Lisdexamfetamine CF 20 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LISDEXAMFETAMINEMESILAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; DEXAMFETAMINE 5,9 mg/stuk

INN (Algemene Internationale Benaming):

LISDEXAMFETAMINEMESILAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; DEXAMFETAMINE 5,9 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2023-02-08

Bijsluiter

Centrafarm B.V., Breda, The Netherlands
MODULE 1
Administrative information
and prescribing information
_ _
_LISDEXAMFETAMINE CF 20 MG, harde capsules _
_LISDEXAMFETAMINE CF 30 MG, harde capsules _
_LISDEXAMFETAMINE CF 50 MG, harde capsules _
_LISDEXAMFETAMINE CF 70 MG, harde capsules _
_ _
_SI/H/0240/001/DC - RVG 128857 _
_SI/H/0240/002/DC - RVG 128859 _
_SI/H/0240/004/DC - RVG 128860 _
_SI/H/0240/006/DC - RVG 128861_
losartan / hydrochloorthiazide
1.3.1.3 PACKAGE LEAFLET
1.3.1.3 / 1 VAN
15
Department of
Regulatory Affairs
DATE: 2023-08
AUTHORISATION
CASE MANAGER:
AO
REV. 2.0
APPROVED MEB
PACKAGE LEAFLET: INFORMATION FOR THE USER
LISDEXAMFETAMINE CF 20 MG, HARDE CAPSULES
LISDEXAMFETAMINE CF 30 MG, HARDE CAPSULES
LISDEXAMFETAMINE CF 50 MG, HARDE CAPSULES
LISDEXAMFETAMINE CF 70 MG, HARDE CAPSULES
lisdexamfetamine dimesylate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 lisdexamfetamine
dimesylate which helps with your
brain activity. It helps improve your attention, helps you concentrate
and makes you less impulsive.
This medicine is a long acting medicine which works gradually over a
13 hour time period.
WHAT [PRODUCT NAME] IS USED FOR
[Product Name] is

Productkenmerken

Centrafarm B.V., Breda, The Netherlands
MODULE 1
Administrative information
and prescribing information
_LISDEXAMFETAMINE CF 20 MG, harde capsules _
_LISDEXAMFETAMINE CF 30 MG, harde capsules _
_LISDEXAMFETAMINE CF 50 MG, harde capsules _
_LISDEXAMFETAMINE CF 70 MG, harde capsules _
_SI/H/0240/001/DC - RVG 128857 _
_SI/H/0240/002/DC - RVG 128859 _
_SI/H/0240/004/DC - RVG 128860 _
_SI/H/0240/006/DC - RVG 128861_
losartan / hydrochloorthiazide
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.3.1.1 / 1 VAN
23
Department of
Regulatory Affairs
DATE: 2023-08
AUTHORISATION
CASE MANAGER:
AO
REV. 2.0
APPROVED MEB
1.
NAME OF THE MEDICINAL PRODUCT
Lisdexamfetamine CF 20 mg, harde capsules
Lisdexamfetamine CF 30 mg, harde capsules
Lisdexamfetamine CF 50 mg, harde capsules
Lisdexamfetamine CF 70 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product Name] 20 mg capsules:
Each capsule contains 20 mg lisdexamfetamine dimesylate, equivalent to
5.9 mg of dexamfetamine.
[Product Name] 30 mg capsules:
Each capsule contains 30 mg lisdexamfetamine dimesylate, equivalent to
8.9 mg of dexamfetamine.
[Product Name] 40 mg capsules:
Each capsule contains 40 mg lisdexamfetamine dimesylate, equivalent to
11.9 mg of dexamfetamine.
[Product Name] 50 mg capsules:
Each capsule contains 50 mg lisdexamfetamine dimesylate, equivalent to
14.8 mg of dexamfetamine.
[Product Name] 60 mg capsules:
Each capsule contains 60 mg lisdexamfetamine dimesylate, equivalent to
17.8 mg of dexamfetamine.
[Product Name] 70 mg capsules:
Each capsule contains 70 mg lisdexamfetamine dimesylate, equivalent to
20.8 mg of dexamfetamine.
Excipient with known effect
Product Name] 40 mg capsules:
Each capsule contains 0.0019 mg Allura red AC (E129). per capsule
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
[Product Name] 20 mg capsule
White cap and white body, “ALV” printed axially on the white cap,
“563” printed axially on the white
body, all printing in grey ink and containing white to pale yellow
powder.
Cent