ATTENT XR 30 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

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

Tilgængelig fra:

TEVA ISRAEL LTD

ATC-kode:

N06BA01

Lægemiddelform:

CAPSULES EXTENDED RELEASE

Sammensætning:

DEXTROAMPHETAMINE SULFATE 7.5 MG; DEXTROAMPHETAMINE SACCHARATE 7.5 MG; AMPHETAMINE SULFATE 7.5 MG; AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

TEVA ISRAEL LTD, ISRAEL

Terapeutisk område:

AMFETAMINE

Terapeutiske indikationer:

Treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Autorisation dato:

2022-11-21

Indlægsseddel

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
ATTENT XR 5 MG
ATTENT XR 10 MG
ATTENT XR 15 MG
ATTENT XR 20 MG
ATTENT XR 25 MG
ATTENT XR 30 MG
EXTENDED RELEASE CAPSULES
Each Attent XR 5 mg extended release capsule contains:
1.25 mg dextroamphetamine saccharate
1.25 mg amphetamine aspartate monohydrate
1.25 mg dextroamphetamine sulfate
1.25 mg amphetamine sulfate
The total equivalent amount of amphetamine is 3.1 mg.
Each Attent XR 10 mg extended release capsule contains:
2.5 mg dextroamphetamine saccharate
2.5 mg amphetamine aspartate monohydrate
2.5 mg dextroamphetamine sulfate
2.5 mg amphetamine sulfate
The total equivalent amount of amphetamine is 6.3 mg.
Each Attent XR 15 mg extended release capsule contains:
3.75 mg dextroamphetamine saccharate
3.75 mg amphetamine aspartate monohydrate
3.75 mg dextroamphetamine sulfate
3.75 mg amphetamine sulfate
The total equivalent amount of amphetamine is 9.4 mg.
Each Attent XR 20 mg extended release capsule contains:
5.0 mg dextroamphetamine saccharate
5.0 mg amphetamine aspartate monohydrate
5.0 mg dextroamphetamine sulfate
5.0 mg amphetamine sulfate
The total equivalent amount of amphetamine is 12.5 mg.
Each Attent XR 25 mg extended release capsule contains:
6.25 mg dextroamphetamine saccharate
6.25 mg amphetamine aspartate monohydrate
6.25 mg dextroamphetamine sulfate
6.25 mg amphetamine sulfate
The total equivalent amount of amphetamine is 15.6 mg.
Each Attent XR 30 mg extended release capsule contains:
7.5 mg dextroamphetamine saccharate
7.5 mg amphetamine aspartate monohydrate
7.5 mg dextroamphetamine sulfate
7.5 mg amphetamine sulfate
The total equivalent amount of amphetamine is 18.8 mg.
For information regarding inactive ingredients and allergens, see
section 2 “Important
information about some of the ingredients of the medicine” and
section 6 – “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contain

Produktets egenskaber

1
Attent XR 5, 10, 15, 20, 25, 30 mg RC New SmpC 11.2022
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Attent XR 5 mg
Attent XR 10 mg
Attent XR 15 mg
Attent XR 20 mg
Attent XR 25 mg
Attent XR 30 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Attent XR contains mixed salts of a single-entity amphetamine, a CNS
stimulant.
Attent XR contains equal amounts (by weight) of four salts:
dextroamphetamine sulfate, amphetamine sulfate,
dextroamphetamine saccharate and amphetamine (D,L)-aspartate
monohydrate. This results in a 3.1:1 mixture
of dextro- to levo- amphetamine base equivalent.
Each capsule contains:
Capsule Strength
5 mg
10 mg
15 mg
20 mg
25 mg
30 mg
Dextroamphetamine Saccharate
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Amphetamine (D,L)-Aspartate
Monohydrate
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Dextroamphetamine Sulfate, USP
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Amphetamine Sulfate, USP
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Total amphetamine base equivalence
3.1 mg
6.3 mg
9.4 mg
12.5 mg
15.6 mg
18.8 mg
d-amphetamine base equivalence
2.4 mg
4.7 mg
7.1 mg
9.5 mg
11.9 mg
14.2 mg
l-amphetamine base equivalence
0.75 mg
1.5 mg
2.3 mg
3.0 mg
3.8 mg
4.5 mg
For special warnings and precautions relating to the composition see
section 7.11 under "excipients with known effect". For
the list of excipients, see section 16.
3. PHARMACEUTICAL FORM
Extended-release capsules for oral administration.
Attent XR (dextroamphetamine saccharate, amphetamine aspartate
monohydrate, dextroamphetamine sulfate,
amphetamine sulfate extended-release capsules = MAS ER capsules)
contains two types of beads
(immediate-release and delayed release) which prolong the release of
amphetamine compared to Attent
(dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate,
amphetamine sulfate immediate-release tablet formulation= MAS IR).
4 THERAPEUTIC INDICATIONS
Attent XR Capsules are indicated for the treatment of attention
deficit hyperactivity disorder (ADHD).
WARNING: A