Lenalidomide Teva 5 mg hard capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-07-2023
Summary of Product characteristics
(SPC)
01-02-2024
Active ingredient:
Lenalidomide
Available from:
Teva B.V.
ATC code:
L04AX; L04AX04
INN (International Name):
Lenalidomide
Dosage:
5 milligram(s)
Pharmaceutical form:
Capsule, hard
Therapeutic area:
Other immunosuppressants; lenalidomide
Authorization status:
Marketed
Authorization date:
2019-05-03
Patient Information leaflet
1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE TEVA 2.5 MG HARD CAPSULES
LENALIDOMIDE TEVA 5 MG HARD CAPSULES
LENALIDOMIDE TEVA 7.5 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
lenalidomide
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT LENALIDOMIDE TEVA IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LENALIDOMIDE TEVA
3.
HOW TO TAKE LENALIDOMIDE TEVA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LENALIDOMIDE TEVA
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LENALIDOMIDE TEVA IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE TEVA IS
Lenalidomide Teva contains the active substance ‘lenalidomide’.
This medicine belongs to a group of
medicines which affect how your immune system works.
WHAT LENALIDOMIDE TEVA IS USED FOR
Lenalidomide Teva is used in adults for
•
Multiple myeloma
•
Myelodysplastic syndromes
•
Mantle cell lymphoma
•
Follicular lymphoma
MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain kind of
white blood cell, called the plasma
cell. These cells collect in the bone marrow and divide, becoming out
of control. This can damage the
bones and kidneys.
Multiple myeloma generally cannot be cured. However, the signs and
symptoms can be greatly reduced
or disappear for a period of time. This is called a ‘response’.
Newly diagnosed multiple myeloma – in patients who hav
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Summary of Product characteristics
HealthProductsRegulatoryAuthority
01February2024
CRN00F28W
Page1of53
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
LenalidomideTeva5mgHardCapsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachcapsulecontainslenalidomidehydrochloridehydratecorrespondingto2.5
mgoflenalidomide
Excipientswithknowneffect:
LenalidomideTeva2.5mghardcapsules:
Eachcapsulecontains0.5mgofsodium.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Hardcapsule.
Hard,non-transparentcapsules,size"4"(approximately14.3
mminlength),imprintedinblackwith
'5'onwhitebodyandwith
whitecap,containingoff-whitetopaleyelloworbeigepowderorcompressedpowder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Multiplemyeloma
Lenalidomideasmonotherapyisindicatedforthemaintenancetreatmentofadultpatientswithnewlydiagnosedmultiple
myelomawhohaveundergoneautologousstemcelltransplantation.
Lenalidomideascombinationtherapywithdexamethasone,orbortezomibanddexamethasone,ormelphalanandprednisone
(seesection4.2)isindicatedforthetreatmentofadultpatientswithpreviouslyuntreatedmultiplemyelomawhoarenot
eligiblefortransplant.
Lenalidomideincombinationwithdexamethasoneisindicatedforthetreatmentofmultiplemyelomainadultpatientswho
havereceivedatleastonepriortherapy.
Follicularlymphoma
Lenalidomideincombinationwithrituximab(anti-CD20antibody)isindicatedforthetreatmentofadultpatientswith
previouslytreatedfollicularlymphoma(Grade1–3a).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
LenalidomideTevatreatmentshouldbesupervisedbyaphysicianexperiencedintheuseofanti-cancertherapies.
Forallindicationsdescribedbelow:
Doseismodifiedbaseduponclinical
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