Lenalidomide Pharmascience

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lenalidomide Pharmascience and what is it used for
• 2. Important information before taking Lenalidomide Pharmascience
• 3. How to take Lenalidomide Pharmascience
• 4. Possible side effects
• 5. How to store Lenalidomide Pharmascience
• 6. Contents of the pack and other information

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

What is Lenalidomide Pharmascience

Lenalidomide Pharmascience contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the functioning of the immune system.

What is Lenalidomide Pharmascience used for

Lenalidomide Pharmascience is used in adult patients to treat:

• multiple myeloma,
• myelodysplastic syndromes,
• follicular lymphoma.

Multiple myeloma

Multiple myeloma is a type of cancer that attacks a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and undergo uncontrolled divisions. This can lead to bone and kidney damage.
In principle, multiple myeloma is incurable. However, it is possible to temporarily significantly alleviate or remove the signs and symptoms of the disease. We call this "remission".
Newly diagnosed multiple myeloma - in patients after bone marrow transplantation
In this indication, Lenalidomide Pharmascience is used without other medicines in maintenance treatment after achieving a suitable state after transplantation.
Newly diagnosed multiple myeloma in patients who are not eligible for bone marrow transplantation treatment
Lenalidomide Pharmascience is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan" and
• an immunosuppressant medicine called "prednisone". The patient starts treatment with additional medicines and then continues with Lenalidomide Pharmascience alone.

If the patient is 75 years old or older, or has moderate to severe kidney disease, the doctor will perform thorough tests before starting treatment.
Multiple myeloma - in patients who have received previous treatment
Lenalidomide Pharmascience is taken with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Pharmascience may stop the progression of multiple myeloma symptoms and signs.
It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow diseases. There are abnormal blood cells that do not function properly. Patients may experience various subjective and objective symptoms, including a low number of red blood cells (anemia), the need for blood transfusions, and the risk of infection.
Lenalidomide Pharmascience is used alone in the treatment of adult patients who have been diagnosed with MDS, if all of the following conditions are met:

• the patient has a low number of red blood cells and needs regular blood transfusions ("transfusion-dependent anemia");
• the patient has an abnormality in bone marrow cells called "isolated cytogenetic abnormality in the form of deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously used other treatments that have proven to be ineffective or insufficient.

Taking Lenalidomide Pharmascience may lead to an increase in the number of healthy blood cells produced by the body by reducing the number of abnormal cells:

• this may lead to a reduction in the number of blood transfusions required. It is possible that transfusions will no longer be needed.

Follicular lymphoma (FL)

FL is a slow-growing malignant tumor that attacks B lymphocytes. It is a type of white blood cell that helps the body fight infections. In a patient with FL, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Pharmascience is taken with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Pharmascience works

Lenalidomide Pharmascience works by affecting the functioning of the immune system and directly attacking cancer cells. The medicine works in several different ways:

• by inhibiting the growth of cancer cells;
• by inhibiting the growth of blood vessels in the tumor;
• by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Pharmascience

Before starting treatment with Lenalidomide Pharmascience, you should carefully read the leaflets of all medicines taken at the same time as Lenalidomide Pharmascience.

When not to take Lenalidomide Pharmascience:

• If the patient is pregnant, suspects pregnancy, or plans to become pregnant, as it is expected that Lenalidomide Pharmascience is harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men").
• If the patient may become pregnant, unless they use all required pregnancy prevention measures (see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men"). If the patient may become pregnant, the doctor will always make a note when prescribing the medicine that the necessary measures have been taken and will inform the patient about it.
• If the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). In case of suspected allergy, you should ask your doctor for advice.

If any of these points apply to the patient, they should not take Lenalidomide Pharmascience. In case of doubts, they should consult a doctor.

Warnings and precautions

Before starting treatment with Lenalidomide Pharmascience, you should discuss it with your doctor, pharmacist, or nurse if the patient:

• has had blood clots in the past - this means an increased risk of blood clots in the veins and arteries during treatment;
• has any symptoms of infection, such as cough or fever;
• has a current or past viral infection, especially chickenpox and shingles, hepatitis B, HIV. In case of doubts, you should consult a doctor. Treatment with Lenalidomide Pharmascience may cause the reactivation of viruses in patients who have been infected in the past, leading to the recurrence of the infection. The doctor will check if the patient has had hepatitis B in the past;
• has kidney problems - the doctor may adjust the dose of Lenalidomide Pharmascience;
• has had a heart attack, has had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• has had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• has had a combination of any of the following symptoms in the past: widespread rash, redness of the skin, high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes - these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above applies to the patient, they should consult a doctor, pharmacist, or nurse.
If at any time during or after treatment the patient experiences:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness of the arm or leg, change in gait or balance disturbances due to dizziness of labyrinthine origin or blurred vision, you should immediately tell your doctor or nurse. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If the patient has had such symptoms before treatment with Lenalidomide Pharmascience, they should inform their doctor about any changes;
• shortness of breath, fatigue, dizziness, chest pain, rapid heart rate, or swelling of the feet or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Tests and examinations

Before and during treatment with Lenalidomide Pharmascience, the patient will undergo regular blood tests, as Lenalidomide Pharmascience may cause a decrease in the number of white blood cells that fight infection and blood cells that help blood clot (platelets).
The doctor will call the patient for blood tests:

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

Before starting treatment with lenalidomide and during treatment, the patient may undergo an assessment for circulation and breathing problems.
Patient with MDS taking Lenalidomide Pharmascience
If the patient has myelodysplastic syndromes, there is an increased chance of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Pharmascience affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that will better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Pharmascience.
Patient with FL taking Lenalidomide Pharmascience
The doctor will ask for 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 (more information is provided in section 3 "Treatment cycle"),
• then at the beginning of each cycle and
• at least once a month.

The doctor may perform a test to check if the patient has a large amount of tumor tissue in the body, including bone marrow. This may lead to a situation where the tumor tissue starts to die and causes an abnormal increase in the concentration of various substances in the blood, which can cause kidney failure (a condition called tumor lysis syndrome).
The doctor may perform a test on the patient to check for skin changes, such as red spots or rash.
The doctor may change the dose of Lenalidomide Pharmascience or stop treatment based on the results of the patient's blood tests and overall condition. If the disease is newly diagnosed, the doctor may also assess treatment based on the patient's age and other diseases that may have occurred in the past.

Blood donation

During treatment and for at least 7 days after stopping treatment, the patient must not donate blood.

Children and adolescents

Lenalidomide Pharmascience is not recommended for use in children and adolescents under 18 years of age.

Elderly and patients with kidney problems

If the patient is 75 years old or older, or has moderate to severe kidney disease, the doctor will perform thorough tests before starting treatment.

Lenalidomide Pharmascience and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken. This is necessary because Lenalidomide Pharmascience may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Pharmascience.
In particular, the patient should inform their doctor or nurse if they are taking:

• certain pregnancy prevention medicines, such as oral contraceptives, as they may stop working;
• certain medicines used for heart problems - such as digoxin;
• certain medicines used to thin the blood - such as warfarin.

Pregnancy, breastfeeding, and contraception – information for women and men

Pregnancy

For women taking Lenalidomide Pharmascience

• Lenalidomide Pharmascience must not be taken if the patient is pregnant, as it is expected to be harmful to the unborn child.
• The patient must not become pregnant while taking Lenalidomide Pharmascience.
• Therefore, in women who may become pregnant, it is necessary to use effective pregnancy prevention methods (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Pharmascience, they must stop treatment immediately and inform their doctor.

For men taking Lenalidomide Pharmascience

• If the partner of a man who is being treated with Lenalidomide Pharmascience becomes pregnant, she should immediately inform her doctor. The partner should consult a doctor.
• Men should also use effective contraception methods (see "Contraception").

Breastfeeding

Breastfeeding must not be done while taking Lenalidomide Pharmascience, as it is not known whether lenalidomide passes into breast milk.

Contraception

Women taking Lenalidomide Pharmascience
Before starting treatment, the patient should ask their doctor about the possibility of becoming pregnant, even if they think it is unlikely.
Women who may become pregnant:

• will have pregnancy tests performed under the supervision of a doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless the patient has had their fallopian tubes cut and blocked to prevent the egg from entering the uterus (tubal ligation) AND
• must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. The doctor will recommend the appropriate contraception methods to the patient.

Men taking Lenalidomide Pharmascience
Lenalidomide is present in human semen. If a woman is pregnant or may become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after stopping treatment. This also applies to men who have had a vasectomy.
During treatment and for at least 7 days after stopping treatment, the patient must not donate semen.

Driving and using machines

The patient should not drive or operate machinery if they experience dizziness, fatigue, sleepiness, balance disturbances due to dizziness of labyrinthine origin, or blurred vision after taking Lenalidomide Pharmascience.
Lenalidomide Pharmascience contains lactose, tartrazine, orange yellow (E110), and Allura Red AC.
Lenalidomide Pharmascience contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Lenalidomide Pharmascience.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".
Lenalidomide Pharmascience 2.5 mg contains Allura Red AC (E129), which may cause allergic reactions.
Lenalidomide Pharmascience 5 mg and 7.5 mg contain orange yellow (E110), which may cause allergic reactions.
Lenalidomide Pharmascience 10 mg contains tartrazine (E102), orange yellow (E110), and Allura Red AC (E129), which may cause allergic reactions.
Lenalidomide Pharmascience 15 mg contains tartrazine (E102) and Allura Red AC (E129), which may cause allergic reactions.
Lenalidomide Pharmascience 20 mg contains Allura Red AC (E129), which may cause allergic reactions.

3. How to take Lenalidomide Pharmascience

Lenalidomide Pharmascience must be administered by medical personnel who have experience in treating multiple myeloma, MDS, or FL.

• When patients take Lenalidomide Pharmascience for multiple myeloma, who are not eligible for bone marrow transplantation treatment or have received previous treatment, Lenalidomide Pharmascience is used in combination with other medicines (see section 1 "What is Lenalidomide Pharmascience used for").
• When Lenalidomide Pharmascience is used to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS, this medicine is used alone.
• When Lenalidomide Pharmascience is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Lenalidomide Pharmascience should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
If the patient is taking Lenalidomide Pharmascience with other medicines, they should read the leaflet that comes with their packaging to get information about their use and action.

Treatment cycle

Lenalidomide Pharmascience is taken on specific days during a period of three weeks (21 days).

• Each 21 days is called a treatment cycle.
• Depending on the day of the cycle, the patient takes one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 21-day cycle, the patient should start a new cycle lasting 21 days. OR
• Lenalidomide Pharmascience is taken on specific days during a period of four weeks (28 days).
• Each 28 days is called a treatment cycle.
• Depending on the day of the cycle, the patient takes one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 28-day cycle, the patient should start a new cycle lasting 28 days.

Recommended dose of Lenalidomide Pharmascience

Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide Pharmascience to take;
• how many other medicines to take in combination with Lenalidomide Pharmascience, if other medicines are necessary;
• on which days of the cycle to take these medicines.

How and when to take Lenalidomide Pharmascience

• The capsule should be swallowed whole, preferably with water.
• The capsules should not be broken, opened, or chewed. In case of contact with the powder from a damaged Lenalidomide Pharmascience capsule, the skin should be washed immediately with soap and water.
• People who are medical staff, caregivers, and family members should wear single-use gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of in accordance with local regulations. Then, the hands should be washed thoroughly with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Lenalidomide Pharmascience should be taken at approximately the same time every day, on the days when it is scheduled.

Taking this medicine

To remove the capsule from the blister:

• press the capsule only on one side and push it through the foil;
• do not press the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Pharmascience

Lenalidomide Pharmascience is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor decides to stop treatment.

Taking a higher dose of Lenalidomide Pharmascience than recommended

In case of taking a higher dose of Lenalidomide Pharmascience than prescribed, the patient should immediately inform their doctor.

Missing a dose of Lenalidomide Pharmascience

If a dose of Lenalidomide Pharmascience is missed and:

• it has been less than 12 hours since the scheduled time, the patient should take the capsule immediately;
• it has been more than 12 hours since the scheduled time, the patient should not take the capsule. The next capsule should be taken at the scheduled time the next day.

In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Lenalidomide Pharmascience can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, the patient should stop taking Lenalidomide Pharmascience and immediately consult a doctor – immediate treatment may be necessary:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe forms of allergic reactions called angioedema and anaphylactic reaction;
• severe allergic reaction that may start as a rash in one area, spread to the whole body, and be accompanied by a high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes - these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome" (see also section 2 "Important information before taking Lenalidomide Pharmascience");
• widespread rash, high body temperature, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome") (see also section 2).

The patient should immediately inform their doctor about any of the following serious side effects:

• fever, chills, sore throat, cough, mouth ulcers, or any other symptoms of infection (including blood infections (sepsis);
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion, or fatigue, which may be due to high levels of calcium in the blood.

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

Other side effects

Note that in a small number of patients, Lenalidomide Pharmascience may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Lenalidomide Pharmascience. Therefore, the treating doctor should carefully assess the benefits and risks of prescribing Lenalidomide Pharmascience to the patient.
Very commonside effects (may affect more than 1 in 10 people):

• decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness;
• rash, itching;
• muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalized swelling, including swelling of the hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• numbness, tingling, or burning sensation of the skin, pain in the hands or feet, dizziness, tremors;
• decreased appetite, altered taste;
• increased pain, tumor growth, or redness around the tumor;
• weight loss;
• constipation, diarrhea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium, calcium, or sodium in the blood;
• abnormal 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, including sinusitis, pneumonia, and upper respiratory tract infections;
• shortness of breath;
• blurred vision;
• cloudy vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver test results;
• increased liver enzyme activity;
• changes in blood proteins, leading to blood vessel inflammation (vasculitis)
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• decreased blood pressure;
• general feeling of discomfort, malaise;
• painful mouth ulcers, dry mouth;
• dehydration.

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

• breakdown 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 heart rhythm;
• increased levels of a substance produced by the breakdown of red and abnormal blood cells;
• increased levels of a protein that indicates inflammation in the body;
• skin discoloration; skin discoloration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• increased levels of uric acid in the blood;
• hives, skin redness, flushing, itching, sweating, night sweats;
• difficulty swallowing, sore throat, voice changes, or hoarseness;
• runny nose (rhinitis);
• passing much more or much less urine than normal, or inability to control the timing of urination;
• passing blood in the urine;
• shortness of breath, especially when lying down (which may be a symptom of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (labyrinthine disturbances that cause a feeling of spinning), loss of consciousness;
• chest pain radiating to the arms, neck, jaw, back, or abdomen, 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;
• joint swelling;
• slowing or blocking of bile flow from the liver;
• low levels of phosphate or magnesium in the blood;
• difficulty speaking;
• liver damage;
• balance disturbances, difficulty walking;
• hearing loss, ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excessive iron in the body;
• thirst;
• confusion;
• toothache;
• fall, which can lead to injury.

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

• bleeding in the brain;
• circulation problems;
• vision loss;
• loss of sex drive (libido);
• passing large amounts of urine, with accompanying bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, rash, pain, or swelling of the abdomen - these may be symptoms of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis); kidney cell damage (renal tubular necrosis);
• skin color changes, sensitivity to sunlight;
• tumor lysis syndrome - a metabolic complication that can occur during cancer treatment, as well as sometimes without treatment. This complication is caused by the breakdown products of dying cancer cells and can include changes in blood chemistry; high levels of potassium, phosphate, uric acid, and low levels of calcium, leading to kidney function disorders, heart rhythm disturbances, seizures, and sometimes death;
• increased blood pressure in the blood vessels that lead to the lungs (pulmonary hypertension).

Side effects with unknownfrequency (frequency cannot be estimated from the available data):

• sudden or gradual, but worsening, pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever, and a rapid heart rate - these symptoms may occur in connection with pancreatitis;
• wheezing, shortness of breath, or dry cough, which may be caused by lung inflammation;
• rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Pharmascience was taken with a statin (a type of cholesterol-lowering medicine);
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis);
• rupture of the stomach or intestine wall, which can lead to a severe infection. The patient should tell their doctor if they experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function;
• viral infections, including chickenpox and shingles, and recurrence of hepatitis B virus infection (which can cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting);
• rejection of a transplanted organ (e.g., kidney, heart).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Lenalidomide Pharmascience

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice any damage or signs of opening of the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Pharmascience contains

Lenalidomide Pharmascience, 2.5 mg

• The active substance of the medicine is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E133), erythrosine (E127), Allura Red AC (E129) (see section 2), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), and gelatin;
• printing ink: shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

Lenalidomide Pharmascience, 5 mg

• The active substance of the medicine is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E133), orange yellow (E110) (see section 2), iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), and gelatin;
• printing ink: shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

Lenalidomide Pharmascience, 7.5 mg

• The active substance of the medicine is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E133), erythrosine (E127), orange yellow (E110) (see section 2), titanium dioxide (E171), and gelatin;
• printing ink: shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

Lenalidomide Pharmascience, 10 mg

• The active substance of the medicine is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E133), Allura Red AC (E129) (see section 2), tartrazine (E102) (see section 2), orange yellow (E110) (see section 2), titanium dioxide (E171), and gelatin;
• printing ink: shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

Lenalidomide Pharmascience, 15 mg

• The active substance of the medicine is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E133), Allura Red AC (E129) (see section 2), tartrazine (E102) (see section 2), iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), and gelatin;
• printing ink: shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

Lenalidomide Pharmascience, 20 mg

• The active substance of the medicine is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E133), Allura Red AC (E129) (see section 2), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), and gelatin;
• printing ink: shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

Lenalidomide Pharmascience, 25 mg

• The active substance of the medicine is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: titanium dioxide (E171) and gelatin;
• printing ink: shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide.

How the medicinal product Lenalidomide Pharmascience looks like and what the pack contains

Lenalidomide Pharmascience, 2.5 mg: hard capsules have dark blue, opaque cap and light orange, opaque body with a size 4, 14-15 mm, with black ink printing "LP" on the cap and "637" on the body.
Lenalidomide Pharmascience, 5 mg: hard capsules have green, opaque cap and light brown, opaque body with a size 2, 18-19 mm, with black ink printing "LP" on the cap and "638" on the body.
Lenalidomide Pharmascience, 7.5 mg: hard capsules have purple, opaque cap and pink, opaque body with a size 1, 19-20 mm, with black ink printing "LP" on the cap and "643" on the body.
Lenalidomide Pharmascience, 10 mg: hard capsules have yellow, opaque cap and gray, opaque body with a size 0, 21-22 mm, with black ink printing "LP" on the cap and "639" on the body.
Lenalidomide Pharmascience, 15 mg: hard capsules have brown, opaque cap and gray, opaque body with a size 2, 18-19 mm, with black ink printing "LP" on the cap and "640" on the body.
Lenalidomide Pharmascience, 20 mg: hard capsules have dark red, opaque cap and light gray, opaque body with a size 1, 19-20 mm, with black ink printing "LP" on the cap and "641" on the body.
Lenalidomide Pharmascience, 25 mg: hard capsules have white, opaque cap and white, opaque body with a size 0, 21-22 mm, with black ink printing "LP" on the cap and "642" on the body.
A cardboard box containing blisters of PVC/ACLAR/Aluminum foil.
Pack size: 7 or 21 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pharmascience International Limited
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer/Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
Adalvo Ltd.
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the Member States of the European

Economic Area under the following names:

Date of last revision of the leaflet: 03/2023