Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
ATOMOXETINE HYDROCHLORIDE
UNIPHARM LTD, ISRAEL
N06BA09
COATED TABLETS
ATOMOXETINE HYDROCHLORIDE 25 MG
PER OS
Required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
ATOMOXETINE
Atomic 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 Atomic 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.
2018-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only ATOMIC 18, 25, 40, 60, 80, 100 FILM-COATED TABLETS COMPOSITION: Each film-coated ATOMIC 18 tablet contains: Atomoxetine (as HCl) 18 mg Each film-coated ATOMIC 25 tablet contains: Atomoxetine (as HCl) 25 mg Each film-coated ATOMIC 40 tablet contains: Atomoxetine (as HCl) 40 mg Each film-coated ATOMIC 60 tablet contains: Atomoxetine (as HCl) 60 mg Each film-coated ATOMIC 80 tablet contains: Atomoxetine (as HCl) 80 mg Each film-coated ATOMIC 100 tablet contains: Atomoxetine (as HCl) 100 mg For the list of inactive and allergenic ingredients in the preparation, see section 6: “Further information” and section 2 “Before using the medicine”. IMPORTANT DETAILS YOU NEED TO KNOW IN REGARDS TO THE MEDICINE Clinical studies performed with ATOMIC have shown an increased frequency of suicidal thoughts and suicide attempts in children and adolescents. Tell the doctor if your child (or if there is a family history): 1. suffers from bipolar disorder. 2. suffers from suicidal thoughts or has tried to commit suicide before starting treatment with ATOMIC. The risk of suicidal thoughts or suicide attempt is higher at the beginning of treatment and when adjusting the dosage. Pay close attention to the mood and behavior of your child during treatment with ATOMIC. Refer to a doctor immediately if any of the following symptoms occur: Anxiety, nervousness, panic attack, sleeping disorders, overexcitedness, hostility, aggressiveness, lack of impulse control, restlessness, mania, depression, suicidal thoughts. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you/your child has further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is simi Lesen Sie das vollständige Dokument