LENALIDOMIDE OLAINFARM 7.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Lenalidomide Olainfarm 7.5 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Lenalidomide Olainfarm and what is it used for
2. What you need to know before you take Lenalidomide Olainfarm
3. How to take Lenalidomide Olainfarm
4. Possible side effects
5. Storage of Lenalidomide Olainfarm
6. Contents of the pack and other information

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

What is Lenalidomide Olainfarm

This medicine contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomide Olainfarm is used for

This medicine is used in adults to:

• Multiple Myeloma
• Follicular Lymphoma.

Multiple Myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cell called plasma cells. These cells accumulate in the bone marrow and multiply out of control. This can damage the bones and kidneys.

Multiple myeloma usually has no cure. However, the signs and symptoms can be greatly reduced or may disappear for a period of time. This is called "remission".

Newly diagnosed multiple myeloma: in patients who have undergone a bone marrow transplant

Lenalidomide is used as maintenance treatment after recovering from a bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomide is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib"
• an anti-inflammatory called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• an immunosuppressant called "prednisone".

You will take these medicines at the start of treatment and then continue to take this medicine alone.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Multiple myeloma: in patients previously treated

This medicine is taken with an anti-inflammatory called "dexamethasone".

This medicine can slow down the worsening of multiple myeloma symptoms. It has also been shown to delay the return of multiple myeloma after treatment.

Follicular Lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infections. When a person has FL, they may have too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

This medicine is used with another medicine called "rituximab" for the treatment of adult patients who have received previous treatment for follicular lymphoma.

How lenalidomide works

This medicine works by affecting the immune system and directly attacking the cancer.

It works in several ways:

• stops the growth of cancer cells
• stops the growth of blood vessels in the cancer
• stimulates part of the immune system to attack cancer cells.

2. What you need to know before you take Lenalidomide Olainfarm

You should read the package leaflet of all the medicines you are going to take in combination with this medicine before starting treatment with this medicine.

Do not take Lenalidomide Olainfarm:

• if you are pregnant, think you may be pregnant or plan to become pregnant, as lenalidomide is expected to be harmful to the fetus(see section 2, "Pregnancy, breastfeeding and contraception: information for women and men").
• if you can become pregnant, unless you use all the necessary measures to prevent it (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men"). If you can become pregnant, your doctor will note with each prescription that all necessary measures have been taken and will provide you with this confirmation.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take this medicine. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting treatment with this medicine if:

• you have ever had blood clots; during treatment, you have a higher risk of developing blood clots in the veins and arteries
• you have any signs of infection, such as cough or fever
• you have or have had a viral infection, especially hepatitis B, varicella zoster or HIV. If in doubt, consult your doctor. Treatment with this medicine may cause the virus to become active again in patients who carry the virus, leading to the return of the infection. Your doctor should check if you have ever had a hepatitis B infection
• you have kidney problems; your doctor may adjust the dose of this medicine
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
• you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as skin rash, itching, swelling, dizziness or breathing problems
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome).

If any of the above conditions apply to you, inform your doctor, pharmacist or nurse before starting treatment.

At any time, during or after treatment, inform your doctor or nurse immediately if you experience:

• blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased or lost sensation, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with this medicine, inform your doctor if you notice any change in these symptoms.
• shortness of breath, tiredness, dizziness, chest pain, faster heartbeat or swelling in the legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting treatment with this medicine and during treatment, you will have regular blood tests. This is because this medicine can cause a decrease in the blood cells that help fight infections (white blood cells) and those that help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

• before treatment;
• every week, during the first 8 weeks of treatment;
• then, at least every month.

You may be evaluated for signs of heart and lung problems before and during treatment with lenalidomide.

For patients with FL who take this medicine

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 3 weeks (1 cycle) of treatment;
• then, every 2 weeks in cycles 2 to 4 (see section 3 "Treatment cycle" for more information).
• after that, at the start of each cycle and
• at least every month.

Your doctor may check if you have a high total tumor burden in the body, including the bone marrow. This could lead to a condition where the tumors break down and produce unusual levels of chemicals in the blood that can cause kidney failure (this condition is called "tumor lysis syndrome").

Your doctor may examine you to check for changes in your skin, such as red spots or skin rash.

Your doctor may adjust the dose of this medicine or interrupt your treatment, depending on the results of your blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other conditions you may have.

Blood donation

You must not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years.

Elderly and patients with kidney problems

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Other medicines and Lenalidomide Olainfarm

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because this medicine can affect how other medicines work. Also, some medicines can affect how this medicine works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working;
• some medicines used for heart problems, such as digoxin;
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking this medicine

• Do not take this medicine if you are pregnant, as it is expected to be harmful to the fetus.
• Do not become pregnant while taking this medicine. Therefore, you must use effective contraceptive methods if you can become pregnant (see "Contraception").
• If you become pregnant during treatment with this medicine, stop treatment and inform your doctor immediately.

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine

Men taking this medicine

• If your partner becomes pregnant while you are taking this medicine, inform your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective contraceptive methods (see "Contraception").

Breastfeeding

Do not breastfeed while taking this medicine, as it is not known whether this medicine passes into breast milk.

Contraception

For women taking this medicine

Before starting treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after the end of treatment) unless it has been confirmed that your fallopian tubes have been blocked (tubal ligation);

And

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after the end of treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking this medicine

This medicine passes into human semen. If your partner is pregnant or can become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking this medicine.

Lenalidomide Olainfarm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

Lenalidomide Olainfarm contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take/use Lenalidomida Olainfarm

This medication should be administered by a healthcare professional with experience in the treatment of multiple myeloma or MF.

• When this medication is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have undergone other treatments before, it is taken with other medications (see section 1 "What Lenalidomida Olainfarm is used for").
• When this medication is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant, it is taken alone.
• When this medication is used for the treatment of follicular lymphoma, it is taken with another medication called "rituximab".

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you are taking this medication with other medications, you should consult the package insert of those other medications for additional information on their use and effects.

Treatment cycle

This medication is taken on certain days during a period of 3 weeks (21 days).

• A "treatment cycle" consists of 21 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each 21-day cycle, you should start a new "cycle" for the next 21 days.

Or

This medication is taken on certain days during a period of 4 weeks (28 days).

• A "treatment cycle" consists of 28 days.
• Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
• After completing each 28-day cycle, you should start a new "cycle" for the next 28 days.

How much Lenalidomida Olainfarm to take

Before starting treatment, your doctor will indicate:

• what quantity of this medication you should take;
• what quantity of other medications you should take with this medication, if applicable;
• which days of the treatment cycle you should take each medication.

How and when to take Lenalidomida Olainfarm

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder of a broken capsule of this medication comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic bag, and dispose of them according to local requirements. Then, they should wash their hands well with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister or capsule.
• The capsules can be taken with or without food.
• You should take this medication approximately at the same time on the scheduled days.

Taking this medication

To remove the capsule from the blister:

• Press only one end of the capsule so that it comes out through the foil.
• Do not press the center of the capsule as it could break.

Duration of treatment with Lenalidomida Olainfarm

This medication is taken in treatment cycles, each cycle lasting 21 or 28 days (see "Treatment cycle" above). You should continue the treatment cycles until your doctor tells you to stop the treatment.

If you take more Lenalidomida Olainfarm than you should

If you take more of this medication than prescribed, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Lenalidomida Olainfarm

If you forget to take this medication at its usual 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 the next day at the usual time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, lenalidomida can cause side effects, although not all people experience them.

Severe side effects that may affect more than 1 in 10 people (very common)

Lenalidomida may reduce the number of white blood cells (cells in the blood that fight infections) and also platelets (cells that help blood clot), which can lead to bleeding disorders, such as nosebleeds and bruising.

Lenalidomida may cause blood clots in the veins (thrombosis).

Therefore, you must inform your doctor immediatelyif you experience:

• fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including in the bloodstream (sepsis)
• bleeding (bleeding) or hematoma (bruising) not due to an injury
• chest pain (thoracic) or in the legs
• difficulty breathing

Other side effects

It is important to note that a small number of patients may develop other types of cancer, and this risk may increase with lenalidomida treatment. Therefore, your doctor should carefully evaluate the benefits and risks when prescribing lenalidomida.

Side effects very common(may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which can cause anemia, leading to fatigue and weakness.
• Constipation, diarrhea, nausea, skin redness, rash, vomiting, muscle cramps, muscle pain, bone pain, joint pain, fatigue, generalized swelling, including swelling of the arms and legs.
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, and chills.
• Numbness, tingling, or a sensation of burning in the skin, pain in the hands or feet, dizziness, tremors, changes in taste.
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, a feeling of sweating and shortness of breath, a feeling of discomfort or nausea, which may be symptoms of a heart attack (myocardial infarction).
• Decreased appetite.
• Low potassium levels in the blood.
• Pain in the legs (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism).
• Infections of all kinds.
• Lung and upper respiratory tract infections, difficulty breathing.
• Blurred vision.
• Eye opacity (cataracts).
• Kidney problems.
• Changes in a blood protein that can cause swelling of the arteries (vasculitis).
• Increased blood sugar levels (diabetes).
• Headache.
• Dry skin.
• Stomach pain.
• Changes in mood, difficulty sleeping.

Side effects common(may affect up to 1 in 10 people):

• Paranasal sinus infection surrounding the nose.
• Bleeding from the gums, stomach, or intestines.
• Increased pain, tumor size, redness around the tumor.
• Increased or decreased blood pressure, slow, fast, or irregular heartbeat.
• Darkening of the skin.
• Skin rashes, cracked skin, peeling, or exfoliation of the skin.
• Hives, itching, increased sweating, dehydration.
• Painful inflammation of the mouth, dry mouth, difficulty swallowing.
• Acid reflux.
• Strong increase or decrease in the amount of urine compared to usual (which may be a symptom of kidney failure), blood in the urine.
• Difficulty breathing, especially when lying down (which may be a symptom of heart failure).
• Difficulty having an erection.
• Stroke, fainting.
• Muscle weakness.
• Swelling of the joints.
• Changes in thyroid hormone levels in the blood, low levels of calcium, phosphate, or magnesium in the blood.
• Depression.
• Hearing loss.
• Abnormal liver test results.
• Balance disorders, difficulty moving.
• Ringing in the ears (tinnitus).
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Weight loss.

Side effects uncommon(may affect up to 1 in 100 people):

• Bleeding inside the skull.
• Circulatory problems.
• Loss of vision.
• Loss of sexual desire (libido).
• Excretion of large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome).
• Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis).
• Urinating much more or much less than usual, which may be a symptom of a type of kidney problem (renal tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Certain types of skin tumors.
• Hives, rashes, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which may be symptoms of an allergic reaction.

Side effects rare(may affect up to 1 in 1,000 people):

• Severe allergic reaction that can start as a rash in one area but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying tumor cells and may include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.

Frequency not known(cannot be estimated from available data):

• Sudden, severe, or mild pain in the upper stomach and/or back that lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of the lung tissue.
• Yellow discoloration of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching of the skin, rash, abdominal pain or swelling; these may be symptoms of liver damage (liver disorder).
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis) have been observed, some of which occurred when lenalidomida was administered with a statin (a type of medication to lower cholesterol).
• A disease that affects the skin, caused by inflammation of the small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Rupture of the stomach or intestine wall. This can lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the reappearance of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). Stop using lenalidomida if you develop these symptoms and contact your doctor or seek immediate medical attention. See also section 2.

• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package insert. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lenalidomida Olainfarm

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister and carton after "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging. This medication does not require special temperature storage conditions.

Do not use this medication if you observe visible signs of deterioration or improper handling.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lenalidomide Olainfarm

Lenalidomide Olainfarm 2.5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.

The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose (E 460(i)), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
• Capsule shell: gelatin, titanium dioxide (E171), indigotine (E132), and yellow iron oxide (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).

Lenalidomide Olainfarm 5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.

The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose (E 460(i)), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
• Capsule shell: gelatin and titanium dioxide (E171).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).

Lenalidomide Olainfarm 7.5 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.

The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose (E 460(i)), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
• Capsule shell: gelatin, titanium dioxide (E171), and yellow iron oxide (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).

Lenalidomide Olainfarm 10 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.

The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose (E 460(i)), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
• Capsule shell: gelatin, titanium dioxide (E171), indigotine (E132), and yellow iron oxide (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).

Lenalidomide Olainfarm 15 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.

The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose (E 460(i)), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
• Capsule shell: gelatin and titanium dioxide (E171), and indigotine (E132).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).

Lenalidomide Olainfarm 20 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.

The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose (E 460(i)), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
• Capsule shell: gelatin, titanium dioxide (E171), indigotine (E132), and yellow iron oxide (E172).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).

Lenalidomide Olainfarm 25 mg hard capsules EFG:

The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.

The other ingredients are:

• Capsule content: anhydrous lactose (see section 2), microcrystalline cellulose (E 460(i)), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
• Capsule shell: gelatin and titanium dioxide (E171).
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).

Product Appearance and Package Contents

Lenalidomide Olainfarm 2.5 mg hard capsules EFG

White capsule filled with white to off-white powder and greenish-blue cap, hard gelatin capsule size 4 (approximately 14.4 mm in length), body printed "2.5 mg" with black ink.

Lenalidomide Olainfarm 5 mg hard capsules EFG

White capsule filled with white to off-white powder and white cap, hard gelatin capsule size 2 (approximately 17.8 mm in length), body printed "5 mg" with black ink.

Lenalidomide Olainfarm 7.5 mg hard capsules EFG

White capsule filled with white to off-white powder and light yellow cap, hard gelatin capsule size 2 (approximately 17.8 mm in length), body printed "7.5 mg" with black ink.

Lenalidomide Olainfarm 10 mg hard capsules EFG

Light yellow capsule filled with white to off-white powder and blue-green cap, hard gelatin capsule size 0 (approximately 21.4 mm in length), body printed "10 mg" with black ink.

Lenalidomide Olainfarm 15 mg hard capsules EFG

White capsule filled with white to off-white powder and light blue cap, hard gelatin capsule size 0 (approximately 21.4 mm in length), body printed "15 mg" with black ink.

Lenalidomide Olainfarm 20 mg hard capsules EFG

Light blue capsule filled with white to off-white powder and greenish-blue cap, hard gelatin capsule size 0 (approximately 21.4 mm in length), body printed "20 mg" with black ink.

Lenalidomide Olainfarm 25 mg hard capsules EFG

White capsule filled with white to off-white powder and white cap, hard gelatin capsule size 0 (approximately 21.4 mm in length), body printed "25 mg" with black ink.

Package size of 7 or 21 capsules in blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder

AS Olainfarm,

Rupnicu iela 5,

LV-2114, Olaine,

Latvia

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Corradino Industrial Estate

Paola PLA3000

Malta

Date of Last Revision of this Leaflet:December 2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es