Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Lisdexamfetamine dimesylate
Takeda Pharmaceuticals International AG Ireland Branch
N06
Lisdexamfetamine dimesylate
Capsule, hard
PSYCHOANALEPTICS
Marketed
2013-02-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER TYVENSE 20 MG CAPSULES, HARD TYVENSE 30 MG CAPSULES, HARD TYVENSE 40 MG CAPSULES, HARD TYVENSE 50 MG CAPSULES, HARD TYVENSE 60 MG CAPSULES, HARD TYVENSE 70 MG CAPSULES, HARD 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 Tyvense is and what it is used for 2. What you need to know before you take Tyvense 3. How to take Tyvense 4. Possible side effects 5. How to store Tyvense 6. Contents of the pack and other information 7. Information for children and young people 1. WHAT TYVENSE IS AND WHAT IT IS USED FOR WHAT TYVENSE IS Tyvense 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. Tyvense is a long acting medicine which works gradually over a 13 hour time period. WHAT IT IS USED FOR Tyvense is a part of a comprehensive treatment programme for ‘attention deficit hyperactivity disorder’ (ADHD) for children and young people between the ages of 6 and 18 who have previously taken a methylphenidate treatment that inadequately treated their ADHD. for adults who have had ADHD since childhood. If you have not been treated for ADHD before, the doctor will check if you have had ADHD since childhood before prescribing Tyvense. You must talk to a doctor if you do not feel better or if you feel worse after one month of treatment. Tyvense i Baca dokumen lengkap
Health Products Regulatory Authority 21 December 2023 CRN00DF2J Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tyvense 50 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg lisdexamfetamine dimesylate, equivalent to 14.8 mg of dexamfetamine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. White opaque body and blue opaque cap, printed ‘S489’ and ‘50 mg’ in black ink. Each capsule measures approximately 16 mm long and 6 mm wide. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tyvense 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 treatment is considered clinically inadequate. Tyvense is also indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults with pre-existing symptoms of ADHD in childhood. Treatment must be under the supervision of a specialist in childhood and/or adolescent behavioural disorders (for paediatric patients) or a specialist in behavioural disorders (for adult patients). 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 symptoms. In adults, the presence of pre-existing symptoms of ADHD in childhood is required and should be confirmed retrospectively (according to the patient's medical record or, if not available, through appropriate and structured instruments or interviews). Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in two or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual's life. The specific aetiology of this syndrome is unknown, and there is no single diagnostic t Baca dokumen lengkap