Prospecto:Information for the Patient

LenaLidomida Teva 5 mg Hard Capsules EFG

LenaLidomida Teva 10 mg Hard Capsules EFG

LenaLidomida Teva 15 mg Hard Capsules EFG

LenaLidomida Teva 20 mg Hard Capsules EFG

LenaLidomida Teva 25 mg Hard Capsules EFG

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication 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 prospectus. See section 4.

1.What is LenaLidomida Teva and what is it used for

2.What you need to know before starting to take LenaLidomida Teva

3.How to take LenaLidomida Teva

4.Possible adverse effects

5.Storage of LenaLidomida Teva

6.Contents of the package and additional information

What is Lenalidomida Teva

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

This medicine affects how the immune system works.

What Lenalidomida Teva is used for

Lena lidomida Teva is used in adults for:

• Multiple myeloma
• Myleodysplastic 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 usually does not have a cure. 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

Lena lidomida Teva 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

Lena lidomida Teva 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 Lena lidomida Teva only.

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

Multiple myeloma: in previously treated patients

Lena lidomida Teva is taken with an anti-inflammatory called “dexametasona”.

Lena lidomida Teva 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.

Lena lidomida Teva 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 5q deletion 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.

Lena lidomida Teva 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.

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.

Lena lidomida Teva 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.

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

How Lenalidomida Teva works

Lena lidomida Teva 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 cancer
• It stimulates part of the immune system to attack cancer cells.

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

Do not take Lenalidomida Teva

• if you are pregnant, think you may be pregnant or intend to become pregnant, as Lenalidomida Teva 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 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 (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 Teva. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Lenalidomida Teva if

• you have ever had blood clots; during treatment, you have a higher risk of presenting blood clots in the 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 Teva may make the virus 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 dose of Lenalidomida Teva.
• 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 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 by its English acronym or drug hypersensitivity syndrome).

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

Inform your doctor or nurse immediately if:

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

Analysis and tests

Before starting treatment with Lenalidomida Teva and during the same, blood tests will be done regularly. This is because Lenalidomida Teva 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 SMD who take Lenalidomida Teva

If you have SMD, you may be more prone to developing a more advanced disease called acute myeloid leukemia (AML). In addition, it is unknown how Lenalidomida Teva 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 Teva.

For patients with LCM who take Lenalidomida Teva

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)
• after that, at the beginning of each cycle and
• at least every month.

For patients with LF who take Lenalidomida Teva

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)
• after that, at the beginning of each cycle and
• at least every month.

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

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

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

Blood donation

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

Children and adolescents

The use of Lenalidomida Teva is not recommended 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.

Other medicines and Lenalidomida Teva

Inform your doctor or nurse if you are taking or have recently taken any other medicine. This is because Lenalidomida Teva may affect the way other medicines work. In addition, some medicines may affect the way Lenalidomida Teva 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 for heart problems, such as digoxin
• some medicines used to thin the blood, such as warfarin

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking Lenalidomida Teva

• You should not take Lenalidomida Teva if you are pregnant, as it is expected to be harmful to the fetus.
• You should not become pregnant while taking Lenalidomida Teva. 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 Teva, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida Teva

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

Breastfeeding

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

Contraception

For women taking Lenalidomida Teva

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 at least 4 weeks after finishing treatment) except that you have confirmed tubal ligation so that the eggs do not reach the uterus (tubal ligation)

And

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

For men taking Lenalidomida Teva

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

Driving and using machines

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

Lenalidomida Teva contains sodium

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

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

• When Lenalidomide Teva 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 Teva is used for”).
• When Lenalidomide Teva 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 Teva is used for the treatment of follicular lymphoma, it is taken with another medication called “rituximab”.

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

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

Treatment cycle

Lenalidomide Teva 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 Teva 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 Teva to take

Before starting treatment, your doctor will indicate:

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

How and when to take Lenalidomide Teva

• 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 Teva 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. They should then wash their hands thoroughly with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister pack or capsule.
• the capsules can be taken with or without food.
• you should take Lenalidomide Teva 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 Teva

Lenalidomide Teva 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 Teva than you should

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

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

If you forget to take Lenalidomide Teva

If you forget to take Lenalidomide Teva 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 doubts about the use of thismedication, ask your doctororpharmacist.

Like all medicines, Teva Lenalidomide can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, stop taking Teva 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 may be symptoms of severe types of allergic reactions called angioedema and anaphylactic reaction
• 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 organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also 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
• Bleeding or hematoma not caused by injury
• Chest or leg pain
• Difficulty breathing
• Bone pain, muscle pain, confusion, or fatigue that may be due to high levels of calcium in the blood.

Teva Lenalidomide can reduce the number of white blood cells that fight infections and also the cells in the blood that help to clot the blood (platelets), which can cause bleeding disorders such as nosebleeds and bruises. Teva 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 treatment with Teva Lenalidomide, therefore, your doctor should carefully evaluate the benefits and risks when prescribing Teva Lenalidomide.

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

• Decreased red blood cell count, which can cause anemia leading to fatigue and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills
• Numbness, tingling, or prickling sensation in the skin, hand or foot pain, dizziness, tremors
• Loss of appetite, change 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 a heart attack), leg pain (which could be a symptom of a blood clot in the lungs, called 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
• 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 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 the accumulation of blood, hematoma
• Increased uric acid levels in the blood
• Rashes, redness of the skin, dry skin, peeling or exfoliation of the skin, urticaria
• Increased sweating, nocturnal sweating
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice
• Nasal discharge
• Significant increase or decrease in urine output compared to usual or inability to control urination
• Blood in the urine
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, vertigo (inner ear disorder 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 may 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 phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disorder, difficulty moving
• Deafness, tinnitus (ringing in the ears)
• Nerve pain, abnormal and unpleasant sensation, especially when touched
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Fall that may cause injury

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 disease (Fanconi syndrome)
• Yellow pigmentation in the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching skin, rash, stomach pain or swelling, diarrhea, which 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)
• Damage to kidney cells (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 levels of potassium, phosphorus, uric acid, and low levels of calcium, which generate changes in kidney 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, severe, or worsening pain in the upper stomach and/or back, which lasts for several days, possibly accompanied by nausea, vomiting, fever, and a rapid pulse. These symptoms may be due to pancreatitis.
• Wheezing or ringing in the lungs, 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 Teva 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 (leucocytoclastic 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.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through 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 medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister and the box after “CAD”. 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 observe visible signs of deterioration or signs of improper handling.

Medications should not be disposed of through drains or in the trash. Return unused medication to your pharmacist. This will help protect the environment.

Composition of Lenalidomide Teva

Lenalidomide Teva 5 mg hard capsules EFG:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate corresponding to 5 mg of lenalidomide.
• The other componentsare:

Content of the capsule:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule coating:

Gelatin and titanium dioxide (E171)

Printing ink:

Lacquer, propylene glycol, iron oxide black (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 10 mg hard capsules EFG:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate corresponding to 10 mg of lenalidomide.
• The other componentsare:

Content of the capsule:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule coating:

Gelatin, titanium dioxide (E171), iron oxide yellow (E172) and indigo carmine (E132)

Printing ink:

Lacquer, propylene glycol, iron oxide black (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 15 mg hard capsules EFG:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate corresponding to 15 mg of lenalidomide.
• The other componentsare:

Content of the capsule:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule coating:

Gelatin, titanium dioxide (E171) and indigo carmine (E132)

Printing ink:

Lacquer, propylene glycol, iron oxide black (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 20 mg hard capsules EFG:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate corresponding to 20 mg of lenalidomide.
• The other componentsare:

Content of the capsule:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule coating:

Gelatin, titanium dioxide (E171),ironoxide yellow (E172) and indigo carmine (E132)

Printing ink:

Lacquer, propylene glycol, iron oxide black (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 25 mg hard capsules EFG:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate corresponding to 25 mg of lenalidomide.
• The other componentsare:

Content of the capsule:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule coating:

Gelatin and titanium dioxide (E171)

Printing ink:

Lacquer, propylene glycol, iron oxide black (E172), potassium hydroxide and concentrated ammonia solution

Appearance of the product and contents of the package

Lenalidomide Teva 5 mg hard capsules EFG are hard, opaque, size “4” (approximately 14.3 mm in length), capsules with a white body and a white cap, containing a white to pale yellowish or beige powder or compressed powder.

Lenalidomide Teva 10 mg hard capsules EFG are hard, opaque, size “2” (approximately 18 mm in length), capsules with a yellowish body and a green cap, containing a white to pale yellowish or beige powder or compressed powder.

Lenalidomide Teva 15 mg hard capsules EFG are hard, opaque, size “1” (approximately 19.4 mm in length), capsules with a white body and a blue cap, containing a white to pale yellowish or beige powder or compressed powder.

Lenalidomide Teva 20 mg hard capsules EFG are hard, opaque, size “0” (approximately 21.7 mm in length), capsules with a blue body and a green cap, containing a white to pale yellowish or beige powder or compressed powder.

Lenalidomide Teva 25 mg hard capsules EFG are hard, opaque, size “0” (approximately 21.7 mm in length), capsules with a white body and a white cap, containing a white to pale yellowish or beige powder or compressed powder.

Packaging sizes:

Lenalidomide Teva is available in blister packs containing 7, 21 or 63 hard capsules and in single-dose blister packs containing 7 x 1, 21 x 1 or 63 x 1 hard capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

89143 Baden-Wuerttemberg

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

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

AustriaLenalidomid TEVA 5 mg Hartkapseln

Lenalidomid TEVA 10 mg Hartkapseln

Lenalidomid TEVA 15 mg Hartkapseln

Lenalidomid TEVA 20 mg Hartkapseln

Lenalidomid TEVA 25 mg Hartkapseln

BelgiumLenalidomide Teva 5 mg harde capsules / gélules / Hartkapseln

Lenalidomide Teva 10 mg harde capsules / gélules / Hartkapseln

Lenalidomide Teva 15 mg harde capsules / gélules / Hartkapseln

Lenalidomide Teva 20 mg harde capsules / gélules / Hartkapseln

Lenalidomide Teva 25 mg harde capsules / gélules / Hartkapseln

Czech RepublicLenalidomid Teva

GermanyLenalidomid-ratiopharm 5 mg Hartkapseln

Lenalidomid-ratiopharm 10 mg Hartkapseln

Lenalidomid-ratiopharm 15 mg Hartkapseln

Lenalidomid-ratiopharm 20 mg Hartkapseln

Lenalidomid-ratiopharm 25 mg Hartkapseln

DenmarkLenalidomide Teva

EstoniaLenalidomide Teva

SpainLenalidomida Teva 5 mg cápsulas duras EFG

Lenalidomida Teva 10 mg cápsulas duras EFG

Lenalidomida Teva 15 mg cápsulas duras EFG

Lenalidomida Teva 20 mg cápsulas duras EFG

Lenalidomida Teva 25 mg cápsulas duras EFG

FinlandLenalidomide ratiopharm 5 mg kapseli, kova

Lenalidomide ratiopharm 10 mg kapseli, kova

Lenalidomide ratiopharm 15 mg kapseli, kova

Lenalidomide ratiopharm 20 mg kapseli, kova

Lenalidomide ratiopharm 25 mg kapseli, kova

FranceLénalidomide Teva 5 mg, gélule

Lénalidomide Teva 10 mg, gélule

Lénalidomide Teva 15 mg, gélule

Lénalidomide Teva 25 mg, gélule

CroatiaLenalidomid Teva 5 mg tvrde kapsule

Lenalidomid Teva 10 mg tvrde kapsule

Lenalidomid Teva 15 mg tvrde kapsule

Lenalidomid Teva 20 mg tvrde kapsule

Lenalidomid Teva 25 mg tvrde kapsule

HungaryLenalidomid Teva 5 mg kemény kapszula

Lenalidomid Teva 10 mg kemény kapszula

Lenalidomid Teva 15 mg kemény kapszula

Lenalidomid Teva 20 mg kemény kapszula

Lenalidomid Teva 25 mg kemény kapszula

IrelandLenalidomide Teva 5 mg Hard Capsules

Lenalidomide Teva 10 mg Hard Capsules

Lenalidomide Teva 15 mg Hard Capsules

Lenalidomide Teva 20 mg Hard Capsules

Lenalidomide Teva 25 mg Hard Capsules

ItalyLENALIDOMIDE TEVA

LithuaniaLenalidomide Teva 25 mg kietosios kapsules

LatviaLenalidomide Teva 25 mg cietas kapsulas

LuxembourgLenalidomide Teva 5 mg gélules dures

Lenalidomide Teva 10 mg gélules dures

Lenalidomide Teva 15 mg gélules dures

Lenalidomide Teva 20 mg gélules dures

Lenalidomide Teva 25 mg gélules dures

MaltaLenalidomide Teva 10 mg Hard Capsules

Lenalidomide Teva 15 mg Hard Capsules

Lenalidomide Teva 25 mg Hard Capsules

NetherlandsLenalidomide Teva 5 mg, harde capsules

Lenalidomide Teva 10 mg, harde capsules

Lenalidomide Teva 15 mg, harde capsules

Lenalidomide Teva 20 mg, harde capsules

Lenalidomide Teva 25 mg, harde capsules

NorwayLenalidomide Teva

PortugalLenalidomide Teva

SwedenLenalidomide Teva

SloveniaLenalidomid Teva 5 mg trde kapsule

Lenalidomid Teva 10 mg trdekapsule

Lenalidomid Teva 15 mg trde kapsule

Lenalidomid Teva 20 mg trde kapsule

Lenalidomid Teva 25 mg trde kapsule

SlovakiaLenalidomide Teva B.V. 5 mg

Lenalidomide Teva B.V. 10 mg

Lenalidomide Teva B.V. 15 mg

Lenalidomide Teva B.V. 25 mg

IcelandLenalidomide Teva

United KingdomLenalidomide 5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hard Capsules

(Northern Ireland)

Last revision date of thissummary of product characteristics: June 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/)