LENALIDOMIDE TEVA 10 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Lenalidomide Teva 5 mg hard capsules EFG

Lenalidomide Teva 10 mg hard capsules EFG

Lenalidomide Teva 15 mg hard capsules EFG

Lenalidomide Teva 20 mg hard capsules EFG

Lenalidomide Teva 25 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.If you have any further questions, ask your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lenalidomide Teva and what is it used for
2. What you need to know before you take Lenalidomide Teva
3. How to take Lenalidomide Teva
4. Possible side effects
5. Storage of Lenalidomide Teva
6. Contents of the pack and other information

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

What isLenalidomide Teva

Lenalidomide Teva contains the active substance “lenalidomide”. This medicine belongs to a group of

medicines that affect how the immune system works.

What Lenalidomide Teva is used for

Lenalidomide Teva is used in adults to:

• Multple myeloma
• Myelodysplastic syndromes (MDS)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma

Multple myeloma

Multple myeloma is a type of cancer that affects a specific type of white blood cell called plasma cells. These cells build up in the bone marrow and multiply out of control. This can damage the bones and kidneys.

Multple myeloma usually cannot be cured. However, the signs and symptoms can be greatly reduced or can disappear for a period of time. This is called “remission”.

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

Lenalidomide Teva is used as maintenance treatment after recovery from a bone marrow transplant.

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

Lenalidomide Teva is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”
• an anti-inflammatory called “dexamethasone”
• a chemotherapy medicine called “melphalan” and
• an immunosuppressant called “prednisone”.

You will take these medicines at the start of treatment and then continue to take Lenalidomide Teva on its own.

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

Multple myeloma: in patients previously treated

Lenalidomide Teva is taken with an anti-inflammatory called “dexamethasone”.

Lenalidomide Teva can delay the worsening of multple myeloma symptoms. It has also been shown to delay the return of multple myeloma after treatment.

Myelodysplastic syndromes (MDS)

MDS are a group of many different blood and bone marrow disorders. The blood cells become abnormal and do not work properly. Patients may experience a variety of signs and symptoms including a low red blood cell count (anaemia), the need for blood transfusions and an increased risk of infection.

Lenalidomide Teva is used to treat adult patients with MDS when all of the following apply:

• you need regular blood transfusions to treat low red blood cell counts (“transfusion-dependent anaemia”);
• you have a bone marrow abnormality called “isolated deletion 5q cytogenetic abnormality”. This means that your body does not produce enough healthy blood cells;
• other treatments you have used before are not suitable or have not worked well enough.

Lenalidomide Teva can increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

• this can reduce the number of blood transfusions you need. You may not need transfusions at all.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymph tissue). It affects a type of white blood cell called “B lymphocytes” or B cells. MCL is a disease in which the B cells grow out of control and build up in the lymph tissue, bone marrow or blood.

Lenalidomide Teva is used on its own to treat adult patients who have previously been treated 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 help the body fight infection. When someone has FL they can build up too many of these B lymphocytes in the blood, bone marrow, lymph nodes and spleen.

Lenalidomide Teva is used with another medicine called “rituximab” to treat adult patients who have previously been treated for follicular lymphoma.

How Lenalidomide Teva works

Lenalidomide Teva works by affecting the immune system and directly attacking the cancer.

It works in several ways:

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

2. What you need to know before you take Lenalidomide Teva

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomide Teva before starting treatment with Lenalidomide Teva.

Do not take Lenalidomide Teva

• if you are pregnant, think you may be pregnant or plan to become pregnant, as Lenalidomide Teva is expected to be harmful to the unborn baby(see section 2, “Pregnancy, breast-feeding and contraception: information for women and men”).
• if you can become pregnant, unless you use effective contraception (see section 2, “Pregnancy, breast-feeding and contraception: information for women and men”). If you can become pregnant, your doctor will record with each prescription that all necessary measures have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor.

If any of these conditions apply to you, do not take Lenalidomide Teva. If you are in doubt, ask your doctor.

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start taking Lenalidomide Teva if

• you have ever had blood clots; during treatment, you have a higher risk of getting blood clots in your veins and arteries.
• you have any signs of infection, such as cough or fever.
• you have had or currently have a viral infection, especially hepatitis B, varicella zoster or HIV. If you are in doubt, ask your doctor. Treatment with Lenalidomide Teva may cause the virus to become active again in patients who carry the virus. This can lead to the infection coming back. Your doctor should check if you have ever had a hepatitis B infection.
• you have kidney problems; your doctor may adjust your dose of Lenalidomide 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 multple myeloma), such as a skin rash, itching, swelling, dizziness or breathing problems.
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated 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) (see also section 4 “Possible side effects”).

If any of these conditions apply to you, tell your doctor, pharmacist or nurse before you start treatment.

At any time during or after treatment, tell your doctor or nurse immediately if:

• you have blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, numbness, decreased sensation or loss of sensation, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with Lenalidomide Teva, tell your doctor if you notice any change in these symptoms.
• you have shortness of breath, tiredness, dizziness, chest pain, faster heart rate or swelling in your legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before you start treatment with Lenalidomide Teva and during treatment, you will have regular blood tests. This is because Lenalidomide Teva can cause a decrease in the blood cells that help to fight infections (white blood cells) and those that help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

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

You may be evaluated for signs of heart and lung problems before and during treatment with lenalidomide.

For patients with MDS taking Lenalidomide Teva

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukaemia (AML). Also, it is not known how Lenalidomide Teva affects your chances of developing AML. Your doctor may therefore ask you to have tests to look for signs that may predict your chances of developing AML during treatment with Lenalidomide Teva.

For patients with MCL taking Lenalidomide Teva

Your doctor will ask you to have a blood test:

• before treatment
• every week during the first 8 weeks (2 cycles) of treatment
• then every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information)
• after that at the start of each cycle and
• at least every month.

For patients with FL taking Lenalidomide Teva

Your doctor will ask you to have a blood test:

• before treatment
• every week during the first 3 weeks (1 cycle) of treatment
• then every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information)
• after that at the start of each cycle and
• at least every month.

Your doctor may check if you have a high amount of tumour in your body, including in your bone marrow. This could lead to a condition in which the tumours break down and produce unusual levels of chemicals in the blood that can cause kidney failure (this condition is called “tumour lysis syndrome”).

Your doctor may examine you to check for changes in your skin, such as red spots or skin rash.

Your doctor may adjust your dose of Lenalidomide Teva or stop your treatment, depending on your blood test results and your overall condition. If you are a newly diagnosed 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 and for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide Teva is not recommended for use in children and adolescents under 18 years.

Elderly and patients with kidney problems

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

Other medicines and Lenalidomide Teva

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This is because Lenalidomide Teva can affect how other medicines work. Also, some medicines can affect how Lenalidomide Teva works.

In particular, tell 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, breast-feeding and contraception: information for women and men

Pregnancy

Women taking Lenalidomide Teva

• Do not take Lenalidomide Teva if you are pregnant, as it is expected to be harmful to the unborn baby.
• Do not become pregnant while taking Lenalidomide Teva. You must use effective contraception if there is a possibility that you may become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomide Teva, stop treatment and tell your doctor immediately.

Men taking Lenalidomide Teva

• If your partner becomes pregnant while you are taking Lenalidomide Teva, tell your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective contraception (see “Contraception”).

Breast-feeding

Do not breast-feed while taking Lenalidomide Teva, as it is not known whether Lenalidomide Teva passes into breast milk.

Contraception

For women taking Lenalidomide Teva

Before starting treatment, ask your doctor if you are able to become 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 at least 4 weeks after the end of treatment) unless it has been confirmed that your fallopian tubes have been blocked (tubal ligation)

And

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

For men taking Lenalidomide Teva

Lenalidomide passes into human semen. If your partner is pregnant or can become pregnant and is not using any effective method of contraception, you must use a condom during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy. Do not donate semen or sperm during treatment or for at least 7 days after the end of treatment.

Driving and using machines

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

Lenalidomide Teva contains sodium

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

3. How to take Lenalidomida Teva

Lenalidomida Teva should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, CMML, or MF.

• When Lenalidomida 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 Lenalidomida Teva is used for").
• When Lenalidomida Teva is used for the treatment of multiple myeloma in patients who have undergone a bone marrow transplant or to treat patients with MDS or CMML, it is taken alone.
• When Lenalidomida Teva is used for the treatment of follicular lymphoma, it is taken with another medication called "rituximab".

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

If you are taking Lenalidomida Teva with other medications, you should consult the package insert of those other medications for additional information on their use and effects.

Treatment cycle

Lenalidomida Teva is taken on certain days during a 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 21-day cycle, you should start a new "cycle" for the next 21 days.

Or

Lenalidomida Teva is taken on certain days during a 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 28-day cycle, you should start a new "cycle" for the next 28 days.

How much Lenalidomida Teva to take

Before starting treatment, your doctor will indicate:

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

How and when to take Lenalidomida 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 Lenalidomida 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 or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic bag, and dispose of them 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 or capsule.
• the capsules can be taken with or without food.
• you should take Lenalidomida Teva approximately at the same time on scheduled days.

Taking 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 Lenalidomida Teva

Lenalidomida 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 tells you to stop the treatment.

If you take more Lenalidomida Teva than you should

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

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

If you forget to take Lenalidomida Teva

If you forget to take Lenalidomida 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 the usual time.

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

4. Possible side effects

Like all medications, Lenalidomida Teva can cause side effects, although not all people experience them.

If you experience any of the following serious side effects, stop treatment with Lenalidomida Teva and see a doctor immediately, as you may need urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth, or face, difficulty breathing or itching, which can be symptoms of severe allergic reactions called angioedema and anaphylactic reaction
• A 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).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Consult your doctor immediately if you notice any of the following serious side effects:

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

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

Other side effects

It is important to note that a small number of patients may develop other types of cancer, and this risk may increase with treatment with Lenalidomida Teva. Therefore, your doctor should carefully evaluate the benefits and risks when prescribing Lenalidomida Teva.

Very common side effects(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
• Skin rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, pain in the limbs.
• 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 a prickling sensation in the skin, pain in the hands or feet, dizziness, tremors
• Decreased appetite, change in taste
• 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 function
• Pain in the legs (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism)
• Infections of all kinds, including sinusitis, pneumonia, and upper respiratory tract infections
• Difficulty breathing
• Blurred vision
• Eye opacity (cataracts)
• Kidney problems, including kidney failure or inability to maintain normal kidney function
• Abnormal liver test results
• High levels in 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, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• A vague feeling of discomfort in the body, feeling unwell
• Painful inflammation of the mouth, dry mouth
• Dehydration

Common side effects(may 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, change in skin color due to internal bleeding, usually caused by bruising, skin inflammation caused by blood accumulation, bruising
• Increased uric acid levels in the blood
• Skin rash, redness of the skin, cracked skin, peeling or flaking of the skin, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice
• Runny nose
• Strong 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 having an erection
• Stroke, fainting, dizziness (a disorder of the inner ear that causes a sensation of spinning), temporary loss of consciousness
• Chest pain that spreads to the arms, neck, jaw, back, 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 phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disturbance, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, abnormal and unpleasant sensation, especially when touched
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Falling that can cause injuries

Uncommon side effects(may affect up to 1 in 100 people):

• Bleeding in the brain
• Circulatory problems
• Loss of vision
• Loss of sexual desire (libido)
• Excretion of large amounts of urine with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching of the skin, rash, pain or swelling of the stomach - these can be symptoms of liver damage (liver failure)
• Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Kidney cell damage (called tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying cancer cells 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 in the blood vessels that supply the lungs (pulmonary hypertension).

Side effects of unknown frequency(cannot be estimated from the available data):

• Sudden, severe, or mild pain in the upper abdomen and/or back that lasts for several days, possibly accompanied by nausea, vomiting, fever, and a rapid pulse. These symptoms can be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) have been observed, which can lead to kidney problems (rhabdomyolysis), some of them when Lenalidomida Teva is administered with a statin (a type of medication to lower cholesterol).
• A disease that affects the skin caused by inflammation of the small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Rupture of the stomach or intestine wall. This can lead to a severe 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 rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects that do not appear in this package insert. You can also report them directly through the Spanish Medication Surveillance 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.

5. Storage of Lenalidomida Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister and carton after "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 visible signs of deterioration or signs of tampering.

Medications should not be thrown down the drain or into the trash. Return any unused medication to your pharmacist. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Lenalidomide Teva

Lenalidomide Teva 5 mg hard capsules EFG:

• The active ingredient is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate equivalent to 5 mg of lenalidomide.
• The other components are:

Capsule content:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, and talc

Capsule shell:

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 equivalent to 10 mg of lenalidomide.
• The other components are:

Capsule content:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, and talc

Capsule shell:

Gelatin, titanium dioxide (E171), yellow iron oxide (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 equivalent to 15 mg of lenalidomide.
• The other components are:

Capsule content:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, and talc

Capsule shell:

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 equivalent to 20 mg of lenalidomide.
• The other components are:

Capsule content:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, and talc

Capsule shell:

Gelatin, titanium dioxide (E171), yellow iron oxide (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 equivalent to 25 mg of lenalidomide.
• The other components are:

Capsule content:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, and talc

Capsule shell:

Gelatin and titanium dioxide (E171)

Printing ink:

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

Product Appearance and Container Contents

Lenalidomide Teva 5 mg hard capsules EFG are hard, non-transparent capsules, size “4” (approximately 14.3 mm in length), printed with “5” in black on the white body and with a white cap, containing a white to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 5 mg is available in blister packs containing 7, 21, or 63 hard capsules and in unit dose blister packs containing 7 x 1, 21 x 1, or 63 x 1 hard capsules.

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

Lenalidomide Teva 10 mg is available in blister packs containing 7, 21, or 63 hard capsules and in unit dose blister packs containing 7 x 1, 21 x 1, or 63 x 1 hard capsules.

Lenalidomide Teva 15 mg hard capsules EFG are hard, non-transparent capsules, size “1” (approximately 19.4 mm in length), printed with “15” in black on the white body and with a blue cap, containing a white to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 15 mg is available in blister packs containing 7, 21, or 63 hard capsules and in unit dose blister packs containing 7 x 1, 21 x 1, or 63 x 1 hard capsules.

Lenalidomide Teva 20 mg hard capsules EFG are hard, non-transparent capsules, size “0” (approximately 21.7 mm in length), printed with “20” in black on the blue body and with a green cap, containing a white to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 20 mg is available in blister packs containing 21 or 63 hard capsules and in unit dose blister packs containing 21 x 1 or 63 x 1 hard capsules.

Lenalidomide Teva 25 mg hard capsules EFG are hard, non-transparent capsules, size “0” (approximately 21.7 mm in length), printed with “25” in black on the white body and with a white cap, containing a white to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 25 mg is available in blister packs containing 7, 21, or 63 hard capsules and in unit dose blister packs containing 7 x 1, 21 x 1, or 63 x 1 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

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:

Austria Lenalidomid TEVA 5 mg Hartkapseln

Lenalidomid TEVA 10 mg Hartkapseln

Lenalidomid TEVA 15 mg Hartkapseln

Lenalidomid TEVA 20 mg Hartkapseln

Lenalidomid TEVA 25 mg Hartkapseln

Belgium Lenalidomide 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 Republic Lenalidomid Teva

Germany Lenalidomid-ratiopharm 5 mg Hartkapseln

Lenalidomid-ratiopharm 10 mg Hartkapseln

Lenalidomid-ratiopharm 15 mg Hartkapseln

Lenalidomid-ratiopharm 20 mg Hartkapseln

Lenalidomid-ratiopharm 25 mg Hartkapseln

Denmark Lenalidomide Teva

Estonia Lenalidomide Teva

Spain 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

Finland Lenalidomide 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

France Lénalidomide Teva 5 mg, gélule

Lénalidomide Teva 10 mg, gélule

Lénalidomide Teva 15 mg, gélule

Lénalidomide Teva 25 mg, gélule

Croatia Lenalidomid 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

Hungary Lenalidomid 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

Ireland Lenalidomide 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

Italy LENALIDOMIDE TEVA

Lithuania Lenalidomide Teva 25 mg kietosios kapsules

Latvia Lenalidomide Teva 25 mg cietas kapsulas

Luxembourg Lenalidomide 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

Malta Lenalidomide Teva 10 mg Hard Capsules

Lenalidomide Teva 15 mg Hard Capsules

Lenalidomide Teva 25 mg Hard Capsules

Netherlands Lenalidomide 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

Norway Lenalidomide Teva

Portugal Lenalidomide Teva

Sweden Lenalidomide Teva

Slovenia Lenalidomid Teva 5 mg trde kapsule

Lenalidomid Teva 10 mg trde kapsule

Lenalidomid Teva 15 mg trde kapsule

Lenalidomid Teva 20 mg trde kapsule

Lenalidomid Teva 25 mg trde kapsule

Slovakia Lenalidomide Teva B.V. 5 mg

Lenalidomide Teva B.V. 10 mg

Lenalidomide Teva B.V. 15 mg

Lenalidomide Teva B.V. 25 mg

Iceland Lenalidomide Teva

United Kingdom Lenalidomide 5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hard Capsules

(Northern Ireland)

Date of last revision of this leaflet:June 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)