Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Atomoxetine hydrochloride
Accord Healthcare Ireland Ltd.
N06BA09
Atomoxetine hydrochloride
10 milligram(s)
Capsule, hard
atomoxetine
Marketed
2019-01-14
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details ATOMOXETINE, ALL STRENGTHS, HARD CAPSULES PIL - UK/IE Black BBBA3213 R.Wrey 19/10/18 22/10/18 R.Wrey 170x700 9pt IL/Pharmathen 19/10/18 19/10/18 3 Version 2 01.11.2017 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 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. • The full name of this medicine is Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules but within this leaflet it will be referred to as Atomoxetine Capsules. WHAT IS IN THIS LEAFLET 1 WHAT ATOMOXETINE CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATOMOXETINE CAPSULES 3 HOW TO TAKE ATOMOXETINE CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ATOMOXETINE CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ATOMOXETINE CAPSULES ARE AND WHAT THEY ARE USED FOR WHAT IT IS USED FOR Atomoxetine Capsules contain the active substance atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD). It is used: • in children over six years of age • in adolescents • in adults. It is used only as a part of Lees het volledige document
Health Products Regulatory Authority 28 July 2023 CRN00DCVX Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atomoxetine Accord 10 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg atomoxetine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque white cap imprinted in black ink with '10' and opaque white body imprinted in black ink with 'mg'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atomoxetine Accord is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in ICD. In adults, the presence of symptoms of ADHD that were pre-existing in childhood should be confirmed. Third-party corroboration is desirable and Atomoxetine Accord should not be initiated when the verification of childhood ADHD symptoms is uncertain. Diagnosis cannot be made solely on the presence of one or more symptoms of ADHD. Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual's life. Additional information for the safe use of this medicinal product: A comprehensive treatment programme typically includes psychological, educational and social measures and is aimed at stabilising patients with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, Lees het volledige document