Lenalidomide Grindeks 2.5 mg Capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LENALIDOMIDE

Available from:

AS GRINDEKS Krustpils iela 53 Riga, LV-1057 , Latvia

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

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-05-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE GRINDEKS 2.5 MG CAPSULES, HARD
LENALIDOMIDE GRINDEKS 5 MG CAPSULES, HARD
LENALIDOMIDE GRINDEKS 7.5 MG CAPSULES, HARD
LENALIDOMIDE GRINDEKS 10 MG CAPSULES, HARD
LENALIDOMIDE GRINDEKS 15 MG CAPSULES, HARD
LENALIDOMIDE GRINDEKS 20 MG CAPSULES, HARD
LENALIDOMIDE GRINDEKS 25 MG CAPSULES, HARD
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 Grindeks is and what it is used for
2.
What you need to know before you take Lenalidomide Grindeks
3.
How to take Lenalidomide Grindeks
4.
Possible side effects
5.
How to store Lenalidomide Grindeks
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE GRINDEKS IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE GRINDEKS IS
Lenalidomide Grindeks is contains the active substance
‘lenalidomide’. This medicine belongs to a
group of medicines which affect how your immune system works.
WHAT LENALIDOMIDE GRINDEKS IS
USED FOR
Lenalidomide Grindeks is used in adults for:
•
Multiple myeloma
•
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’.
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Newly diagnosed multiple myeloma – i

Summary of Product characteristics

Page 1 of 60
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Grindeks 2.5 mg Capsules, hard
Lenalidomide Grindeks 5 mg Capsules, hard
Lenalidomide Grindeks 7.5 mg Capsules, hard
Lenalidomide Grindeks 10 mg Capsules, hard
Lenalidomide Grindeks 15 mg Capsules, hard
Lenalidomide Grindeks 20 mg Capsules, hard
Lenalidomide Grindeks 25 mg Capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lenalidomide Grindeks 2.5 mg Capsules, hard
Each capsule contains lenalidomide ammonium chloride corresponding to
2.5 mg lenalidomide.
Excipient(s) with known effect
Each capsule contains 20 mg of lactose (as anhydrous lactose).
Lenalidomide Grindeks 5 mg Capsules, hard
Each capsule contains lenalidomide ammonium chloride corresponding to
5 mg lenalidomide.
Excipient(s) with known effect
Each capsule contains 39 mg of lactose (as anhydrous lactose).
Lenalidomide Grindeks 7.5 mg Capsules, hard
Each capsule contains lenalidomide ammonium chloride corresponding to
7.5 mg lenalidomide.
Excipient(s) with known effect
Each capsule contains 59 mg of lactose (as anhydrous lactose).
Lenalidomide Grindeks 10 mg Capsules, hard
Each capsule contains lenalidomide ammonium chloride corresponding to
10 mg lenalidomide.
Excipient(s) with known effect
Each capsule contains 79 mg of lactose (as anhydrous lactose).
Lenalidomide Grindeks 15 mg Capsules, hard
Each capsule contains lenalidomide ammonium chloride corresponding to
15 mg lenalidomide.
Excipient(s) with known effect
Each capsule contains 118 mg of lactose (as anhydrous lactose).
Lenalidomide Grindeks 20 mg Capsules, hard
Each capsule contains lenalidomide ammonium chloride corresponding to
20 mg lenalidomide.
Excipient(s) with known effect
Each capsule contains 157 mg of lactose (as anhydrous lactose).
Lenalidomide Grindeks 25 mg Capsules, hard
Each capsule contains lenalidomide ammonium chloride corresponding to
25 mg lenalidomide.
Excipient(s) with known effect
Each capsule contains 197 mg of lactose (as anhydrous lactose).
For the full list of excipi