LENALIDOMIDE 2.5 mg Hard capsules

Содержание инструкции

1. 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
   1. What is Lenalidomide Qilu and what is it used for
   2. What you need to know before taking Lenalidomide Qilu
   3. How to take Lenalidomide Qilu
   4. Possible side effects
   5. How to store Lenalidomide Qilu
   6. Package contents and other information

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
Generic medicine

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

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

Contents of this leaflet

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

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

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

What is Lenalidomide Qilu 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 collect in the bone marrow and divide, in an uncontrolled way. This
can damage the bones and kidneys.
Multiple myeloma is usually incurable. However, the signs and symptoms can be significantly
reduced or disappear for a certain period. This result is called “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Lenalidomide Qilu is used alone as maintenance therapy in patients who have
recovered adequately after bone marrow transplantation.
Newly diagnosed multiple myeloma: in patients who cannot undergo bone marrow
transplantation
Lenalidomide Qilu is taken with other medicines, which may include:

• a chemotherapy medicine called “bortezomib”
• an anti-inflammatory medicine called “dexamethasone”
• a chemotherapy medicine called “melphalan” and
• an immunosuppressant medicine called “prednisone”. You will take these other medicines at the beginning of treatment and then continue to take Lenalidomide Qilu alone.

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

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

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

Lenalidomide 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. You may not need any transfusions.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer that affects B lymphocytes, a type of white blood cells that
help the body fight infections. In the presence of FL, an excessive number
of these B lymphocytes can accumulate in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide 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 works on the body's immune system and directly on the tumor, in several
ways:

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

2. What you need to know before taking Lenalidomide Qilu

medicines you must take in association with Lenalidomide Qilu.
Do not take Lenalidomide Qilu:

• if you are pregnant, think you may be pregnant, or if you are planning a pregnancy, because Lenalidomide Qilu is expected to harm the fetus(see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men’).
• if there is a possibility that you may become pregnant unless you follow all the necessary measures to avoid pregnancy (see section 2 ‘Pregnancy, breastfeeding and contraception - information for women and men’). If there is a possibility that you may become pregnant, on each prescription the doctor will take note and confirm to you that the necessary measures to avoid pregnancy have been adopted.
• if you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

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

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Lenalidomide Qilu if:

• you have had episodes of blood clot formation in the past, as the risk of blood clots in the veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have had a viral infection in the past, in particular: hepatitis B infection, shingles, HIV. If you have doubts, consult your doctor. Treatment with Lenalidomide Qilu may cause reactivation of the virus in patients carrying the virus. This causes the infection to reappear. The doctor must check if you have had a hepatitis B infection in the past
• you have kidney problems - your doctor may adjust the dose of Lenalidomide 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 for the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• you have previously had 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, tell your doctor, pharmacist or nurse before starting
treatment.
At any time during or after treatment, immediately inform your doctor or nurse
if:

• you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, changes in the way you walk or problems with balance, persistent numbness, decreased sensitivity 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, tell 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 checks
Before and during treatment with Lenalidomide Qilu you will undergo regular blood tests.
This is because Lenalidomide Qilu can cause a reduction in the blood cells that defend
you from infections (white blood cells) and those that promote blood clotting (platelets).
The doctor will ask you to undergo a blood test:

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

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

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

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

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

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

Blood donation
You must not donate blood during therapy with lenalidomide and for at least 7 days after the end of
treatment.

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

Elderly and people with kidney problems
If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will
subject you to careful checks before starting treatment.

Other medicines and Lenalidomide Qilu
Tell your doctor or nurse if you are taking or have recently taken any other
medicines. This is because Lenalidomide Qilu can affect the action of other medicines and other
medicines can affect the action of Lenalidomide Qilu.
In particular, tell your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, because they may no longer be effective
• some medicines used for heart problems, such as digoxin
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception information for women and men
Pregnancy
For women taking Lenalidomide Qilu

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

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 if there is any possibility for you to become
pregnant, even if you think it is unlikely.
If there is a 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 the end of treatment) except in cases where it has been confirmed that your fallopian tubes have been cut and closed to prevent eggs from reaching the uterus (sterilization by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after stopping treatment. Your doctor will provide you with all the information on appropriate contraceptive methods.

For men taking Lenalidomide Qilu
Lenalidomide Qilu passes into human seminal fluid. If there is a possibility that your partner is
pregnant or becomes pregnant and she is not using effective contraceptive methods, you must
use condoms during treatment and for at least 7 days after the end of treatment, even if
you have undergone a vasectomy. You must not donate seminal fluid or sperm during
therapy with lenalidomide and for at least 7 days after the end of treatment.

Driving and using machines
Do not drive or use machines 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 intolerance to some
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 administered by healthcare professionals experienced in the treatment of multiple myeloma, MDS, or FL.

• When Lenalidomide Qilu is used for the treatment of multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received other treatments previously, it is taken with other medicines (see section 1 “What Lenalidomide Qilu is and what it is used for”).
• When Lenalidomide Qilu is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation or to treat patients with MDS, it is taken alone.
• When Lenalidomide Qilu is used to treat follicular lymphoma, it is taken with another medicine called “rituximab”.

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

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

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

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

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

How and when to take Lenalidomide Qilu

• The capsules should be swallowed whole, preferably with water.
• Do not break, open or chew the capsules. If the powder from a broken capsule of

Lenalidomide Qilu comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.

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

Taking this medicine
To remove the capsule from the blister:

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

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

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

If you forget to take Lenalidomide Qilu
If you forget to take Lenalidomide Qilu at the usual time and:

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

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

4. Possible side effects

Like all medicines, Lenalidomide Qilu can cause side effects, although not everyone gets them.

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

• Hives, skin rashes, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe types of allergic reactions called angioedema and

anaphylactic reaction.

• Severe allergic reaction, which may start as a rash in one area but spread with extensive skin loss all over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Seek immediate medical attention if you experience any of the following serious side effects:

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

Lenalidomide Qilu can reduce the number of white blood cells that fight infections and also the blood cells that help blood clotting (platelets), which can cause bleeding disorders such as nosebleeds and bruising.
Lenalidomide Qilu can also cause blood clots in the veins (thrombosis).

Other side effects
It is important to note that a small number of patients may develop other types of cancer, and this risk may increase with treatment with Lenalidomide Qilu. Therefore, the doctor must carefully assess the benefit and risk when prescribing Lenalidomide Qilu.

Very common: may affect more than 1 in 10 people

• Decreased number of red blood cells (anemia), which can cause fatigue and weakness
• Skin rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle soreness, bone pain, joint pain, back pain, limb pain
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills
• Numbness, tingling, or burning sensation on the skin, pain in the hands or feet, dizziness, tremor
• Decreased appetite, altered sense of taste
• Increased pain, size of the tumor, or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood
• Low thyroid function
• Leg pain (which may be a symptom of thrombosis), chest pain, or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism)
• Infections of any kind, including infections of the sinuses around the nose, lungs, and upper respiratory tract
• Shortness of breath
• Blurred vision
• Clouding of the lens of the eye (cataract)
• Kidney problems, including improper kidney function or the inability of the kidneys to maintain normal function
• Abnormal liver function test values
• Increased values in liver function tests
• Changes in a blood protein that can cause inflammation of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of discomfort, unwell
• Inflammation of the mouth, dry mouth
• Dehydration

Common: may affect up to 1 in 10 people

• Destruction of red blood cells in the blood (hemolytic anemia)
• Some types of skin cancer
• Bleeding from the gums, stomach, or intestines
• Increased blood pressure, slow, fast, or irregular heartbeat
• Increased amount of a substance derived from the normal and abnormal breakdown of red blood cells
• Increased amount of a type of protein that indicates inflammation in the body
• Darkening of the skin, changes in skin color due to bleeding under the skin, typically caused by bruising, swelling of the skin due to the presence of blood, bruising
• Increased uric acid in the blood
• Skin rashes, redness of the skin, cracking of the skin, scaling or peeling, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, problems with voice quality, or changes in voice
• Runny nose
• Production of urine much more or less than usual, or inability to control the urge to urinate
• Blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty getting an erection
• Stroke, fainting, dizziness (inner ear problem that causes a spinning sensation, temporary loss of consciousness
• Chest pain that radiates to the 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
• Swollen joints
• Slowing or blockage of bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disorders, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, altered sensitivity, especially to touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which can cause injury

Uncommon: may affect up to 1 in 100 people

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

Not known: frequency cannot be estimated based on available data

• Sudden, or mild but worsening, pain in the upper abdomen and/or back, lasting for several days, with possible nausea, vomiting, fever, and rapid pulse; these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath, or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) have been observed, which can cause kidney problems (rhabdomyolysis), some of which when Lenalidomide Qilu is administered with a statin (a type of drug that lowers cholesterol).
• A disease affecting the skin that is caused by inflammation of small blood vessels, with joint pain and fever (leucocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine, which can cause very serious infections. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in your bowel habits.
• Viral infections, including herpes zoster (also known as “shingles,” a viral illness that causes a painful rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and feeling sick).
• Solid organ transplant rejection (such as kidney, heart).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to
adverse. Reporting side effects 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 which is stated on the blister and the box after
“Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30 C.
Do not use this medicine if you notice damaged packages or those showing signs of tampering.
Do not dispose of any medicine in wastewater or household waste. 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 ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:
• capsule content: 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: deparaffined shellac, black iron oxide (E172) and potassium hydroxide.

Lenalidomide Qilu 5 mg hard capsules:

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

Lenalidomide Qilu 7.5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (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: deparaffined shellac, black iron oxide (E172) and potassium hydroxide.

Lenalidomide Qilu 10 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
• capsule content: 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 yellow sunset FCF (E110)
• printing ink: deparaffined shellac, black iron oxide (E172) and potassium

hydroxide.
Lenalidomide Qilu 15 mg hard capsules:

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

Lenalidomide Qilu 20 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:
• capsule content: 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: deparaffined shellac, black iron oxide (E172) and potassium hydroxide.

Lenalidomide Qilu 25 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
• capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin and titanium dioxide (E171)
• printing ink: deparaffined 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 a light green opaque cap,
measuring 5, 11.1±1.0 mm, with “65 2.5 mg” printed on the body in black ink.
Lenalidomide Qilu 5 mg hard capsules are opaque white, measuring 4, 14.3±1.0 mm, with
“67 5 mg” printed on the body in black ink.
Lenalidomide Qilu 7.5 mg hard capsules have an opaque white body and a light orange opaque cap,
measuring 3, 15.9±1.0 mm, with “70 7.5 mg” printed on the body in black ink.
Lenalidomide Qilu 10 mg hard capsules have a light yellow opaque body and a dark green opaque cap,
measuring 2, 18.0±1.0 mm, with “76 10 mg” printed on the body in black ink.
Lenalidomide Qilu 15 mg hard capsules have an opaque white body and a powder blue opaque cap,
measuring 1, 19.4±1.0 mm, with “78 15 mg” printed on the body in black ink.
Lenalidomide Qilu 20 mg hard capsules have a powder blue opaque body and a light green opaque cap,
measuring 1, 19.4±1.0 mm, with “79 20 mg” printed on the body in black ink.
Lenalidomide Qilu 25 mg hard capsules are opaque white, measuring 0, 21.7±1.0 mm, with
“82 25 mg” printed on the body in black ink.
The capsules are supplied in cartons, each containing one or three perforated blisters. Each blister contains
seven capsules, for a total of 7x1 or 21x1 capsules per carton.
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,
Planta 8, 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 with the
following denominations:
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