Lenalidomide Medical Vallei

Leaflet accompanying the packaging: patient information

Lenalidomide Medical Valley, 2.5 mg, hard capsules

Lenalidomide Medical Valley, 5 mg, hard capsules

Lenalidomide Medical Valley, 7.5 mg, hard capsules

Lenalidomide Medical Valley, 10 mg, hard capsules

Lenalidomide Medical Valley, 15 mg, hard capsules

Lenalidomide Medical Valley, 20 mg, hard capsules

Lenalidomide Medical Valley, 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 your 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 as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lenalidomide Medical Valley and what is it used for

What is Lenalidomide Medical Valley

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

What is Lenalidomide Medical Valley used for

Lenalidomide Medical Valley is used in adults to treat:

• Multple myeloma
• MDS (myelodysplastic syndromes)
• Mantle cell lymphoma
• Follicular lymphoma

Multple myeloma

Multple myeloma is a type of cancer that affects 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, multple myeloma is incurable. However, it is possible to temporarily significantly alleviate or eliminate the signs and symptoms of the disease. We call this "remission".
Newly diagnosed multple myeloma — in patients who have undergone a bone marrow transplant
In this indication, Lenalidomide Medical Valley is used without other medicines as maintenance treatment after achieving a suitable state after transplantation.
Newly diagnosed multple myeloma – in patients who are not eligible for bone marrow transplant treatment
Lenalidomide Medical Valley 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 called "prednisone" The patient starts treatment with additional medicines and then continues with Lenalidomide Medical Valley alone.

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

MDS (myelodysplastic syndromes)

MDS are a group of different blood and bone marrow diseases. Abnormal blood cells are present 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 Medical Valley is used alone to treat 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 a genetic abnormality in bone marrow cells called "isolated deletion 5q". This means that the patient's body does not produce enough healthy blood cells
• the patient has previously received other treatments that were not suitable or not effective enough.

Taking Lenalidomide Medical Valley 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 needed. It is possible that transfusions will no longer be needed.

Mantle cell lymphoma

Mantle cell lymphoma is a cancer of part of the immune system (lymphoid tissue). It affects a certain type of white blood cell called B lymphocytes or B cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B lymphocytes, resulting in their accumulation in lymphoid tissue, bone marrow, or blood.
Lenalidomide Medical Valley is used alone to treat adult patients who have previously received other medicines.

Follicular lymphoma

Follicular lymphoma is a slow-growing malignant cancer that affects B lymphocytes. It is a type of white blood cell that helps the body fight infections. In patients with follicular lymphoma, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Medical Valley is taken with another medicine called "rituximab" to treat adult patients with previously treated follicular lymphoma.

How Lenalidomide Medical Valley works

Lenalidomide Medical Valley 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 Medical Valley

Before starting treatment with Lenalidomide Medical Valley, you should carefully read the leaflets of all medicines taken in combination with Lenalidomide Medical Valley.

When not to take Lenalidomide Medical Valley:

because Lenalidomide Medical Valley may be harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men");

Warnings and precautions

Before starting treatment with Lenalidomide Medical Valley, you should discuss it with your doctor, pharmacist, or nurse if you:

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

If any of the above apply to you, you should consult your doctor, pharmacist, or nurse before starting treatment.
You should immediately inform your doctor or nurse if you experience any of the following at any time during or after treatment:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness in the arm or leg, change in walking or balance disturbances, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation, 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 you have had such symptoms before treatment with Lenalidomide Medical Valley, you should inform your 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 Medical Valley, you will have regular blood tests, as Lenalidomide Medical Valley may cause a decrease in the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets).
Your doctor will call you 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, you may undergo an assessment for circulation and breathing problems.
Patient with MDS taking Lenalidomide Medical Valley
If you have MDS, there is an increased risk of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Medical Valley affects the likelihood of developing acute myeloid leukemia. Therefore, your doctor may perform tests to check for signs that may predict the risk of acute myeloid leukemia during treatment with Lenalidomide Medical Valley.
Patient with MCL taking Lenalidomide Medical Valley
Your doctor will ask you to have 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 (more information is provided in section 3 "Treatment cycle")
• then at the beginning of each cycle and
• at least once a month.

Patient with FL taking Lenalidomide Medical Valley
Your doctor will ask you to have 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

Your doctor may perform a test to check if you have a large amount of tumor tissue in your body, including bone marrow. This may lead to a situation where the tumor tissue starts to die and causes abnormal growth of various substances in the blood, which can lead to kidney failure (a condition called tumor lysis syndrome).
Your doctor may perform a test to check if you have any skin changes, such as red spots or rash.
Your doctor may change the dose of Lenalidomide Medical Valley or stop treatment based on the results of your blood tests and your overall condition. If the disease is newly diagnosed, your doctor may also assess treatment based on your age and other diseases you have had in the past.

Blood donation

During treatment and for at least 7 days after stopping treatment, you should not donate blood.

Children and adolescents

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

Elderly patients with kidney problems

If you are 75 years old or older, or have moderate to severe kidney problems, your doctor will perform thorough tests before starting treatment.

Lenalidomide Medical Valley and other medicines

You should tell your doctor or nurse about all medicines you are taking, or have recently taken, and about any medicines you plan to take. This is necessary because Lenalidomide Medical Valley may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Medical Valley.
In particular, you should inform your doctor or nurse if you are taking:

• certain contraceptive medicines, such as oral contraceptives, as they may stop working;
• certain medicines for heart disease, such as digoxin;
• certain medicines for blood thinning, such as warfarin.

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

Pregnancy

For women taking Lenalidomide Medical Valley

• You should not take Lenalidomide Medical Valley if you are pregnant, as it may be harmful to the unborn child.
• You should not become pregnant while taking Lenalidomide Medical Valley. Therefore, women who can become pregnant must use effective contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the appropriate contraceptive methods.
• If you become pregnant while taking Lenalidomide Medical Valley, you should stop treatment immediately and inform your doctor.

For men taking Lenalidomide Medical Valley

• If your partner becomes pregnant while you are taking Lenalidomide Medical Valley, she should immediately inform her doctor. Your partner should consult her doctor.
• Men should also use effective contraception (see "Contraception").

Breastfeeding

You should not breastfeed while taking Lenalidomide Medical Valley, as it is not known whether Lenalidomide Medical Valley passes into human milk.

Contraception

Women taking Lenalidomide Medical Valley
Before starting treatment, you should ask your doctor about the possibility of becoming pregnant, even if you think it is unlikely.
Women who can become pregnant

• will have pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless you have had your fallopian tubes cut and tied (tubal sterilization). AND
• must use effective contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the appropriate contraceptive methods. Men taking Lenalidomide Medical Valley Lenalidomide Medical Valley passes into 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. You should not donate sperm or semen during treatment and for at least 7 days after stopping treatment.

Driving and using machines

You should not drive or operate machinery if you experience dizziness, fatigue, drowsiness, balance disturbances caused by dizziness, or blurred vision after taking Lenalidomide Medical Valley.

Lenalidomide Medical Valley contains lactose

Lenalidomide Medical Valley contains lactose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is "sodium-free".

3. How to take Lenalidomide Medical Valley

Lenalidomide Medical Valley must be administered by a healthcare professional who has experience in treating multple myeloma, MDS, MCL, or FL.

• When Lenalidomide Medical Valley is used to treat multple myeloma in patients who are not eligible for bone marrow transplant treatment or who have received previous treatment, the medicine is taken with other medicines (see section 1 "What is Lenalidomide Medical Valley used for").
• When Lenalidomide Medical Valley is used to treat multple myeloma in patients who have undergone a bone marrow transplant or to treat patients with MDS or MCL, the medicine is taken alone.
• When Lenalidomide Medical Valley is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Lenalidomide Medical Valley should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
If you are taking Lenalidomide Medical Valley with other medicines, you should read the leaflet that comes with their packaging to get information about their use and effects.

Treatment cycle

Lenalidomide Medical Valley is taken on specific days during a period of three 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 medicines.
• After completing each 21-day cycle, you should start a new 21-day cycle.

OR
Lenalidomide Medical Valley is taken on specific days during a period of four 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 medicines.
• After completing each 28-day cycle, you should start a new 28-day cycle.

Recommended dose of Lenalidomide Medical Valley

Before starting treatment, your doctor will inform you:

• what dose of Lenalidomide Medical Valley you should take;
• what dose of other medicines you should take in combination with Lenalidomide Medical Valley, if other medicines are necessary;
• on which days of the cycle you should take which medicines.

How and when to take Lenalidomide Medical Valley

• the capsule should be swallowed whole, preferably with water;
• do not break, open, or chew the capsules. If you come into contact with the powder from a damaged Lenalidomide Medical Valley capsule, you should immediately wash your skin with soap and water;
• healthcare professionals, caregivers, and family members should wear disposable 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 according to local regulations. Then, wash your hands 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 Medical Valley should be taken at approximately the same time every day, on the days when the product is scheduled to be taken.

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 cause damage.

Duration of treatment with Lenalidomide Medical Valley

Lenalidomide Medical Valley is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor stops the treatment.

Taking a higher dose of Lenalidomide Medical Valley than recommended

If you take a higher dose of Lenalidomide Medical Valley than prescribed, you should immediately inform your doctor.

Missing a dose of Lenalidomide Medical Valley

If you miss a dose of Lenalidomide Medical Valley at the scheduled time and

• it has been less than 12 hours since then: you should take the capsule immediately;
• it has been more than 12 hours since then: do not take the capsule. You should take the next capsule at the scheduled time the next day. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following severe side effects, you should stop taking Lenalidomide Medical Valley and immediately consult your doctor - you may need urgent medical attention:

Severe allergic reactions:

• Hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis.
• A severe allergic reaction that starts as a rash in one area and spreads to the whole body, accompanied by a high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), and enlarged lymph nodes - these are symptoms of a severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or "drug hypersensitivity syndrome" (see also section 2).

You should immediately inform your doctor about any of the following severe side effects:

• Fever, chills, sore throat, cough, mouth sores, or any other symptoms of infection, including blood infections (sepsis)
• Bleeding or bruising without injury
• Chest pain or leg pain
• Shortness of breath
• Pain in the bones, muscle weakness, feeling of confusion, or fatigue that may be due to high levels of calcium in the blood. Lenalidomide Medical Valley may decrease the number of white blood cells that fight infection and the number of blood cells that help blood clot (platelets), which can lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide Medical Valley may also cause the formation of blood clots in the veins (thrombosis).

Other side effects

Note that in a small number of patients, Lenalidomide Medical Valley may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Lenalidomide Medical Valley. Therefore, your doctor should carefully assess the benefits and risks of prescribing Lenalidomide Medical Valley to you.
Very commonside effects (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
• 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 sense of 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
• Pain in the legs (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be a sign of blood clots in the lungs, called pulmonary embolism)
• All types of infections, including sinusitis, pneumonia, and upper respiratory tract infections
• Shortness of breath
• Blurred vision
• Blurred 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)
• High blood sugar levels (diabetes)
• Low blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, sleep disturbances
• Cough
• Low blood pressure
• General feeling of discomfort, malaise
• Painful inflammation of the mouth, 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
• High blood pressure, slow, fast, or irregular heart rate
• Increased levels of a substance produced by the breakdown of red blood cells
• Increased levels of a protein that indicates inflammation in the body
• Darkening of the skin; discoloration of the skin due to bleeding under the skin, usually caused by bruising; swelling of the skin filled with blood, bruising
• High levels of uric acid in the blood
• Rash, skin redness, peeling, cracking, or flaking of the skin, hives
• Itching, increased sweating, night sweats
• Difficulty swallowing, sore throat, voice problems, or voice changes
• Rhinitis (runny nose)
• Passing much more or much less urine than normal, or inability to control the timing of urination
• Blood in the urine
• Shortness of breath, especially when lying down (which may be a sign of heart failure)
• Difficulty getting an erection
• Stroke, fainting, dizziness (inner ear disorders 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 down or blocking the flow of bile from the liver
• Low levels of phosphates or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance disturbances, difficulty walking
• Deafness, ringing in the ears (tinnitus)
• Nerve pain, unpleasant abnormal sensations, especially in response to touch
• Excessive iron in the body
• Thirst
• Feeling of confusion
• Toothache
• Falling, 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 (tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome - a complication of metabolism that can occur during cancer treatment, as well as sometimes without treatment. These complications are caused by the breakdown products of dying cancer cells and can include changes in blood chemistry; high levels of potassium, phosphorus, uric acid, and low levels of calcium, leading to kidney function disorders, heart rhythm disturbances, seizures, and sometimes death
• High blood pressure in the blood vessels that lead to the lungs (pulmonary hypertension)

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

• Sudden or mild but worsening pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever, and rapid heart rate - these symptoms may occur in connection with pancreatitis;
• Wheezing, shortness of breath, or dry cough, which may be caused by lung tissue 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 Medical Valley 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);
• Breakdown of the stomach or intestine wall, which can lead to a very severe infection. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function;
• Viral infections, including varicella-zoster virus (a viral disease that causes a painful rash with blisters) and hepatitis B virus reactivation (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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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 181 C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Medical Valley

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 "EXP" or "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice any damage or signs of opening.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 the medicine Lenalidomide Medical Valley contains

Lenalidomide Medical Valley, 2.5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E 133), erythrosine (E 127), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
• ink for printing: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E 133), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
• ink for printing: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 7.5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: brilliant blue FCF (E 133), erythrosine (E 127), iron oxide red (E 172), titanium dioxide (E 171), and gelatin;
• ink for printing: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide. Lenalidomide Medical Valley, 10 mg, hard capsules:
• The active substance of the medicine is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: iron oxide black (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
• ink for printing: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide. Lenalidomide Medical Valley, 15 mg, hard capsules:
• The active substance of the medicine is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), and gelatin;
• ink for printing: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide. Lenalidomide Medical Valley, 20 mg, hard capsules:
• The active substance of the medicine is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide (E 171), and gelatin;
• ink for printing: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

Lenalidomide Medical Valley, 25 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
• capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: titanium dioxide (E 171) and gelatin;
• ink for printing: shellac, propylene glycol, iron oxide black (E 172), and potassium hydroxide.

What Lenalidomide Medical Valley looks like and what the pack contains

Lenalidomide Medical Valley 2.5 mg: hard capsules with a dark blue, opaque cap and a light orange, opaque body, with a capsule shell size of 4, 14-15 mm in length, marked with black ink symbols "LP" on the cap and "637" on the body.
Lenalidomide Medical Valley 5 mg: hard capsules with a green, opaque cap and a light brown, opaque body, with a capsule shell size of 2, 18-19 mm in length, marked with black ink symbols "LP" on the cap and "638" on the body.
Lenalidomide Medical Valley 7.5 mg: hard capsules with a purple, opaque cap and a pink, opaque body, with a capsule shell size of 1, 19-20 mm in length, marked with black ink symbols "LP" on the cap and "643" on the body.
Lenalidomide Medical Valley 10 mg: hard capsules with a yellow, opaque cap and a gray, opaque body, with a capsule shell size of 0, 21-22 mm in length, marked with black ink symbols "LP" on the cap and "639" on the body.
Lenalidomide Medical Valley 15 mg: hard capsules with a brown, opaque cap and a gray, opaque body, with a capsule shell size of 2, 18-19 mm in length, marked with black ink symbols "LP" on the cap and "640" on the body.
Lenalidomide Medical Valley 20 mg: hard capsules with a dark red, opaque cap and a light gray, opaque body, with a capsule shell size of 1, 19-20 mm in length, marked with black ink symbols "LP" on the cap and "641" on the body.
Lenalidomide Medical Valley 25 mg: hard capsules with a white, opaque cap and a white, opaque body, with a capsule shell size of 0, 21-22 mm in length, marked with black ink symbols "LP" on the cap and "642" on the body.
A cardboard box containing blisters of polyvinyl chloride (PVC)/Aclar/Aluminum foil, each blister containing 7 capsules.
Pack sizes: 21 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer/Importer

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

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

Economic Area under the following names:

Denmark:
Lenalidomide Medical Valley
Iceland:
Lenalidomide Medical Valley 2.5 mg hard capsules
Lenalidomide Medical Valley 5 mg hard capsules
Lenalidomide Medical Valley 7.5 mg hard capsules
Lenalidomide Medical Valley 10 mg hard capsules
Lenalidomide Medical Valley 15 mg hard capsules
Lenalidomide Medical Valley 20 mg hard capsules
Lenalidomide Medical Valley 25 mg hard capsules
Germany: Lenalidomide Axiromed
Norway: Lenalidomide Medical Valley
Poland:
Lenalidomide Medical Valley
Sweden:
Lenalidomide Medical Valley 2.5 mg hard capsules
Lenalidomide Medical Valley 5 mg hard capsules
Lenalidomide Medical Valley 7.5 mg hard capsules
Lenalidomide Medical Valley 10 mg hard capsules
Lenalidomide Medical Valley 15 mg hard capsules
Lenalidomide Medical Valley 20 mg hard capsules
Lenalidomide Medical Valley 25 mg hard capsules
Date of last revision of the leaflet:31.01.2024