REVLIMID 20 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Revlimid 2.5mg hard capsules

Revlimid 5mg hard capsules

Revlimid 7.5mg hard capsules

Revlimid 10mg hard capsules

Revlimid 15mghard capsules

Revlimid 20mghard capsules

Revlimid 25mghard capsules

lenalidomide

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Revlimid and what is it used for
2. What you need to know before you take Revlimid
3. How to take Revlimid
4. Possible side effects
5. Storage of Revlimid
6. Contents of the pack and other information

1. What is Revlimid and what is it used for

What is Revlimid

Revlimid contains the active substance lenalidomide. This medicine belongs to a group of medicines that affect the immune system.

What Revlimid is used for

Revlimid is used in adults for:

• Multiple myeloma
• Myelodysplastic 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 called plasma cells. These cells accumulate in the bone marrow and multiply out of control. This can damage the bones and kidneys.

Multiple myeloma usually cannot be cured. However, the signs and symptoms can be greatly reduced or may disappear for a period of time. This is called a "remission".

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

Revlimid is used as maintenance treatment after recovery from a bone marrow transplant.

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

Revlimid is taken with other medicines, including:

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

You will take these medicines at the start of treatment and then continue to take Revlimid on its own.

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

Multiple myeloma: in patients who have been previously treated

Revlimid is taken with an anti-inflammatory called dexamethasone.

Revlimid can delay the worsening of multiple myeloma symptoms. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

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

Revlimid is used to treat adult patients with MDS, when all of the following apply:

• you need regular blood transfusions to treat low red blood cell counts ("transfusion-dependent anaemia")
• you have a bone marrow abnormality called "isolated deletion 5q cytogenetic abnormality". This means that your body does not produce enough healthy blood cells
• other treatments you have used before are not suitable or have not worked well enough.

Revlimid 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 you need. You may not need transfusions at all.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cell called B cells or B lymphocytes. MCL is a disease where B cells grow out of control and accumulate in lymphatic tissue, bone marrow or blood.

Revlimid is used on its own to treat adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B cells. These are a type of white blood cell that help the body fight infection. When someone has FL, they can have too many of these B cells in their blood, bone marrow, lymph nodes and spleen.

Revlimid is used with another medicine called rituximab to treat adult patients who have been previously treated for follicular lymphoma.

How Revlimid works

Revlimid works by affecting the immune system and directly attacking the cancer. It works in several ways:

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

2. What you need to know before you take Revlimid

You must read the summary of product characteristics of all medicines you are going to take in combination with Revlimid before starting treatment with Revlimid.

Do not take Revlimid:

• if you are pregnant, think you may be pregnant or plan to become pregnant, as Revlimid is expected to be harmful to the unborn baby (see section 2, "Pregnancy, breast-feeding and contraception: information for women and men").
• if you can become pregnant, unless you use effective contraception (see section 2, "Pregnancy, breast-feeding and contraception: information for women and men"). If you can become pregnant, your doctor will record that all necessary measures have been taken and will provide you with this confirmation for each prescription.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor.

If any of these conditions apply to you, do not take Revlimid. If you are in doubt, consult your doctor.

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start taking Revlimid if:

• you have ever had blood clots; during treatment, you have a higher risk of getting blood clots in your veins and arteries
• you have any signs of infection, such as cough or fever
• you have or have had a viral infection, especially hepatitis B, varicella zoster or HIV. If you are in doubt, ask your doctor. Treatment with Revlimid may cause the virus to become active again in patients who carry the virus. This can lead to the infection coming back. Your doctor should check if you have ever had a hepatitis B infection
• you have kidney problems; your doctor may adjust your dose of Revlimid
• 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 a skin rash, itching, swelling, dizziness or breathing problems
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated 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 or drug hypersensitivity syndrome) (see also section 4 "Possible side effects").

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

At any time during or after treatment, tell your doctor or nurse immediately if you:

• have blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or problems with balance, numbness, decreased sensation or loss of sensation, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with Revlimid, tell your doctor if you notice any change in these symptoms.

• have shortness of breath, tiredness, dizziness, chest pain, faster heart rate or swelling in your legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before you start treatment with Revlimid and during treatment, you will have regular blood tests. This is because Revlimid can cause a decrease in the blood cells that help fight infections (white blood cells) and those that help your blood to clot (platelets).

Your doctor will ask you to have a blood test:

• before treatment
• every week during the first 8 weeks of treatment
• then at least every month.

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

For patients with MDS taking Revlimid

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukaemia (AML). Also, it is not known how Revlimid affects your chances of developing AML. Your doctor may therefore ask you to have tests to look for signs that may predict your chances of developing AML during treatment with Revlimid.

For patients with MCL taking Revlimid

Your doctor will ask you to have a blood test:

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

For patients with FL taking Revlimid

Your doctor will ask you to have a blood test:

• before treatment
• every week during the first 3 weeks (1 cycle) of treatment
• then every 2 weeks in cycles 2 to 4 (see section 3 "Treatment cycle" for more information)
• after that, at the start of each cycle and
• at least every month.

Your doctor may check if you have a high amount of tumour in your body, including in your bone marrow. This could lead to a condition where the tumours break down and produce abnormal levels of chemicals in the blood that can cause kidney failure (this condition is called "tumour lysis syndrome").

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

Your doctor may adjust your dose of Revlimid or stop your treatment, depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also assess your treatment based on your age and any other conditions you may have.

Blood donation

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

Children and adolescents

Revlimid is not recommended for use in children and adolescents under 18 years.

Elderly and patients with kidney problems

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

Other medicines and Revlimid

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because Revlimid can affect the way other medicines work. Also, some medicines can affect the way Revlimid works.

In particular, tell 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 for heart problems, such as digoxin
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breast-feeding and contraception: information for women and men

Pregnancy

Women taking Revlimid

• do not take Revlimid if you are pregnant, as it is expected to be harmful to the unborn baby.
• do not become pregnant while taking Revlimid. You must use effective contraception if there is a possibility that you may become pregnant (see "Contraception").
• if you become pregnant during treatment with Revlimid, stop treatment and tell your doctor immediately.

Men taking Revlimid

• if your partner becomes pregnant while you are taking Revlimid, tell your doctor immediately. It is recommended that your partner seeks medical advice.
• you must also use effective contraception (see "Contraception").

Breast-feeding

do not breast-feed while taking Revlimid, as it is not known whether Revlimid passes into breast milk.

Contraception

For women taking Revlimid

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

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after the end of treatment) unless it has been confirmed that your fallopian tubes have been blocked (tubal ligation)

And

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

For men taking Revlimid

Revlimid passes into human semen. If your partner is pregnant or may become pregnant and is not using any effective contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy. Do not donate semen or sperm during treatment or for at least 7 days after the end of treatment.

Driving and using machines

do not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking Revlimid.

Revlimid contains lactose

Revlimid contains lactose. If your doctor has told you that you have an intolerance to some sugars, ask your doctor before taking this medicine.

3. How to take Revlimid

Revlimid should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, CLL, or FL.

• When Revlimid is used to treat multiple myeloma in patients who cannot undergo a bone marrow transplant or have undergone other treatments, it is taken with other medications (see section 1 "What Revlimid is used for").
• When Revlimid 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 Revlimid is used to treat follicular lymphoma, it is taken with another medication called "rituximab".

Follow your doctor's instructions for taking Revlimid exactly. If you are unsure, consult your doctor or pharmacist.

If you are taking Revlimid with other medications, you should read the package insert for those medications to get additional information about their use and effects.

Treatment cycle

Revlimid is taken on certain days during a 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 21-day cycle, you should start a new "cycle" for the next 21 days.

Or

Revlimid is taken on certain days during a 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 28-day cycle, you should start a new "cycle" for the next 28 days.

How much Revlimid to take

Before starting treatment, your doctor will tell you:

• how much Revlimid you should take
• how much of the other medications you should take with Revlimid, if applicable
• which days of the treatment cycle you should take each medication.

How and when to take Revlimid

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken Revlimid capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic 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 or capsule.
• The capsules can be taken with or without food.
• You should take Revlimid at approximately the same time on scheduled days.

Taking this medication

To remove the capsule from the blister:

• Press only one end of the capsule to release it through the foil.
• Do not press on the center of the capsule as it may break.

Duration of treatment with Revlimid

Revlimid is taken in treatment cycles, each cycle lasting 21 or 28 days (see "Treatment cycle" above). You should continue the treatment cycles until your doctor tells you to stop treatment.

If you take more Revlimid than you should

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

If you forget to take Revlimid

If you forget to take Revlimid 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 following day at the usual time.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Revlimid can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, stop treatment with Revlimid and see a doctor immediately, as you may need urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which can be symptoms of severe allergic reactions called angioedema and anaphylactic reaction.
• A severe allergic reaction that can 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 (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 in the bloodstream (sepsis)
• Bleeding (bleeding) or bruising (bruising) not due to injury
• Chest pain (thoracic) or leg pain
• Difficulty breathing
• Bone pain, muscle pain, confusion, or fatigue that may be due to high calcium levels in the blood.

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

Other side effects

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

Very common side effects(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
• Skin rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, pain in the limbs
• 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 a sensation of burning in the skin, pain in the hands or feet, dizziness, tremors
• Decreased appetite, changes in taste
• 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 function
• Pain in the legs (which may be a symptom of thrombosis), chest pain, or difficulty breathing (which may be a symptom of blood clots in the lungs, called pulmonary embolism)
• Infections of all kinds, including sinusitis, pneumonia, and upper respiratory tract infections
• Difficulty breathing
• Blurred vision
• Eye opacity (cataracts)
• Kidney problems, including kidney failure or inability to maintain normal kidney function
• Abnormal liver test results
• High liver test results
• Changes in a blood protein that can cause artery swelling (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• A vague feeling of discomfort in the body, feeling unwell
• Painful inflammation of the mouth, dry mouth
• Dehydration

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

• Destruction of red blood cells (hemolytic anemia)
• Certain types of skin tumors
• 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 red blood cell destruction
• Increased levels of a protein that indicates inflammation in the body
• Darkening of skin color; change in skin color due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising
• Increased uric acid levels in the blood
• Skin rash, redness, cracked skin, peeling, or flaking of the skin, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice
• Runny nose
• Strong increase or decrease in urine output or inability to control urination
• Blood in the urine
• Difficulty breathing, especially when lying down (which may be a symptom of heart failure)
• Difficulty having an erection
• Stroke, fainting, vertigo (a disorder of the inner ear that causes a sensation of spinning), temporary loss of consciousness
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, a feeling of sweating and 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
• Swollen joints
• Slower or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disturbance, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Pain in the nerves, abnormal and unpleasant sensation, especially when touched
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Falling, which can cause injuries

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

• Bleeding in 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)
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, skin rash, pain, or swelling of the stomach; these may be symptoms of liver damage (liver failure)
• Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Kidney cell damage (called tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying cancer cells and can include changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.
• Increased blood pressure in the blood vessels that supply the lungs (pulmonary hypertension).

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

• Sudden, severe, or mild pain in the upper stomach and/or back that lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) have been observed, which can lead to kidney problems (rhabdomyolysis), some of which occur when Revlimid 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).
• Rupture of the stomach or intestinal wall. This can 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.
• Viral infections, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package insert. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Revlimid

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date stated on the blister and carton after "EXP". The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use this medication if you notice visible signs of deterioration or evidence of tampering.
• Medications should not be disposed of through wastewater or household waste. Return any unused medication to your pharmacist. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Revlimid

Revlimid 2.5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172).
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Revlimid 5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: gelatin and titanium dioxide (E171).
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Revlimid 7.5 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), and yellow iron oxide (E172).
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Revlimid 10 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172).
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Revlimid 15 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), and indigo carmine (E132).
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Revlimid 20 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172).
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Revlimid 25 mg hard capsules:

• The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Capsule shell: gelatin and titanium dioxide (E171).
• Printing ink: shellac, propylene glycol (E1520), potassium hydroxide, and black iron oxide (E172).

Appearance and Packaging of the Product

The Revlimid 2.5 mg hard capsules are greenish-blue/white, with the inscription “REV 2.5 mg”.

The capsules are presented in packs. Each pack contains one or three blisters, each blister contains seven capsules. This corresponds to a total of 7 or 21 capsules per pack.

The Revlimid 5 mg hard capsules are white, with the inscription “REV 5 mg”.

The capsules are presented in packs. Each pack contains one or three blisters, each blister contains seven capsules. This corresponds to a total of 7 or 21 capsules per pack.

The Revlimid 7.5 mg hard capsules are pale yellow/white, with the inscription “REV 7.5 mg”.

The capsules are presented in packs. Each pack contains one or three blisters, each blister contains seven capsules. This corresponds to a total of 7 or 21 capsules per pack.

The Revlimid 10 mg hard capsules are greenish-blue/pale yellow, with the inscription “REV 10 mg”.

The capsules are presented in packs. Each pack contains one or three blisters, each blister contains seven capsules. This corresponds to a total of 7 or 21 capsules per pack.

The Revlimid 15 mg hard capsules are pale blue/white, with the inscription “REV 15 mg”.

The capsules are presented in packs. Each pack contains one or three blisters, each blister contains seven capsules. This corresponds to a total of 7 or 21 capsules per pack.

The Revlimid 20 mg hard capsules are greenish-blue/pale blue, with the inscription “REV 20 mg”.

The capsules are presented in packs. Each pack contains one or three blisters, each blister contains seven capsules. This corresponds to a total of 7 or 21 capsules per pack.

The Revlimid 25 mg hard capsules are white, with the inscription “REV 25 mg”.

The capsules are presented in packs. Each pack contains one or three blisters, each blister contains seven capsules. This corresponds to a total of 7 or 21 capsules per pack.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Manufacturer

Celgene Distribution B.V.

Orteliuslaan 1000

3528 BD Utrecht

Netherlands

Date of Last Revision of this Leaflet:

Other Sources of Information

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

There are also links to other websites on rare diseases and orphan medicines.