REVLIMID 5 mg Hard Capsule

Зміст інструкції

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. How to store Revlimid
6. Contents of the pack and other information

Revlimid 2.5 mg hard capsules
Revlimid 5 mg hard capsules
Revlimid 7.5 mg hard capsules
Revlimid 10 mg hard capsules
Revlimid 15 mg hard capsules
Revlimid 20 mg hard capsules
Revlimid 25 mg hard capsules
lenalidomide

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced during
the use of this medicinal product. See the end of section 4 for information on how to report adverse effects.

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

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Revlimid is and what it is used for
• 2. What you need to know before you take Revlimid
• 3. How to take Revlimid
• 4. Possible side effects
• 5. How to store 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 way the immune system works.

What is Revlimid used for
Revlimid is used in adults for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells, called plasma cells.
These cells collect in the bone marrow and divide in an uncontrolled way. This can damage the
bones and kidneys.
Multiple myeloma is usually incurable. However, the signs and symptoms can be significantly reduced or
disappear for a certain period. This result is called “response”.
Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Revlimid is used alone as a maintenance therapy in patients who have recovered adequately after bone
marrow transplantation.
Newly diagnosed multiple myeloma: in patients who cannot undergo bone
marrow transplantation
Revlimid is taken with other medicines, which may include:

• a chemotherapy medicine called “bortezomib”
• an anti-inflammatory medicine called “dexamethasone”
• a chemotherapy medicine called “melphalan” and
• an immunosuppressant medicine called “prednisone”. You will take these other medicines at the beginning of treatment and then continue to take Revlimid alone.

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will subject you to
careful checks before starting treatment.
Multiple myeloma: in patients already treated
Revlimid is taken together with an anti-inflammatory medicine called “dexamethasone”.
Revlimid can stop the worsening of the signs and symptoms of multiple myeloma. It has also been
shown to delay the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
MDS are a group of many different blood and bone marrow diseases. Blood cells
become abnormal and do not function properly. Patients may experience various signs and symptoms, including
a low number of red blood cells (anemia), the need for blood transfusions, and the risk of infection.
Alone, Revlimid is used to treat adult patients diagnosed with MDS, in the presence of
all of the following conditions:

• if you need regular blood transfusions to treat low levels of red blood cells (“transfusion-dependent anemia”)
• if you have an abnormality of the bone marrow cells, called “isolated 5q deletion cytogenetic abnormality”. This means that your body is not producing enough healthy blood cells
• if other treatments used previously are not suitable or are not effective enough.

Revlimid can increase the number of healthy red blood cells produced by the body, reducing the number of
abnormal cells:

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

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (the lymphatic tissue). It affects a type of white blood cells called B lymphocytes, or B cells. In MCL, B lymphocytes grow out of control and
accumulate in the lymphatic tissue, bone marrow, or blood.
Revlimid is used alone for the treatment of adult patients previously treated with other medicines.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer that affects B lymphocytes, a type of white blood cell that helps the
body fight infections. In the presence of FL, an excessive number of these
B lymphocytes can accumulate in the blood, bone marrow, lymph nodes, and spleen.
Revlimid is taken together with another medicine called “rituximab” for the treatment of adult patients with previously treated follicular lymphoma.

How Revlimid works
Revlimid works on the body’s immune system and directly on the tumor, in several ways:

• stopping the development of cancer cells
• stopping the growth of blood vessels that bring blood to the tumor cells
• stimulating part of the immune system to attack the cancer cells.

2. What you need to know before you take Revlimid

you must take in association with Revlimid.
Do not take Revlimid

• If you are pregnant, think you may be pregnant, or if you are planning a pregnancy, because it is expectedthat Revlimid is harmful to the fetus(see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men’).
• If there is a possibility that you may become pregnant unless you follow all the necessary measures to avoid pregnancy (see section 2 ‘Pregnancy, breastfeeding and contraception - information for women and men’). If there is a possibility that you may become pregnant, on each prescription the doctor will take note and confirm to you that the necessary measures to avoid pregnancy have been taken.
• If you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

If any of these conditions apply to you, do not take Revlimid. If you have doubts, consult your doctor.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Revlimid if:

• you have had episodes of blood clot formation in the past, as the risk of blood clots forming in veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have had in the past a viral infection, in particular: hepatitis B infection, shingles, HIV. If you have doubts, consult your doctor. Treatment with Revlimid may cause reactivation of the virus in patients carrying the virus. This causes the infection to reappear. The doctor must check if you have had a hepatitis B infection in the past
• you have kidney problems - your doctor may adjust the dose of Revlimid
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• you have had an allergic reaction during treatment with thalidomide (another medicine for the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or difficulty breathing
• you have had in the past 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; these are signs of a serious 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 starting the
treatment.
At any time during or after treatment, immediately inform your doctor or nurse if:

• you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, changes in the way you walk or problems with balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may be symptoms of a serious brain condition that can be fatal, known as

progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment
with Revlimid, tell your doctor of any changes in these symptoms.

• you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and checks
Before and during treatment with Revlimid you will undergo regular blood tests. This is because
Revlimid can cause a reduction in the blood cells that defend you from infections (white blood cells) and those that promote blood clotting (platelets).
The doctor will ask you to undergo a blood test:

• before treatment
• every week for the first 8 weeks of treatment
• then at least once a month thereafter.

You may be evaluated for signs of cardiopulmonary problems before and during
treatment with lenalidomide.
For patients with MDS who are taking Revlimid
If you suffer from MDS, you are more likely to develop a more advanced disease called acute myeloid leukemia (AML). Furthermore, the role of Revlimid in the probability of developing AML is not known. The doctor
may ask you to undergo some tests to check for signs that may more accurately predict the probability
that you will develop AML during treatment with Revlimid.
For patients with MCL who are taking Revlimid
The doctor will ask you to undergo a blood test:

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

For patients with FL who are taking Revlimid
The doctor will ask you to undergo a blood test:

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

The doctor may check if you have a high tumor load throughout the body, including in the bone marrow.
This may cause a disease in which tumors break down and cause the presence of unusual levels of
chemicals in the blood, which can lead to kidney failure (this disease is called
“tumor lysis syndrome”).
The doctor may check for changes on the skin, such as red spots or rashes.
The doctor may decide to adjust the dose of Revlimid or stop treatment depending on
the results of blood tests and your overall condition. If you are a newly diagnosed patient, the
doctor may also evaluate the treatment based on your age and any other conditions you may already
have.

Blood donation
You must not donate blood during therapy with lenalidomide and for at least 7 days after the end of
treatment.

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

Elderly and people with kidney problems
If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will subject you to
careful checks before starting treatment.

Other medicines and Revlimid
Tell your doctor or nurse if you are taking or have recently taken any other medicines.
This is because Revlimid can affect the action of other medicines and other medicines can affect
the action of Revlimid.
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, because they may no longer be effective
• some medicines used for heart problems, such as digoxin
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Revlimid

• You must not take Revlimid if you are pregnant, as this medicine is expected to be harmful to the fetus.
• During treatment with Revlimid, you must not become pregnant. If there is a possibility of becoming pregnant, you must use effective contraceptive methods (see the “Contraception” section).
• If you become pregnant during treatment with Revlimid, you must stop treatment immediately and inform your doctor.

For men taking Revlimid

• If your partner becomes pregnant while you are taking Revlimid, immediately inform your doctor. It is also recommended that your partner contact their doctor.
• In addition, you must use effective contraceptive methods (see the “Contraception” section).

Breastfeeding
You must not breastfeed while taking Revlimid, as it is not known whether this medicine passes into breast milk.

Contraception
For women taking Revlimid
Before starting treatment, ask your doctor if there is a possibility for you to become pregnant,
even if you think it is unlikely.
If there is a possibility of becoming pregnant

• you must undergo pregnancy tests under the supervision of your doctor (before each treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment) except in cases where it has been confirmed that the fallopian tubes have been cut and closed to prevent eggs from reaching the uterus (sterilization by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after stopping treatment. Your doctor will provide you with all the information on appropriate contraceptive methods.

For men taking Revlimid
Revlimid passes into human seminal fluid. If there is a possibility that your partner is pregnant or
becomes pregnant and she is not using effective contraception, you must use condoms
during treatment and for at least 7 days after the end of treatment, even if you have undergone a
vasectomy. You must not donate seminal fluid or sperm during therapy with lenalidomide and
for at least 7 days after the end of treatment.

Driving and using machines
Do not drive or use machines if you experience dizziness, fatigue, drowsiness, vertigo or blurred vision after
taking Revlimid.

Revlimid contains lactose
Revlimid contains lactose. If your doctor has diagnosed you with an intolerance to some sugars, contact
them before taking this medicine.

3. How to take Revlimid

Revlimid must be administered by healthcare professionals experienced in the treatment of multiple myeloma, MDS, MCL or FL.

• When Revlimid is used for the treatment of multiple myeloma in patients who are not eligible for stem cell transplant or who have received prior therapies, it is taken with other medications (see section 1 “What Revlimid is and what it is used for”).
• When Revlimid is used for the treatment of multiple myeloma in patients who have undergone stem cell transplant or to treat patients with MDS or MCL, it is taken alone.
• When Revlimid is used to treat follicular lymphoma, it is taken with another medication called “rituximab”.

Take Revlimid exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
medicines for further information on their use and effects.

Treatment cycle
Revlimid is taken on some days over a 3-week (21-day) period.

• Each 21-day period is called a “treatment cycle”.
• Depending on the day of the cycle, you will take one or more of the medications. However, on some days you will not take any medication.
• Once each 21-day cycle is completed, you will need to start a new “cycle” over the next 21 days. OR Revlimid is taken on some days over a 4-week (28-day) period.
• Each 28-day period is called a “treatment cycle”.
• Depending on the day of the cycle, you will take one or more of the medications. However, on some days you will not take any medication.
• Once each 28-day cycle is completed, you will need to start a new “cycle” over the next 28 days.

Dose of Revlimid to take
Before starting treatment, your doctor will tell you:

• the dose of Revlimid to take
• the dose of any other medications to take with Revlimid, if prescribed
• on which days of the treatment cycle to take each medication.

How and when to take Revlimid

• The capsules should be swallowed whole, preferably with water.
• Do not break, open or chew the capsules. If powder from a broken Revlimid capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, those providing care to the patient, and family members must wear disposable gloves when handling the blister or the capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Women who are pregnant or suspect they may be pregnant should not handle the blister or the capsule.
• The capsules can be taken with or without food.
• You should take Revlimid on the scheduled days at approximately the same time.

Taking this medicine
To remove the capsule from the blister:

• press on one side of the capsule only, pushing it through the aluminum foil
• do not press on the center of the capsule, otherwise it may break.

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

If you take more Revlimid than you should
If you have taken more Revlimid than you have been prescribed, tell your doctor immediately.

If you forget to take Revlimid
If you forget to take Revlimid at the usual time and:

• less than 12 hours have passed: take your capsule immediately
• more than 12 hours have passed: do not take the forgotten capsule, but take your next capsule the following day at the usual time.

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

4. Possible side effects

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

Stop taking Revlimid and consult your doctor immediately if you experience any of the following serious side effects – urgent medical treatment may be needed:

• Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction, which may start as a rash in one area but spread with extensive skin loss all over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Contact your doctor immediately if you experience any of the following side effects:

• Fever, chills, sore throat, cough, ulcers in the mouth or any other symptom of infection, even in the bloodstream (sepsis)
• Bleeding or bruising without injury
• Chest or leg pain
• Shortness of breath
• Bone pain, muscle weakness, confusion or fatigue, which may be due to a high level of calcium in the blood.

Revlimid can reduce the number of white blood cells that fight infections and also the blood cells that help the 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 important to note that a small number of patients may develop other types of cancer and it is possible that this risk may increase with treatment with Revlimid. Therefore, the doctor must carefully assess the benefit and risk when prescribing Revlimid.
Side effects very common(may affect more than 1 in 10 people):

• Decrease in the number of red blood cells (anemia), which can cause fatigue and weakness
• Skin rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle soreness, bone pain, joint pain, back pain, pain in the extremities
• 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 burning sensation on the skin, pain in the hands or feet, dizziness, tremor
• Decreased appetite, altered sense of taste
• Increased pain, size of the tumor or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood
• Low thyroid function
• Leg pain (which may be a symptom of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism)
• Infections of any kind, including infections of the sinuses around the nose, lungs and upper respiratory tract
• Shortness of breath
• Blurred vision
• Clouding of the vision (cataract)
• Kidney problems, including improper functioning of the kidneys or the inability of the kidneys to maintain normal function
• Abnormal values in liver function tests
• Increased values in liver function tests
• Changes in a protein in the blood that can cause inflammation of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of discomfort, malaise
• Inflammation of the oral cavity, dry mouth
• Dehydration

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

• Destruction of red blood cells in the blood (hemolytic anemia)
• Some types of skin cancer
• Bleeding from the gums, stomach or intestines
• Increased blood pressure, slow, rapid or irregular heartbeat
• Increased amount of a substance that comes from the normal and abnormal breakdown of red blood cells
• Increase in a type of protein that indicates inflammation in the body
• Darkening of the skin, changes in skin color due to bleeding under the skin, typically caused by bruising, swelling of the skin due to the presence of blood, bruising
• Increased uric acid in the blood
• Skin rashes, redness of the skin, cracking of the skin, scaling or peeling, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, problems with voice quality or changes in voice
• Runny nose
• Production of urine much more or less than usual or inability to control the urge to urinate
• Blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty having an erection
• Stroke, fainting, dizziness (inner ear problem that causes the sensation that everything is spinning), temporary loss of consciousness
• Chest pain that radiates to the arms, neck, jaw, back or stomach, feeling of sweating and shortness of breath, feeling unwell or vomiting, which may be the symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Swelling of the joints
• Slowing or blockage of bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disorders, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, altered sensitivity especially to touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which can cause injury

Side effects uncommon(may affect up to 1 in 100 people):

• Bleeding inside the skull
• Circulatory problems
• Loss of vision
• Loss of sexual drive (libido)
• Abundant urinary flow with pain and bone 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, bloating or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome: metabolic complications that can occur during cancer treatment and sometimes even without treatment. These complications are caused by the products of decomposition of tumor cells that are dying, and can include changes in hematological parameters with high levels of potassium, phosphorus and uric acid as well as low levels of calcium, which involve changes in kidney function and heartbeat, seizures and sometimes death.
• Increased blood pressure in the vessels that carry blood to the lungs (pulmonary hypertension).

Side effects with unknown frequency(frequency cannot be estimated on the basis of available data):

• Sudden, or mild but worsening, pain in the upper abdomen and/or back, lasting for several days, with possible nausea, vomiting, fever and rapid pulse; these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (pain, weakness or swelling of the muscles), which can cause kidney problems (rhabdomyolysis), some of which when Revlimid is administered with a statin (a type of drug that lowers cholesterol).
• A disease that affects the skin and is caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine, which can cause very serious infections. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool or changes in your bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease that causes painful blistering rash) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, brown-colored urine, pain in the stomach on the right side, fever and feeling sick).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Revlimid

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and the packaging after “Exp.”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice damaged packaging or signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Return any unused medicine to the pharmacist. This will help protect the environment.

6. Contents of the pack and other information

What Revlimid contains
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 paragraph 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 paragraph 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 paragraph 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171), 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 paragraph 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 paragraph 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 paragraph 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 paragraph 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).

Description of the appearance of Revlimid and contents of the pack
Revlimid 2.5 mg hard capsules are blue-green/white in colour, with the inscription ’REV 2.5 mg’.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven
capsules, for a total of 7 or 21 capsules per pack.
Revlimid 5 mg hard capsules are white in colour, with the inscription ’REV 5 mg’.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven
capsules, for a total of 7 or 21 capsules per pack.
Revlimid 7.5 mg hard capsules are light yellow/white in colour, with the inscription ’REV 7.5 mg’.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven
capsules, for a total of 7 or 21 capsules per pack.
Revlimid 10 mg hard capsules are blue-green/light yellow in colour, with the inscription ’REV 10 mg’.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven
capsules, for a total of 7 or 21 capsules per pack.
Revlimid 15 mg hard capsules are light blue/white in colour, with the inscription ’REV 15 mg’.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven
capsules, for a total of 7 or 21 capsules per pack.
Revlimid 20 mg hard capsules are blue-green/light blue in colour, with the inscription ’REV 20 mg’.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven
capsules, for a total of 7 or 21 capsules per pack.
Revlimid 25 mg hard capsules are white in colour, with the inscription ’REV 25 mg’.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven
capsules, for 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
For further information on this medicine, contact the local representative of the marketing authorisation
holder:

Belgique/België/Belgien
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Lietuva
Swixx Biopharma UAB
Tel: + 370 52 369140
[email protected]

България
Swixx Biopharma EOOD
Teл.: + 359 2 4942 480
[email protected]

Luxembourg/Luxemburg
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Česká republika
Bristol-Myers Squibb spol. s r.o.
Tel: + 420 221 016 111
[email protected]

Magyarország
Bristol-Myers Squibb Kft.
Tel.: + 36 1 301 9797
[email protected]

Danmark
Bristol-Myers Squibb Denmark
Tlf: + 45 45 93 05 06
[email protected]

Malta
A.M. Mangion Ltd
Tel: + 356 23976333
[email protected]

Deutschland
Bristol-Myers Squibb GmbH & Co. KGaA
Tel: 0800 0752002 (+ 49 89 121 42 350)
[email protected]

Nederland
Bristol-Myers Squibb B.V.
Tel: + 31 (0)30 300 2222
[email protected]

Eesti
Swixx Biopharma OÜ
Tel: + 372 640 1030
[email protected]

Norge
Bristol-Myers Squibb Norway AS
Tlf: + 47 67 55 53 50
[email protected]

Ελλάδα
Bristol-Myers Squibb A.E.
Τηλ: + 30 210 6074300
[email protected]

Österreich
Bristol-Myers Squibb GesmbH
Tel: + 43 1 60 14 30
[email protected]

España
Bristol-Myers Squibb, S.A.
Tel: + 34 91 456 53 00
[email protected]

Polska
Bristol-Myers Squibb Polska Sp. z o.o.
Tel.: + 48 22 2606400
[email protected]

France
Bristol-Myers Squibb SAS
Tél: + 33 (0)1 58 83 84 96
[email protected]

Portugal
Bristol-Myers Squibb Farmacêutica Portuguesa,
S.A.
Tel: + 351 21 440 70 00
[email protected]

Hrvatska
[email protected]

România
Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 40 (0)21 272 16 19
[email protected]

Ireland
Bristol-Myers Squibb Pharmaceuticals uc
Tel: 1 800 749 749 (+ 353 (0)1 483 3625)
[email protected]

Slovenija
Tel: + 386 1 2355 100
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000
[email protected]
[email protected]

Slovenská republika
Tel: + 421 2 20833 600
[email protected]

Italia
Bristol-Myers Squibb S.r.l.
Tel: + 39 06 50 39 61
[email protected]

Suomi/Finland
Oy Bristol-Myers Squibb (Finland) Ab
Puh/Tel: + 358 9 251 21 230
[email protected]

Κύπρος
Bristol-Myers Squibb A.E.
Τηλ: 800 92666 (+ 30 210 6074300)
[email protected]

Sverige
Bristol-Myers Squibb Aktiebolag
Tel: + 46 8 704 71 00
[email protected]

Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu .
Additionally, links to other websites on rare diseases and related therapeutic treatments are provided.