ATOMIC 40

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

ATOMOXETINE HYDROCHLORIDE

から入手可能:

UNIPHARM LTD, ISRAEL

ATCコード:

N06BA09

医薬品形態:

COATED TABLETS

構図:

ATOMOXETINE HYDROCHLORIDE 40 MG

投与経路:

PER OS

処方タイプ:

Required

製:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

治療領域:

ATOMOXETINE

適応症:

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.

承認日:

2018-02-28

情報リーフレット

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