ATTENT 10 MG

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Mevcut itibaren:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC kodu:

N06BA01

Farmasötik formu:

TABLETS

Kompozisyon:

AMPHETAMINE SULFATE 2.500 MG; DEXTROAMPHETAMINE SULFATE 2.500 MG; AMPHETAMINE ASPARTATE MONOHYDRATE 2.500 MG; DEXTROAMPHETAMINE SACCHARATE 2.500 MG

Uygulama yolu:

PER OS

Reçete türü:

Required

Tarafından üretildi:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terapötik alanı:

AMFETAMINE

Terapötik endikasyonlar:

Treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Yetkilendirme tarihi:

2020-06-30

Bilgilendirme broşürü

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
ATTENT 10 MG TABLETS
ATTENT 20 MG TABLETS
ATTENT 30 MG TABLETS
COMPOSITION
EACH ATTENT 10 MG TABLET CONTAINS:
2.5 mg of each of the following ingredients:
Dextroamphetamine saccharate
Amphetamine aspartate monohydrate
Dextroamphetamine sulfate
Amphetamine sulfate
The total equivalent amount of amphetamine
is 6.3 mg.
EACH ATTENT 20 MG TABLET CONTAINS:
5 mg of each of the following ingredients:
Dextroamphetamine saccharate
Amphetamine aspartate monohydrate
Dextroamphetamine sulfate
Amphetamine sulfate
The total equivalent amount of amphetamine
is 12.6 mg.
EACH ATTENT 30 MG TABLET CONTAINS:
7.5 mg of each of the following ingredients:
Dextroamphetamine saccharate
Amphetamine aspartate monohydrate
Dextroamphetamine sulfate
Amphetamine sulfate
The total equivalent amount of amphetamine
is 18.8 mg.
For information on inactive and allergenic
ingredients in the preparation, see in section 2
“Important information about some of the
ingredients of the medicine” and section 6 –
“Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet contains
concise information about the medicine. If you
have further questions, refer to the doctor or
pharmacist.
THIS MEDICINE HAS BEEN PRESCRIBED FOR THE
TREATMENT OF YOUR AILMENT. DO NOT PASS IT ON
TO OTHERS. IT MAY HARM THEM EVEN IF IT SEEMS
TO YOU THAT THEIR MEDICAL CONDITION IS SIMILAR.
THE MEDICINE CAN BE TAKEN BY ADULTS AND ALSO
BY CHILDREN AND THEREFORE, THE INFORMATION
IN THIS LEAFLET IS ALSO INTENDED FOR CHILDREN
TAKING THIS MEDICINE.
The medicine contains amphetamines, which
have potential to be misused. Taking for a
long time may lead to dependence. Misuse
of amphetamines may cause sudden death
and severe cardiac side effects.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine contains a mix of amphetamine
salts, which are central nervous system
stimulants, and is in

Ürün özellikleri

Attent FW 11-2023- Notification
SUMMARY OF PRODUCT CHARACTERISTICS
Attent 10 mg, 20 mg & 30 mg
Tablets
1.
NAME OF THE MEDICINAL PRODUCT
Attent 10 mg
Attent 20 mg
Attent 30 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A single entity amphetamine product combining the neutral sulfate
salts of
dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine saccharate and
d, l-amphetamine aspartate.
EACH TABLET CONTAINS
Attent 10 mg
Attent 20 mg
Attent 30 mg
Dextroamphetamine Saccharate
2.5 mg
5 mg
7.5 mg
Amphetamine Aspartate Monohydrate
2.5 mg
5 mg
7.5 mg
Dextroamphetamine Sulfate
2.5 mg
5 mg
7.5 mg
Amphetamine Sulfate
2.5 mg
5 mg
7.5 mg
Total amphetamine base equivalence
6.3 mg
12.6 mg
18.8 mg
Excipients with known effect:
Saccharin sodium, compressible sugar, Attent 20 mg and 30 mg tablets
contain FD & C
Yellow No. 6 Aluminium lake (sunset yellow FCF). See section 4.4
"excipients with known
effect".
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets for oral administration.
ATTENT 10 mg:
Blue oval tablet, debossed with "b" over "972" between two horizontal
lines on one side. On
the other side, debossed with "1" and "0" on both sides of a bisect
line [1│0] and between two
horizontal lines.
ATTENT 20 mg:
Peach oval tablet, debossed with "b" over "973" between two horizontal
lines on one side. On
the other side, debossed with "2" and "0" on both sides of a bisect
line [2 │ 0] and
betweentwo horizontal lines.
ATTENT 30 mg
Peach oval tablet, debossed with "b" over "974" between two horizontal
lines on one side. On
the other side, debossed with "3" and "0" on both sides of a bisect
line [3 │ 0] and between
two horizontal lines.
Attent tablets can be divided into equal parts.
Attent FW 11-2023 Notification
2
WARNING: ABUSE, MISUSE, AND ADDICTION
Attent tablets have a high potential for abuse and misuse, which can
lead to the
development of a substance use disorder, including addiction. Misuse
and abuse of CNS
stimulants, including Attent tablets, can result in overdose and