Leaflet: information for the user
Lenalidomida Zentiva 5 mg hard capsules EFG
lenalidomida
Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
-Keep this leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1. What Lenalidomida Zentiva is and what it is used for
2. What you need to know before taking Lenalidomida Zentiva
3. How to take Lenalidomida Zentiva
4. Possible side effects
5. Storage of Lenalidomida Zentiva
6. Contents of the pack and additional information
What isLenalidomidaZentiva
Lenalidomida Zentiva contains the active ingredient “lenalidomida”. This medicine belongs to a group of medicines that affect how the immune system works.
What is LenalidomidaZentiva used for
Lenalidomida is used in adults for:
Multiple myeloma
Multiple myeloma is a type of cancer that affects a specific type of white blood cell in the blood called plasma cells. These cells accumulate in the bone marrow and multiply, becoming uncontrolled. This can damage bones and kidneys.
Multiple myeloma is usually not curable. However, the symptoms and signs can be greatly reduced or disappear for a period of time. This is called “remission”.
Multiple myeloma newly diagnosed: in patients who have undergone a bone marrow transplant
Lenalidomida is used as maintenance treatment after recovering adequately from a bone marrow transplant.
Multiple myeloma newly diagnosed: in patients who cannot be treated with a bone marrow transplant
Lenalidomida is taken with other medicines:
You will take these medicines when starting treatment and then continue taking lenalidomida only.
If you are 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.
Multiple myeloma: in previously treated patients
Lenalidomida is taken with an anti-inflammatory called “dexametasona”.
Lenalidomida can slow the worsening of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.
Myleodysplastic syndromes (MDS)
MDS are a group of many different blood and bone marrow diseases. Blood cells become abnormal and do not function correctly. Patients may experience a variety of symptoms, including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.
Lenalidomida is used to treat adult patients diagnosed with MDS, when all the following points are applicable:
Lenalidomida can increase the number of healthy red blood cells produced by the body by reducing the number of abnormal cells:
Diffuse large B-cell lymphoma (DLBCL)
DLBCL is a cancer of a part of the immune system (lymphoid tissue). It affects a type of white blood cell in the blood called B lymphocytes or B cells. DLBCL is a disease in which B cells grow uncontrollably and accumulate in lymphoid tissue, bone marrow, or blood.
Lenalidomida is used in monotherapy to treat adult patients who have received previous treatment with other medicines.
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 store too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomida is used with another medicine called “rituximab” for the treatment of adult patients who have received previous treatment for follicular lymphoma.
How Lenalidomida Zentiva works
Lenalidomida acts by affecting the body's immune system and directly attacking cancer.
It acts in several ways:
You must read the leaflet for all the medicines you are going to take in combination with lenalidomida before starting the treatment with lenalidomida.
Do not take Lenalidomida Zentiva:
If any of these conditions apply to you, do not take lenalidomida. In case of doubt, consult your doctor.
Warnings and precautions
Consult your doctor, pharmacist or nurse before starting to take lenalidomida if:
If any of the above conditions apply to you, inform your doctor before starting treatment.
At any time, during or after treatment, inform your doctor or nurse immediately if you experience:
Analysis and tests
Before starting treatment with lenalidomida and during it, you will have regular blood tests, as lenalidomida may cause a decrease in the blood cells that help fight infections (white blood cells) and those that participate in coagulation (platelets).
Your doctor will ask you to have a blood test:
You may be evaluated to detect signs of cardiopulmonary problems before and during treatment with lenalidomida.
For patients with MDS who take Lenalidomida Zentiva
If you have MDS, you may be more prone to developing a more advanced disease called acute myeloid leukemia (AML). Additionally, it is unknown how lenalidomida affects the likelihood of developing AML. Your doctor may perform tests to detect signs that may better predict the likelihood of developing AML during treatment with lenalidomida.
For patients with MCL who take Lenalidomida Zentiva
Your doctor will ask you to have a blood test:
at least once a month.
For patients with MM who take Lenalidomida Zentiva
Your doctor will ask you to have a blood test:
Your doctor may check if you have a high total tumor burden in the body, including the bone marrow. This could lead to a disease in which the tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may cause kidney failure (this disease is called “tumor lysis syndrome”).
Your doctor may examine you to check if any changes have occurred in your skin, such as red spots or skin rashes.
Your doctor may adjust your lenalidomida dose or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a new diagnosis patient, your doctor may also evaluate your treatment based on your age and any other conditions you already have.
Blood donation
You must not donate blood during treatment or for 1 week after the end of treatment.
Children and adolescents
Lenalidomida is not recommended for use in children and adolescents under 18 years old.
Older people and people with kidney problems
If you are 75 years old or more or have moderate to severe kidney problems, your doctor will examine you carefully before starting treatment.
Taking Lenalidomida Zentiva with other medicines
Inform your doctor or nurse if you are taking or have recently taken any other medicine. This is because lenalidomida may affect the way other medicines work. Additionally, some medicines may affect the way lenalidomida works.
In particular, inform your doctor or nurse if you are taking any of the following medicines:
Pregnancy, breastfeeding and contraception: information for women and men
Pregnancy
Women taking Lenalidomida Zentiva
Men taking Lenalidomida Zentiva
Breastfeeding
You must not breastfeed while taking lenalidomida, as it is unknown whether lenalidomida passes into breast milk.
Contraception
For women taking Lenalidomida Zentiva
Before starting treatment, ask your doctor if you are capable of becoming pregnant, although you may think this is unlikely.
If you can become pregnant
And
For men taking Lenalidomida Zentiva
Lenalidomida passes into human semen. If your partner becomes pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for 1 week after finishing treatment, even if you have had a vasectomy.
Driving and using machines
You must not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking lenalidomida.
Lenalidomida Zentiva contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is, essentially “sodium-free”.
Lenalidomide should be administered by a healthcare professional experienced in the treatment of multiple myeloma, SMD, LCM or LF.
Follow exactly the administration instructions for lenalidomide indicated by your doctor.In case of doubt, consult your doctor or pharmacist.
If you are taking lenalidomide with other medications, you must consult the prospectus of those other medications to obtain additional information on their use and effects.
Treatment Cycle
Lenalidomide is taken on certain days during the period of 3 weeks (21 days).
Or
Lenalidomide is taken on certain days during the period of 4 weeks (28 days).
How Much Lenalidomide Zentiva to Take
Before starting treatment, your doctor will indicate:
How and When to Take Lenalidomide Zentiva
Administration of this Medication
To remove the capsule from the blister:
Duration of Treatment with Lenalidomide Zentiva
Lenalidomide 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 informs you to stop treatment.
If You Take More Lenalidomide Zentiva Than You Should
If you take more lenalidomide than prescribed, inform your doctor immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested
If You Forget to Take Lenalidomide
If you forget to take lenalidomide at your usual time and
If you have any other doubts about the use of thismedication, ask your doctororpharmacist.
Like all medicines, lenalidomide can cause side effects, although not everyone will experience them.
Stop taking lenalidomide and consult a doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment:
- Hives, skin rashes, swelling of the eyes, mouth, or face, difficulty breathing or itching, which can be symptoms of severe allergic reactions called angioedema and anaphylaxis.
- A severe allergic reaction that can start as a rash in an area but spread with a large loss of skin throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
- Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ dysfunction (pharmacological reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome). See also section 2.
Inform your doctor immediatelyif you experience any of the following adverse reactions:
Lenalidomide can reduce the number of white blood cells (blood cells that fight infections),red blood cells (blood cells that transport oxygen)and also platelets (cells that help blood to clot).Lenalidomide can also cause blood clots in the veins (thrombosis).
Other side effects
It is essential to note that a reduced number of patients may develop other types of cancer, and it is possible that this risk may increase with lenalidomide treatment. Therefore, your doctor must carefully evaluate the benefits and risks of prescribing lenalidomide to you.
Side effectsvery common(can affect more than 1 in 10 people):
Side effectscommon(can affect up to 1 in 10 people):
Side effectsuncommon(can affect up to 1 in 100 people):
Unknown frequency(cannot be estimated from available data):
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish Medicines Vigilance System for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the blister pack and the box after “CAD”/“EXP”. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Do not use this medication if you observe visible signs of deterioration or signs of improper handling.
Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.
Composition of Lenalidomida Zentiva5 mg hard EFG capsules
Appearance of the product and contents of the package
The 5 mg hard capsules have an opaque green cap and a light brown opaque body, with a capule size of 2, 18-19 mm, printed in black ink with “LP” on the cap and “638” on the body.
The capsules are presented in carton boxes with PVC/PCTFE/Aluminium blisters of 7 capsules each.
21 capsules in PVC/PCTFE/Aluminium blisters.
21x1 capsules in perforated single-dose PVC/PCTFE/Aluminium blisters.
7 capsules in PVC/PCTFE/Aluminium blisters.
Only some package sizes may be marketed.
Marketing authorization holder and responsible person for manufacturing
Marketing authorization holder
Zentiva k.s.,
U kabelovny 130,
Dolní Mecholupy,
102 37 Prague 10
Czech Republic
Responsible person for manufacturing
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
or
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:
Zentiva Spain S.L.U.
Avenida de Europa, 19, Edificio 3, Planta 1.
28224 Pozuelo de Alarcón, Madrid
Spain
This medicinal product is authorized in the Member States of the EEA with the following names:
IslandiaLenalidomid Aristo 5 mg hörð hylki
AustriaLenalidomid Aristo 5 mg Hartkapseln
CroatiaLenalidomid Aristo 5 mg tvrde kapsule
DenmarkLenalidomid Aristo
GermanyLenalidomid Aristo 5 mg Hartkapseln
ItalyLenalidomid Aristo
NorwayLenalidomid Aristo 5 mg harde kapsler
SpainLenalidomida Zentiva 5 mg cápsulas duras EFG
SwedenLenalidomid Aristo 5 mg hårda kapslar
Last revision date of this leaflet:July 2022
Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
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