Prospect: information for the user

Lenalidomida Kern Pharma 2.5 mg hard capsules EFG

Lenalidomida Kern Pharma 5 mg hard capsules EFG

Lenalidomida Kern Pharma 7.5 mg hard capsules EFG

Lenalidomida Kern Pharma 10 mg hard capsules EFG

Lenalidomida Kern Pharma 15 mg hard capsules EFG

Lenalidomida Kern Pharma 20 mg hard capsules EFG

Lenalidomida Kern Pharma 25 mg hard capsules EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given 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 prospect. See section 4.

What is Lenalidomida Kern Pharma

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

What Lenalidomida Kern Pharma is used forLenalidomida Kern Pharma

This medicine is used in adults for:

• Multiple myeloma
• Myleodysplastic syndromes (MDS)
• Diffuse large B-cell lymphoma (DLBCL)
• Follicular lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cell in the blood, called plasma cells. These cells accumulate in the bone marrow and multiply, becoming uncontrolled. This can damage bones and kidneys.

Multiple myeloma is usually incurable. However, the symptoms and signs can be significantly reduced or disappear for a period of time. This is called “remission”.

Multiple myeloma: newly diagnosed patients: after stem cell transplantation

Lenalidomida Kern Pharma is used as maintenance treatment after recovering adequately from a stem cell transplant.

Multiple myeloma: newly diagnosed patients: who cannot undergo stem cell transplantation

This medicine 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 this medicine only.

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

Multiple myeloma: previously treated patients

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

Lenalidomida can slow the progression of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myleodysplastic syndromes (MDS)

MDS is a group of many different blood and bone marrow diseases. Blood cells become abnormal and do not function correctly. Patients may experience a variety of symptoms, including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.

Lenalidomida Kern Pharma is used to treat adult patients diagnosed with MDS, when all the following points are applicable:

• You need periodic blood transfusions to treat low red blood cell levels (“anemia-dependent transfusions”);
• You have a bone marrow cell anomaly called “isolated deletion 5q cytogenetic abnormality”. 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.

Lenalidomida Kern Pharma can increase the number of healthy red blood cells produced by the body by reducing the number of abnormal cells:

• This can reduce the number of blood transfusions needed. It may be possible to avoid transfusions.

Diffuse large B-cell lymphoma (DLBCL)

DLBCL is a cancer of a part of the immune system (lymphoid tissue). It affects a type of white blood cell in the blood called “B lymphocytes” or B cells. DLBCL is a disease in which B cells grow uncontrollably and accumulate in lymphoid tissue, bone marrow, or blood.

Lenalidomida Kern Pharma 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.

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

How Lenalidomida Kern Pharma works

This medicineacts 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 the cancer
• It stimulates part of the immune system to attack cancer cells.

You must read the leaflet for all the medicines you are going to take in combination with lenalidomida before starting treatment.

Do not takeLenalidomida Kern Pharma:

• if you are pregnant, think you may be pregnant or intend to become pregnant,since lenalidomida is expected to be harmful to the fetus(see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”).
• if you can become pregnant, unless you follow all the necessary measures to avoid it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you can become pregnant, your doctor will note with each prescription that all necessary measures have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomida or to any of the other components of this medicine (included in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take lenalidomida. In case of doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take lenalidomida if:

• you have ever had blood clots; during treatment, you have a higher risk of presenting blood clots in veins and arteries
• you have any sign of infection, such as cough or fever
• you have or have had previously a viral infection, especially hepatitis B infection, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with lenalidomida may make the virus become active again in patients who are virus carriers. 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 lenalidomida dose
• you have had a heart attack, have ever had a blood clot or if you smoke, have high blood pressure or high cholesterol levels
• you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as for example skin rash, itching, swelling, dizziness or respiratory problems
• you have experienced in the past a combination of any of the following symptoms:

generalised rash, skin redness, high 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 for its English acronym or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above alterations 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 experience:

• blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. All of 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, inform your doctor if you notice any change in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These may be symptoms of a serious condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with lenalidomida and during the same, blood tests will be done regularly. This is because lenalidomida may cause a decrease in the blood cells that help fight infections (white blood cells) and those that participate in coagulation (platelets).

Your doctor will ask you to have a blood test:

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

You may be evaluated to detect signs of cardiopulmonary problems before and during treatment with lenalidomida.

For patients with MDS who takelenalidomida

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

For patients with MM who takelenalidomida

Your doctor will ask you to have a blood test:

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

For patients with FL who takelenalidomida

Your doctor will ask you to have a blood test:

• before treatment
• every week during the first 3 weeks (1 cycle) of treatment
• later, every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information)
• then, 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 your lenalidomida dose or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a new diagnosis patient, your doctor may also evaluate your treatment based on your age and any other conditions you already have.

Blood donation

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

Children and adolescents

The use of lenalidomida is not recommended in children and adolescents under 18 years old.

Older 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 andLenalidomida Kern Pharma

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

Specifically, inform your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working
• some medicines used to treat heart problems, such as digoxin
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women takinglenalidomida

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

Men taking lenalidomida

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

Breastfeeding

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

Contraception

Forwomen taking lenalidomida

Before starting treatment, ask your doctor if you are capable of becoming pregnant, although you think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after completing treatment) except that you have had 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 for at least 4 weeks after completing treatment. Your doctor will advise you on the most suitable contraceptive methods.

Formen taking lenalidomida

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

Driving and using machines

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

Excipients

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

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

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

• When this medication 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 Kern Pharma is used for”).
• When this medication is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant or to treat patients with SMD or LCM, it is taken alone.
• When this medication is used for the treatment of follicular lymphoma, it is taken with another medication called “rituximab”.

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

If you are taking lenalidomide with other medications, you must consult the prospectus of those other medications to obtain additional information on their use and effects.

Treatment cycle

Lenalidomide is taken on certain days during the period of 3 weeks (21 days).

• A “treatment cycle” consists of 21 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 21 days, you must start a new “cycle” during the following 21 days.

Or

Lenalidomide is taken on certain days during the period of 4 weeks (28 days).

• A “treatment cycle” consists of 28 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 28 days, you must start a new “cycle” during the following 28 days.

How much Lenalidomide Kern Pharma to take

Before starting treatment, your doctor will indicate:

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

How and when to take Lenalidomide Kern Pharma

• Swallow the capsules whole, preferably with water.
• Do not break, open or chew the capsules. In the case of lenalidomide powder from a broken capsule coming 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. Subsequently, they should carefully remove the gloves to avoid skin exposure, introduce them into a plastic polyethylene bag and dispose of them in accordance with 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.

Administration of this medication

To remove the capsule from the blister:

• Press only one end of the capsule to allow it to come out through the foil.
• Do not press in the center of the capsule as it may break.

Duration of treatment with Lenalidomide Kern Pharma

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

If you take more Lenalidomide Kern Pharma than you should

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

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

If you forgot to take Lenalidomide Kern Pharma

If you forget to take this medication 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.

Like all medicines, Lenalidomida Kern Pharma may cause side effects, although not everyone will experience them.

Stop taking this medicine and consult your doctor immediately if you experience any of the following side effects – you may need urgent medical treatment:

• Urticaria, hives, 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.
• A severe allergic reaction that may start as a rash in an area but spreads with extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ dysfunction (pharmacological reaction with eosinophilia and systemic symptoms also known as drug hypersensitivity syndrome or DRESS). See also section 2.

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

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

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

Other side effects

It is essential to note that a reduced number of patients may develop other types of cancer, and this risk may increase with treatment with this medicine. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing lenalidomida to you.

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

• A decrease in the number of red blood cells, which may 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.
• Decreased appetite, changes in the taste of things.
• Increased pain, tumor size, or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn.
• Low levels of potassium, calcium, or sodium in the blood.
• Decreased thyroid function.
• Leg pain (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism).
• All types of infections, 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 indicates inflammation in the body.
• Darkening of the skin. Change in skin color due to internal bleeding, usually caused by hematomas, inflammation of the skin caused by the accumulation of blood, hematoma.
• High levels of uric acid in the blood.
• Rash, 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.
• Strong increase or decrease in the amount of urine 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 problems, difficulty moving.
• Deafness, tinnitus (ringing in the ears).
• Nerve pain, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Dental pain.
• Fall that may cause injuries.

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

• Red blood cell destruction (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 hematomas, inflammation of the skin caused by the accumulation of blood, hematoma.
• High levels of uric acid in the blood.
• Rash, 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.
• Strong increase or decrease in the amount of urine 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 problems, difficulty moving.
• Deafness, tinnitus (ringing in the ears).
• Nerve pain, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Dental pain.
• Fall that may cause injuries.

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

• Brain hemorrhage.
• Circulatory problems.
• Loss of vision.
• Loss of libido.
• Expulsion of large amounts of urine with bone pain and weakness, which may be symptoms of kidney disorder (Fanconi syndrome).
• Yellow pigmentation in the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching skin, rash, skin pain, or swelling of the stomach, 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 (renal tubular necrosis).
• 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, phosphate, uric acid, and low levels of calcium, which generate changes in renal function and heart rhythm, seizures, and sometimes death.
• High blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

Side effects ofunknown frequency(cannot be estimated from available data):

• Sudden, or mild pain that worsens in the upper stomach and/or back, lasting several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis.
• Whistling 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 this medicine is administered with a statin (a type of medicine to reduce cholesterol).
• A disease that affects the skin produced by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).
• Rupture 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister pack after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if you observe visible signs of deterioration or signs of improper handling.

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

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

Appearance of the product and contents of the pack

Lenalidomide Kern Pharma 2.5 mg hard capsules

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

Lenalidomide Kern Pharma 5 mg hard capsules

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

Lenalidomide Kern Pharma 7.5 mg hard capsules

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

Lenalidomide Kern Pharma 10 mg hard capsules

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

Lenalidomide Kern Pharma 15 mg hard capsules

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

Lenalidomide Kern Pharma 20 mg hard capsules

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

Lenalidomide Kern Pharma 25 mg hard capsules

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

PVC/PCTFE/aluminium blisters containing 7 hard capsules each.

Lenalidomide Kern Pharma 2.5 mg/5 mg hard capsules

Pack size of 7 or 21 capsules.

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

Pack size of 21 capsules.

Only some pack sizes may be marketed.

Marketing authorisation holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

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 authorised in the member states of the European Economic Area with the following names:

Last revision date 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 Medical Devices (AEMPS)http://www.aemps.gob.es/