Polalid

Package leaflet: Information for the patient

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

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

Leaflet contents

1. What Polalid is and what it is 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 Polalid is and what it is used for

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

What Polalid is used for
Polalid 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 kind 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 temporary significant reduction or disappearance of signs and symptoms of the disease. This is called "remission".

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

Newly diagnosed multiple myeloma – in patients who cannot be treated with stem cell transplantation
Polalid is taken in combination with other medicines, including:

• a chemotherapy drug called "bortezomib";
• an anti-inflammatory drug called "dexamethasone";
• a chemotherapy drug called "melphalan"; and
• an immunosuppressive drug called "prednisone".

Treatment is initiated with additional medicines and then continued with Polalid alone.
If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will perform careful evaluations before starting treatment.

Multiple myeloma – in previously treated patients
Polalid is taken in combination with an anti-inflammatory drug called "dexamethasone".
Polalid may halt the progression of signs and symptoms of multiple myeloma. It has also been shown to delay relapse 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, which do not function properly. Patients may experience various subjective and objective symptoms, including low number of red blood cells (anemia), need for blood transfusions, and risk of infection.

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

• the patient requires regular blood transfusions due to low red blood cell count ("transfusion-dependent anemia");
• 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 Polalid may lead to increased production of healthy blood cells by the body, by reducing the number of abnormal cells.

• This may result in reduced need for blood transfusions. It may even become possible to discontinue transfusions altogether.

Follicular lymphoma (FL)
FL is a slowly growing malignant tumour affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, excessive numbers of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Polalid is taken together with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Polalid works
Polalid 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 part of the immune system to attack tumour cells.

2. Important information before taking Polalid

Before starting treatment with Polalid, carefully read the package 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, because Polalid is expected to 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 all required contraceptive measures are used (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient may become pregnant, the doctor will always document that necessary precautions have been taken and 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 an allergy is suspected, consult the doctor for advice.

If any of these points apply, Polalid must not be used. In case of doubt, consult the doctor.
Warnings and precautions
Before starting to take Polalid, discuss this with the doctor, pharmacist or nurse if the patient:

• Has previously experienced blood clots – this indicates 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, hepatitis B, or HIV. In case of doubt, consult the doctor. Treatment with Polalid may reactivate 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 Polalid;
• Has had a heart attack (myocardial infarction), has previously had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• Experienced allergic reactions while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness or breathing difficulties;
• Previously had a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased 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 (DRESS), also known as "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above apply, consult the 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, inform the doctor or nurse immediately. 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 Polalid, 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 Polalid, regular blood tests will be performed because Polalid may reduce the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets). The doctor will call the patient for 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 Polalid
If the patient has myelodysplastic syndromes, there is an increased risk of developing a serious disease called acute myeloid leukemia. Furthermore, 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 help better predict the risk of acute myeloid leukemia during treatment with Polalid.
Patients with FL taking Polalid
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 tumour tissue in the body, including in the bone marrow. This may lead to tumour tissue beginning to die, causing abnormal increases in various substances in the blood, which may lead to kidney failure (a condition known as tumour lysis syndrome).
The doctor may examine the patient to check for skin changes such as red spots or rash.
The doctor may change the dose of Polalid or discontinue treatment based on the patient's blood test results and general 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
Polalid is not recommended for use in children and adolescents under 18 years of age.
Elderly patients and patients with kidney problems
If the patient is 75 years of age or older, or has kidney problems of moderate to severe severity, the doctor will perform thorough examinations before starting treatment.
Polalid and other medicines
Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken. This is necessary because Polalid may affect the action of other medicines. Likewise, other medicines may affect the action of Polalid.
In particular, inform the doctor or nurse if the patient is taking the following medicines:

• Certain contraceptives, such as oral contraceptives, because 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 must not be used if the patient is pregnant, because it is expected to be harmful to the unborn child.
• Women must not become pregnant while taking Polalid.
• Therefore, women who may become pregnant must use an effective method of contraception (see "Contraception").
• If the patient becomes pregnant while being treated with Polalid, treatment must be stopped immediately and the doctor informed.

For men taking Polalid

• If the partner of a man undergoing treatment with Polalid becomes pregnant, he must immediately inform the doctor. The partner should seek medical advice. Men must also use an effective method of contraception (see "Contraception").

Breastfeeding
Breastfeeding must not be done while taking Polalid, because it is not known whether Polalid passes into human milk.
Contraception
Women taking Polalid
Before starting treatment, ask the doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who may become pregnant:

• Will undergo pregnancy tests under the doctor's supervision (before each treatment, 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 blocked to prevent the egg from reaching the uterus (tubal sterilization) AND
• Must use effective methods of contraception 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 Polalid
Polalid passes into human semen. If a woman is pregnant or may become pregnant and does not use an effective contraceptive method, her partner should use a condom during treatment and for at least 7 days after treatment ends. This applies also 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 vestibular dizziness, or blurred vision after taking Polalid.
Polalid contains lactose
Polalid contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking Polalid.
3. How to take Polalid
Polalid must be administered by medical personnel experienced in the treatment of multiple myeloma, MDS or FL.

• When Polalid is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously undergone other treatment, the medicine is used in combination with other medicines (see section 1 "Why Polalid is used").
• When Polalid 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 Polalid is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab".

Polalid should always be taken as directed by the doctor. In case of doubt, consult the doctor or pharmacist.
If the patient takes Polalid together with other medicines, they should read the package leaflet included with those medicines to obtain information on their use and effects.
Treatment cycle
Polalid is taken on specific days over 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 over 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 should be taken;
• What dose of other medicines the patient should take in combination with Polalid, if other medicines are required;
• On which days of the cycle to take which medicines.

How and when to take Polalid

• Swallow the capsule whole, preferably with water.
• Do not crush, open, or chew the capsules. If powder from a damaged Polalid capsule comes into contact with the skin, wash the skin thoroughly with soap and water immediately.
• Medical personnel, 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 touch the blister pack or capsule.
• Capsules may be taken with or without food.
• Polalid should be taken approximately at the same time each day on which the medicine is scheduled.

Taking Polalid
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 treatment with Polalid
Polalid is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should continue until the doctor decides to stop treatment.
Taking more than the recommended dose of Polalid
If more than the prescribed dose of Polalid is taken, inform the doctor immediately.
Missing a dose of Polalid
If a dose of Polalid is 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.

If there are 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 Polalid immediately
and seek medical advice without delay – immediate treatment may be required:

• urticaria, rash, swelling of the eyes, lips or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction;
• severe allergic reaction possibly starting as a rash in one area, spreading over the entire body and associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high body temperature, 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.

Polalid 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.
Polalid may also cause blood clots in veins (venous thrombosis).
Other adverse reactions
It should be noted that in a small number of patients, development of other types of cancer may occur, and it is possible that this risk may be increased by treatment with Polalid. Therefore, the prescribing physician should carefully evaluate the benefits and risks before prescribing Polalid to a patient.
Very common (may affect 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, myalgia, 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, ear pain, cough and chills;
• numbness, tingling or burning sensation of the skin, pain in hands or feet, dizziness, tremor;
• decreased appetite, altered taste;
• increased pain, enlargement or redness around a tumour;
• weight loss;
• constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium or 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 blood vessel swelling (vasculitis);
• increased blood glucose levels (diabetes);
• decreased blood glucose 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 (may affect 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 substances produced by normal and abnormal breakdown of red blood cells;
• increased concentration of a protein indicating presence of inflammation in the body;
• darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruising;
• increased uric acid levels in the blood;
• skin eruptions, redness of the skin, cracking, peeling or flaking of the skin, urticaria;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice quality problems or voice changes;
• rhinitis (runny nose);
• 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 difficulties;
• stroke, fainting, dizziness (inner ear disorder causing a sensation that everything is spinning), transient loss of consciousness;
• chest pain spreading to arms, neck, jaw, back or abdomen, sweating, 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 blockage of bile flow from the liver;
• low levels of phosphates or magnesium in the blood;
• speech difficulties;
• liver damage;
• balance disorders, 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 (may affect 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-coloured stools, dark-coloured 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 products released from dying tumour 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 sudden increase in heart rate – these symptoms may occur in association with pancreatitis;
• wheezing, shortness of breath or dry cough, possibly due to inflammation of lung tissue;
• rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some occurring when Polalid was administered concomitantly with a statin (a type of medicine that lowers blood cholesterol levels);
• skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leucocytoclastic 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 stools or changes in bowel function;
• viral infections, including herpes zoster (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 you experience any adverse reactions, including any 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 181C
02-222 Warsaw
Phone: +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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Polalid medicine

• Keep the medicine out of the 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 stated month. The code on the blister and carton following the abbreviation "Lot" indicates the batch number.
• Do not store this medicine above 30 °C.
• Do not use this medicine if you notice any damage or signs of tampering with the packaging.
• Medicines must not be disposed of via wastewater or household waste. Unused medicines should be returned to a pharmacy. This helps protect the environment.

6. Contents of the packaging 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • gelatin capsule shell: gelatin, titanium dioxide (E172).

What Polalid looks like and contents of the pack
Polalid, 2.5 mg, hard capsules:
Hard gelatin capsule size 4. The capsule body and cap are green.
Inside the capsule there is a white or almost white powder.
Each pack contains 21 hard capsules.

Polalid, 5 mg, hard capsules:
Hard gelatin capsule size 4. The capsule body and cap are blue.
Inside the capsule there is a white or almost white powder.
Each pack contains 21 hard capsules.

Polalid, 7.5 mg, hard capsules:
Hard gelatin capsule size 2. The capsule body is grey, the cap is green.
Inside the capsule there is a white or almost white powder.
Each pack contains 21 hard capsules.

Polalid, 10 mg, hard capsules:
Hard gelatin capsule size 2. The capsule body is white, the cap is green.
Inside the capsule there is a white or almost white powder.
Each pack contains 21 hard capsules.

Polalid, 15 mg, hard capsules:
Hard gelatin capsule size 0. The capsule body is white, the cap is blue.
Inside the capsule there is a white or almost white powder.
Each pack contains 21 hard capsules.

Polalid, 20 mg, hard capsules:
Hard gelatin capsule size 0. The capsule body is blue, the cap is green.
Inside the capsule there is a white or almost white powder.
Each pack contains 21 hard capsules.

Polalid, 25 mg, hard capsules:
Hard gelatin capsule size 0el. The capsule body and cap are white.
Inside the capsule there is a white or almost white powder.
Each pack contains 21 hard capsules.

Marketing Authorisation 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 medicinal product is authorised 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