Linorion

Leaflet accompanying the packaging: patient information

Linorion, 2.5 mg, hard capsules

Linorion, 5 mg, hard capsules

Linorion, 7.5 mg, hard capsules

Linorion, 10 mg, hard capsules

Linorion, 15 mg, hard capsules

Linorion, 20 mg, hard capsules

Linorion, 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 Linorion and what is it used for
• 2. Important information before taking Linorion
• 3. How to take Linorion
• 4. Possible side effects
• 5. How to store Linorion
• 6. Contents of the packaging and other information

1. What is Linorion and what is it used for

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

Linorion 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, Linorion is used alone in maintenance treatment after achieving a suitable condition after transplantation.

Newly diagnosed multiple myeloma - in patients who are not eligible for bone marrow transplantation treatment

Linorion is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan" and
• a medicine that suppresses the immune system called "prednisone". The patient starts treatment with additional medicines and then continues with Linorion 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.

Multiple myeloma - in patients who have received previous treatment

Linorion is taken in combination with an anti-inflammatory medicine called "dexamethasone".

Linorion 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. 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.

Linorion is used alone in the treatment of adult patients 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 cytogenetic 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 have proven ineffective or insufficient.

Taking Linorion 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 patients with FL, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Linorion is taken in combination with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

HOW LINORION WORKS

Linorion 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 Linorion

Before starting treatment with Linorion, you should carefully read the leaflets of all medicinal products taken in combination with Linorion.

When not to take Linorion:

as it is expected that Linorion will be harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men").

If any of these points apply to you, you should not take Linorion. In case of doubts, you should consult your doctor.

Warnings and precautions

Before starting treatment with Linorion, 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 forming 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 chickenpox and shingles, hepatitis B, HIV. In case of doubts, you should consult your doctor. Treatment with Linorion may cause the reactivation of viruses in patients who have been infected in the past, leading to the 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 Linorion;
• have had a heart attack (myocardial infarction), 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 multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• have had in the past a combination of any of the following symptoms: 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 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 of 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 Linorion, 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 Linorion, you will have regular blood tests, as Linorion may cause a decrease in the number of blood cells that fight infection (white blood cells) and cells that help blood clot (platelets), which may lead to bleeding or infection.

• 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 Linorion

If you have myelodysplastic syndromes, there is an increased chance of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Linorion affects the likelihood of developing acute myeloid leukemia. Therefore, your doctor may perform tests to check for signs that can better predict the risk of acute myeloid leukemia during treatment with Linorion.

Patient with FL taking Linorion

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 an abnormal increase in 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 Linorion 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 conditions that may have occurred in the past.

Blood donation

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

Children and adolescents

Linorion 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.

Linorion and other medicines

You should tell your doctor or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is necessary because Linorion may affect the action of other medicines. Other medicines may also affect the action of Linorion.

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 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 Linorion

• You should not take Linorion if you are pregnant, as it is expected to be harmful to the unborn child.
• You should not become pregnant while taking Linorion. Therefore, women who can become pregnant must use effective contraception (see "Contraception").
• If you become pregnant while taking Linorion, you should stop treatment immediately and inform your doctor. For men taking Linorion
• If your partner becomes pregnant while you are taking Linorion, she should inform your doctor immediately. Your partner should consult a doctor.
• Men should also use effective contraception (see "Contraception").

Breastfeeding

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

Contraception

Women taking Linorion

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 the supervision of a doctor (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), except in cases where the fallopian tubes have been cut and sealed to prevent the egg from entering the uterus (tubal sterilization) AND
• 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 recommend suitable contraceptive methods.

Men taking Linorion

Linorion 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.

Driving and using machines

You should not drive or use machines if you experience dizziness, fatigue, sleepiness, balance disturbances caused by dizziness, or blurred vision after taking Linorion.

Linorion contains lactose

Linorion contains lactose. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking Linorion.

Linorion contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, so it can be considered "sodium-free".

3. How to take Linorion

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

• In the case of using Linorion to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received previous treatment, the medicine is taken with other medicines (see section 1 "What is Linorion and what is it used for").
• In the case of using Linorion to treat multiple myeloma in patients after bone marrow transplantation or in patients with MDS, the medicine is taken alone.
• When Linorion is used to treat follicular lymphoma, it is taken in combination with another medicine called "rituximab".

Linorion should always be taken according to your doctor's instructions. In case of doubts, you should consult your doctor or pharmacist.

If you are taking Linorion with other medicines, you should read the leaflet that comes with their packaging to get information about their use and effects.

Treatment cycle

Linorion 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

Linorion 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 Linorion

Before starting treatment, your doctor will inform you:

• how much Linorion you should take;
• how many other medicines you should take in combination with Linorion, if it is necessary to take other medicines;
• on which days of the cycle you should take which medicines.

How and when to take Linorion

• The capsule should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Linorion capsule comes into contact with your skin, you should wash the skin immediately 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 in accordance with local regulations. Then, wash your hands 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.
• Linorion 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 a 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 Linorion

Linorion 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 Linorion than recommended

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

Missing a dose of Linorion

If you miss a dose of Linorion at the scheduled time and

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

4. Possible side effects

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

If you experience any of the following severe side effects, you should stop taking Linorion and immediately consult your doctor - you may need immediate treatment:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylactic reaction;
• a severe allergic reaction that may start as a rash in one area and spread to the entire body, accompanied by a significant loss of the skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, 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.

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

• fever, chills, sore throat, cough, mouth sores, or any other signs of infection (including bloodstream infections);
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion, or fatigue that may be due to high calcium levels in the blood. Linorion may decrease the number of white blood cells that fight infection and cells that help blood clot, which may lead to bleeding or infection.

Other side effects

Note that in a small number of patients, Linorion may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Linorion. Therefore, the treating doctor should carefully weigh the benefits and risks of prescribing Linorion 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 sign of a blood clot), chest pain, or shortness of breath (which may be symptoms of a blood clot in the lungs, called pulmonary embolism);
• all types of infections, including sinusitis, pneumonia, and upper respiratory tract infections;

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

• red blood cell breakdown (hemolytic anemia);
• certain types of skin tumors;
• bleeding from the gums, stomach, or intestines;
• high 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 darkening; skin discoloration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• increased uric acid levels in the blood;
• hives, skin redness, peeling, cracking, or shedding of the skin, itching;
• itching, increased sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• 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, 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;
• deafness, ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excessive iron in the body;
• thirst;
• confusion;
• toothache;
• fall that may cause 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 of the skin, 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);
• 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;
• high blood pressure in the blood vessels leading to the lungs (pulmonary hypertension). Side effects with unknownfrequency (frequency cannot be estimated from available data):
• sudden or gradual but worsening pain in the upper abdomen and/or back, lasting for several days, usually with accompanying nausea, vomiting, fever, and rapid heart rate - these symptoms may occur in association 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 Linorion 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 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 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, 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 gather more information on the safety of this medicine.

5. How to store Linorion

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.

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 packaging and other information

What Linorion contains

Linorion 2.5 mg hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin and titanium dioxide (E 171), indigo carmine (E 132), and yellow iron oxide (E 172);
• ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E 172).

Linorion 5 mg hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin and titanium dioxide (E 171);
• ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E 172).

Linorion 7.5 mg hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E 171), and yellow iron oxide (E 172);
• ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E 172). Linorion 10 mg hard capsules:
• The active substance of the medicine is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132), and yellow iron oxide (E 172);
• ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E 172).

Linorion 15 mg hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E 171), and indigo carmine (E 132);
• ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E 172). Linorion 20 mg hard capsules:
• The active substance of the medicine is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132), and yellow iron oxide (E 172);
• ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E 172).

Linorion 25 mg hard capsules:

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

What Linorion looks like and contents of the pack

Linorion 2.5 mg: hard capsules with a non-transparent white body and a non-transparent green to light green cap, approximately 14.3 mm in length, marked with the symbols "L9NL" and "2.5".

Linorion 5 mg: hard capsules with a non-transparent white body and a non-transparent white cap, approximately 18.0 mm in length, marked with the symbols "L9NL" and "5".

Linorion 7.5 mg: hard capsules with a non-transparent white body and a non-transparent yellow cap, approximately 18.0 mm in length, marked with the symbols "L9NL" and "7.5".

Linorion 10 mg: hard capsules with a non-transparent yellow body and a non-transparent green to light green cap, approximately 21.7 mm in length, marked with the symbols "L9LN" and "10".

Linorion 15 mg: hard capsules with a non-transparent white body and a non-transparent blue to light blue cap, approximately 21.7 mm in length, marked with the symbols "L9LN" and "15".

Linorion 20 mg: hard capsules with a non-transparent blue to light blue body and a non-transparent green to light green cap, approximately 21.7 mm in length, marked with the symbols "L9LN" and "20".

Linorion 25 mg: hard capsules with a non-transparent white body and a non-transparent white cap, approximately 21.7 mm in length, marked with the symbols "L9NL" and "25".

Package size: 21 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturers

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Synthon Hispania S.L.

Calle De Castello 1

08830 Sant Boi de Llobregat

Spain

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o.o.

contact@orionpharma.info.pl

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia:

Lenalidomide Auxilia

Finland:

Lenalidomide Avansor 2.5 mg, 5 mg, 7.5 mg, 15 mg, 20 mg, 25 mg capsules

France:

LENALIDOMIDE STRAGEN 2.5 mg, 5 mg, 7.5 mg, 15 mg, 20 mg, 25 mg gelules

Greece:

LENALIDOMID/FARAN 5 mg/cap, 10 mg/cap, 15 mg/cap, 20 mg/cap, 25 mg/cap

Croatia:

Lenalidomid Alpha-Medical 10 mg, 25 mg hard capsules

Netherlands:

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

Iceland:

Lenalidomid WH

Lithuania:

Lenalidomide Norameda 5 mg, 10 mg, 15 mg hard capsules

Latvia:

Lenalidomide Norameda 5 mg, 10 mg, 15 mg hard capsules

Malta:

Lenalidomide Synthon 2.5 mg, 5 mg, 7.5 mg, 15 mg, 20 mg, 25 mg, hard capsules

Poland:

Linorion

Slovakia:

Lenalidomid Pharmevid 5 mg, 10 mg, 15 mg, 25 mg

Sweden:

Lenalidomide Avansor 2.5 mg, 5 mg, 7.5 mg, 15 mg, 20 mg, 25 mg hard capsules

Hungary:

Lenalidomid Onkogen 10 mg, 15 mg, 25 mg, capsule, hard

Date of last revision of the leaflet:20.08.2022