Lenalidomide Mylan 10 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. 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 Lenalidomida Mylan is and what it is used for

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

Lenalidomida 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 specific type of white blood cells called plasma cells. These cells accumulate in the bone marrow and multiply uncontrollably. This can damage bones and kidneys.

Multiple myeloma is generally not curable. However, signs and symptoms can be greatly reduced or may disappear for a period of time. This is called "remission".

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

Lenalidomida Mylan is used as maintenance treatment after adequate recovery from a bone marrow transplant.

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

Lenalidomida Mylan is taken together with other medicines, including:

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

You will take these medicines at the beginning of treatment and then continue taking Lenalidomida Mylan alone.

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

Multiple myeloma: in previously treated patients

Lenalidomida Mylan is taken together with an anti-inflammatory medicine called "dexamethasone".

Lenalidomida Mylan may slow down 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 diseases. Blood cells become abnormal and do not function properly. Patients may experience a variety of signs and symptoms, including low red blood cell count (anaemia), the need for blood transfusions, and increased risk of infection.

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

• you require regular blood transfusions to treat low red blood cell levels ("transfusion-dependent anaemia");
• you have an abnormality in bone marrow cells called "isolated 5q cytogenetic abnormality". This means your body does not produce enough healthy blood cells;
• other treatments you have previously used are not suitable or have not worked well enough.

Lenalidomida 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 needed. Blood transfusions may no longer be required.

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. MCL is a disease in which B-cells grow uncontrollably and accumulate in lymphatic tissue, bone marrow, or blood.

Lenalidomida Mylan is used as monotherapy to treat adult patients who have previously received treatment with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, too many of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomida Mylan is used in combination with another medicine called "rituximab" for the treatment of adult patients who have received prior treatment for follicular lymphoma.

How Lenalidomida Mylan works

Lenalidomida Mylan works by affecting the body's immune system and directly attacking cancer cells. It acts in several ways:

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

2. What you need to know before starting Lenalidomida Mylan

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomida Mylan before starting treatment with Lenalidomida Mylan.

Do not take Lenalidomida Mylan

• if you are pregnant, think you may be pregnant, or intend to become pregnant, as Lenalidomida Mylan is expected to be harmful to the fetus (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”);
• if you are capable of becoming pregnant, unless you follow all necessary measures to prevent pregnancy (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you are capable of becoming pregnant, your doctor will document with each prescription that all necessary measures have been taken and will provide you with this confirmation;
• if you are allergic to lenalidomide or any of the other components 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 Lenalidomida Mylan. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Lenalidomida Mylan if:

• you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have previously had a viral infection, especially hepatitis B, varicella zoster, or HIV. If in doubt, consult your doctor. Treatment with Lenalidomida Mylan may reactivate the virus in patients who carry it, leading to recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of Lenalidomida 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 multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties;
• 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), swollen lymph nodes (these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above 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, double vision, difficulty speaking, weakness in one arm or leg, change in walking pattern or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss or confusion. These may be symptoms of a serious and potentially fatal brain disease known as progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting lenalidomide treatment, inform your doctor if you notice any changes in these symptoms.

• shortness of breath, fatigue, dizziness, chest pain, faster 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 starting treatment with Lenalidomida Mylan and during treatment, you will have regular blood tests. This is because Lenalidomida Mylan may cause a decrease in blood cells that help fight infections (white blood cells) and those involved in blood clotting (platelets).

Your doctor will ask you to have blood tests:

• before treatment;
• weekly during the first 8 weeks of treatment;
• thereafter, at least once a month.

You may be evaluated for signs of cardiopulmonary problems before and during treatment with lenalidomida.

For patients with MDS taking Lenalidomida Mylan

If you have MDS, you may be at higher risk of developing a more advanced disease called acute myeloid leukemia (AML). In addition, it is unknown how lenalidomide affects the likelihood of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the possibility of developing AML during treatment with Lenalidomida Mylan.

For patients with MCL taking Lenalidomida Mylan

Your doctor will ask you to have blood tests:

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

For patients with FL taking Lenalidomida Mylan

Your doctor will ask you to have blood tests:

• before treatment;
• weekly during the first 3 weeks (1 cycle) of treatment;
• then every 2 weeks during cycles 2 to 4 (see section 3 “Treatment cycle” for more information);
• after this, at the beginning of each cycle;
• at least once a month.

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

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

Your doctor may adjust the dose of Lenalidomida Mylan or interrupt your treatment, depending on the results of your blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other existing conditions.

Blood donation

You must not donate blood during treatment or for at least 7 days after treatment ends.

Children and adolescents

Lenalidomida Mylan is not recommended for use in children and adolescents under 18 years of age.

Elderly patients and patients with kidney problems

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will carefully evaluate you before starting treatment.

Other medicines and Lenalidomida Mylan

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

This is because Lenalidomida Mylan may affect how other medicines work. In addition, some medicines may affect how Lenalidomida Mylan works.

Specifically, 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 ineffective;
• 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

Women taking Lenalidomida Mylan

• You must not take Lenalidomida Mylan if you are pregnant, as it is expected to be harmful to the fetus.
• You must not become pregnant while taking Lenalidomida Mylan. Therefore, you must use effective contraceptive methods if there is any possibility you could become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomida Mylan, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida Mylan

• If your partner becomes pregnant while you are taking Lenalidomida Mylan, you must inform your doctor immediately. It is advisable that your partner seeks medical advice.
• You must also use effective contraceptive methods (see “Contraception”).

Breastfeeding

You must not breastfeed while taking Lenalidomida Mylan, as it is unknown whether Lenalidomida Mylan passes into breast milk.

Contraception

For women taking Lenalidomida Mylan

Before starting treatment, ask your doctor whether you are capable of becoming pregnant, even if you think this is unlikely.

If you are capable of becoming pregnant:

• you will undergo pregnancy tests under medical supervision (before each treatment cycle, at least every 4 weeks during treatment, and for at least 4 weeks after treatment ends), unless it has been confirmed that your fallopian tubes are permanently closed (tubal ligation) to prevent eggs from reaching the uterus;

And

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout treatment, and for at least 4 weeks after treatment ends. Your doctor will advise you on the most appropriate contraceptive methods.

For men taking Lenalidomida Mylan

Lenalidomida Mylan is present in human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, you must use condoms during treatment and for at least 7 days after treatment ends, even if you have had a vasectomy.

Driving and use of machines

Do not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo, or blurred vision after taking Lenalidomida Mylan.

Lenalidomida Mylan contains sodium

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

3. How to take Lenalidomida Mylan

Lenalidomida Mylan must be prescribed and administered by a healthcare professional experienced in the treatment of multiple myeloma, MDS, CMML, or FL.

• When Lenalidomida Mylan is used for the treatment of multiple myeloma in patients who cannot undergo a bone marrow transplant or who have received prior treatments, it is taken in combination 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 undergone a bone marrow transplant, or for treating patients with MDS or CMML, it is taken alone.
• When Lenalidomida Mylan is used for the treatment of follicular lymphoma, it is taken together with another medicine called “rituximab”.

Always follow exactly the instructions for taking Lenalidomida Mylan provided by your doctor. If in doubt, consult your doctor or pharmacist.

If you are taking Lenalidomida Mylan together with other medications, you should refer to the package leaflet of those other medicines for additional information on their use and effects.

Treatment cycle

Lenalidomida Mylan is taken on certain days during a 3-week period (21 days).

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

Or

Lenalidomida Mylan is taken on certain days during a 4-week period (28 days).

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

How much Lenalidomida Mylan to take

Before starting treatment, your doctor will inform you:

• of the dose of Lenalidomida Mylan you should take;
• of the dose of any other medications you should take together with Lenalidomida Mylan, if applicable;
• on 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. If the powder from a broken Lenalidomida Mylan capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed into a sealable polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed 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 should take Lenalidomida Mylan at approximately the same time each day on the scheduled days.

How to take this medicine

To remove the capsule from the blister:

• Press only on one end of the capsule to push it through the foil.

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

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 must continue the treatment cycles until your doctor tells you to stop.

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 your dose of Lenalidomida Mylan at the usual time and:

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

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

4. Possible adverse effects

Like all medicines, Lenalidomida Mylan may cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects, stop treatment with Lenalidomida Mylan and seek immediate medical attention, as you may require urgent medical treatment:

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

Contact your doctor immediately if you notice any of the following serious adverse effects:

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

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

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

Other adverse 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 must carefully evaluate the benefits and risks before prescribing Lenalidomida Mylan.

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

• A decrease in the number of red blood cells, which may lead to anaemia causing tiredness and weakness.
• Skin rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
• Generalised swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms including fever, muscle pain, headache, earache, cough and chills.
• Numbness, tingling or burning sensations in the skin, pain in hands or feet, dizziness, tremor.
• Decreased appetite, changes in taste.
• Increased pain, size or redness around the tumour.
• Weight loss.
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn.
• Low levels of potassium, calcium and/or sodium in the blood.
• Underactive thyroid function.
• Leg pain (which could be a symptom of thrombosis), chest pain or difficulty breathing (which could be symptoms of blood clots in the lungs, known as pulmonary embolism).
• Infections of all types, including infection of the sinuses around the nose (sinusitis), lung infection and upper respiratory tract infections.
• Difficulty breathing.
• Blurred vision.
• Clouding of the eye (cataracts).
• Kidney problems including kidneys that do not function properly or that are unable to maintain normal function.
• Abnormal results in liver function tests.
• High values in liver function tests.
• Changes in a blood protein 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.
• Low blood pressure.
• A general feeling of discomfort, feeling unwell.
• Painful inflammation of the mouth, dry mouth.
• Dehydration.

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

• Destruction of red blood cells (haemolytic anaemia).
• Certain types of skin tumours.
• Bleeding from the gums, stomach or intestines.
• Increased blood pressure, slow, fast or irregular heartbeat.
• Increased levels of a substance released following normal or abnormal destruction of red blood cells.
• Increased levels of a protein indicating inflammation in the body.
• Darkening of skin colour; skin colour change due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising.
• Increased uric acid levels in the blood.
• Skin rashes, skin redness, cracked skin, peeling or flaking skin, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes.
• Runny nose.
• Marked increase or decrease in urine output compared to normal, or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
• Difficulty achieving an erection.
• Stroke, fainting, dizziness (inner ear disorder causing a sensation of spinning), temporary loss of consciousness.
• Chest pain spreading to arms, neck, jaw, back or stomach, 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.
• Swelling of the joints.
• Slowed or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Loss of balance, movement difficulties.
• Hearing loss, ringing in the ears (tinnitus).
• Nerve pain, abnormal and unpleasant sensation, especially upon touch.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Falls that may cause injuries.

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

• Bleeding inside the skull.
• Circulatory problems.
• Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension).
• Loss of vision.
• Loss of sexual desire (libido).
• Excretion of large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome).
• Yellow pigmentation of the skin, mucous membranes or eyes (jaundice), pale stools, dark-coloured urine, skin itching, skin rash, stomach pain or swelling; these may be symptoms of liver damage (liver failure).
• Stomach pain, abdominal swelling 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 may occur during cancer treatment and sometimes even without treatment. These complications arise due to breakdown products from dying tumour cells and may include: changes in blood biochemistry, high levels of potassium, phosphate, uric acid and low calcium levels, leading to changes in kidney function and heart rhythm, seizures and, sometimes, death.

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

• Sudden or mild pain in the upper abdomen and/or back that worsens and lasts several days, possibly accompanied by nausea, vomiting, fever and a rapid pulse. These symptoms may be due to inflammation of the pancreas.
• Wheezing or whistling sounds when breathing, difficulty breathing or dry cough, which may be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of them when lenalidomide is administered with a statin (a type of medicine used to lower cholesterol).
• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).
• Perforation of the stomach or intestinal wall. This may lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the 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 and nausea or feeling unwell).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomida 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 pack and the carton after “CAD”/“EXP”. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.
• Do not use this medicine if you notice any visible signs of deterioration or evidence of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lenalidomida Mylan

Lenalidomida 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, 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).

Lenalidomida 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 shell: titanium dioxide (E171), gelatin.

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

Lenalidomida 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 shell: yellow iron oxide (E172), titanium dioxide (E171), gelatin.

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

Lenalidomida 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 shell: 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.

Lenalidomida 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 shell: titanium dioxide (E171), gelatin.

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

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

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

Lenalidomida 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 shell: titanium dioxide (E171), gelatin.

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

Appearance of the product and contents of the pack

Lenalidomida Mylan 2.5 mg hard capsules are green and white in color, size 4, 14 mm long, and marked with “MYLAN/LL 2.5 mg”.

Lenalidomida Mylan 5 mg hard capsules are white in color, size 2, 18 mm long, and marked with “MYLAN/LL 5 mg”.

Lenalidomida Mylan 7.5 mg hard capsules are light grey and white in color, size 2, 18 mm long, and marked with “MYLAN/LL 7.5 mg”.

Lenalidomida Mylan 10 mg hard capsules are green and light grey in color, size 0, 22 mm long, and marked with “MYLAN/LL 10 mg”.

Lenalidomida Mylan 15 mg hard capsules are white in color, size 0, 22 mm long, and marked with “MYLAN/LL 15 mg”.

Lenalidomida Mylan 20 mg hard capsules are green and white in color, size 0, 22 mm long, and marked with “MYLAN/LL 20 mg”.

Lenalidomida Mylan 25 mg hard capsules are white in color, size 0, 22 mm long, and marked with “MYLAN/LL 25 mg”.

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

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

Only certain 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

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Mylan bvba/sprl Tel/Tel: + 32 (0)2 658 61 00	Lithuania Mylan Healthcare UAB Tel: +370 5 205 1288
	Luxembourg/Luxembourg Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00 (Belgium/Belgium)
Czech Republic Viatris CZ s.r.o. Tel: + 420 222 004 400	Hungary Mylan EPD Kft Tel.: + 36 1 465 2100
Denmark Viatris ApS Tlf: +45 28 11 69 32	Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Germany Viatris Healthcare GmbH Tel: +49 800 0700 800	Netherlands Mylan BV Tel: +31 (0)20 426 3300
Estonia BGP Products Switzerland GmbH Estonia Branch Tel: + 372 6363 052	Norway Viatris AS Tlf: + 47 66 75 33 00
Greece Generics Pharma Hellas EPE Tel: +30 210 993 6410	Austria Arcana Arzneimittel GmbH Tel: +43 1 416 2418
Spain Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 712	Poland Mylan Healthcare Sp. z o.o. Tel.: + 48 22 546 64 00
France* Viatris Santé Tél: +33 4 37 25 75 00	Portugal Mylan, Lda. Tel: + 351 214 127 200
Croatia Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BGP Products SRL Tel: +40 372 579 000
Ireland Mylan Ireland Limited Tel: +353 1 8711600	Slovenia Viatris d.o.o. Tel: + 386 1 23 63 180
Iceland* Icepharma hf. Sími: +354 540 8000	Slovakia Viatris Slovakia s.r.o. Tel: +421 2 32 199 100
Italy Mylan Italia S.r.l. Tel: + 39 02 612 46921	Finland Viatris Oy Puh/Tel: +358 20 720 9555
Cyprus Varnavas Hadjipanayis Ltd Tel: +357 2220 7700	Sweden Viatris AB Tel: + 46 (0)8 630 19 00
Latvia Mylan Healthcare SIA Tel: +371 676 055 80	United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600

Date of the most recent revision of this leaflet: {MM/YYYY}

Other sources of information

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