Polalid

Leaflet accompanying the packaging: patient information

Polalid, 2.5 mg, hard capsules

Polalid, 5 mg, hard capsules Polalid, 7.5 mg, hard capsules

Polalid, 10 mg, hard capsules

Polalid, 15 mg, hard capsules

Polalid, 20 mg, hard capsules

Polalid, 25 mg, hard capsules

Lenalidomide

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

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

Table of contents of the leaflet

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

1. What is Polalid and what is it used for

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

What is Polalid used for

Polalid 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 eliminate the signs and symptoms of the disease. We call this "remission". New diagnosis of multiple myeloma - in patients after bone marrow transplantation In this indication, Polalid is used without other medicines in maintenance treatment after achieving a suitable condition after transplantation. New diagnosis of multiple myeloma - in patients who are not eligible for bone marrow transplantation treatment Polalid 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 Polalid 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 Polalid is taken in combination with an anti-inflammatory medicine called "dexamethasone". Polalid 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. Polalid is used as monotherapy 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 an abnormality in bone marrow cells called "isolated cytogenetic deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously used other treatments that have proven to be ineffective or insufficient.

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

How Polalid works

Polalid works by affecting the functioning of the immune system and directly attacking cancer cells. The medicine works in several 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 Polalid

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

When not to take Polalid:

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

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

Warnings and precautions

Before starting treatment with Polalid, the patient should discuss it with their doctor, pharmacist, or nurse if:

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

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

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness in the arm or leg, change in gait, or balance disturbances, persistent numbness, reduced sensation, or loss of sensation, memory loss, or disorientation, they should immediately tell their doctor or nurse. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before treatment with Polalid, they should inform their doctor about any changes.
• shortness of breath, fatigue, dizziness, chest pain, rapid heart rate, or swelling of the legs or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Tests and examinations

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

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

Before starting treatment with lenalidomide and during treatment, the patient may undergo an assessment for circulation and breathing problems. Patients with MDS taking Polalid If the patient has myelodysplastic syndromes, there is an increased risk of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Polalid affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that will help better predict the risk of acute myeloid leukemia during treatment with Polalid. Patients with FL taking Polalid The doctor will ask for a blood test:

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

The doctor may perform a test to check if the patient has a large amount of tumor tissue in the body, including bone marrow. This may lead to a situation where the tumor tissue starts to die and causes abnormal growth of various substances in the blood, which can lead to kidney failure (a condition called tumor lysis syndrome). The doctor may perform a test to check for skin changes, such as red spots or rash. The doctor may change the dose of Polalid or stop treatment based on the results of the patient's blood tests and their overall condition. If the disease is newly diagnosed, the doctor may also assess 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 stopping treatment, the patient should not donate blood.

Children and adolescents

It is not recommended to use Polalid in children and adolescents under 18 years of age.

Elderly and patients with kidney problems

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

Polalid and other medicines

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

• 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 Polalid

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

For men taking Polalid

• If the partner of a man taking Polalid becomes pregnant, he should immediately inform his doctor. The partner should consult a doctor. Men should also use effective contraception methods (see "Contraception").

Breastfeeding

Polalid should not be taken while breastfeeding, as it is not known whether Polalid passes into human milk.

Contraception

Women taking Polalid

• Before starting treatment, the patient should ask their doctor about the possibility of becoming pregnant, even if they think it is unlikely.
• Women who may become pregnant:
• will have pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), unless they have had their fallopian tubes cut and unblocked (tubal sterilization) AND
• must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. The doctor will recommend the appropriate contraception methods to the patient.

Men taking Polalid

Polalid 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.

Driving and using machines

The patient should not drive or use machines if they experience dizziness, fatigue, drowsiness, balance disturbances caused by dizziness, or blurred vision after taking Polalid.

Polalid contains lactose

Polalid contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Polalid.

3. How to take Polalid

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

• When using Polalid 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 Polalid used for").
• When using Polalid to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS, the medicine is taken as monotherapy.
• When using Polalid to treat follicular lymphoma, it is taken in combination with another medicine called "rituximab".

Polalid should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist. If the patient is taking Polalid with other medicines, they should read the leaflet that comes with their packaging to get information about the use and effects of those medicines.

Treatment cycle

Polalid 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, 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

Polalid 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, 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 Polalid

Before starting treatment, the doctor will inform the patient:

• what dose of Polalid they should take;
• what dose of other medicines they should take in combination with Polalid, if other medicines are necessary;
• on which days of the cycle they should take which medicines.

How and when to take Polalid

• The capsule should be swallowed whole, preferably with water.
• The capsule should not be broken, opened, or chewed. If the powder from a damaged Polalid capsule comes into contact with the skin, it should be washed 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, the hands should be washed thoroughly with soap and water. Pregnant women or those who suspect they may be pregnant should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Polalid should be taken at approximately the same time every day, on the days when the medicine is scheduled to be taken.

Taking Polalid

To remove the capsule from the blister:

• the capsule should be pressed only on one side and pushed through the foil;
• the center of the capsule should not be pressed, as this may damage it.

Duration of treatment with Polalid

Polalid 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 Polalid than recommended

If a higher dose of Polalid than prescribed is taken, the doctor should be informed immediately.

Missing a dose of Polalid

If a dose of Polalid is missed at the scheduled time and

• less than 12 hours have passed since then: the capsule should be taken immediately;
• more than 12 hours have passed since then: the capsule should not be taken. The next capsule should be taken at the scheduled time the next day.

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

4. Possible side effects

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

If any of the following serious side effects occur, the patient should stop taking Polalid and immediately consult their doctor - they may need urgent 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 anaphylaxis;
• a severe allergic reaction that starts as a rash in one area and spreads to the whole body, accompanied by a 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");
• 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.

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

• fever, chills, sore throat, cough, mouth sores, 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 that may be due to high calcium levels in the blood.

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

Other side effects

It should be noted that in a small number of patients, Polalid may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Polalid. Therefore, the treating doctor should carefully weigh the benefits and risks when prescribing Polalid to the patient.

Very common (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 edema, including edema 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 thrombosis), chest pain, or shortness of breath (which may be a sign of pulmonary embolism);
• infections, including sinusitis, pneumonia, and upper respiratory tract infections;
• shortness of breath;
• blurred vision;
• cloudy vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver function tests;
• increased liver enzyme activity;
• changes in blood proteins, leading to blood vessel inflammation (vasculitis)
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of physical discomfort, malaise;
• mouth ulcers, dry mouth;
• dehydration.

Common (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 rate;
• increased levels of a substance produced by the breakdown of red and abnormal red 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;
• rash, skin redness, peeling, cracking, or scaling of the skin, hives;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• nasal congestion (runny nose);
• 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 sign of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), transient 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 phosphorus or magnesium in the blood;
• difficulty speaking;
• liver damage;
• balance disturbances, difficulty walking; hearing loss, ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excessive iron in the body;
• thirst;
• confusion;
• toothache;
• fall that may cause injury.

Uncommon (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, accompanied by bone pain and weakness, which may be a sign 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 or proctitis);
• kidney cell damage (renal tubular necrosis);
• skin color changes, sensitivity to sunlight;
• tumor lysis syndrome - a metabolic complication that can occur during cancer treatment, as well as sometimes without treatment. This complication is caused by the breakdown products of dying cancer cells and can include changes in blood chemistry; high levels of potassium, 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 unknown frequency (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 accompanied by 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 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 Polalid was taken with a statin (a type of cholesterol-lowering medicine);
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis);
• rupture of the stomach or intestine wall, which can lead to a severe infection. The patient should tell their doctor if they experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function;
• viral infections, including chickenpox and shingles, and reactivation of hepatitis B virus (which can cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting);
• rejection of a transplanted organ (e.g., kidney, heart).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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, more information can be collected on the safety of the medicine.

5. How to store Polalid

• The medicine should be stored in a place that is out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month stated. The inscription on the blister and carton after the abbreviation "Lot" indicates the batch number.
• The medicine should not be stored at temperatures above 30°C.
• Do not use this medicine if you notice any damage or signs of opening of the packaging.
• Medicines should not be disposed of via wastewater or household waste. Unused medicines should be returned to the pharmacy. This will help protect the environment.

6. Contents of the pack and other information

What Polalid contains

Polalid, 2.5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule shell: gelatin, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), brilliant blue (E133).

Polalid, 5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule shell: gelatin, titanium dioxide (E171), brilliant blue (E133).

Polalid, 7.5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule shell: gelatin, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172), brilliant blue (E133).

Polalid, 10 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), brilliant blue (E133).

Polalid, 15 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule shell: gelatin, titanium dioxide (E171), brilliant blue (E133).

Polalid, 20 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue (E133), black iron oxide (E172).

Polalid, 25 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule shell: gelatin, titanium dioxide (E172).

What Polalid looks like and contents of the pack

Polalid, 2.5 mg, hard capsules:
A hard gelatin capsule, size 4. The body and cap of the capsule are green.
The capsule contains a white or almost white powder.
Each pack contains 21 hard capsules.
Polalid, 5 mg, hard capsules:
A hard gelatin capsule, size 4. The body and cap of the capsule are blue.
The capsule contains a white or almost white powder.
Each pack contains 21 hard capsules.
Polalid, 7.5 mg, hard capsules:
A hard gelatin capsule, size 2. The body of the capsule is gray, the cap is green.
The capsule contains a white or almost white powder.
Each pack contains 21 hard capsules.
Polalid, 10 mg, hard capsules:
A hard gelatin capsule, size 2. The body of the capsule is white, the cap is green.
The capsule contains a white or almost white powder.
Each pack contains 21 hard capsules.
Polalid, 15 mg, hard capsules:
A hard gelatin capsule, size 0. The body of the capsule is white, the cap is blue.
The capsule contains a white or almost white powder.
Each pack contains 21 hard capsules.
Polalid, 20 mg, hard capsules:
A hard gelatin capsule, size 0. The body of the capsule is blue, the cap is green.
The capsule contains a white or almost white powder.
Each pack contains 21 hard capsules.
Polalid, 25 mg, hard capsules:
A hard gelatin capsule, size 0el. The body and cap of the capsule are white.
The capsule contains a white or almost white powder.
Each pack contains 21 hard capsules.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Importer

Tecnimede – Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

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

Lithuania: Polalid, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg plėvele dengtos tabletės
Latvia: Polalid, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 apvalkotās tabletes

Date of last revision of the leaflet: