Lenalidomide pharmascience

Package leaflet: information for the patient

Lenalidomide Pharmascience, 2.5 mg, hard capsules
Lenalidomide Pharmascience, 5 mg, hard capsules
Lenalidomide Pharmascience, 7.5 mg, hard capsules
Lenalidomide Pharmascience, 10 mg, hard capsules
Lenalidomide Pharmascience, 15 mg, hard capsules
Lenalidomide Pharmascience, 20 mg, hard capsules
Lenalidomide Pharmascience, 25 mg, hard capsules
Lenalidomide
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Lenalidomide Pharmascience is and what it is used for

What Lenalidomide Pharmascience is
Lenalidomide Pharmascience contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the function of the immune system.

What Lenalidomide Pharmascience is used for
Lenalidomide Pharmascience is used in adult patients for the treatment of:

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

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

Newly diagnosed multiple myeloma – in patients after bone marrow transplantation
In this indication, Lenalidomide Pharmascience is used as monotherapy for maintenance treatment following achievement of an adequate response after transplantation.

Newly diagnosed multiple myeloma in patients not eligible for bone marrow transplantation
Lenalidomide Pharmascience is taken in combination with other medicines, including:

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

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

Multiple myeloma – in previously treated patients
Lenalidomide Pharmascience is taken together with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Pharmascience 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 (anaemia), need for blood transfusions, and risk of infection.

Lenalidomide Pharmascience, 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 anaemia");
• the patient has an abnormality in bone marrow cells known as "isolated cytogenetic abnormality with deletion 5q". This means the patient's body does not produce enough healthy blood cells;
• the patient has previously received other treatments that were inappropriate or insufficiently effective.

Taking Lenalidomide Pharmascience 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 required blood transfusions. It may become possible to discontinue transfusions altogether.

Follicular lymphoma (FL)
FL is a slowly growing malignant tumour that affects 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.
Lenalidomide Pharmascience is used in combination with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Pharmascience works
Lenalidomide Pharmascience 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 the tumour;
• by stimulating part of the immune system to attack tumour cells.

2. Important information before taking Lenalidomide Pharmascience

Before starting treatment with Lenalidomide Pharmascience, carefully read the package leaflets of all medicines being taken concurrently with Lenalidomide Pharmascience.
When not to take Lenalidomide Pharmascience:

• If the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because Lenalidomide Pharmascience is expected to be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men").
• If the patient could become pregnant, unless all required contraceptive measures are being used (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document at the time of prescription that necessary precautions have been taken and will ensure the patient is aware of them.
• If the patient has an allergy to lenalidomide or any of the other ingredients of this medicine (listed in section 6). In case of suspected allergy, consult a doctor for advice.

If any of these points apply, do not take Lenalidomide Pharmascience. If in doubt, consult a doctor.
Warnings and precautions
Before starting treatment with Lenalidomide Pharmascience, discuss this with your doctor, pharmacist or nurse if the patient:

• Has previously had blood clots – this increases the risk of developing blood clots in veins and arteries during treatment;
• Has any signs of infection, such as cough or fever;
• Currently has or has previously had a viral infection, particularly varicella-zoster virus (chickenpox and shingles), hepatitis B, or HIV. If in doubt, consult a doctor. Treatment with Lenalidomide Pharmascience 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 Lenalidomide Pharmascience;
• Has had a heart attack (myocardial infarction), has ever had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• Experienced allergic reactions while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or breathing difficulties;
• Has previously experienced a combination of any of the following symptoms: widespread rash, redness of the skin, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes – these are symptoms of a severe skin reaction known as drug rash with eosinophilia and systemic symptoms (DRESS), also referred to as "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above apply, consult a doctor, pharmacist or nurse.
If at any time during or after completion of 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, immediately inform the doctor or nurse. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before treatment with Lenalidomide Pharmascience, inform the doctor of any changes in these symptoms,
• 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
Regular blood tests will be performed before and during treatment with Lenalidomide Pharmascience because the medicine may reduce the number of blood cells that help fight infection (white blood cells) and help blood to clot (platelets).
The doctor will schedule blood tests:

• Before treatment,
• Weekly for the first 8 weeks of treatment,
• Then at least once a month.

Before starting treatment with lenalidomide and during treatment, the patient may be evaluated for circulatory and respiratory problems.
Patients with MDS taking Lenalidomide Pharmascience
If the patient has myelodysplastic syndromes (MDS), there is an increased risk of developing a serious disease called acute myeloid leukemia. Furthermore, it is not known how Lenalidomide Pharmascience affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests to check for signs that better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Pharmascience.
Patients with FL taking Lenalidomide Pharmascience
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 a situation where tumour tissue begins to die, causing abnormal increases in various substances in the blood, which may result in 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 adjust the dose of Lenalidomide Pharmascience or discontinue treatment based on blood test results and the patient's overall condition. If the disease was recently diagnosed, the doctor may also consider the patient's age and any previous medical conditions when evaluating treatment.
Blood donation
During treatment and for at least 7 days after treatment ends, the patient must not donate blood.
Children and adolescents
Lenalidomide Pharmascience 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 moderate to severe kidney problems, the doctor will perform thorough evaluations before starting treatment.
Lenalidomide Pharmascience and other medicines
Inform the doctor or nurse about all medicines currently or recently taken. This is necessary because Lenalidomide Pharmascience may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Pharmascience.
In particular, inform the doctor or nurse if the patient is taking the following medicines:

• Certain contraceptives, such as oral contraceptives, as they may become ineffective;
• 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 Lenalidomide Pharmascience

• Do not take Lenalidomide Pharmascience if the patient is pregnant, as it is expected to be harmful to the unborn child.
• Women must not become pregnant while taking Lenalidomide Pharmascience.
• Therefore, women who could become pregnant must use an effective method of contraception (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Pharmascience, treatment must be stopped immediately and the doctor informed.

For men taking Lenalidomide Pharmascience

• If the male patient’s partner becomes pregnant during his treatment with Lenalidomide Pharmascience, she should immediately inform the doctor. The partner should seek medical advice.
• Men must also use an effective method of contraception (see "Contraception").

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

• Will undergo pregnancy tests under medical supervision (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and sealed to prevent the egg from reaching the uterus (tubal sterilization) AND
• Must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends. The doctor will advise the patient on appropriate contraceptive methods.

Men taking Lenalidomide Pharmascience
Lenalidomide passes into human sperm. If a woman is pregnant or could become pregnant and is not using an effective contraceptive method, her partner should use a condom during treatment and for at least 7 days after treatment ends. This applies even to men who have had a vasectomy.
During treatment and for at least 7 days after treatment ends, the patient must not donate semen.
Driving and operating machinery
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances due to vertigo, or blurred vision after taking Lenalidomide Pharmascience.
Lenalidomide Pharmascience contains lactose, tartrazine, sunset yellow (E110), and Allura red AC.
Lenalidomide Pharmascience contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Lenalidomide Pharmascience.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".
Lenalidomide Pharmascience 2.5 mg contains Allura red AC (E129), which may cause allergic reactions.
Lenalidomide Pharmascience 5 mg and 7.5 mg contain sunset yellow (E110), which may cause allergic reactions.
Lenalidomide Pharmascience 10 mg contains tartrazine (E102), sunset yellow (E110), and Allura red AC (E129), which may cause allergic reactions.
Lenalidomide Pharmascience 15 mg contains tartrazine (E102) and Allura red AC (E129), which may cause allergic reactions.
Lenalidomide Pharmascience 20 mg contains Allura red AC (E129), which may cause allergic reactions.

3. How to take Lenalidomide Pharmascience

Lenalidomide Pharmascience must be administered by medical professionals experienced in the treatment of multiple myeloma, MDS, or FL.

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

Lenalidomide Pharmascience should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
If you are taking Lenalidomide Pharmascience together with other medicines, you should read the package leaflet included with those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Pharmascience is taken on specific days during a three-week period (21 days).

• Each 21-day period is called a treatment cycle.
• Depending on the day of the cycle, you may take one or more medicines. However, on certain days you will not take any medicines.
• After completing each 21-day cycle, you should start a new 21-day cycle. OR
• Lenalidomide Pharmascience is taken on specific days during a four-week period (28 days).
• Each 28-day period is called a treatment cycle.
• Depending on the day of the cycle, you may take one or more medicines. However, on certain days you will not take any medicines.
• After completing each 28-day cycle, you should start a new 28-day cycle.

Recommended dose of Lenalidomide Pharmascience
Before starting treatment, your doctor will inform you:

• how much Lenalidomide Pharmascience you should take;
• how much of any other medicines you should take in combination with Lenalidomide Pharmascience, if other medicines are required;
• on which days of the cycle you should take these medicines.

How and when to take Lenalidomide Pharmascience

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

Taking this medicine
To remove the capsule from the blister pack:

• 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 Lenalidomide Pharmascience
Lenalidomide Pharmascience is administered in treatment cycles; each cycle lasts 21 or 28 days (see above, "Treatment cycle"). Treatment cycles should continue until treatment discontinuation is advised by the doctor.

Overdose of Lenalidomide Pharmascience
If you take more than the prescribed dose of Lenalidomide Pharmascience, contact your doctor immediately.

Missed dose of Lenalidomide Pharmascience
If you miss a dose of Lenalidomide Pharmascience 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 on the following day.

If you have any further questions about the use of this medicine, consult your 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
Lenalidomide Pharmascience immediately and contact your doctor 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 progressing with significant loss of the outer layer of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, increased liver enzyme activity, abnormalities in blood tests (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.

Contact your doctor immediately 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 levels of calcium in the blood.

Lenalidomide Pharmascience may reduce the number of white blood cells that fight infection, as well
as blood cells that help blood to clot (platelets), which may lead to bleeding disorders, such as nosebleeds and bruising.
Lenalidomide Pharmascience may also cause blood clots in the veins (venous thrombosis).
Other adverse reactions
It should be noted that in a small number of patients, other types of cancer may develop, and it is possible that this risk may be increased by treatment with Lenalidomide Pharmascience.
Therefore, your doctor should carefully assess the benefits and risks before prescribing Lenalidomide
Pharmascience to you.
Very common adverse reactions (may affect more than 1 in 10 people):

• reduction in the number of red blood cells, which may lead to anaemia causing tiredness and weakness;
• rash, itching;
• muscle cramps, muscle weakness, muscle pain, bone pain, joint pain, back pain, limb pain;
• generalised swelling, including swelling of the hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills;
• tingling, numbness or burning sensation of the skin, pain in hands or feet, dizziness, muscle tremor;
• decreased appetite, altered taste sensation;
• worsening of 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;
• underactive thyroid gland;
• leg pain (which may be a sign of venous 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 function test results;
• increased values in liver function tests;
• changes in blood proteins leading to blood vessel swelling (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, difficulty sleeping;
• cough;
• low blood pressure;
• general physical discomfort, malaise;
• painful inflammation of the mouth, dryness in the mouth;
• dehydration.

Common adverse reactions (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 a substance formed during normal and abnormal breakdown of red blood cells;
• increased levels of a protein indicating inflammation in the body;
• darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruises;
• increased levels of uric acid in the blood;
• skin eruptions, redness of the skin, cracking, peeling or flaking of the skin, urticaria;
• itching, excessive sweating, night sweats;
• difficulty swallowing, sore throat, problems with voice quality or voice changes;
• rhinitis (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 and breathlessness, nausea or vomiting, which may be symptoms of 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;
• difficulty speaking;
• liver damage;
• loss of balance, difficulty moving;
• deafness, tinnitus (ringing in the ears);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excess iron in the body;
• thirst;
• confusion;
• toothache;
• fall, which may lead to injury.

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

• bleeding inside the skull;
• circulation problems;
• loss of vision;
• loss of sexual desire (libido);
• passing large amounts of urine, accompanied by bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, abdominal pain or swelling – may be symptoms of liver damage (liver failure);
• abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis); kidney tubular cell damage (known as tubular necrosis);
• change in skin colour, sensitivity to sunlight;
• tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate and 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 of 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 pulse – 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 of them when Lenalidomide Pharmascience was administered concomitantly with a statin (a type of medicine that lowers blood cholesterol levels);
• skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis);
• rupture 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 the stool or changes in bowel function;
• viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark brown urine, pain in the right lower abdomen, fever, nausea and vomiting);
• solid organ transplant rejection (e.g. kidney, heart).

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 .
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 Lenalidomide Pharmascience

Keep this 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: "Expiry
date (EXP)". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Pharmascience contains
Lenalidomide Pharmascience, 2.5 mg

• The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
  • capsule shell: Brilliant Blue FCF (E 133), Erythrosine (E 127), Allura Red AC (E 129) (see section 2), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172) and potassium hydroxide.

Lenalidomide Pharmascience, 5 mg

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
  • capsule shell: Brilliant Blue FCF (E 133), Sunset Yellow FCF (E 110) (see section 2), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172) and potassium hydroxide.

Lenalidomide Pharmascience, 7.5 mg

• The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
  • capsule shell: Brilliant Blue FCF (E 133), Erythrosine (E 127), Sunset Yellow FCF (E 110) (see section 2), titanium dioxide (E 171) and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172) and potassium hydroxide.

Lenalidomide Pharmascience, 10 mg

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
  • capsule shell: Brilliant Blue FCF (E 133), Allura Red AC (E 129) (see section 2), Tartrazine (E 102) (see section 2), Sunset Yellow FCF (E 110) (see section 2), titanium dioxide (E 171) and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172) and potassium hydroxide.

Lenalidomide Pharmascience, 15 mg

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
  • capsule shell: Brilliant Blue FCF (E 133), Allura Red AC (E 129) (see section 2), Tartrazine (E 102) (see section 2), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172) and potassium hydroxide.

Lenalidomide Pharmascience, 20 mg

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
  • capsule shell: Brilliant Blue FCF (E 133), Allura Red AC (E 129) (see section 2), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172) and potassium hydroxide.

Lenalidomide Pharmascience, 25 mg

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate;
  • capsule shell: titanium dioxide (E 171) and gelatin;
  • printing ink: shellac, propylene glycol, iron oxide black (E 172) and potassium hydroxide.

What Lenalidomide Pharmascience looks like and contents of the pack
Lenalidomide Pharmascience, 2.5 mg: hard capsules with dark blue, opaque cap and light orange, opaque body, size 4, 14-15 mm, coated, printed in black ink with "LP" on the cap and "637" on the body.
Lenalidomide Pharmascience, 5 mg: hard capsules with green, opaque cap and light brown, opaque body, size 2, 18-19 mm, coated, printed in black ink with "LP" on the cap and "638" on the body.
Lenalidomide Pharmascience, 7.5 mg: hard capsules with violet, opaque cap and pink, opaque body, size 1, 19-20 mm, coated, printed in black ink with "LP" on the cap and "643" on the body.
Lenalidomide Pharmascience, 10 mg: hard capsules with yellow, opaque cap and grey, opaque body, size 0, 21-22 mm, coated, printed in black ink with "LP" on the cap and "639" on the body.
Lenalidomide Pharmascience, 15 mg: hard capsules with brown, opaque cap and grey, opaque body, size 2, 18-19 mm, coated, printed in black ink with "LP" on the cap and "640" on the body.
Lenalidomide Pharmascience, 20 mg: hard capsules with dark red, opaque cap and light grey, opaque body, size 1, 19-20 mm, coated, printed in black ink with "LP" on the cap and "641" on the body.
Lenalidomide Pharmascience, 25 mg: hard capsules with white, opaque cap and white, opaque body, size 0, 21-22 mm, coated, printed in black ink with "LP" on the cap and "642" on the body.
Cardboard box containing blisters made of PVC/ACLAR/Aluminium.
Pack sizes: 7 or 21 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmascience International Limited
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
Adalvo Ltd.
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the European Economic Area member states under the following names: