LENALIDOMIDE 2.5 мг Капсулы твердые

Содержание инструкции

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

Lenalidomide Biocon 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

Lenalidomide Biocon 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

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

What is Lenalidomide Biocon used for
Lenalidomide Biocon is used in adults for:

• 1. Multiple myeloma
• 2. 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 Biocon 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 Biocon 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 Biocon alone.

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will
closely monitor you before starting treatment.
Multiple myeloma: in patients already treated
Lenalidomide Biocon is taken together with an anti-inflammatory medicine called
“dexamethasone”.
Lenalidomide Biocon 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.

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 Biocon is taken together with another medicine called “rituximab” for the
treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Biocon works
Lenalidomide Biocon 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 carry blood to cancer cells
• stimulating part of the immune system to attack cancer cells.

2. What you need to know before taking Lenalidomide Biocon

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

• If you are pregnant, think you might be pregnant, or are planning to become pregnant, because Lenalidomide Biocon 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 make a note and confirm to you that the necessary measures to avoid pregnancy have been taken.
• 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 for advice.

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

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

• you have had episodes of blood clot formation in the past, because the risk of blood clot formation 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 any doubts, consult your doctor. Treatment with Lenalidomide Biocon 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 - the doctor may adjust the dose of Lenalidomide Biocon
• 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), 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 diplopia, 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 Biocon, 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 Biocon you will undergo regular blood tests.
This is because Lenalidomide Biocon 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 afterwards.

You may be evaluated for signs of cardiopulmonary problems before and during
treatment with lenalidomide.
For patients with MDS taking Lenalidomide Biocon
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 Biocon in the likelihood
of developing AML is not known. The doctor may ask you to undergo some tests to check the signs that could
more accurately predict the likelihood that you will develop AML during treatment with
Lenalidomide Biocon.
For patients with MCL taking Lenalidomide Biocon
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 further 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 Biocon
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 further 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 may 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 Biocon or stop the
treatment depending on the results of the blood tests and your overall condition. If you are a
newly diagnosed patient, the doctor may also evaluate the treatment based on your age and any other
conditions you may already have.

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

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

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

Contraception
For women taking Lenalidomide Biocon
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 must 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) 103 except in cases where it has been confirmed that the 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 Biocon
Lenalidomide Biocon passes into human seminal fluid. If there is a possibility that your partner is
pregnant or becomes pregnant and she is not using effective contraception, 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 Biocon.

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

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

3. How to take Lenalidomide Biocon

Lenalidomide Biocon must be administered by healthcare professionals experienced in the treatment of
multiple myeloma or FL.

• When Lenalidomide Biocon 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 is Lenalidomide Biocon and what it is used for”).
• When Lenalidomide Biocon is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, it is taken alone.
• When Lenalidomide Biocon is used to treat follicular lymphoma, it is taken with another medicine called “rituximab”.

Take Lenalidomide Biocon following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
If you are taking Lenalidomide Biocon in combination with other medicines, consult the leaflet
of those medicines for further information on their use and their effects.

Treatment cycle
Lenalidomide Biocon 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” over the next 21 days.

OR
Lenalidomide Biocon 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” over the next 28 days.

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

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

How and when to take Lenalidomide Biocon

• the capsules should be swallowed whole, preferably with water.
• do not break, open or chew the capsules. If the powder from a broken Lenalidomide Biocon 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. Women who are pregnant or suspected of being pregnant must not handle the blister or the capsule.
• the capsules can be taken with or without food.
• you should take Lenalidomide Biocon 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 Biocon
Lenalidomide Biocon 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 Biocon than you should
If you have taken more Lenalidomide Biocon than prescribed, inform your
doctor immediately.

If you forget to take Lenalidomide Biocon
If you forget to take Lenalidomide Biocon 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 questions about the use of this medicine, ask 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 Biocon 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 can be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction, which can 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, ulcers in the mouth or any other symptom 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 Biocon can reduce the number of white blood cells that fight infections and also of blood cells that help blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising.
Lenalidomide Biocon 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 it is possible that this risk may increase with treatment with Lenalidomide Biocon. Therefore, the doctor must carefully assess the benefit and risk when prescribing Lenalidomide Biocon.
Effects very common(may affect more than 1 in 10 people):

• Decrease in the 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
• Generalised swelling, including swelling of the 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 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 surrounding 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)
• Increases in blood sugar levels (diabetes)
• Decreases in blood sugar levels
• Headache
• Nosebleed
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of discomfort, unwell
• Inflammation of the oral cavity, dry mouth
• Dehydration

Common side 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
• Increase in 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; change 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 having an erection
• Stroke, fainting, dizziness (inner ear problem that causes the sensation that everything is spinning), temporary loss of consciousness
• Chest pain that radiates to the arms, neck, jaw, back or stomach, feeling of 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
• Fall, which can cause an injury

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

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sexual drive (libido)
• Abundant urinary 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 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 tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome: metabolic complications that can occur during cancer treatment and sometimes even in the absence of treatment. These complications are caused by the products of decomposition of cancer cells that are dying, and can include changes in hematological parameters with high values of potassium, phosphorus and uric acid as well as low values of calcium, which involve changes in kidney function and heartbeat, convulsions 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 stomach 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), which can cause kidney problems (rhabdomyolysis), some of which when Lenalidomide Biocon 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 stools or changes in your bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease that causes painful blistering rash) and recurrence of hepatitis B infection 108 (which can cause yellowing of the skin and eyes, brown urine, stomach pain on the right side, fever and nausea or vomiting).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you get any side effects, 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
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 Biocon

• 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.
• Lenalidomide Biocon 2.5 mg, 5 mg, 7.5 mg, hard capsules: Store at a temperature below 30°C.
• Lenalidomide Biocon 10 mg, 15 mg, 20 mg, 25 mg hard capsules: This medicine does not require any special storage conditions.
• Do not use this medicine if you notice damaged packaging or signs of tampering.
• Do not dispose of any medicine in waste water or household waste. Return any unused medicine to the pharmacist. This will help protect the environment.

6. Package contents and other information

What Lenalidomide Biocon contains
The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
The other ingredients are:

• capsule content: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule coating: gelatin, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.
The other ingredients are:

• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule coating: gelatin, titanium dioxide (E171) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
The other ingredients are:

• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule coating: gelatin, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other ingredients are:

• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other ingredients are:

• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule coating: gelatin, titanium dioxide (E171) and brilliant blue FCF (E133).

The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
The other ingredients are:

• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133) and black iron oxide (E172).

The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other ingredients are:

• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• capsule coating: gelatin and titanium dioxide (E171).

Description of the appearance of Lenalidomide Biocon and package contents
Lenalidomide Biocon 2.5 mg hard capsules are size 4 capsules with a green capsule body and
a green capsule cap, with dimensions of 14.3 mm ± 0.3 mm x 5.32 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Biocon 5 mg hard capsules are size 4 capsules with a blue capsule body and
a blue capsule cap, with dimensions of 14.3 mm ± 0.3 mm x 5.32 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Biocon 7.5 mg hard capsules are size 2 capsules with a grey capsule body and
a green capsule cap, with dimensions of 18.0 mm ± 0.3 mm x 6.35 mm.
The capsules are supplied in packs containing 21 capsules.
Lenalidomide Biocon 10 mg hard capsules are size 2 capsules with a white capsule body and
a green capsule cap, with dimensions of 18.0 mm ± 0.3 mm x 6.35 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Biocon 15 mg hard capsules are size 0 capsules with a white capsule body and
a blue capsule cap, with dimensions of 21.7 mm ± 0.3 mm x 7.64 mm.
The capsules are supplied in packs containing 7 or 21 capsules.
Lenalidomide Biocon 20 mg hard capsules are size 0 capsules with a blue capsule body and
a green capsule cap, with dimensions of 21.7 mm ± 0.3 mm x 7.64 mm.
The capsules are supplied in packs containing 21 capsules.
Lenalidomide Biocon 25 mg hard capsules are size 0 capsules with a white capsule body and
a white capsule cap, with dimensions of 24.2 mm ± 0.3 mm x 7.66 mm.
The capsules are supplied in packs containing 21 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biocon Pharma Malta I Limited
The Victoria Centre, Unit 2, Lower Ground Floor
Valletta Road, Mosta MST 9012, Malta

Manufacturer
Tecnimede – Sociedade Técnico-Medicinal S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: