Lenalidomide Aurobindo

Patient Information Leaflet: Information for the User

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Lenalidomide Aurobindo is and what it is used for

What Lenalidomide Aurobindo is
Lenalidomide Aurobindo contains the active substance "lenalidomide". This medicine belongs to a
group of medicines that affect the functioning of the immune system.
What Lenalidomide Aurobindo is 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 accumulate in the bone marrow and divide uncontrollably. This
can damage bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be significantly
reduced or disappear for a certain period. This outcome is called "response".
Newly diagnosed multiple myeloma – in patients undergoing bone marrow transplantation
Lenalidomide Aurobindo 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 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 taking Lenalidomide Aurobindo alone.

If you are aged 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.
Multiple myeloma – in previously treated patients
Lenalidomide Aurobindo is taken together with an anti-inflammatory medicine called
"dexamethasone".
Lenalidomide Aurobindo can stop the worsening of 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 different blood and bone marrow diseases. 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 the risk of infection.
Lenalidomide Aurobindo alone is used to treat adult patients diagnosed with MDS, if all the following conditions apply:

• 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 "isolated 5q 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 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 required. You may no longer need any transfusions.

Mantle cell lymphoma (MCL)
MCL is a cancer of a part of the immune system (lymphatic tissue). It affects a type of white blood cells called "B lymphocytes" or "B cells". In MCL, B lymphocytes grow uncontrollably and accumulate in lymphatic tissue, bone marrow or blood.
Lenalidomide 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 may 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 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 Aurobindo

Before starting treatment with Lenalidomide Aurobindo, you must read the package leaflet of
all the medicines you are required to take 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 be harmful to the unborn baby (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men').
• if there is any possibility that you may become pregnant unless you follow all the necessary measures to avoid pregnancy (see section 2 'Pregnancy, breastfeeding and contraception – information for women and men'). If there is any possibility of becoming pregnant, your doctor will record and confirm at each prescription that the necessary measures to prevent pregnancy have been 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 are allergic, consult your doctor.

If any of these conditions apply to you, do not take Lenalidomide Aurobindo. If you have any doubts, consult your doctor.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Lenalidomide Aurobindo if:

• you have previously experienced episodes of blood clot formation, as the risk of developing blood clots in veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, HIV. If you have any doubts, consult your doctor. Treatment with Lenalidomide Aurobindo may cause reactivation of the virus in patients who carry the virus. This leads to the recurrence of the infection. Your doctor must check whether you have previously had hepatitis B infection
• you have kidney problems – your doctor may adjust the dose of Lenalidomide Aurobindo
• you have had a heart attack, blood clots, or if you smoke, have high blood pressure, or high cholesterol levels
• you have previously had an allergic reaction during treatment with thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
• you have previously experienced any combination of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), 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 Aurobindo, 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 Aurobindo, you will undergo regular blood tests.
This is because Lenalidomide Aurobindo may cause a reduction in blood cells that protect you from infections (white blood cells) and those that help blood to clot (platelets). Your doctor will ask you to have blood tests:

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

You may be evaluated for signs of cardiopulmonary problems before and during treatment with lenalidomide.
For patients with MDS taking Lenalidomide Aurobindo
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 Aurobindo 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 Lenalidomide Aurobindo.
For patients with MCL taking Lenalidomide Aurobindo
Your doctor will ask you to have a blood test:

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

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

• before starting treatment
• once a week for the first 3 weeks (1 cycle) of treatment
• then every 2 weeks 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, potentially leading to kidney failure (this condition is called “tumour lysis syndrome”).
Your doctor may monitor for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Aurobindo or discontinue treatment depending on the results of blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also consider your age and any other pre-existing conditions when evaluating treatment.
Blood donation
You must not donate blood during treatment with lenalidomide or 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 patients and patients with kidney problems
In patients aged 75 years or older, or with moderate or severe kidney problems, your doctor will perform careful monitoring before starting treatment.
Other medicines and Lenalidomide Aurobindo
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This is because Lenalidomide Aurobindo may affect the action of other medicines and other medicines may affect the action of Lenalidomide Aurobindo.
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 Aurobindo

• You must not take Lenalidomide Aurobindo if you are pregnant, as this medicine is expected to be harmful to the unborn baby.
• During treatment with Lenalidomide Aurobindo, 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 Aurobindo, you must stop treatment immediately and inform your doctor.
  For men taking Lenalidomide Aurobindo
• If your partner becomes pregnant while you are taking Lenalidomide Aurobindo, 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 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 whether there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant:

• you will need to undergo pregnancy tests under the supervision of your doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), except in cases where it has been confirmed that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (sterilisation by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will provide you with all necessary information regarding appropriate contraceptive methods.
  For men taking Lenalidomide Aurobindo
  Lenalidomide Aurobindo is present in human semen. If there is any possibility that your partner is pregnant or could become pregnant and she is not using effective contraceptive methods, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy. You must not donate semen or sperm during treatment with lenalidomide or for at least 7 days after stopping treatment.

Driving and using machines
Do not drive or operate machinery 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 certain 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 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 Aurobindo is and what it is used for”).
• When Lenalidomide Aurobindo is used to treat 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 together with another medicine called "rituximab". Always take Lenalidomide Aurobindo exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.

If you are taking Lenalidomide Aurobindo in combination with other medicines, please refer to the package leaflets of those medicines for further information on their use and effects.
Treatment cycle
Lenalidomide Aurobindo is taken on certain days within a 3-week period (21 days).

• Each 21-day period is called a "treatment cycle".
• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.
• After completing each 21-day cycle, you must start a new "cycle" within the following 21 days. OR Lenalidomide Aurobindo is taken on certain days within a 4-week period (28 days).
• Each 28-day period is called a "treatment cycle".
• Depending on the day of the cycle, you will take one or more of the medicines. However, on some days you will not take any medicine.
• After completing each 28-day cycle, you must start a new "cycle" within the following 28 days.

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

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

• swallow the capsules whole, preferably with water.
• 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 soap and water.
• healthcare providers, caregivers and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene bag, and disposed of according to local regulations. Hands should then be thoroughly washed with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• the capsules may be taken with or without food.
• you must take Lenalidomide Aurobindo on the scheduled days at approximately the same time each day.

How to take this medicine
To remove the capsule from the blister

• press on one side of the capsule, pushing it through the aluminium foil
• do not press in the center of the capsule, as this may break 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.
If you take more Lenalidomide Aurobindo than you should
If you have taken more Lenalidomide Aurobindo than prescribed, inform your doctor immediately.
If you forget to take Lenalidomide Aurobindo
If you forget to take Lenalidomide Aurobindo at your usual time and:

• less than 12 hours have passed: take your capsule immediately
• more than 12 hours have passed: do not take the missed capsule. Take the next capsule at your usual time the following day. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lenalidomide Aurobindo 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 severe types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction, which may start as a rash in one area but spreads with extensive skin loss over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2. Contact your doctor immediately if you experience any of the following side effects:
• Fever, chills, sore throat, cough, mouth ulcers or any other sign of infection including within the bloodstream (sepsis)
• Bleeding or bruising without injury
• Chest or leg pain
• Shortness of breath
• Bone pain, muscle weakness, confusion or fatigue, which may be due to high levels of calcium in the blood. Lenalidomide Aurobindo can reduce the number of white blood cells that fight infections and also the blood cells that help blood to clot (platelets), which may lead to 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 this risk may possibly increase with treatment with Lenalidomide Aurobindo. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Lenalidomide Aurobindo to you.
Very common side effects (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, acute muscle pain, muscle aches, bone pain, joint pain, back pain, pain in limbs
• 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 sense of taste
• Increase in pain, size of tumour or redness around tumour
• Weight loss
• 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 symptom of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism)
• Any type of infection, including infections of the sinuses around the nose, lungs and upper respiratory tract
• Shortness of breath
• Blurred vision
• Clouding of the vision (cataract)
• Kidney problems, including improper functioning of the kidneys or inability of the kidneys to maintain normal function
• Abnormal liver function test results
• Increased liver function test values
• Changes in a protein in the blood that may cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• Vague feeling of physical discomfort, malaise
• Inflammation of the mouth, dry mouth
• Dehydration

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

• Breakdown of red blood cells in the blood (haemolytic anaemia)
• Some types of skin cancer
• Bleeding from gums, stomach or intestine
• Increased blood pressure, slow, fast or irregular heartbeat
• Increase in a substance resulting from normal and abnormal breakdown of red blood cells
• Increase in a type of protein indicating inflammation in the body
• Darkening of the skin, skin colour changes due to bleeding under the skin, typically caused by bruising, skin swelling due to blood, bruising
• Increased uric acid in the blood
• Skin rashes, redness of the skin, skin cracking, peeling or flaking, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, voice quality problems or voice changes
• Runny nose
• Urine production much greater or less than usual, or inability to control the urge to urinate
• Presence of blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (inner ear problem causing a sensation that everything is spinning), temporary loss of consciousness
• Chest pain spreading to arms, neck, jaw, back or stomach, sweating and breathlessness, 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
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, altered sensation, especially touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which may lead to injury

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

• Bleeding within the skull
• Circulatory problems
• Loss of vision
• Loss of sexual desire (libido)
• Abundant urine flow with pain and bone weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowish colouring of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, 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 anticancer 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).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Sudden, or mild but worsening, pain in the upper abdomen and/or back, persisting for several days, possibly accompanied by nausea, vomiting, fever and rapid pulse; these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness or swelling), which may lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Aurobindo was administered with a statin (a type of cholesterol-lowering medicine), have been observed.
• A disease affecting the skin caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
• Deterioration of the stomach or intestinal wall, which may lead to very serious infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools or changes in bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease causing painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever and nausea or vomiting).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at 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 carton after "Exp.".
The expiry date refers to the last day of that month.
Store below 30°C.
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

• The active substance 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.
• The other components are: Capsule contents: lactose, microcrystalline cellulose (grade-102), croscarmellose sodium and magnesium stearate. Capsule coating: 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 contents of the pack Hard capsule.

Lenalidomide Aurobindo 2.5 mg hard capsules: [size 14.4 mm]
Opaque green hard gelatin capsule of size '4', printed with "L2.5" in black ink on the cap, filled with powder ranging from white to pale yellow.
Lenalidomide Aurobindo 5 mg hard capsules: [size 17.8 mm]
Opaque white hard gelatin capsule of size '2', printed with "L5" in black ink on the cap, filled with powder ranging from white to pale yellow.
Lenalidomide Aurobindo 10 mg hard capsules: [size 21.4 mm]
Hard gelatin capsule with an opaque green cap and opaque orange body, size '0', printed with "L10" in black ink on the cap, filled with powder ranging from white to pale yellow.
Lenalidomide Aurobindo 15 mg hard capsules: [size 21.4 mm]
Opaque dark orange hard gelatin capsule of size '0', printed with "L15" in black ink on the cap, filled with powder ranging from white to pale yellow.
Lenalidomide Aurobindo 20 mg hard capsules: [size 21.4 mm]
Opaque orange hard gelatin capsule of size '0', printed with "L20" in black ink on the cap, filled with powder ranging from white to pale yellow.
Lenalidomide Aurobindo 25 mg hard capsules: [size 21.4 mm]
Opaque white hard gelatin capsule of size '0', printed with "L25" in black ink on the cap, filled with powder ranging from white to pale yellow.
Packs:
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 European Economic Area countries with the following
trade names:
Italy: Lenalidomide Aurobindo
Portugal: Lenalidomida Generis Phar