Lenalidomide Kern Pharma 15 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: 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 the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Lenalidomida Kern Pharma is and what it is used for
2. What you need to know before taking Lenalidomida Kern Pharma
3. How to take Lenalidomida Kern Pharma
4. Possible side effects
5. How to store Lenalidomida Kern Pharma
6. Contents of the pack and other information

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

What Lenalidomida Kern Pharma is

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

What Lenalidomida Kern Pharma is used for

This medicine is used in adults for:

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

Multiple myeloma

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

Multiple myeloma is generally incurable. However, signs and symptoms can be greatly reduced or may disappear for a period of time. This is known as “remission”.

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

Lenalidomida Kern Pharma is used as maintenance treatment after adequate recovery from a bone marrow transplant.

Newly diagnosed multiple 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 beginning of treatment and then continue taking this medicine alone.

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

Multiple myeloma: in previously treated patients

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

Lenalidomide may slow down the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

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

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

• you require regular blood transfusions to treat low red blood cell levels (“transfusion-dependent anaemia”);
• you have an abnormality in the bone marrow cells called “isolated 5q cytogenetic abnormality”. This means your body does not produce enough healthy blood cells;
• other treatments you have previously used are not suitable or have not worked well enough.

Lenalidomida Kern Pharma can 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. It may even become possible to stop transfusions.

Mantle cell lymphoma (MCL)

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

Lenalidomida Kern Pharma is used as monotherapy 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 cells that help the body fight infections. When a person has FL, too many of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

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

How Lenalidomida Kern Pharma works

This medicine works by affecting the body’s immune system and directly attacking the cancer. It works in several ways:

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

2. What you need to know before starting Lenalidomida Kern Pharma

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

Do not take Lenalidomida Kern Pharma:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, as lenalidomide is expected to be harmful to the unborn child (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men").
• if you are capable of becoming pregnant, unless you follow all necessary measures to prevent pregnancy (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men"). If you are capable of becoming pregnant, your doctor will document with each prescription that all necessary measures have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with lenalidomide if:

• you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in the veins and arteries
• you have any signs of infection, such as cough or fever
• you have or have previously had a viral infection, especially hepatitis B, varicella zoster, or HIV. If in doubt, consult your doctor. Treatment with lenalidomide may cause the virus to become active again in patients who carry the virus. This may lead to a recurrence of the infection. Your doctor should check whether you have ever had 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 multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties
• you have previously experienced a combination of any of the following symptoms:

widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS, or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above 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 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 problems with balance, persistent numbness, decreased sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially life-threatening brain disease known as 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.
• shortness of breath, fatigue, dizziness, chest pain, faster heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Analysis and Testing

Before starting treatment with lenalidomida and during treatment, you will have regular blood tests. This is because lenalidomida may cause a decrease in blood cells that help fight infections (white blood cells) and in those involved in blood clotting (platelets).

Your doctor will request that you have blood tests:

• before starting treatment
• weekly during the first 8 weeks of treatment
• thereafter, at least once a month.

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

For patients with MDS taking lenalidomide

If you have MDS, you may be more likely to develop an advanced disease called acute myeloid leukemia (AML). In addition, it is unknown how lenalidomide affects your chances of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the likelihood of developing AML during treatment with this medicine.

For patients with CLL taking lenalidomide

Your doctor will request blood tests:

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

For patients with FL taking lenalidomide

Your doctor will request blood tests:

• before starting treatment
• weekly during the first 3 weeks (1 cycle) of treatment
• then every 2 weeks during cycles 2 to 4 (see section 3, “Treatment cycle,” for more information)
• after this, at the beginning of each cycle and
• at least once a month.

Your doctor may assess whether you have a high overall tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure (this condition is called "tumor lysis syndrome").

Your doctor may examine you to check for skin changes, 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 pre-existing medical conditions.

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 of age.

Elderly patients and patients with renal problems

If you are 75 years of age or older or have moderate to severe renal problems, your doctor will carefully evaluate you before starting treatment.

Other medicines and Lenalidomida Kern Pharma

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because lenalidomida may affect how other medicines work. In addition, some medicines may affect how 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 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

• You must not take this medicine if you are pregnant, as it is expected to be harmful to the unborn baby.
• You must not become pregnant while taking lenalidomide. Therefore, you must use effective methods of contraception if there is any possibility that you could become pregnant (see “Contraception”).
• If you become pregnant during treatment with this medicine, you must stop 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 advisable for your partner to seek medical advice.
• You should also use effective contraceptive methods (see “Contraception”).

Breastfeeding

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

Contraception

For women taking lenalidomide

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

If you are able to become pregnant:

• you will undergo physician-supervised pregnancy testing (before each treatment cycle, at least every 4 weeks during treatment, and for at least 4 weeks after stopping treatment), unless surgical sterilization (tubal ligation) has been confirmed to prevent eggs from reaching the uterus

And

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout treatment, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the most appropriate contraceptive methods.

For men taking lenalidomide

Lenalidomide is present in human semen. If your partner is pregnant or could become pregnant and is not using an effective method of contraception, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy. You must 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 lenalidomida.

Excipients

Lenalidomide contains lactose. If your doctor has informed you that you are intolerant to certain sugars, consult with him before taking this medicine.

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

3. How to take Lenalidomida Kern Pharma

Lenalidomida must be prescribed and managed by a healthcare professional experienced in the treatment of multiple myeloma, MDS, CLL, or FL.

• When this medicine is used to treat multiple myeloma in patients who cannot undergo a bone marrow transplant or who have received prior treatments, it is taken in combination with other medicines (see section 1 “What Lenalidomida Kern Pharma is used for”).
• When this medicine is used to treat multiple myeloma in patients who have undergone a bone marrow transplant, or to treat patients with MDS or CLL, it is taken alone.
• When this medicine is used to treat follicular lymphoma, it is taken together with another medicine called “rituximab”.

Always follow exactly the instructions provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

If you are taking lenalidomide together with other medicines, you should read the package leaflet of those other medicines for additional information about their use and side effects.

Treatment cycle

Lenalidomide is taken on certain days within a 3-week period (21 days).

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

Or

Lenalidomide is taken on certain days within a 4-week period (28 days).

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

How much Lenalidomida Kern Pharma to take

Before starting treatment, your doctor will inform you:

• of the dose of lenalidomide you should take,
• of the dose of any other medicines you should take together with lenalidomide, if applicable,
• on which days of the treatment cycle you should take each medicine.

How and when to take Lenalidomida Kern Pharma

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If powder from a broken lenalidomide capsule comes into contact with your skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed with water and soap. Pregnant women or those who suspect they may be pregnant must not handle the blister pack or capsule.
• The capsules may be taken with or without food.
• You should take this medicine at approximately the same time each scheduled day.

Taking this medicine

To remove the capsule from the blister:

• Press only one end of the capsule so it comes through the foil.
• Do not press in the center of the capsule, as this may break it.

Duration of treatment with Lenalidomida Kern Pharma

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

If you take more Lenalidomida Kern Pharma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, stating the medicine and the amount ingested.

If you forget to take Lenalidomida Kern Pharma

If you forget to take your usual dose:

• If less than 12 hours have passed: take the capsule immediately.
• If more than 12 hours have passed: do not take the missed capsule. Take the next capsule at the usual time the following day.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

• Hives, rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of serious allergic reactions called angioedema and anaphylactic reaction.
• A severe allergic reaction that may start as a rash in one area but spreads with extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as drug hypersensitivity syndrome or DRESS). See also section 2.

Contact your doctor immediately if you notice any of the following serious adverse effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection including in the bloodstream (sepsis).
• Bleeding or bruising not due to injury.
• Chest (thoracic) or leg pain.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue, which 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 reduce blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. This medicine may also cause blood clots in veins (thrombosis).

Other adverse 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 using this medicine. Therefore, your doctor must carefully evaluate the benefits and risks before prescribing lenalidomide.

Very common adverse effects (may affect more than 1 in 10 people):

• Decrease in the number of red blood cells, which may cause anemia leading to tiredness and weakness
• Skin rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain
• Generalized swelling, including swelling of arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms including fever, muscle pain, headache, earache, cough, and chills
• Numbness, tingling, or burning sensation in the skin, pain in hands or feet, dizziness, tremor
• Loss of appetite, changes in taste
• Increased pain, size of tumor, or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium, and/or sodium in the blood
• Underactive 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)
• Infections of all types, including infection of the sinuses around the nose (sinusitis), lung infection, and upper respiratory tract infections
• Difficulty breathing
• Blurred vision
• Clouding of the eye (cataracts)
• Kidney problems including kidneys that do not function properly or that are unable to maintain normal function
• Abnormal results in liver function tests
• High results in liver function tests
• Changes in a blood protein that may cause swelling of arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• General feeling of discomfort, feeling unwell
• Painful inflammation of the mouth, dry mouth
• Dehydration

Common adverse effects (may affect up to 1 in 10 people):

• Destruction of red blood cells (hemolytic anemia)
• Certain types of skin tumors
• Bleeding from gums, stomach, or intestines
• Increased blood pressure, slow, fast, or irregular heartbeat
• Increased levels of a substance released following normal or abnormal destruction of red blood cells
• Increased levels of a protein indicating inflammation in the body
• Darkening of skin color, skin color changes due to internal bleeding, usually caused by bruising, skin inflammation caused by blood accumulation, bruising
• Increased uric acid levels in the blood
• Skin rashes, redness of the skin, cracked skin, peeling or flaking skin, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes
• Runny nose
• Marked increase or decrease in urine output compared to normal or inability to control urination
• Blood in the urine
• Difficulty breathing especially when lying down (which could be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (inner ear disorder causing a spinning sensation), temporary loss of consciousness
• Chest pain spreading to arms, neck, jaw, back, or stomach, accompanied by sweating, 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
• Swelling of joints
• Slowed or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Loss of balance, movement difficulties
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, abnormal and unpleasant sensation, especially upon touch
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Falls that may cause injuries

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

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sexual desire (libido)
• Excessive urination with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellow pigmentation of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itchy skin, rash, stomach pain or swelling—these may be symptoms of liver damage (liver failure)
• Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called renal tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome – metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications result from the breakdown products of dying tumor cells and may include: changes in blood biochemistry, high levels of potassium, phosphate, and uric acid, and low calcium levels, leading to changes in kidney function and heart rhythm, seizures, and sometimes death
• Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension)

Adverse effects with unknown frequency (cannot be estimated from available data):

• Sudden or mild pain in the upper abdomen and/or back that worsens and lasts several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to inflammation of the pancreas
• Wheezing or whistling sounds when breathing, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of lung tissue
• Rare cases of muscle breakdown (muscle pain, weakness, or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of them occurring when this medicine is taken with a statin (a type of medicine used to lower cholesterol)
• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis)
• Perforation of the stomach or intestinal wall. This may lead to a serious infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits
• Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and nausea or feeling unwell)
• Rejection of solid organ transplants (such as kidney, heart)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomida Kern Pharma

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration or evidence of improper handling.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Package contents and other information

Composition of Lenalidomida Kern Pharma

Lenalidomida Kern Pharma 2.5 mg hard capsules EFG

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

Lenalidomida Kern Pharma 5 mg hard capsules EFG

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

Lenalidomida Kern Pharma 7.5 mg hard capsules EFG

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

Lenalidomida Kern Pharma 10 mg hard capsules EFG

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

Lenalidomida Kern Pharma 15 mg hard capsules EFG

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

Lenalidomida Kern Pharma 20 mg hard capsules EFG

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

Lenalidomida Kern Pharma 25 mg hard capsules EFG

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other components are:
  • Capsule contents: 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.

Presentation of the product and contents of the pack

Lenalidomida 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, containing white powder inside.

Lenalidomida 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, containing white powder inside.

Lenalidomida Kern Pharma 7.5 mg hard capsules

Opaque capsules with a lilac 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, containing white powder inside.

Lenalidomida 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, containing white powder inside.

Lenalidomida 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, containing white powder inside.

Lenalidomida 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, containing white powder inside.

Lenalidomida 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, containing white powder inside.

Carton boxes containing blisters of polyvinyl chloride (PVC) / polychlorotrifluoroethylene (PCTFE) / aluminum foil, each containing 7 hard capsules.

Lenalidomida Kern Pharma 2.5 mg / 5 mg hard capsules

Pack sizes of 7 or 21 capsules.

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

Pack size of 21 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer responsible

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:

Spain	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
Portugal	Lenalidomide Pharmakern 2.5 mg capsules Lenalidomide Pharmakern 5 mg capsules Lenalidomide Pharmakern 7.5 mg capsules Lenalidomide Pharmakern 10 mg capsules Lenalidomide Pharmakern 15 mg capsules Lenalidomide Pharmakern 20 mg capsules Lenalidomide Pharmakern 25 mg capsules

Date of the last revision of this leaflet: January 2025

Detailed and up-to-date 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/