Patient Information Leaflet

Lenalidomide Sandoz 2.5 mg hard capsules, 5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 25 mg hard capsules

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

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

Contents of this leaflet:

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

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

What Lenalidomide Sandoz is
Lenalidomide Sandoz contains the active substance lenalidomide. This medicine belongs to a
group of medicines that affect the way the immune system works.
What Lenalidomide Sandoz is used for
Lenalidomide Sandoz is used in adults for:

Multiple myeloma
Myelodysplastic syndromes
Mantle cell lymphoma
Follicular lymphoma

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells called
plasma cells. These cells accumulate in the bone marrow and divide uncontrollably.
This can damage bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms may be greatly
reduced or disappear for a certain period. This outcome is called a “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Lenalidomide Sandoz 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 Sandoz 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 immunosuppressive medicine called “prednisone”.
You will take these other medicines at the beginning of treatment and then continue taking Lenalidomide
Sandoz alone.
If you are aged 75 years or older or have moderate to severe kidney problems, your doctor will
closely monitor you before starting treatment.
Multiple myeloma: in patients who have been previously treated
Lenalidomide Sandoz is taken together with an anti-inflammatory medicine called
“dexamethasone”.
Lenalidomide Sandoz can stop the worsening of signs and symptoms of multiple myeloma. It
has also been shown to delay the return of multiple myeloma after treatment.
Myelodysplastic syndromes (MDS)
MDS are a group of different blood and bone marrow disorders. Blood cells become abnormal and do not function properly. Patients may experience various signs and symptoms, including a low number of red blood cells (anaemia), the need for blood transfusions, and risk of infection.
Lenalidomide Sandoz alone is used to treat adult patients diagnosed with MDS who meet all of the following conditions:

if they require regular blood transfusions to treat low levels of red blood cells (“transfusion-dependent anaemia”)
if they have an abnormality in bone marrow cells called “isolated 5q cytogenetic abnormality”. This means that their body does not produce enough healthy blood cells
if previous treatments used were not suitable or not effective enough.

Lenalidomide Sandoz 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. It may become possible to avoid transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cells called B-lymphocytes, or B-cells. In MCL, B-lymphocytes grow uncontrollably
and accumulate in lymphatic tissue, bone marrow, or blood.
Lenalidomide Sandoz is used alone to treat 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 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 Sandoz is taken together with another medicine called “rituximab” for the treatment of adult patients with previously treated follicular lymphoma.
How Lenalidomide Sandoz works
Lenalidomide Sandoz acts on the body's immune system and directly on the tumour in several ways:
by stopping the development of tumour cells,
by stopping the growth of blood vessels that supply blood to tumour cells,
by stimulating part of the immune system to attack tumour cells.

2. What you should know before taking Lenalidomide Sandoz

Before starting treatment with Lenalidomide Sandoz, you must read the package leaflet of
all the medicines you are required to take in combination with Lenalidomide Sandoz.
Do not take Lenalidomide Sandoz:
if you are pregnant, think you may be pregnant, or are planning a pregnancy, as Lenalidomide Sandoz is expected to be harmful to the unborn baby (see section 2,
"Pregnancy, breastfeeding and contraception – information for women and men").
if there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see section 2, "Pregnancy, breastfeeding and
contraception – information for women and men"). If there is any possibility of becoming pregnant, your doctor will record and confirm at each prescription that the necessary measures to prevent 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 are allergic, consult your doctor.
If any of these conditions apply to you, do not take Lenalidomide Sandoz. If you have any doubts, consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Lenalidomide Sandoz if:
you have previously experienced episodes of blood clots, as the risk of developing blood clots in 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, chickenpox, or HIV. If you are unsure, consult your doctor. Treatment with Lenalidomide Sandoz may cause reactivation of the virus in patients who carry the virus, leading to recurrence of the infection. Your doctor should check whether you have previously had hepatitis B infection
you have kidney problems – your doctor may adjust the dose of Lenalidomide Sandoz
you have had a heart attack, blood clots, 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), or 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, inform your doctor or nurse immediately if:
you experience blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in walking or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious brain condition that can be fatal, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomide, inform your doctor of any changes in these symptoms.
you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and monitoring
Before and during treatment with Lenalidomide Sandoz, you will undergo regular blood tests.
This is because Lenalidomide Sandoz 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
weekly for the first 8 weeks of treatment
then at least once a month thereafter.
You may be evaluated for signs of heart or lung problems before and during treatment with lenalidomide.

For patients with MDS taking Lenalidomide Sandoz
If you have MDS, you have a higher risk of developing a more advanced disease called acute myeloid leukaemia (AML). Furthermore, the role of Lenalidomide Sandoz in the risk of developing AML is not known. Your doctor may request certain tests to monitor signs that could more accurately predict your likelihood of developing AML during treatment with Lenalidomide Sandoz.

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

before treatment
once a week for the first 8 weeks (2 cycles) of treatment
then every 2 weeks during cycles 3 and 4 (for further information, see section 3, "Treatment cycle")
subsequently at the beginning of each cycle and
at least once a month.

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

before treatment
once a week for the first 3 weeks (1 cycle) of treatment
then every 2 weeks during cycles 2 to 4 (for further information, see section 3, "Treatment cycle")
subsequently at the beginning of each cycle and
at least once a month.

Your doctor may 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 check for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Sandoz or stop treatment based on the results of blood tests and your overall condition. If you are newly diagnosed, your doctor may also consider treatment based on your age and any other existing medical conditions.

Blood donation
You must not donate blood during treatment with lenalidomide and for at least 7 days after stopping treatment.

Children and adolescents
Lenalidomide Sandoz is not recommended for use in children and adolescents under 18 years of age.

Elderly and patients with kidney problems
If you are 75 years of age or older, or have moderate or severe kidney problems, your doctor will perform careful monitoring before starting treatment.

Other medicines and Lenalidomide Sandoz
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This is because Lenalidomide Sandoz may affect the action of other medicines, and other medicines may affect the action of Lenalidomide Sandoz.
In particular, inform your doctor or nurse if you are taking any of the following medicines:
some medicines used to prevent pregnancy, such as oral contraceptives, as they may 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 Sandoz
Do not take Lenalidomide Sandoz if you are pregnant, as this medicine is expected to be harmful to the unborn baby.
During treatment with Lenalidomide Sandoz, you must not become pregnant. If there is any possibility of becoming pregnant, you must use effective contraceptive methods (see section "Contraception").
If you become pregnant during treatment with Lenalidomide Sandoz, stop treatment immediately and inform your doctor.

For men taking Lenalidomide Sandoz
If your partner becomes pregnant while you are taking Lenalidomide Sandoz, inform your doctor immediately. It is also recommended that your partner contacts her doctor.
In addition, you must use effective contraceptive methods (see section "Contraception").

Breastfeeding
You must not breastfeed while taking Lenalidomide Sandoz, as it is not known whether Lenalidomide Sandoz passes into breast milk.

Contraception
For women taking Lenalidomide Sandoz
Before starting treatment, ask your doctor whether there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant:
you must undergo pregnancy tests under the supervision of your doctor (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), 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 full guidance on suitable contraceptive methods.

For men taking Lenalidomide Sandoz
Lenalidomide Sandoz 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 contraception, you must use condoms during treatment and for at least 7 days after treatment ends, 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 Sandoz.

Lenalidomide Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".

3. How to take Lenalidomide Sandoz

Lenalidomide Sandoz must be prescribed by healthcare professionals experienced in the treatment of
multiple myeloma, MDS, MCL, or FL.
When Lenalidomide Sandoz 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 Sandoz is').
When Lenalidomide Sandoz is used for the treatment of multiple myeloma in patients
who have undergone bone marrow transplantation or for treating patients with MDS or MCL,
it is taken alone.
When Lenalidomide Sandoz is used to treat follicular lymphoma, it is taken in combination with another medicine called "rituximab".
Always take Lenalidomide Sandoz exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
If you are taking Lenalidomide Sandoz in combination with other medicines, please consult the package leaflet of those medicines for further information on their use and side effects.

Treatment cycle
Lenalidomide Sandoz 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 of the 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 next 21 days.

OR
Lenalidomide Sandoz 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 of the 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 next 28 days.

How much Lenalidomide Sandoz to take
Before starting treatment, your doctor will inform you about:

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

How and when to take Lenalidomide Sandoz

Swallow the capsules whole, preferably with water.
Do not break, open, or chew the capsules. If the powder from a broken Lenalidomide Sandoz capsule comes into contact with your 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.
Capsules may be taken with or without food.
You must take Lenalidomide Sandoz on the scheduled 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 in the center of the capsule, as it may break

Duration of treatment with Lenalidomide Sandoz
Lenalidomide Sandoz 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.

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

If you forget to take Lenalidomide Sandoz
If you forget to take Lenalidomide Sandoz at the usual time:

If less than 12 hours have passed: take your capsule immediately
If 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 Sandoz 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 serious 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 Sandoz can reduce the number of white blood cells that fight infections and of blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising.
Lenalidomide Sandoz may also cause blood clots in 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 Sandoz; therefore, your doctor must carefully evaluate the benefit and risk when prescribing Lenalidomide Sandoz to you.
Side effects very common (may affect more than 1 in 10 people):
Decrease in the number of red blood cells (anaemia), which may cause fatigue and weakness
Skin rash, itching
Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, pain in extremities
Generalised swelling, including swelling of arms and legs
Weakness, fatigue
Fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor
Loss of appetite, altered 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)
Any type of infection, including infections of the sinuses around the nose, lungs and upper respiratory tract
Shortness of breath
Blurred vision
Clouding of the lens of the eye (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 blood protein that may cause swelling of 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
Side effects common (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 levels 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
Production of much more or much less urine 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 disorders, 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 cause injury
Side effects uncommon (may affect up to 1 in 100 people):
Bleeding within the skull
Circulatory problems
Loss of vision
Loss of sexual desire (libido)
Abundant urine flow with pain and bone weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
Yellowish colouring of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itching, rash, stomach pain or swelling. These may be symptoms of liver damage (liver failure).
Stomach pain, swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
Damage to kidney cells (called renal tubular necrosis)
Changes in skin colour, sensitivity to sunlight
Tumour lysis syndrome – metabolic complications that may occur during cancer treatment and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include the following: changes in haematological parameters; high levels of potassium, phosphate and uric acid; and low calcium levels, leading consequently to changes in kidney function, heartbeat, seizures and sometimes death.
Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).
Frequency not known (frequency cannot be estimated from the available data):
Sudden or mild but worsening pain in the upper stomach and/or back, lasting 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 Sandoz 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 (leukocytoclastic vasculitis).
Deterioration of the stomach or intestinal wall, which may lead to serious infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stools or changes in bowel habits.
Viral infections, including herpes zoster (also known as "shingles", a viral disease causing 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 or pharmacist. You can also report side effects directly via the national reporting system at https://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 Sandoz

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 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 any damage or signs of tampering on the packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

Lenalidomide Sandoz 2.5 mg hard capsules:
The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
The other components are:

capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172)
printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Sandoz 5 mg hard capsules:
The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
The other components are:

capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
capsule shell: gelatin and titanium dioxide (E171)
printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Sandoz 10 mg hard capsules:
The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other components are:

capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172)
printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Sandoz 15 mg hard capsules:
The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other components are:

capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
capsule shell: gelatin, titanium dioxide (E171), and indigo carmine (E132)
printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Sandoz 25 mg hard capsules:
The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other components are:

capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
capsule shell: gelatin and titanium dioxide (E171)
printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Description of the appearance of Lenalidomide Sandoz and package contents
Lenalidomide Sandoz 2.5 mg hard capsules are capsules with an opaque white body and an opaque green to light green cap, approximately 14.3 mm in length, printed with “L9NL” and “2.5”.
Lenalidomide Sandoz 5 mg hard capsules are capsules with an opaque white body and an opaque white cap, approximately 18.0 mm in length, printed with “L9NL” and “5”.
Lenalidomide Sandoz 10 mg hard capsules are capsules with an opaque yellow body and an opaque green to light green cap, approximately 21.7 mm in length, printed with “L9NL” and “10”.
Lenalidomide Sandoz 15 mg hard capsules are capsules with an opaque white body and an opaque blue to light blue cap, approximately 21.7 mm in length, printed with “L9NL” and “15”.
Lenalidomide Sandoz 25 mg hard capsules are capsules with an opaque white body and an opaque white cap, approximately 21.7 mm in length, printed with “L9NL” and “25”.
The hard capsules are packaged in OPA/aluminum/PVC/aluminum blisters.
Pack sizes: 7, 14, 21, 28, 42 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Synthon Hispania S.L.
C/Castellò, 1 Poligono Las Salinas
08830 Sant Boi de Llobregat, Barcelona
Spain
Synthon BV
Microweg 22, 6545 CM Nijmegen
The Netherlands
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, 39179 Barleben
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Croatia: Lenalidomid Sandoz 2.5 mg tvrde kapsule
Lenalidomid Sandoz 5 mg tvrde kapsule
Lenalidomid Sandoz 10 mg tvrde kapsule
Lenalidomid Sandoz 15 mg tvrde kapsule
Lenalidomid Sandoz 25 mg tvrde kapsule
Denmark: Lenalidomid Sandoz
Estonia: Lenalidomide Sandoz
Finland: Lenalidomide Sandoz 2.5 mg kapselit, kovat
Lenalidomide Sandoz 5 mg kapselit, kovat
Lenalidomide Sandoz 7.5 mg kapselit, kovat
Lenalidomide Sandoz 10 mg kapselit, kovat
Lenalidomide Sandoz 15 mg kapselit, kovat
Lenalidomide Sandoz 20 mg kapselit, kovat
Lenalidomide Sandoz 25 mg kapselit, kovat
France: LENALIDOMIDE SANDOZ 2.5 mg, gélule
LENALIDOMIDE SANDOZ 5 mg, gélule
LENALIDOMIDE SANDOZ 7.5 mg, gélule
LENALIDOMIDE SANDOZ 10 mg, gélule
LENALIDOMIDE SANDOZ 15 mg, gélule
LENALIDOMIDE SANDOZ 20 mg, gélule
LENALIDOMIDE SANDOZ 25 mg, gélule
Germany: Lenalidomid HEXAL 2.5 mg Hartkapseln
Lenalidomid HEXAL 5 mg Hartkapseln
Lenalidomid HEXAL 7.5 mg Hartkapseln
Lenalidomid HEXAL 10 mg Hartkapseln
Lenalidomid HEXAL 15 mg Hartkapseln
Lenalidomid HEXAL 20 mg Hartkapseln
Lenalidomid HEXAL 25 mg Hartkapseln
Greece: Lenalidomide/Sandoz
Iceland: Lenalidomide Sandoz 2.5 mg hörð hylki
Lenalidomide Sandoz 5 mg hörð hylki
Lenalidomide Sandoz 7.5 mg hörð hylki
Lenalidomide Sandoz 10 mg hörð hylki
Lenalidomide Sandoz 15 mg hörð hylki
Lenalidomide Sandoz 20 mg hörð hylki
Lenalidomide Sandoz 25 mg hörð hylki
Italy: Lenalidomide Sandoz
Latvia: Lenalidomide Sandoz 2.5 mg cietās kapsulas
Lenalidomide Sandoz 5 mg cietās kapsulas
Lenalidomide Sandoz 10 mg cietās kapsulas
Lenalidomide Sandoz 15 mg cietās kapsulas
Lenalidomide Sandoz 25 mg cietās kapsulas
Norway: Lenalidomide Sandoz
The Netherlands: Lenalidomide Sandoz 2.5 mg, harde capsules
Lenalidomide Sandoz 5 mg, harde capsules
Lenalidomide Sandoz 7.5 mg, harde capsules
Lenalidomide Sandoz 10 mg, harde capsules
Lenalidomide Sandoz 15 mg, harde capsules
Lenalidomide Sandoz 20 mg, harde capsules
Lenalidomide Sandoz 25 mg, harde capsules
Poland: Lenalidomide Sandoz
United Kingdom: Lenalidomide Sandoz 2.5 mg hard capsules
Lenalidomide Sandoz 5 mg hard capsules
Lenalidomide Sandoz 7.5 mg hard capsules
Lenalidomide Sandoz 10 mg hard capsules
Lenalidomide Sandoz 15 mg hard capsules
Lenalidomide Sandoz 20 mg hard capsules
Lenalidomide Sandoz 25 mg hard capsules
Slovakia: Lenalidomid Sandoz 2.5 mg
Lenalidomid Sandoz 5 mg
Lenalidomid Sandoz 10 mg
Lenalidomid Sandoz 15 mg
Lenalidomid Sandoz 25 mg
Romania: Lenalidomidă Sandoz 2.5 mg capsule
Lenalidomidă Sandoz 5 mg capsule
Lenalidomidă Sandoz 7.5 mg capsule
Lenalidomidă Sandoz 10 mg capsule
Lenalidomidă Sandoz 15 mg capsule
Lenalidomidă Sandoz 20 mg capsule
Lenalidomidă Sandoz 25 mg capsule
Slovenia: Lenalidomid Sandoz 2.5 mg trde kapsule
Lenalidomid Sandoz 5 mg trde kapsule
Lenalidomid Sandoz 7.5 mg trde kapsule
Lenalidomid Sandoz 10 mg trde kapsule
Lenalidomid Sandoz 15 mg trde kapsule
Lenalidomid Sandoz 20 mg trde kapsule
Lenalidomid Sandoz 25 mg trde kapsule
Spain: Lenalidomida Sandoz 2.5 mg cápsulas duras EFG
Lenalidomida Sandoz 5 mg cápsulas duras EFG
Lenalidomida Sandoz 10 mg cápsulas duras EFG
Lenalidomida Sandoz 15 mg cápsulas duras EFG
Lenalidomida Sandoz 20 mg cápsulas duras EFG
Lenalidomida Sandoz 25 mg cápsulas duras EFG
Sweden: Lenalidomide Sandoz 2.5 mg hårda kapslar
Lenalidomide Sandoz 5 mg hårda kapslar
Lenalidomide Sandoz 7.5 mg hårda kapslar
Lenalidomide Sandoz 10 mg hårda kapslar
Lenalidomide Sandoz 15 mg hårda kapslar
Lenalidomide Sandoz 20 mg hårda kapslar
Lenalidomide Sandoz 25 mg hårda kapslar