Product Information for the User

Lenalidomida Sun 2.5 mg Hard Capsules EFG

Lenalidomida Sun 5 mg Hard Capsules EFG

Lenalidomida Sun 7.5 mg Hard Capsules EFG

Lenalidomida Sun 10 mg Hard Capsules EFG

Lenalidomida Sun 15 mg Hard Capsules EFG

Lenalidomida Sun 20 mg Hard Capsules EFG

Lenalidomida Sun 25 mg Hard Capsules EFG

lenalidomida

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Lenalidomida Sun

3. How to take Lenalidomida Sun

4. Possible side effects

5. Storage of Lenalidomida Sun

6. Contents of the pack and additional information

What isLenalidomida Sun

Lenalidomida Sun contains the active ingredient “lenalidomida”. This medicine belongs to a group of medicines that affect how the immune system works.

What is Lenalidomida Sun used forLenalidomida Sun

Lenalidomida is used in adults for:

• Multiple myeloma
• Myleodysplastic syndromes (MDS)
• Diffuse large B-cell lymphoma (DLBCL)
• Follicular lymphoma

Multiple myeloma

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

Multiple myeloma is generally incurable. However, the symptoms and signs can be significantly reduced or disappear for a period of time. This is called “remission”.

Multiple myeloma: newly diagnosed patients: after a bone marrow transplant

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

Multiple myeloma: newly diagnosed patients: who cannot undergo a bone marrow transplant

Lenalidomida is taken with other medicines, including:

• A chemotherapy medicine called “bortezomib”;
• An anti-inflammatory medicine called “dexametasona”
• A chemotherapy medicine called “melfalán” and
• An immunosuppressant called “prednisona”.

You will take these medicines when starting treatment and then continue taking lenalidomida alone.

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

Multiple myeloma: previously treated patients

Lenalidomida is taken with an anti-inflammatory medicine called “dexametasona”.

Lenalidomida can slow the progression of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myleodysplastic syndromes (MDS)

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

Lenalidomida is used to treat adult patients diagnosed with MDS, when all the following points are applicable:

• They need periodic blood transfusions to treat low red blood cell levels (“anemia-dependent transfusions”);
• They have a bone marrow cell abnormality called “isolated deletion 5q cytogenetic anomaly”. This means their body does not produce enough healthy blood cells;
• Other treatments they have used previously are not suitable or do not work well enough.

Lenalidomida can increase the number of healthy red blood cells produced by the body by reducing the number of abnormal cells:

• This can reduce the number of blood transfusions needed. It may be possible to avoid transfusions.

Diffuse large B-cell lymphoma (DLBCL)

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

Lenalidomida is used in monotherapy 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 store too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomida is used with another medicine called “rituximab” for the treatment of adult patients who have received previous treatment for follicular lymphoma.

How it worksLenalidomida Sun

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

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

You should read the leaflet for all the medicines you are going to take in combination with Lenalidomida Sun before starting treatment with this medicine.

Do not takeLenalidomida Sun:

• if you are pregnant, think you may be pregnant or intend to become pregnant,since lenalidomida 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 follow all the necessary measures to avoid it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you can become pregnant, your doctor will note with each prescription that all necessary measures have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomida or to any of the other components ofthis medicine (included in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take lenalidomida. In case of doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to takeLenalidomida Sunif:

• you have ever had blood clots; during treatment, you have a higher risk of presenting blood clots in veins and arteries;
• you have any sign of infection, such as cough or fever;
• you have or have previously had a viral infection, especially hepatitis B infection, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment withlenalidomidamay make the virus become active again in patients who are carriers of the virus, leading to the reappearance of the infection. Your doctor must check if you have ever had a hepatitis B infection;
• you have kidney problems; your doctor may adjust your lenalidomida dose;
• 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 multiple myeloma), such as skin rash, itching, swelling, dizziness or respiratory problems;
• you have experienced in the past a combination of any of the following symptoms: generalized rash, skin redness, high body temperature, flu-like symptoms,increased liver enzymes, blood abnormalities (eosinophilia) swollen lymph nodes (these are symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS by its English acronym or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above alterations apply to you, inform your doctor, pharmacist or nurse before starting treatment.

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

• blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. All of them may be symptoms of a severe and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with lenalidomida, inform your doctor if you notice any change in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with lenalidomida and during the same, blood tests will be performed regularly, as lenalidomida may cause a decrease in the blood cells that help fight infections (white blood cells) and those that participate in coagulation (platelets).

Your doctor will ask you to have a blood test:

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

You may be evaluated to detect signs of cardiopulmonary problems before and during treatment with lenalidomida.

For patients with MDS who take Lenalidomida Sun

If you have MDS, you may be more prone to developing a more advanced disease called acute myeloid leukemia (AML). Additionally, it is unknown how lenalidomida affects your chances of developing AML. Your doctor may perform analyses to detect signs that may better predict your chances of developing AML during treatment with lenalidomida.

For patients with MCL who take Lenalidomida Sun

Your doctor will ask you to have a blood test:

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

• after that, it will be done at the beginning of each cycle and
• at least once a month.

For patients with MM who take Lenalidomida Sun

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 3 weeks (1 cycle) of treatment;
• subsequently, every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information);
• after that, it will be done at the beginning 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 disease in which the tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may cause kidney failure (this disease is called “tumor lysis syndrome”).

Your doctor may examine you to check if any changes have occurred in your skin, such as red spots or skin rashes.

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

Blood donation

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

Children and adolescents

The use of lenalidomida is not recommended in children and adolescents under 18 years old.

Older adults and patients with kidney problems

If you are 75 years old or more or have moderate to severe kidney problems, your doctor will carefully examine you before starting treatment.

Other medicines and Lenalidomida Sun

Inform your doctor or nurse if you are taking, have taken recently or may need to take any other medicine. This is because lenalidomida may affect how other medicines work. Additionally, some medicines may affect how lenalidomida works.

Specifically, inform 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 to treat 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 Lenalidomida Sun

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

Men taking Lenalidomida Sun

• If your partner becomes pregnant while you are taking lenalidomida, you must inform your doctor immediately. It is recommended that your partner seek medical advice.
• You should also use effective contraceptive methods (see “Contraception”).

Breastfeeding

You should not breastfeed while taking lenalidomida, as it is unknown whether lenalidomida passes into breast milk.

Contraception

For women taking Lenalidomida Sun

Before starting treatment, ask your doctor if you are capable of becoming pregnant, even if you think this 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 finishing treatment) except that tubal ligation has been confirmed so that eggs do not reach the uterus (tubal ligation).

And

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

For men taking Lenalidomida Sun

Lenalidomida passes into human semen. If your partner becomes pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after finishing treatment, even if you have undergone a vasectomy.You should not donate semen or sperm during treatment and for at least 7 days after finishing treatment.

Driving and using machines

You should not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking lenalidomida.

Lenalidomida Sun contains lactose

This medicine contains lactose. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

Lenalidomide should be administered by a healthcare professional with experience in the treatment of multiple myeloma, SMD, LCM or LF.

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

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

If you are taking lenalidomide with other medications, you must consult the leaflet of those other medications to obtain additional information on their use and effects.

Treatment Cycle

Lenalidomide is taken on certain days during the 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 cycle of 21 days, you must start a new “cycle” during the following 21 days.

O

Lenalidomide is taken on certain days during the 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 cycle of 28 days, you must start a new “cycle” during the following 28 days.

How much Lenalidomide Sun to take

Before starting treatment, your doctor will indicate:

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

How and when to take Lenalidomide Sun

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

Administration of 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 may break.

Duration of treatment with Lenalidomide Sun

Lenalidomide 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 informs you to stop treatment.

If you take more Lenalidomide Sun than you should

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

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

If you forget to take Lenalidomide Sun

If you forget to take lenalidomide 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 thismedication, ask your doctororpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, stop taking Lenalidomida Sun and seek medical attention immediately, as it may require emergency medical treatment:

• Urticaria, rashes, swelling of the eyes, mouth, or face, difficulty breathing or itching, which can be symptoms of severe types of 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 body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Seek medical attention immediately if you notice any of the following serious side effects:

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

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

Other side effects

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

Side effectsvery common(may affect more than 1 in 10 people):

• Decreased red blood cell count, which can cause anemia leading to fatigue and weakness.
• Rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
• 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, hand or foot pain, dizziness, tremors.
• Decreased appetite, changes in the taste of things.
• Increased pain, tumor size, or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, acid reflux.
• Low levels of potassium, calcium, or sodium in the blood.
• Underactive 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 types, including sinusitis, lung infection, and upper respiratory tract infections.
• Difficulty breathing.
• Blurred vision.
• Cataracts.
• Renal problems, including kidneys that do not function correctly or are unable to maintain normal function.
• Abnormal liver test results.
• High liver test results.
• Changes in a blood protein that can cause swelling of the arteries (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Headache.
• Nasal bleeding.
• Dry skin.
• Depression, changes in mood, difficulty sleeping.
• Cough.
• Low blood pressure.
• A vague feeling of discomfort in the body, feeling unwell.
• Inflammatory pain in the mouth, dry mouth.
• Dehydration.

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

• Red blood cell destruction (hemolytic anemia).
• Certain types of skin tumors.
• Bleeding from the gums, stomach, or intestines.
• Increased blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance released after normal or abnormal destruction of red blood cells.
• Increased levels of a type of protein indicating inflammation in the body.
• Darkening of the skin color; change in skin color due to internal bleeding, usually caused by hematomas; inflammation of the skin caused by blood accumulation; hematoma.
• Increased uric acid levels in the blood.
• Rashes, redness of the skin, dry skin, peeling or exfoliation of the skin, urticaria.
• Increased sweating, nocturnal sweating.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Nasal discharge.
• Significant 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 achieving an erection.
• Stroke, fainting, vertigo (inner ear disorder causing the sensation of everything spinning), temporary loss of consciousness.
• Chest pain extending to arms, neck, jaw, spine, or stomach, sensation of sweating and lack of air, nausea, or vomiting, which can be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Neck pain, chest pain.
• Chills.
• Joint swelling.
• Bile flow from the liver slowed or blocked.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Balance disorder, difficulty moving.
• Deafness, tinnitus (ringing in the ears).
• Nerve pain, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Fall that can cause injuries.

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

• Bleeding in the skull.
• Circulatory problems.
• Loss of vision.
• Loss of libido (sex drive).
• Expulsion of large amounts of urine with bone pain and weakness, which can be symptoms of kidney disorder (Fanconi syndrome).
• Yellow pigmentation in the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching skin, rash, stomach pain, or swelling; these can be symptoms of liver damage (hepatic insufficiency).
• Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (colitis or typhlitis).
• Kidney cell damage (renal tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome – complications may occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of tumor cells that die and may include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which generate changes in renal function and heart rhythm, seizures, and sometimes death.
• Increased blood pressure within the blood vessels that irrigate the lungs (pulmonary hypertension).

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

• Sudden, or mild pain that worsens in the upper stomach and/or back, lasting several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis inflammation.
• Whistling or ringing in the lungs, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle degradation (pain, weakness, or swelling) that may 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 affecting the skin produced by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Perforation of the stomach or intestine wall. This can lead to a very serious infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viruses, including herpes zoster (also known as shingles, a viral disease that causes painful skin rash with blisters) and the reappearance of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, right-sided stomach pain, fever, and nausea or feeling sick).

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the blister pack and the box after “CAD”/“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 signs of improper handling.
• Medications should not be disposed of through drains or in the trash. Return unused medication to your pharmacist, thereby helping to protect the environment.

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.
• The other components are:

• Filler of the capsules: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: 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.
• The other components are:

• Filler of the capsules: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: 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.
• The other components are:

• Filler of the capsules: lactose monohydrate (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capsule coating: 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.
• The other components are:

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

Appearance of the product and contents of the pack

Lenalidomida Sun 2.5 mg hard capsules EFGare hard gelatin capsules of 14 mm in length, with a blue-green 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 EFGare hard gelatin capsules of 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 EFGare hard gelatin capsules of 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 EFGare hard gelatin capsules of 21 mm in length, with a blue-green 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 EFGare hard gelatin capsules of 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 EFGare hard gelatin capsules of 21 mm in length, with a blue-green 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 EFGare hard gelatin capsules of 21 mm in length, with a white opaque cap and a white opaque 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 supplied 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 supplied 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.

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible for manufacturing

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 the last review of this leaflet:January 2024

Other sources of information

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