Dexamfetamine Tablets

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Dexamfetamine sulfate 5mg;  ;  

Beschikbaar vanaf:

Noumed Pharmaceuticals Limited

INN (Algemene Internationale Benaming):

Dexamfetamine sulfate 5 mg

Dosering:

5 mg

farmaceutische vorm:

Tablet

Samenstelling:

Active: Dexamfetamine sulfate 5mg     Excipient: Acacia Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Purified talc

Eenheden in pakket:

Bottle, glass, 100 tablets

klasse:

Class B1 Controlled Drug

Prescription-type:

Class B1 Controlled Drug

Geproduceerd door:

Cambrex Charles City Inc

therapeutische indicaties:

The treatment of well-established and proven narcolepsy.

Product samenvatting:

Package - Contents - Shelf Life: Bottle, glass, 30 ml amber glass - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, glass, - 1000 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

Autorisatie datum:

1969-12-30

Bijsluiter

New Zealand Consumer Medicine Information
1
DEXAMFETAMINE TABLETS
_DEXAMFETAMINE SULFATE _
_ _
Tablet, uncoated 5 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Dexamfetamine Tablets.
This leaflet answers some common questions about Dexamfetamine
Tablets. It does
not contain all 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 using
Dexamfetamine Tablets against the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT DEXAMFETAMINE TABLETS ARE USED FOR
Dexamfetamine belongs to a group of medicines called stimulants. These
work by
increasing activity in the brain.
Dexamfetamine works by affecting some of the natural chemicals that
are found in
the brain.
In particular, it increases the activity of chemicals called dopamine
and noradrenaline
in areas of the brain that play a part in controlling attention and
behaviour.
Dexamfetamine stimulates activity in the brain, helping to keep people
alert and
active during the day.
Dexamfetamine Tablets are used for:
The treatment of well-established and proven narcolepsy. It is also
indicated for
children with refractory hyperkinetic states under the supervision of
a physician
specialising in child psychiatry.
Your doctor may have prescribed Dexamfetamine Tablets for another
reason.
Ask your doctor if you have any questions about why Dexamfetamine
Tablets has
been prescribed for you.
This medicine is available only with a doctor's prescription.
It is possible to develop tolerance to Dexamfetamine so that more
tablets have to be
taken to achieve the same effect. This, in turn, can lead to
dependence on
New Zealand Consumer Medicine Information
2
Dexamfetamine. With increasing doses and dependence, mental
instability and
behavioural changes can occur.
If any of the side ef

Productkenmerken

NEW ZEALAND DATA SHEET
Page 1 of 12
1.
PRODUCT NAME
Dexamfetamine Tablets, Tablet, 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NAME AND STRENGTH OF THE ACTIVE SUBSTANCE:
Dexamfetamine sulfate 5 mg
EXCIPIENT(S) WITH KNOWN EFFECT:
Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral – tablet
PRESENTATION
White, 8 mm, normal convex tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of well-established and proven narcolepsy. It is
also indicated for
children with refractory hyperkinetic states under the supervision of
a physician
specialising in child psychiatry.
4.2.
DOSE 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.
FOR NARCOLEPSY:
Adults:
Oral, 5 to 20 mg a day in divided doses as needed and tolerated. The
usual starting dose
is 5 mg a day, given in divided doses. Doses may be increased, if
necessary, by 5 mg a day
at weekly intervals to a suggested maximum of 20 mg a day.
Elderly:
Start with 5 mg a day and increase by increments of 5 mg at weekly
intervals to a
suggested maximum of 20 mg a day.
Children:
•
_Children up to 6 years of age: _
Dosage has not been established.
NEW ZEALAND DATA SHEET
Page 2 of 12
•
_Children 6 to 12 years of age: _
Oral, 5mg a day, the dosage being increased by 5 mg a day at one-week
intervals
until the desired response is obtained or until the adult dose is
reached.
FOR ATTENTION-DEFICIT HYPERACTIVITY DISORDERS:
Where possible, drug administration should be interrupted occasionally
to determine if
there is an occurrence of behaviour symptoms sufficient to require
continued therapy.
If therapy is recommenced after discontinuation, it should not be
started at the dose
that had been reached prior to treatment interruption but should be
re-titrated from the
usual starting dose.
Children: