Lenalidomide Sun 10 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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 the 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 "lenalidomida". This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomida Sun is used for

Lenalidomida 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 bones and kidneys.

Multiple myeloma is generally not curable. 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

Lenalidomida 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

Lenalidomida 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 lenalidomida 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.

Relapsed or refractory multiple myeloma: in previously treated patients

Lenalidomida is taken together with an anti-inflammatory medicine called "dexamethasone".

Lenalidomida may slow the progression 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 several 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 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 no longer 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 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 cell that helps 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 Lenalidomide 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 taking 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 unborn baby (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, “Pregnacy, 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 precautions have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take 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 patients who carry it, leading to a recurrence of 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 using 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), or 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, 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 changes 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).

Blood tests and monitoring

Before starting treatment with lenalidomide and during treatment, 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 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 leukaemia (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;
• subsequently, 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;
• subsequently, 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 check whether you have a high total tumour burden in the body, including in the bone marrow. This could lead to a condition in which tumours break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure (this condition is called “tumour 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 become ineffective;
• 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 unborn baby.
• 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 capable of becoming pregnant, even if you think this is unlikely.

If you are capable of becoming pregnant:

• you will undergo pregnancy tests under medical supervision (before each treatment cycle, 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 are closed (tubal ligation) so that eggs cannot reach 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 Lenalidomida Sun

Lenalidomide is present in 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 treatments, it is taken in combination with other medicines (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 for lenalidomide provided by your doctor. If in doubt, consult your doctor or pharmacist.

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

Before starting treatment, your doctor will inform you:

• of the amount of lenalidomide you should take;
• of the amount 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 Sun

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the 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. Hands should then be thoroughly washed 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 to push it 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 treatment cycles until your doctor instructs 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 or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of 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 your 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 can 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 severe types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction that may start as a rash in one area but spreads, leading to 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 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 effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection, including in the bloodstream (sepsis).
• Bleeding (haemorrhage) or bruising (haematoma) not due to injury.
• Chest (thoracic) 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, as well as 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 effects

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 lenalidomide.

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

• A decrease in the number of red blood cells, which may cause anaemia leading to fatigue 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 sensations 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, indigestion.
• Low levels of potassium, calcium, and/or sodium in the blood.
• Underactive thyroid function.
• Leg pain (which could be a sign of thrombosis), chest pain, or difficulty breathing (which could be symptoms of blood clots in the lungs, known as pulmonary embolism).
• Infections of any kind, 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.
• Elevated liver function test results.
• 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, 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 (haemolytic anaemia).
• Certain types of skin tumours.
• Bleeding from the gums, stomach, or intestines.
• High blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance released following normal or abnormal breakdown of red blood cells.
• Increase in a type of protein indicating inflammation in the body.
• Darkening of the skin; skin colour changes due to internal bleeding, usually caused by bruising; skin inflammation due to 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 urine volume compared to usual, or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a sign of heart failure).
• Difficulty achieving an erection.
• Stroke, fainting, dizziness (a disorder of the inner ear causing a sensation of spinning), temporary loss of consciousness.
• Chest pain spreading to the 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 the joints.
• Slowed or blocked flow of bile from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Loss of balance, difficulty with movement.
• 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 injury.

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).
• 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, skin itching, 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 result from the breakdown products of dying tumour 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 the 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 lenalidomide is administered 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 (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 the 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, 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, pharmacist, or nurse, 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 Sun

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and the carton after “CAD”/“EXP”. The expiry date is 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: lactose monohydrate (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: lactose monohydrate (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: lactose monohydrate (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: lactose monohydrate (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 granular powder, white to off-white.

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 granular powder, white to off-white.

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 granular powder, white to off-white.

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 granular powder, white to off-white.

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 granular powder, white to off-white.

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 granular powder, white to off-white.

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 granular powder, white to off-white.

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 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 marketed.

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/.