Leaflet: information for the user

Lenalidomida Zentiva 5 mg hard capsules EFG

lenalidomida

Read this 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 Zentiva is and what it is used for

2. What you need to know before taking Lenalidomida Zentiva

3. How to take Lenalidomida Zentiva

4. Possible side effects

5. Storage of Lenalidomida Zentiva

6. Contents of the pack and additional information

What isLenalidomidaZentiva

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

What is LenalidomidaZentiva used for

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 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

Lenalidomida 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

Lenalidomida is taken with other medicines:

• 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 only.

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 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.

Lenalidomida is used to treat adult patients diagnosed with MDS, when all 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;
• previous treatments you have used 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 that no transfusions are needed.

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 Lenalidomida Zentiva works

Lenalidomida acts by affecting the body's immune system and directly attacking cancer.

It acts in several ways:

• stops the development of cancer cells
• stops the growth of blood vessels in cancer
• 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 the treatment with lenalidomida.

Do not take Lenalidomida Zentiva:

• if you are pregnant, think you may be pregnant or intend to become pregnant, as 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 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 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, 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 for example 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 fever, 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 by its English acronym or drug hypersensitivity syndrome), (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, 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 can 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 can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with lenalidomida and during it, you will have regular blood tests, 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 for 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 Zentiva

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 the likelihood of developing AML. Your doctor may perform tests to detect signs that may better predict the likelihood of developing AML during treatment with lenalidomida.

For patients with MCL who take Lenalidomida Zentiva

Your doctor will ask you to have a blood test:

• 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 MM who take Lenalidomida Zentiva

Your doctor will ask you to have a blood test:

• 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 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 must not donate blood during treatment or for 1 week after the end of treatment.

Children and adolescents

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

Older people and people with kidney problems

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

Taking Lenalidomida Zentiva with other medicines

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

In particular, 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 Zentiva

• 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” below).
• If you become pregnant during treatment with lenalidomida, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida Zentiva

• 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” below).

Breastfeeding

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

Contraception

For women taking Lenalidomida Zentiva

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, every 4 weeks during treatment and 4 weeks after finishing treatment) except that you have had a tubal ligation to prevent the egg from reaching the uterus (tubal ligation)

And

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

For men taking Lenalidomida Zentiva

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 1 week after finishing treatment, even if you have had a vasectomy.

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 Zentiva contains lactose

This medicine contains lactose. 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 experienced 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).
• 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 prospectus 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 Zentiva 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 Zentiva

• 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 must use disposable gloves when handling the blister or capsule. After that, the gloves must be removed carefully to avoid skin exposure, placed in a sealed polyethylene plastic bag and disposed of in accordance with local requirements. Hands must be washed well with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister or capsule.
• the capsules can be taken with or without food.
• you should take 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 Zentiva

Lenalidomide is taken in treatment cycles, each cycle lasting 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 Zentiva 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

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, lenalidomide can cause side effects, although not everyone will experience them.

Stop taking lenalidomide and consult a doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment:

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

- A severe allergic reaction that can start as a rash in an area but spread with a large loss of skin throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).

- Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ dysfunction (pharmacological reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome). See also section 2.

Inform your doctor immediatelyif you experience any of the following adverse reactions:

• fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including sepsis in the bloodstream
• bleeding (bleeding) or hematoma (bruise) not due to injury
• chest pain (thoracic) or leg pain
• difficulty breathing
• bone pain, muscle weakness, confusion, or fatigue that may be due to high blood calcium levels.

Lenalidomide can reduce the number of white blood cells (blood cells that fight infections),red blood cells (blood cells that transport oxygen)and also platelets (cells that help blood to clot).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 it is possible that this risk may increase with lenalidomide treatment. Therefore, your doctor must carefully evaluate the benefits and risks of prescribing lenalidomide to you.

Side effectsvery common(can 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.
• skin 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, cough, and chills.
• numbness, tingling, or prickling sensation in the skin, hand or foot pain, dizziness,
• loss of 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.
• thyroid function lower than it should be.
• 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).
• any type of infection, including sinusitis, pneumonia, and upper respiratory tract infections.
• difficulty breathing.
• blurred vision.
• eye opacity (cataracts).
• kidney problems, including kidneys that do not function properly or are unable to maintain normal function.
• abnormal liver test results.
• high values in liver test results.
• changes in a blood protein that can cause swelling of the arteries (vasculitis).
• high blood sugar levels (diabetes).
• low blood sugar levels.
• headache.
• nosebleed.
• dry skin.
• depression, changes in mood, difficulty sleeping.
• cough.
• low blood pressure.
• a vague feeling of discomfort in the body, feeling unwell.
• inflammation and pain in the mouth, dry mouth.
• dehydration.

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

• destruction of red blood cells (hemolytic anemia).
• certain types of skin tumors.
• bleeding from the gums, stomach, or intestines.
• increased blood pressure, slow, fast, or irregular heartbeat.
• increased 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 color; 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.
• skin rashes, redness of the skin, dry skin, peeling or exfoliation of the skin, hives.
• increased sweating, nocturnal sweating.
• difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• nasal discharge.
• marked increase or decrease in urine production 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 everything 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).
• muscle weakness, lack of energy.
• neck pain, chest pain.
• chills.
• joint swelling
• slower or blocked bile flow from the liver.
• low levels of phosphorus, magnesium, or calcium in the blood.
• difficulty speaking.
• liver damage.
• balance disorder, difficulty moving.
• hearing loss, tinnitus.
• nerve pain, abnormal and unpleasant sensation, especially when touched.
• excess iron in the body.
• thirst.
• confusion.
• toothache.
• fall that can cause injuries.

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

• intracranial 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, 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 (renal tubular necrosis).
• 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.
• increased blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

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 a rapid pulse. These symptoms may be due to pancreatitis.
• whistling or ringing in the lungs, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue.
• there have been 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).
• rupture 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.
• viral infections, including herpes zoster (also known as shingles, a viral disease that causes a 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 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 Medicines Vigilance System for Human Use: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.

This medication does not require special conditions for conservation.

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. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Lenalidomida Zentiva5 mg hard EFG capsules

• The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.

• The other components are:

• Capule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
• Capule coating: brilliant blue FCF (E133), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171) and gelatin
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide and iron oxide black (E172)

Appearance of the product and contents of the package

The 5 mg hard capsules have an opaque green cap and a light brown opaque body, with a capule size of 2, 18-19 mm, printed in black ink with “LP” on the cap and “638” on the body.

The capsules are presented in carton boxes with PVC/PCTFE/Aluminium blisters of 7 capsules each.

21 capsules in PVC/PCTFE/Aluminium blisters.

21x1 capsules in perforated single-dose PVC/PCTFE/Aluminium blisters.

7 capsules in PVC/PCTFE/Aluminium blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Zentiva k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Responsible person for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:
Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

IslandiaLenalidomid Aristo 5 mg hörð hylki

AustriaLenalidomid Aristo 5 mg Hartkapseln

CroatiaLenalidomid Aristo 5 mg tvrde kapsule

DenmarkLenalidomid Aristo

GermanyLenalidomid Aristo 5 mg Hartkapseln

ItalyLenalidomid Aristo

NorwayLenalidomid Aristo 5 mg harde kapsler

SpainLenalidomida Zentiva 5 mg cápsulas duras EFG

SwedenLenalidomid Aristo 5 mg hårda kapslar

Last revision date of this leaflet:July 2022

Further 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/