Lenalidomide Teva

Package leaflet: Information for the patient

Lenalidomide Teva 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

lenalidomide
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Lenalidomide Teva is and what it is used for
2. What you need to know 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 functioning of the immune system.

What Lenalidomide Teva is used for
Lenalidomide Teva is used in adults for:

• 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 can damage bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be significantly reduced or disappear for a period of time. This outcome is called a "response".

Newly diagnosed multiple myeloma – in patients undergoing bone marrow transplantation
Lenalidomide Teva is used alone as maintenance therapy in patients who have adequately recovered after bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients who cannot undergo bone marrow transplantation
Lenalidomide Teva is taken with other medicines, which may include:

• a chemotherapy medicine called "bortezomib"
• an anti-inflammatory medicine called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• an immunosuppressant medicine called "prednisone"

You will take these other medicines at the beginning of treatment and then continue taking Lenalidomide Teva alone. If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Multiple myeloma – in patients previously treated
Lenalidomide Teva is taken together with an anti-inflammatory medicine called "dexamethasone".

Lenalidomide Teva can stop the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
MDS are a group of different blood and bone marrow diseases. Blood cells become abnormal and do not function properly. Patients may experience various signs and symptoms, including a low number of red blood cells (anaemia), the need for blood transfusions and risk of infection.

Lenalidomide Teva alone is used to treat adult patients diagnosed with MDS, when all of the following conditions apply:

• if you require regular blood transfusions to treat low levels of red blood cells ("transfusion-dependent anaemia")
• if you have an abnormality in the bone marrow cells called "5q cytogenetic abnormality with isolated deletion". This means your body does not produce enough healthy blood cells
• if previous treatments used have not been suitable or have not been effective enough.

Lenalidomide Teva can increase the number of healthy red blood cells produced by the body, reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. It may become possible to do without transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer of a part of the immune system (lymphatic tissue). It affects a type of white blood cells called B-lymphocytes, or B-cells. In MCL, B-lymphocytes grow uncontrollably and accumulate in lymphatic tissue, bone marrow or blood.
Lenalidomide Teva is used alone to treat adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer that affects B-lymphocytes, a type of white blood cells that help the body fight infections. In FL, an excessive number of these B-lymphocytes can 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 acts on the body's immune system and directly on the tumour in several ways:

• by stopping the development of tumour cells
• by stopping the growth of blood vessels in the tumour
• by stimulating part of the immune system so that it attacks tumour cells.

2. What you need to know before taking Lenalidomide Teva

Before starting treatment with Lenalidomide Teva, you must read the package leaflet of all
medicines that you are required to take in combination with Lenalidomide Teva.
Do not take Lenalidomide Teva

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Lenalidomide Teva is expected to be harmful to the unborn baby (see section 2, “Pregnancy, breastfeeding and contraception – information for women and men”).
• If there is any possibility that you could become pregnant, unless you follow all the necessary measures to avoid pregnancy (see section 2 “Pregnancy, breastfeeding and contraception – information for women and men”). If there is any possibility that you could become pregnant, your doctor will record and confirm at each prescription that the necessary measures to prevent pregnancy have been taken.
• If you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

If you think you fall into any of these categories, do not take Lenalidomide Teva. If you have any doubts, consult your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lenalidomide Teva if:

• you have previously had episodes of blood clots – because the risk of developing blood clots in veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have previously had a viral infection, particularly hepatitis B, varicella-zoster, or HIV. If in doubt, consult your doctor. Treatment with Lenalidomide Teva may cause reactivation of the virus in patients who carry the virus. This leads to the recurrence of the infection. Your doctor must check whether you have previously had hepatitis B infection
• you have kidney problems – your doctor may need to adjust the dose of Lenalidomide Teva
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• you have had an allergic reaction during treatment with thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• you have previously experienced any combination of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes; these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome (see also section 4 “Possible side effects”).

If any of these conditions apply to you, inform your doctor, pharmacist or nurse before starting
treatment.

• At any time during or after treatment, immediately inform your doctor or nurse if you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, changes in the way you walk or problems with balance, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. These may be symptoms of a serious brain condition that can lead to death, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with Lenalidomide Teva, inform your doctor of any changes in these symptoms.

• You experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling in your legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and monitoring
Before and during treatment with Lenalidomide Teva, you will undergo regular blood tests.
This is because Lenalidomide Teva may cause a reduction in blood cells that protect you from
infections (white blood cells) and those that help blood clotting (platelets). Your doctor will ask you to
undergo blood tests:

• before starting treatment
• every week for the first 8 weeks of treatment
• then at least once a month thereafter

You may be evaluated for signs of cardiopulmonary problems before and during treatment with
lenalidomide.
For patients with MDS taking Lenalidomide Teva
If you have MDS, you have a higher risk of developing a more advanced disease called acute myeloid
leukemia (AML). Furthermore, the role of Lenalidomide Teva in the risk of developing AML is not known.
Your doctor may request certain tests to monitor signs that could more accurately predict the likelihood
of you developing AML during treatment with Lenalidomide Teva.
For patients with MCL taking Lenalidomide Teva
Your doctor will ask you to undergo a blood test:

• before starting treatment
• once a week for the first 8 weeks (2 cycles) of treatment
• then every 2 weeks during cycles 3 and 4 (for further information see section 3 “Treatment cycle”)
• thereafter at the beginning of each cycle and at least once a month.

For patients with FL taking Lenalidomide Teva
Your doctor will ask you to undergo a blood test:

• before starting treatment
• once a week for the first 3 weeks (1 cycle) of treatment
• then every 2 weeks during cycles 2 to 4 (for further information see section 3 “Treatment cycle”)
• thereafter at the beginning of each cycle and at least once a month.

Your doctor may need to evaluate you for high tumor burden throughout the body, including in the
bone marrow. This could lead to a condition in which tumors break down and cause abnormally high
levels of certain chemicals in the blood, which may result in kidney failure (this condition is called
“tumor lysis syndrome”).
Your doctor may need to monitor you for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Lenalidomide Teva or stop treatment depending on the
results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor
may also consider treatment based on your age and any other pre-existing conditions.
Blood donation
You must not donate blood during treatment with lenalidomide or for at least 7 days after stopping
treatment.
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 you are aged 75 years or older or have moderate to severe kidney problems, your doctor will closely
monitor you before starting treatment.
Other medicines and Lenalidomide Teva
Inform your doctor or nurse if you are taking or have recently taken any other medicines.
This is because Lenalidomide Teva may affect how other medicines work. Some other medicines may
also affect how Lenalidomide Teva works.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

• certain medicines used to prevent pregnancy, such as oral contraceptives, because they may no longer be effective
• 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

• You must not take Lenalidomide Teva if you are pregnant, because this medicine is expected to be harmful to the unborn baby.
• During treatment with Lenalidomide Teva, you must not become pregnant. If there is any possibility of becoming pregnant, you must use effective contraceptive methods (see the section “Contraception”).
• If you become pregnant during treatment with Lenalidomide Teva, you must stop treatment immediately and inform your doctor.

For men taking Lenalidomide Teva

• If your partner becomes pregnant while you are taking Lenalidomide Teva, inform your doctor immediately. It is also recommended that your partner contacts her doctor.
• In addition, you must use effective contraceptive methods (see the section “Contraception”).

Breastfeeding
You must not breastfeed while taking Lenalidomide Teva, because it is not known whether Lenalidomide
Teva passes into breast milk.
Contraception
For women taking Lenalidomide Teva
Before starting treatment, ask your doctor whether there is any possibility that you could become
pregnant, even if you think it is unlikely.
If there is any possibility that you could become pregnant

• you will need to undergo pregnancy tests under the supervision of your doctor (before each treatment, every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless it has been confirmed that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (sterilization by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will provide you with all necessary guidance on appropriate contraceptive methods.

For men taking Lenalidomide Teva
Lenalidomide is present in human seminal fluid. If there is any possibility that your partner is pregnant
or could become pregnant and is not using effective contraceptive methods, you must use condoms
during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo or blurred
vision after taking Lenalidomide Teva.
Lenalidomide Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Lenalidomide Teva

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

• When Lenalidomide Teva is used for the treatment of multiple myeloma in patients who cannot undergo bone marrow transplantation or who have previously received other treatments, it is taken in combination with other medicines (see section 1, “What Lenalidomide Teva is and what it is used for”).
• When Lenalidomide Teva is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, or for treating patients with MDS or MCL, it is taken alone.
• When Lenalidomide Teva is used to treat follicular lymphoma, it is taken in combination with another medicine called “rituximab”.

Always take Lenalidomide Teva exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you are taking Lenalidomide Teva in combination with other medicines, refer to the package leaflet of those medicines for further information on their use and possible side effects.

Treatment cycle
Lenalidomide Teva is taken on certain days within a 3-week period (21 days).

• Each 21-day period is called a “treatment cycle”.

• Depending on the day of the cycle, you will take one or more medicines. However, there will be some days when you do not take any medicine.

• After completing each 21-day cycle, you must start a new “cycle” within the following 21 days.
  OR
  Lenalidomide Teva is taken on certain days within a 4-week period (28 days).

• Each 28-day period is called a “treatment cycle”.

• Depending on the day of the cycle, you will take one or more medicines. However, there will be some days when you do not take any medicine.

• After completing each 28-day cycle, you must start a new “cycle” within the following 28 days.

How much Lenalidomide Teva to take
Before starting treatment, your doctor will inform you:

• of the dose of Lenalidomide Teva to take
• of the dose of any other medicines to take in combination with Lenalidomide Teva, if prescribed
• on which days of the treatment cycle to take each medicine.

How and when to take Lenalidomide Teva

• swallow the capsules whole, preferably with water
• do not break, open, or chew the capsules. If the powder from a broken Lenalidomide Teva capsule comes into contact with your skin, wash the skin immediately and thoroughly with soap and water
• healthcare providers, 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 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 must not handle the blister pack or capsule
• the capsules may be taken with or without food
• you should take Lenalidomide Teva on the scheduled days at approximately the same time each day.

How to take this medicine
To remove the capsule from the blister:

• press on one side of the capsule, pushing it through the aluminium foil
• do not press in the center of the capsule, as this may cause it to break.

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

If you take more Lenalidomide Teva than you should
If you have taken more Lenalidomide Teva than prescribed, inform your doctor immediately.

If you forget to take Lenalidomide Teva
If you forget to take your usual dose of Lenalidomide Teva:

• if less than 12 hours have passed: take the missed capsule immediately
• if more than 12 hours have passed: do not take the missed capsule; instead, take the next capsule at the usual time the following day.
  If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lenalidomide Teva can cause side effects, although not everyone gets them.
Stop taking Lenalidomide Teva and contact your doctor immediately if you experience any of the
following serious side effects – you may need urgent medical treatment:

• Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction, which may start as a rash in one area but spread with extensive skin loss over the entire body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, 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.

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

• Fever, chills, sore throat, cough, mouth ulcers or any other sign of infection including within the bloodstream (sepsis)
• Bleeding or bruising without injury
• Chest or leg pain
• Shortness of breath
• Bone pain, muscle weakness, confusion or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomide Teva may reduce the number of white blood cells that fight infections and also the blood cells that help blood 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
It is important to note that a small number of patients may develop other types of cancer, and this risk may possibly increase with treatment with Lenalidomide Teva. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Lenalidomide Teva to you.
Very common side effects (may affect more than 1 in 10 people):

• Decrease in red blood cell count, which may cause anaemia and consequently fatigue and weakness
• Rash, itching
• Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, limb pain
• Generalised swelling, including swelling of arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, earache and chills
• Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor
• Loss of appetite, altered taste
• Increased pain, size or redness around the tumour
• Loss of body weight
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium and/or sodium in the blood
• Underactive thyroid gland
• Leg pain (which may be a symptom of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, so-called pulmonary embolism)
• Any type of infection, including infections of the sinuses around the nose, lungs and upper respiratory tract
• Shortness of breath
• Blurred vision
• Clouding of vision (cataract)
• Kidney problems, including impaired kidney function or inability of the kidneys to maintain normal function
• Abnormal liver function test results
• Increased liver function test values
• Changes in a protein in the blood that may cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of physical discomfort, malaise
• Inflammation of the mouth, dry mouth
• Dehydration

Common side effects (may affect up to 1 in 10 people):

• Destruction of red blood cells in the blood (haemolytic anaemia)
• Certain types of skin cancer
• Bleeding from gums, stomach or intestine
• Increased blood pressure, slow, fast or irregular heartbeat
• Increase in a substance resulting from normal and abnormal breakdown of red blood cells
• Increase in a type of protein indicating inflammation in the body
• Darkening of the skin; skin colour changes due to bleeding under the skin, typically caused by bruising; skin swelling due to blood; bruising
• Increased uric acid in the blood
• Skin rashes, redness of the skin, skin cracking, peeling or flaking, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, voice quality problems or voice changes
• Runny nose
• Urine output much greater or less than usual or inability to control the urge to urinate
• Presence of blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (inner ear disorder causing a sensation of spinning), temporary loss of consciousness
• Chest pain radiating to arms, neck, jaw, back or stomach, sweating and breathlessness, feeling unwell or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Swelling of joints
• Slowing or blockage of bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance problems, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, altered sensation, especially touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which may lead to injury

Uncommon side effects (may affect more than 1 in 100 people):

• Bleeding within the skull
• Circulatory problems
• Loss of vision
• Loss of sex drive (libido)
• Abundant urine flow with pain and bone weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowish discoloration of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, stomach pain or swelling. These may be symptoms of liver damage (hepatic failure).
• Stomach pain, swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called typhlitis or colitis)
• Damage to kidney cells (called renal tubular necrosis)
• Changes in skin colour, sensitivity to sunlight
• Tumour lysis syndrome: metabolic complications that may occur during anticancer treatment and sometimes even without treatment. These complications are caused by breakdown products from dying tumour cells and may include changes in blood parameters with high levels of potassium, phosphate and uric acid and low levels of calcium, leading to changes in kidney function and heart rhythm, seizures and, sometimes, death.
• Widespread rash, high body temperature, increased liver enzymes, 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). Stop taking Lenalidomide Teva if you experience these symptoms and contact your doctor or seek immediate medical help. See also section 2.
• Increased 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, possibly accompanied by nausea, vomiting, fever and rapid pulse. These symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath or dry cough, which could be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Teva was administered with a statin (a type of cholesterol-lowering medicine).
• A skin disease caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
• Deterioration of the stomach or intestinal wall, which may lead to severe infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools or changes in bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease causing a painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, pain on the right side of the stomach, fever and nausea or vomiting).
• Rejection of solid organ transplant (such as kidney or heart).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 or carton after the word “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lenalidomide Teva contains

• The active substance is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate equivalent to 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg or 25 mg of lenalidomide.
• The other components are:
  Capsule contents: Anhydrous colloidal silica, microcrystalline cellulose, croscarmellose sodium and talc
  Capsule shell:
  Lenalidomide Teva 2.5 mg: Gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) and indigo carmine (E 132)
  Lenalidomide Teva 5 mg: Gelatin and titanium dioxide (E 171)
  Lenalidomide Teva 7.5 mg: Gelatin, titanium dioxide (E 171) and yellow iron oxide (E 172)
  Lenalidomide Teva 10 mg: Gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) and indigo carmine (E 132)
  Lenalidomide Teva 15 mg: Gelatin, titanium dioxide (E 171) and indigo carmine (E 132)
  Lenalidomide Teva 20 mg: Gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) and indigo carmine (E 132)
  Lenalidomide Teva 25 mg: Gelatin and titanium dioxide (E 171)
  Printing ink: Shellac, propylene glycol, black iron oxide (E 172), potassium hydroxide and concentrated ammonium hydroxide solution

Description of the appearance of Lenalidomide Teva and contents of the pack
Lenalidomide Teva 2.5 mg hard capsules are presented as opaque hard gelatin capsules, size “4” (approximately 14.3 mm in length), with “2.5” printed in black on a white body and a green cap, containing a powder varying in colour from white to pale yellow or beige, or compressed powder.
Lenalidomide Teva 5 mg hard capsules are presented as opaque hard gelatin capsules, size “4” (approximately 14.3 mm in length), with “5” printed in black on a white body and a white cap, containing a powder varying in colour from white to pale yellow or beige, or compressed powder.
Lenalidomide Teva 7.5 mg hard capsules are presented as opaque hard gelatin capsules, size “2” (approximately 18 mm in length), with “7.5” printed in black on a white body and an ivory cap, containing a powder varying in colour from white to pale yellow or beige, or compressed powder.
Lenalidomide Teva 10 mg hard capsules are presented as opaque hard gelatin capsules, size “2” (approximately 18 mm in length), with “10” printed in black on a white body and a green cap, containing a powder varying in colour from white to pale yellow or beige, or compressed powder.
Lenalidomide Teva 15 mg hard capsules are presented as opaque hard gelatin capsules, size “1” (approximately 19.4 mm in length), with “15” printed in black on a white body and a blue cap, containing a powder varying in colour from white to pale yellow or beige, or compressed powder.
Lenalidomide Teva 20 mg hard capsules are presented as opaque hard gelatin capsules, size “0” (approximately 21.7 mm in length), with “20” printed in black on a blue body and a green cap, containing a powder varying in colour from white to pale yellow or beige, or compressed powder.
Lenalidomide Teva 25 mg hard capsules are presented as opaque hard gelatin capsules, size “0” (approximately 21.7 mm in length), with “25” printed in black on a white body and a white cap, containing a powder varying in colour from white to pale yellow or beige, or compressed powder.

Pack sizes:
Lenalidomide Teva 2.5 mg, 5 mg, 10 mg and 15 mg are available in blister packs containing 7 or 21 hard capsules and in single-dose blister packs containing 7 x 1 or 21 x 1 hard capsules.
Lenalidomide Teva 7.5 mg, 20 mg and 25 mg are available in blister packs containing 21 hard capsules and in single-dose blister packs containing 21 x 1 hard capsules.
Not all pack sizes may be marketed.

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

Manufacturer
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, Kraków, 31-546 – Poland
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143 – Germany
Teva B.V., Swensweg 5, 2031 GA Haarlem – The Netherlands
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.), Prilaz baruna Filipovića 25, Zagreb, 10000 – Croatia

This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Austria Lenalidomid Teva
Belgium Lenalidomide Teva
Czech Republic Lenalidomid Teva
Germany Lenalidomid-ratiopharm
Denmark Lenalidomide Teva
Estonia Lenalidomide Teva
Spain Lenalidomida Teva
Finland Lenalidomide ratiopharm
France Lénalidomide Teva
Croatia Lenalidomid Teva
Hungary Lenalidomid Teva
Ireland Lenalidomide Teva
Italy Lenalidomide Teva
Lithuania Lenalidomide Teva
Latvia Lenalidomide Teva
Luxembourg Lenalidomide Teva
Malta Lenalidomide Teva
The Netherlands Lenalidomide Teva
Norway Lenalidomide Teva
Portugal Lenalidomide Teva
Sweden Lenalidomide Teva
Slovenia Lenalidomid Teva
Slovak Republic Lenalidomide Teva B.V.

This leaflet was last updated on