Prospect: Information for the user

Lenalidomida Aurovitas 5 mg hard capsules EFG

Lenalidomida Aurovitas 10 mg hard capsules EFG

Lenalidomida Aurovitas 15 mg hard capsules EFG

Lenalidomida Aurovitas 20 mg hard capsules EFG

Lenalidomida Aurovitas 25 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What isLenalidomida Aurovitasand for what it is used

2.What you need to know before starting totakeLenalidomida Aurovitas

3.How to takeLenalidomida Aurovitas

4.Possible adverse effects

5.Storage ofLenalidomida Aurovitas

6.Contents of the package and additional information

What is Lenalidomida Aurovitas

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

For what it is usedLenalidomida Aurovitas

Lenalidomida is used in adults for:

•Multiple myeloma

•Myelodysplastic syndromes (MDS)

•Castleman's disease (LCD)

•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 generally does not have a cure. However, it is possible to significantly reduce symptoms and signs or make them disappear for a period of time. This is called “remission”.

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

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

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

Lenalidomida is taken with other medicines, including:

•A chemotherapy medicine called “bortezomib”

•An anti-inflammatory 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: in previously treated patients

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

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

Myelodysplastic 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 the following points are applicable:

•They need periodic blood transfusions to treat low red blood cell levels (“transfusion-dependent anemia”).

•They have a bone marrow cell abnormality called “isolated 5q deletion 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.

Castleman's disease (LCD)

Castleman's disease 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. Castleman's disease 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 suffers from 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 Lenalidomida Aurovitas works

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 must read the leaflet for all the medicines you are going to take in combination with lenalidomida before starting treatment with this medicine.

Do not take Lenalidomida Aurovitas

•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, lactation 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, lactation 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 of this medicine (including 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 take Lenalidomida Aurovitas if:

•you have ever had blood clots; during treatment, you have a higher risk of developing 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, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with lenalidomida may cause the virus to become active again in patients who are carriers of the virus. This leads 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: generalised rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome 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, 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 these may 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 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 serious condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with lenalidomida and during treatment, you will have regular blood tests. This is because lenalidomida can cause a decrease in the blood cells that help fight infections (white blood cells) and those involved in blood clotting (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 once a month.

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

For patients with MDS who take lenalidomida

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 tests to detect signs that may better predict your likelihood of developing AML during treatment with lenalidomida.

For patients with MM who take lenalidomida

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)

•then, at the start of each cycle and

•at least once a month

For patients with FL who take lenalidomida

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)

•then, at the start of each cycle and

•at least once a 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 patches 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

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

Older patients and individuals with kidney problems

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

Other medicines and Lenalidomida Aurovitas

Inform your doctor or nurse if you are taking, have recently taken 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, lactation and contraception: information for women and men

Pregnancy

Women taking lenalidomida

•You must not take lenalidomida if you are pregnant, as it is expected to be harmful to the fetus.

•You must 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 immediately inform your doctor.

Men taking lenalidomida

•If your partner becomes pregnant while you are taking lenalidomida, you must immediately inform your doctor. It is recommended that your partner seek medical advice.

•You must also use effective contraceptive methods (see “Contraception”).

Lactation

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

Contraception

For women taking lenalidomida

Before starting treatment, ask your doctor if you are capable of becoming pregnant, although you may 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 treatment ends) except that tubal ligation has been confirmed so that the eggs do not reach the uterus.

And

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

For men taking lenalidomida

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 treatment ends, even if you have undergone a vasectomy. You must not donate semen or sperm during treatment or for at least 7 days after treatment ends.

Driving and using machines

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

Lenalidomida Aurovitas 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.

Lenalidomida Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is, essentially “sodium-free”.

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 undergone other treatments before, it is taken with other medications (see section 1 “What Lenalidomide Aurovitas is used for”).

•When lenalidomide is used for the treatment of multiple myeloma in patients who have received 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 of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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 next 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 next 28 days.

How much Lenalidomide Aurovitas 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.

•what days of the treatment cycle you should take each medication.

How and when to take Lenalidomide Aurovitas

•Swallow the capsules whole, preferably with water.

•Do not break, open, or chew the capsules. In the event that the powder from a broken lenalidomide 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 pack or capsule. Subsequently, they should carefully remove the gloves to avoid skin exposure, place them in a plastic polyethylene bag, and dispose of them in accordance with local requirements. Then, they should 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 each day on the scheduled days.

Administration of this medication

To remove the capsule from the blister pack:

•Press only one end of the capsule to allow it to come out through the foil.

•Do not press in the center of the capsule as it may break.

Duration of treatment with Lenalidomide Aurovitas

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 Aurovitas 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 Aurovitas

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 your usual time.

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

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 lenalidomide and seek medical attention immediately, as it may require emergency medical treatment:

•Hives, rashes, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis.

•Severe allergic reaction that may 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 section 2).

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

•Fever, chills, sore throat, cough, mouth ulcers, or any other symptoms of infection, including in the bloodstream (sepsis).

•Bleeding (hemorrhage) or hematoma (bruise) not due to injury.

•Chest pain (thoracic) or leg pain.

•Difficulty breathing.

•Muscle pain, confusion, or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomide may reduce the number of white blood cells that fight infections and also the cells in the blood that help to clot (platelets), which may cause bleeding disorders such as nosebleeds and bruises. Lenalidomide may 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 this risk may increase with lenalidomide treatment. Therefore, your doctor must carefully evaluate the benefits and risks of prescribing lenalidomide.

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

•Decreased red blood cell count, which may 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 pseudogripal symptoms that include fever, muscle pain, headache, ear pain, cough, and chills.

•Numbness, tingling, or prickling sensation in the skin, hand or foot pain, dizziness, tremor.

•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, heartburn.

•Low levels of potassium, calcium, or sodium in the blood.

•Decreased thyroid function.

•Leg pain (which may be a symptom of thrombosis), chest pain, or difficulty breathing (which may 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 that include kidneys that do not function correctly or are unable to maintain normal function.

•Abnormal liver test results.

•High values in liver test results.

•Changes in a blood protein that may cause swelling of the arteries (vasculitis).

•Increased blood sugar levels (diabetes).

•Decreased blood sugar levels.

•Headache.

•Nosebleeds.

•Dry skin.

•Depression, changes in mood, difficulty sleeping.

•Cough.

•Low blood pressure.

•A vague feeling of discomfort in the body, feeling unwell.

•Inflammation of 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 of 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 that indicates inflammation in the body.

•Darkening of the skin; change in skin color due to internal bleeding, usually caused by hematomas; inflammation of the skin caused by the accumulation of blood; hematoma.

•Increased uric acid levels in the blood.

•Rashes, redness of the skin, skin cracking, peeling, or exfoliation, hives.

•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 normal or inability to control urination.

•Blood in the urine.

•Difficulty breathing, especially when lying down (which may be a symptom of heart failure).

•Difficulty achieving an erection.

•Stroke, fainting, vertigo (inner ear disorder that causes the sensation of everything spinning), temporary loss of consciousness.

•Chest pain that radiates to arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, nausea or vomiting, which may 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 problems, difficulty moving.

•Deafness, tinnitus (ringing in the ears).

•Nerve pain, abnormal and unpleasant sensation, especially when touched.

•Excess iron in the body.

•Thirst.

•Confusion.

•Dental pain.

•Fall, which may cause injuries.

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

•Brain hemorrhage.

•Circulatory problems.

•Loss of vision.

•Loss of libido (sex drive).

•Expulsion of large amounts of urine with bone pain and weakness, which may be symptoms of kidney disorder (Fanconi syndrome).

•Yellow pigmentation of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, skin itching, rash, stomach pain, or swelling; these may be symptoms of liver damage (hepatic insufficiency).

•Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis).

•Renal cell damage (necrotic tubular renal).

•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 potassium levels, high phosphorus levels, high uric acid levels, and low calcium levels, which generate changes in renal function and heart rhythm, seizures, and sometimes death.

•Increased blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

Side effects ofunknown 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.

•Wheezing or tinnitus while breathing, difficulty breathing, or dry cough, which may 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 lenalidomide 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).

•Perforation of the stomach or intestine wall. This may 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 a painful skin rash with blisters) and the reactivation of hepatitis B infection (which may 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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: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 packaging and blister, after “CAD”. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition ofLenalidomide Aurovitas

-The active ingredient is lenalidomide.

Each hard capsule contains 5 mg of lenalidomide.

Each hard capsule contains 10 mg of lenalidomide.

Each hard capsule contains 15 mg of lenalidomide.

Each hard capsule contains 20 mg of lenalidomide.

Each hard capsule contains 25 mg of lenalidomide.

-The other components are:

Hard capsule content:lactose, microcrystalline cellulose (grade 102), sodium croscarmellose and magnesium stearate.

Hard capsule coating:titanium dioxide (E171), yellow iron oxide (E172) (only for 10 mg and 20 mg),indigo carmine (E132)(only for 10 mg), red iron oxide (E172) (only for 10 mg, 15 mg and 20 mg) and gelatin.

Printing ink:Shellac lacquer, black iron oxide (E172), potassium hydroxide.

Appearance of the product and packaging content

Lenalidomide Aurovitas 5 mg hard capsules EFG[approximately 17.8 mm in size]

Hard gelatin capsule of size “2”, with a white opaque cap and a white opaque body, with “L5” printed on the cap in black ink, filled with a white or pale yellow powder.

Lenalidomide Aurovitas 10 mg hard capsules EFG[approximately 21.4 mm in size]

Hard gelatin capsule of size “0”, with a greenish olive opaque cap and a orange opaque body, with “L10” printed on the cap in black ink, filled with a white or pale yellow powder.

Lenalidomide Aurovitas 15 mg hard capsules EFG[approximately 21.4 mm in size]

Hard gelatin capsule of size “0”, with a dark orange opaque cap and a dark orange opaque body, with “L15” printed on the cap in black ink, filled with a white or pale yellow powder.

Lenalidomide Aurovitas 20 mg hard capsules EFG[approximately 21.4 mm in size]

Hard gelatin capsule of size “0”, with a orange opaque cap and a orange opaque body, with “L20” printed on the cap in black ink, filled with a white or pale yellow powder.

Lenalidomide Aurovitas 25 mg hard capsules EFG[approximately 21.4 mm in size]

Hard gelatin capsule of size “0”, with a white opaque cap and a white opaque body, with “L25” printed on the cap in black ink, filled with a white or pale yellow powder.

Packaging sizes:

Blister:7, 14, 21, 28 and 42 hard capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorized in the European Economic Area member states with the following names:

Germany:Lenalidomid PUREN 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mgHard capsules

Belgium:Lenalidomide AB 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg,gélules, Hartkapseln

Spain:Lenalidomida Aurovitas 5 mg/10 mg/15 mg/20 mg/25 mghard capsules EFG

France:Lenalidomide Arrow 2.5 mg, 5 mg, 7.5 mg,10 mg, 15 mg, 20 mg & 25 mg, gélules

Netherlands:LenalidomideEugia2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg, 25 mg, harde capsules

Poland:LenalidomideEugia

Portugal:LenalidomidaGeneris

Last review date of this leaflet:July 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).