LENALIDOMIDE KERN PHARMA 7.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Lenalidomide Kern Pharma 2.5 mg hard capsules EFG

Lenalidomide Kern Pharma 5 mg hard capsules EFG

Lenalidomide Kern Pharma 7.5 mg hard capsules EFG

Lenalidomide Kern Pharma 10 mg hard capsules EFG

Lenalidomide Kern Pharma 15 mg hard capsules EFG

Lenalidomide Kern Pharma 20 mg hard capsules EFG

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

1. What Lenalidomide Kern Pharma is and what it is used for

What Lenalidomide Kern Pharma is

Lenalidomide Kern Pharma contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomide Kern Pharma is used for

This medicine 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 may disappear for a period of time. This is called “remission”.

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

Lenalidomide Kern Pharma 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

This medicine 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 this medicine alone.

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

This medicine is taken with an anti-inflammatory called “dexamethasone”.

Lenalidomide 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 low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.

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

• need regular blood transfusions to treat low red blood cell counts (“transfusion-dependent anemia”);
• 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 do not work well enough.

Lenalidomide Kern Pharma may increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

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

Mantle cell lymphoma (MCL)

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

Lenalidomide Kern Pharma is used alone 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 a person has FL, they may have too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

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

How Lenalidomide Kern Pharma works

This medicine 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 cancer cells.

2. What you need to know before you take Lenalidomide Kern Pharma

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

Do not take Lenalidomide Kern Pharma:

• if you are pregnant, think you may be pregnant or plan to become pregnant, as lenalidomide 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 use effective contraception (see section 2, “Pregnancy, breastfeeding, 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, talk to your doctor.

If any of these conditions apply to you, do not take lenalidomide. If in doubt, talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting lenalidomide 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 or have had a viral infection, especially hepatitis B, varicella-zoster, or HIV. If in doubt, talk to your doctor. Treatment with lenalidomide may cause the virus to become active again in patients who carry the virus. This can lead to the return of the infection. 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
• 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:

generalized 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 or hypersensitivity syndrome) (see also section 4 “Possible side effects”).

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

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

• 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 sensitivity, or loss of sensitivity, 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, inform your doctor if you notice any change in these symptoms.
• have shortness of breath, tiredness, dizziness, chest pain, faster heartbeat, or swelling in the legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting treatment with lenalidomide and during treatment, you will have regular blood tests. This is because lenalidomide can cause a decrease in the blood cells that help 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

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). Additionally, it is not known how lenalidomide affects the chances of developing AML. Your doctor may therefore have you undergo tests to detect signs that may predict a higher chance of developing AML during treatment with this medicine.

For patients with MCL taking lenalidomide

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, once a month.

For patients with FL taking lenalidomide

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 total tumor burden in your body, including the bone marrow. This could lead to a condition in which the tumors break down and produce unusual levels of chemicals in the blood, which can cause kidney failure (this condition is called “tumor lysis syndrome”).

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

Your doctor may adjust the dose of lenalidomide or interrupt your treatment, depending on the results of your blood tests 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 may have.

Blood donation

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

Children and adolescents

The use of lenalidomide is not recommended 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 Kern Pharma

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This is because lenalidomide can affect how other medicines work. Additionally, some medicines can affect how lenalidomide 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 not work
• 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 lenalidomide

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

Men taking lenalidomide

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

Breastfeeding

Do not breastfeed while taking lenalidomide, as it is not known if this medicine passes into breast milk.

Contraception

For women taking lenalidomide

Before starting treatment, ask your doctor if you are able to become pregnant, even if you think it is unlikely.

If you can become pregnant:

• pregnancy tests will be performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and for 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 for at least 4 weeks after the end of treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking lenalidomide

Lenalidomide passes into human semen. If your partner is pregnant or may become pregnant and does not use any effective contraception, you must use condoms 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.

Excipients

Lenalidomide contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

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

3. How to take Lenalidomida Kern Pharma

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

• When this medication is used to treat 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 Kern Pharma is used for").
• When this medication is used to treat multiple myeloma in patients who have received a bone marrow transplant or to treat patients with MDS or MCL, it is taken alone.
• When this medication is used to treat follicular lymphoma, it is taken with another medication called "rituximab".

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

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

Treatment cycle

Lenalidomida 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 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 Kern Pharma to take

Before starting treatment, your doctor will indicate:

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

How and when to take Lenalidomida Kern Pharma

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken lenalidomida 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 this medication approximately at the same time on the 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 Kern Pharma

This medication 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 Kern Pharma than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Lenalidomida Kern Pharma

If you forget to take this medication at its 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 Kern Pharma can cause side effects, although not all people experience them.

Stop taking this medication and consult your doctor immediately if you experience any of the following side effects - 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 with extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• A widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). 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 symptoms of infection, including in the bloodstream (sepsis).
• Bleeding (bleeding) or bruising (bruising) not due to an injury.
• Chest pain (thoracic) or leg pain.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue that may be due to high calcium levels in the blood.

This medication can reduce the number of white blood cells that fight infections and also the blood cells that help blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising. This medication can 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 this medication. Therefore, your doctor should carefully evaluate the benefits and risks when prescribing lenalidomida.

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

• A decrease in the number of red blood cells, which can cause anemia, leading to fatigue and weakness
• 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 pseudo-flu symptoms, including fever, muscle pain, headache, ear pain, cough, and chills
• Numbness, tingling, or prickling sensation on the skin, pain in hands or feet, dizziness, tremors
• Decreased appetite, changes 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 artery swelling (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

Side effects common(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 red blood cell destruction
• Increased levels of a protein that indicates inflammation in the body
• Darkening of skin color, change in skin color due to internal bleeding, usually caused by bruising, inflammation of the skin caused by blood accumulation, bruising
• Increased uric acid levels in the blood
• Skin rashes, 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
• Rhinorrhea
• Strong increase or decrease in urine output 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, vertigo (inner ear disorder that causes a sensation of spinning), temporary loss of consciousness
• Chest pain that spreads to 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
• Cervical pain, chest pain
• Chills
• Joint swelling
• Slower or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disturbance, difficulty moving
• Deafness, ringing in the ears (tinnitus)
• Pain in the nerves, abnormal and unpleasant sensation, especially when touched
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Fall that can cause injury

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

• Bleeding inside the skull
• 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, mild, or severe pain in the upper abdomen and/or back, which lasts for several days, possibly accompanied by nausea, vomiting, fever, and 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 this medication is administered with a statin (a type of medication to lower 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 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 or pharmacist, 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 Kern Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister 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 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 Kern Pharma

Lenalidomide Kern Pharma 2.5 mg hard capsules EFG

• The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other components are:
• • Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Capsule shell: brilliant blue FCF (E133), erythrosine (E127), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and gelatin
  • Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Kern Pharma 5 mg hard capsules EFG

• The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other components are:
• • Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Capsule shell: brilliant blue FCF (E133), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and gelatin
  • Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Kern Pharma 7.5 mg hard capsules EFG

• The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other components are:
• • Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Capsule shell: brilliant blue FCF (E133), erythrosine (E127), red iron oxide (E172), titanium dioxide (E171), and gelatin
  • Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Kern Pharma 10 mg hard capsules EFG

• The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other components are:
• • Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Capsule shell: black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and gelatin
  • Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Kern Pharma 15 mg hard capsules EFG

• The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other components are:
• • Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Capsule shell: black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and gelatin
  • Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Kern Pharma 20 mg hard capsules EFG

• The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other components are:
• • Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Capsule shell: red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), and gelatin
  • Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Lenalidomide Kern Pharma 25 mg hard capsules EFG

• The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other components are:
• • Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
  • Capsule shell: titanium dioxide (E171) and gelatin
  • Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), and potassium hydroxide.

Product appearance and packaging contents

Lenalidomide Kern Pharma 2.5 mg hard capsules

Opaque capsules with a dark blue cap and a light orange opaque body, capsule shell size No. 4, 14-15 mm, marked with “LP” on the cap and “637” on the body, and containing a white powder inside.

Lenalidomide Kern Pharma 5 mg hard capsules

Opaque capsules with a green cap and a light brown opaque body, capsule shell size No. 2, 18-19 mm, marked with “LP” on the cap and “638” on the body, and containing a white powder inside.

Lenalidomide Kern Pharma 7.5 mg hard capsules

Opaque capsules with a purple cap and a pink opaque body, capsule shell size No. 1, 19-20 mm, marked with “LP” on the cap and “643” on the body, and containing a white powder inside.

Lenalidomide Kern Pharma 10 mg hard capsules

Opaque capsules with a yellow cap and a grey opaque body, capsule shell size No. 0, 21-22 mm, marked with “LP” on the cap and “639” on the body, and containing a white powder inside.

Lenalidomide Kern Pharma 15 mg hard capsules

Opaque capsules with a brown cap and a grey opaque body, capsule shell size No. 2, 18-19 mm, marked with “LP” on the cap and “640” on the body, and containing a white powder inside.

Lenalidomide Kern Pharma 20 mg hard capsules

Opaque capsules with a dark red cap and a light grey opaque body, capsule shell size No. 1, 19-20 mm, marked with “LP” on the cap and “641” on the body, and containing a white powder inside.

Lenalidomide Kern Pharma 25 mg hard capsules

Opaque capsules with a white cap and a white opaque body, capsule shell size No. 0, 21-22 mm, marked with “LP” on the cap and “642” on the body, and containing a white powder inside.

Cardboard boxes containing PVC/PCTFE/aluminum blisters that contain 7 hard capsules each.

Lenalidomide Kern Pharma 2.5 mg/5 mg hard capsules

Package size of 7 or 21 capsules.

Lenalidomide Kern Pharma 7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules

Package size of 21 capsules.

Only some package sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

or

Adalvo Ltd.

Malta Life Sciences Park

Building 1, Level 4

Sir Temi Zammit Buildings

San Gwann,

SGN 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:January 2025

Detailed and updated 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/