ASPEN DEXAMFETAMINE dexamphetamine sulphate 5mg tablet bottle

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

dexamfetamine sulfate, Quantity: 5 mg

Fáanlegur frá:

Aspen Pharmacare Australia Pty Ltd

Lyfjaform:

Tablet, uncoated

Samsetning:

Excipient Ingredients: povidone; wheat starch; magnesium stearate; lactose monohydrate

Stjórnsýsluleið:

Oral

Einingar í pakka:

100 tablets

Tegund:

Medicine Registered

Gerð lyfseðils:

(S8) Controlled Drug

Ábendingar:

INDICATIONS AS AT 22 January 1997: Narcolepsy and hyperkinetic behaviour disorders in children.

Vörulýsing:

Visual Identification: A white round flat plain tablet with bevelled edges, one face plain, one embossed 'D5' about break bar and diameter 5/16".; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

1991-10-14

Upplýsingar fylgiseðill

ASPEN DEXAMFETAMINE tablets - Consumer Medicine Information
Page 1 of 5
ASPEN DEXAMFETAMINE
DEXAMFETAMINE SULFATE 5 MG TABLETS
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASPEN
DEXAMFETAMINE 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
ASPEN DEXAMFETAMINE 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 ASPEN
DEXAMFETAMINE
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. ASPEN
DEXAMFETAMINE 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

Vara einkenni

1
AUSTRALIAN PRODUCT INFORMATION
ASPEN DEXAMFETAMINE (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
ASPEN DEXAMFETAMINE tablets contain dexamfetamine sulfate 5 mg.
List of excipients with known effect include sugars (as lactose) and
gluten. For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ASPEN DEXAMFETAMINE 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