LENALIDOMIDE 2.5 mg Twarde kapsułki

Treść ulotki

1. Lenalidomide Accord 2.5 mg hard capsules
2. Lenalidomide Accord 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules
   1. What is Lenalidomide Accord and what it is used for
   2. What you need to know before taking Lenalidomide Accord
   3. How to take Lenalidomide Accord
   4. Possible side effects
   5. How to store Lenalidomide Accord
   6. Contents of the pack and other information

Lenalidomide Accord 2.5 mg hard capsules

Lenalidomide Accord 5 mg hard capsules

Lenalidomide Accord 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

lenalidomide

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What is Lenalidomide Accord
Lenalidomide Accord contains the active substance “lenalidomide”. This medicine belongs to a
group of medicines that affect the way the immune system works.

What is Lenalidomide Accord used for
Lenalidomide Accord is used for:

• 1. Multiple myeloma
• 2. Myelodysplastic syndromes
• 3. Mantle cell lymphoma
• 4. 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 collect in the bone marrow and divide, in an uncontrolled way. This
can damage the bones and kidneys.
Multiple myeloma is usually incurable. However, the signs and symptoms can be significantly
reduced or disappear for a certain period. This result is called “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 to take Lenalidomide alone.

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will
subject you to careful monitoring before starting treatment.
Multiple myeloma: in patients already treated
Lenalidomide Accord is taken together with an anti-inflammatory medicine called
“dexamethasone”.
Lenalidomide can stop the worsening of the signs and symptoms of multiple myeloma. It has also
been shown to delay the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
MDS are a group of many different blood and bone marrow diseases. Blood cells become
abnormal and do not function properly. Patients may experience various signs
and symptoms, including a low number of red blood cells (anemia), the need for blood transfusions, and
the risk of infection.
Alone, Lenalidomide Accord is used to treat adult patients who have been diagnosed with
MDS, in the presence of all of the following conditions:

• if you need regular blood transfusions to treat low levels of red blood cells (“transfusion-dependent anemia”)
• if you have an abnormality of the bone marrow cells, called “isolated deletion 5q cytogenetic abnormality”. This means that your body does not produce enough healthy blood cells
• if other treatments used previously are not suitable or are not 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 not need any transfusions.

Mantle cell lymphoma (MCL)
MCL is a cancer of a part of the immune system (the 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 the lymphatic tissue, bone marrow, or blood.
Lenalidomide Accord is used alone for the treatment of adult patients 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 cell that
helps the body fight infections. In the presence of FL, an excessive number
of these B lymphocytes can 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 acts on the body's immune system and directly on the tumor, in several
ways:

• stopping the development of cancer cells
• stopping the growth of blood vessels that bring blood to the tumor cells
• stimulating part of the immune system to attack the tumor cells.

2. What you need to know before taking Lenalidomide Accord

all medicines that you are taking in combination with Lenalidomide Accord.
Do not take Lenalidomide Accord:

• If you are pregnant, think you may be pregnant, or if you are planning a pregnancy, as lenalidomide is expected to harm the fetus (see section 2, ‘Pregnancy, breastfeeding and contraception – information for women and men’).
• If there is a possibility that you may become pregnant unless you follow all the necessary measures to avoid pregnancy (see section 2 ‘Pregnancy, breastfeeding and contraception – information for women and men’). If there is a possibility of becoming pregnant, on each prescription the doctor will take note and confirm to you that the necessary measures to avoid pregnancy have been adopted.
• 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, ask your doctor for advice.

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 had episodes of blood clot formation in the past, as the risk of blood clots forming in the veins and arteries increases during treatment
• if you have any signs of infection, such as cough or fever
• if you have or have had a viral infection, in particular hepatitis B infection, shingles, HIV. If you have any doubts, consult your doctor. Treatment with lenalidomide may cause reactivation of the virus in patients carrying the virus. This causes the infection to recur. The doctor must check if you have had a hepatitis B infection in the past
• if you have kidney problems - your doctor may adjust the dose of lenalidomide
• if you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• if you have had an allergic reaction during treatment with thalidomide (another medicine for the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• if you have had in the past any combination 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 or drug hypersensitivity syndrome (see also section 4 “Possible side effects”).

If any of these conditions apply to you, tell 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 or double vision, difficulty speaking, weakness in an arm or leg, changes in the way you walk or problems with balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may be symptoms of a serious brain disease that can be life-threatening, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomide, tell 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 checks
Before and during treatment with lenalidomide you will undergo regular blood tests. This
is because Lenalidomide Accord can cause a reduction in the blood cells that defend you from
infections (white blood cells) and those that promote blood clotting (platelets). The doctor
will ask you to undergo blood tests:

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

You may be evaluated for signs of cardiopulmonary problems before and during
treatment with lenalidomide.
For patients with MDS taking lenalidomide
If you suffer from MDS, you are more likely to develop a more advanced disease called
acute myeloid leukemia (AML). Furthermore, the role of Lenalidomide Accord in the probability
of developing AML is not known. The doctor may ask you to undergo some tests to check for signs that could
more accurately predict the probability that you will develop AML during treatment with
Lenalidomide Accord.
For patients with MCL taking lenalidomide
The doctor will ask you to undergo a blood test:

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

For patients with FL taking lenalidomide
The doctor will ask you to undergo a blood test:

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

The doctor may check if you have a high tumor burden throughout the body, including in the bone
marrow. This can cause a disease in which tumors break down and cause the presence of unusual levels of chemicals in the blood, which can lead to kidney failure (this disease is
called “tumor lysis syndrome”).
The doctor may check for changes on the skin, such as red spots or rashes.
The doctor may decide to adjust the dose of lenalidomide or stop treatment
depending on the results of blood tests and your general condition. If you are a newly diagnosed patient, the doctor may also assess treatment based on your age and any other existing conditions.

Blood donation
You must not donate blood during therapy 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 and people with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, the doctor
will perform careful checks before starting treatment.

Other medicines and Lenalidomide Accord
Tell your doctor or nurse if you are taking, have recently taken or may take
any other medicines. This is because lenalidomide can affect the action of other medicines and
other medicines can affect the action of lenalidomide.
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, because they may no longer be effective
• 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
For women taking lenalidomide

• You must not take lenalidomide if you are pregnant, as this medicine is expected to harm the fetus.
• During treatment with lenalidomide you must not start a pregnancy. If there is a possibility of becoming pregnant, you must use effective contraceptive methods (see the ‘Contraception’ section).
• 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, immediately inform your doctor. It is also recommended that your partner contact the doctor.
• In addition, you must use effective contraceptive methods (see the “Contraception” section).

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 if there is a possibility for you to become
pregnant, even if you think it is unlikely.
If there is a possibility of becoming pregnant

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

except in cases where it has been confirmed that the fallopian tubes have been cut and
closed to prevent eggs from reaching the uterus (sterilization 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 all the information on appropriate contraceptive methods.

For men taking lenalidomide
Lenalidomide passes into human seminal fluid. If there is a possibility that your partner is
pregnant or becomes 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 undergone 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 use machines 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 intolerance to
some sugars, contact him before taking this medicine

3. How to take Lenalidomide Accord

Lenalidomide Accord must be 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 are not eligible for bone marrow transplant or who have received other prior treatments, it is taken 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 transplant or to treat patients with MDS or MCL, it is taken alone.
• When lenalidomide is used to treat follicular lymphoma, it is taken with another medicine called “rituximab”.

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult
your doctor or pharmacist.
medicines for further information on their use and effects.

Treatment cycle
Lenalidomide is taken on some days over a 3-week (21-day) period.

• Each 21-day period is called a “treatment cycle”.
• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.
• Once each 21-day cycle is completed, you will need to start a new “cycle” over the next 21 days. OR Lenalidomide is taken on some days over a 4-week (28-day) period.
• Each 28-day period is called a “treatment cycle”.
• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.
• Once each 28-day cycle is completed, you will need to start a new “cycle” over the next 28 days.

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

• the dose of lenalidomide to be taken
• the dose of 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

• the capsules should be swallowed 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 water and soap.
• healthcare professionals, those providing care to the patient, and family members must wear disposable gloves when handling the blister or the capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Pregnant or suspected pregnant women should not handle the blister or capsule.
• the capsules can be taken with or without food.
• you should take lenalidomide on the established days at more or less the same time.

Taking this medicine
To remove the capsule from the blister:

• press on one side of the capsule only, pushing it through the aluminum foil
• do not press on the center of the capsule, otherwise there is a risk of breaking it.

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

If you take more lenalidomide than you should
If you have taken more lenalidomide than you have been prescribed, inform your doctor immediately.

If you forget to take lenalidomide
If you forget to take lenalidomide at the usual time and

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
li manifestino.

Stop taking Lenalidomide and consult your doctor immediately if you experience any of the
following serious side effects – urgent medical treatment may be needed:

• Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which can be symptoms of serious 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 all over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged 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.

See your doctor immediately if you experience any of the following side effects:

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

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

Other side effects
It is important to note that a small number of patients may develop other types of cancer and it is possible
that this risk may increase with treatment with lenalidomide. Therefore, the doctor must
carefully assess the benefit and risk when prescribing lenalidomide.
Very common(may affect more than 1 in 10 people):

• Decrease in the number of red blood cells, which can cause anemia, which can cause fatigue and weakness
• Skin rash, itching
• Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, limb pain
• General swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle aches, headache, earache, cough and chills
• Numbness, tingling or burning sensation on the skin, pain in the hands or feet, dizziness, tremor
• Decreased appetite, altered sense of taste
• Increased pain, size of the tumor or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood
• Underactive thyroid
• 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)
• Infections of any kind, 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 improper functioning of the kidneys or the inability of the kidneys to maintain normal function
• Abnormal values in liver function tests
• Increased values in liver function tests
• Changes in a protein in the blood that can cause inflammation of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of discomfort, unwell
• Inflammation of the oral cavity, dry mouth
• Dehydration

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

• Destruction of red blood cells in the blood (hemolytic anemia)
• Some types of skin cancer
• Bleeding from the gums, stomach or intestines
• Increased blood pressure, slow, fast or irregular heartbeat
• Increased amount of a substance that comes from the normal and abnormal breakdown of red blood cells
• Increase in a type of protein that indicates inflammation in the body
• Darkening of the skin; change in skin color due to bleeding under the skin, typically caused by bruising; swelling of the skin due to the presence of blood; bruising
• Increased uric acid in the blood
• Skin rashes, redness of the skin, cracked skin, scaling or peeling, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, problems with voice quality or changes in voice
• Runny nose
• Production of urine much more or 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 having an erection
• Stroke, fainting, dizziness (inner ear problem that causes a sensation that everything is spinning), temporary loss of consciousness
• Chest pain that radiates to the arms, neck, jaw, back or stomach, feeling of sweating and shortness of breath, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Swollen 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 sensitivity especially to touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which can cause injury

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

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sex drive (libido)
• Abundant urine flow with pain and bone weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itching, skin rash, pain or swelling of the stomach. These may be symptoms of liver damage (liver failure).
• Stomach pain, bloating or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome: metabolic complications that can occur during cancer treatment and sometimes even without treatment. These complications are caused by the breakdown products of cancer cells that are dying, and can include changes in blood parameters with high levels of potassium, phosphorus and uric acid as well as low levels of calcium, which involve changes in kidney function and heartbeat, seizures and sometimes death.
• Increased blood pressure in the vessels that carry blood to the lungs (pulmonary hypertension).

Not known(frequency cannot be estimated based on available data):

• Sudden, or mild but worsening, pain in the upper stomach and/or back, lasting for several days, with possible 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 (pain, weakness or swelling of the muscles), which can cause kidney problems (rhabdomyolysis), some of which when lenalidomide is given with a statin (a type of medicine that lowers cholesterol).
• A disease that affects the skin and is caused by inflammation of small blood vessels, with joint pain and fever (leucocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine, which can cause very serious infections. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool or changes in your bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral illness that causes a painful rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, brown-colored urine, pain in the right side of the stomach, fever and nausea or vomiting).
• Solid organ transplant rejection (such as kidney, heart)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 which is stated on the box and on the blister after
’Exp.’. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice damaged packages or those showing signs of tampering.
Do not dispose of any medicine in 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 ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate
• capsule shell: gelatin, black iron oxide (E172), titanium dioxide (E171)
• legend 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 ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171)
• legend ink: black and green ink (containing shellac, propylene glycolic (E1520) or, 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 ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate
• capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), indigo carmine (E132)
• legend 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 ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate
• capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172) and titanium dioxide (E171)
• legend 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 ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:
• capsule content: 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)
• legend 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 ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate
• capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172) and titanium dioxide (E171)
• legend 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 ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171)
• legend 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 powder ranging in colour from white to
off-white, with “LENALIDOMIDE” printed 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 powder ranging in colour from white to
off-white, with “LENALIDOMIDE” printed 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 powder ranging in colour from white
to off-white, with “LENALIDOMIDE” printed 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 powder ranging in colour from white to
off-white, with “LENALIDOMIDE” printed 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 powder ranging in colour from
white to off-white, with “LENALIDOMIDE” printed 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 powder ranging in colour from white to
off-white, with “LENALIDOMIDE” printed 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 powder ranging in colour from white to
off-white, with “LENALIDOMIDE” printed in black on the cap and “25 mg” in green on the body.
Lenalidomide Accord hard capsules are available in aluminium OPA/aluminium/PVC foil blister packs with perforated unit doses.
Pack sizes of 7 x 1 or 21 x 1 capsules.
Not all pack sizes may be available.

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,
Netherlands
For further information on this medicinal product, 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.
Τel: +30 210 74 88 821

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