Package leaflet: Information for the patient

Lenalidomide Qilu 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

lenalidomide
Equivalent medicine
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 other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Lenalidomide Qilu is
Lenalidomide Qilu contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect the functioning of the immune system.
What Lenalidomide Qilu is used for
Lenalidomide Qilu is used in adults for:

Multiple myeloma
Myelodysplastic syndromes
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 period of time. This outcome is called a “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Lenalidomide Qilu 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 Qilu is taken in combination 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 Qilu alone.

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will carefully monitor you before starting treatment.
Multiple myeloma: in previously treated patients
Lenalidomide Qilu is taken together with an anti-inflammatory medicine called “dexamethasone”.
This medicine 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 Qilu alone is used to treat adult patients diagnosed with MDS who meet all of the following conditions:

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

Lenalidomide Qilu 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.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer affecting B-lymphocytes, a type of white blood cell that helps 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 Qilu is taken together with another medicine called “rituximab” for the treatment of adult patients with previously treated follicular lymphoma.
How Lenalidomide Qilu works
Lenalidomide Qilu 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 Qilu

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

if you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide Qilu 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 you could 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 you could become 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 are allergic, consult your doctor.

If any of these conditions apply to you, do not take Lenalidomide Qilu. If you have any doubts, consult your
doctor.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Lenalidomide Qilu 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 currently 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 Qilu may cause reactivation of the virus in patients who carry the virus. This leads to the recurrence of infection. Your doctor must check whether you have previously had a hepatitis B infection
you have kidney problems – your doctor may adjust the dose of Lenalidomide Qilu
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 used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
you have previously experienced a combination of any 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, inform your doctor or nurse immediately 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, 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 Qilu, 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 Qilu, you will undergo regular blood tests.
This is because Lenalidomide Qilu may cause a reduction in blood cells that protect you
against infections (white blood cells) and those that help blood clot (platelets).
Your doctor will ask you to have a blood test:

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

You may be evaluated for signs of cardiopulmonary problems (conditions affecting the heart and lungs) before and during treatment with lenalidomide.
For patients with MDS taking Lenalidomide Qilu
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 Qilu in the likelihood of developing AML is not known. Your doctor may request certain tests to monitor signs that could more accurately predict your risk of developing AML during treatment with this medicine.
For patients with MCL taking Lenalidomide Qilu
Your doctor will ask you to have a blood test:

before starting treatment
every 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 Qilu
Your doctor will ask you to have a blood test:

before starting treatment
every 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 the body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormally high levels of certain chemicals in the blood, which may result in kidney failure (this condition is called “tumour lysis syndrome”).
Your doctor may monitor for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Qilu or discontinue treatment based on the results of blood tests and your general condition. If you are newly diagnosed, 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 treatment ends.
Children and adolescents
The use of Lenalidomide Qilu is not recommended in children and adolescents under 18 years of age.
Elderly patients and patients with kidney problems
If you are aged 75 years or older, or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.
Other medicines and Lenalidomide Qilu
Inform your doctor or nurse if you are taking or have recently taken any other
medicines. This is because Lenalidomide Qilu may affect the action of other medicines and other
medicines may affect the action of Lenalidomide Qilu.
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 no longer be 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 Qilu

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

For men taking Lenalidomide Qilu

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

you will need to 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 appropriate contraceptive methods.

For men taking Lenalidomide Qilu
Lenalidomide Qilu passes into human seminal fluid. 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 treatment ends, even if you have had a vasectomy. You must not donate seminal fluid or sperm during treatment with lenalidomide and for at least 7 days after treatment ends.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo, or blurred vision
after taking Lenalidomide Qilu.
Lenalidomide Qilu contains lactose and sodium
Lenalidomide Qilu contains lactose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is essentially sodium-free.

3. How to take Lenalidomide Qilu

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

When Lenalidomide Qilu is used to treat 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 Qilu is and what it is used for”).
When Lenalidomide Qilu is used to treat multiple myel游戏副本

4. Possible side effects

Like all medicines, Lenalidomide Qilu can cause side effects, although not everybody gets them.
Stop taking Lenalidomide Qilu and contact 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 serious types of allergic reactions called angioedema and
anaphylactic reaction.
Severe allergic reaction, which may start as a rash in one area but spread with extensive skin loss 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 Qilu can reduce the number of white blood cells that fight infections and also the blood cells that help blood clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising.
Lenalidomide Qilu 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 Qilu. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Lenalidomide Qilu to you.
Very common: may affect more than 1 in 10 people

Decrease in red blood cells (anaemia), which may cause tiredness and weakness
Rash, itching
Muscle cramps, muscle weakness, muscle pain, muscle tenderness, 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 or redness around the tumour
Loss of body weight
Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
Low levels of potassium, calcium and/or sodium in the blood
Underactive thyroid gland
Leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be signs of blood clots in the lungs, called pulmonary embolism)
Any type of infection, including infections of the sinuses around the nose, lungs and upper respiratory tract
Shortness of breath
Blurred vision
Clouding of the vision (cataract)
Kidney problems, including impaired kidney function or inability of the kidneys to maintain normal function
Abnormal liver function test results
Increase in liver function test values
Changes in a protein in the blood that may cause swelling of the arteries (vasculitis)
Increased blood sugar levels (diabetes)
Decreased blood sugar levels
Headache
Nosebleeds
Dry skin
Depression, mood changes, difficulty sleeping
Cough
Low blood pressure
Vague feeling of physical discomfort, malaise
Inflammation of the mouth, dry mouth
Dehydration

Common: may affect up to 1 in 10 people

Breakdown of red blood cells in the blood (haemolytic anaemia)
Certain 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, swelling of the skin due to blood, bruising
Increased uric acid in the blood
Skin rashes, redness of the skin, skin cracking, peeling or flaking, hives
Increased sweating, night sweats
Difficulty swallowing, sore throat, voice quality problems or voice changes
Runny nose
Urinating much more or 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 sign of heart failure)
Difficulty achieving an erection
Stroke, fainting, dizziness (inner ear disorder causing a sensation that everything is spinning), temporary loss of consciousness
Chest pain spreading to arms, neck, jaw, back or stomach, sweating, shortness of breath, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction)
Muscle weakness, lack of energy
Neck pain, chest pain
Chills
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
Deafness, ringing in the ears (tinnitus)
Nerve pain, altered sensation, especially touch
Excess iron in the blood
Thirst
Confusion
Toothache
Fall, which may lead to injury

Uncommon: may affect up to 1 in 100 people

Bleeding inside the skull
Circulatory problems
Loss of vision
Loss of sex drive (libido)
Excessive urination 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, swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
Damage to kidney cells (called renal tubular necrosis)
Changes in skin colour, sensitivity to sunlight
Tumour lysis syndrome: metabolic complications that may occur during anti-cancer treatment and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include changes in blood parameters with high levels of potassium, phosphate and uric acid, and low levels of calcium, leading to changes in kidney function and heart rhythm, seizures and sometimes death.
Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

Not known: frequency cannot be estimated from the available data

Sudden or mild but worsening pain in the upper stomach 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 Qilu 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 wall of the stomach or intestine, which may lead to severe infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stools or changes in bowel habits.
Viral infections, including herpes zoster (also known as “shingles”, a viral disease causing painful blistering rash) 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 feeling nauseous or unwell).
Rejection of solid organ transplant (such as kidney, heart).

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

5. How to store Lenalidomide Qilu

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.
Store below 30°C.
Do not use this medicine if you notice damaged packaging or signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Return unused medicines to the pharmacist. This will help protect the environment.

6. Package contents and other information

What Lenalidomide Qilu contains
Lenalidomide Qilu 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 (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133) and yellow iron oxide (E172)
printing ink: deparaffinised shellac, black iron oxide (E172) and potassium hydroxide.

Lenalidomide Qilu 5 mg hard capsules:

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

Lenalidomide Qilu 7.5 mg hard capsules:

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

Lenalidomide Qilu 10 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other components are:
capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), brilliant blue FCF (E133) and sunset yellow FCF (E110)
printing ink: deparaffinised shellac, black iron oxide (E172) and potassium hydroxide.

Lenalidomide Qilu 15 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other components are:
capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
capsule shell: gelatin, titanium dioxide (E171) and brilliant blue FCF (E133)
printing ink: deparaffinised shellac, black iron oxide (E172) and potassium hydroxide.

Lenalidomide Qilu 20 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
The other components are:
capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133) and yellow iron oxide (E172)
printing ink: deparaffinised shellac, black iron oxide (E172) and potassium hydroxide.

Lenalidomide Qilu 25 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other components are:
capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
capsule shell: gelatin and titanium dioxide (E171)
printing ink: deparaffinised shellac, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Lenalidomide Qilu and contents of the pack
Lenalidomide Qilu 2.5 mg hard capsules have an opaque white body and an opaque light green cap, size 5, 11.1±1.0 mm, printed with “65 2.5 mg” on the body in black ink.
Lenalidomide Qilu 5 mg hard capsules are opaque white, size 4, 14.3±1.0 mm, printed with “67 5 mg” on the body in black ink.
Lenalidomide Qilu 7.5 mg hard capsules have an opaque white body and an opaque light orange cap, size 3, 15.9±1.0 mm, printed with “70 7.5 mg” on the body in black ink.
Lenalidomide Qilu 10 mg hard capsules have an opaque light yellow body and an opaque dark green cap, size 2, 18.0±1.0 mm, printed with “76 10 mg” on the body in black ink.
Lenalidomide Qilu 15 mg hard capsules have an opaque white body and an opaque powder blue cap, size 1, 19.4±1.0 mm, printed with “78 15 mg” on the body in black ink.
Lenalidomide Qilu 20 mg hard capsules have an opaque powder blue body and an opaque light green cap, size 1, 19.4±1.0 mm, printed with “79 20 mg” on the body in black ink.
Lenalidomide Qilu 25 mg hard capsules are opaque white, size 0, 21.7±1.0 mm, printed with “82 25 mg” on the body in black ink.
The capsules are supplied in cardboard boxes, each containing one or three perforated blisters. Each blister contains seven capsules, for a total of 7x1 or 21x1 capsules per box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40,
8th Floor, 28046 - Madrid,
Spain

Manufacturer
KYMOS S.L.
Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallès),
Cerdanyola del Vallès,
08290 Barcelona,
Spain
or
Eurofins Analytical Services Hungary Kft.
Anonymus utca 6.
Budapest, H-1045,
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Lenalidomid Qilu 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hartkapseln
Spain: Lenalidomida Qilu 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg cápsulas duras EFG
Italy: Lenalidomide Qilu