Lenalidomide zentiva: detailed information

Package leaflet: Information for the patient

Lenalidomide Zentiva, 5 mg, hard capsules
Lenalidomide Zentiva, 10 mg, hard capsules
Lenalidomide Zentiva, 15 mg, hard capsules
Lenalidomide Zentiva, 25 mg, hard capsules
Lenalidomide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Lenalidomide Zentiva is and what it is used for

Lenalidomide Zentiva contains the active substance lenalidomide and belongs to a group of medicines that affect the immune system.
Lenalidomide Zentiva is used in adults to treat:

multiple myeloma,
myelodysplastic syndromes,
mantle cell lymphoma,
follicular lymphoma.

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain kind of white blood cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage of bones and kidneys.
Multiple myeloma is generally incurable. However, it is possible to achieve a temporary significant reduction or disappearance of disease symptoms. This condition is called "remission".

Newly diagnosed multiple myeloma – in patients undergoing bone marrow transplantation
Lenalidomide Zentiva is used alone as maintenance therapy in patients who have responded adequately to bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients not eligible for bone marrow transplantation
Lenalidomide Zentiva is taken together with other medicines:

a chemotherapy medicine called "bortezomib",
an anti-inflammatory medicine called "dexamethasone",
a chemotherapy medicine called "melphalan",
an immunosuppressive medicine called "prednisone".
You will start treatment with Lenalidomide Zentiva together with additional medicines and then continue with Lenalidomide Zentiva alone.
If you are 75 years of age or older, or if you have moderate or severe kidney problems, your doctor will perform careful assessments before starting treatment.

Multiple myeloma – in previously treated patients
Lenalidomide Zentiva is taken together with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Zentiva may prevent worsening of symptoms of multiple myeloma. It has also been shown to delay relapse of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow disorders. Abnormal blood cells are present which do not function properly. Patients may experience various symptoms, including low numbers of red blood cells (anaemia), need for blood transfusions, and risk of infection.
Lenalidomide Zentiva, used as monotherapy, is indicated for the treatment of adult patients with MDS when all of the following conditions are met:

the patient requires regular blood transfusions due to low numbers of red blood cells ("transfusion-dependent anaemia");
the patient has an abnormality in bone marrow cells called "isolated cytogenetic abnormality with deletion 5q". This means the patient's body does not produce enough healthy blood cells;
the patient has previously received other treatments which were inappropriate or not sufficiently effective.

Taking Lenalidomide Zentiva may lead to an increase in the number of healthy blood cells produced by the body by reducing the number of abnormal cells.

this may lead to a reduction in the number of blood transfusions required. It may even become possible to stop blood transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting part of the immune system (lymphatic tissue). It attacks a type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is a disease characterised by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow or blood.

Follicular lymphoma (FL)
FL is a slowly growing malignant cancer affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, excessive numbers of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes and spleen.
Lenalidomide Zentiva is taken together with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Zentiva works
The medicine works by affecting the body's immune system and directly attacking cancer cells. Its mechanism of action includes:

inhibition of cancer cell growth,
inhibition of blood vessel formation in tumours,
stimulation of part of the immune system to attack cancer cells.

2. Important information before using Lenalidomide Zentiva

Before starting treatment with Lenalidomide Zentiva, carefully read the package leaflets of all medicinal products being used in combination with Lenalidomide Zentiva.
When not to use Lenalidomide Zentiva

if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because Lenalidomide Zentiva may harm the unborn child (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2);
if the patient is of childbearing age, unless she follows all necessary measures to prevent pregnancy (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2). If the patient is a woman of childbearing age, the physician will document at each follow-up visit that the required actions have been taken and will provide the patient with such confirmation.
if the patient is allergic to lenalidomide or to any of the excipients of this medicine (listed in section 6). If the patient suspects he or she may be allergic, he or she should consult a doctor. If any of the above situations apply, Lenalidomide Zentiva must not be taken. In case of doubt, consult a doctor.

Warnings and precautions
Before taking Lenalidomide Zentiva, discuss this with a doctor or pharmacist if:

the patient has previously had blood clots – this means an increased risk of developing blood clots in veins and arteries during treatment;
the patient has any symptoms of infection, such as cough or fever; the patient has or has previously had a viral infection, especially hepatitis B, varicella-zoster virus infection, or HIV. In case of doubt, consult a doctor. The use of lenalidomide may reactivate viruses in patients previously infected, leading to a recurrence of infection. The doctor will check whether the patient has previously had hepatitis B;
the patient has impaired kidney function – the doctor may adjust the dose of Lenalidomide Zentiva;
the patient has had a heart attack, previously had blood clots, smokes tobacco, has high blood pressure, or high cholesterol levels;
the patient experienced an allergic reaction after taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
the patient previously experienced a combination of any of the following symptoms: facial rash or widespread rash, skin redness, high fever, flu-like symptoms, increased liver enzyme activity, increased number of certain white blood cells (eosinophilia), enlarged lymph nodes (symptoms of a severe skin reaction known as "drug reaction with eosinophilia and systemic symptoms", DRESS); see also "Possible side effects" in section 4). If any of the above situations apply, inform the doctor, pharmacist, or nurse before starting treatment.

Immediately inform the doctor or nurse if, at any time during or
after treatment, the patient experiences:

vision disturbances, loss of vision, or double vision, difficulty speaking, weakness in the arm or leg, change in walking or balance, persistent numbness, reduced sensation, or loss of sensation, memory loss or disorientation – inform the doctor or nurse immediately. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML).
If the patient had such symptoms before treatment with lenalidomide, inform the doctor of any changes.
shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and examinations
Before starting Lenalidomide Zentiva and during treatment, the patient will undergo regular blood tests, as lenalidomide may reduce the number of blood cells that help fight infection (white blood cells) and those that help blood to clot (platelets).
The doctor will order blood tests:

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

Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.
Patients with MDS taking Lenalidomide Zentiva
If the patient has myelodysplastic syndromes (MDS), there is an increased chance of developing a serious disease called acute myeloid leukaemia. Furthermore, it is not known how Lenalidomide Zentiva affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that may better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide Zentiva.
Patients with MCL taking Lenalidomide Zentiva
The 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 (more information in section 3 "Treatment cycle"),
then at the beginning of each cycle, and
at least once a month.

Patients with FL taking Lenalidomide Zentiva
The 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 (more information in section 3 "Treatment cycle"),
then at the beginning of each cycle,
at least once a month.

The doctor may perform a test to check whether the patient has a large amount of tumour tissue in the body, including in the bone marrow. This may lead to a condition in which tumour tissue breaks down, causing abnormal increases in levels of various chemicals in the blood and potentially leading to kidney failure (this condition is called "tumour lysis syndrome").
The doctor may examine the patient's skin to check for changes such as red spots or rash.
The doctor may adjust the dose of Lenalidomide Zentiva or discontinue treatment based on blood test results and the patient's overall condition. If the disease has been recently diagnosed, the doctor may also consider the patient's age and other existing medical conditions when assessing treatment.
Blood donation
Do not donate blood during treatment and for at least 7 days after treatment ends.
Children and adolescents
Lenalidomide Zentiva is not recommended for use in children and adolescents under 18 years of age.
Elderly patients and patients with impaired kidney function
If the patient is 75 years of age or older, or has moderate to severe kidney impairment, the doctor will perform thorough evaluations before starting treatment.
Lenalidomide Zentiva and other medicines
Inform the doctor or nurse about all medicines currently or recently taken by the patient, as lenalidomide and certain other medicines may interact with each other.
Especially inform the doctor or nurse if any of the following medicines or substances are being used:

certain contraceptives, such as oral contraceptives, as they may lose effectiveness;
certain medicines used for heart conditions, such as digoxin;
certain medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
Information for women taking Lenalidomide Zentiva

Do not take Lenalidomide Zentiva if the patient is pregnant, as it may harm the unborn child.
Women must not become pregnant while taking Lenalidomide Zentiva. Therefore, women of childbearing age must use effective methods of contraception (see below "Contraception").
If the patient becomes pregnant while taking Lenalidomide Zentiva, she must immediately stop treatment and inform her doctor.

Information for men taking Lenalidomide Zentiva

If the partner of a man taking Lenalidomide Zentiva becomes pregnant, inform the doctor immediately. It is recommended that the partner seek medical advice.
The patient must also use effective contraception (see below "Contraception").

Breastfeeding
Do not breastfeed while taking Lenalidomide Zentiva, as it is not known whether lenalidomide passes into human milk.
Contraception
Information for women taking Lenalidomide Zentiva
Before starting treatment, the patient should ask the doctor whether she could become pregnant, even if she considers it unlikely.
If the patient is of childbearing age:

she will undergo pregnancy tests under the supervision of a doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless the doctor confirms that she has undergone tubal ligation (sterilization of the fallopian tubes) to prevent the passage of egg cells to the uterus
AND
she must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends. The doctor will advise the patient on appropriate contraceptive methods.

Information for men taking Lenalidomide Zentiva
Lenalidomide passes into human semen. If the patient's partner is pregnant or could become pregnant and is not using effective contraception, the patient must use condoms during treatment and for at least 7 days after treatment ends. This applies even to men who have undergone vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen.
Driving and operating machinery
If after taking Lenalidomide Zentiva the patient experiences dizziness, fatigue, drowsiness, a sensation of spinning, or blurred vision, he or she should not drive or operate machinery.
Lenalidomide Zentiva contains lactose and sodium
If the patient has been diagnosed with an intolerance to certain sugars, he or she should consult a doctor before using this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Lenalidomide Zentiva

Lenalidomide Zentiva must be administered by medical professionals experienced in the treatment of multiple myeloma, MDS, MCL or FL.

If Lenalidomide Zentiva is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatments, the medicine is given together with other drugs (see section 1 "Why Lenalidomide Zentiva is used").
If Lenalidomide Zentiva is used to treat multiple myeloma in patients after bone marrow transplantation, or in the treatment of patients with MDS or MCL, the medicine is used alone (monotherapy).
When Lenalidomide Zentiva is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab".

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
If the patient is taking Lenalidomide Zentiva together with other medicines, they should read the package leaflets of those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Zentiva is taken on specific days for 3 weeks (21 days).

Each 21-day period is called a "treatment cycle".
Depending on the day of the cycle, the patient may take one or more medicines. However, on some days the patient will not take any medicines.
After completion of each 21-day cycle, the patient should start a new 21-day cycle.

OR
Lenalidomide Zentiva is taken on specific days for 4 weeks (28 days).

Each 28-day period is called a "treatment cycle".
Depending on the day of the cycle, the patient takes one or more medicines. However, on some days the patient does not take any medicines.
After completion of each 28-day cycle, the patient should start a new 28-day cycle.

How much Lenalidomide Zentiva to take
Before starting treatment, the doctor will inform the patient:

how much Lenalidomide Zentiva to take;
how many other medicines (if any) the patient should take together with Lenalidomide Zentiva;
on which days of the cycle to take each of these medicines.

How and when to take Lenalidomide Zentiva

Swallow the capsule whole, preferably with water.
Do not crush, open or chew the capsule. If powder from a damaged Lenalidomide Zentiva 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 in a sealed polyethylene plastic bag and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
Capsules may be taken with food or independently of meals.
The medicine should be taken on the designated days at approximately the same time each day.

Taking this medicine
To remove the capsule from the blister:

press only on one side of the capsule and push it through the foil,
do not press on the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Zentiva
Lenalidomide Zentiva is used in treatment cycles, each lasting 21 or 28 days (see above "Treatment cycle"). Treatment should continue until the doctor advises stopping.
If more Lenalidomide Zentiva has been taken than recommended
If the patient has taken more capsules than prescribed, contact the doctor immediately.
Missed dose of Lenalidomide Zentiva
If the patient forgets to take Lenalidomide Zentiva at the usual time:

and less than 12 hours have passed since then, take the missed capsule as soon as possible;
and more than 12 hours have passed, do not take the missed capsule. Take the next dose at the usual time on the following day.

If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following serious side effects occur, stop taking Lenalidomide Zentiva and contact your doctor immediately – immediate treatment may be necessary:

hives, rash, swelling of the eyes, lips or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction;
severe allergic reaction possibly starting as a rash in one area, spreading over the entire body and associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as “DRESS” or “drug hypersensitivity syndrome”). See also section 2. Immediately inform your doctor if any of the following serious side effects occur:
fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (including blood infection – sepsis);
bleeding or bruising without injury;
chest pain or leg pain;
shortness of breath;
bone pain, muscle weakness, confusion or fatigue, which may result from high calcium levels in the blood.

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

Other side effects
A small number of patients may develop another type of tumour, and the risk of developing such tumours may be higher during lenalidomide treatment. For this reason, your doctor will carefully assess the benefits and risks before prescribing this medicine.

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

decreased number of red blood cells, which may lead to anaemia causing tiredness and weakness
rash, itching
muscle cramps, muscle weakness, muscle pain, bone pain, joint pain, back pain, limb pain
generalised swelling, including swelling of hands and feet
weakness, fatigue
fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
numbness, tingling or burning sensation of the skin, pain in hands or feet, dizziness, tremor
decreased appetite, altered taste sensation
increased pain, enlargement or redness around a tumour
weight loss
constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn
low levels of potassium, calcium and/or sodium in the blood
abnormally low thyroid function
leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may indicate presence of blood clots in the lungs, known as pulmonary embolism)
all types of infections, including sinus infection, lung infection and upper respiratory tract infections
shortness of breath
blurred vision
cloudy vision (cataract)
kidney problems, including abnormal kidney function or inability to maintain normal kidney function
abnormal liver test results
increased liver function test values
changes in blood proteins leading to blood vessel swelling (vasculitis)
increased blood sugar levels (diabetes)
decreased blood sugar levels
headache
nosebleeds
dry skin
depression, mood changes, sleep disturbances
cough
low blood pressure
vague feeling of physical discomfort, malaise
painful inflammation of the mouth, dry mouth
dehydration

Common (may affect up to 1 in 10 people)

breakdown 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 substances produced during normal and abnormal breakdown of red blood cells
increased levels of a protein indicating inflammation in the body
darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruising
increased uric acid levels in the blood
skin eruptions, skin redness, skin cracking, peeling or flaking, hives
itching, excessive sweating, night sweats
difficulty swallowing, sore throat, voice quality problems or voice changes
runny nose
passing significantly more or less urine than normal or inability to control urination
passing blood in the urine
shortness of breath, especially when lying down (which may be a sign of heart failure)
erection difficulties
stroke, fainting, dizziness (inner ear disorder causing a sensation that everything is spinning), transient loss of consciousness
chest pain spreading to arms, neck, jaw, back or abdomen, sweating, breathlessness, nausea or vomiting, which may be signs of a heart attack (myocardial infarction)
muscle weakness, lack of energy
neck pain, chest pain
chills
joint swelling
slowing or blockage of bile flow from the liver
low levels of phosphates or magnesium in the blood
speech difficulties
liver damage
loss of balance, difficulty moving
hearing loss, tinnitus (ringing in the ears)
nerve pain, unpleasant abnormal sensations, especially in response to touch
excess iron in the body
thirst
confusion
toothache
falls that may lead to injury

Uncommon (may affect up to 1 in 100 people)

bleeding inside the skull
circulation problems
loss of vision
loss of sex drive (libido)
passing large amounts of urine, accompanied by bone pain and weakness, which may be signs of kidney disease (Fanconi syndrome)
yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, abdominal pain or swelling – may be signs of liver damage (liver failure)
abdominal pain, bloating or diarrhoea, which may be signs of inflammation of the large intestine (so-called colitis or typhlitis)
kidney tubule cell damage (called tubular necrosis)
skin colour changes, sensitivity to sunlight
tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying cancer cells and may include: changes in blood chemistry; high levels of potassium, phosphate and uric acid, and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death
high blood pressure in blood vessels leading to the lungs (pulmonary hypertension)

Frequency not known (cannot be estimated from available data)

sudden or gradually worsening pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever and rapid heartbeat – these symptoms may indicate pancreatitis
wheezing, shortness of breath or dry cough, possibly due to lung tissue inflammation
rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some occurring when lenalidomide was taken concomitantly with statins (a class of drugs that lower blood cholesterol levels)
skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leucocytoclastic vasculitis)
rupture of the stomach or intestinal wall, which may lead to a serious infection. Inform your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in your stool or changes in bowel habits.
viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea and vomiting)
solid organ transplant rejection (e.g. kidney, heart)

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Lenalidomide Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack marked EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Do not use the medicine if visible signs of damage are present or if there are indications that the packaging seals have been broken.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Zentiva contains
Lenalidomide Zentiva 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, magnesium stearate
- capsule shell: gelatin, titanium dioxide (E171)
- printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Lenalidomide Zentiva 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, magnesium stearate
- capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E 132), iron oxide yellow (E 172)
- printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Lenalidomide Zentiva 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, magnesium stearate
- capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E 132)
- printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Lenalidomide Zentiva 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, magnesium stearate
- capsule shell: gelatin, titanium dioxide (E171)
- printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

What Lenalidomide Zentiva looks like and contents of the pack
Lenalidomide Zentiva 5 mg: hard capsule with an opaque white body and opaque white cap, approximately 18.0 mm in length, marked with "L9NL" and "5".
Lenalidomide Zentiva 10 mg: hard capsule with an opaque yellow body and opaque green to light green cap, approximately 21.7 mm in length, marked with "L9NL" and "10".
Lenalidomide Zentiva 15 mg: hard capsule with an opaque white body and opaque blue to light blue cap, approximately 21.7 mm in length, marked with "L9NL" and "15".
Lenalidomide Zentiva 25 mg: hard capsule with an opaque white body and opaque white cap, approximately 21.7 mm in length, marked with "L9NL" and "25".
Lenalidomide Zentiva hard capsules are available in cardboard boxes containing 7 or 21 capsules in blisters made of OPA/Aluminium/PVC/Aluminium.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s., U kabelovny 130, Dolni Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer/Importer
Synthon Hispania S.L.
C/ Castelló 1, Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona, Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Lenalidomid Zentiva: Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Norway, Sweden, United Kingdom (Northern Ireland).
Lenalidomide Zentiva: France, Italy, Poland.
Lenalidomida Zentiva: Portugal.

For further information, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00