Lenalidomide Mylan 15 mg hard capsules are white, size 0, 22 mm, marked “MYLAN/LL15”.
Lenalidomide Mylan 20 mg hard capsules are green and white, size 0, 22 mm, marked “MYLAN/LL 20”.
Lenalidomide Mylan 25 mg hard capsules are white, size 0, 22 mm, marked “MYLAN/LL 25”.
Lenalidomide Mylan 2.5 mg, 7.5 mg, 10 mg, 20 mg, and 25 mg are supplied in blister packs containing 7 hard capsules.
Lenalidomide Mylan 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, and 25 mg hard capsules are supplied in blister packs containing 21 hard capsules and in perforated blister packs containing 7 x 1 or 21 × 1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Mylan Healthcare Sp. z. o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00
Latvija
Viatris SIA
Tel: +371 676 055 80

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.