Lenalidomide Rowex 10 mg hard capsules

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Lenalidomide

Disponible depuis:

Rowex Ltd

Code ATC:

L04AX04

DCI (Dénomination commune internationale):

Lenalidomide

Dosage:

10 milligram(s)

forme pharmaceutique:

Capsule, hard

Domaine thérapeutique:

lenalidomide

Statut de autorisation:

Marketed

Date de l'autorisation:

2021-06-04

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE ROWEX 2.5 MG HARD CAPSULES
LENALIDOMIDE ROWEX 5 MG HARD CAPSULES
LENALIDOMIDE ROWEX 7.5 MG HARD CAPSULES
LENALIDOMIDE ROWEX 10 MG HARD CAPSULES
LENALIDOMIDE ROWEX 15 MG HARD CAPSULES
LENALIDOMIDE ROWEX 20 MG HARD CAPSULES
LENALIDOMIDE ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you take Lenalidomide Rowex
3.
How to take Lenalidomide Rowex
4.
Possible side effects
5.
How to store Lenalidomide Rowex
6.
Contents of the pack and other information
1
WHAT LENALIDOMIDE ROWEX IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE ROWEX IS
Lenalidomide Rowex contains the active substance lenalidomide. This
medicine belongs to a group of
medicines which affect how your immune system works.
WHAT LENALIDOMIDE ROWEX IS USED FOR
Lenalidomide Rowex 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 have had a bone
marrow t

Résumé des caractéristiques du produit

Health Products Regulatory Authority
18 July 2023
CRN00DJ8K
Page 1 of 57
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lenalidomide Rowex 10 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg of lenalidomide.
Excipient with known effect
Each hard capsule contains 132.9 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Opaque yellow body and opaque green to light green cap, with a length
of approximately 21.7 mm, marked "L9NL" and "10".
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Multiple myeloma
Lenalidomide Rowex as monotherapy is indicated for the maintenance
treatment of adult patients with newly diagnosed
multiple myeloma who have undergone autologous stem cell
transplantation.
Lenalidomide Rowex as combination therapy with dexamethasone, or
bortezomib and dexamethasone, or melphalan and
prednisone (see section 4.2) is indicated for the treatment of adult
patients with previously untreated multiple myeloma who
are not eligible for transplant.
Lenalidomide Rowex in combination with dexamethasone is indicated for
the treatment of multiple myeloma in adult patients
who have received at least one prior therapy.
Myelodysplastic syndromes
Lenalidomide Rowex as monotherapy is indicated for the treatment of
adult patients with transfusion-dependent anaemia due
to low- or intermediate-1-risk myelodysplastic syndromes associated
with an isolated deletion 5q cytogenetic abnormality
when other therapeutic options are insufficient or inadequate.
Mantle cell lymphoma
Lenalidomide Rowex as monotherapy is indicated for the treatment of
adult patients with relapsed or refractory mantle cell
lymphoma (see sections 4.4 and 5.1).
Follicular lymphoma
Lenalidomide Rowex in combination with rituximab (anti-CD20 antibody)
is indicated for the treatment of adult patients with
previously treated follicular lymphoma (grade 1 – 3a).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lenalidomide Rowex treatment should be sup