Dexamfetamine Sulfate ATNAHS 5mg Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

DEXAMFETAMINE SULFATE

Tilgængelig fra:

Waymade BV Herikerbergweg 88, 1101CM Amsterdam , Netherlands

ATC-kode:

N06BA02

INN (International Name):

DEXAMFETAMINE SULFATE 5 mg

Lægemiddelform:

TABLET

Sammensætning:

DEXAMFETAMINE SULFATE 5 mg

Recept type:

POM

Terapeutisk område:

PSYCHOANALEPTICS

Autorisation status:

Authorised

Autorisation dato:

2019-02-18

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMFETAMINE SULFATE ATNAHS 5 MG TABLETS
dexamfetamine sulfate
WHAT IS IN THIS LEAFLET:
1.
What Dexamfetamine sulfate ATNAHS 5 mg tablets are and what they are
used for
2.
What you need to know before you take Dexamfetamine sulfate ATNAHS 5
mg tablets
3.
How to take Dexamfetamine sulfate ATNAHS 5 mg tablets
4.
Possible side effects
5.
How to store Dexamfetamine sulfate ATNAHS 5 mg tablets
6.
Contents of the pack and other information
1.
WHAT DEXAMFETAMINE SULFATE ATNAHS 5 MG TABLETS
ARE AND WHAT THEY ARE USED FOR
Dexamfetamine sulfate ATNAHS 5 mg tablets contain the active substance
dexamfetamine
sulfate.
Dexamfetamine belongs to a group of medicines called stimulants.
It improves activity in parts of the brain. This medicine can help to
improve attention span,
concentration, and reduce impulsive behaviour.
Dexamfetamine is used:
•
To treat attention deficit hyperactivity disorder (ADHD) 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
treatment
programme,
which
typically
includes
psychological,
educational and social measures. Dexamfetamine 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 you or your child does not feel better or
if you feel worse after a
month. The doctor may decide that a different treatment is needed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXAMFETAMINE SULFATE ATNAHS 5
MG TABLETS
DO NOT TAKE DEXAMFETAMINE IF YOU OR YOUR CHILD:
•
are allergic (hypersensitive) to dexamfetamine or other amfetamine
compounds or any
of the other ingredients of this medicine (listed in section 6)
•
have a thyroid problem
•
have increased pressure in the eyes (glaucoma)
•
have a tumour of the adrenal gland (phaeochromocytoma)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START T

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dexamfetamine Sulfate 5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg dexamfetamine sulfate.
Excipients with known effect: lactose 152mg, sucrose 14mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white round tablet of 9 mm diameter, with a score line on
one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dexamfetamine sulfate 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 DSM-5 criteria or the guidelines
in ICD-10 and should
be based on a comprehensive multidisciplinary evaluation of the
patient.
Diagnosis cannot be made solely on the presence of one or more
symptoms.
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.
Appropriate educational placement is essential, and psychosocial
intervention is generally
necessary.
Treatment should be under the supervision of a specialist in childhood
and/or adolescent
behavioural disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be under the supervision of a specialist in childhood
and/or adolescent
behaviour disorders.
Precautions to be taken before handling or administering the medicinal
product
_Pre-treatment screening _
Prior to prescribing, it is necessary to conduct a baseline evaluation
of the patient’s
cardiovascular status including blood pressure and heart rate. A
comprehensive history shou