Lenalidomide Medac 10 mg harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LENALIDOMIDEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; LENALIDOMIDE

Beschikbaar vanaf:

Medac Pharma s.r.l.

ATC-code:

L04AX04

INN (Algemene Internationale Benaming):

LENALIDOMIDEHYDROCHLORIDE 1-WATER COMPOSITION corresponding to ; LENALIDOMIDE

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lenalidomide

Autorisatie datum:

2019-11-20

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE MEDAC 5 MG HARDE CAPSULES
LENALIDOMIDE MEDAC 10 MG HARDE CAPSULES
LENALIDOMIDE MEDAC 15 MG HARDE CAPSULES
LENALIDOMIDE MEDAC 25 MG HARDE 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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT [PRODUCT NAME] IS
[Product name] contains the active substance ‘lenalidomide’. This
medicine belongs to a group of
medicines which affect how your immune system works.
[Product name] is used in adults for Multiple myeloma.
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 transplant
[Product name] is used on its own as maintenance therapy after
patients have recovered enough
following a bone marrow transplant.
Newly diagnosed multiple myeloma – in patients who cannot have a
bone marrow transplant
[Product name] is taken w

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Medac 5 mg harde capsules
Lenalidomide Medac 10 mg harde capsules
Lenalidomide Medac 15 mg harde capsules
Lenalidomide Medac 25 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 5 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 5 mg of lenalidomide.
[Product name] 10 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 10 mg of lenalidomide.
[Product name] 15 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 15 mg of lenalidomide.
[Product name] 25 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 25 mg of lenalidomide.
Excipients with known effect:
[Product name] 5 mg hard capsules:
Each capsule contains 0.5 mg of sodium.
[Product name] 10 mg hard capsules:
Each capsule contains 0.9 mg of sodium.
[Product name] 15 mg hard capsules:
Each capsule contains 1.35 mg of sodium.
[Product name] 25 mg hard capsules:
Each capsule contains 2.25 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
[Product name] 5 mg hard capsules
Hard, non-transparent capsules, size “4” (approximately 14.3 mm in
length), imprinted in black with ‘5’
on white body and with white cap, containing off-white to pale yellow
or beige powder or compressed
powder.
[Product name] 10 mg hard capsules
Hard, non-transparent capsules, size “2” (approximately 18 mm in
length), imprinted in black with ‘10’
on ivory body and with green cap, containing off-white to pale yellow
or beige powder or compressed
powder.
2
[Product name] 15 mg hard capsules
Hard, non-transparent capsules, size “1” (approximately 19.4 mm in
length), imprinted in black
with ‘15’ on white body and with blue cap, containing off-white to
pale yellow or beige powder or
compressed powder.
[Product name] 25 mg hard capsules
Hard, non-transparent capsu