Lenalidomide sandoz

Package leaflet: Information for the patient

Lenalidomide Sandoz, 7.5 mg, hard capsules
Lenalidomide
Please read this leaflet carefully before taking 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 you personally. Do not pass it on to others. It may harm other people, 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 this leaflet

1. What Lenalidomide Sandoz is and what it is used for
2. Important information before taking Lenalidomide Sandoz
3. How to take Lenalidomide Sandoz
4. Possible side effects
5. How to store Lenalidomide Sandoz
6. 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 function of 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 specific type of white blood cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage to bones and kidneys. Multiple myeloma is generally incurable. However, it is possible to achieve a significant temporary reduction or even disappearance of disease symptoms. This condition is called "remission".

Newly diagnosed multiple myeloma – in patients undergoing bone marrow transplantation
Lenalidomide Sandoz is used alone (without other medicines) as maintenance therapy in patients who have responded well to bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients not eligible for bone marrow transplantation
Lenalidomide Sandoz is taken in combination with other medicines, including:

• a chemotherapy drug called "bortezomib",
• an anti-inflammatory medicine called "dexamethasone",
• a chemotherapy drug called "melphalan", and
• an immunosuppressive medicine called "prednisone".

Treatment begins with Lenalidomide Sandoz taken together with other 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.

Multiple myeloma – in previously treated patients
Lenalidomide Sandoz is taken in combination with the anti-inflammatory medicine dexamethasone.
Lenalidomide Sandoz may help prevent worsening of multiple myeloma symptoms. It has also been shown to delay disease recurrence 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 infections.

Lenalidomide Sandoz is used as monotherapy in the treatment of adult patients diagnosed with MDS, provided 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 a bone marrow cell abnormality known as "isolated cytogenetic abnormality with deletion 5q". This means the patient's body does not produce enough healthy blood cells;
• the patient has previously received other treatments that were inappropriate or insufficiently effective.

Taking Lenalidomide Sandoz may increase the number of healthy blood cells produced by the body by reducing the number of abnormal cells.

• This may reduce the need for blood transfusions. It may even become possible to discontinue transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting part of the immune system (lymphatic tissue). It attacks a 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 is used as monotherapy in the treatment of adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)
Follicular lymphoma is a slowly growing malignant cancer affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with 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 reproductive age, unless she complies with all required contraceptive measures (see "Pregnacy, breastfeeding and contraception – information for women and men" in section 2). If the patient is a woman of reproductive age, the doctor will document at each follow-up visit that necessary actions have been taken and will provide the patient with written confirmation.
• if the patient is allergic to lenalidomide or to any of the excipients of this medicine (listed in section 6). If the patient suspects an allergy, she or he 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

Talk to your doctor, pharmacist or nurse before taking Lenalidomide Sandoz 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 these viruses, 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 high cholesterol levels;
• the patient previously had an allergic reaction to thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing;
• the patient previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes – these are symptoms of a serious skin reaction known as drug reaction with eosinophilia and systemic symptoms (DRESS), also referred to as "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

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

Contact your doctor, pharmacist or nurse immediately 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 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 lenalidomide treatment, 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 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 that help blood to clot (platelets).

The doctor will order blood tests:

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

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. Furthermore, 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 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 follicular lymphoma receiving Lenalidomide Sandoz

The doctor will request blood tests:

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

Before starting lenalidomide treatment and during treatment, the patient may undergo assessments 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 cells break down rapidly, causing abnormal increases in various chemical substances 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 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

Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as Lenalidomide Sandoz and certain other medicines may interact with each other.

In particular, inform your 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 medicines used to thin the blood, 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 reproductive age must use effective contraceptive methods (see "Contraception").
• If the patient becomes pregnant while taking Lenalidomide Sandoz, treatment must be stopped immediately and the doctor must be 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 seeks medical advice.
• The patient must also use effective contraception (see "Contraception").

Breastfeeding

Do not breastfeed while taking Lenalidomide Sandoz, as it is not known 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 reproductive age:

• she will undergo pregnancy tests under the supervision of a doctor (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless

the doctor confirms that she has undergone tubal ligation (surgical blockage or removal of the fallopian tubes) to prevent egg cells from reaching the uterus (tubal sterilization)
AND

• she must use effective contraceptive 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 using machines

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

Lenalidomide Sandoz contains lactose and sodium

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

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

3. How to take Lenalidomide Sandoz

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

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

This medicine should always be taken exactly as your doctor has instructed. If in 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 for information on how they should be used and their 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 may 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 over a 4-week period (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 may 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 break, open, or chew the capsules. If 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 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.
• The medicine should be taken on the designated days at approximately the same time each day.

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

• 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 Sandoz
Lenalidomide Sandoz is administered in treatment cycles, each lasting either 21 or 28 days (see above, "Treatment cycle"). Treatment should continue until your doctor advises you to stop.

If you take more Lenalidomide Sandoz than you should
If you take more capsules than prescribed, contact your doctor immediately.

If you forget to take Lenalidomide Sandoz
If you forget to take your dose of Lenalidomide Sandoz at the usual time:

• if less than 12 hours have passed, take the missed dose as soon as possible;
• if more than 12 hours have passed, do not take the missed dose. 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 everyone will experience them.
If any of the following serious adverse effects occur, stop taking Lenalidomide Sandoz immediately
and consult a doctor straight away – 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 body temperature, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome"). See also section 2.

Immediately inform your doctor if any of the following serious 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 calcium levels in the blood.

Lenalidomide Sandoz may cause a reduction in white blood cells, which fight infection, and in 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 when Lenalidomide Sandoz is used. Therefore, before prescribing this medicine, your doctor will carefully assess the benefits and risks of treatment.
Very common adverse effects (may affect more than 1 in 10 people)

• Decreased number of red blood cells, which may lead to anaemia causing fatigue and weakness;
• Rash, itching;
• Muscle cramps, muscle weakness, muscle pain, tenderness in muscles, 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 perception;
• Worsening of pain, enlargement or redness around a tumour;
• Weight loss;
• Constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn;
• Low levels of potassium or calcium and/or sodium in the blood;
• Underactive thyroid gland;
• Leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, known as pulmonary embolism);
• All types of infections, including sinus infection, lung infection and upper respiratory tract infections;
• Shortness of breath;
• Blurred vision;
• Cloudy vision (cataract);
• Kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• Abnormal liver test results;
• Increased liver function test values;
• Changes in blood proteins leading to blood vessel swelling (vasculitis);
• Increased blood sugar levels (diabetes);
• Decreased blood sugar levels;
• Headache;
• Nosebleeds;
• Dry skin;
• Depression, mood changes, difficulty sleeping;
• Cough;
• Low blood pressure;
• Vague feeling of physical discomfort, malaise;
• Painful inflammation of the mouth, dry mouth;
• Dehydration.

Common 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 resulting from 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; skin swelling filled with blood, 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, problems with voice quality or voice changes;
• Nasal inflammation (rhinitis);
• Passing significantly more or significantly less urine than normal, or inability to control the timing of urination;
• 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;
• Difficulty speaking;
• Liver damage;
• Loss of balance, difficulty moving;
• Hearing loss, tinnitus (ringing in the ears);
• Nerve pain, unpleasant abnormal sensations, especially in response to touch;
• Excess iron in the body;
• Thirst;
• Confusion;
• Toothache;
• Falls 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-coloured stools, dark-coloured 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 (called 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, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death;
• High blood pressure in blood vessels leading to the lungs (pulmonary hypertension).

Frequency not known 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 inflammation of lung tissue;
• Rare cases of muscle breakdown (muscle pain, weakness or swelling), which may lead to kidney dysfunction (rhabdomyolysis), some of which occurred when lenalidomide was given with a statin (a cholesterol-lowering medicine);
• Skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leucocytoclastic vasculitis);
• Perforation of the stomach or intestine wall, which may lead to a very serious infection. Inform your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the 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-coloured urine, pain in the right side of the abdomen, fever, nausea or vomiting);
• Rejection of transplanted organs (such as kidney or heart).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
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 and the outer carton 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 visible signs of damage are present or if there are any indications that the packaging seals have been broken.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Sandoz contains

• The active substance is lenalidomide. One capsule contains 7.5 mg of lenalidomide.
• The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), iron oxide yellow (E172). Printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E172).

What Lenalidomide Sandoz looks like and contents of the pack
The capsule has a matte white body and a matte yellow cap, approximately 18.0 mm in length,
marked with "L9NL" and "7.5".
Hard capsules are packed in blisters made of OPA/Aluminium/PVC/Aluminium foil.
Pack sizes:
OPA/Aluminium/PVC/Aluminium foil blisters: packs containing 21 hard capsules.
Single-dose blisters made of OPA/Aluminium/PVC/Aluminium foil: packs 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 further information about the medicinal product and its trade names in the countries of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel. 22 209 70 00