DEXMINE dexamfetamine sulphate 5 mg tablet bottle

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

dexamfetamine sulfate

Dostupné s:

Aspen Pharma Pty Ltd

INN (Mezinárodní Name):

dexamfetamine sulfate

Stav Autorizace:

Registered

Informace pro uživatele

DEXMINE tablets - Consumer Medicine Information
Page 1 of 5
DEXMINE
dexamfetamine sulfate 5 mg tablets
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DEXMINE tablets.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
DEXMINE tablets against the
benefits they expect it will have.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT IS DEXMINE
The active ingredient is called
dexamfetamine sulfate which
belongs to a group of medicines
called central nervous system
stimulants and is a
sympathomimetic amine of the
amphetamine group.
It is used to treat a number of
medical conditions.
•
Hyperkinetic behaviour disorders
in children. This behavioural
disorder is also known as Attention-
deficit Hyperactivity Disorder
(ADHD). Not all people with this
disorder are hyperactive, which
affects the ability to concentrate on
tasks for any length of time.
Children suffering from ADHD may
have trouble learning or doing
school work, and may become
aggressive or unmanageable at
school or at home. DEXMINE helps
focus attention and shuts out
distraction, allowing the child to
concentrate.
•
Narcolepsy (a sleep disorder).
People with narcolepsy have
recurring attacks of irresistible day-
time sleepiness in spite of a good
night’s sleep.
Note:
Because of the liability for abuse,
drugs of the amphetamine type are
subject to special restrictions on
their availability. Prescriptions for
this substance may require
validation by State or Territory
Health Departments or
Commissions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
this medicine for another purpose.
IF YOU HAVE ANY CONCERNS, YOU
SHOULD DISCUSS THIS WITH YOUR
DOC

Charakteristika produktu

1
AUSTRALIAN PRODUCT INFORMATION
DEXMINE (DEXAMFETAMINE SULFATE)
TABLETS
DRUG DEPENDENCE: DEXAMFETAMINE SHOULD BE GIVEN CAUTIOUSLY TO PATIENTS
WITH A
HISTORY OF DRUG DEPENDENCE OR ALCOHOLISM. CHRONIC ABUSE USE CAN LEAD
TO MARKED
TOLERANCE AND PSYCHOLOGICAL DEPENDENCE WITH VARYING DEGREES OF
ABNORMAL BEHAVIOUR.
1
NAME OF THE MEDICINE
Dexamfetamine sulfate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DEXMINE tablets contain dexamfetamine sulfate 5 mg.
List of excipients with known effect include lactose monohydrate and
wheat starch. For the
full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DEXMINE tablets are a round, white, scored tablet marked ‘D5’ on
one side and plain on the
other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Narcolepsy and hyperkinetic behaviour disorders in children.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dexamfetamine should be started at the lowest possible dose and should
then be individually
and slowly adjusted to the lowest effective dose for each individual.
Time of administration should receive special attention because of
insomnia. Late evening
medication should be avoided.
NARCOLEPSY
The usual daily dose ranges from 5 to 60 mg (given in divided doses)
for optimal response. If
bothersome adverse reactions appear (e.g. insomnia or anorexia) reduce
the dosage. In
patients from 6 to 12 years of age, start with 5 mg daily. The dosage
may be raised in
increments of 5 mg at weekly intervals until the optimal response is
obtained. In patients 12
years or older, start with 10 mg daily. The daily dosage may be raised
in increments of 10 mg
at weekly intervals until the optimal response is obtained.
2
ATTENTION DEFICIT DISORDER (HYPERKINETIC ACTIVITY BEHAVIOUR DISORDERS)
Not recommended for children under 3 years of age.
In children over 3 years of age start with 2.5 mg daily. Then the
daily dosage may be raised
in 2.5 mg increments, at weekly intervals, until the optimal response
is obtained, up to a
maximum of 40 mg daily in two divided doses. T