Package Insert: Information for the Patient

Lenalidomida Sandoz 2.5 mg Hard Capsules EFG

Lenalidomida Sandoz 5 mg Hard Capsules EFG

Lenalidomida Sandoz 10 mg Hard Capsules EFG

Lenalidomida Sandoz 15 mg Hard Capsules EFG

Lenalidomida Sandoz 20 mg Hard Capsules EFG

Lenalidomida Sandoz 25 mg Hard Capsules EFG

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

• Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, and you must 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 package insert. See section 4.

What is Lenalidomida Sandoz

Lenalidomida Sandoz contains the active ingredient lenalidomide. This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomida Sandoz is used for

Lenalidomide is used in adults for:

• Multiple myeloma.
• Myleodysplastic syndromes (MDS).
• mantle cell lymphoma (MCL).
• 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 usually not curable. However, the symptoms and signs can be greatly reduced or disappear for a period of time. This is called “remission”.

Multiple myeloma newly diagnosed: in patients who have undergone a bone marrow transplant

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

Multiple myeloma newly diagnosed: in patients who cannot be treated with a bone marrow transplant

Lenalidomide is taken with other medicines. These include:

• a chemotherapy medicine called “bortezomib”,
• a corticosteroid called “dexamethasone”.
• a chemotherapy medicine called “melphalan” and,
• a immunosuppressant called “prednisone”.

You will take these medicines when starting treatment and then continue taking lenalidomide 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

Lenalidomide is taken with a corticosteroid called “dexamethasone”.

Lenalidomide can slow the worsening 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.

Lenalidomide is used as monotherapy to treat adult patients diagnosed with MDS, when the following points are applicable:

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

Lenalidomide 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.

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 in the blood called “B lymphocytes” or B cells. MCL is a disease in which B cells grow uncontrollably and accumulate in lymphatic tissue, bone marrow, or blood. Lenalidomide is used as 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.

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

How lenalidomide works

Lenalidomide works by affecting the body's immune system and directly attacking cancer.

It acts in several ways:

• prevents the development of cancer cells,
• prevents the growth of blood vessels in cancer,
• stimulates part of the immune system to attack cancer cells.

You must read the leaflet accompanying all the medicines you are going to take in combination withLenalidomida Sandozbefore starting treatment withLenalidomida Sandoz.

Do not take Lenalidomida Sandoz:

• 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 on 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 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 take Lenalidomida Sandoz if:

• 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 had previously a viral infection, especially hepatitis B infection, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with lenalidomida may 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: facial or generalised rash, skin redness, high fever, flu-like symptoms,increased liver enzymes, blood abnormalities (eosinophilia),swollen lymph nodes (symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms DRESS, (see also section 4 “Possible side effects”).

If any of the above conditions apply to you, inform your doctor before starting treatment.

At any time during or after treatment, contact 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 can be symptoms of a serious and potentially fatal brain disease called multifocal progressive leukoencephalopathy (LMP). 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 can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with lenalidomida and during treatment, regular blood tests will be performed, as lenalidomida may cause a decrease in the white blood cells that help fight infections and platelets that participate in blood clotting.

Your doctor will ask you to have blood tests:

• before treatment,
• every week for 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 SMD who take lenalidomida

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

For patients with LCM who take lenalidomida

Your doctor will ask you to have blood tests:

• before treatment,
• every week for 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,
• at least once a month.

For patients with LF who take lenalidomida

Your doctor will ask you to have blood tests:

• before treatment,
• every week for 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 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 must 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 Sandoz

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, 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 inform your doctor immediately.

Men taking lenalidomida

• 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 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, 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 treatment ends) except if you have had a tubal ligation to prevent the egg from reaching 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 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 had a vasectomy. You must not donate semen or sperm during treatment or for at least 7 days after treatment ends.

Driving and operating machinery

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

Lenalidomida Sandoz contains lactose and sodium

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

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 is Lenalidomide Sandoz and what it 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 of 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.

Or

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 Sandoz 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 Sandoz

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. In the event that the powder from a broken 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, introduce them into a plastic bag of polyethylene, seal it, and dispose of it 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 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.

Medication intake

To remove the capsule from the blister pack:

• 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 Sandoz

Lenalidomide is taken in treatment cycles, each cycle lasts 21 or 28 days (see “Treatment cycle” above). You must continue the treatment cycles until your doctor informs you to stop treatment.

If you take more Lenalidomide Sandoz 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 forgot to take Lenalidomide Sandoz

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 lenalidomide 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 allergic reactions called angioedema and anaphylaxis.
• 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 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 symptom of infection, including sepsis in the bloodstream.
• Bleeding (hemorrhage) or hematoma (bruise) not caused by 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.

Lenalidomide 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. Lenalidomide 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 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):

• A decrease in the number of red blood cells, 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, pain in the extremities.
• 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, heartburn.
• Low levels of potassium, calcium, or sodium in the blood.
• Underactive thyroid.
• Chest pain (which could be a symptom of pulmonary embolism), difficulty breathing (which could be a symptom of pulmonary embolism).
• Infections of all types, including sinusitis, pneumonia, 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 levels of 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.
• Nosebleeds.
• Dry skin.
• Stomach pain.
• Depression, changes in mood, difficulty sleeping.
• Cough.
• Low blood pressure.
• A vague feeling of discomfort in the body, feeling unwell.
• Inflamed, painful mouth, dry mouth.
• Dehydration.

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

• Red blood cell destruction (hemolytic anemia)
• Certain types of skin cancer.
• 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 that indicates inflammation in the body.
• Darkening of the skin; change in skin color due to internal bleeding, usually caused by hematomas; skin inflammation caused by blood accumulation; hematoma.
• Increased uric acid levels in the blood.
• Rashes, redness of the skin, dry skin, peeling or exfoliating 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 normal 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 that causes the sensation of spinning), temporary loss of consciousness.
• Chest pain that radiates to arms, neck, jaw, spine, or stomach, sensation of sweating and shortness of breath, nausea or vomiting, which can be symptoms of a heart attack (myocardial infarction).
• 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 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.
• Dental pain.
• Fall that can 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 can be symptoms of kidney disease (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).
• Damage to kidney cells (necrotic tubular renal).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome, complications can 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 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.
• Pulmonary hypertension.

Unknown frequency(cannot be estimated from available data):

• Sudden, sharp, or worsening pain 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 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 can 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 caused 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.
• Rejection of solid organ transplants (such as kidney, heart).

Reporting of 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 theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and blisterafter “CAD/EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you notice any damage or signs of damage to the packaging seal.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

What Lenalidomida Sandoz contains

Lenalidomida Sandoz 2.5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other excipients are:
• Capule content: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capule coating: gelatin, titanium dioxide (E 171), indigo carmine (E 132) and yellow iron oxide (E 172).

• Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other excipients are:
• Capule content: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capule coating: gelatin and titanium dioxide (E 171).
• Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 10 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other excipients are:
• Capule content: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capule coating: gelatin, titanium dioxide (E 171), indigo carmine (E 132) and yellow iron oxide (E 172).

• Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 15 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other excipients are:
• Capule content: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capule coating: gelatin, titanium dioxide (E 171) and indigo carmine (E 132).

• Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 20 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other excipients are:
• Capule content: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capule coating: gelatin, titanium dioxide (E 171), indigo carmine (E 132) and yellow iron oxide (E 172).

• Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other excipients are:
• Capule content: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capule coating: gelatin and titanium dioxide (E 171).
• Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Appearance of the product and contents of the pack

Lenalidomida Sandoz 2.5 mg hard capsules:

White opaque body and green to light green opaque cap, approximately 14.3 mm in length, marked with “L9NL” and “2.5”.

Lenalidomida Sandoz 5 mg hard capsules:

White opaque body and white opaque cap, approximately 18.0 mm in length, marked with “L9NL” and “5”.

Lenalidomida Sandoz 10 mg hard capsules:

Yellow opaque body and green to light green opaque cap, approximately 21.7 mm in length, marked with “L9NL” and “10”.

Lenalidomida Sandoz 15 mg hard capsules:

White opaque body and blue to light blue opaque cap, approximately 21.7 mm in length, marked with “L9NL” and “15”.

Lenalidomida Sandoz 20 mg hard capsules:

Blue to light blue opaque body and green to light green opaque cap, approximately 21.7 mm in length, marked with “L9NL” and “20”.

Lenalidomida Sandoz 25 mg hard capsules:

White opaque body and white opaque cap, approximately 21.7 mm in length, marked with “L9NL” and “25”.

The hard capsules are packaged in:

OPA/Al/PVC/Al blisters

OPA/Al/PVC/Al calendarised blisters

OPA/Al/PVC/Al perforated unit blisters

OPA/Al/PVC/Al perforated unit calendarised blisters

Pack sizes:

OPA/Al/PVC/Al blisters: packs containing 7, 14, 21, 28, 42 hard capsules.

OPA/Al/PVC/Al calendarised blisters: packs containing 7, 14, 21, 28 and 42 hard capsules in 1, 2, 3, 4 and 6 calendarised blisters of 7 hard capsules each.

OPA/Al/PVC/Al perforated unit blisters: packs containing 7 x 1, 14 x 1, 21 x 1, 28 x 1 hard capsules.

OPA/Al/PVC/Al perforated unit calendarised blisters: packs containing 7 x 1, 14 x 1, 21 x 1, 28 x 1 hard capsules.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible person for manufacturing

Synthon B.V.

Microweg 22

6545 CM

Nijmegen

Netherlands

or

Synthon Hispania, S.L.

C/ Castelló, nº 1

Sant Boi de Llobregat

08830 Barcelona

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Alle 1

39179 Barleben

Germany

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:Lenalidomid HEXAL 2.5mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg Hartkapseln

Croatia:Lenalidomid Sandoz 2.5 mg/10 mg/15 mg/25 mg tvrde capsule

Denmark:Lenalidomida Sandoz

Slovakia:Lenalidomid Sandoz 2.5 mg/ 5 mg/10 mg/15 mg/ 25 mg

Slovenia:Lenalidomid Sandoz 2.5 mg/ 5 mg/ 7.5 mg/10 mg/15 mg/20 mg/25 mgtrde kapsule

Estonia:Lenalidomide Sandoz

Spain:Lenalidomida Sandoz 2.5 mg/5 mg/10 mg/15 mg/20 mg/25 mg hard capsules EFG

Finland:Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg kapselit, kovat

France:LENALIDOMIDE SANDOZ 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg, gélule

Greece:Lenalidomide/Sandoz

Netherlands:Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg, harde capsules

Iceland:LenalidomideSandoz 2.5 mg hörð hylki

Italy:Lenalidomide Sandoz

Latvia:Lenalidomide Sandoz 2.5 mg/5 mg/10 mg/15 mg/25 mg cietas kapsulas

Norway:Lenalidomide Sandoz

Poland:Lenalidomide Sandoz

Romania:Lenalidomida Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg capsule

Sweden:Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg hard capsules

United Kingdom (Northern Ireland):Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules

Last update of this leaflet: 06/2023.

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/