LENALIDOMIDE ACCORD 2.5 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Lenalidomida Accord 2.5 mg hard capsules EFG

Lenalidomida Accord 5 mg hard capsules EFG

Lenalidomida Accord 7.5 mg hard capsules EFG

Lenalidomida Accord 10 mg hard capsules EFG

Lenalidomida Accord 15 mg hard capsules EFG

Lenalidomida Accord 20 mg hard capsules EFG

Lenalidomida Accord 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 or pharmacist.
• 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 and other information

1. What is Lenalidomida Accord and what is it used for
2. What you need to know before you take Lenalidomida Accord
3. How to take Lenalidomida Accord
4. Possible side effects
5. How to store Lenalidomida Accord
6. Contents of the pack and other information

1. What is Lenalidomida Accord and what is it used for

What is Lenalidomida Accord

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

What is Lenalidomida Accord used for

Lenalidomida Accord is used in adults to:

• Multple myeloma
• Myelodysplastic syndromes (MDS)
• Mantle cell lymphoma (MCL)
• 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 build up in the bone marrow and multiply out of control. This can damage the bones and kidneys.

Multple myeloma usually cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called “remission”.

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

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

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

Lenalidomida Accord 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 alone.

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

Lenalidomida Accord is taken with an anti-inflammatory called “dexamethasone”.

Lenalidomida Accord 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 the risk of infection.

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

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

Lenalidomida Accord can increase the number of healthy red blood cells produced by the body by reducing the number of abnormal cells:

• this can reduce the number of blood transfusions needed. You may not need transfusions.

Mantle cell lymphoma (MCL)

MCL is a cancer of the immune system (lymphatic 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 build up in the lymphatic tissue, bone marrow, or blood.

Lenalidomide is used alone 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 help the body fight infections. When a person has FL, they may have too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

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

How Lenalidomida Accord works

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

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

2. What you need to know before you take Lenalidomida Accord

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

Do not take Lenalidomida Accord:

• if you are pregnant, think you may be pregnant or plan to become pregnant, as lenalidomide 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 record 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 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. If in doubt, talk to your doctor.

Warnings and precautions

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

• you have ever had blood clots; during treatment, you have a higher risk of getting blood clots in the 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 may cause the virus to become active again in patients who carry the virus. This can lead to the infection coming back. Your doctor should check if you have ever had a hepatitis B infection
• you have kidney problems; your doctor may adjust your dose of lenalidomide
• 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 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, increased 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 the above applies to you, inform your doctor, pharmacist or nurse before starting treatment.

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

• you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in the arm or leg, a change in the way you walk or problems with balance, decreased or lost sensation, memory loss or confusion. These can all be symptoms of a serious and potentially life-threatening brain condition called progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomide, tell your doctor about any change in these symptoms.
• you experience shortness of breath, tiredness, dizziness, chest pain, faster heart rate or swelling in the 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 and during treatment, you will have regular blood tests. This is because Lenalidomida Accord 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

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 ask you to have tests to detect signs that may predict a higher chance of developing AML during treatment with lenalidomide.

For patients with MCL taking lenalidomide

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;
• and at least once a month.

For patients with FL taking lenalidomide

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 the 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 or stop your treatment, depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other conditions you may have.

Blood donation

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

Children and adolescents

The use of lenalidomide is not recommended 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 Lenalidomida Accord

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because lenalidomide may affect how other medicines work. Also, some medicines may affect how lenalidomide 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

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

Men taking lenalidomide

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

Breastfeeding

Do not take lenalidomide during breastfeeding, as it is not known whether lenalidomide passes into breast milk.

Contraception

For women taking lenalidomide

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

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, every 4 weeks during treatment and for at least 4 weeks after the end of treatment) unless it has been confirmed that your fallopian tubes have been 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

Lenalidomide passes into human semen. If your partner is pregnant or may become pregnant and does not use 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.

Lenalidomida Accord contains lactose

Lenalidomida Accord contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to Take Lenalidomida Accord

Lenalidomida Accord should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, CMML, or MF.

• When lenalidomide is used to treat 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 lenalidomide is used for").
• When lenalidomide is used to treat multiple myeloma in patients who have undergone a bone marrow transplant or to treat patients with MDS or CMML, it is taken alone.
• When lenalidomide is used to treat follicular lymphoma, it is taken with another medication called "rituximab".

Follow the administration instructions for this medication exactly as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist.

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

Treatment Cycle

Lenalidomide 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 should start a new "cycle" for the next 21 days.

Or

Lenalidomide 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 should start a new "cycle" for the next 28 days.

How Much Lenalidomida to Take

Before starting treatment, your doctor will indicate:

• what quantity of lenalidomide you should take
• what quantity of other medications you should take with lenalidomide, if applicable
• which days of the treatment cycle you should take each medication.

How and When to Take Lenalidomida

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken lenalidomide 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 lenalidomide 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 for it to come out through the foil.
• Do not press in the center of the capsule as it may break.

Duration of Treatment with Lenalidomida

Lenalidomide 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 than you Should

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

If you Miss a Dose of Lenalidomida

If you forget to take lenalidomida 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 doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

If you Experience any of the Following Serious Adverse Effects, Stop Treatment with Lenalidomida and Seek Medical Attention Immediately, as you may Require 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.
• 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 Adverse Effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other symptoms of infection, including in the bloodstream (sepsis).
• Bleeding (bleeding) or hematoma (bruise) 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 may reduce the number of white blood cells that fight infections and also the cells in the blood that help blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising. Lenalidomida can also cause blood clots in the veins (thrombosis).

Other Adverse Effects

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

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 sensation of burning in 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.
• Leg pain (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, lung infection, and upper respiratory tract infection.
• Difficulty breathing.
• Blurred vision.
• Eye opacity (cataracts).
• Kidney problems, including kidney failure or inability to maintain normal kidney function.
• Abnormal liver test results.
• High levels in liver 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.

Adverse effects Frequent(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 the 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 rash, 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 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.
• Slower 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).
• Pain in the nerves, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Falling, which can cause injuries.

Adverse effects Rare(may affect up to 1 in 100 people):

• Bleeding in the skull.
• Circulatory problems.
• Vision loss.
• 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).
• Damage to the kidney cells (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 cancer 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.

Adverse effects of Unknown Frequency(cannot be estimated from the available data):

• Sudden, severe, or mild 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 the 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 which occur when lenalidomide is administered with a statin (a type of medication to lower cholesterol).
• A disease that affects the skin, caused by inflammation of the 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this package insert. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lenalidomida Accord

• Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date shown on the box and blister after "EXP". The expiration date is the last day of the month indicated.

• This medication does not require special storage conditions.

• Do not use this medication if you observe visible signs of deterioration or signs of tampering.

• Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Lenalidomide Composition

Lenalidomide Accord 2.5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.

The other components are:

• Capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capsule shell: gelatin, black iron oxide (E172), titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide).

Lenalidomide Accord 5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.

The other components are:

• Capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide).

Lenalidomide Accord 7.5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.

The other components are:

• Capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), indigo carmine (E132)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide).

Lenalidomide Accord 10 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.

The other components are:

• Capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), and titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide).

Lenalidomide Accord 15 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.

The other components are:

• Capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capsule shell: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide).

Lenalidomide Accord 20 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.

The other components are:

• Capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), and titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide).

Lenalidomide Accord 25 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.

The other components are:

• Capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide).

Appearance of Lenalidomide Accord and Package Contents

Lenalidomide Accord 2.5 mg are hard gelatin capsules, size "5", approximately 11.0 mm to 11.8 mm in length, with a grey cap and a white opaque body, with "LENALIDOMIDE" printed on the cap in black and "2.5" mg printed on the body in green, containing a white to off-white powder.

Lenalidomide Accord 5 mg are hard gelatin capsules, size "5", approximately 11.0 mm to 11.8 mm in length, with a white opaque cap and body, with "LENALIDOMIDE" printed on the cap in black and "5" mg printed on the body in green, containing a white to off-white powder.

Lenalidomide Accord 7.5 mg are hard gelatin capsules, size "4", approximately 14.0 mm to 14.8 mm in length, with a lavender opaque cap and a white opaque body, with "LENALIDOMIDE" printed on the cap in black and "7.5" mg printed on the body in green, containing a white to off-white powder.

Lenalidomide Accord 10 mg are hard gelatin capsules, size "3", approximately 15.4 mm to 16.2 mm in length, with a green leaf cap and a white opaque body, with "LENALIDOMIDE" printed on the cap in black and "10 mg" printed on the body in green, containing a white to off-white powder.

Lenalidomide Accord 15 mg are hard gelatin capsules, size "2", approximately 17.4 mm to 18.2 mm in length, with an orange opaque cap and a white opaque body, with "LENALIDOMIDE" printed on the cap in black and "15 mg" printed on the body in green, containing a white to off-white powder.

Lenalidomide Accord 20 mg are hard gelatin capsules, size "1", approximately 19.0 mm to 19.8 mm in length, with a green opaque cap and a white opaque body, with "LENALIDOMIDE" printed on the cap in black and "20 mg" printed on the body in green, containing a white to off-white powder.

Lenalidomide Accord 25 mg are hard gelatin capsules, size "0", approximately 21.0 mm to 21.8 mm in length, with a white opaque cap and body, with "LENALIDOMIDE" printed on the cap in black and "25 mg" printed on the body in green, containing a white to off-white powder.

Lenalidomide Accord hard capsules are available in pre-cut single-dose OPA-AL-PVC/aluminum blisters.

Package size: 7x1 or 21x1 capsules

Only some package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona,

s/n, Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF

United Kingdom

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Date of Last Revision of this Leaflet:

Other Sources of Information

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