Lenalidomide Sandoz 5 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lenalidomida Sandoz 2.5 mg hard capsules EFG

Lenalidomida Sandoz 5 mg hard capsules EFG

Lenalidomida Sandoz 10 mg hard capsules EFG

Lenalidomida Sandoz 15 mg hard capsules EFG

Lenalidomida Sandoz 20 mg hard capsules EFG

Lenalidomida Sandoz 25 mg hard capsules EFG

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

Keep this leaflet, 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What Lenalidomida Sandoz is and what it is used for
What you need to know before taking Lenalidomida Sandoz
How to take Lenalidomida Sandoz
Possible side effects
How to store Lenalidomida Sandoz
Contents of the pack and other information

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

What Lenalidomida Sandoz is

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

What Lenalidomida Sandoz is used for

Lenalidomide 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 kind of white blood cells 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 may 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 adequate recovery from a bone marrow transplant.

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

Lenalidomide is taken in combination 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 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 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), the need for blood transfusions, and increased risk of infection.

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

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

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

this may reduce the need for blood transfusions. Blood transfusions may no longer be needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cells 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 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. In patients with FL, too many 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 treatment for follicular lymphoma.

How lenalidomide 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 the tumour,
stimulates part of the immune system to attack cancer cells.

2. What you need to know before starting Lenalidomida Sandoz

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

Do not take Lenalidomida Sandoz:

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, “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 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

Talk to your doctor, pharmacist, or nurse before starting Lenalidomida Sandoz if:

you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in veins and arteries,
you have 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 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 using thalidomide (another medicine used to treat multiple myeloma), such as skin rash, itching, swelling, dizziness, or breathing problems,
you have previously experienced a combination of any of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, DRESS) (see also section 4 “Possible side effects”).

If any of the above conditions apply to you, inform your doctor before starting treatment.

At any time during or after treatment, contact 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 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 treatment starts,
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 lenalidomide

If you have MDS, you may be at higher risk of developing a more advanced disease called acute myeloid leukaemia (AML). In addition, it is unknown how lenalidomide affects the likelihood of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the risk of developing AML during treatment with lenalidomide.

For patients with MM taking lenalidomide

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),
thereafter at the beginning of each cycle,
at least once a month.

For patients with FL taking lenalidomide

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),
thereafter at the beginning of each cycle,
at least once a month.

Your doctor may assess 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 Sandoz

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 lenalidomide

You must not take lenalidomide if you are pregnant, as it is expected to be harmful to the unborn child.
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 lenalidomide

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 lenalidomide

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 medically supervised pregnancy testing (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 have been closed to prevent eggs from reaching the uterus (tubal ligation),

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 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 or 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 dizziness, or blurred vision after taking lenalidomide.

Lenalidomida Sandoz contains lactose and sodium

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

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

3. How to take Lenalidomida Sandoz

Lenalidomide must be 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 medications (see section 1 “What Lenalidomida Sandoz is and what it 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 with another medicine called “rituximab”.

Follow exactly the instructions given by your doctor for taking lenalidomide. If you have any doubts, consult your doctor or pharmacist.

If you are taking lenalidomide together with other medicines, you should consult the package leaflet of those other medicines for additional information about their use and 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 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 next 21 days.

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 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 next 28 days.

How much Lenalidomida Sandoz 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 Sandoz

Swallow the capsules whole, preferably with water.
Do not break, open, or chew the capsules. If powder from a broken capsule comes into contact with the 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. Afterwards, gloves should be carefully removed to avoid skin exposure, placed into 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 women 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 lenalidomide at approximately the same time on the scheduled days.

Taking 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 middle of the capsule, as this may break it.

Duration of treatment with Lenalidomida Sandoz

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

If you take more Lenalidomida Sandoz 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 medicine and the amount ingested.

If you forget to take Lenalidomida Sandoz

If you forget to take your dose of lenalidomide at the usual time and

less than 12 hours have passed: take the 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 can cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects, stop treatment with lenalidomide and seek medical attention immediately, as you may require urgent medical treatment:

Hives, rashes, 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, causing significant loss of skin 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 body organs (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 and also reduce 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 should 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 lead to anaemia causing 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, tumour 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 function.
Leg pain (which could be a symptom of thrombosis), chest pain or difficulty breathing (which could be symptoms 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 not functioning properly or unable to maintain normal function.
Abnormal results in liver function tests.
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.
Stomach pain.
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 gums, stomach or intestines.
Increased blood pressure, slow, fast or irregular heartbeat.
Increased levels of a substance released after normal or abnormal destruction of red blood cells.
Increased levels of a protein indicating inflammation in the body.
Darkening of skin colour; skin discolouration due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising.
Increased uric acid in the blood.
Skin rashes, redness of the skin, 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 output 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 spinning sensation), temporary loss of consciousness.
Chest pain spreading to arms, neck, jaw, back or stomach, 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 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 on 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).
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, 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 chemistry, high levels of potassium, phosphate and uric acid, and low calcium levels, leading to changes in kidney function and heart rhythm, seizures and, occasionally, death.
Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension).

Frequency not known (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 a rapid pulse. These symptoms may be due to inflammation of the pancreas.
Wheezing or whistling 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 lenalidomide is given 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 have 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 blistering skin rash) and reactivation of hepatitis B (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, 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 Sandoz

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 pack after "CAD/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 damage or signs of tampering with the container seal.

Medicines should not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines and packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

What Lenalidomida Sandoz contains

Lenalidomida Sandoz 2.5 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
The other ingredients are:
Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine lake (E 132) and yellow iron oxide (E 172).
Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 5 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
The other ingredients are:
Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E 171).
Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 10 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other ingredients are:
Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine lake (E 132) and yellow iron oxide (E 172).
Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 15 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other ingredients are:
Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171) and indigo carmine lake (E 132).
Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 20 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
The other ingredients are:
Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine lake (E 132) and yellow iron oxide (E 172).
Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Lenalidomida Sandoz 25 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other ingredients are:
Capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E 171).
Printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Description of the product and contents of the pack

Lenalidomida Sandoz 2.5 mg hard capsules:

Opaque white body and opaque green to light green cap, approximately 14.3 mm in length, marked with “L9NL” and “2.5”.

Lenalidomida Sandoz 5 mg hard capsules:

Opaque white body and opaque white cap, approximately 18.0 mm in length, marked with “L9NL” and “5”.

Lenalidomida Sandoz 10 mg hard capsules:

Opaque yellow body and opaque green to light green cap, approximately 21.7 mm in length, marked with “L9NL” and “10”.

Lenalidomida Sandoz 15 mg hard capsules:

Opaque white body and opaque blue to light blue cap, approximately 21.7 mm in length, marked with “L9NL” and “15”.

Lenalidomida Sandoz 20 mg hard capsules:

Opaque blue to light blue body and opaque green to light green cap, approximately 21.7 mm in length, marked with “L9NL” and “20”.

Lenalidomida Sandoz 25 mg hard capsules:

Opaque white body and opaque white cap, approximately 21.7 mm in length, marked with “L9NL” and “25”.

Hard capsules are packed in:

OPA/Al/PVC/Al blisters

OPA/Al/PVC/Al calendared blisters

OPA/Al/PVC/Al perforated unit-dose blisters

OPA/Al/PVC/Al perforated unit-dose calendared blisters

Pack sizes:

OPA/Al/PVC/Al blisters: packs containing 7, 14, 21, 28, 42 hard capsules.

OPA/Al/PVC/Al calendared blisters: packs containing 7, 14, 21, 28 and 42 hard capsules; 1, 2, 3, 4 and 6 calendared blisters each containing 7 hard capsules.

OPA/Al/PVC/Al perforated unit-dose blisters: packs containing 7 x 1, 14 x 1, 21 x 1, 28 x 1 hard capsules.

OPA/Al/PVC/Al perforated unit-dose calendared blisters: packs containing 7 x 1, 14 x 1, 21 x 1, 28 x 1 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Synthon B.V.

Microweg 22

6545 CM

Nijmegen

The Netherlands

Synthon Hispania, S.L.

C/ Castelló, nº 1

Sant Boi de Llobregat

08830 Barcelona

Spain

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Lek Pharmaceuticals d.d.

Verovškova ulica 57

SI - 1526 Ljubljana

Slovenia

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Germany: Lenalidomid HEXAL 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg Hard capsules
Croatia: Lenalidomid Sandoz 2.5 mg/10 mg/15 mg/25 mg tvrde capsule
Denmark: Lenalidomida Sandoz
Slovakia: Lenalidomid Sandoz 2.5 mg/5 mg/10 mg/15 mg/25 mg
Slovenia: Lenalidomid Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg trde kapsule
Estonia: Lenalidomide Sandoz
Spain: Lenalidomida Sandoz 2.5 mg/5 mg/10 mg/15 mg/20 mg/25 mg hard capsules EFG
Finland: Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg kapselit, kovat
France: LENALIDOMIDE SANDOZ 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg, gélule
Greece: Lenalidomide/Sandoz
Netherlands: Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg, harde capsules
Iceland: Lenalidomide Sandoz 2.5 mg hörð hylki
Italy: Lenalidomide Sandoz
Latvia: Lenalidomide Sandoz 2.5 mg/5 mg/10 mg/15 mg/25 mg cietas kapsulas
Norway: Lenalidomide Sandoz
Poland: Lenalidomide Sandoz
Romania: Lenalidomida Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg capsule
Sweden: Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg hårda kapslar
United Kingdom (Northern Ireland): Lenalidomide Sandoz 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules

Date of the most recent review of this leaflet: 06/2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/