Package leaflet: Information for the patient

Lenalidomide Teva, 5 mg, hard capsules
Lenalidomide Teva, 10 mg, hard capsules
Lenalidomide Teva, 15 mg, hard capsules
Lenalidomide Teva, 25 mg, hard capsules
Lenalidomidum
Please read all of this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Lenalidomide Teva is and what it is used for
Important information before taking Lenalidomide Teva
How to take Lenalidomide Teva
Possible side effects
How to store Lenalidomide Teva
Contents of the pack and other information

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

What Lenalidomide Teva is
Lenalidomide Teva contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the function of the immune system.

What Lenalidomide Teva is used for
Lenalidomide Teva is used in adult patients for the treatment of:

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.
Generally, multiple myeloma is incurable. However, it is possible to achieve temporary significant reduction or disappearance of signs and symptoms of the disease. This is called "remission".

Newly diagnosed multiple myeloma – in patients who have undergone stem cell transplantation
In this indication, Lenalidomide Teva is used as a single agent for maintenance therapy after achieving an adequate response following transplantation.

Newly diagnosed multiple myeloma – in patients not eligible for stem cell transplantation
Lenalidomide Teva is taken in combination with other medicines, including:

a chemotherapy drug called "bortezomib";
an anti-inflammatory drug called "dexamethasone";
a chemotherapy drug called "melphalan"; and
an immunosuppressive drug called "prednisone".
Treatment is initiated with additional medicines, followed by continuation with Lenalidomide Teva alone.

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

Multiple myeloma – in previously treated patients
Lenalidomide Teva is taken in combination with an anti-inflammatory drug called "dexamethasone".
Lenalidomide Teva may stop the progression of signs and symptoms of multiple myeloma. It has also been shown to delay the recurrence 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 subjective and objective symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infection.

Lenalidomide Teva as monotherapy is used to treat adult patients diagnosed with MDS, if all the following conditions are met:

the patient requires regular blood transfusions due to low red blood cell count ("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 been treated with other therapies that were inappropriate or not sufficiently effective.

Taking Lenalidomide Teva 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 discontinue 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 characterized by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow, or blood.
Lenalidomide Teva as monotherapy is used in the treatment of adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)
Follicular lymphoma (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 Teva is taken together with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Teva works
Lenalidomide Teva works by affecting the function of the immune system and directly attacking cancer cells. The medicine acts in several different ways:

by inhibiting the growth of cancer cells;
by inhibiting the development of blood vessels in the tumour;
by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Teva

Before starting treatment with Lenalidomide Teva, carefully read the package leaflets
of all medicinal products used in combination with Lenalidomide Teva.
When not to take Lenalidomide Teva:

if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because Lenalidomide Teva is expected to be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men");
if the patient could become pregnant, unless she uses all required contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document at the time of prescribing that necessary measures have been taken and will ensure the patient is aware of this;
if the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If allergy is suspected, consult the doctor for advice.

If any of these points apply to the patient, Lenalidomide Teva must not be used.
In case of doubt, consult the doctor.
Warnings and precautions
Before starting to take Lenalidomide Teva, discuss this with the doctor,
pharmacist, or nurse, if the patient:

has previously had blood clots – this means an increased risk of developing blood clots in veins and arteries during treatment;
has any signs of infection, such as cough or fever;
currently has or has previously had a viral infection, particularly varicella-zoster virus, hepatitis B virus, or HIV infection. In case of doubt, consult the doctor. Treatment with Lenalidomide Teva may reactivate viruses in patients previously infected, leading to recurrence of infection. The doctor will check whether the patient has previously had hepatitis B;
has kidney problems – the doctor may adjust the dose of Lenalidomide Teva;
has had a heart attack (heart attack), ever had a blood clot, if the patient smokes, has high blood pressure, or high cholesterol levels;
experienced allergic reactions while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties;
previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes
- these are symptoms of a serious skin reaction called drug rash with eosinophilia and systemic symptoms, also known as DRESS syndrome (DRESS – Drug Reaction with Eosinophilia and Systemic Symptoms) or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above points apply to the patient, consult the doctor,
pharmacist, or nurse.
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 disturbances, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation. 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 Teva, inform the doctor of any changes in these symptoms.
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
Regular blood tests will be performed before and during treatment with Lenalidomide Teva because Lenalidomide Teva may reduce the number of blood cells that help fight infection (white blood cells) and help blood to clot (platelets). The doctor will schedule blood tests for the patient:

before treatment,
weekly for 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 Teva
If the patient has myelodysplastic syndromes, there is an increased chance of developing a serious disease called acute myeloid leukemia. Furthermore, it is not known how Lenalidomide Teva affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that help better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Teva.
Patients with MCL taking Lenalidomide Teva
The doctor will request blood tests:

before treatment,
weekly for 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 Teva
The doctor will request blood tests:

before treatment,
weekly for the first 3 weeks (1st 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 and
at least once a month.

The doctor may perform an assessment to determine whether the patient has a large amount of tumour tissue in the body, including in the bone marrow. This may lead to a situation where tumour tissue begins to die, causing abnormal increases in various substances in the blood, which may lead to kidney failure (a condition known as tumour lysis syndrome).
The doctor may examine the patient to check for skin changes, such as red spots or rash.
The doctor may change the dose of Lenalidomide Teva or discontinue treatment based on the patient's blood test results and general condition. If the disease was recently diagnosed, the doctor may also evaluate treatment based on the patient's age and other conditions that may have occurred in the past.
Blood donation
During treatment and for at least 7 days after treatment ends, the patient must not donate blood.
Children and adolescents
Lenalidomide Teva is not recommended for use in children and adolescents under 18 years of age.
Elderly patients and patients with kidney problems
If the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform thorough evaluations before starting treatment.
Lenalidomide Teva and other medicines
Inform the doctor or nurse about all medicines the patient is currently taking or has recently taken. This is necessary because Lenalidomide Teva may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Teva.
In particular, inform the doctor or nurse if the patient is taking the following medicines:

certain contraceptives, such as oral contraceptives, because 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
For women taking Lenalidomide Teva

Do not use Lenalidomide Teva if the patient is pregnant, because it is expected to be harmful to the unborn child.
Women must not become pregnant while taking Lenalidomide Teva. Therefore, women who could become pregnant must use an effective method of contraception (see "Contraception").
If the patient becomes pregnant during treatment with Lenalidomide Teva, treatment must be stopped immediately and the doctor must be informed.

For men taking Lenalidomide Teva

If the female partner of a man undergoing treatment with Lenalidomide Teva becomes pregnant, she must immediately inform the doctor. The partner should seek medical advice.
Men must also use an effective method of contraception (see "Contraception").

Breastfeeding
Do not breastfeed while taking Lenalidomide Teva, because it is not known whether Lenalidomide Teva passes into human milk.
Contraception
Women taking Lenalidomide Teva
Before starting treatment, ask the doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who could become pregnant:

will have pregnancy tests performed under the supervision of a doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and blocked to prevent the egg from reaching the uterus (tubal sterilization) AND
must use effective methods of contraception for at least 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.

Men taking Lenalidomide Teva
Lenalidomide Teva passes into human sperm. If a woman is pregnant or could become pregnant and is not using an effective contraceptive method, her partner should use a condom during treatment and for at least 7 days after treatment ends. This applies also 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
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances due to vestibular dizziness, or blurred vision after taking Lenalidomide Teva.
Lenalidomide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Lenalidomide Teva

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

When Lenalidomide Teva is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatment, the medicine is given in combination with other medicines (see section 1 “Why Lenalidomide Teva is used”).
When Lenalidomide Teva is used to treat multiple myeloma in patients after bone marrow transplantation, or in patients with MDS or MCL, the medicine should be used as monotherapy.
When Lenalidomide Teva is used to treat follicular lymphoma, it is taken together with another medicine called “rituximab”.

Lenalidomide Teva should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
If the patient is taking Lenalidomide Teva together with other medicines, they should read the package leaflet supplied with those medicines for information on how to use and the effects of those medicines.

Treatment cycle
Lenalidomide Teva is taken on specific days over a period of three weeks (21 days).

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

Lenalidomide Teva is taken on specific days over a period of four weeks (28 days).

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

Recommended dose of Lenalidomide Teva
Before starting treatment, the doctor will inform the patient:

how much Lenalidomide Teva to take;
how much of any other medicines to take in combination with Lenalidomide Teva, if combination therapy is required;
which medicines to take on which days of the cycle.

How and when to take Lenalidomide Teva

Swallow the capsule whole, preferably with water.
Do not crush, open, or chew the capsules. If the powder from a damaged Lenalidomide Teva 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 capsules. Gloves should 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 capsules.
Capsules may be taken with or without food.
Lenalidomide Teva should be taken at approximately the same time each day on which dosing is scheduled.

Taking this medicine
To remove a capsule from the blister pack:

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

Four diagrams showing opening a medication package by pressing the edge, breaking off the cap, and removing the capsule with fingers

Duration of treatment with Lenalidomide Teva
Lenalidomide Teva is administered in treatment cycles; each cycle lasts 21 or 28 days (see above, “Treatment cycle”). Treatment cycles should continue until the doctor decides to discontinue treatment.

If you take more Lenalidomide Teva than you should
If you take more than the prescribed dose of Lenalidomide Teva, contact your doctor immediately.

If you miss a dose of Lenalidomide Teva
If you miss a dose of Lenalidomide Teva at the scheduled 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 scheduled time on the following day.

If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop taking
Lenalidomide Teva and contact your doctor immediately – you may need
urgent treatment:

hives, rash, swelling of the eyes, lips or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylactic reaction;
severe allergic reaction possibly starting as a rash in one area, spreading over the whole body and associated with significant loss of the outer layer of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
widespread rash, high fever, increased liver enzyme activity, blood test abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms also known as “DRESS” or “drug hypersensitivity syndrome”). See also section 2.

Contact your doctor immediately if you experience any of the following serious
side effects:

fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (including blood infections (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 levels of calcium in the blood.

Lenalidomide Teva may reduce the number of white blood cells that fight infection, as well as
blood cells that help blood to clot (platelets), which may lead to bleeding disorders, such as
nosebleeds and bruising.
Lenalidomide Teva may also cause blood clots in the veins (thrombosis).
Other side effects
Please note that in a small number of patients, other types of cancer may develop, and treatment with Lenalidomide Teva may increase this risk. Therefore, your doctor should carefully evaluate the benefits and risks before prescribing Lenalidomide Teva.
Very common side effects (may affect more than 1 in 10 people):

reduced 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;
flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, 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, swelling or redness around a tumour;
weight loss;
constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn;
low levels of potassium or calcium and (or) sodium in the blood;
underactive thyroid gland;
leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be symptoms 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, difficulty sleeping;
cough;
low blood pressure;
vague feeling of physical discomfort, malaise;
painful inflammation of the mouth, dry mouth;
dehydration.

Common side effects (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 levels of uric acid in the blood;
skin eruptions, redness of the skin, cracking, peeling or flaking of the skin, hives;
excessive sweating, night sweats;
difficulty swallowing, sore throat, voice quality problems or voice changes;
nasal inflammation (rhinitis);
passing significantly more or significantly less urine than normal, or inability to control the timing of urination;
passing blood in the urine;
shortness of breath, especially when lying down (which may be a sign of heart failure);
erection problems;
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 symptoms of a heart attack (myocardial infarction);
muscle weakness, lack of energy;
neck pain, chest pain;
chills;
joint swelling;
slowed or blocked outflow of bile 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 side effects (may affect up to 1 in 100 people):

bleeding inside the skull;
circulatory problems;
loss of vision;
loss of sex drive (libido);
passing large amounts of urine, accompanied by bone pain and weakness, which may be symptoms 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 symptoms of liver damage (liver failure);
abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis);
kidney cell damage (known as 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 the products released from dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures and sometimes death;
high blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

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

sudden or mild but 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 inflammation of lung tissue;
rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some of them when Lenalidomide Teva was given together with a statin (a type of medicine that lowers blood cholesterol);
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 severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool or changes in bowel function;
viral infections, including herpes zoster (a viral disease causing a painful skin rash with blisters, also known as “shingles”) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark brown urine, pain in the right lower abdomen, 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 for Monitoring Adverse Drug Reactions of the 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.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Lenalidomide Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP" or Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
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 Teva contains

The active substance is lenalidomide. Each capsule contains micronized lenalidomide hydrochloride monohydrate in an amount equivalent to 5 mg, 10 mg, 15 mg, or 25 mg of lenalidomide.
The other ingredients are:
- capsule contents: colloidal anhydrous silica, microcrystalline cellulose type 301, sodium croscarmellose type A, talc,
- capsule shell:
  Lenalidomide Teva, 5 mg: gelatin, titanium dioxide (E171)
  Lenalidomide Teva, 10 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine FD&C (E132)
  Lenalidomide Teva, 15 mg: gelatin, titanium dioxide (E171), indigo carmine FD&C (E132)
  Lenalidomide Teva, 25 mg: gelatin, titanium dioxide (E171)
- printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), potassium hydroxide and ammonium hydroxide, concentrated (E527).

What Lenalidomide Teva looks like and contents of the pack

Lenalidomide Teva, 5 mg, hard capsules: opaque, hard gelatin capsules of size “4” (approximately 14.3 mm in length), with a black print “5” on a white body and a white cap, containing white to off-white, pale yellow or beige powder or compressed powder.

Lenalidomide Teva, 10 mg, hard capsules: opaque, hard gelatin capsules of size “2” (approximately 18 mm in length), with a black print “10” on an ivory-colored body and a green cap, containing white to off-white, pale yellow or beige powder or compressed powder.

Lenalidomide Teva, 15 mg, hard capsules: opaque, hard gelatin capsules of size “1” (approximately 19.4 mm in length), with a black print “15” on a white body and a blue cap, containing white to off-white, pale yellow or beige powder or compressed powder.

Lenalidomide Teva, 25 mg, hard capsules: opaque, hard gelatin capsules of size “0” (approximately 21.7 mm in length), with a black print “25” on a white body and a white cap, containing white to off-white, pale yellow or beige powder or compressed powder.

Pack sizes
Lenalidomide Teva, 5 mg, 10 mg, and 15 mg are available in blisters containing 7, 21, or 63 hard capsules, and in unit-dose blisters containing 7 x 1, 21 x 1, or 63 x 1 hard capsules.
Lenalidomide Teva, 25 mg is available in blisters containing 21 or 63 hard capsules, and in unit-dose blisters containing 21 x 1 or 63 x 1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers
Pliva Hrvatska d.o.o.
Prilaz baruna Filipovića 25
10000 Zagreb, Croatia
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków, Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Greece: Lenalidomide/Teva
Poland: Lenalidomide Teva
Romania: Lenalidomidă TEVA 5 mg, 10 mg, 15 mg, 20 mg, capsule

For more detailed information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw, Poland
Tel: (22) 345 93 00

Lenalidomide teva