LENALIDOMIDE SUN 7.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Lenalidomide Sun 2.5 mg hard capsules EFG

Lenalidomide Sun 5 mg hard capsules EFG

Lenalidomide Sun 7.5 mg hard capsules EFG

Lenalidomide Sun 10 mg hard capsules EFG

Lenalidomide Sun 15 mg hard capsules EFG

Lenalidomide Sun 20 mg hard capsules EFG

Lenalidomide Sun 25 mg hard capsules EFG

lenalidomide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

What isLenalidomide Sun

Lenalidomide Sun contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect how the immune system works.

What isLenalidomide Sunused for

Lenalidomide is used in adults to:

• Multple myeloma
• Myelodysplastic syndromes (MDS)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma

Multple myeloma

Multple myeloma is a type of cancer that affects a specific type of white blood cell called plasma cells. These cells accumulate in the bone marrow and multiply out of control. This can damage bones and kidneys.

Multple myeloma usually has no cure. However, the signs and symptoms can be greatly reduced or may disappear for a period of time. This is called “remission”.

Newly diagnosed multple myeloma: in patients who have undergone a bone marrow transplant

Lenalidomide is used as maintenance treatment after recovering adequately from a bone marrow transplant.

Newly diagnosed multple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomide is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”;
• an anti-inflammatory medicine called “dexamethasone”
• a chemotherapy medicine called “melphalan” and
• an immunosuppressant called “prednisone”.

You will take these medicines at the start of treatment and then continue taking lenalidomide alone.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Multple myeloma: in patients previously treated

Lenalidomide is taken along with an anti-inflammatory called “dexamethasone”.

Lenalidomide may slow down the worsening of multple myeloma symptoms. It has also been shown to delay the return of multple myeloma after treatment.

Myelodysplastic syndromes (MDS)

MDS are a group of many different blood and bone marrow disorders. Blood cells become abnormal and do not work properly. Patients may experience a variety of signs and symptoms including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.

Lenalidomide is used to treat adult patients diagnosed with MDS, when all of the following apply:

• need regular blood transfusions to treat low red blood cell counts (“transfusion-dependent anemia”);
• have a bone marrow cell abnormality called “isolated deletion 5q cytogenetic abnormality”. This means your body does not produce enough healthy blood cells;
• other treatments you have used before are not suitable or do not work well enough.

Lenalidomide may increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. You may not need transfusions at all.

Mantle cell lymphoma (MCL)

MCL is a cancer of a part of the immune system (lymphatic tissue). It affects a type of white blood cell called “B lymphocytes” or B cells. MCL is a disease in which B cells grow out of control and accumulate in lymphatic tissue, bone marrow, or blood.

Lenalidomide is used alone to treat adult patients who have received previous treatment with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infections. When a person has FL, they may have too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomide is used with another medicine called “rituximab” to treat adult patients who have received previous treatment for follicular lymphoma.

HowLenalidomide Sunworks

Lenalidomide works by affecting the body's immune system and directly attacking cancer. It works in several ways:

• stops the growth of cancer cells;
• stops the growth of blood vessels in the cancer;
• stimulates part of the immune system to attack cancer cells.

2. What you need to know before you take Lenalidomide Sun

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomide Sun before you start treatment with this medicine.

Do not takeLenalidomide Sun:

• if you are pregnant, think you may be pregnant or plan to become pregnant, as lenalidomide is expected to be harmful to the fetus(see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”).
• if you can become pregnant, unless you use effective contraception (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you can become pregnant, your doctor will record with each prescription that all necessary measures have been taken and will provide you with this confirmation.
• 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, talk to your doctor.

If any of these conditions apply to you, do not take lenalidomide. If in doubt, talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start takingLenalidomide Sunif:

• you have ever had blood clots; during treatment, you have a higher risk of getting blood clots in the veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have had a viral infection, especially hepatitis B, varicella-zoster or HIV. If in doubt, talk to your doctor. Treatment with lenalidomide may cause the virus to become active again, in patients who carry the virus, leading to the return of the infection. Your doctor should check if you have ever had a hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of lenalidomide;
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels;
• you have had an allergic reaction while using thalidomide (another medicine used to treat multple myeloma), such as skin rash, itching, swelling, dizziness or breathing problems;
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia) enlarged lymph nodes (these are symptoms of a severe 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 the above conditions apply to you, inform your doctor, pharmacist or nurse before starting treatment.

At any time, during or after treatment, tell your doctor or nurse immediately if you:

• have blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with lenalidomide, tell your doctor if you notice any change in these symptoms.
• have shortness of breath, tiredness, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting treatment with lenalidomide and during treatment, you will have regular blood tests. This is because lenalidomide can cause a decrease in the blood cells that help fight infections (white blood cells) and those that help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

• before treatment;
• every week, during the first 8 weeks of treatment;
• then at least every month.

You may be evaluated for signs of heart and lung problems before and during treatment with lenalidomide.

For patients with MDS taking Lenalidomide Sun

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). Additionally, it is not known how lenalidomide affects the chances of developing AML. Your doctor may therefore have you undergo tests to detect signs that may predict a higher chance of developing AML during treatment with lenalidomide.

For patients with MCL taking Lenalidomide Sun

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 8 weeks (2 cycles) of treatment;
• then every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information);

• then at the start of each cycle and
• at least once a month.

For patients with FL taking Lenalidomide Sun

Your doctor will ask you to have a blood test:

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

Your doctor may check if you have a high total tumor burden in the body, including the bone marrow. This could lead to a condition in which tumors break down and produce unusual levels of chemicals in the blood, which can cause kidney failure (this condition is called “tumor lysis syndrome”).

Your doctor may examine you to check for changes in your skin, such as red spots or skin rash.

Your doctor may adjust your dose of lenalidomide or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other conditions you may have.

Blood donation

You must not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide is not recommended for use in children and adolescents under 18 years.

Elderly people and people with kidney problems

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Other medicines and Lenalidomide Sun

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because lenalidomide may affect how other medicines work. Also, some medicines may affect how lenalidomide works.

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, as they may stop working;
• 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

Women taking Lenalidomide Sun

• Do not take lenalidomide if you are pregnant, as it is expected to be harmful to the fetus.
• Do not become pregnant while taking lenalidomide. You must use effective contraception if there is a possibility that you may become pregnant (see “Contraception”).
• If you become pregnant during treatment with lenalidomide, stop treatment and tell your doctor immediately.

Men taking Lenalidomide Sun

• If your partner becomes pregnant while you are taking lenalidomide, tell your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective contraception (see “Contraception”).

Breastfeeding

Do not breastfeed while taking lenalidomide, as it is not known whether lenalidomide passes into breast milk.

Contraception

For women taking Lenalidomide Sun

Before starting treatment, ask your doctor if you are able to become pregnant, even if you think it is unlikely.

If you can become pregnant

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after the end of treatment) unless it has been confirmed that your fallopian tubes have been blocked (tubal ligation)

And

• you must use effective contraception from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after the end of treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking Lenalidomide Sun

Lenalidomide passes into human semen. If your partner is pregnant or may become pregnant and does not use effective contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy. Do not donate semen or sperm during treatment and for at least 7 days after the end of treatment.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking lenalidomide.

Lenalidomide Sun contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to Take Lenalidomida Sun

Lenalidomida should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, MCL, or MF.

• When lenalidomida is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have undergone other treatments before, it is taken with other medications (see section 1 "What Lenalidomida Sun is used for").
• When lenalidomida is used for the treatment of multiple myeloma in patients who have undergone a bone marrow transplant or to treat patients with MDS or MCL, it is taken alone.
• When lenalidomida is used for the treatment of follicular lymphoma, it is taken with another medication called "rituximab".

Follow exactly the administration instructions of lenalidomida indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you are taking lenalidomida with other medications, you should consult the prospectus of those other medications for additional information on their use and effects.

Treatment Cycle

Lenalidomida is taken on certain days during a period of 3 weeks (21 days).

• A "treatment cycle" consists of 21 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each 21-day cycle, you must start a new "cycle" during the following 21 days.

Or

Lenalidomida is taken on certain days during a period of 4 weeks (28 days).

• A "treatment cycle" consists of 28 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each 28-day cycle, you must start a new "cycle" during the following 28 days.

How Much Lenalidomida Sun to Take

Before starting treatment, your doctor will indicate:

• what quantity of lenalidomida you should take;
• what quantity of other medications you should take with lenalidomida, if applicable;
• which days of the treatment cycle you should take each medication.

How and When to Take Lenalidomida Sun

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. In the event that the powder of a broken lenalidomida capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic bag, and dispose of them according to local requirements. Then, they should wash their hands well with water and soap.
• Pregnant women or those who suspect they may be pregnant should not handle the blister or capsule.
• The capsules can be taken with or without food.
• You should take lenalidomida approximately at the same time on scheduled days.

Taking this Medication

To remove the capsule from the blister:

• press only one end of the capsule so that it comes out through the foil.
• do not press in the center of the capsule as it could break.

Duration of Treatment with Lenalidomida Sun

Lenalidomida is taken in treatment cycles, each cycle lasting 21 or 28 days (see "Treatment Cycle" above). You should continue the treatment cycles until your doctor tells you to stop the treatment.

If you Take More Lenalidomida Sun than you Should

If you take more lenalidomida than prescribed, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you Miss a Dose of Lenalidomida Sun

If you forget to take lenalidomida at your usual time and

• less than 12 hours have passed: take the capsule immediately.
• more than 12 hours have passed: do not take the capsule. Take the next capsule the next day at the usual time.

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

If you Experience any of the Following Serious Adverse Effects, Stop Treatment with Lenalidomida Sun and Go to a Doctor Immediately, as you may Require Emergency Medical Treatment:

• Hives, rash, swelling of the eyes, mouth, or face, difficulty breathing or itching, which can be symptoms of serious allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction that can start as a rash in one area but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Generalized rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Consult your Doctor Immediately if you Notice any of the Following Serious Adverse Effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including in the bloodstream (sepsis).
• Bleeding (bleeding) or hematoma (bruise) not due to an injury.
• Chest pain (thoracic) or in the legs.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue that may be due to high calcium levels in the blood.

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

Other Adverse Effects

It is essential to note that a small number of patients may develop other types of cancer, and this risk may increase with lenalidomida treatment. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing lenalidomida.

Adverse effects very common(may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which can produce anemia, leading to fatigue and weakness.
• Skin rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, pain in the limbs.
• Generalized swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, and chills.
• Numbness, tingling, or prickling sensation in the skin, pain in hands or feet, dizziness, tremors.
• Decreased appetite, changes in taste.
• Increased pain, tumor size, or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, stomach acid.
• Low levels of potassium, calcium, or sodium in the blood.
• Decreased thyroid function.
• Leg pain (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism).
• Infections of all kinds, including sinusitis, lung infection, and upper respiratory tract infection.
• Difficulty breathing.
• Blurred vision.
• Eye opacity (cataracts).
• Kidney problems, including kidneys that do not function properly or are unable to maintain normal function.
• Abnormal results in liver tests.
• High values in liver test results.
• Changes in a blood protein that can produce artery swelling (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, mood changes, difficulty sleeping.
• Cough.
• Low blood pressure.
• A vague feeling of discomfort in the body, feeling unwell.
• Painful inflammation of the mouth, dry mouth.
• Dehydration.

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

• Destruction of red blood cells (hemolytic anemia).
• Certain types of skin tumors.
• Bleeding from the gums, stomach, or intestines.
• Increased blood pressure, slow, fast, or irregular heartbeat.
• Increased amount of a substance released after normal or abnormal destruction of red blood cells.
• Increased amount of a protein that indicates inflammation in the body.
• Darkening of skin color; change in skin color due to internal bleeding, usually caused by bruising; skin inflammation caused by blood accumulation; bruising.
• Increased uric acid in the blood.
• Skin rash, redness of the skin, cracked skin, scaling, or peeling of the skin, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Rhinorrhea.
• Strong increase or decrease in urine output compared to usual or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
• Difficulty having an erection.
• Stroke, fainting, vertigo (inner ear disorder that causes a sensation of everything spinning), temporary loss of consciousness.
• Chest pain that spreads to arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, nausea, or vomiting, which can be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Cervical pain, chest pain.
• Chills.
• Joint swelling.
• Slower or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Balance disturbance, movement difficulty.
• Deafness, ringing in the ears (tinnitus).
• Pain in nerves, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Fall that can cause injuries.

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

• Bleeding inside the skull.
• Circulatory problems.
• Vision loss.
• Loss of sexual desire (libido).
• Excretion of large amounts of urine with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome).
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, skin rash, pain, or swelling of the stomach; these can be symptoms of liver damage (liver failure).
• Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (called colitis or typhlitis).
• Kidney cell damage (called tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying cancer cells and can include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.
• Increased blood pressure in the blood vessels that supply the lungs (pulmonary hypertension).

Adverse effects of unknown frequency(cannot be estimated from available data):

• Sudden, mild, or worsening pain in the upper abdomen and/or back, which lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms can be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) have been observed, which can lead to kidney problems (rhabdomyolysis), some of which occur when lenalidomida is administered with a statin (a type of medication to reduce cholesterol).
• A disease that affects the skin, produced by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Rupture of the stomach or intestine wall. This can lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease that produces a painful rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).

• Rejection of solid organ transplants (such as kidney, heart).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lenalidomida Sun

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date shown on the blister and carton after "EXP". The expiration date is the last day of the month indicated.
• Store below 25°C.
• Do not use this medication if you observe visible signs of deterioration or undue handling.
• Medications should not be thrown away in drains or trash. Return unused medication to your pharmacist; this will help protect the environment.

6. Package Contents and Additional Information

Composition of Lenalidomida Sun

Lenalidomida Sun 2.5/10/20 mg hard capsules EFG:

• The active ingredient is lenalidomida. Each capsule contains 2.5/10/20 mg of lenalidomida, respectively.
• Other components are:

• Capsule content: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: titanium dioxide (E171), indigo carmine (E132), gelatin, and yellow iron oxide (E172).
• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Lenalidomida Sun 5/25 mg hard capsules EFG:

• The active ingredient is lenalidomida. Each capsule contains 5/25 mg of lenalidomida, respectively.
• Other components are:

• Capsule content: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: titanium dioxide (E171), gelatin.
• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Lenalidomida Sun 7.5 mg hard capsules EFG:

• The active ingredient is lenalidomida. Each capsule contains 7.5 mg of lenalidomida.
• Other components are:

• Capsule content: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: titanium dioxide (E171), gelatin, and yellow iron oxide (E172).
• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Lenalidomida Sun 15 mg hard capsules EFG:

• The active ingredient is lenalidomida. Each capsule contains 15 mg of lenalidomida.
• Other components are:

• Capsule content: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: titanium dioxide (E171), indigo carmine (E132), gelatin.
• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Appearance of the Product and Package Contents

Lenalidomida Sun 2.5 mg hard capsules EFG are hard gelatin capsules 14 mm in length, with a light greenish-blue opaque cap and a white opaque body, printed with “RL” on the cap and “78” on the body, and containing a white to off-white granular powder.

Lenalidomida Sun 5 mg hard capsules EFG are hard gelatin capsules 18 mm in length, with a white opaque cap and body, printed with “RL” on the cap and “79” on the body, and containing a white to off-white granular powder.

Lenalidomida Sun 7.5 mg hard capsules EFG are hard gelatin capsules 18 mm in length, with a pale yellow opaque cap and a white opaque body, printed with “RL” on the cap and “86” on the body, and containing a white to off-white granular powder.

Lenalidomida Sun 10 mg hard capsules EFG are hard gelatin capsules 21 mm in length, with a greenish-blue opaque cap and a pale yellow opaque body, printed with “RL” on the cap and “80” on the body, and containing a white to off-white granular powder.

Lenalidomida Sun 15 mg hard capsules EFG are hard gelatin capsules 21 mm in length, with a blue opaque cap and a white opaque body, printed with “RL” on the cap and “81” on the body, and containing a white to off-white granular powder.

Lenalidomida Sun 20 mg hard capsules EFG are hard gelatin capsules 21 mm in length, with a greenish-blue opaque cap and a blue opaque body, printed with “RL” on the cap and “82” on the body, and containing a white to off-white granular powder.

Lenalidomida Sun 25 mg hard capsules EFG are hard gelatin capsules 21 mm in length, with a white opaque cap and body, printed with “RL” on the cap and “83” on the body, and containing a white to off-white granular powder.

Lenalidomida Sun 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules EFG are available in packs containing 7, 14, 21, 28, or 42 capsules.

Lenalidomida Sun 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules EFG are available in packs containing 7 x 1, 14 x 1, 21 x 1, 28 x 1, or 42 x 1 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Terapia S.A.

124 Fabricii Street

400 632 Cluj Napoca,

Romania

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

+34 93 342 78 90

Date of Last Revision of this Leaflet:January 2024

Other Sources of Information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.aemps.gob.es/.