Attentin 20 mg Tablett

Riik: Rootsi

keel: rootsi

Allikas: Läkemedelsverket (Medical Products Agency)

Toimeaine:

dexamfetaminsulfat

Saadav alates:

Orifarm AB

ATC kood:

N06BA02

INN (Rahvusvaheline Nimetus):

dexamfetaminsulfat

Annus:

20 mg

Ravimvorm:

Tablett

Koostis:

isomalt Hjälpämne; dexamfetaminsulfat 20 mg Aktiv substans

Retsepti tüüp:

Receptbelagt

Volitamisolek:

Avregistrerad

Loa andmise kuupäev:

2018-06-27

Infovoldik

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATTENTIN 10 MG/20 MG TABLETS
dexamfetamine sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same.
•
If your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Attentin is and what it is used for
2. What you need to know before you use Attentin
3. How to use Attentin
4. Possible side effects
5. How to store Attentin
6. Contents of the pack and other information
1. WHAT ATTENTIN IS AND WHAT IT IS USED FOR
WHAT ATTENTIN IS
Attentin tablets contain the active substance dexamfetamine sulfate.
Attentin is a psychostimulant. It improves activity in parts of the
brain. This medicine can help to improve
attention span, concentration, and reduce impulsive behaviour.
WHAT IT IS USED FOR
Attentin is used to treat attention-deficit/hyperactivity disorder
(ADHD).
•
It is used in children and adolescents aged 6-17 years.
•
It is not indicated in all children with ADHD.
•
It is used only after when another medicine called methylphenidate was
not sufficiently effective.
•
It should be used as part of a treatment programme which typically
includes psychological,
educational and social measures.
Attentin treatment must only be initiated by, and used under the
supervision of a specialist in childhood or
adolescent behavioural disorders.
You must talk to a doctor if your child does not feel better or if
they feel worse after a month. The doctor
may decide that a different treatment is needed.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATTENTIN
DO NOT USE ATTENTIN IF YOUR CHILD:
•
is allerg

Toote omadused

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Attentin10 mg tablets
Attentin 20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Attentin 10 mg
Each tablet contains 10 mg dexamfetamine sulfate.
Attentin 20 mg
Each tablet contains 20 mg dexamfetamine sulfate.
Excipient with known effect:
Isomalt (E953) 147.7 mg per 10 mg tablet
Isomalt (E953) 137.7 mg per 20 mg tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Attentin 10 mg
Yellow, round, cloverleaf-shaped tablets of 8.4 mm diameter with a
notched, cross-scored line on the top
side and a cross-scored line embossed with ”M” on each quarter on
the rear side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Attentin 20 mg
Reddish, round, cloverleaf-shaped tablets of 8.4 mm diameter with a
notched, cross-scored line on the top
side and a cross-scored line embossed with ”L” on each quarter on
the rear side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dexamfetamine
is
indicated
as
part
of
a
comprehensive
treatment
programme
for
attention-
deficit/hyperactivity disorder (ADHD) in children and adolescents aged
6 to 17 years when response to
previous methylphenidate treatment is considered clinically
inadequate. A comprehensive treatment
programme typically includes psychological, educational and social
measures.
Diagnosis should be made according to current DSM criteria or the
guidelines in ICD-10 and should be
based on a comprehensive multidisciplinary evaluation of the patient.
Page 2 of 15
Dexamfetamine is not indicated in all children with ADHD and the
decision to use dexamfetamine must be
based on a very thorough assessment of the severity and chronicity of
the child’s symptoms in relation to
the child’s age and potential for abuse, misuse or diversion.
Treatment should be under the supervision of a specialist i