Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
guanfacine hydrochloride
Takeda Pharmaceuticals International AG Ireland Branch
C02AC02
guanfacine
Antiadrenergic agents, centrally acting, Antihypertensives,
Attention Deficit Disorder with Hyperactivity
Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.,
Revision: 12
Authorised
2015-09-17
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT INTUNIV 1 MG PROLONGED-RELEASE TABLETS INTUNIV 2 MG PROLONGED-RELEASE TABLETS INTUNIV 3 MG PROLONGED-RELEASE TABLETS INTUNIV 4 MG PROLONGED-RELEASE TABLETS guanfacine This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. 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. This leaflet has been written as though the person taking the medicine is reading it. If you are giving this medicine to your child, please replace “you” with “your child” throughout. WHAT IS IN THIS LEAFLET: 1. What Intuniv is and what it is used for 2. What you need to know before you take Intuniv 3. How to take Intuniv 4. Possible side effects 5. How to store Intuniv 6. Contents of the pack and other information 1. WHAT INTUNIV IS AND WHAT IT IS USED FOR WHAT INTUNIV IS Intuniv contains the active substance guanfacine. This medicine belongs to a group of medicines which affects brain activity. This medicine can help improve your attention, concentration and make you less impulsive and hyperactive. WHAT INTUNIV IS USED FOR This medicine is used to treat ‘attention deficit hyperactivity disorder’ (ADHD) in children and adolescents 6-17 years old for whom current stimulant medication is not appropriate and/or current medication does not adequately control ADHD symptoms. The medicine is given a Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Intuniv 1 mg prolonged-release tablets Intuniv 2 mg prolonged-release tablets Intuniv 3 mg prolonged-release tablets Intuniv 4 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Intuniv 1 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine. _Excipient(s) with known effect_ Each tablet contains 22.41 mg of lactose (as monohydrate). Intuniv 2 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine. _Excipient(s) with known effect_ Each tablet contains 44.82 mg of lactose (as monohydrate). Intuniv 3 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine. _Excipient(s) with known effect_ Each tablet contains 37.81 mg of lactose (as monohydrate). Intuniv 4 mg prolonged-release tablet Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine. _Excipient(s) with known effect_ Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Intuniv 1 mg prolonged-release tablet 7.14 mm round, white to off-white tablets debossed with ‘1MG’ on one side and ‘503’ on the other side. 3 Intuniv 2 mg prolonged-release tablet 12.34 mm x 6.10 mm oblong shaped, white to off-white tablets debossed with ‘2MG’ on one side and “503” on the other side. Intuniv 3 mg prolonged-release tablet 7.94 mm round, green tablets debossed with ‘3MG’ on one side and ‘503’ on the other side. Intuniv 4 mg prolonged-release tablet 12.34 mm x 6.10 mm oblong shaped, green tablets debossed with ‘4MG’ on on Lesen Sie das vollständige Dokument