Lenalidomide Teva 5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lenalidomida Teva 5 mg hard capsules EFG

Lenalidomida Teva 10 mg hard capsules EFG

Lenalidomida Teva 15 mg hard capsules EFG

Lenalidomida Teva 20 mg hard capsules EFG

Lenalidomida Teva 25 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 other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Lenalidomida Teva is and what it is used for

What Lenalidomida Teva is

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

What Lenalidomida Teva is used for

Lenalidomida Teva is used in adults for:

• Multiple myeloma
• Myelodysplastic syndromes (MDS)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma (FL)

Multiple myeloma

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

Multiple myeloma generally cannot be cured. However, 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
Lenalidomida Teva is used as maintenance treatment after adequate recovery from a bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant
Lenalidomida Teva is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”
• an anti-inflammatory called “dexamethasone”
• a chemotherapy medicine called “melphalan”
• an immunosuppressant called “prednisone”.

You will take these medicines at the beginning of treatment and then continue taking Lenalidomida Teva alone.

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

Multiple myeloma: in previously treated patients
Lenalidomida Teva is taken together with an anti-inflammatory called “dexamethasone”.

Lenalidomida Teva can slow down the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

MDS are a group of different blood and bone marrow diseases. Blood cells become abnormal and do not function properly. Patients may experience a variety of signs and symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infection.

Lenalidomida Teva is used to treat adult patients diagnosed with MDS when all of the following apply:

• you require periodic blood transfusions to treat low red blood cell levels (“transfusion-dependent anaemia”);
• you have an abnormality in bone marrow cells called “isolated 5q cytogenetic abnormality”. This means your body does not produce enough healthy blood cells;
• other treatments you have previously used are not suitable or do not work well enough.

Lenalidomida Teva can increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. Transfusions may no longer be required.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cells called “B-lymphocytes” or B-cells. MCL is a disease in which B-cells grow uncontrollably and accumulate in lymphatic tissue, bone marrow, or blood.

Lenalidomida Teva is used as monotherapy to treat adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, too many of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomida Teva is used in combination with another medicine called “rituximab” for the treatment of adult patients who have received prior treatment for follicular lymphoma.

How Lenalidomida Teva works

Lenalidomida Teva works by affecting the body's immune system and directly attacking cancer cells.

It works in several ways:

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

2. What you need to know before starting Lenalidomida Teva

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomida Teva before starting treatment with Lenalidomida Teva.

Do not take Lenalidomida Teva

• if you are pregnant, think you might be pregnant, or intend to become pregnant, as Lenalidomida Teva is expected to be harmful to the fetus (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”).
• if you could become pregnant, unless you follow all necessary measures to prevent it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you could become pregnant, your doctor will document with each prescription that all necessary precautions 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 Lenalidomida Teva. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Lenalidomida Teva if

• you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in veins and arteries.
• you have any signs of infection, such as cough or fever.
• you have or have previously had a viral infection, especially hepatitis B, varicella zoster, or HIV. If in doubt, consult your doctor. Treatment with Lenalidomida Teva may cause the virus to become active again in patients who carry the virus. This leads to the recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.
• you have kidney problems; your doctor may adjust your dose of Lenalidomida Teva.
• you have had a heart attack, previously 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 rash, itching, swelling, dizziness, or breathing problems.
• you have previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (signs of a serious skin reaction called drug reaction 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 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, double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk, balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may all be symptoms of a serious and potentially life-threatening brain disease known as progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with Lenalidomida Teva, inform your doctor if you notice any changes in these symptoms.
• you experience shortness of breath, fatigue, dizziness, chest pain, faster heartbeat, or swelling in your legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Blood tests and monitoring

Before starting treatment with Lenalidomida Teva and during treatment, you will have regular blood tests. This is because Lenalidomida Teva may cause a decrease in blood cells that help fight infections (white blood cells) and those involved in blood clotting (platelets).

Your doctor will ask you to have blood tests:

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

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

For patients with MDS taking Lenalidomida Teva

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). In addition, it is not known how Lenalidomida Teva affects your chances of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the likelihood of developing AML during treatment with Lenalidomida Teva.

For patients with MM taking Lenalidomida Teva

Your doctor will ask you to have blood tests:

• before treatment
• every week during the first 8 weeks (2 cycles) of treatment
• then every 2 weeks during cycles 3 and 4 (see section 3 “Treatment cycle” for more information)
• after this, at the beginning of each cycle and
• at least once a month.

For patients with FL taking Lenalidomida Teva

Your doctor will ask you to have blood tests:

• before treatment
• every week during the first 3 weeks (1 cycle) of treatment
• then every 2 weeks during cycles 2 to 4 (see section 3 “Treatment cycle” for more information)
• after this, at the beginning of each cycle and
• at least once a month.

Your doctor may check whether you have a high overall tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure (this condition is called “tumor lysis syndrome”).

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

Your doctor may adjust the dose of Lenalidomida Teva 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 pre-existing conditions.

Blood donation

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

Children and adolescents

Use of Lenalidomida Teva is not recommended in children and adolescents under 18 years of age.

Elderly people and people with kidney problems

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will carefully evaluate you before starting treatment.

Other medicines and Lenalidomida Teva

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This is because Lenalidomida Teva may affect how other medicines work. In addition, some medicines may affect how Lenalidomida Teva works.

Specifically, inform your doctor or nurse if you are taking any of the following medicines:

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

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking Lenalidomida Teva

• You must not take Lenalidomida Teva if you are pregnant, as it is expected to be harmful to the fetus.
• You must not become pregnant while taking Lenalidomida Teva. Therefore, you must use effective contraceptive methods if there is any possibility you could become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomida Teva, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida Teva

• If your partner becomes pregnant while you are taking Lenalidomida Teva, you must inform your doctor immediately. It is advisable that your partner seeks medical advice.
• You must also use effective contraceptive methods (see “Contraception”).

Breastfeeding

You must not breastfeed while taking Lenalidomida Teva, as it is not known whether Lenalidomida Teva passes into breast milk.

Contraception

For women taking Lenalidomida Teva

Before starting treatment, ask your doctor whether you are capable of becoming pregnant, even if you think this is unlikely.

If you could become pregnant

• you will undergo pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless it has been confirmed that your fallopian tubes have been closed so that eggs cannot reach the uterus (tubal ligation)

And

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, during treatment, and for at least 4 weeks after treatment ends. Your doctor will advise you on the most appropriate contraceptive methods.

For men taking Lenalidomida Teva

Lenalidomide passes into human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, you must use condoms during treatment and for at least 7 days after treatment ends, even if you have had a vasectomy. You must not donate semen or sperm during treatment or for at least 7 days after the end of treatment.

Driving and using machines

Do not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo, or blurred vision after taking Lenalidomida Teva.

Lenalidomida Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; that is, essentially “sodium-free”.

3. How to take Lenalidomide Teva

Lenalidomide Teva must be prescribed and administered by a healthcare professional experienced in the treatment of multiple myeloma, MDS, CMML, or FL.

• When Lenalidomide Teva is used for the treatment of multiple myeloma in patients who cannot undergo a bone marrow transplant or who have received prior treatments, it is taken in combination with other medications (see section 1 “What Lenalidomide Teva is used for”).
• When Lenalidomide Teva is used for the treatment of multiple myeloma in patients who have undergone a bone marrow transplant, or for treating patients with MDS or CMML, it is taken alone.
• When Lenalidomide Teva is used for the treatment of follicular lymphoma, it is taken together with another medicine called “rituximab”.

Always follow your doctor’s instructions exactly for taking Lenalidomide Teva. If you are unsure, consult your doctor or pharmacist.

If you are taking Lenalidomide Teva together with other medicines, you should read the package leaflet of those other medicines for additional information about their use and side effects.

Treatment cycle

Lenalidomide Teva is taken on certain days during a 3-week period (21 days).

• A “treatment cycle” consists of 21 days.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 21-day cycle, you must start a new “cycle” for the following 21 days.

Or

Lenalidomide Teva is taken on certain days during a 4-week period (28 days).

• A “treatment cycle” consists of 28 days.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 28-day cycle, you must start a new “cycle” for the following 28 days.

How much Lenalidomide Teva to take

Before starting treatment, your doctor will inform you:

• how much Lenalidomide Teva you should take
• how much of any other medicines you should take together with Lenalidomide Teva, if applicable
• on which days of the treatment cycle you should take each medicine.

How and when to take Lenalidomide Teva

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken Lenalidomide Teva 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 capsule. Gloves should then be carefully removed to avoid skin exposure, placed into a sealable polyethylene plastic bag, and disposed of according to local requirements. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• The capsules may be taken with or without food.
• You should take Lenalidomide Teva at approximately the same time each scheduled day.

Taking this medicine

To remove the capsule from the blister:

• Press only one end of the capsule so it pushes through the foil.
• Do not press in the center of the capsule, as this may break it.

Duration of treatment with Lenalidomide Teva

Lenalidomide Teva is taken in treatment cycles, each lasting 21 or 28 days (see “Treatment cycle” above). You must continue treatment cycles until your doctor tells you to stop.

If you take more Lenalidomide Teva than you should

If you take more Lenalidomide Teva than prescribed, inform your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Poison Information Service immediately at telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Lenalidomide Teva

If you forget to take Lenalidomide Teva at your usual time and

• less than 12 hours have passed – take the capsule immediately.
• more than 12 hours have passed – do not take the missed capsule. Take the next capsule at your usual time the following day.

If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Lenalidomide Teva may cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects, stop treatment with Lenalidomide Teva and seek immediate medical attention, as you may require emergency medical treatment:

• Hives, rashes, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction
• Severe allergic reaction that may start as a rash in one area but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome). See also section 2.

Contact your doctor immediately if you notice any of the following serious adverse effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection, including in the bloodstream (sepsis)
• Bleeding or bruising not caused by injury
• Chest or leg pain
• Difficulty breathing
• Bone pain, muscle pain, confusion, or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomide Teva may reduce the number of white blood cells that fight infections and also the number of blood cells that help blood to clot (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide Teva may also cause blood clots in the veins (thrombosis).

Other adverse effects

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

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

• A decrease in the number of red blood cells, which may lead to anaemia causing fatigue and weakness
• Skin rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain
• Generalised swelling, including swelling of arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms including fever, muscle pain, headache, earache, cough, and chills
• Numbness, tingling, or burning sensation in the skin, pain in hands or feet, dizziness, tremor
• Loss of appetite, altered taste
• Increased pain, size, or redness around the tumour
• Weight loss
• Constipation, diarrhoea, nausea, vomiting, stomach pain, indigestion
• Low levels of potassium, calcium, and/or sodium in the blood
• Underactive thyroid function
• Leg pain (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be symptoms of blood clots in the lungs, known as pulmonary embolism)
• Infections of all types, including infection of the sinuses around the nose (sinusitis), lung infection, and upper respiratory tract infections
• Difficulty breathing
• Blurred vision
• Clouding of the eye (cataract)
• Kidney problems, including kidneys that do not function properly or are unable to maintain normal function
• Abnormal liver function test results
• High values in liver function tests
• Changes in a blood protein that may cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Low blood pressure
• General feeling of discomfort, feeling unwell
• Painful inflammation of the mouth, dry mouth
• Dehydration

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

• Destruction 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 released following normal or abnormal destruction of red blood cells
• Increased levels of a protein indicating inflammation in the body
• Skin darkening, skin colour changes due to internal bleeding, usually caused by bruising, skin inflammation due to blood accumulation, bruising
• Increased uric acid levels in the blood
• Skin rashes, skin redness, cracked skin, skin peeling or exfoliation, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes
• Runny nose
• Marked increase or decrease in urine output compared to usual, or inability to control urination
• Blood in the urine
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (an inner ear disorder causing a sensation of spinning), temporary loss of consciousness
• Chest pain spreading to arms, neck, jaw, back, or stomach, accompanied by 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
• Slowed or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Loss of balance, movement difficulties
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, abnormal and unpleasant sensation, especially on touch
• Excess iron in the body
• Thirst
• Confusion
• Tooth pain
• Falls that may cause injuries

Adverse 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)
• Yellow pigmentation of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itchy skin, skin rash, stomach pain or swelling – these may be symptoms of liver damage (liver failure)
• Stomach pain, abdominal swelling, or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called renal tubular necrosis)
• Changes in skin colour, sensitivity to sunlight
• Tumour lysis syndrome – metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications result from 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 changes in kidney function and heart rhythm, seizures, and sometimes death
• Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension)

Adverse effects with frequency not known (cannot be estimated from available data):

• Sudden or mild pain in the upper abdomen and/or back that worsens and lasts several days, possibly accompanied by nausea, vomiting, fever, and a rapid pulse. These symptoms may be due to inflammation of the pancreas.

• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of lung tissue.

• Rare cases of muscle breakdown (muscle pain, weakness, or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of them occurring when Lenalidomide Teva is administered with a statin (a type of medicine used to lower cholesterol).

• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).

• Rupture of the wall of the stomach or intestine. This may lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stools, or changes in bowel habits.

• Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful blistering skin rash) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and nausea or feeling unwell).

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomida Teva

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, following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration or evidence of improper handling.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lenalidomide Teva

Lenalidomide Teva 5 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate equivalent to 5 mg of lenalidomide.
• The other components are:

Capsule contents:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule shell:

Gelatin and titanium dioxide (E171)

Printing ink:

Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 10 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate equivalent to 10 mg of lenalidomide.
• The other components are:

Capsule contents:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule shell:

Gelatin, titanium dioxide (E171), yellow iron oxide (E172) and indigo carmine (E132)

Printing ink:

Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 15 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate equivalent to 15 mg of lenalidomide.
• The other components are:

Capsule contents:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule shell:

Gelatin, titanium dioxide (E171) and indigo carmine (E132)

Printing ink:

Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 20 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate equivalent to 20 mg of lenalidomide.
• The other components are:

Capsule contents:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule shell:

Gelatin, titanium dioxide (E171), yellow iron oxide (E172) and indigo carmine (E132)

Printing ink:

Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide and concentrated ammonia solution

Lenalidomide Teva 25 mg hard capsules EFG:

• The active substance is lenalidomide. Each capsule contains lenalidomide hydrochloride hydrate equivalent to 25 mg of lenalidomide.
• The other components are:

Capsule contents:

Colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose and talc

Capsule shell:

Gelatin and titanium dioxide (E171)

Printing ink:

Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide and concentrated ammonia solution

Appearance of the product and contents of the pack

Lenalidomide Teva 5 mg hard capsules EFG are hard, opaque capsules of size "4" (approximately 14.3 mm in length), printed with "5" in black on a white body and white cap, containing a whitish to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 5 mg is available in blister packs containing 7, 21 or 63 hard capsules and in unit-dose blister packs containing 7 x 1, 21 x 1 or 63 x 1 hard capsules.

Lenalidomide Teva 10 mg hard capsules EFG are hard, opaque capsules of size "2" (approximately 18 mm in length), printed with "10" in black on a yellowish body and green cap, containing a whitish to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 10 mg is available in blister packs containing 7, 21 or 63 hard capsules and in unit-dose blister packs containing 7 x 1, 21 x 1 or 63 x 1 hard capsules.

Lenalidomide Teva 15 mg hard capsules EFG are hard, opaque capsules of size "1" (approximately 19.4 mm in length), printed with "15" in black on a white body and blue cap, containing a whitish to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 15 mg is available in blister packs containing 7, 21 or 63 hard capsules and in unit-dose blister packs containing 7 x 1, 21 x 1 or 63 x 1 hard capsules.

Lenalidomide Teva 20 mg hard capsules EFG are hard, opaque capsules of size "0" (approximately 21.7 mm in length), printed with "20" in black on a blue body and green cap, containing a whitish to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 20 mg is available in blister packs containing 21 or 63 hard capsules and in unit-dose blister packs containing 21 x 1 or 63 x 1 hard capsules.

Lenalidomide Teva 25 mg hard capsules EFG are hard, opaque capsules of size "0" (approximately 21.7 mm in length), printed with "25" in black on a white body and white cap, containing a whitish to pale yellow or beige powder or compressed powder.

Lenalidomide Teva 25 mg is available in blister packs containing 7, 21 or 63 hard capsules and in unit-dose blister packs containing 7 x 1, 21 x 1 or 63 x 1 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

89143 Baden-Wuerttemberg

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Austria Lenalidomid TEVA 5 mg Hartkapseln
Lenalidomid TEVA 10 mg Hartkapseln
Lenalidomid TEVA 15 mg Hartkapseln
Lenalidomid TEVA 20 mg Hartkapseln
Lenalidomid TEVA 25 mg Hartkapseln

Belgium Lenalidomide Teva 5 mg harde capsules / gélules / Hartkapseln
Lenalidomide Teva 10 mg harde capsules / gélules / Hartkapseln
Lenalidomide Teva 15 mg harde capsules / gélules / Hartkapseln
Lenalidomide Teva 20 mg harde capsules / gélules / Hartkapseln
Lenalidomide Teva 25 mg harde capsules / gélules / Hartkapseln

Czech Republic Lenalidomid Teva

Germany Lenalidomid-ratiopharm 5 mg Hartkapseln
Lenalidomid-ratiopharm 10 mg Hartkapseln
Lenalidomid-ratiopharm 15 mg Hartkapseln
Lenalidomid-ratiopharm 20 mg Hartkapseln
Lenalidomid-ratiopharm 25 mg Hartkapseln

Denmark Lenalidomide Teva

Estonia Lenalidomide Teva

Spain Lenalidomida Teva 5 mg cápsulas duras EFG
Lenalidomida Teva 10 mg cápsulas duras EFG
Lenalidomida Teva 15 mg cápsulas duras EFG
Lenalidomida Teva 20 mg cápsulas duras EFG
Lenalidomida Teva 25 mg cápsulas duras EFG

Finland Lenalidomide ratiopharm 5 mg kapseli, kova
Lenalidomide ratiopharm 10 mg kapseli, kova
Lenalidomide ratiopharm 15 mg kapseli, kova
Lenalidomide ratiopharm 20 mg kapseli, kova
Lenalidomide ratiopharm 25 mg kapseli, kova

France Lénalidomide Teva 5 mg, gélule
Lénalidomide Teva 10 mg, gélule
Lénalidomide Teva 15 mg, gélule
Lénalidomide Teva 25 mg, gélule

Croatia Lenalidomid Teva 5 mg tvrde kapsule
Lenalidomid Teva 10 mg tvrde kapsule
Lenalidomid Teva 15 mg tvrde kapsule
Lenalidomid Teva 20 mg tvrde kapsule
Lenalidomid Teva 25 mg tvrde kapsule

Hungary Lenalidomid Teva 5 mg kemény kapszula
Lenalidomid Teva 10 mg kemény kapszula
Lenalidomid Teva 15 mg kemény kapszula
Lenalidomid Teva 20 mg kemény kapszula
Lenalidomid Teva 25 mg kemény kapszula

Ireland Lenalidomide Teva 5 mg Hard Capsules
Lenalidomide Teva 10 mg Hard Capsules
Lenalidomide Teva 15 mg Hard Capsules
Lenalidomide Teva 20 mg Hard Capsules
Lenalidomide Teva 25 mg Hard Capsules

Italy LENALIDOMIDE TEVA

Lithuania Lenalidomide Teva 25 mg kietosios kapsules

Latvia Lenalidomide Teva 25 mg cietas kapsulas

Luxembourg Lenalidomide Teva 5 mg gélules dures
Lenalidomide Teva 10 mg gélules dures
Lenalidomide Teva 15 mg gélules dures
Lenalidomide Teva 20 mg gélules dures
Lenalidomide Teva 25 mg gélules dures

Malta Lenalidomide Teva 10 mg Hard Capsules
Lenalidomide Teva 15 mg Hard Capsules
Lenalidomide Teva 25 mg Hard Capsules

Netherlands Lenalidomide Teva 5 mg, harde capsules
Lenalidomide Teva 10 mg, harde capsules
Lenalidomide Teva 15 mg, harde capsules
Lenalidomide Teva 20 mg, harde capsules
Lenalidomide Teva 25 mg, harde capsules

Norway Lenalidomide Teva

Portugal Lenalidomide Teva

Sweden Lenalidomide Teva

Slovenia Lenalidomid Teva 5 mg trde kapsule
Lenalidomid Teva 10 mg trde kapsule
Lenalidomid Teva 15 mg trde kapsule
Lenalidomid Teva 20 mg trde kapsule
Lenalidomid Teva 25 mg trde kapsule

Slovakia Lenalidomide Teva B.V. 5 mg
Lenalidomide Teva B.V. 10 mg
Lenalidomide Teva B.V. 15 mg
Lenalidomide Teva B.V. 25 mg

Iceland Lenalidomide Teva

United Kingdom Lenalidomide 5 mg, 10 mg, 15 mg, 20 mg, 25 mg Hard Capsules
(Northern Ireland)

Date of the most recent review of this leaflet: June 2023

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