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 immune system.

What is Polalid used for

Polalid is used to treat adult patients with:

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

Multiple myeloma

Multiple myeloma is a type of cancer that affects a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and undergo uncontrolled divisions. This can lead to bone and kidney damage. Multiple myeloma is generally incurable. However, it is possible to achieve temporary significant relief or removal of signs and symptoms of the disease. This is called "remission". New diagnosis of multiple myeloma - in patients after bone marrow transplantation In this indication, Polalid is used alone as maintenance treatment after achieving a suitable state 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 disorders. 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 alone to treat adult patients with MDS, if all of the following conditions are met:

• the patient has anemia that requires regular blood transfusions ("transfusion-dependent anemia");
• the patient has a genetic 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 received other treatments that were not suitable or effective.

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 with another medicine called "rituximab" to treat adult patients with previously treated follicular lymphoma.

How Polalid works

Polalid works by affecting 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 you are pregnant, suspect you are pregnant, or plan 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 you may become pregnant, unless you use all required contraceptive measures (see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men"). If you may become pregnant, your doctor will always check when prescribing the medicine that the necessary measures have been taken and will inform you about it.
• If you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you suspect an allergy, you should ask your doctor for advice.

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

Warnings and precautions

Before starting Polalid, you should discuss it with your doctor, pharmacist, or nurse if you:

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

If any of the above apply to you, you should consult a doctor, pharmacist, or nurse. If at any time during or after treatment you experience:

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

Tests and examinations

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

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

Before starting lenalidomide treatment and during treatment, you may undergo an assessment for circulation and breathing problems. Patients with MDS taking Polalid If you have 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, your 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 Your doctor will ask you to have a blood test:

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

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

Blood donation

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

Children and adolescents

Polalid is not recommended for children and adolescents under 18 years of age.

Elderly and patients with kidney problems

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

Polalid and other medicines

You should tell your doctor or nurse about all medicines you are taking now or have taken recently. This is necessary because Polalid may affect the action of other medicines. Other medicines may also affect the action of Polalid. In particular, you should inform your doctor or nurse if you are taking:

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

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

Pregnancy

For women taking Polalid

• You should not take Polalid if you are pregnant, as it is expected to be harmful to the unborn child.
• You should not become pregnant while taking Polalid.
• Therefore, women who may become pregnant must use effective contraception (see "Contraception").
• If you become pregnant while taking Polalid, you should stop treatment immediately and inform your doctor.

For men taking Polalid

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

Breastfeeding

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

Contraception

Women taking Polalid

• Before starting treatment, you should ask your doctor about the possibility of becoming pregnant, even if you 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 you have had your fallopian tubes cut and sealed (tubal ligation) AND
• must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will recommend the appropriate contraceptive methods.

Men taking Polalid

Polalid is present in human semen. If a woman is pregnant or may become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after stopping treatment. This also applies to men who have had a vasectomy.

Driving and using machines

You should not drive or operate machines if you experience dizziness, fatigue, drowsiness, balance disturbances caused by dizziness, or blurred vision after taking Polalid.

Polalid contains lactose

Polalid contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your 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 Polalid is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have received previous treatment, it is used in combination with other medicines (see section 1 "What is Polalid used for").
• When Polalid is used to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS, it is used alone.
• When Polalid is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Polalid should always be taken according to your doctor's instructions. If you have any doubts, you should consult a doctor or pharmacist. If you are taking Polalid with other medicines, you should read the leaflet that comes with their packaging to get information about their use and effects.

Treatment cycle

Polalid is taken on specific days during a 3-week period (21 days).

• Each 21-day period is called a treatment cycle.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days, you will not take any medicines.
• After completing each 21-day cycle, you should start a new 21-day cycle.

OR

Polalid is taken on specific days during a 4-week period (28 days).

• Each 28-day period is called a treatment cycle.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days, you will not take any medicines.
• After completing each 28-day cycle, you should start a new 28-day cycle.

Recommended dose of Polalid

Before starting treatment, your doctor will inform you:

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

How and when to take Polalid

• The capsule should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. If you come into contact with the powder from a damaged Polalid capsule, wash your skin immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of according to local regulations. Then, wash your hands with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Polalid should be taken at approximately the same time every day, on the days when the medicine is scheduled.

Taking Polalid

To remove a capsule from the blister:

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

Taking a higher dose of Polalid than recommended

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

Missing a dose of Polalid

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

• less than 12 hours have passed since then: you should take the capsule immediately;
• more than 12 hours have passed since then: you should not take the capsule. You should take the next capsule at the scheduled time the next day.

If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, you should stop taking Polalid and immediately consult a doctor - you 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 body temperature, 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");

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

• fever, chills, sore throat, cough, mouth ulcers, or any other symptoms of infection (including blood infections);
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion, or fatigue that may be due to high calcium levels in the blood.

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

Other side effects

Note 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 Polalid treatment. Therefore, your doctor should carefully weigh the benefits and risks of prescribing Polalid to you.

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 swelling, including swelling of the hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• numbness, tingling, or burning sensation of the skin, pain in the hands or feet, dizziness, tremors;
• decreased appetite, altered taste;
• increased pain, tumor growth, or redness around the tumor;
• weight loss;
• constipation, diarrhea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium, calcium, or sodium in the blood;
• abnormal thyroid function;
• leg pain (which may be a symptom of thrombosis), chest pain, or shortness of breath (which may be symptoms of pulmonary embolism);
• all types of 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 test results;
• 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 heartbeat;
• 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;
• skin rashes, redness, cracking, peeling, or flaking of the skin, hives;
• increased sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• runny nose (rhinitis);
• passing much more or much less urine than normal, or inability to control the timing of urination;
• passing blood in the urine;
• shortness of breath, especially when lying down (which may be a symptom of heart failure);
• erectile dysfunction;
• stroke, fainting, 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 phosphate or magnesium in the blood;
• speech difficulties;
• 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 lead to 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 symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, rash, abdominal pain, or swelling - these may be symptoms of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis);
• kidney cell damage (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, phosphate, uric acid, and low levels of calcium, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death;
• increased 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 with accompanying nausea, vomiting, fever, and rapid heartbeat - these symptoms may occur 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. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function;
• viral infections, including chickenpox and shingles, and 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polalid

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month stated. The inscription on the blister and carton after "Lot" refers to the batch number.
• Do not store the medicine 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.
• Other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule: 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.
• Other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule: 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.
• Other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule: 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.
• Other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule: 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.
• Other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule: gelatin, titanium dioxide (E171), brilliant blue (E133).

Polalid, 20 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• Other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule: 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.
• Other ingredients are:
• capsule core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate
• hard gelatin capsule: 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

Polpharma S.A.
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: