STRATTERA 80 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

ATOMOXETINE AS HYDROCHLORIDE

Tilgængelig fra:

ELI LILLY ISRAEL LTD, ISRAEL

ATC-kode:

N06BA09

Lægemiddelform:

HARD CAPSULE

Sammensætning:

ATOMOXETINE AS HYDROCHLORIDE 80 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

ELI LILLY & COMPANY LTD., USA

Terapeutisk område:

ATOMOXETINE

Terapeutiske indikationer:

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’

Autorisation dato:

2021-06-30

Indlægsseddel

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

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