Lenalidomide teva

Patient Information Leaflet

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 this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, 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.

Table of Contents

1. What Lenalidomide Teva is and what it is used for
2. Important information before taking Lenalidomide Teva
3. How to take Lenalidomide Teva
4. Possible side effects
5. How to store Lenalidomide Teva
6. 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 type 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 temporary significant reduction or elimination of signs and symptoms of the disease. This is called "remission".
Newly diagnosed multiple myeloma – in patients after bone marrow transplantation
In this indication, Lenalidomide Teva is used alone as maintenance therapy following adequate response after transplantation.
Newly diagnosed multiple myeloma – in patients not eligible for bone marrow transplantation
Lenalidomide Teva 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 immunosuppressive medicine called "prednisone". The patient starts treatment with additional medicines and then continues 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 medicine called "dexamethasone".
Lenalidomide Teva may stop the progression of signs and 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 that 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 del(5q)". This means the patient's body does not produce enough healthy blood cells;
• the patient has previously received other treatments that were inappropriate or insufficiently 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 required blood transfusions. It may become possible that transfusions are no longer needed.

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (lymphatic tissue). It attacks a certain type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is a disease characterised by uncontrolled growth of B-lymphocytes, resulting in their accumulation in lymphatic tissue, bone marrow or blood.
Lenalidomide Teva as monotherapy is used to treat adult patients who have been previously treated with other medicines.
Follicular lymphoma (FL)
Follicular lymphoma (FL) is a slowly growing malignant disease 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 to be 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 an allergy is suspected, consult a doctor for advice.

If any of these points apply, do not use Lenalidomide Teva.
If in doubt, consult a doctor.
Warnings and precautions
Before starting treatment with Lenalidomide Teva, discuss with your doctor,
pharmacist or nurse if the patient:

• has previously experienced 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 (chickenpox and shingles), hepatitis B virus, HIV infection. If in doubt, consult a 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 (infarction), has previously developed blood clots, is a smoker, 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 difficulty breathing;
• has 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 severe skin reaction known as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) or drug hypersensitivity syndrome (see also section 4 “Possible side effects”).

If any of the above points apply, consult a 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 gait 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 about 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:

• before treatment,
• weekly during the first 8 weeks of treatment,
• thereafter 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 (MDS), there is an increased risk of developing a serious disease called acute myeloid leukaemia. Furthermore, it is not known how Lenalidomide Teva affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that may help better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide Teva.
Patients with MCL taking Lenalidomide Teva
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 Teva
The doctor will request blood tests:

• before treatment,
• weekly during the first 3 weeks (cycle 1) 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 examination 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, potentially leading to kidney failure (a condition known as tumour lysis syndrome).
The doctor may examine the patient for skin changes such as red spots or rash.
The doctor may adjust the dose of Lenalidomide Teva or discontinue treatment based on blood test results and the patient’s general condition. If the disease was recently diagnosed, the doctor may also consider treatment based on the patient’s age and other conditions the patient may have had 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 assessments before starting treatment.
Lenalidomide Teva and other medicines
Inform the doctor or nurse about all medicines currently taken or recently taken by the patient. 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 become ineffective;
• certain medicines used for heart problems – such as digoxin;
• certain medicines used to thin the blood – such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Lenalidomide Teva

• Do not take 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 sealed 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 semen. If a woman is pregnant or could become pregnant and is not using an effective contraceptive method, her partner must use a condom during treatment and for at least 7 days after treatment ends. This applies even to men who have had a vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen.
Driving and using machines
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 prescribed and administered by medical personnel 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 been previously treated, the medicine is used 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 to treat 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 included with those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Teva is taken on specific days during 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 may 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 during 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 may 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 they should take;
• how many other medicines they should take in combination with Lenalidomide Teva, if additional medicines are 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 thoroughly with soap and water immediately.
• 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 the dose is scheduled.

Taking this medicine
To remove a 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 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 therapy.

Taking more Lenalidomide Teva than prescribed
If more Lenalidomide Teva has been taken than prescribed, contact the doctor immediately.

Missed dose of Lenalidomide Teva
If a dose of Lenalidomide Teva has been missed 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 there are any further doubts 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 Teva immediately and contact your doctor without delay – immediate
treatment may be required:

• urticaria, 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 test 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 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 calcium levels in the blood.

Lenalidomide Teva 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 Teva may also cause blood clots in veins (venous thrombosis).
Other side effects
It should be noted that in a small number of patients, other types of cancer may develop, and
this risk may potentially be increased by treatment with Lenalidomide Teva. 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, 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, swelling 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;
• underactive thyroid gland;
• 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 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 a substance 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, bruises;
• increased levels of uric acid in the blood;
• skin eruptions, redness of the skin, cracking, peeling or flaking of the skin, urticaria;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice quality problems or voice changes;
• rhinitis (nasal inflammation);
• passing significantly more or significantly less urine than normal or inability to control urination;
• blood in the urine;
• shortness of breath, especially when lying down (which may be a sign of heart failure);
• erectile 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, 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;
• joint swelling;
• slowed or blocked flow of bile from the liver;
• low levels of phosphates or magnesium in the blood;
• speech difficulties;
• liver damage;
• balance disorders, difficulty moving;
• deafness, tinnitus (ringing in the ears);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excess iron in the body;
• thirst;
• confusion;
• toothache;
• falls which may result in 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-coloured stools, dark-coloured 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 tubular cell damage (known as tubular necrosis);
• skin colour changes, sensitivity to sunlight;
• tumour lysis syndrome – metabolic complications which may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying tumour 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 the blood vessels leading to the lungs (pulmonary hypertension).

Side effects with unknown frequency (frequency 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 inflammation of lung tissue;
• rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some occurring when Lenalidomide Teva was administered concomitantly with a statin (a type of medicine that lowers blood cholesterol levels);
• skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leucocytoclastic vasculitis);
• perforation of the stomach or intestine, which may lead to severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool or changes in bowel function;
• viral infections, including shingles (a viral disease causing a painful skin rash with blisters, also known as “herpes zoster”) 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 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 can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and 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 you no longer use.
This helps 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.
• 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), iron oxide yellow (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)
    Ink for printing:
    Shellac, propylene glycol (E1520), iron oxide black (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 a powder or compressed powder ranging from whitish to pale yellow or beige.

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 a powder or compressed powder ranging from whitish to pale yellow or beige.

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 a powder or compressed powder ranging from whitish to pale yellow or beige.

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 a powder or compressed powder ranging from whitish to pale yellow or beige.

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 further information about this medicinal product, contact the local 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