Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
ATOMOXETINE AS HYDROCHLORIDE
ELI LILLY ISRAEL LTD, ISRAEL
N06BA09
HARD CAPSULE
ATOMOXETINE AS HYDROCHLORIDE 25 MG
PER OS
Required
ELI LILLY & COMPANY LTD., USA
ATOMOXETINE
Strattera 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 Strattera 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’
2021-06-30
I STRACP A 03 Page 1 of 9 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only STRATTERA® 10 MG Hard capsules ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule contains: Atomoxetine 10 mg STRATTERA® 18 MG Hard capsules ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule contains: Atomoxetine 18 mg STRATTERA® 25 MG Hard capsules ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule contains: Atomoxetine 25 mg STRATTERA 40® MG Hard capsules ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule contains: Atomoxetine 40 mg STRATTERA 60® MG Hard capsules ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule contains: Atomoxetine 60 mg STRATTERA 80® MG Hard capsules ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule contains: Atomoxetine 80 mg STRATTERA 100® MG Hard capsules ACTIVE INGREDIENT AND ITS QUANTITY: Each capsule contains: Atomoxetine 100 mg INACTIVE INGREDIENTS AND ALLERGENS: see “important information about the ingredients of this medicine” in section 2 and section 6 “additional information. IMPORTANT INFORMATION YOU NEED TO KNOW ABOUT THE MEDICINE Clinical studies carried out on STRATTERA have shown an increase in the frequency of suicidal thoughts and suicide attempts in children and adolescents. Tell your doctor if your child (or if there is a family history): 1. suffers from bipolar disorder 2. has suffered from suicidal thoughts or has attempted suicide before starting treatment with STRATTERA The risk of suicidal thoughts or suicide attempts is higher at the beginning of treatment and when changing the dose. During treatment with STRATTERA, you must closely monitor your child’s mood and behavior. If you have any of the following symptoms, contact your doctor immediately: anxiety, irritability, panic attack, sleep disorders, over excitement, hostility, aggressiveness, impulsive, restlessness, mania, depression, suicidal thoughts. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaf Baca dokumen lengkap
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