Lenalidomide Biocon

Package leaflet: Information for the patient

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, 25 mg hard capsules

lenalidomide
equivalent medicine
Please read all of 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including 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 taking 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 Lenalidomide Biocon is and what it is used for

What Lenalidomide Biocon is
Lenalidomide Biocon contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect the way the immune system works.
What Lenalidomide Biocon is 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 accumulate in the bone marrow and divide uncontrollably. This can damage the bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be significantly reduced or disappear for a certain period. This outcome is called a “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Lenalidomide Biocon 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 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 immunosuppressive medicine called “prednisone”. You will take these other medicines at the beginning of treatment and then continue taking Lenalidomide Biocon 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 who have been previously treated
Lenalidomide Biocon is taken together with an anti-inflammatory medicine called “dexamethasone”.
Lenalidomide Biocon can stop the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

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 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 acts on the body's immune system and directly on the tumour in several ways:

• by stopping the growth 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 need to know before taking Lenalidomide Biocon

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

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide Biocon is expected to be harmful to the unborn baby (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men').
• If there is any possibility you could become pregnant unless you follow all necessary measures to avoid pregnancy (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men'). If there is any possibility you could become pregnant, your doctor will record and confirm at each prescription that the necessary measures to avoid pregnancy have been taken.
• If you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

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

• you have previously experienced episodes of blood clots, as the risk of developing blood clots in veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you currently have or have previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, or HIV. If you have any doubts, consult your doctor. Treatment with Lenalidomide Biocon may cause reactivation of the virus in patients who carry the virus, leading to 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 Biocon
• you have had a heart attack, blood clots, or if you smoke, have high blood pressure, or high cholesterol levels
• you 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), or swollen lymph nodes; these are signs of a serious skin reaction known as 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, 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 Biocon, inform your doctor of any changes in these symptoms.
• you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling in your 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 Biocon, you will undergo regular blood tests.
This is because Lenalidomide Biocon 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 Biocon
If you have MDS, you have a higher risk of developing a more advanced disease called acute myeloid leukemia (AML). Additionally, the role of Lenalidomide Biocon in the risk 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 Biocon.
For patients with MCL taking Lenalidomide Biocon
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 Biocon
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 from 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 tumor burden throughout your body, including in the bone marrow. This could lead to a condition in which tumors break down and cause abnormal levels of chemicals in the blood, potentially leading to kidney failure (this condition is called "tumor lysis syndrome").
Your doctor may check for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Biocon or stop treatment based on blood test results and your overall condition. If you are a newly diagnosed patient, your doctor may also consider treatment based on your age and other pre-existing conditions.
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 Biocon 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 Biocon
Inform your doctor or nurse if you are taking, have recently taken, or might take any other
medicines. This is because Lenalidomide Biocon may affect the action of other
medicines and other medicines may affect the action of Lenalidomide Biocon.
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 become less 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 Biocon

• You must not take Lenalidomide Biocon if you are pregnant, as this medicine is expected to be harmful to the unborn baby.
• During treatment with Lenalidomide Biocon, 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 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. 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 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 whether there is any possibility you could become pregnant, even if you think it is unlikely.
If there is any possibility you could become pregnant

• you will need to undergo pregnancy testing under the supervision of your doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), 103 except in cases where it has been confirmed that your fallopian tubes have been cut and tied 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 full guidance on appropriate contraceptive methods.

For men taking Lenalidomide Biocon
Lenalidomide Biocon passes into 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 the end of treatment, even if you have had a vasectomy.
Driving and using machines
Do not drive or operate machinery 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 certain
sugars, contact him 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 prescribed and 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 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 Biocon is 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 in combination with another medicine called “rituximab”.

Always take Lenalidomide Biocon exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
If you are taking Lenalidomide Biocon in combination with other medicines, please refer to the package leaflet of those medicines for further information on their use and effects.

Treatment cycle
Lenalidomide Biocon 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 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 Biocon 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 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 Biocon to be taken
Before starting treatment, your doctor will inform you:

• of the dose of Lenalidomide Biocon to be taken
• of the dose of any 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

• swallow the capsules 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 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 washed thoroughly with soap and water. Pregnant women or those who suspect they may be pregnant must not handle the blister pack or capsule.
• the capsules may be taken with or without food.
• take Lenalidomide Biocon 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 cause it to break.

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.

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 your usual time and:

• less than 12 hours have passed: take the missed capsule immediately
• more than 12 hours have passed: do not take the missed capsule; instead, take the next capsule at the 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 Biocon and contact your doctor immediately if you experience any of the
following serious side effects – you may need urgent medical treatment:

• 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 skin rash in one area but spread with extensive skin loss over the entire 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 Biocon may reduce the number of white blood cells that fight infections and also
the number of blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising.
Lenalidomide Biocon 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 Biocon. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Lenalidomide Biocon to you.
Side effects very common (may affect more than 1 in 10 people):

• Decrease in the number of red blood cells (anaemia), which may cause tiredness and weakness
• Skin rash, itching
• Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, pain in extremities
• Generalised swelling, including swelling of arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
• Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor
• Loss of appetite, altered taste
• Increase in pain, size of tumour or redness around the tumour
• Weight loss
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium and/or sodium in the blood Hypothyroidism (underactive thyroid)
• 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, known as 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 lens of the eye (cataract)
• Kidney problems, including impaired kidney function or inability of the kidneys to maintain normal function
• Abnormal liver function test results
• Increase in liver function test values
• Changes in a protein in the blood that may cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of discomfort, malaise
• Inflammation of the mouth, dry mouth
• Dehydration

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

• Destruction of red blood cells in the blood (haemolytic anaemia)
• Certain types of skin tumours
• Bleeding from gums, stomach or intestine
• Increased blood pressure, slow, rapid 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 output 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 the 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
• Deafness, ringing in the ears (tinnitus)
• Nerve pain, altered sensation, especially touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which may result in injury

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

• Bleeding within the skull
• Circulatory problems
• Loss of vision
• Loss of sexual desire (libido)
• Excessive urine flow with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowish discoloration of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, stomach pain or swelling. These may be symptoms of liver damage (hepatic failure).
• Stomach pain, swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called renal tubular necrosis)
• Changes in skin colour, sensitivity to sunlight
• Tumour lysis syndrome: metabolic complications that may occur during anti-tumour 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 the 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) have been observed, which may lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Biocon was administered with a statin (a type of medicine that lowers cholesterol).
• A skin disease caused by inflammation of small blood vessels, with joint pain and fever (leucocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine, which may lead to very serious infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stools or changes in bowel habits.
• Viral infections, including herpes zoster (also known as "shingles", a viral disease causing a 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
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 stated on the blister pack and the carton 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 below 30°C.
• Lenalidomide Biocon 10 mg, 15 mg, 20 mg, 25 mg hard capsules: This medicine requires no special storage conditions.
• Do not use this medicine if you notice damaged packaging or signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Return unused medicines to the pharmacist. This will help protect the environment.

6. Package contents and other information

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

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

The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
The other components are:

• Other components: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171) and brilliant blue FCF (E133).

The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
The other components are:

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

The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other components are:

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

The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other components are:

• Other components: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171) and brilliant blue FCF (E133).

The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
The other components are:

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

The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other components are:

• Other components: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule shell: 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 green cap, measuring 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 blue cap, measuring 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 green cap, measuring 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 green cap, measuring 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 blue cap, measuring 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 green cap, measuring 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 white cap, measuring 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 under the following names: