Lisdexamfetamine Teva 70 mg, harde capsules

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

LISDEXAMFETAMINEMESILAAT 70 mg/stuk SAMENSTELLING overeenkomend met ; DEXAMFETAMINE 20,8 mg/stuk

INN (Nama Internasional):

LISDEXAMFETAMINEMESILAAT 70 mg/stuk SAMENSTELLING overeenkomend met ; DEXAMFETAMINE 20,8 mg/stuk

Bentuk farmasi:

Capsule, hard

Komposisi:

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) ; INDIGOKARMIJN (E 132) ; 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) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Rute administrasi :

Oraal gebruik

Tanggal Otorisasi:

2023-04-03

Selebaran informasi

1
rvg 129375-6-7 EU PIL IA/003 met NL info-clean
PACKAGE LEAFLET: INFORMATION FOR THE USER
LISDEXAMFETAMINE TEVA 30 MG, HARDE CAPSULES
LISDEXAMFETAMINE TEVA 50 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, for more information.
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.
[Product name] is a long acting medicine which works gradually over a
14 hour time period.
WHAT IT IS USED FOR
[Product name] is a treatment for ‘attention deficit hyperactivity
disorder’ (ADHD) in adults.
You must talk to a doctor if you do not feel better or if you feel
worse after one month of treatment.
For children and adolescents aged 6 to 17 years, another product
containing lisdexamfetamine
dimesylate is available. [Product name] is not used as a treatment for
ADHD in children under 6 years
of age because it is not known if it is safe or of benefit in such
young people.
How it works
[Product name] improves the activity

Karakteristik produk

Rvg 129375-6-7 EU SPC IA/003 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Lisdexamfetamine Teva 30 mg, harde capsules
Lisdexamfetamine Teva 50 mg, harde capsules
Lisdexamfetamine Teva 70 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
30 mg Capsules: Each capsule contains 30 mg lisdexamfetamine
dimesylate, equivalent to 8.9 mg of
dexamfetamine.
50 mg Capsules: Each capsule contains 50 mg lisdexamfetamine
dimesylate, equivalent to 14.8 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.
[Product name] 30 mg capsule: Withe body and orange cap, printed 'TEV'
and '30 mg' in black ink.
[Product name] 50 mg capsule: White body and blue cap, printed 'TEV'
and '50 mg' in black ink.
[Product name] 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
4.1
THERAPEUTIC INDICATIONS
[Product name] is indicated as part of a comprehensive treatment
programme for attention
deficit/hyperactivity disorder (ADHD) in adults.
[Product name] is not indicated in all adult patients and the decision
to use the medicinal product must
take into consideration the profile of the patient, including a
thorough assessment of the severity and
chronicity of the patient's symptoms, the potential for abuse, misuse
or diversion and clinical response
to any previous pharmacotherapies for the treatment of ADHD.
Treatment must be under the supervision of a specialist in behavioural
disorders. Diagnosis should be
based on a complete history and evaluation of the patient according to
current DSM criteria or ICD
guidelines. Diagnosis cannot be made solely on the presence of one or
more symptom. In adults, the
presence of symptoms of ADHD that were pre-existing in childhood is
required and should be
confirmed retrospectively (according to the