LENALIDOMIDE 2.5 mg Hard capsules

Зміст інструкції

1. Lenalidomide Aurobindo 2.5 mg hard capsules, 5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules
   1. What is Lenalidomide Aurobindo and what it is used for
   2. What you need to know before taking Lenalidomide Aurobindo
   3. How to take Lenalidomide Aurobindo
   4. Possible side effects
   5. How to store Lenalidomide Aurobindo
   6. Package Contents and Other Information

Lenalidomide Aurobindo 2.5 mg hard capsules, 5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

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

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

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

What is Lenalidomide Aurobindo used for
Lenalidomide Aurobindo 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 collect in the bone marrow and divide, in an uncontrolled way. This
can damage the bones and kidneys.
Multiple myeloma is usually incurable. However, the signs and symptoms can be significantly
reduced or disappear for a certain period. This result is called “response”.
Newly diagnosed multiple myeloma - in patients undergoing bone marrow transplant
Lenalidomide Aurobindo is used alone as maintenance therapy in patients who have
recovered adequately after bone marrow transplant.
Newly diagnosed multiple myeloma - in patients who cannot undergo bone marrow
transplant
Lenalidomide Aurobindo 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 Aurobindo 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 patients already treated Lenalidomide Aurobindo is taken together with an anti-inflammatory medicine called “dexamethasone”.

Lenalidomide Aurobindo can stop the worsening of the 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 many different blood and bone marrow diseases. The 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 Aurobindo 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 “an isolated 5q deletion cytogenetic abnormality”. This means that your body is not producing enough healthy blood cells
• if other treatments used previously are not suitable or are not effective enough.

Lenalidomide Aurobindo 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 you need. You may not need any transfusions. -

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (the 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 the lymphatic tissue, bone marrow, or blood.
Lenalidomide Aurobindo 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 can accumulate in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Aurobindo is taken together with another medicine called “rituximab” for the
treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Aurobindo works
Lenalidomide Aurobindo works on the body’s immune system and directly on the cancer, in
several ways:

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

2. What you need to know before taking Lenalidomide Aurobindo

all medicines that you are taking in combination with Lenalidomide Aurobindo.
Do not take Lenalidomide Aurobindo:

• if you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide Aurobindo 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 of becoming 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 any of the other ingredients of this medicine listed in section 6. If you think you may be allergic, ask your doctor. -

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

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

• you have had episodes of blood clot formation in the past, as the risk of blood clots forming in 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 Aurobindo may cause the virus to reactivate 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 Aurobindo
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• you have had an allergic reaction during treatment with thalidomide (another medicine for the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• you have had in the past any combination of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), enlarged 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 the
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 Aurobindo, tell your doctor about 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 Aurobindo you will undergo regular blood tests.
This is because Lenalidomide Aurobindo can cause a reduction in blood cells that defend you from infections (white blood cells) and those that promote blood clotting
(platelets). The doctor will ask you to undergo blood tests:

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

You may be evaluated for signs of cardiopulmonary problems before and during
treatment with lenalidomide.
For patients with MDS taking Lenalidomide Aurobindo
If you suffer from MDS, you are more likely to develop a more advanced disease called acute myeloid leukemia (AML). In addition, the role of Lenalidomide Aurobindo 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 likelihood that you will develop AML during treatment with Lenalidomide
Aurobindo.
For patients with MCL taking Lenalidomide Aurobindo
The doctor will ask you to undergo a blood test:

• before treatment -
• once a 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 Aurobindo
The doctor will ask you to undergo a blood test:

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

The doctor may check if you have a high tumor 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 Aurobindo or stop the
treatment depending on the results of the blood tests and your general condition. If you are a
newly diagnosed patient, the doctor may also assess the treatment based on your age and any other
pre-existing conditions.

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

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

Elderly and people with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, the doctor
will perform careful checks before starting treatment.

Other medicines and Lenalidomide Aurobindo
Tell your doctor or nurse if you are taking, have recently taken or may take any
other medicines. This is because Lenalidomide Aurobindo can affect the action of other medicines and
other medicines can affect the action of Lenalidomide Aurobindo.
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 Aurobindo

• You must not take Lenalidomide Aurobindo if you are pregnant, as this medicine is expected to harm the fetus.
• During treatment with Lenalidomide Aurobindo 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 Aurobindo, you must stop treatment immediately and tell your doctor. For men taking Lenalidomide Aurobindo
• If your partner becomes pregnant while you are taking Lenalidomide Aurobindo, tell your doctor immediately. Your partner is also recommended to contact the doctor.
• In addition, you must use effective contraceptive methods (see the “Contraception” section).

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

Contraception
For women taking Lenalidomide Aurobindo
Before starting treatment, ask your doctor if there is a possibility of you becoming 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 Aurobindo
Lenalidomide Aurobindo 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 stopping treatment, even if you have
undergone a vasectomy.

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

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

Lenalidomide Aurobindo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Lenalidomide Aurobindo

Lenalidomide Aurobindo must be administered by healthcare professionals experienced in the treatment of
multiple myeloma, MDS, MCL or FL.

• When Lenalidomide Aurobindo 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 paragraph 1 “What Lenalidomide Aurobindo is and what it is used for”).
• When Lenalidomide Aurobindo is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation or to treat patients with MDS or MCL, it is taken alone.
• When Lenalidomide Aurobindo is used to treat follicular lymphoma, it is taken with another medicine called “rituximab”. Always take Lenalidomide Aurobindo exactly as your doctor has instructed you. If you have any doubts, ask your doctor or pharmacist.

If you are taking Lenalidomide Aurobindo in combination with other medicines, read the
package leaflet of those medicines for further information on their use and their effects.

Treatment cycle
Lenalidomide Aurobindo is taken on some days over a period of 3 weeks (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.
• Once each 21-day cycle is completed, you will need to start a new “cycle” within the next 21 days. OR Lenalidomide Aurobindo is taken on some days over a period of 4 weeks (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. -
• Once each 28-day cycle is completed, you will need to start a new “cycle” within the next 28 days. -

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

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

How and when to take Lenalidomide Aurobindo

• the capsules should be swallowed whole, preferably with water.
• the capsules can be taken with or without food.
• you must take Lenalidomide Aurobindo on the scheduled days at approximately the same time.
• do not break, open or chew the capsules. If the powder from a broken Lenalidomide Aurobindo capsule 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 the capsule. The gloves should then be removed carefully to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Pregnant or potentially pregnant women should not handle the blister or the capsule.

How 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 Aurobindo
Lenalidomide Aurobindo 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 treatment.

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

If you forget to take Lenalidomide Aurobindo
If you forget to take Lenalidomide Aurobindo 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. Take the next capsule the following day at the usual time. If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

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

• Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of 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 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.

Contact your doctor immediately if you experience any of the following 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 a high level of calcium in the blood. Lenalidomide Aurobindo may 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 Aurobindo 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 it is possible
that this risk may increase with treatment with Lenalidomide Aurobindo. Therefore, the doctor
must carefully assess the benefit and risk when prescribing Lenalidomide Aurobindo.
Very commonside effects (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, acute muscle pain, muscle aches, bone pain, joint pain, back pain, pain in the extremities
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough and chills
• Numbness, tingling or burning sensation on the skin, pain in the hands or feet, dizziness, tremor
• Decreased appetite, altered sense of taste
• Increased pain, size of the tumor or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood -
• Thyroid insufficiency
• 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 vision (cataract)
• Kidney problems, including improper functioning of the kidneys or the inability of the kidneys to maintain normal function -
• Abnormal values in liver function tests -
• Increased values in liver function tests -
• Changes in a protein in the blood that can cause inflammation of the arteries (vasculitis) -
• 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, unwellness -
• Inflammation of the oral cavity, dry mouth -
• Dehydration -

Commonside effects (may affect up to 1 in 10 people):

• Destruction of red blood cells in the blood (hemolytic anemia)
• Some types of skin cancer
• Bleeding from the gums, stomach or intestines
• Increased blood pressure, slow, rapid or irregular heartbeat
• Increased amount of a substance that comes from the normal and abnormal breakdown of red blood cells
• Increase in a type of protein that indicates inflammation in the body -
• Darkening of the skin, 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 sensation of spinning, temporary loss of consciousness)
• Chest pain that radiates to the arms, neck, jaw, back or stomach, sweating, and shortness of breath, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction) -
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Swelling of the joints
• Slowing or blockage of bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disorders, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, altered sensitivity especially to touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which can cause injury -

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

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sexual drive (libido)
• Abundant urine flow with pain and weakness in the bones, which may be symptoms of a

kidney disorder (Fanconi syndrome)

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

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

• Sudden, or mild but worsening, pain in the upper abdomen and/or back, which persists 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 Aurobindo is administered with a statin (a type of drug that lowers cholesterol).
• A disease that affects the skin and is caused by inflammation of small blood vessels, with joint pain and fever (leucocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine, which can cause very serious infections. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool or changes in your bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease that causes painful blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, pain in the right side of the stomach, fever and nausea or vomiting).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 Aurobindo

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 package after “Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water or household waste. Return any unused medicines to the pharmacist. This will help protect the environment. 

6. Package Contents and Other Information

• The active ingredient is: - Each hard capsule contains 2.5 mg of lenalidomide. Each hard capsule contains 5 mg of lenalidomide. Each hard capsule contains 10 mg of lenalidomide. Each hard capsule contains 15 mg of lenalidomide. Each hard capsule contains 20 mg of lenalidomide. Each hard capsule contains 25 mg of lenalidomide.
• Other ingredients are: - Capsule content: lactose, microcrystalline cellulose (grade-102), sodium croscarmellose and magnesium stearate. Capsule shell: titanium dioxide (E171), yellow iron oxide (E172) (only for 2.5 mg, 10 mg and 20 mg), indigo carmine (E132) (only for 2.5 mg and 10 mg), red iron oxide (E172) (only for 10 mg, 15 mg and 20 mg), gelatin. Printing ink: shellac, black iron oxide and potassium hydroxide.

Description of the appearance of Lenalidomide Aurobindo and package contents
Hard capsule.

Lenalidomide Aurobindo 2.5 mg hard capsules: [size 14.4 mm]
Opaque green gelatin hard capsule size ‘4’, imprinted with "L2.5" in black ink on the cap, filled with off-white to pale yellow powder.

Lenalidomide Aurobindo 5 mg hard capsules: [size 17.8 mm]
Opaque white gelatin hard capsule size ‘2’, imprinted with "L5" in black ink on the cap, filled with off-white to pale yellow powder.

Lenalidomide Aurobindo 10 mg hard capsules: [size 21.4 mm]
Gelatin hard capsule with an opaque green cap and opaque orange body, size ‘0’, imprinted with "L10" in black ink on the cap, filled with off-white to pale yellow powder.

Lenalidomide Aurobindo 15 mg hard capsules: [size 21.4 mm]
Opaque dark orange gelatin hard capsule size ‘0’, imprinted with "L15" in black ink on the cap, filled with off-white to pale yellow powder.

Lenalidomide Aurobindo 20 mg hard capsules: [size 21.4 mm]
Opaque orange gelatin hard capsule size ‘0’, imprinted with "L20" in black ink on the cap, filled with off-white to pale yellow powder.

Lenalidomide Aurobindo 25 mg hard capsules: [size 21.4 mm]
Opaque white gelatin hard capsule size ‘0’, imprinted with "L25" in black ink on the cap, filled with off-white to pale yellow powder.

Package sizes:
Blister packs: 7, 14, 21, 28 and 42 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer:
APL Swift Services (Malta) Ltd. - HF26, Hal Far Industrial Estate Hal Far - Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A. - Rua João de Deus, 19, Venda Nova, Amadora 2700-487 Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
Italy: Lenalidomide Aurobindo
Portugal: Lenalidomida Generis Phar