Lenalidomide Fresenius Kabi 2.5 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LENALIDOMIDE

Available from:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC code:

L04AX04

INN (International Name):

LENALIDOMIDE 2.5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

LENALIDOMIDE 2.5 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Authorised

Authorization date:

2018-11-06

Patient Information leaflet

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

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Fresenius Kabi 2.5 mg hard capsules
Lenalidomide Fresenius Kabi 5 mg hard capsules
Lenalidomide Fresenius Kabi 7.5 mg hard capsules
Lenalidomide Fresenius Kabi 10 mg hard capsules
Lenalidomide Fresenius Kabi 15 mg hard capsules
Lenalidomide Fresenius Kabi 20 mg hard capsules
Lenalidomide Fresenius Kabi 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2.5 mg of lenalidomide.
Each capsule contains 5 mg of lenalidomide.
Each capsule contains 7.5 mg of lenalidomide.
Each capsule contains 10 mg of lenalidomide.
Each capsule contains 15 mg of lenalidomide.
Each capsule contains 20 mg of lenalidomide.
Each capsule contains 25 mg of lenalidomide.
Excipient(s) with known effect:
Each capsule contains 33.2 mg of lactose.
Each capsule contains 66.4 mg of lactose.
Each capsule contains 99.7 mg of lactose.
Each capsule contains 132.9 mg of lactose.
Each capsule contains 199.3 mg of lactose.
Each capsule contains 265.8 mg of lactose.
Each capsule contains 332.2 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Opaque white body and opaque green to light green cap, with a length
of approximately14.3 mm, marked
“L9NL” and “2.5”.
Opaque white body and opaque white cap, with a length of approximately
18.0 mm, marked “L9NL” and “5”.
Opaque white body and opaque yellow cap, with a length of
approximately 18.0 mm, marked “L9NL” and
“7.5”.
Opaque yellow body and opaque green to light green cap, with a length
of approximately 21.7 mm, marked
“L9NL” and “10”.
Opaque white body and opaque blue to light blue cap, with a length of
approximately 21.7 mm, marked “L9NL”
and “15”.
Opaque blue to light blue body and opaque green to light green cap,
with a length of approximately 21.7 mm,
marked “L9NL” and “20”.
Opaque white body and opaque white cap, with a length of approximately
21.7 mm, marked “L9NL” and “25”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDI