Linorion

Package leaflet: Information for the user

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
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Linorion is and what it is 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 pack and other information

1. What Linorion is and what it is used for

Linorion contains the active substance lenalidomide. This medicine belongs to a group of medicines that affect the function of the immune system.
Linorion is used in adult patients for the treatment of:

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

MULTIPLE MYELOMA
Multiple myeloma is a type of cancer that affects a certain type of white blood cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage of bones and kidneys.
Multiple myeloma is generally incurable. However, it is possible to achieve a significant temporary reduction or disappearance of signs and symptoms of the disease. This is called "remission".

Newly diagnosed multiple myeloma – in patients who have undergone bone marrow transplantation
In this indication, Linorion is used alone as maintenance therapy after achieving an adequate response following transplantation.

Newly diagnosed multiple myeloma – in patients who cannot be treated with bone marrow transplantation
Linorion is taken in combination with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan"; and
• an immunosuppressive medicine called "prednisone".
  Treatment is initiated with additional medicines, and then continued with Linorion alone.

If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will perform careful assessments before starting treatment.

Multiple myeloma – in previously treated patients
Linorion is taken in combination with an anti-inflammatory medicine called "dexamethasone".
Linorion may stop the progression of signs and symptoms of multiple myeloma. 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 disorders. Abnormal blood cells are present and do not function properly. Patients may experience various subjective and objective symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infection.

Linorion, used as monotherapy, is indicated for the treatment of adult patients with MDS when all of the following conditions are met:

• the patient requires regular blood transfusions due to low red blood cell count ("transfusion-dependent anaemia");
• the patient has an abnormality in bone marrow cells known as "isolated cytogenetic abnormality with deletion 5q". This means the patient's body does not produce enough healthy blood cells;
• the patient has previously received other treatments that were inappropriate or insufficiently effective.

Taking Linorion may increase 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 required blood transfusions. Blood transfusions may no longer be needed.

FOLLICULAR LYMPHOMA (FL)
FL is a slowly growing malignant tumour affecting B-lymphocytes. These are a type of white blood cell that helps the body fight infections. In patients with FL, excessive numbers of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

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

HOW LINORION WORKS
Linorion works by affecting the function of the immune system and directly attacking tumour cells. The medicine acts in several different ways:

• by inhibiting the growth of tumour cells;
• by inhibiting the development of blood vessels in tumours;
• by stimulating parts of the immune system to attack tumour cells.

2. Important information before using Linorion

Before starting treatment with Linorion, carefully read the package leaflets of all medicinal products used in combination with Linorion.
When not to use Linorion:

• if the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because Linorion is expected to be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men").
• if the patient could become pregnant, unless she uses all required contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document that necessary precautions have been taken and will confirm this with the patient.
• if the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic, they should consult a doctor.

If any of these points apply, do not use Linorion. In case of
doubt, consult a doctor.
Warnings and precautions
Before starting treatment with Linorion, discuss this with your doctor, pharmacist or nurse if the patient:

• has previously experienced blood clots – this means an increased risk of developing blood clots in veins and arteries during treatment;
• has any signs of infection, such as cough or fever;
• currently has or has previously had a viral infection, particularly varicella-zoster virus (chickenpox and shingles), hepatitis B virus, or HIV. In case of doubt, consult a doctor. Treatment with Linorion may cause reactivation of viruses in patients previously infected, leading to recurrence of infection. The doctor will check whether the patient has previously had hepatitis B;
• has kidney problems – the doctor may adjust the dose of Linorion;
• has had a heart attack (myocardial infarction), has ever had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• experienced allergic reactions when taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties;
• previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), or swollen lymph nodes – these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms (DRESS), also known as "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above apply, consult a doctor, pharmacist,
or nurse before starting treatment.
Immediately inform the doctor or nurse if, at any time during
or after treatment, the patient experiences:

• vision disturbances, loss of vision, double vision, difficulty speaking, weakness in the arm or leg, change in walking pattern or balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation – immediately inform the doctor or nurse. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before treatment with Linorion, inform the doctor of any changes.

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

Tests and examinations
Before and during treatment with Linorion, the patient will undergo regular blood tests because Linorion may reduce the number of blood cells that help fight infection (white blood cells) and help blood to clot (platelets). The doctor will schedule blood tests:

• before treatment,
• weekly for the first 8 weeks of treatment,
• then at least once a month. Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.

Patients with MDS taking Linorion
If the patient has myelodysplastic syndromes (MDS), there is an increased chance of developing a serious disease called acute myeloid leukemia. Additionally, it is not known how Linorion affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that help better predict the risk of acute myeloid leukemia during treatment with Linorion.
Patients with FL taking Linorion
The doctor will request blood tests:

• before treatment,
• weekly for the first 3 weeks (1 cycle) of treatment,
• then every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment cycle"),
• then at the beginning of each cycle, and
• at least once a month.

The doctor may perform an assessment to determine whether the patient has a large amount of tumor tissue in the body, including in the bone marrow. This may lead to a situation where tumor tissue begins to die, causing an abnormal increase in the concentration of various substances in the blood, potentially leading to kidney failure (a condition known as tumor lysis syndrome).
The doctor may examine the patient to check for skin changes, such as red spots or rash.
The doctor may adjust the dose of Linorion or discontinue treatment based on blood test results and the patient's overall condition. If the disease was recently diagnosed, the doctor may also evaluate treatment based on the patient's age and other conditions that may have occurred in the past.
Blood donation
During treatment and for at least 7 days after treatment ends, the patient must 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 the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform thorough examinations before starting treatment.
Linorion and other medicines
Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Linorion may affect the action of other medicines. Likewise, other medicines may affect the action of Linorion.
In particular, inform the doctor or nurse if the patient is taking the following medicines:

• certain contraceptives, 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
• Do not use Linorion if the patient is pregnant, because it is expected to be harmful to the unborn child.
• Women must not become pregnant while taking Linorion. Therefore, women who could become pregnant must use an effective method of contraception (see "Contraception").
• If the patient becomes pregnant while being treated with Linorion, she must immediately stop treatment and inform the doctor. For men taking Linorion
• If the male patient's partner becomes pregnant while he is being treated with Linorion, she must immediately inform the doctor. The partner should seek medical advice.
• Men must also use an effective method of contraception (see "Contraception").

Breastfeeding
Do not breastfeed while taking Linorion, because it is not known whether Linorion passes into human milk.
Contraception
Women taking Linorion
Before starting treatment, ask the doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who could become pregnant

• will have pregnancy tests performed under the doctor's supervision (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and sealed to prevent the egg from reaching the uterus (tubal sterilization) OR
• must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends.

The doctor will advise the patient on appropriate contraceptive methods.
Men taking Linorion
Linorion passes into human semen. If a woman is pregnant or could become pregnant and is not using an effective method of contraception, her partner should use a condom during treatment and for at least 7 days after treatment ends. This applies even to men who have had a vasectomy.
Driving and operating machinery
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances due to vertigo, or blurred vision after taking Linorion.
Linorion contains lactose
Linorion contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking Linorion.
Linorion contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule and can therefore be considered essentially "sodium-free".
3. How to take Linorion
Linorion must be administered by healthcare professionals experienced in the treatment of multiple myeloma, MDS, or FL.

• When Linorion is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatments, the medicine is used in combination with other drugs (see section 1 "Why is Linorion used?").
• When Linorion is used to treat multiple myeloma in patients after bone marrow transplantation or in patients with MDS, the medicine should be used as monotherapy.
• When Linorion is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab".

Linorion should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
If the patient is taking Linorion together with other medicines, they should read the package leaflet included with those medicines to obtain information on their use and effects.
Treatment cycle
Linorion is taken on specific days over a period of three weeks (21 days).

• Every 21 days is called a treatment cycle.
• Depending on the day of the cycle, the patient will take 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 21-day cycle.

OR
Linorion is taken on specific days over a period of four weeks (28 days).

• Every 28 days is called a treatment cycle.
• Depending on the day of the cycle, the patient will take 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 28-day cycle.

Recommended dose of Linorion
Before starting treatment, the doctor will inform the patient:

• how much Linorion to take;
• how much of any other medicines to take in combination with Linorion, if necessary;
• which medicines to take on which days of the cycle. How and when to take Linorion
• Swallow the capsule whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Linorion capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Capsules may be taken with or without food.
• Linorion should be taken approximately at the same time each day on which administration is scheduled.

Taking this medicine
To remove the capsule from the blister:

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

Duration of Linorion treatment
Linorion is administered in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should continue until the doctor decides to discontinue treatment.
Taking more Linorion than prescribed
If more Linorion than prescribed has been taken, inform the doctor immediately.
Missing a dose of Linorion
If a dose of Linorion has been missed at the scheduled time and

• less than 12 hours have passed: take the capsule immediately;
• more than 12 hours have passed: do not take the capsule. Take the next capsule at the scheduled time the following day. For any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking Linorion and seek immediate
medical advice – immediate treatment may be necessary:

• urticaria, rash, swelling of the eyes, lips or face, breathing difficulties or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction;
• severe allergic reaction which may start as a rash in one area and spread over the entire body, progressing with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome"). See also section 2. Immediately inform your doctor if any of the following serious adverse reactions occur:
• fever, chills, sore throat, cough, mouth ulcers or any other signs 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 result from high calcium levels in the blood. Linorion may reduce the number of white blood cells that fight infection, as well as blood cells that help blood clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Linorion may also cause blood clots in veins (venous thrombosis).

Other adverse reactions
Please note that in a small number of patients, other types of cancer may develop, and this risk may potentially be increased by treatment with Linorion. Therefore, the treating physician should carefully evaluate the benefits and risks before prescribing Linorion.
Very common adverse reactions (may occur in more than 1 in 10 people):

• reduction in red blood cells, which may lead to anaemia causing fatigue and weakness;

• rashes, itching;

• muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;

• generalised swelling, including swelling of hands and feet;

• weakness, fatigue;

• flu and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills;

• numbness, tingling or burning sensation of the skin, pain in hands or feet, dizziness, tremor, decreased appetite, altered taste sensation;

• increased pain, swelling or redness around a tumour;

• weight loss;

• constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn;

• low levels of potassium, calcium and/or sodium in the blood;

• abnormally low thyroid function;

• leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, known as pulmonary embolism);

• all types of infections, including sinus infection, lung infection 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 values in liver function tests;

• changes in blood proteins leading to vessel swelling (vasculitis);

• increased blood sugar levels (diabetes);

• decreased blood sugar levels;

• headache;

• nosebleeds;

• dry skin;

• depression, mood changes, sleep disturbances;

• cough;

• low blood pressure;

• vague feeling of physical discomfort, malaise;

• painful inflammation of the mouth, dry mouth;

• dehydration.

Common adverse reactions (may occur in up to 1 in 10 people):

• breakdown of red blood cells (haemolytic anaemia);
• certain types of skin tumours;
• bleeding from gums, stomach or intestines;
• increased blood pressure, slow, fast or irregular heartbeat;
• increased levels of a substance produced during normal and abnormal breakdown of red blood cells;
• increased levels of a protein indicating inflammation in the body;
• darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruises;
• increased levels of uric acid in the blood;
• skin eruptions, skin redness, cracking, peeling or flaking of the skin, urticaria;
• itching, excessive sweating, night sweats;
• difficulty swallowing, sore throat, problems with voice quality or voice changes;
• rhinitis (nasal inflammation);
• passing significantly more or significantly 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);
• erectile dysfunction;
• stroke, fainting, transient loss of consciousness;
• chest pain spreading to arms, neck, jaw, back or abdomen, sweating, breathlessness, 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 blockage of bile flow from the liver;
• low levels of phosphates or magnesium in the blood;
• speech difficulties;
• liver damage;
• loss of balance, difficulty moving;
• deafness, tinnitus (ringing in the ears);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excess iron in the body;
• thirst;
• confusion;
• toothache;
• falls that may lead to injury.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• bleeding inside the skull;
• circulatory problems;
• loss of vision;
• loss of sex drive (libido);
• passing large amounts of urine, accompanied by 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, itchy skin, rash, abdominal pain or swelling – may be symptoms of liver damage (liver failure);
• abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis);
• kidney cell damage (known as tubular necrosis);
• change in skin colour, sensitivity to sunlight;
• tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and may include: changes in blood chemistry; high levels of potassium, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death;
• high blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• sudden or mild but progressively worsening pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever and rapid heartbeat – these symptoms may indicate pancreatitis;
• wheezing, shortness of breath or dry cough, possibly due to lung tissue inflammation;
• rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some of which occurred when Linorion was taken concomitantly with a statin (a type of medicine that lowers blood cholesterol);
• skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis);
• perforation of the stomach or intestinal wall, which may lead to severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool or changes in bowel function;
• viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark brown urine, pain in the right lower abdomen, fever, nausea and vomiting);
• rejection of solid organ transplant (e.g. kidney, heart).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Linorion

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after:
"EXP" or "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not use this medicine if you notice any damage or signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Pack and Other Information

What Linorion Contains

Linorion 2.5 mg hard capsules:

• The active substance 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, titanium dioxide (E 171), indigo carmine (E 132) and yellow iron oxide (E 172);
  • printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Linorion 5 mg hard capsules:

• The active substance 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);
  • printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Linorion 7.5 mg hard capsules:

• The active substance 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);
  • printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Linorion 10 mg hard capsules:

• The active substance 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);
  • printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Linorion 15 mg hard capsules:

• The active substance 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);
  • printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Linorion 20 mg hard capsules:

• The active substance 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);
  • printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E 172).

Linorion 25 mg hard capsules:

• The active substance 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 and titanium dioxide (E 171);
  • printing 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 an opaque white body and an opaque green to light green cap, approximately 14.3 mm in length, marked with "L9NL" and "2.5".
Linorion 5 mg: hard capsules with an opaque white body and an opaque white cap, approximately 18.0 mm in length, marked with "L9NL" and "5".
Linorion 7.5 mg: hard capsules with an opaque white body and an opaque yellow cap, approximately 18.0 mm in length, marked with "L9NL" and "7.5".
Linorion 10 mg: hard capsules with an opaque yellow body and an opaque green to light green cap, approximately 21.7 mm in length, marked with "L9LN" and "10".
Linorion 15 mg: hard capsules with an opaque white body and an opaque blue to light blue cap, approximately 21.7 mm in length, marked with "L9LN" and "15".
Linorion 20 mg: hard capsules with an opaque blue to light blue body and an opaque green to light green cap, approximately 21.7 mm in length, marked with "L9LN" and "20".
Linorion 25 mg: hard capsules with an opaque white body and an opaque white cap, approximately 21.7 mm in length, marked with "L9NL" and "25".
Pack size: 21 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
8830 Sant Boi de Llobregat
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia: Lenalidomide Auxilia
Finland: Lenalidomide Avansor 2.5 mg, 5 mg, 7.5 mg, 15 mg, 20 mg, 25 mg kapseli kova
France: LENALIDOMIDE STRAGEN 2.5 mg, 5 mg, 7.5 mg, 15 mg, 20 mg, 25 mg gélule
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 tvrde kapsule
The Netherlands: Lenalidomide Synthon 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg, harde capsules
Iceland: Lenalidomid WH
Lithuania: Lenalidomide Norameda 5 mg, 10 mg, 15 mg kietosios kapsulės
Latvia: Lenalidomide Norameda 5 mg, 10 mg, 15 mg cietās kapsulas
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 hårda kapslar
Hungary: Lenalidomid Onkogen 10 mg, 15 mg, 25 mg, capsule, hard