Riik: Holland
keel: hollandi
Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LISDEXAMFETAMINEMESILAAT 60 mg/stuk SAMENSTELLING overeenkomend met ; LISDEXAMFETAMINE 34,7 mg/stuk ; SAMENSTELLING overeenkomend met DEXAMFETAMINE 17,8 mg/stuk
LISDEXAMFETAMINEMESILAAT 60 mg/stuk SAMENSTELLING overeenkomend met ; LISDEXAMFETAMINE 34,7 mg/stuk ; SAMENSTELLING overeenkomend met DEXAMFETAMINE 17,8 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; 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 ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
1900-01-01
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. Lugege kogu dokumenti
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 Lugege kogu dokumenti