Patient Information Leaflet

Lenalidomida Accord 2.5 mg Hard Capsules EFG

Lenalidomida Accord 5 mg Hard Capsules EFG

Lenalidomida Accord 7.5 mg Hard Capsules EFG

Lenalidomida Accord 10 mg Hard Capsules EFG

Lenalidomida Accord 15 mg Hard Capsules EFG

Lenalidomida Accord 20 mg Hard Capsules EFG

Lenalidomida Accord 25 mg Hard Capsules EFG

lenalidomida

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Lenalidomida Accord

Lenalidomida Accord contains the active ingredient “lenalidomida”. This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomida Accord is used for

Lenalidomida Accord is used in adults for:

• Multiple myeloma
• Myleodysplastic syndromes (MDS)
• mantle cell lymphoma (MCL)
• Follicular lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cell in the blood, called plasma cells. These cells accumulate in the bone marrow and multiply, becoming uncontrolled. This can damage bones and kidneys.

Multiple myeloma is usually incurable. However, it is possible to significantly reduce symptoms and signs or make them disappear for a period of time. This is called “remission”.

Multiple myeloma newly diagnosed: in patients who have undergone a bone marrow transplant.

Lenalidomida Accord is used as maintenance treatment after recovering adequately from a bone marrow transplant.

Multiple myeloma newly diagnosed: in patients who cannot be treated with a bone marrow transplant

Lenalidomida Accord is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”
• a corticosteroid called “dexametasona”
• a chemotherapy medicine called “melfalán” and
• a immunosuppressant called “prednisona”.

You will take these medicines when starting treatment and then continue taking lenalidomida alone.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.

Multiple myeloma: in previously treated patients

Lenalidomida Accord is taken with a corticosteroid called “dexametasona”.

Lenalidomida Accord may slow the worsening of multiple myeloma symptoms.

It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myleodysplastic syndromes (MDS)

MDS are a group of many different blood and bone marrow diseases. Blood cells become abnormal and do not function correctly. Patients may experience a variety of symptoms, including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.

Lenalidomida Accord is used to treat adult patients diagnosed with MDS, when all the following points are applicable:

• you need periodic blood transfusions to treat low red blood cell levels (“anemia-dependent transfusions”);
• you have a bone marrow cell anomaly called “isolated deletion 5q cytogenetic anomaly”. This means your body does not produce enough healthy blood cells;
• other treatments you have used previously are not suitable or do not work well enough.

Lenalidomida Accord may increase the number of healthy red blood cells produced by the body by reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. It may be possible to avoid transfusions.

Mantle cell lymphoma (MCL)

MCL is a cancer of a part of the immune system (lymphoid tissue). It affects a type of white blood cell in the blood called “B lymphocytes” or B cells. MCL is a disease in which B cells grow uncontrollably and accumulate in lymphoid tissue, bone marrow, or blood.

Lenalidomida is used in monotherapy to treat adult patients who have received previous treatment with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infections. When a person has FL, they may store too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomida is used with another medicine called “rituximab” for the treatment of adult patients who have received previous treatment for follicular lymphoma.

How Lenalidomida Accord works

Lenalidomida acts by affecting the body's immune system and directly attacking cancer. It acts in several ways:

• it stops the development of cancer cells
• it stops the growth of blood vessels in cancer
• it stimulates part of the immune system to attack cancer cells.

You should read the leaflet for all the medicines you are going to take in combination with Lenalidomida before starting the treatment with Lenalidomida.

Do not take Lenalidomida Accord:

• if you are pregnant, think you may be pregnant or intend to become pregnant,since lenalidomide is expected to be harmful to the fetus(see section 2, “Pregnancy, lactation and contraception: information for women and men”).
• if you can become pregnant, unless you follow all the necessary measures to avoid it (see section 2, “Pregnancy, lactation and contraception: information for women and men”). If you can become pregnant, your doctor will note on each prescription that all necessary measures have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomide or to any of the other components of this medicine (including in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take lenalidomide. In case of doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take lenalidomida if:

• you have ever had blood clots; during treatment, you have a higher risk of presenting blood clots in veins and arteries
• you have any sign of infection, such as cough or fever
• you have or have had previously a viral infection, especially hepatitis B infection, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with lenalidomide may make the virus become active again in patients who are carriers of the virus. This leads to the reappearance of the infection. Your doctor must check if you have ever had a hepatitis B infection
• you have kidney problems; your doctor may adjust your lenalidomida dose
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as skin rash, itching, swelling, dizziness or respiratory problems
• you have experienced in the past a combination of any of the following symptoms: generalised rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

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

Inform your doctor or nurse immediately if:

• you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in the arm or leg, a change in the way you walk or balance problems, decreased sensitivity or loss of sensitivity, memory loss or confusion. These may be all symptoms of a severe and potentially fatal brain condition called progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomida, inform your doctor about any change in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with lenalidomida and during treatment, you will have blood tests regularly. This is because lenalidomida can cause a decrease in the white blood cells that help fight infections and in the platelets that participate in blood clotting.

Your doctor will ask you to have a blood test:

• Before treatment
• Every week for the first 8 weeks of treatment
• Subsequently, at least once a month.

You may be evaluated to detect signs of cardiopulmonary problems before and during treatment with lenalidomida.

For patients with SMD who take lenalidomida

If you have SMD, you may be more prone to developing a more advanced disease called acute myeloid leukemia (AML). Additionally, it is unknown how lenalidomida affects your chances of developing AML. Your doctor may perform tests to detect signs that may better predict your chances of developing AML during treatment with lenalidomida.

For patients with MCL who take lenalidomida

Your doctor will ask you to have a blood test:

• before treatment;
• every week for the first 8 weeks (2 cycles) of treatment;
• subsequently, every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information);
• then at the start of each cycle;
• at least once a month.

For patients with LF who take lenalidomida

Your doctor will ask you to have a blood test:

• before treatment;
• every week for the first 3 weeks (1 cycle) of treatment;
• subsequently, every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).
• then at the start of each cycle and
• at least once a month.

Your doctor may check if you have a high total tumor burden in the body, including the bone marrow. This could lead to a disease in which the tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may cause kidney failure (this disease is called tumor lysis syndrome).

Your doctor may examine you to check if you have developed changes in your skin, such as red spots or skin rashes.

Your doctor may adjust your lenalidomida dose or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a new diagnosis patient, your doctor may also evaluate your treatment based on your age and any other conditions you already have.

Blood donation

You should not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

The use of lenalidomida is not recommended in children and adolescents under 18 years old.

Older adults and patients with kidney problems

If you are 75 years old or more or have moderate to severe kidney problems, your doctor will examine you carefully before starting treatment.

Other medicines and Lenalidomida Accord

Inform your doctor or nurse if you are taking, have taken recently or may need to take any other medicine. This is because lenalidomida may affect how other medicines work. Additionally, some medicines may affect how lenalidomida works.

Specifically, inform your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working
• some medicines used to treat heart problems, such as digoxin
• some medicines used to thin the blood, such as warfarin

Pregnancy, lactation and contraception: information for women and men

Pregnancy

Women taking lenalidomida

• You should not take lenalidomida if you are pregnant, as it is expected to be harmful to the fetus.
• You should not become pregnant while taking lenalidomida. Therefore, you must use effective contraceptive methods if there is a possibility that you may become pregnant (see “Contraception”).
• If you become pregnant during treatment with lenalidomida, you must stop treatment and inform your doctor immediately.

Men taking lenalidomida

• If your partner becomes pregnant while you are taking lenalidomida, you must inform your doctor immediately. It is recommended that your partner seek medical advice.
• You should also use effective contraceptive methods (see “Contraception” below).

Lactation

You should not take lenalidomida during lactation, as it is unknown whether lenalidomida passes into breast milk.

Contraception

For women taking lenalidomida

Before starting treatment, ask your doctor if you are capable of becoming pregnant, although you may think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, every 4 weeks during treatment and for at least 4 weeks after finishing treatment) except that tubal ligation has been confirmed so that eggs do not reach the uterus (tubal ligation)

And

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after finishing treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking lenalidomida

Lenalidomida passes into human semen. If your partner becomes pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after finishing treatment, even if you have undergone a vasectomy.

Driving and using machines

You should not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking lenalidomida.

Lenalidomida Accord contains lactose

Lenalidomida Accord contains lactose. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

Lenalidomide Accord should be administered by a healthcare professional with experience in the treatment of multiple myeloma, SMD, LCM or LF.

• When lenalidomide is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have undergone other treatments before, it is taken with other medications (see section 1 “What lenalidomide is used for”).
• When lenalidomide is used for the treatment of multiple myeloma in patients who have undergone a bone marrow transplant or to treat patients with SMD or LCM, it is taken alone.
• When lenalidomide is used for the treatment of follicular lymphoma, it is taken with another medication called “rituximab”.

Follow exactly the administration instructions of this medication indicated by your doctor.

In case of doubt, consult your doctor or pharmacist.

If you are taking lenalidomide with other medications, you must consult the leaflet of those other medications to obtain additional information on their use and effects.

Treatment Cycle

Lenalidomide is taken on certain days during the period of 3 weeks (21 days).

• A “treatment cycle” consists of 21 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 21 days, you must start a new “cycle” during the following 21 days.

Or

Lenalidomide is taken on certain days during the period of 4 weeks (28 days).

• A “treatment cycle” consists of 28 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each cycle of 28 days, you must start a new “cycle” during the following 28 days.

How Much Lenalidomide to Take

Before starting treatment, your doctor will indicate:

• what amount of lenalidomide you should take
• what amount of the other medications you should take with lenalidomide, if applicable
• which days of the treatment cycle you should take each medication.

How and When to Take Lenalidomide

• Swallow the capsules whole, preferably with water.
• Do not break, open or chew the capsules. In the case of lenalidomide powder coming into contact with the skin from a broken capsule, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister pack or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, put them in a sealed plastic polyethylene bag and dispose of them according to local requirements. Then, they should wash their hands well with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister pack or capsule.
• The capsules can be taken with or without food.
• You should take lenalidomide approximately at the same time on the scheduled days.

Administration of this Medication

To remove the capsule from the blister pack:

• Press only one end of the capsule to make it come out through the foil.
• Do not press in the center of the capsule as it may break.

Duration of Treatment with Lenalidomide

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

If You Take More Lenalidomide Than You Should

If you take more lenalidomide than prescribed, inform your doctor immediately.

If You Forget to Take Lenalidomide

If you forget to take lenalidomide at your usual time and:

• less than 12 hours have passed: take the capsule immediately.
• more than 12 hours have passed: do not take the capsule. Take the next capsule the next day at the usual time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, stop taking lenalidomide and seek medical attention immediately, as it may require emergency medical treatment:

• Urticaria, rashes, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis.
• Severe allergic reaction that may start as a rash in one area but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Generalized rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Consult your doctor immediately if you notice any of the following serious side effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including sepsis.
• Bleeding (hemorrhage) or hematoma (bruise) not caused by injury.
• Chest pain (thoracic) or leg pain.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue that may be due to high levels of calcium in the blood.

Lenalidomide can reduce the number of white blood cells that fight infections and also the cells in the blood that help to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruises. Lenalidomide can also cause blood clots in the veins (thrombosis).

Other side effects

It is essential to note that a reduced number of patients may develop other types of cancer, and this risk may increase with lenalidomide treatment. Therefore, your doctor must carefully evaluate the benefits and risks of prescribing lenalidomide.

Very common (may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which can cause anemia leading to fatigue and weakness.
• Rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
• Generalized swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills.
• Numbness, tingling, or prickling sensation in the skin, hand or foot pain, dizziness, tremor.
• Decreased appetite, changes in the taste of things.
• Increased pain, tumor size, or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn.
• Low levels of potassium, calcium, or sodium in the blood.
• Underactive thyroid.
• Chest pain (may be a symptom of pulmonary embolism), difficulty breathing (may be a symptom of pulmonary embolism).
• Infections of all types, including sinusitis, pneumonia, and upper respiratory tract infections.
• Difficulty breathing.
• Blurred vision.
• Cataracts.
• Renal problems, including kidneys that do not function correctly or are unable to maintain normal function.
• Abnormal liver test results.
• High levels in liver test results.
• Changes in a blood protein that can cause swelling of the arteries (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, changes in mood, difficulty sleeping.
• Cough.
• Low blood pressure.
• A vague feeling of discomfort in the body, feeling unwell.
• Inflammation of the mouth, dry mouth.
• Dehydration.

Side effectscommon (may affect up to 1 in 10 people):

• Red blood cell destruction (hemolytic anemia).
• Certain types of skin cancer.
• Bleeding from the gums, stomach, or intestines.
• Increased blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance released after normal or abnormal destruction of red blood cells.
• Increased levels of a type of protein that indicates inflammation in the body.
• Darkening of the skin; change in skin color due to internal bleeding, usually caused by hematomas; inflammation of the skin caused by the accumulation of blood; hematoma.
• Increased uric acid levels in the blood.
• Rashes, redness of the skin, dry skin, peeling or exfoliation of the skin, urticaria.
• Increased sweating, nocturnal sweating.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Nasal discharge.
• Significant increase or decrease in urine output compared to normal or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (may be a symptom of heart failure).
• Difficulty achieving an erection.
• Stroke, fainting, vertigo (inner ear disorder causing the sensation of spinning), temporary loss of consciousness.
• Chest pain that radiates to arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, nausea or vomiting, which may be symptoms of a heart attack (myocardial infarction).
• Weakness, lack of energy.
• Cervical pain, chest pain.
• Chills.
• Joint swelling.
• Slowed or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Balance disorder, difficulty moving.
• Deafness, tinnitus (ringing in the ears).
• Nerve pain, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Fall that may cause injury.

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

• Sudden, severe, or worsening pain in the upper stomach and/or back, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis.
• Wheezing or ringing in the lungs, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle degradation (pain, weakness, or swelling) that may lead to kidney problems (rhabdomyolysis), some of which occur when lenalidomide is administered with a statin (a type of cholesterol-lowering medication).
• A disease that affects the skin caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Perforation of the stomach or intestine wall. This may lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viruses, including herpes zoster (also known as shingles, a viral disease that causes painful skin rash with blisters) and the reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, right-sided stomach pain, fever, and nausea or feeling unwell).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

• This medication does not require special conditions for conservation.

• Do not use this medication if you observe visible signs of deterioration or signs of improper handling.

• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

Composition of Lenalidomide

Lenalidomide Accord 2.5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.

The other components are:

• Capshell content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capshell coating: gelatin, iron oxide black (E172), titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide).

Lenalidomide Accord 5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.

The other components are:

• Capshell content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capshell coating: gelatin, titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide).

Lenalidomide Accord 7.5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.

The other components are:

• Capshell content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capshell coating: gelatin, iron oxide red (E172), titanium dioxide (E171), indigo carmine (E132)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide).

Lenalidomide Accord 10 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.

The other components are:

• Capshell content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capshell coating: gelatin, indigo carmine (E132), iron oxide yellow (E172) and titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide).

Lenalidomide Accord 15 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.

The other components are:

• Capshell content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capshell coating: gelatin, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide).

Lenalidomide Accord 20 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.

The other components are:

• Capshell content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capshell coating: gelatin, indigo carmine (E132), iron oxide yellow (E172) and titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide).

Lenalidomide Accord 25 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.

The other components are:

• Capshell content: lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
• Capshell coating: gelatin, titanium dioxide (E171)
• Printing ink: black and green ink (containing shellac, propylene glycol (E1520), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide).

Appearance of Lenalidomide Accord and packaging contents

Lenalidomide Accord 2.5 mg are hard gelatin capsules of size "5" with a length of approximately 11.0 mm to 11.8 mm, grey cap and white opaque body with "LENALIDOMIDE" printed in black on the cap and "2.5 mg" printed in green on the body, containing white to off-white powder.

Lenalidomide Accord 5 mg are hard gelatin capsules of size "5" with a length of approximately 11.0 mm to 11.8 mm, white opaque cap and body with "LENALIDOMIDE" printed in black on the cap and "5 mg" printed in green on the body, containing white to off-white powder.

Lenalidomide Accord 7.5 mg are hard gelatin capsules of size "4" with a length of approximately 14.0 mm to 14.8 mm, lavender opaque cap and white opaque body with "LENALIDOMIDE" printed in black on the cap and "7.5 mg" printed in green on the body, containing white to off-white powder.

Lenalidomide Accord 10 mg are hard gelatin capsules of size "3" with a length of approximately 15.4 mm to 16.2 mm, green leaf opaque cap and white opaque body with "LENALIDOMIDE" printed in black on the cap and "10 mg" printed in green on the body, containing white to off-white powder.

Lenalidomide Accord 15 mg are hard gelatin capsules of size "2" with a length of approximately 17.4 mm to 18.2 mm, orange opaque cap and white opaque body with "LENALIDOMIDE" printed in black on the cap and "15 mg" printed in green on the body, containing white to off-white powder.

Lenalidomide Accord 20 mg are hard gelatin capsules of size "1" with a length of approximately 19.0 mm to 19.8 mm, green opaque cap and white opaque body with "LENALIDOMIDE" printed in black on the cap and "20 mg" printed in green on the body, containing white to off-white powder.

Lenalidomide Accord 25 mg are hard gelatin capsules of size "0" with a length of approximately 21.0 mm to 21.8 mm, white opaque cap and body with "LENALIDOMIDE" printed in black on the cap and "25 mg" printed in green on the body, containing white to off-white powder.

Lenalidomide Accord hard capsules are available in blister packs of 7 x 1 or 21 x 1 capsules.

Only some sizes of packaging may be commercially available.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona,

s/n, Edifici Est 6th floor,

08039 Barcelona,

Spain

Responsible person

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF

United Kingdom

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.