LENALIDOMIDE 2.5 MG Капсулы твердые

Содержание инструкции

1. Lenalidomide Olainfarm 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules
   1. What is Lenalidomide Olainfarm and what it is used for
   2. What you need to know before taking Lenalidomide Olainfarm
   3. How to take Lenalidomide Olainfarm
   4. Possible side effects
   5. How to store Lenalidomide Olainfarm
   6. Contents of the pack and other information

Lenalidomide Olainfarm 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

Generic medicine

Read this leaflet carefully before taking 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 Lenalidomide Olainfarm is and what it is used for
• 2. What you need to know before you take Lenalidomide Olainfarm
• 3. How to take Lenalidomide Olainfarm
• 4. Possible side effects
• 5. How to store Lenalidomide Olainfarm
• 6. Contents of the pack and other information

1. What is Lenalidomide Olainfarm and what it is used for

What is Lenalidomide Olainfarm
Lenalidomide Olainfarm contains the active substance “lenalidomide”. This medicine belongs to a
group of medicines that affect the way the immune system works.

What is Lenalidomide Olainfarm used for
Lenalidomide Olainfarm 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 of time. This result is called “response”.
Newly diagnosed multiple myeloma - in patients undergoing bone marrow transplant
Lenalidomide Olainfarm is used alone as maintenance therapy in patients who have
adequately recovered after bone marrow transplantation.
Newly diagnosed multiple myeloma - in patients who cannot undergo bone marrow
transplantation
Lenalidomide Olainfarm 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 Lenalidomide Olainfarm 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
Lenalidomide Olainfarm is taken together with an anti-inflammatory medicine called “dexamethasone”.
Lenalidomide Olainfarm 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 work 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 Lenalidomide Olainfarm is used to treat adult patients who have been 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 does not produce enough healthy blood cells
• if other treatments used previously are not suitable or do not work well enough.

Lenalidomide Olainfarm 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. You may not need any transfusions.

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. MCL is a disease in which B lymphocytes grow in an
uncontrolled way and accumulate in the lymphatic tissue, bone marrow, or blood.
Lenalidomide Olainfarm 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.
Lenalidomide Olainfarm is taken together with another medicine called “rituximab” for the
treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Olainfarm works
Lenalidomide Olainfarm works on the body’s immune system and by directly attacking the cancer.
It works in several ways:

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

2. What you need to know before taking Lenalidomide Olainfarm

medicines that you are taking in combination with Lenalidomide Olainfarm.
Do not take Lenalidomide Olainfarm:

• if you are pregnant, think you may be pregnant, or if you are planning a pregnancy, because Lenalidomide Olainfarm is expectedto harm 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 make a note and confirm to you that the necessary measures to avoid pregnancy have been adopted.
• 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 Lenalidomide Olainfarm. If you have any doubts, consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lenalidomide Olainfarm if:

• you have had episodes of blood clot formation in the past - during treatment the risk of blood clot formation in the veins and arteries increases
• you have any signs of infection, such as cough or fever
• you have or have had a viral infection in the past, in particular: hepatitis B infection, varicella-zoster, HIV. If you have any doubts, consult your doctor. Treatment with Lenalidomide Olainfarm may cause reactivation of the virus in patients carrying the virus. This causes the infection to recur. The doctor must check if you have had a hepatitis B infection in the past
• you have kidney problems - the doctor may adjust the dose of Lenalidomide Olainfarm
• 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 any combination of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), enlarged 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 and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with Lenalidomide Olainfarm, 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 Lenalidomide Olainfarm you will undergo regular blood tests.
This is because Lenalidomide Olainfarm can cause a reduction in blood cells that help you
fight infections (white blood cells) and those that promote blood clotting (platelets).
The doctor will ask you to undergo blood tests:

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

You may be evaluated for signs of cardiopulmonary problems before and during
treatment with lenalidomide.
For patients with MDS who are taking Lenalidomide Olainfarm
If you suffer from MDS, you are more likely to develop a more advanced disease called acute
myeloid leukemia (AML). Furthermore, the role of Lenalidomide Olainfarm on the probability of developing
AML is unknown. The doctor may ask you to undergo some tests to check for signs that could more
accurately predict the likelihood that you will develop AML during treatment with Lenalidomide Olainfarm.
For patients with CLM who are taking Lenalidomide Olainfarm
The doctor will ask you to undergo a blood test:

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

For patients with LF who are taking Lenalidomide Olainfarm
The doctor will ask you to undergo a blood test:

• before treatment
• once a week for the first 3 weeks (1 cycle) of treatment
• then every 2 weeks in cycles 2 to 4 (for further 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 burden 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 Lenalidomide Olainfarm 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 assess treatment based on your age and any other pre-existing conditions.

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

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

Elderly and people with kidney problems
In patients aged 75 years or older or with moderate or severe kidney problems, the doctor will perform
careful checks before starting treatment.

Other medicines and Lenalidomide Olainfarm
Tell your doctor or nurse if you are taking, have recently taken or may take any
other medicines. This is because Lenalidomide Olainfarm can affect the action of other medicines and other
medicines can affect the action of Lenalidomide Olainfarm.
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 Lenalidomide Olainfarm

• You must not take Lenalidomide Olainfarm if you are pregnant, as this medicine is expected to harm the fetus.
• During treatment with Lenalidomide Olainfarm you must not start a pregnancy. If you are a woman of childbearing potential, you must use effective contraceptive methods (see the section “Contraception”).
• If you become pregnant during treatment with Lenalidomide Olainfarm, you must stop treatment immediately and inform your doctor.

For men taking Lenalidomide Olainfarm

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

Breastfeeding
You must not breastfeed while taking Lenalidomide Olainfarm, as it is not known whether lenalidomide passes into
breast milk.

Contraception
For women taking Lenalidomide Olainfarm
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 your 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 Lenalidomide Olainfarm Lenalidomide passes into human seminal fluid. If your partner is pregnant or may become pregnant and is not using effective contraceptive methods, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have undergone a vasectomy.

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

Lenalidomide Olainfarm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

Lenalidomide Olainfarm contains lactose
Lenalidomide Olainfarm contains lactose. If you have been diagnosed with an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Lenalidomide Olainfarm

Lenalidomide Olainfarm must be administered by healthcare professionals experienced in the treatment of multiple myeloma, MDS, LCL, or LF.

• When Lenalidomide Olainfarm is used for the treatment of multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatments, it is taken with other medicines (see section 1 “What Lenalidomide Olainfarm is and what it is used for”).
• When Lenalidomide Olainfarm is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation or to treat patients with MDS or LCL, it is taken alone.
• When Lenalidomide Olainfarm is used to treat follicular lymphoma, it is taken with another medicine called ‘rituximab’.

Take Lenalidomide Olainfarm following your doctor’s instructions exactly. If you have any doubts, consult your doctor or pharmacist.
of these medicines for further information on their use and effects.

Treatment cycle
Lenalidomide Olainfarm is taken on some days over a period of 3 weeks (21 days).

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

How much Lenalidomide Olainfarm to take
Before starting treatment, your doctor will tell you:

• how much Lenalidomide Olainfarm you should take
• the dose of other medicines to be taken in combination with Lenalidomide Olainfarm, if prescribed
• on which days of the treatment cycle to take each medicine.

How and when to take Lenalidomide Olainfarm

• swallow the capsules whole, preferably with water.
• do not break, open or chew the capsules. If the powder from a broken Lenalidomide Olainfarm 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 removed carefully to avoid skin exposure, placed in a sealable polyethylene plastic bag, and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister or the capsule.
• the capsules can be taken with or without food.
• you must take Lenalidomide Olainfarm on the established days at approximately the same time.

Taking this medicine
To remove the capsule from the blister:

• press on only one side of the capsule, pushing it through the aluminum foil
• do not press on the center of the capsule, otherwise there is a risk of breaking it.

Duration of treatment with Lenalidomide Olainfarm
Lenalidomide Olainfarm 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 the treatment.

If you take more Lenalidomide Olainfarm than you should
If you have taken more Lenalidomide Olainfarm than you have been prescribed, inform your doctor immediately.

If you forget to take Lenalidomide Olainfarm
If you forget to take Lenalidomide Olainfarm 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. Take the next capsule the following day at the usual time.

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

4. Possible side effects

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

Stop taking Lenalidomide Olainfarm 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 can be symptoms of serious 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.

Seek immediate medical attention 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 within 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.

Lenalidomide Olainfarm can reduce the number of white blood cells that fight infections and also the
blood cells that help blood clotting (platelets), which can cause bleeding disorders such as nosebleeds and bruising.
Lenalidomide Olainfarm 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 Lenalidomide Olainfarm. Therefore, the doctor must
carefully assess the benefit and risk when prescribing Lenalidomide Olainfarm.
Side effects very common(may affect more than 1 in 10 people):

• Decrease in the number of red blood cells, which can cause anemia leading to fatigue and weakness
• Skin rashes, itching
• Muscle cramps, muscle weakness, acute muscle pain, muscle aches, bone pain, joint pain, back pain, limb pain
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, earache, 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
• Decreased 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 surrounding the nose, lung infections and upper respiratory tract infections
• Shortness of breath
• Blurred vision
• Clouding of the lens of the eye (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 swings, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of discomfort, unwell
• 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, fast 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; change 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, scaling or peeling of the skin, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, problems with voice quality or changes in voice
• Runny nose
• Production of much more or much less urine 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 a sensation of spinning, temporary loss of consciousness
• Chest pain that radiates to the arms, neck, jaw, back or stomach, sweating and shortness of breath, feeling unwell or vomiting, which may be 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, unpleasant change in sensation especially touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which can cause injury

Uncommon side effects (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 weakness in the bones, 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 the cells of the kidney (called tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome: metabolic complications that can occur during cancer treatment and, sometimes, even in the absence of treatment. These complications are caused by the breakdown products of tumor cells that are dying and can include changes in hematological parameters, high levels of potassium, phosphorus, uric acid and 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 frequency not known(frequency cannot be estimated on the basis of the available
data):

• Sudden, or mild but worsening, pain in the upper stomach and/or back, which persists 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 Lenalidomide Olainfarm 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 (leucocytoclastic vasculitis).
• Deterioration of the wall of the stomach or intestine. This can cause very serious infections. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stools or changes in bowel habits.
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease that causes painful blisters rash) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, brown urine, stomach pain on the right side, fever and nausea or vomiting).
• 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. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Lenalidomide Olainfarm

• 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 carton after “Scad./EXP”. The expiry date refers to the last day of that month.
• Store in the original packaging. This medicine does not require any particular storage temperature 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 Lenalidomide Olainfarm contains
Lenalidomide Olainfarm 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, indigo carmine and yellow iron oxide
• inscription ink: shellac, black iron oxide, propylene glycol, potassium hydroxide and concentrated ammonia solution

Lenalidomide Olainfarm 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
• inscription ink: shellac, black iron oxide, propylene glycol, potassium hydroxide and concentrated ammonia solution

Lenalidomide Olainfarm 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 and titanium dioxide
• inscription ink: shellac, black iron oxide, propylene glycol, potassium hydroxide and concentrated ammonia solution

Lenalidomide Olainfarm 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, indigo carmine and yellow iron oxide
• inscription ink: shellac, black iron oxide, propylene glycol, potassium hydroxide and concentrated ammonia solution

Lenalidomide Olainfarm 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 and indigo carmine
• inscription ink: shellac, black iron oxide, propylene glycol, potassium hydroxide and concentrated ammonia solution

Lenalidomide Olainfarm 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, indigo carmine and yellow iron oxide
• inscription ink: shellac, black iron oxide, propylene glycol, potassium hydroxide and concentrated ammonia solution

Lenalidomide Olainfarm 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
• inscription ink: shellac, black iron oxide, propylene glycol, potassium hydroxide and concentrated ammonia solution

Description of the appearance of Lenalidomide Olainfarm and contents of the pack
Lenalidomide Olainfarm 2.5 mg hard capsules are formed by a cap of blue-green color and a body white in color bearing the black inscription printed “2.5 mg”. The capsule is approximately 14.4 mm long and is filled with white to off-white powder.
Lenalidomide Olainfarm 5 mg hard capsules are formed by a cap of white color and a body white in color bearing the black inscription printed “5 mg”. The capsule is approximately 17.8 mm long and is filled with white to off-white powder.
Lenalidomide Olainfarm 7.5 mg hard capsules are formed by a cap of light yellow color and a body white in color bearing the black inscription printed “7.5 mg”. The capsule is approximately 17.8 mm long and is filled with white to off-white powder.
Lenalidomide Olainfarm 10 mg hard capsules are formed by a cap of blue-green color and a body light yellow in color bearing the black inscription printed “10 mg”. The capsule is approximately 21.4 mm long and is filled with white to off-white powder.
Lenalidomide Olainfarm 15 mg hard capsules are formed by a cap of light blue color and a body white in color bearing the black inscription printed “15 mg”. The capsule is approximately 21.4 mm long and is filled with white to off-white powder.
Lenalidomide Olainfarm 20 mg hard capsules are formed by a cap of blue-green color and a body light blue in color bearing the black inscription printed “20 mg”. The capsule is approximately 21.4 mm long and is filled with white to off-white powder.
Lenalidomide Olainfarm 25 mg hard capsules are formed by a cap of white color and a body white in color bearing the black inscription printed “25 mg”. The capsule is approximately 21.4 mm long and is filled with white to off-white powder.
The capsules are provided in packs. Each pack contains one or three blisters, each blister containing seven capsules, for a total of 7 or 21 capsules per pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AS Olainfarm,
Rupnicu iela 5,
LV-2114, Olaine,
Latvia
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Corradino Industrial Estate
Paola PLA3000
Malta