Lenalidomide Gedeon Richter 5 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LENALIDOMIDE

Available from:

Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary

ATC code:

L04AX04

INN (International Name):

LENALIDOMIDE 5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

LENALIDOMIDE 5 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-08-18

Patient Information leaflet

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

Summary of Product characteristics

Page 1 of 59
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Gedeon Richter 2.5 mg hard capsules
Lenalidomide Gedeon Richter 5 mg hard capsules
Lenalidomide Gedeon Richter 7.5 mg hard capsules
Lenalidomide Gedeon Richter 10 mg hard capsules
Lenalidomide Gedeon Richter 15 mg hard capsules
Lenalidomide Gedeon Richter 20 mg hard capsules
Lenalidomide Gedeon Richter 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lenalidomide Gedeon Richter 2.5 mg hard capsules
Each capsule contains 2.5 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 53.5 mg of lactose and 0.0274 mg Allura red AC
(E129).
Lenalidomide Gedeon Richter 5 mg hard capsules
Each capsule contains 5 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 107 mg of lactose and 0.0277 mg Sunset yellow
FCF (E110).
Lenalidomide Gedeon Richter 7.5 mg hard capsules
Each capsule contains 7.5 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 160.5 mg of lactose and 0.023 mg Sunset yellow
FCF (E110).
Lenalidomide Gedeon Richter 10 mg hard capsules
Each capsule contains 10 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 214 mg of lactose, 0.0436 mg tartrazine (E102),
0.0119 mg Sunset yellow FCF (E110)
and 0.0153 mg Allura red AC (E129).
Lenalidomide Gedeon Richter 15 mg hard capsules
Each capsule contains 15 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 120 mg of lactose, 0.0032 mg tartrazine (E102)
and 0.0058 mg Allura red AC (E129).
Lenalidomide Gedeon Richter 20 mg hard capsules
Each capsule contains 20 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 160 mg of lactose and 0.0011 mg Allura red AC
(E129).
Lenalidomide Gedeon Richter 25 mg hard capsules
Each capsule contains 25 mg of lenalidomide.
Excipient with known effect:
Each capsule contains 200 mg of lactose.
For the full list of excipients, see section 6.1.
Page 2 of 59
3.
PHARMACEUTICAL FORM
Hard capsule.
Lenalidomide Gedeon Richter 2.5 mg hard capsules
A dark blue opa