Lenalidomide sandoz: detailed information

Package leaflet: Information for the patient

Lenalidomide Sandoz, 20 mg, hard capsules
Lenalidomide
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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 Sandoz is and what it is used for
What you need to know before you take Lenalidomide Sandoz
How to take Lenalidomide Sandoz
Possible side effects
How to store Lenalidomide Sandoz
Contents of the pack and other information

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

What Lenalidomide Sandoz is
Lenalidomide Sandoz contains the active substance lenalidomide and belongs to a group of medicines that affect the immune system.

What Lenalidomide Sandoz is used for
Lenalidomide Sandoz is used in adults to treat:

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

Multiple myeloma
Multiple myeloma is a type of cancer that arises from the uncontrolled growth of 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 a significant temporary reduction or disappearance of symptoms, known as "remission".

Newly diagnosed multiple myeloma – in patients who have undergone bone marrow transplantation
Lenalidomide Sandoz is used as a single agent for maintenance therapy in patients who have responded adequately after bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients who cannot undergo bone marrow transplantation
Lenalidomide Sandoz 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".

Treatment starts with Lenalidomide Sandoz together with additional medicines, followed by continued treatment with Lenalidomide Sandoz alone.
If you are 75 years of age or older, or if you have moderate to severe kidney impairment, your doctor will perform careful assessments before starting Lenalidomide Sandoz treatment.

Multiple myeloma – in previously treated patients
Lenalidomide Sandoz is taken together with the anti-inflammatory medicine dexamethasone.
Lenalidomide Sandoz may prevent worsening of multiple myeloma symptoms. It has also been shown to delay relapse 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 symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infections.

Lenalidomide Sandoz, used as monotherapy, is indicated for the treatment of adult patients with MDS when all of the following conditions are met:

the patient requires regular blood transfusions due to low red blood cell count ("transfusion-dependent anaemia");
the patient has an abnormality in bone marrow cells known as "isolated cytogenetic abnormality with deletion 5q", meaning 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 Sandoz may increase the production of healthy blood cells by reducing the number of abnormal cells.

This may lead to a reduced need for blood transfusions. It may even become possible to stop transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting 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 characterized by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow, or blood.
Lenalidomide Sandoz, used as monotherapy, is indicated for the treatment of adult patients who have been previously treated with other medicines.

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

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

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

2. Important information before using Lenalidomide Sandoz

Before starting treatment with Lenalidomide Sandoz, carefully read the package leaflets of all medicinal products used in combination with Lenalidomide Sandoz.

When not to use Lenalidomide Sandoz

if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because Lenalidomide Sandoz may harm the unborn baby (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2);
if the patient is of childbearing age, unless she complies with all required measures to prevent pregnancy (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2). If the patient is a woman of childbearing age, the doctor will document at each follow-up visit that the necessary actions have been taken and will provide written confirmation to the patient.
if the patient is allergic to lenalidomide or to any of the excipients of this medicine (listed in section 6). If the patient suspects he or she may be allergic, he or she should consult a doctor.

If any of the above situations apply, Lenalidomide Sandoz must not be taken. If in doubt, consult a doctor.

Warnings and precautions

Before using Lenalidomide Sandoz, discuss with your doctor, pharmacist, or nurse if:

the patient has previously had blood clots, as there is an increased risk of developing blood clots in veins and arteries;
the patient has any signs of infection, such as cough or fever;
the patient has or has previously had a viral infection, especially hepatitis B, varicella-zoster virus (chickenpox and shingles), or HIV. If in doubt, consult a doctor. Treatment with Lenalidomide Sandoz may reactivate the virus, leading to a recurrence of infection. The doctor should check whether the patient has ever had hepatitis B.
the patient has kidney function impairment – the doctor may adjust the dose of Lenalidomide Sandoz;
the patient has had a heart attack, previously experienced blood clots, smokes, has high blood pressure, or elevated cholesterol levels;
the patient experienced an allergic reaction after taking thalidomide (another drug used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
the patient previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), or swollen lymph nodes – these are symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), also known as "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above situations apply, inform the doctor, pharmacist, or nurse before starting treatment.

Seek immediate medical advice from a doctor, pharmacist, or nurse if at any time during or after treatment the patient experiences:

vision disturbances, loss of vision, double vision, difficulty speaking, weakness in the arm or leg, change in gait or balance problems, 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, inform the doctor about any changes.
shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting treatment with Lenalidomide Sandoz and during treatment, the patient will undergo regular blood tests, as this medicine may reduce the number of blood cells that help fight infection (white blood cells) and those involved in blood clotting (platelets).

The doctor will order blood tests:

before treatment,
weekly for the first 8 weeks of treatment,
thereafter at least once a month.

Patients with MDS receiving Lenalidomide Sandoz

If the patient has myelodysplastic syndromes (MDS), there is an increased risk of developing a serious disease called acute myeloid leukaemia. In addition, it is not known how Lenalidomide Sandoz affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and monitor symptoms to better assess the risk of acute myeloid leukaemia during treatment with Lenalidomide Sandoz.

Patients with MCL receiving Lenalidomide Sandoz

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 follicular lymphoma receiving Lenalidomide Sandoz

The doctor will request blood tests:

before treatment,
weekly for the first 3 weeks (1 cycle) of treatment,
then every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment cycle"),
then at the beginning of each cycle, and
at least once a month.

Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.

The doctor may perform tests 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 condition in which tumour tissue breaks down rapidly, causing abnormally high levels of various chemicals in the blood, potentially leading to kidney failure (this condition is known as "tumour lysis syndrome").

The doctor may examine the patient's skin to check for any changes, such as red spots or rash.

The doctor may adjust the dose of Lenalidomide Sandoz or discontinue treatment based on blood test results and the patient's overall condition. If the disease has been recently diagnosed, the doctor may also consider the patient's age and other existing medical conditions when evaluating treatment.

Blood donation

Do not donate blood during treatment and for at least 7 days after treatment ends.

Children and adolescents

Lenalidomide Sandoz is not recommended for use in children and adolescents under 18 years of age.

Elderly patients and patients with kidney function impairment

If the patient is 75 years of age or older or has moderate to severe kidney function impairment, the doctor will perform thorough assessments before starting treatment.

Lenalidomide Sandoz and other medicines

Inform the doctor or nurse about all medicines currently taken or recently used, as Lenalidomide Sandoz and certain other medicines may interact with each other.

Especially inform the doctor or nurse if the patient is taking any of the following medicines or substances:

certain contraceptives, such as oral contraceptives, as they may become less effective;
certain medicines used for heart conditions, such as digoxin;
certain anticoagulants, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men

Pregnancy

Information for women taking Lenalidomide Sandoz

Do not take Lenalidomide Sandoz if the patient is pregnant, as it may harm the unborn baby.
Women must not become pregnant while taking Lenalidomide Sandoz. Therefore, women of childbearing potential must use effective contraception methods (see "Contraception").
If the patient becomes pregnant while taking Lenalidomide Sandoz, treatment must be stopped immediately and the doctor informed.

Information for men taking Lenalidomide Sandoz

If the male patient's partner becomes pregnant while he is taking Lenalidomide Sandoz, inform the doctor immediately. It is recommended that the partner seek medical advice.
The patient must also use effective contraception methods (see "Contraception").

Breastfeeding

Do not breastfeed while taking Lenalidomide Sandoz, as it is unknown whether the medicine passes into human milk.

Contraception

Information for women taking Lenalidomide Sandoz

Before starting treatment, the patient should ask the doctor whether she could become pregnant, even if she considers it unlikely.

If the patient is of childbearing age:

she will undergo pregnancy tests under medical supervision (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless the doctor confirms surgical sterilization (tubal ligation) OR
she must use effective contraception methods 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.

Information for men taking Lenalidomide Sandoz

Lenalidomide Sandoz is present in human semen. If the patient's partner is pregnant or could become pregnant and is not using effective contraception, the patient must use condoms during treatment and for at least 7 days after treatment ends, even if he has had a vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen or sperm.

Driving and operating machinery

If the patient experiences dizziness, fatigue, drowsiness, vertigo, or blurred vision after taking Lenalidomide Sandoz, he or she should not drive or operate machinery.

Lenalidomide Sandoz contains lactose and sodium

If the patient has been diagnosed with an intolerance to certain sugars, he or she should consult a doctor before using this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".

3. How to use Lenalidomide Sandoz

Lenalidomide Sandoz must be administered by healthcare professionals experienced in the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, or follicular lymphoma.

If Lenalidomide Sandoz is used for the treatment of multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatments, the medicine is used in combination with other drugs (see section 1 "Why Lenalidomide Sandoz is used").
If Lenalidomide Sandoz is used for the treatment of multiple myeloma in patients after bone marrow transplantation, or for the treatment of myelodysplastic syndromes or mantle cell lymphoma, the medicine is used alone (monotherapy).
If Lenalidomide Sandoz is used for the treatment of follicular lymphoma, it is taken together with another medicine called "rituximab".

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

Treatment cycle
Lenalidomide Sandoz is taken on specific days during a 3-week period (21 days).

Each 21-day period is called a "treatment cycle".
Depending on the day of the cycle, you may take one or more medicines. However, on some days you will not take any medicines.
After completing each 21-day cycle, you should start a new 21-day cycle. OR Lenalidomide Sandoz is taken on specific days for 4 weeks (28 days).
Each 28-day period is called a "treatment cycle".
Depending on the day of the cycle, you may take one or more medicines. However, on some days you will not take any medicines.
After completing each 28-day cycle, you should start a new 28-day cycle.

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

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

How and when to take Lenalidomide Sandoz

Swallow the capsule whole, preferably with water.
Do not crush, open, or chew the capsule. If the powder from a damaged Lenalidomide Sandoz capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
The capsules may be taken with food or independently of meals.
The medicine should be taken on the designated days at approximately the same time each day.

Taking this medicine
To remove the capsule from the blister:

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

Duration of treatment with Lenalidomide Sandoz
Lenalidomide Sandoz is administered in treatment cycles, each lasting 21 or 28 days (see above, "Treatment cycle"). Treatment should continue until your doctor advises stopping.
If you take more Lenalidomide Sandoz than you should
If you have taken more capsules than prescribed, contact your doctor immediately.
If you miss a dose of Lenalidomide Sandoz
If you forget to take Lenalidomide Sandoz at your usual time:

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If any of the following serious adverse effects occur, stop taking Lenalidomide Sandoz immediately
and contact your doctor straight away – immediate treatment may be required:

Urticaria, rash, swelling of the eyes, lips or face, breathing difficulties 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 progressing 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 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 any of the following serious adverse 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 levels of calcium in the blood.

Lenalidomide Sandoz may reduce the number of white blood cells, which fight infection, and platelets, which help blood to clot, potentially leading to bleeding disorders such as nosebleeds and bruising.
Lenalidomide Sandoz may also cause blood clots in the veins (thrombosis).
Other adverse effects
A small number of patients may develop another type of cancer, and the risk of developing it may be higher during treatment with Lenalidomide Sandoz. For this reason, your doctor will carefully assess the benefits and risks of treatment before prescribing this medicine.
Very common adverse effects (may affect more than 1 in 10 people)

Decrease in red blood cells, which may lead to anaemia causing tiredness and weakness;
Skin rashes, itching;
Muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
Generalised swelling, including swelling of hands and feet;
Weakness, fatigue;
Fever, flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough and chills;
Numbness, tingling or burning sensation of the skin, prickling in hands or feet, dizziness, tremor;
Loss of appetite, changes in taste sensation;
Worsening of pain, increase in size or redness around a lump;
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, sleep disturbances;
Cough;
Low blood pressure;
Vague feeling of physical discomfort, malaise;
Painful inflammation of the mouth, dry mouth;
Dehydration.
Common adverse 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 concentration of a protein indicating inflammation in the body;
Darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruising;
Increased uric acid levels in the blood;
Skin eruptions, 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;
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 symptom 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;
Slowing or blockage of bile flow from the liver;
Low levels of phosphates or magnesium in the blood;
Speech difficulties;
Liver damage;
Loss of balance, difficulty moving;
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 lead to injury

Uncommon adverse effects (may affect up to 1 in 100 people)

Bleeding inside the skull;
Circulatory disorders;
Loss of vision;
Loss of libido;
Passing large amounts of urine accompanied by bone pain and weakness – these may be symptoms of kidney dysfunction (Fanconi syndrome);
Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, abdominal pain or swelling – these 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);
Damage to kidney cells (known as tubular necrosis);
Change in skin colour, sensitivity to sunlight;
Tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphorus, 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).

Frequency not known adverse effects (frequency cannot be estimated from available data)

Sudden or mild but worsening pain in the upper abdomen and/or back, lasting for several days and possibly accompanied by nausea, vomiting, fever and rapid heartbeat. These symptoms may be caused by inflammation of the pancreas (pancreatitis);
Wheezing, shortness of breath or dry cough – these may be symptoms of lung tissue inflammation;
Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney dysfunction (rhabdomyolysis); some of these cases occurred when lenalidomide was administered with a statin (a cholesterol-lowering medicine);
Skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leukocytoclastic vasculitis);
Perforation of the stomach or intestinal wall, which may lead to severe infection. Inform your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in stool or changes in bowel habits;
Viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus (which may cause yellowing of the skin and eyes, dark urine, pain in the right side of the abdomen, fever, nausea or vomiting);
Rejection of transplanted organs (such as kidney, heart).

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Lenalidomide Sandoz

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

6. Contents of the package and other information

What Lenalidomide Sandoz contains

The active substance is lenalidomide. One capsule contains 20 mg of lenalidomide.
The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), indigo carmine, lac dye (E132) and yellow iron oxide (E172). Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

What Lenalidomide Sandoz looks like and contents of the pack
The capsule has a matte blue to light blue body and a matte green to light green cap, approximately 21.7 mm in length, marked with "L9NL" and "20".
Hard capsules are packed in blisters made of OPA/Aluminum/PVC/Aluminum foil.
Pack sizes:
OPA/Aluminum/PVC/Aluminum foil blisters: packages containing 21 hard capsules.
Single-dose blisters made of OPA/Aluminum/PVC/Aluminum foil: packages containing 21 x 1 hard capsule.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer
Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona, Spain
Synthon BV
Microweg 22
6545 CM Nijmegen, Netherlands
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For more detailed information about the medicine and its names in the Member States of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00