LENALIDOMIDE 2.5 mg Hard capsules

Зміст інструкції

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

Lenalidomide SUN 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

Lenalidomide SUN 25 mg hard capsules
Equivalent Medicinal Product
lenalidomide

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor 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 SUN is and what it is used for
• 2. What you need to know before you take Lenalidomide SUN
• 3. How to take Lenalidomide SUN
• 4. Possible side effects
• 5. How to store Lenalidomide SUN
• 6. Contents of the pack and other information

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

What is Lenalidomide SUN

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

What is Lenalidomide SUN used for
Lenalidomide SUN is used in adults for:

• 1. Multiple myeloma
• 2. 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 transplant
Lenalidomide SUN is used alone as maintenance therapy in patients who
have recovered adequately after bone marrow transplant.
Newly diagnosed multiple myeloma: in patients who cannot undergo
bone marrow transplant
Lenalidomide SUN is taken with other medicines, which may include:

• a chemotherapy medicine called “bortezomib”. -
• an anti-inflammatory medicine called “dexamethasone”. -
• a chemotherapy medicine called “melphalan” and -
• an immunosuppressant medicine called “prednisone”. - You will take these other medicines at the beginning of treatment and then continue to take Lenalidomide SUN alone. If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Multiple myeloma: in patients already treated
Lenalidomide SUN is taken together with an anti-inflammatory medicine called
“dexamethasone”.
Lenalidomide SUN 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.

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 the presence of FL, an excessive number
of these B lymphocytes can accumulate in the blood, bone marrow, lymph nodes and spleen.
Lenalidomide SUN is taken together with another medicine called “rituximab” for
the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide SUN works
Lenalidomide SUN works 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 cancer cells -
• stimulating part of the immune system to attack cancer cells. -

2. What you need to know before taking Lenalidomide SUN

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

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide SUN 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 measures

necessary to avoid pregnancy (see section 2 ‘Pregnancy, breastfeeding and
contraception – information for women and men’). If there is a possibility that you may become
pregnant, at each prescription the doctor will note and confirm to you
that the necessary measures to avoid pregnancy have been taken. 

• If you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor. -

If any of these conditions apply to you, do not take Lenalidomide SUN. If you have doubts, consult
your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lenalidomide SUN if:

• you have had episodes of blood clot formation in the past, as the risk of blood clots in the veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have had a viral infection in the past, in particular: hepatitis B infection, shingles, HIV. If you have doubts, consult your doctor. Treatment with Lenalidomide SUN may cause reactivation of the virus in patients carrying the virus. This causes the infection to reappear. The doctor must check if you have had a hepatitis B infection in the past
• you have kidney problems, your doctor may adjust the dose of Lenalidomide SUN
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• 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
• 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 condition that can be fatal, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with Lenalidomide SUN, tell your doctor of any changes in these symptoms. -
• you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling in your 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 SUN you will undergo regular blood tests. This is because Lenalidomide SUN can cause a decrease in 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. -

For patients with FL who are taking Lenalidomide SUN
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 load throughout the body, including in the
bone marrow. This could 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 SUN or stop the
treatment depending on the results of the blood tests and your general condition. If you
are a newly diagnosed patient, the doctor may also assess the 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 SUN 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 SUN
Tell your doctor or nurse if you are taking, have recently taken or may
take any other medicines. This is because Lenalidomide SUN can affect the action
of other medicines and other medicines can affect the action of Lenalidomide SUN.
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 SUN

• You must not take Lenalidomide SUN if you are pregnant, as this medicine is expected to harm the fetus. -
• During treatment with Lenalidomide SUN, 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 SUN, you must stop treatment immediately
  and inform your doctor. -

For men taking Lenalidomide SUN

• If your partner becomes pregnant while you are taking Lenalidomide SUN, 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 SUN, as it is not known whether this
medicine passes into breast milk.

Contraception
For women taking Lenalidomide SUN
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 your 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 SUN
Lenalidomide SUN 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 the end of
treatment, even if you have undergone a vasectomy.

Driving and using machines
Do not drive or use machines if you experience dizziness, fatigue, drowsiness, vertigo or blurred vision
after taking Lenalidomide SUN.

Lenalidomide SUN contains lactose
Lenalidomide SUN contains lactose. If your doctor has diagnosed you with an intolerance to
some sugars, contact him before taking this medicine.

3. How to take Lenalidomide SUN

Lenalidomide SUN must be administered by healthcare professionals experienced in the treatment of
multiple myeloma or FL.

• When Lenalidomide SUN is used for the treatment of multiple myeloma in patients who cannot be subjected to bone marrow transplantation or who have taken other

treatments previously, it is taken with other medicines (see paragraph 1 “What is
Lenalidomide SUN and what it is used for”). 

• When Lenalidomide SUN is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, it is taken alone. -
• When Lenalidomide SUN is used to treat follicular lymphoma, it is taken with another medicine called “rituximab”. -

Take Lenalidomide SUN following the doctor's instructions exactly. If you have any doubts
consult your doctor or pharmacist.
If you are taking Lenalidomide SUN in combination with other medicines, consult the leaflet of those
medicines for further information on their use and their effects.

Treatment cycle
Lenalidomide SUN 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 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” within the next 21 days. -
• OR Lenalidomide SUN 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 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” within the next 28 days. -
• Dose of Lenalidomide SUN to be takenBefore starting treatment, your doctor will tell you:
• the dose of Lenalidomide SUN to be taken -
• the dose of other medicines to be taken in combination with Lenalidomide SUN, if prescribed -
• on which days of the treatment cycle to take each medicine. -

How and when to take Lenalidomide SUN

• the capsules should be swallowed whole, preferably with water. -
• do not break, open or chew the capsules. If the powder from a broken Lenalidomide SUN capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap. -
• healthcare professionals, those providing assistance to the patient and family members must wear disposable gloves when handling the blister or the capsule. The gloves should then be removed carefully 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. Women who are pregnant or suspected of being pregnant should not handle the blister or the capsule. -
• the capsules can be taken with or without food. -
• you must take Lenalidomide SUN on the established days at more or less the same time. -

Taking this medicine
To remove the capsule from the blister:

• press on only one side of the capsule, 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 SUN
Lenalidomide SUN is taken in treatment cycles, each lasting 21 or 28
days (see above “Treatment cycle”). You must continue the treatment cycles until
your doctor tells you to stop the treatment.

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

If you forget to take Lenalidomide SUN
If you forget to take Lenalidomide SUN 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 everyone will experience them.

Stop taking Lenalidomide SUN 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 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 all over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis). -
• Extensive 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. -

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

• Fever, chills, sore throat, cough, ulcers in the mouth or any other symptom of infection, even 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 a high level of calcium in the blood. -

Lenalidomide SUN can reduce the number of white blood cells that fight infections and also of blood cells that promote blood clotting (platelets), which may cause bleeding disorders such as nosebleeds and bruising. Lenalidomide SUN 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 SUN. Therefore, the doctor must carefully assess the benefit and risk when prescribing Lenalidomide SUN.
Effects very common(may affect more than 1 in 10 people):

• Decrease in the number of red blood cells (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, pain in the extremities -
• 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 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 -
• Insufficient thyroid function -
• 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 surrounding 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) -
• Increases in blood sugar levels (diabetes) -
• Decreases in blood sugar levels -
• Headache -
• Nosebleeds -
• Dry skin -
• Depression, mood changes, difficulty sleeping -
• Cough -
• Decreased blood pressure -
• Vague feeling of discomfort, unwellness -
• Inflammation of the oral cavity, dry mouth -
• Dehydration -

Common side effects (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 -
• Increase in 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, cracking of the 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 of everything spinning around, 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 -
• Swelling of the 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 side effects (may affect up to 1 in 100 people):

• Bleeding inside the skull -
• Circulatory problems -
• Loss of vision -
• Loss of sexual 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 the cells of the kidneys (called tubular necrosis) -
• Changes in skin color, sensitivity to sunlight -
• Tumor lysis syndrome: metabolic complications that can occur during cancer treatment and sometimes even in the absence of treatment. These complications are caused by the breakdown products of tumor cells that are dying, and can include changes in hematological parameters with high levels of potassium, phosphorus and uric acid, as well as low levels of calcium, which lead to changes in kidney function and heartbeat, seizures and sometimes death. -
• Increased blood pressure in the vessels that carry blood to the lungs (pulmonary hypertension). -

Side effects with unknown frequency(frequency cannot be estimated on the basis of available data):

• Sudden, or mild but worsening, pain in the upper abdomen 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 SUN is administered with a statin (a type of drug 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 bowel habits. -
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease that causes painful blisters rash) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, pain in the upper right side of the stomach, fever and nausea or vomiting). -
• Rejection of solid organ transplant (such as kidney, heart) -

Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide SUN

• 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 blister and the packaging box 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 packaging or signs of tampering. -
• Do not dispose of any medicine in wastewater or household waste. Return any unused medicine to the pharmacist. This will help protect the environment. -

6. Contents of the pack and other information

information
What Lenalidomide SUN contains
Lenalidomide SUN 2.5, 10, 20 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 2.5, 10, 20 mg of lenalidomide. -
• The other ingredients are: -
• capsule content: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide (E172)
• ink for lettering: shellac, black iron oxide (E172) and potassium hydroxide

Lenalidomide SUN 5 and 25 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 5, 25 mg of lenalidomide. -
• The other ingredients are: -
• capsule content: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: titanium dioxide (E171) and gelatin
• ink for lettering: shellac, black iron oxide (E172) and potassium hydroxide

Lenalidomide SUN 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 monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: titanium dioxide (E171), gelatin and yellow iron oxide (E172)
• ink for lettering: shellac, black iron oxide (E172) and potassium hydroxide

Lenalidomide SUN 15 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide. -
• The other ingredients are: -
• capsule content: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: titanium dioxide (E171), indigo carmine (E132) and gelatin
• ink for lettering: shellac, black iron oxide (E172) and potassium hydroxide

Description of the appearance of Lenalidomide SUN and contents of the pack
Lenalidomide SUN 2.5 mg hard capsules are hard gelatin capsules approximately 14 mm in length
with an opaque blue-green cap and an opaque white body, with the inscription "RL" on the cap and "78" on the
body, containing white to off-white granular powder.
Lenalidomide SUN 5 mg hard capsules are hard gelatin capsules approximately 18 mm in length with
an opaque white cap and an opaque white body, with the inscription "RL" on the cap and "79" on the body,
containing white to off-white granular powder.
Lenalidomide SUN 7.5 mg hard capsules are hard gelatin capsules approximately 18 mm in length
with an opaque light yellow cap and an opaque white body, with the inscription "RL" on the cap and "86" on the
body, containing white to off-white granular powder.
Lenalidomide SUN 10 mg hard capsules are hard gelatin capsules approximately 21 mm in length with a
cap of opaque blue-green color and an opaque light yellow body, with the inscription "RL" on the cap and "80" on the body,
containing white to off-white granular powder.
Lenalidomide SUN 15 mg hard capsules are hard gelatin capsules approximately 21 mm in length
with an opaque blue cap and an opaque white body, with the inscription "RL" on the cap and "81" on the body,
containing white to off-white granular powder.
Lenalidomide SUN 20 mg hard capsules are hard gelatin capsules approximately 21 mm in length
with an opaque blue-green cap and an opaque blue body, with the inscription "RL" on the cap and "82" on the body,
containing white to off-white granular powder.
Lenalidomide SUN 25 mg hard capsules are hard gelatin capsules approximately 21 mm in length
with an opaque white cap and an opaque white body, with the inscription "RL" on the cap and "83" on the
body, containing white to off-white granular powder.
Lenalidomide SUN 2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 15 mg/ 20 mg/ 25 mg hard capsules are packaged
in cartons containing 7, 14, 21, 28 or 42 capsules.
Lenalidomide SUN 2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 15 mg/ 20 mg/ 25 mg hard capsules are packaged
in cartons containing 7 x 1, 14 x 1, 21 x 1, 28 x 1 or 42 x 1 capsules
Not all pack sizes may be available.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87, 2132 JH
Hoofddorp,
Netherlands

Legal Representative
Sun Pharma Italia Srl - Viale Giulio Richard, 1 - 20143 Milan

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.,
Str. Fabricii nr. 124 400632 Cluj-Napoca Romania

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the
following denominations:
Germany: LENALIDOMID BASICS 2,5 mg Hartkapseln
LENALIDOMID BASICS 5 mg Hartkapseln
LENALIDOMID BASICS 7,5 mg Hartkapseln
LENALIDOMID BASICS 10 mg Hartkapseln
LENALIDOMID BASICS 15 mg Hartkapseln
LENALIDOMID BASICS 20 mg Hartkapseln
LENALIDOMID BASICS 25 mg Hartkapseln
Denmark: Lenalidomid SUN 2,5 mg hårde kapsler
Lenalidomid SUN 5 mg hårde kapsler
Lenalidomid SUN 7,5 mg hårde kapsler
Lenalidomid SUN 10 mg hårde kapsler
Lenalidomid SUN 15 mg hårde kapsler
Lenalidomid SUN 20 mg hårde kapsler
Lenalidomid SUN 25 mg hårde kapsler
France: Lenalidomide SUN 2,5 mg gélule
Lenalidomide SUN 5 mg gélule
Lenalidomide SUN 7,5 mg gélule
Lenalidomide SUN 10 mg gélule
Lenalidomide SUN 15 mg gélule
Lenalidomide SUN 20 mg gélule
Lenalidomide SUN 25 mg gélule
Italy: Lenalidomide SUN
Norway: Lenalidomid SUN 2,5 mg harde kapsler
Lenalidomid SUN 5 mg harde kapsler
Lenalidomid SUN 7,5 mg harde kapsler
Lenalidomid SUN 10 mg harde kapsler
Lenalidomid SUN 15 mg harde kapsler
Lenalidomid SUN 20 mg harde kapsler
Lenalidomid SUN 25 mg harde kapsler
Romania: Lenalidomidă Terapia 5 mg capsule
Lenalidomidă Terapia 10 mg capsule
Lenalidomidă Terapia 15 mg capsule
Lenalidomidă Terapia 20 mg capsule
Sweden: Lenalidomid SUN 2,5 mg hårda kapslar
Lenalidomid SUN 5 mg hårda kapslar
Lenalidomid SUN 7,5 mg hårda kapslar
Lenalidomid SUN 10 mg hårda kapslar
Lenalidomid SUN 15 mg hårda kapslar
Lenalidomid SUN 20 mg hårda kapslar
Lenalidomid SUN 25 mg hårda kapslar
Spain: Lenalidomida SUN 2.5 mg cápsulas duras EFG
Lenalidomida SUN 5 mg cápsulas duras EFG
Lenalidomida SUN 7.5 mg cápsulas duras EFG
Lenalidomida SUN 10 mg cápsulas duras EFG
Lenalidomida SUN 15 mg cápsulas duras EFG
Lenalidomida SUN 20 mg cápsulas duras EFG
Lenalidomida SUN 25 mg cápsulas duras EFG
Poland: Lenalidomide Ranbaxy
United Kingdom: Lenalidomide Ranbaxy 2.5 mg hard capsules
Lenalidomide Ranbaxy 5 mg hard capsules
Lenalidomide Ranbaxy 7.5 mg hard capsules
Lenalidomide Ranbaxy 10 mg hard capsules
Lenalidomide Ranbaxy 15 mg hard capsules
Lenalidomide Ranbaxy 20 mg hard capsules
Lenalidomide Ranbaxy 25 mg hard capsules