Lisdexamfetamine Teva 30 mg, harde capsules

Quốc gia: Hà Lan

Ngôn ngữ: Tiếng Hà Lan

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

Thành phần hoạt chất:

LISDEXAMFETAMINEMESILAAT 30 mg/stuk SAMENSTELLING overeenkomend met ; LISDEXAMFETAMINE 17,3 mg/stuk ; SAMENSTELLING overeenkomend met DEXAMFETAMINE 8,9 mg/stuk

INN (Tên quốc tế):

LISDEXAMFETAMINEMESILAAT 30 mg/stuk SAMENSTELLING overeenkomend met ; LISDEXAMFETAMINE 17,3 mg/stuk ; SAMENSTELLING overeenkomend met DEXAMFETAMINE 8,9 mg/stuk

Dạng dược phẩm:

Capsule, hard

Thành phần:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Tuyến hành chính:

Oraal gebruik

Ngày ủy quyền:

1900-01-01

Tờ rơi thông tin

Rvg 129369-70-1-2-3-4 EU PIL IA-004 met NL info-clean
PACKAGE LEAFLET: INFORMATION FOR THE USER
LISDEXAMFETAMINE TEVA 20 MG, HARDE CAPSULES
LISDEXAMFETAMINE TEVA 30 MG, HARDE CAPSULES
LISDEXAMFETAMINE TEVA 40 MG, HARDE CAPSULES
LISDEXAMFETAMINE TEVA 50 MG, HARDE CAPSULES
LISDEXAMFETAMINE TEVA 60 MG, HARDE CAPSULES
LISDEXAMFETAMINE TEVA 70 MG, HARDE CAPSULES
lisdexamfetamine dimesylate
IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE
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
7.
Information for children and young people
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.
[Product name] is a long acting medicine which works gradually over a
13 hour time period.
WHAT IT IS USED FOR
[Product name] is a treatment for ‘attention deficit hyperactivity
disorder’ (ADHD). It is used:
•
in children and young people between the ages of 6 and 18 who have
previously taken a
methylphenidate treatment that inadequately treated their ADHD. You
may continue to take
[Product name] into adulthood if your doctor thinks you are benefiting
from treatment.

Đặc tính sản phẩm

Rvg 129369-70-1-2-3-4 EU SPC IA/004 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAAM VAN HET GENEESMIDDEL
Lisdexamfetamine Teva 20 mg, harde capsules
Lisdexamfetamine Teva 30 mg, harde capsules
Lisdexamfetamine Teva 40 mg, harde capsules
Lisdexamfetamine Teva 50 mg, harde capsules
Lisdexamfetamine Teva 60 mg, harde capsules
Lisdexamfetamine Teva 70 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
20 mg Capsules: Each capsule contains 20 mg lisdexamfetamine
dimesylate, equivalent to 5.9 mg of
dexamfetamine.
30 mg Capsules: Each capsule contains 30 mg lisdexamfetamine
dimesylate, equivalent to 8.9 mg of
dexamfetamine.
40 mg Capsules: Each capsule contains 40 mg lisdexamfetamine
dimesylate, equivalent to 11.9 mg of
dexamfetamine.
50 mg Capsules: Each capsule contains 50 mg lisdexamfetamine
dimesylate, equivalent to 14.8 mg of
dexamfetamine.
60 mg Capsules: Each capsule contains 60 mg lisdexamfetamine
dimesylate, equivalent to 17.8 mg of
dexamfetamine.
70 mg Capsules: Each capsule contains 70 mg lisdexamfetamine
dimesylate, equivalent to 20.8 mg of
dexamfetamine.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule, hard.
20 mg capsule: Yellow body and yellow cap, printed ‘TEV' and '20 mg'
in black ink.
30 mg capsule: White body and orange cap, printed 'TEV' and '30 mg' in
black ink.
40 mg capsule: White body and green cap, printed 'TEV' and '40 mg' in
black ink.
50 mg capsule: White body and blue cap, printed 'TEV' and '50 mg' in
black ink.
60 mg capsule: Light blue body and light blue cap, printed 'TEV' and
'60 mg' in black ink.
70 mg capsule: Blue body and orange cap, printed 'TEV' and '70 mg' in
black ink.
Each capsule measures approximately 19 mm x 6mm.
4.
CLINICAL PARTICULARS
Rvg 129369-70-1-2-3-4 EU SPC IA/004 met NL info-clean
4.1
THERAPEUTIC INDICATIONS
[Product name] is indicated as part of a comprehensive treatment
programme for attention
deficit/hyperactivity disorder (ADHD) in children aged 6 years and
over when response to previous
methylphenidate