Lenalidomide Sun

Package leaflet: Information for the user

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, 25 mg hard capsules

Generic Medicine
lenalidomide
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including 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 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

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

What Lenalidomide SUN is

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

What Lenalidomide SUN is 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 accumulate in the bone marrow and divide uncontrollably. This can damage the bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be significantly reduced or disappear for a certain period of time. This outcome is called a “response”.

Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplant
Lenalidomide SUN 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 transplant
Lenalidomide SUN is taken together with other medicines, which may include:

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

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

Follicular lymphoma (FL)
FL is a slow-growing form of cancer affecting 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 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 acts on the body’s immune system and directly on the tumour in several ways:

• by stopping the growth 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 should know before taking Lenalidomide SUN

Before starting treatment with Lenalidomide SUN, you must read the package leaflet
of all the medicines you are required to take 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 be harmful to the unborn child (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 record and confirm at each prescription that the 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 SUN. If you have any doubts, consult your doctor.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Lenalidomide SUN if:

• you have previously experienced episodes of blood clots, as the risk of developing 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 previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, HIV. If you have any doubts, consult your doctor. Treatment with Lenalidomide SUN may cause reactivation of the virus in patients who carry the virus. This leads to recurrence of the infection. Your doctor must check whether you have previously had hepatitis B infection
• 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 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
• 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), 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, 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 or double vision, difficulty speaking, weakness in one arm or leg, changes in the way you walk or problems with balance, persistent numbness, reduced 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, inform 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 monitoring
Before and during treatment with Lenalidomide SUN, you will undergo regular blood tests. This is because Lenalidomide SUN may cause a reduction in blood cells that protect you from infections (white blood cells) and those that help blood clot (platelets). Your doctor will ask you to have blood tests:

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

For patients with FL taking Lenalidomide SUN
Your doctor will ask you to have a blood test:

• before starting treatment -
• once a week for the first 3 weeks (1 cycle) of treatment -
• then every 2 weeks for 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 check whether you have a high tumour burden throughout your body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, potentially leading to 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 SUN or stop treatment depending on the results of blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also consider treatment based on your age and any other pre-existing conditions.
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 SUN 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 checks before starting treatment.
Other medicines and Lenalidomide SUN
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This is because Lenalidomide SUN may affect the action of other medicines and other medicines may affect the action of Lenalidomide SUN.
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 SUN

• You must not take Lenalidomide SUN if you are pregnant, as this medicine is expected to be harmful to the unborn child. -
• During treatment with Lenalidomide SUN, 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 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, 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 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 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 will need to 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 stopping treatment) – except in cases where 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 all necessary information on appropriate contraceptive methods. -

For men taking Lenalidomide SUN
Lenalidomide SUN is present in human semen. If there is any possibility that your partner is pregnant or could become pregnant and she is not using effective contraceptive methods, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy.
Driving and using machines
Do not drive or operate machinery 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 certain sugars, contact him or her before taking this medicine.

3. How to take Lenalidomide SUN

Lenalidomide SUN should be prescribed and 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 undergo bone marrow transplantation or who have previously received other treatments, it is taken in combination with other medicines (see section 1 “What Lenalidomide SUN is 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 together with another medicine called "rituximab".

Always take Lenalidomide SUN exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
If you are taking Lenalidomide SUN in combination with other medicines, refer to the package leaflet of those medicines for further information on their use and possible effects.

Treatment cycle
Lenalidomide SUN is taken on certain days within a 3-week period (21 days).

• 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.
• After completing each 21-day cycle, you must start a new "cycle" within the following 21 days.
• OR Lenalidomide SUN is taken on certain days within a 4-week period (28 days).
• 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.
• After completing each 28-day cycle, you must start a new "cycle" within the following 28 days.

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

• the dose of Lenalidomide SUN to take
• the dose of any 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

• swallow the capsules whole, preferably with water
• do not crush, 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 soap and water
• healthcare providers, 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 those who suspect they may be pregnant, must not handle the blister pack or capsule
• the capsules may be taken with or without food
• take Lenalidomide SUN on the prescribed days at approximately the same time each day

Taking 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 on the center of the capsule, as this may cause it to break

Duration of treatment with Lenalidomide SUN
Lenalidomide SUN 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 SUN than you should
If you have taken more Lenalidomide SUN than prescribed, inform your doctor immediately.

If you forget to take Lenalidomide SUN
If you forget to take your dose of Lenalidomide SUN at the usual time 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 SUN and contact your doctor immediately if you experience
any of the following serious side effects – you may need urgent medical treatment:

• 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 spreads 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 SUN may reduce the number of white blood cells that fight infections and also the blood cells that help blood to clot (platelets), which may cause bleeding disorders such as nosebleeds and bruising. Lenalidomide SUN 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 treatment with Lenalidomide SUN.
Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Lenalidomide SUN to you.
Very common side effects (may affect more than 1 in 10 people):

• Decrease in the number of red blood cells (anaemia), which may cause tiredness and weakness -
• Rash, itching -
• Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, limb pain -
• 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 taste -
• Increase in pain, size of tumour or redness around tumour -
• Loss of body weight -
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn -
• Low levels of potassium or 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) -
• Infections of any type, including infections of the sinuses around the nose, lungs and upper respiratory tract -
• Shortness of breath -
• Blurred vision -
• Clouding of 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 side effects (may affect up to 1 in 10 people):

• Destruction of red blood cells in the blood (haemolytic anaemia) -
• Some types of skin cancer -
• 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 -
• Urine production much greater or less than usual, or inability to control the urge to urinate -
• Presence of 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 sensation of spinning), temporary loss of consciousness -
• Chest pain radiating to arms, neck, jaw, back or stomach, sweating and breathlessness, feeling of discomfort 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 problems, difficulty moving -
• Hearing loss, ringing in the ears (tinnitus) -
• Nerve pain, altered sensation, especially of touch -
• Excess iron in the blood -
• Thirst -
• Confusion -
• Toothache -
• Falls, which may lead to injury -

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

• Bleeding inside the skull -
• Circulatory problems -
• Loss of vision -
• Loss of sexual desire (libido) -
• Excessive urine flow with pain and bone weakness, which may be symptoms of a kidney disorder (Fanconi syndrome) -
• Yellowish discoloration of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, skin itching, rash, stomach pain or swelling. These may be symptoms of liver damage (liver failure). -
• Stomach pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis) -
• Damage to kidney cells (called renal tubular necrosis) -
• Skin colour changes, sensitivity to sunlight -
• Tumour lysis syndrome: metabolic complications that may occur during anti-tumour 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). -

Side effects with unknown frequency (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 SUN was administered with a statin (a type of cholesterol-lowering medicine). -
• 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 illness causing a painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever and nausea or vomiting). -
• Rejection of solid organ transplant (such as kidney, heart) -

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 stated on the blister and the carton 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. Return unused medicines to your pharmacist. This will help protect the environment.

6. Package contents and other information

What Lenalidomide SUN contains

Lenalidomide SUN 2.5, 10, 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5, 10, or 20 mg of lenalidomide.
• Other components are:
  • Capsule contents: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172)
  • Printing ink: shellac, black iron oxide (E172), and potassium hydroxide

Lenalidomide SUN 5 and 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 or 25 mg of lenalidomide.
• Other components are:
  • Capsule contents: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • Capsule shell: titanium dioxide (E171) and gelatin
  • Printing ink: shellac, black iron oxide (E172), and potassium hydroxide

Lenalidomide SUN 7.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• Other components are:
  • Capsule contents: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • Capsule shell: titanium dioxide (E171), gelatin, and yellow iron oxide (E172)
  • Printing ink: shellac, black iron oxide (E172), and potassium hydroxide

Lenalidomide SUN 15 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other components are:
  • Capsule contents: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
  • Capsule shell: titanium dioxide (E171), indigo carmine (E132), and gelatin
  • Printing ink: shellac, black iron oxide (E172), and potassium hydroxide

Description of the appearance of Lenalidomide SUN and package contents

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, marked with "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, marked with "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, marked with "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 an opaque blue-green cap and an opaque light yellow body, marked with "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, marked with "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, marked with "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, marked with "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 cardboard boxes 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 also packaged in cardboard boxes 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 Authorization Holder
Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87, 2132 JH
Hoofddorp,
The Netherlands

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

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Terapia S.A.,
Str. Fabricii nr. 124, 400632 Cluj-Napoca, Romania

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Germany:
LENALIDOMID BASICS 2.5 mg Hard Capsules
LENALIDOMID BASICS 5 mg Hard Capsules
LENALIDOMID BASICS 7.5 mg Hard Capsules
LENALIDOMID BASICS 10 mg Hard Capsules
LENALIDOMID BASICS 15 mg Hard Capsules
LENALIDOMID BASICS 20 mg Hard Capsules
LENALIDOMID BASICS 25 mg Hard Capsules

Denmark:
Lenalidomid SUN 2.5 mg hard capsules
Lenalidomid SUN 5 mg hard capsules
Lenalidomid SUN 7.5 mg hard capsules
Lenalidomid SUN 10 mg hard capsules
Lenalidomid SUN 15 mg hard capsules
Lenalidomid SUN 20 mg hard capsules
Lenalidomid SUN 25 mg hard capsules

France:
Lenalidomide SUN 2.5 mg capsule
Lenalidomide SUN 5 mg capsule
Lenalidomide SUN 7.5 mg capsule
Lenalidomide SUN 10 mg capsule
Lenalidomide SUN 15 mg capsule
Lenalidomide SUN 20 mg capsule
Lenalidomide SUN 25 mg capsule

Italy:
Lenalidomide SUN

Norway:
Lenalidomid SUN 2.5 mg hard capsules
Lenalidomid SUN 5 mg hard capsules
Lenalidomid SUN 7.5 mg hard capsules
Lenalidomid SUN 10 mg hard capsules
Lenalidomid SUN 15 mg hard capsules
Lenalidomid SUN 20 mg hard capsules
Lenalidomid SUN 25 mg hard capsules

Romania:
Lenalidomidă Terapia 5 mg capsules
Lenalidomidă Terapia 7.5 mg capsules
Lenalidomidă Terapia 10 mg capsules
Lenalidomidă Terapia 15 mg capsules
Lenalidomidă Terapia 20 mg capsules

Sweden:
Lenalidomid SUN 2.5 mg hard capsules
Lenalidomid SUN 5 mg hard capsules
Lenalidomid SUN 7.5 mg hard capsules
Lenalidomid SUN 10 mg hard capsules
Lenalidomid SUN 15 mg hard capsules
Lenalidomid SUN 20 mg hard capsules
Lenalidomid SUN 25 mg hard capsules

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