Lenalidomide Teva 20 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 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, as 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 this 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 is Lenalidomida Teva

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 is generally not curable. 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 myel游戏副本

2. What you need to know before starting Lenalidomida Teva

You must read the package leaflet of all medications 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 are capable of becoming pregnant, unless you follow all necessary measures to prevent pregnancy (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you are capable of becoming pregnant, your doctor will document 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 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 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, 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 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, or balance problems, persistent numbness, decreased sensation, or loss of sensation, memory loss, or confusion. These may 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 can cause a decrease in blood cells that help fight infections (white blood cells) and those involved in blood clotting (platelets).

Your doctor will request 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 unknown how Lenalidomida Teva affects your risk of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict your risk of developing AML during treatment with Lenalidomida Teva.

For patients with MM taking Lenalidomida Teva

Your doctor will request blood tests:

• before treatment
• every week during the first 8 weeks (2 cycles) of treatment
• thereafter, 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 request blood tests:

• before treatment
• every week during the first 3 weeks (1 cycle) of treatment
• thereafter, 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 total 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 changes in your skin, 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 treatment ends.

Children and adolescents

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

Elderly patients and patients 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

Inform 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 unknown 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 are capable of becoming pregnant

• you 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), unless it has been confirmed that your fallopian tubes are permanently 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, throughout 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 treatment ends.

Driving and use of 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 are not eligible for bone marrow transplantation or who have received prior treatment, it is taken in combination with other medicines (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 bone marrow transplantation 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 in combination with another medicine called “rituximab”.

Always follow exactly the dosing instructions provided by your doctor. If you are unsure, consult your doctor or pharmacist.

If you are taking Lenalidomide Teva together with other medicines, you should refer to the package leaflet of those medicines for additional information on their use and possible effects.

Treatment cycle

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

• A “treatment cycle” consists of 21 days.
• Depending on the day of the cycle, you may 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 within a 4-week period (28 days).

• A “treatment cycle” consists of 28 days.
• Depending on the day of the cycle, you may 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:

• of the dose of Lenalidomide Teva you should take
• of the dose of any other medicines you should take in combination 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 affected area 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. Afterwards, hands should 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 day on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

• Press only on one end of the capsule so that it comes 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 cycle lasting 21 or 28 days (see “Treatment cycle” above). You must continue the treatment cycles until your doctor instructs you to stop treatment.

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 Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lenalidomide Teva

If you forget to take your dose of Lenalidomide Teva at the usual time:

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

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

4. Possible adverse effects

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

If you experience any of the following serious adverse effects, stop treatment with Lenalidomide Teva and seek medical attention immediately, as you may require urgent 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, leading to extensive 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 due to 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 reduce 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 possibly 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 tiredness 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, heartburn
• 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 a symptom 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 (cataracts)
• Kidney problems including kidneys not functioning properly or unable to maintain normal function
• Abnormal results in liver function tests
• High results in liver function tests
• Changes in a blood protein which 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
• High blood pressure, slow, fast or irregular heartbeat
• Increased levels of a substance released after normal or abnormal destruction of red blood cells
• Increase in a type of 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 in the blood
• Skin rashes, skin redness, cracked skin, peeling or flaking skin, 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
• Breathing difficulty especially when lying down (which could be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (inner ear disorder causing a spinning sensation), temporary loss of consciousness
• Chest pain spreading to arms, neck, jaw, back or stomach, sweating, shortness of breath, nausea or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Joint swelling
• 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, 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 arise 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, occasionally, death
• Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension)

Adverse effects of unknown frequency (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 which occurred when Lenalidomide Teva was 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 stomach or intestinal wall. This may lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools or changes in bowel habits.

• Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful blistering 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, nausea or feeling unwell).

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

Reporting of adverse effects

If you experience any adverse effect, talk to 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 the outer 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 should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help 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 monohydrate 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 monohydrate 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 monohydrate 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 monohydrate 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 monohydrate 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

Nature of the product and contents of the pack

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

Lenalidomide Teva 10 mg hard capsules EFG are hard, non-transparent capsules, size “2” (approximately 18 mm in length), printed with “10” in black on a yellowish body and green cap, containing a white to pale yellow or beige powder or compressed powder.

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

Lenalidomide Teva 20 mg hard capsules EFG are hard, non-transparent capsules, size “0” (approximately 21.7 mm in length), printed with “20” in black on a blue body and green cap, containing a white to pale yellow or beige powder or compressed powder.

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

Pack sizes:

Lenalidomide Teva 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 Member States of the European Economic Area 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

The 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 revision 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/)