Lenalidomide Sun 5 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lenalidomida Sun 2.5 mg hard capsules EFG

Lenalidomida Sun 5 mg hard capsules EFG

Lenalidomida Sun 7.5 mg hard capsules EFG

Lenalidomida Sun 10 mg hard capsules EFG

Lenalidomida Sun 15 mg hard capsules EFG

Lenalidomida Sun 20 mg hard capsules EFG

Lenalidomida Sun 25 mg hard capsules EFG

lenalidomide

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask 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, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Lenalidomida Sun is and what it is used for

What Lenalidomida Sun is

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

What Lenalidomida Sun is used for

Lenalidomide is used in adults for:

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

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 the bones and kidneys.

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

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

Lenalidomide is used as maintenance treatment after adequately recovering from a bone marrow transplant.

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

Lenalidomide is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”;
• an anti-inflammatory medicine 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 lenalidomide 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

Lenalidomide is taken together with an anti-inflammatory medicine 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 (anemia), the need for blood transfusions, and increased risk of infection.

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

• they require periodic blood transfusions to treat low red blood cell levels ("transfusion-dependent anemia");
• they have an abnormality in bone marrow cells called "isolated 5q cytogenetic abnormality". This means their body does not produce a sufficient number of healthy blood cells;
• previous treatments they have used are not suitable or have not worked well enough.

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

• this may reduce the number of blood transfusions required. Transfusions may no longer be needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of a 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 the lymphatic tissue, bone marrow, or blood.

Lenalidomide is used as monotherapy to treat adult patients who have previously received treatment 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. In individuals with FL, excessive numbers of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomide is used in combination with another medicine called "rituximab" for the treatment of adult patients who have received prior therapy for follicular lymphoma.

How Lenalidomida Sun works

Lenalidomide works by affecting the body's immune system and directly attacking cancer cells. It acts in several ways:

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

2. What you need to know before starting Lenalidomida Sun

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

Do not take Lenalidomida Sun:

• if you are pregnant, think you might be pregnant, or intend 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 could become pregnant, unless you follow all necessary measures to prevent it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you could become pregnant, your doctor will document with each prescription that all necessary precautions have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomide or any of the other components 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 Lenalidomida Sun if:

• you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in 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 reactivate the virus in carriers, leading to 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, previously had a blood clot, or if you smoke, have high blood pressure, or high cholesterol levels;
• you have had an allergic reaction while taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or breathing problems;
• 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 (these are symptoms 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, change in walking pattern or balance problems, persistent numbness, reduced 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 legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Blood tests and monitoring

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

Your doctor will request 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 lenalidomide.

For patients with MDS taking Lenalidomida Sun

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). In addition, it is unknown how lenalidomide affects the risk 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 lenalidomide.

For patients with MCL taking Lenalidomida Sun

Your doctor will request blood tests:

• before 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 this, at the beginning of each cycle and
• at least once a month.

For patients with FL taking Lenalidomida Sun

Your doctor will request blood tests:

• before 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 every month.

Your doctor may check whether you have a high total 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 for skin changes such as red spots or 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 other pre-existing conditions.

Blood donation

You must not donate blood during treatment or for at least 7 days after treatment ends.

Children and adolescents

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

Elderly patients and patients with kidney problems

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

Other medicines and Lenalidomida Sun

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

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

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

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking Lenalidomida Sun

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

Men taking Lenalidomida Sun

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

Breastfeeding

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

Contraception

For women taking Lenalidomida Sun

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

If you could become pregnant

• you will undergo pregnancy testing under medical supervision (before each treatment, at least every 4 weeks during treatment, and for at least 4 weeks after stopping treatment), unless it has been confirmed that your fallopian tubes have been closed so that eggs cannot reach the uterus (tubal ligation)

And

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

For men taking Lenalidomida Sun

Lenalidomide passes into human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, 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 and for at least 7 days after stopping treatment.

Driving and using machines

Do not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo, or blurred vision after taking lenalidomide.

Lenalidomide Sun contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Lenalidomida Sun

Lenalidomide must be prescribed and administered by a healthcare professional experienced in the treatment of multiple myeloma, MDS, CMML, or FL.

• When lenalidomide is used for the treatment of multiple myeloma in patients who cannot undergo a bone marrow transplant or who have received prior therapies, it is taken in combination with other medications (see section 1 “What Lenalidomida Sun is used for”).
• When lenalidomide is used for the treatment of multiple myeloma in patients who have undergone a bone marrow transplant, or for treating patients with MDS or CMML, it is taken alone.
• When lenalidomide is used for the treatment of follicular lymphoma, it is taken in combination with another medicine called “rituximab”.

Always follow exactly the dosing instructions provided by your doctor. If in doubt, consult your doctor or pharmacist.

If you are taking lenalidomide together with other medicines, please refer to the package leaflet of those other medicines for additional information on their use and side effects.

Treatment cycle

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

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

Or

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

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

How much Lenalidomida Sun 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 in combination with lenalidomide, if applicable;
• on which days of the treatment cycle you should take each medicine.

How and when to take Lenalidomida Sun

• 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 the skin, wash the skin immediately and thoroughly with soap and water.
• 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 into a sealable polyethylene plastic bag, and disposed of according to local requirements. Afterwards, hands should be washed thoroughly with soap and water.
• Pregnant women or those who suspect they may be pregnant must not handle the blister pack or capsule.
• Capsules may be taken with or without food.
• You should take lenalidomide at approximately the same time each day on the scheduled days.

How to take this medicine

To remove the capsule from the blister:

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

Duration of treatment with Lenalidomida Sun

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

If you take more Lenalidomida Sun than you should

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lenalidomida Sun

If you forget to take your usual dose of lenalidomide and

• less than 12 hours have passed: take the missed capsule immediately.
• 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, this medicine may cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects, stop treatment with Lenalidomide Sun immediately and seek medical attention right away, as 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 types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction that may start as a rash in one area but spreads, causing extensive skin loss all over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome). See also section 2.

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

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

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

Other adverse reactions

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

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

• A decrease in the number of red blood cells, which may cause anaemia leading to tiredness and weakness.
• Skin rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
• Generalised swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms including fever, muscle pain, headache, earache, 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, or redness around the tumour.
• Weight loss.
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn.
• Low levels of potassium, calcium, and/or sodium in the blood.
• Underactive thyroid gland.
• 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 liver function test results.
• High values in liver function tests.
• Changes in a blood protein that may cause swelling of the arteries (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, mood changes, difficulty sleeping.
• Cough.
• Low blood pressure.
• A general feeling of discomfort or feeling unwell.
• Painful inflammation of the mouth, dry mouth.
• Dehydration.

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

• Destruction of red blood cells (haemolytic anaemia).
• Certain types of skin tumours.
• Bleeding from gums, stomach, or intestines.
• High blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance released after normal or abnormal destruction of red blood cells.
• Increase in a type of protein indicating inflammation in the body.
• Darkening of skin colour; skin discolouration due to internal bleeding, usually caused by bruising; skin inflammation caused by blood accumulation; bruising.
• Increased uric acid levels in the blood.
• Skin rashes, skin redness, cracked skin, skin peeling or flaking, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes.
• Runny nose.
• Marked 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, dizziness (inner ear disorder causing a sensation of spinning), 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.
• Deafness, 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 reactions (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 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, skin rash, stomach pain or swelling; these may be symptoms of liver damage (liver failure).
• Stomach pain, abdominal swelling, or diarrhoea, 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 colour, sensitivity to sunlight.
• Tumour lysis syndrome – metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications arise due to the breakdown products of dying tumour cells and may include: changes in blood biochemistry, high levels of potassium, phosphate, 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 reactions 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 occurring when lenalidomide is administered with a statin (a type of cholesterol-lowering medicine).

• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).

• Perforation of the stomach or intestinal wall. This may lead to a severe infection. Inform your doctor if you experience 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 blistering skin rash) 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 reactions

If you experience any adverse reaction, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse reaction 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 reactions, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomide Sun

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and the carton after “CAD”/“EXP”. The expiry date refers to the last day of the month indicated.
• Store below 25°C.
• Do not use this medicine if you notice any visible signs of deterioration or evidence of improper handling.
• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist, thus helping to protect the environment.

6. Contents of the pack and other information

Composition of Lenalidomida Sun

Lenalidomida Sun 2.5 / 10 / 20 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains 2.5 / 10 / 20 mg of lenalidomide, respectively.

• The other components are:

• Capsule contents: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

• Capsule shell: titanium dioxide (E171), indigo carmine (E132), gelatin, and yellow iron oxide (E172).

• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Lenalidomida Sun 5 / 25 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains 5 / 25 mg of lenalidomide, respectively.

• The other components are:

• Capsule contents: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

• Capsule shell: titanium dioxide (E171), gelatin.

• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Lenalidomida Sun 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: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

• Capsule shell: titanium dioxide (E171), gelatin, and yellow iron oxide (E172).

• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Lenalidomida Sun 15 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.

• The other components are:

• Capsule contents: monohydrate lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

• Capsule shell: titanium dioxide (E171), indigo carmine (E132), gelatin.

• Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Appearance of the product and contents of the pack

Lenalidomida Sun 2.5 mg hard capsules EFG are 14 mm long, opaque greenish-blue cap and opaque white body hard gelatin capsules, printed with “RL” on the cap and “78” on the body, containing a white to off-white granular powder.

Lenalidomida Sun 5 mg hard capsules EFG are 18 mm long, opaque white cap and opaque white body hard gelatin capsules, printed with “RL” on the cap and “79” on the body, containing a white to off-white granular powder.

Lenalidomida Sun 7.5 mg hard capsules EFG are 18 mm long, opaque pale yellow cap and opaque white body hard gelatin capsules, printed with “RL” on the cap and “86” on the body, containing a white to off-white granular powder.

Lenalidomida Sun 10 mg hard capsules EFG are 21 mm long, opaque greenish-blue cap and opaque pale yellow body hard gelatin capsules, printed with “RL” on the cap and “80” on the body, containing a white to off-white granular powder.

Lenalidomida Sun 15 mg hard capsules EFG are 21 mm long, opaque blue cap and opaque white body hard gelatin capsules, printed with “RL” on the cap and “81” on the body, containing a white to off-white granular powder.

Lenalidomida Sun 20 mg hard capsules EFG are 21 mm long, opaque greenish-blue cap and opaque blue body hard gelatin capsules, printed with “RL” on the cap and “82” on the body, containing a white to off-white granular powder.

Lenalidomida Sun 25 mg hard capsules EFG are 21 mm long, opaque white cap and opaque white body hard gelatin capsules, printed with “RL” on the cap and “83” on the body, containing a white to off-white granular powder.

Lenalidomida Sun 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules EFG are available in packs containing 7, 14, 21, 28 or 42 capsules.

Lenalidomida Sun 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules EFG are also available in packs containing 7 x 1, 14 x 1, 21 x 1, 28 x 1 or 42 x 1 capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer Responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Terapia S.A.

124 Fabricii Street

400 632 Cluj Napoca,

Romania

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

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

+34 93 342 78 90

Date of the most recent review of this leaflet: January 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.aemps.gob.es/.