Lenalidomide Accord 20 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

lenalidomide

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

What Lenalidomida Accord is and what it is used for
What you need to know before taking Lenalidomida Accord
How to take Lenalidomida Accord
Possible side effects
How to store Lenalidomida Accord
Contents of the pack and other information

1. What Lenalidomida Accord is and what it is used for

What Lenalidomida Accord is

Lenalidomida Accord contains the active substance “lenalidomide”. 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
Myelodysplastic syndromes (MDS)
Mantle cell lymphoma (MCL)
Follicular lymphoma (FL)

Multiple myeloma

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

Multiple myeloma is generally incurable. However, signs and symptoms can be greatly reduced or disappear for a period of time. This is called “remission”.

Newly diagnosed multiple myeloma: in patients who have undergone a bone marrow transplant

Lenalidomida Accord is used as maintenance treatment after adequate recovery from a bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomida Accord is taken in combination with other medicines, including:

a chemotherapy medicine called “bortezomib”
an anti-inflammatory medicine called “dexamethasone”
a chemotherapy medicine called “melphalan”
an immunosuppressant called “prednisone”.

You will take these medicines at the beginning of treatment and then continue taking lenalidomide alone.

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

Multiple myeloma: in previously treated patients

Lenalidomida Accord is taken together with an anti-inflammatory medicine called “dexamethasone”.

Lenalidomida Accord may slow down the worsening of signs and symptoms of multiple myeloma.

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

Myelodysplastic syndromes (MDS)

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

Lenalidomida Accord is used to treat adult patients diagnosed with MDS when all of the following apply:

you require regular blood transfusions to treat low red blood cell levels (“transfusion-dependent anaemia”);
you have an abnormality in bone marrow cells called “isolated 5q cytogenetic abnormality”. This means your body does not produce enough healthy blood cells;
previous treatments you have used are not suitable or have not worked well enough.

Lenalidomida Accord can increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

this may reduce the number of blood transfusions needed. It may even become possible to stop transfusions.

Mantle cell lymphoma (MCL)

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

Lenalidomide is used as monotherapy to treat adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, too many of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomide is used in combination with another medicine called “rituximab” for the treatment of adult patients who have received prior treatment for follicular lymphoma.

How Lenalidomida Accord works

Lenalidomide works by affecting the body’s immune system and directly attacking cancer cells. It acts in several ways:

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

2. What you need to know before starting Lenalidomida Accord

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomida before starting treatment with Lenalidomida.

Do not take Lenalidomida Accord:

if you are pregnant, think you might be pregnant, or intend to become pregnant, as lenalidomide is expected to be harmful to the fetus (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”).
if you could become pregnant, unless you follow all necessary measures to prevent it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you could become pregnant, your doctor will confirm with 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 (listed 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. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting lenalidomide if:

you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in veins and arteries
you have any signs of infection, such as cough or fever
you have or have previously had a viral infection, especially hepatitis B, varicella zoster, or HIV. If in doubt, consult your doctor. Treatment with lenalidomide may cause the virus to become active again in patients who carry the virus. This leads to a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection
you have kidney problems; your doctor may adjust your dose of lenalidomide
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 rash, itching, swelling, dizziness, or breathing problems
you have previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (signs of a serious 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 conditions apply to you, inform your doctor, pharmacist, or nurse before starting treatment.

At any time during or after 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 problems with balance, decreased or loss of sensation, memory loss, or confusion. These may all be symptoms of a serious or potentially life-threatening brain condition known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with lenalidomide, inform your doctor about any changes in these symptoms.
you experience shortness of breath, tiredness, dizziness, chest pain, faster heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Blood tests and monitoring

Before starting treatment with lenalidomide and during treatment, you will have regular blood tests. This is because Lenalidomide can cause a decrease in blood cells that help fight infections (white blood cells) and those involved in blood clotting (platelets).

Your doctor will request blood tests:

Before treatment
Weekly during the first 8 weeks of treatment
Afterwards, at least once a month.

You may be evaluated for signs of cardiopulmonary problems before and during treatment with lenalidomide.

For patients with MDS taking lenalidomide

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). In addition, it is not known how lenalidomide affects the chances of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the likelihood of developing AML during treatment with lenalidomide.

For patients with MCL taking lenalidomide

Your doctor will request blood tests:

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

For patients with FL taking lenalidomide

Your doctor will request blood tests:

before treatment;
every week during the first 3 weeks (1 cycle) of treatment;
then every 2 weeks during cycles 2 to 4 (see section 3 “Treatment cycle” for more information);
after this, at the beginning of each cycle;
at least once a month.

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

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

Your doctor may adjust the dose of lenalidomide or interrupt your treatment, depending on the results of your blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other existing conditions.

Blood donation

You must not donate blood during treatment or for at least 7 days after treatment ends.

Children and adolescents

The use of lenalidomide is not recommended in children and adolescents under 18 years of age.

Elderly patients and patients with kidney problems

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will carefully evaluate you before starting treatment.

Other medicines and Lenalidomida Accord

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

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

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

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking lenalidomide

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

Men taking lenalidomide

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

Breastfeeding

Do not take lenalidomide while breastfeeding, as it is unknown whether lenalidomide passes into breast milk.

Contraception

For women taking lenalidomide

Before starting treatment, ask your doctor whether you are able to become pregnant, even if you think this is unlikely.

If you are able to become pregnant:

you will undergo pregnancy tests under medical supervision (before each treatment, every 4 weeks during treatment, and for at least 4 weeks after treatment ends), unless it has been confirmed that your fallopian tubes are closed so that eggs cannot reach the uterus (tubal ligation)

And

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

For men taking lenalidomide

Lenalidomide is present in human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy.

Driving and use of machines

Do not drive or operate machinery if you feel dizzy, tired, drowsy, have dizziness, or blurred vision after taking lenalidomide.

Lenalidomida Accord contains lactose

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

3. How to take Lenalidomide Accord

Lenalidomide Accord must be prescribed and managed by a healthcare professional experienced in the treatment of multiple myeloma, MDS, CLL, or FL.

When lenalidomide is used to treat multiple myeloma in patients who cannot undergo a bone marrow transplant or who have received prior treatments, it is taken in combination with other medicines (see section 1, “What lenalidomide is used for”).
When lenalidomide is used to treat multiple myeloma in patients who have undergone a bone marrow transplant or to treat patients with MDS or CLL, it is taken alone.
When lenalidomide is used to treat follicular lymphoma, it is taken together with another medicine called “rituximab”.

Always follow your doctor’s instructions exactly for taking this medicine.

If you are unsure, consult your doctor or pharmacist.

If you are taking lenalidomide together with other medicines, you should read the package leaflet of those medicines for additional information about their use and side effects.

Treatment cycle

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

A “treatment cycle” lasts 21 days.
Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
After completing each 21-day cycle, you must start a new “cycle” for the next 21 days.

Lenalidomide is taken on certain days within a 4-week period (28 days).

A “treatment cycle” lasts 28 days.
Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
After completing each 28-day cycle, you must start a new “cycle” for the next 28 days.

How much lenalidomide to take

Before starting treatment, your doctor will inform you:

how much lenalidomide you should take
how much of any other medicines you should take together with lenalidomide, if applicable
on which days of the treatment cycle you should take each medicine.

How and when to take lenalidomide

Swallow the capsules whole, preferably with water.
Do not break, open, or chew the capsules. If powder from a broken lenalidomide 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 sealable polyethylene plastic bag, and disposed of according to local requirements. Afterwards, hands should be thoroughly washed with soap and water. Pregnant women or those who suspect they may be pregnant must not handle the blister pack or capsule.
The capsules may be taken with or without food.
You should take lenalidomide at approximately the same time each day on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

Press only on one end of the capsule so that it comes through the foil.
Do not press in the center of the capsule, as this may break it.

Schematic drawing showing the steps to extract a tablet from a blister by pressing the thumb on the base of the container

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 tells you to stop.

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 your lenalidomide at your usual time:

less than 12 hours have passed: take the missed dose immediately.
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, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you experience any of the following serious adverse effects, stop treatment with lenalidomide and seek immediate medical attention, as you may require urgent medical treatment:

Hives, rashes, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction.
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).
Widespread 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 syndrome or drug hypersensitivity syndrome). See also section 2.

Contact your doctor immediately if you notice any of the following serious adverse effects:

Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection including in the bloodstream (sepsis).
Bleeding or bruising not due to injury.
Chest (thoracic) pain or leg pain.
Difficulty breathing.
Bone pain, muscle pain, confusion or fatigue, which may be due to high levels of calcium in the blood.

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

Other adverse effects

It is important to note that a small 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 before prescribing lenalidomide.

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

A decrease in the number of red blood cells, which may lead to anaemia causing tiredness and weakness.
Skin rash, itching.
Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
Generalised swelling, including swelling of the arms and legs.
Weakness, fatigue.
Fever and flu-like symptoms including fever, muscle pain, headache, earache, cough and chills.
Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor.
Decreased appetite, changes in taste.
Increased pain, size, or redness around the tumour.
Weight loss.
Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn.
Low levels of potassium, calcium and/or sodium in the blood.
Underactive thyroid function.
Leg pain (which could be a symptom of thrombosis), chest pain or difficulty breathing (which could be a symptom of blood clots in the lungs, known as pulmonary embolism).
Infections of all types, including infection of the sinuses around the nose (sinusitis), lung infection and upper respiratory tract infections.
Difficulty breathing.
Blurred vision.
Clouding of the eye (cataracts).
Kidney problems including kidneys not functioning properly or unable to maintain normal function.
Abnormal results in liver function tests.
High values in liver function tests.
Changes in a blood protein that may cause swelling of the arteries (vasculitis).
Increased blood sugar levels (diabetes).
Decreased blood sugar levels.
Headache.
Nosebleeds.
Dry skin.
Depression, mood changes, difficulty sleeping.
Cough.
Low blood pressure.
A general feeling of discomfort or malaise.
Painful inflammation of the mouth, dry mouth.
Dehydration.

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

Destruction of red blood cells (haemolytic anaemia).
Certain types of skin tumours.
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 protein indicating inflammation in the body.
Darkening of the skin; skin colour change due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising.
Increased blood uric acid levels.
Skin rashes, skin redness, cracked skin, skin peeling or flaking, hives.
Increased sweating, night sweats.
Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes.
Runny nose.
Marked increase or decrease in urine output compared to usual, or inability to control urination.
Blood in the urine.
Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
Difficulty achieving an erection.
Stroke, fainting, dizziness (an inner ear disorder causing a sensation of spinning), temporary loss of consciousness.
Chest pain spreading to arms, neck, jaw, back or stomach, sweating, shortness of breath, nausea or vomiting, which may be symptoms of a heart attack (myocardial infarction).
Muscle weakness, lack of energy.
Neck pain, chest pain.
Chills.
Joint swelling.
Slowed or blocked bile flow from the liver.
Low levels of phosphate or magnesium in the blood.
Difficulty speaking.
Liver damage.
Loss of balance, difficulty with movement.
Deafness, ringing in the ears (tinnitus).
Nerve pain, abnormal and unpleasant sensation, especially upon touch.
Excess iron in the body.
Thirst.
Confusion.
Toothache.
Falls that may result in injury.

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

Bleeding inside the skull.
Circulatory problems.
Loss of vision.
Loss of sexual desire (libido).
Excretion of large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome).
Yellow pigmentation of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, skin rash, stomach pain or swelling; these may be symptoms of liver damage (hepatic failure).
Stomach pain, abdominal swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis).
Damage to kidney cells (called renal tubular necrosis).
Changes in skin colour, sensitivity to sunlight.
Tumour lysis syndrome – metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications result from the breakdown products of dying tumour cells and may include: changes in blood biochemistry, high levels of potassium, phosphate, uric acid and low calcium levels, leading to changes in kidney function and heart rhythm, seizures, and sometimes death.

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

Sudden or mild pain in the upper abdomen and/or back that worsens and lasts several days, possibly accompanied by nausea, vomiting, fever and rapid pulse. These symptoms may be due to inflammation of the pancreas.
Wheezing or whistling when breathing, difficulty breathing or dry cough, which may be symptoms caused by inflammation of lung tissue.
Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some occurring when lenalidomide is administered with a statin (a type of medicine used to lower cholesterol).
A skin condition caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
Perforation of the stomach or intestinal wall. This may lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stools or changes in bowel habits.
Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful blistering skin rash) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, nausea or feeling unwell).
Rejection of solid organ transplants (such as kidney, heart).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomida Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration or evidence of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lenalidomida

Lenalidomida Accord 2.5 mg hard capsules EFG:

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

The other components are:

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

Lenalidomida Accord 5 mg hard capsules EFG:

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

The other components are:

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

Lenalidomida Accord 7.5 mg hard capsules EFG:

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

The other components are:

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

Lenalidomida Accord 10 mg hard capsules EFG:

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

The other components are:

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

Lenalidomida Accord 15 mg hard capsules EFG:

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

The other components are:

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

Lenalidomida Accord 20 mg hard capsules EFG:

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

The other components are:

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

Lenalidomida Accord 25 mg hard capsules EFG:

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

The other components are:

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

Appearance of Lenalidomida Accord and contents of the pack

Lenalidomida Accord 2.5 mg are hard gelatin capsules, size "5", approximately 11.0 mm to 11.8 mm in length, grey cap and opaque white 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.

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

Lenalidomida Accord 7.5 mg are hard gelatin capsules, size "4", approximately 14.0 mm to 14.8 mm in length, opaque lavender cap and opaque white 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.

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

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

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

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

Lenalidomida Accord hard capsules are available in pre-scored unit dose blisters OPA-AL-PVC/aluminum.

Pack sizes of 7x1 or 21x1 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona,

s/n, Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

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,

The Netherlands

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.