Lenalidomide Clonmel 2.5 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lenalidomide

Available from:

Clonmel Healthcare Ltd

ATC code:

L04AX04

INN (International Name):

Lenalidomide

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

lenalidomide

Authorization status:

Not marketed

Authorization date:

2021-04-30

Patient Information leaflet

Page 1 of 13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Lenalidomide Clonmel 2.5 mg Hard Capsules
Lenalidomide Clonmel 5 mg Hard Capsules
Lenalidomide Clonmel 7.5 mg Hard Capsules
Lenalidomide Clonmel 10 mg Hard Capsules
Lenalidomide Clonmel 15 mg Hard Capsules
Lenalidomide Clonmel 20 mg Hard Capsules
Lenalidomide Clonmel 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 Clonmel is and what it is used for
2. What you need to know before you take Lenalidomide Clonmel
3. How to take Lenalidomide Clonmel
4. Possible side effects
5. How to store Lenalidomide Clonmel
6. Contents of the pack and other information
1. WHAT LENALIDOMIDE CLONMEL IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE CLONMEL IS
Lenalidomide Clonmel contains the active substance ‘lenalidomide’.
This medicine belongs to a group
of medicines which affect how your immune system works.
WHAT LENALIDOMIDE CLONMEL IS USED FOR
Lenalidomide Clonmel 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

Summary of Product characteristics

Health Products Regulatory Authority
10 October 2023
CRN00DP5N
Page 1 of 52
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lenalidomide Clonmel 2.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2.5 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 53.5 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
A dark blue opaque cap and light orange opaque body, capsule shell
size No. 4, 14‑15 mm, imprinted in black ink with "LP" on
the cap and "637" on the body and filled with white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Multiple myeloma
Lenalidomide Clonmel as monotherapy is indicated for the maintenance
treatment of adult patients with newly diagnosed
multiple myeloma who have undergone autologous stem cell
transplantation.
Lenalidomide Clonmel 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 Clonmel 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 Clonmel 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 Clonmel 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 Clonmel 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 POSO