Package leaflet: Information for the user

Lenalidomide Accord 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 this leaflet carefully before 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Lenalidomide Accord is and what it is used for
What you need to know before taking Lenalidomide Accord
How to take Lenalidomide Accord
Possible side effects
How to store Lenalidomide Accord
Contents of the pack and other information

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

What Lenalidomide Accord is
Lenalidomide Accord contains the active substance "lenalidomide". This medicine belongs to a
group of medicines that affect the way the immune system works.
What Lenalidomide Accord is used for
Lenalidomide Accord is used 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 bones and kidneys.
Multiple myeloma is usually 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 transplantation
Lenalidomide Accord 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 Accord is taken with other medicines. These may include:

a chemotherapy medicine called "bortezomib",
an anti-inflammatory medicine called "dexamethasone",
a chemotherapy medicine called "melphalan", and
an immunosuppressant medicine called "prednisone".
You will take these other medicines at the beginning of treatment and then continue taking Lenalidomide 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 patients who have been previously treated
Lenalidomide Accord is taken together with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide 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 diseases. Blood cells become abnormal and do not function properly. Patients may have various signs and symptoms, including a low number of red blood cells (anaemia), need for blood transfusions, and risk of infection.
Lenalidomide Accord alone is used to treat adult patients diagnosed with MDS who meet all of the following conditions:

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

Lenalidomide Accord 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 needed. You may no longer require 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 Accord is used alone to treat adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer that affects 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 Accord is taken together with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Accord works
Lenalidomide 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 need to know before taking Lenalidomide Accord

Before starting treatment with Lenalidomide Accord, you must read the patient leaflet of
all medicines that you are required to take in combination with Lenalidomide Accord.
Do not take Lenalidomide Accord:

If you are pregnant, think you may be pregnant, or are planning a pregnancy, because lenalidomide 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 that 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 of becoming pregnant, your doctor will document and confirm at each prescription that all necessary measures to avoid pregnancy have been taken.
If you are allergic to lenalidomide or to 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. If you have any doubts, consult your doctor.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking lenalidomide:

if you have previously experienced episodes of blood clot formation, as the risk of developing blood clots in veins and arteries increases during treatment
if you have any signs of infection, such as cough or fever
if you have or have previously had a viral infection, particularly hepatitis B, varicella-zoster, or HIV. If you are in doubt, consult your doctor. Treatment with lenalidomide 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
if you have kidney problems – your doctor may adjust the dose of lenalidomide
if you have had a heart attack, blood clot, or if you smoke, have high blood pressure, or high cholesterol levels
if you 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
if you have previously experienced any combination 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 may be signs of a serious skin reaction known as 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, immediately inform your doctor or
nurse if you experience:

blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in walking or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially life-threatening brain disease 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, you will undergo regular blood tests. This is because
Lenalidomide Accord may cause a reduction in blood cells that protect you from infections (white blood cells) and those involved in blood clotting (platelets). Your doctor will request blood tests:

before starting treatment
weekly for 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 lenalidomide.
For patients with MDS taking lenalidomide
If you have MDS, you have a higher risk of developing a more advanced disease called acute myeloid leukaemia (AML). Furthermore, the role of Lenalidomide Accord 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 Accord.
For patients with MCL taking lenalidomide
Your doctor will request blood tests:

before starting treatment
once a week 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
Your doctor will request blood tests:

before starting treatment
once a week 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 assess whether you have a high tumour burden throughout the body, including in the bone marrow. This may lead to a condition in which tumours break down and cause abnormally high levels of certain chemicals in the blood, which may result in 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 or discontinue treatment based on blood test results 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 stopping
treatment.
Children and adolescents
The use of lenalidomide is not recommended in children and adolescents under 18 years of age.
Elderly patients and patients with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, your doctor will perform careful monitoring before starting treatment.
Other medicines and Lenalidomide Accord
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This is because lenalidomide may affect the action of other medicines and other medicines may affect the action of lenalidomide.
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

You must not take lenalidomide if you are pregnant, as this medicine is expected to be harmful to the unborn baby.
During treatment with lenalidomide, 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, you must stop treatment immediately and inform your doctor.

For men taking lenalidomide

If your partner becomes pregnant while you are taking lenalidomide, 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, as it is not known whether this medicine passes into
breast milk.
Contraception
For women taking lenalidomide
Before starting treatment, ask your doctor whether there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant

you must undergo pregnancy tests under the supervision of your doctor (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment)

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 guidance on appropriate contraceptive methods.

For men taking lenalidomide
Lenalidomide is present in 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 stopping treatment, even if you have had a vasectomy. You must not donate seminal fluid or sperm during treatment with lenalidomide and for at least 7 days after stopping treatment.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo, or blurred vision after taking lenalidomide.
Lenalidomide Accord contains lactose
Lenalidomide Accord contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Lenalidomide Accord

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

When lenalidomide 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 is and what it is used for").
When lenalidomide is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, or for treating patients with MDS or MCL, it is taken alone.
When lenalidomide is used to treat follicular lymphoma, it is taken in combination with another medicine called "rituximab".

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
If you are taking lenalidomide in combination with other medicines, please refer to the package leaflet of those
medicines for further information on their use and possible side effects.
Treatment cycle
Lenalidomide is taken on certain days within a period of 3 weeks (21 days).

Each 21-day period is called a "treatment cycle".
Depending on the day of the cycle, you will take one or more of the prescribed 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 is taken on certain days within a period of 4 weeks (28 days).
Each 28-day period is called a "treatment cycle".
Depending on the day of the cycle, you will take one or more of the prescribed 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 to be taken
Before starting treatment, your doctor will inform you:

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

How and when to take lenalidomide

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 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 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 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.

Schematic drawing showing four steps to press the thumb on a medical device to release the content through constant pressure

Duration of treatment with lenalidomide
Lenalidomide is taken in treatment cycles, each lasting either 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 than you should
If you have taken more lenalidomide than prescribed, inform your doctor immediately.
If you forget to take lenalidomide
If you forget to take your usual dose of lenalidomide and

less than 12 hours have passed: take the missed 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lenalidomide and contact your doctor immediately if you experience any of the
following serious side effects – 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 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 side effects:

Fever, chills, sore throat, cough, mouth ulcers or any other sign of infection, including within 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 may reduce the number of white blood cells that fight infections and also the blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising.
Lenalidomide may also cause blood clots in the veins (thrombosis).
Other side effects
It is important to note that a small number of patients may develop other types of cancer, and this risk may possibly increase with lenalidomide treatment. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing lenalidomide to you.
Very common (may affect more than 1 in 10 people):

Decrease in red blood cells which may cause anaemia, leading to tiredness and weakness
Rash, itching
Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, pain in extremities
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 sense of taste
Increased pain, tumour size or redness around the 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, called 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 vision (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 values
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
Low blood pressure
Vague feeling of physical discomfort, malaise
Inflammation of the mouth, dry mouth
Dehydration

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 type of protein indicating inflammation in the body
Darkening of the skin; skin colour changes 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 much less than usual, or inability to control the urge to urinate
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 (inner ear problem causing a spinning sensation), temporary loss of consciousness
Chest pain spreading 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

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

Bleeding inside 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 (liver failure).
Stomach pain, 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 that may occur during anti-cancer 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, sometimes, death.
Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

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 of which occurred when lenalidomide was administered with a statin (a type of medicine that lowers cholesterol).
A skin disease caused by inflammation of small blood vessels, with joint pain and fever (leucocytoclastic 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 vomiting).
Rejection of solid organ transplant (such as kidney, heart)

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

5. How to store Lenalidomide Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after 'Exp.'. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice damaged packaging or signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Accord contains
Lenalidomide Accord 2.5 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
The other components are:
capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and 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:

The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
The other components are:
capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and 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:

The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
The other components are:
capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and 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:

The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other components are:
capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate
capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), titanium dioxide (E171)
printing ink: black and green ink (containing shellac, propylene glycol (E1520), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132), and potassium hydroxide)

Lenalidomide Accord 15 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other components are:
capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and 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:

The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
The other components are:
capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate
capsule shell: gelatin, indigo carmine (E132), 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 25 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other components are:
capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and 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)

Description of the appearance of Lenalidomide Accord and contents of the pack
Lenalidomide Accord 2.5 mg hard capsules are hard gelatin capsules, size 5, 11.0–11.8 mm in length, with an opaque white body and grey cap, filled with white to off-white powder, printed with “LENALIDOMIDE” in black on the cap and “2.5 mg” in green on the body.
Lenalidomide Accord 5 mg hard capsules are hard gelatin capsules, size 5, 11.0–11.8 mm in length, with an opaque white body and grey cap, filled with white to off-white powder, printed with “LENALIDOMIDE” in black on the cap and “5 mg” in green on the body.
Lenalidomide Accord 7.5 mg hard capsules are hard gelatin capsules, size 4, 14.0–14.8 mm in length, with an opaque white body and opaque lavender cap, filled with white to off-white powder, printed with “LENALIDOMIDE” in black on the cap and “7.5 mg” in green on the body.
Lenalidomide Accord 10 mg hard capsules are hard gelatin capsules, size 3, 15.4–16.2 mm in length, with an opaque white body and leaf green cap, filled with white to off-white powder, printed with “LENALIDOMIDE” in black on the cap and “10 mg” in green on the body.
Lenalidomide Accord 15 mg hard capsules are hard gelatin capsules, size 2, 17.4–18.2 mm in length, with an opaque white body and opaque orange cap, filled with white to off-white powder, printed with “LENALIDOMIDE” in black on the cap and “15 mg” in green on the body.
Lenalidomide Accord 20 mg hard capsules are hard gelatin capsules, size 1, 19.0–19.8 mm in length, with an opaque white body and opaque green cap, filled with white to off-white powder, printed with “LENALIDOMIDE” in black on the cap and “20 mg” in green on the body.
Lenalidomide Accord 25 mg hard capsules are hard gelatin capsules, size 0, 21.0–21.8 mm in length, with opaque white body and cap, filled with white to off-white powder, printed with “LENALIDOMIDE” in black on the cap and “25 mg” in green on the body.
Lenalidomide Accord hard capsules are available in perforated unit dose aluminum OPA/aluminum/PVC-aluminum foil blisters.
Pack sizes: 7 x 1 or 21 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
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,
The Netherlands

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT /
NL / NO / PL / PT / RO / SE / SI / SK / UK (NI)
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Pharmaceutical S.A.
Tel: +30 210 74 88 821

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