General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some
common questions about DEXAMPHETAMINE
It
does not contain all of the available information
about DEXAMPHETAMINE.
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 DEXAMPHETAMINE against the benefits he/she
expect it will have.
If you have any
concerns about taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet
with the medicine. You may need to read it again.
What is DEXAMPHETAMINE
The name of
your medicine is DEXAMPHETAMINE.
The active
ingredient is called dexamphetamine sulfate.
Dexamphetamine sulfate belongs to a group of
medicines called central nervous system stimulants
and is a sympathomimetic amine of the amphetamine
group.
Dexamphetamine is available as a
5.0mg tablet.
What DEXAMPHETAMINE is used
for
DEXAMPHETAMINE is used to treat 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. Dexamphetamine helps focus attention and
shuts out distraction, allowing the child to
concentrate.
Narcolepsy (a sleep disorder).
People with narcolepsy fall asleep during the
working day which is caused by severe 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.
Your doctor, however, may have prescribed
DEXAMPHETAMINE for another purpose.
Ask
your doctor if you have any questions about why
DEXAMPHETAMINE has been prescribed for you.
If you have any concerns, you should discuss
this with your doctor.
This medicine is
available only with a doctor's prescription.
Before you take DEXAMPHETAMINE
When you
must not take it
Do not take DEXAMPHETAMINE
if you are allergic to: DEXAMPHETAMINE or other
amphetamine type medications including other
sympathomimetic amines or any of the ingredients
listed at the end of this leaflet.
Some of
the symptoms of an allergic reaction to
DEXAMPHETAMINE may include urticaria and other
skin rashes, difficulty breathing, hay fever,
swelling of the face or throat or faintness.
Do not take DEXAMPHETAMINE if:
you
have heart or severe blood vessel disease
you
have moderate to severe high blood pressure
you have glaucoma
you suffer from
hyperthyroidism (overactive thyroid)
you have
tics (muscle twitching usually in the face or
shoulders)
you suffer from degenerative
diseases of the nervous system or suffer from
epilepsy
you suffer from Tourette's syndrome
or you have a family history of this disorder
you have severe depression, suicidal ideation
or behaviour, thoughts or acts of self-harm;
abnormal thinking; worsening anxiety, tension or
agitation
you are taking Mono Amine Oxidase
Inhibitors (MAOI drugs) or it is not yet 14 days
since MAOI therapy was discontinued
Do not
take DEXAMPHETAMINE if you are breastfeeding or
plan to breast feed.
Do not use
DEXAMPHETAMINE after the expiry date (EXP.)
printed on the pack. If you take it after the
expiry date has passed, it may have no effect at
all, or worse, there may be an entirely unexpected
effect.
Do not give it to children unless
your doctor has prescribed it. It is not
recommended for use in children under three years
of age.
Before you start to take it
You must tell your doctor if:
1.
you are allergic to any other medicines, or any
foods, dyes or preservatives.
2. you have any
other medical conditions or health problems,
including:
suspicion or presence of any
cardiac or heart-related abnormalities; irregular
heart beats or rate; family history of
sudden/cardiac death
angina (chest pain)
disease of the arteries due to cholesterol
deposits
drug dependence or addiction
including alcoholism
suffer from insomnia (an
inability to sleep).
suffer from depression or
schizophrenia or another mental illness.
suffer from motor tic or Tourette syndrome (or
a family member does)
renal insufficiency
suffer from blood pressure and/or take any
medications to treat blood pressure.
3.
You drink alcohol regularly.
Alcohol should
not be taken with DEXAMPHETAMINE.
4.
You are pregnant or plan to become pregnant.
DEXAMPHETAMINE like all medicines should not
be used during pregnancy, unless your doctor tells
you.
5. You are breastfeeding or plan
to breastfeed.
If you have not told your
doctor about any of the above, tell them before
you take any DEXAMPHETAMINE.
Taking other
medicines
Tell your doctor if you are
taking any other medicines, including medicines
that you buy without a prescription from a
pharmacy, supermarket or health food shop.
Some medicines may interfere with
DEXAMPHETAMINE. These include:
drugs
which are used to treat depression (e.g. tricyclic
antidepressants).
drugs used to treat other
types of mental illnesses such as schizophrenia
(e.g. chlorpromazine) or manic depressive
psychosis (e.g. Lithium Carbonate)
medicines
used to treat mental illnesses such as psychotic
disorders (e.g. haloperidol (Haldol))
some
medicines including Vitamin C and fruit juices
which can affect the gastric or urine pH (that is
make it acidic or alkaline) may alter the rate of
absorption or urinary excretion of dexamphetamine
e.g. (guanethidine, reserpine, glutamic acid,
ammonium chloride, sodium bicarbonate,
acetazolamide, some thiazide diuretics).
blood
pressure drugs
some antihistamines
anti-
epileptic drugs e.g. phenytoin (Dilantin),
ethosuximide (Zarontin)
some opioid type
analgesics e.g. Pethidine
barbiturates e.g.
phenobarbitone
The above medicines may
either reduce the effectiveness of DEXAMPHETAMINE,
reduce its own effectiveness and/ or react with
DEXAMPHETAMINE resulting in untoward or sometimes
dangerous side effects.
This list is not
exhaustive. Your doctor or pharmacist has more
information on medicines to be careful with or
avoid while taking DEXAMPHETAMINE.
How to
take DEXAMPHETAMINE
How much to take
The dose of DEXAMPHETAMINE may be different
for each person and their medical condition. Your
doctor will decide the right dose for you.
The recommended doses are for:
Narcolepsy: for children 6 to 12 years one
tablet (5mg) is given daily. The dose may be
raised in 5mg increments at weekly intervals until
the required response is obtained.
For
patients 12 years or older your doctor may start
treatment with two tablets (10mg) daily. The dose
may be raised in 10mg increments at weekly
intervals until the required response is obtained.
Attention Deficit Disorder: for children
over 3 years, your doctor may start treatment with
half a tablet (2.5mg) daily. The dose may be
raised in 2.5mg increments at weekly intervals
until the required response is obtained up to a
maximum of 40 mg per day taken in two divided
doses.
How to take it
Swallow the
medicine with water. If the dose is one-half
tablet, there is a breakline on the tablet to help
you divide it.
When to take it
DEXAMPHETAMINE should be taken either early in
the day or in the morning.
How long to take
it
Continue taking DEXAMPHETAMINE as long
as your doctor recommends it.
If you forget
to take it
If your dosing schedule is one
dose a day, take the missed dose as soon as
possible, but not later than 6 hours before
bedtime. If it is almost time for your next dose,
skip the dose you missed and take your next dose
when you are meant to. Otherwise, take it as soon
as you remember, and then go back to taking it as
you would normally.
Do not try to make up
for missed doses by taking more than one dose at a
time. This may increase the chance of you getting
an unwanted side effect.
If you are unsure
about whether to take your next dose, speak to
your doctor or pharmacist.
If you have
trouble remembering when to take your medicine,
ask your pharmacist for some hints.
If you
take too much (Overdose):
Immediately
telephone your doctor or Poisons Information
Centre (telephone 13 11 26) for advice, or go to
casualty at your nearest hospital, if you think
that you or anyone else may have taken too much
DEXAMPHETAMINE. Do this even if there are no signs
of discomfort or poisoning. Also report any other
medicine or alcohol which has been taken. You may
need urgent medical attention.
Keep
telephone numbers for these places handy.
If you take too much DEXAMPHETAMINE you may
have symptoms of nausea, vomiting, diarrhoea,
chills, sweating, restlessness, hallucinations,
panic, headache, convulsions and symptoms
associated with severe high blood pressure or
manifestations of acute psychosis.
While
you are using DEXAMPHETAMINE
Things you
must do:
Use DEXAMPHETAMINE exactly as your
doctor has prescribed.
Tell all doctors,
dentists and pharmacists who are treating you that
you are taking DEXAMPHETAMINE.
Tell your
doctor (immediately) if you become pregnant while
you are taking DEXAMPHETAMINE.
Tell your
doctor if you feel DEXAMPHETAMINE is not helping
your condition.
Visit your doctor regularly
for checking on your blood pressure and pulse.
Your doctor needs to check your progress and see
whether you need to keep taking DEXAMPHETAMINE.
Always discuss with your doctor any
problems or difficulties during or after taking
DEXAMPHETAMINE. Like all CNS stimulants,
DEXAMPHETAMINE may become habit-forming and can be
abused by some people. Using DEXAMPHETAMINE
strictly as your doctor has prescribed will ensure
that abuse or drug dependence will not be a
problem.
Tell your doctor if, for any
reason, you have not taken your medicine exactly
as prescribed. Otherwise your doctor may think
that it was not effective and change your
treatment unnecessarily.
Keep enough
DEXAMPHETAMINE to last weekends and holidays.
Things you must not do:
Do not take any
other medicines while you are taking
DEXAMPHETAMINE without first telling your doctor.
Do not drive or operate machinery until
you know how DEXAMPHETAMINE affects you.
DEXAMPHETAMINE may cause dizziness in some people
and therefore may affect alertness.
Make
sure you know how you react to DEXAMPHETAMINE
before you drive a car, operate machinery, or do
anything else that could be dangerous if you are
dizzy or overstimulated.
Do not take
DEXAMPHETAMINE for a longer time than your doctor
has prescribed.
Do not change your dose
without first checking with your doctor.
Do
not stop taking DEXAMPHETAMINE or lower the dose,
without first checking with your doctor. Stopping
this medicine suddenly may cause some unwanted
effects, or your condition may reappear. Your
doctor will slowly reduce your dose of
DEXAMPHETAMINE before you can stop taking it
completely.
Do not suddenly stop taking
DEXAMPHETAMINE, as you may get side effects such
as mental depression or extreme tiredness.
Do not use this medicine to treat any other
complaints unless your doctor says to.
Do
not give this medicine to anyone else, even if
their symptoms seem similar to yours.
Things to be careful of:
Strenuous
exercise or activity and drinking alcohol while
taking DEXAMPHETAMINE. If you drink alcohol, it
could make some of the unwanted side effects of
DEXAMPHETAMINE worse.
Your doctor may
suggest that you avoid alcohol completely or
reduce the amount of alcohol you drink while you
are taking DEXAMPHETAMINE.
Some people may
experience side effects such as nausea, headache
and dizziness which may affect co-ordination and
increase the risk when using dangerous machinery.
Side effects
Tell your doctor or
pharmacist as soon as possible if you do not feel
well while you are taking DEXAMPHETAMINE.
DEXAMPHETAMINE helps most people with medical
conditions listed in the beginning of this
leaflet, but it may have unwanted side effects in
some people.
All medicines have side
effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment
if you get some of the side effects. Ask your
doctor or pharmacist any questions you may have.
Common Side Effects:
Tell your
doctor if you notice any of the following and they
worry you:
nausea (feeling sick)
vomiting or abdominal pain. This can usually
be relieved by taking the medicine with food.
headache
dizziness
tremor or
palpitations
restlessness, nervousness or
insomnia. This can usually be relieved by taking
the dose no later than 4 hours before bedtime.
loss of appetite which can lead to weight loss
or slower growth in children. Your doctor may
consider breaks from treatment in order to avoid
this.
The above side effects are usually
mild and mostly occur during the first few days of
treatment and some may disappear as your body
adjusts to the treatment.
There are other
side effects which occur less often, for example
stomach pain or other stomach problems that won't
go away, dry mouth, metallic taste, uncontrolled
movements, impotence, skin rash or itchiness,
Raynaud's phenomenon.
Contact your doctor
or mental health professional immediately or go to
Accident and Emergency at your nearest hospital if
you /your child develop
chest pain or
tightness in the chest
shortness of breath
irregular heart beat
feeling faint or loss
of consciousness
fits
vision problems
suicidal or self-harm thoughts or behaviour
hallucinations
confusion
abnormal
thinking (psychosis)
aggression or
hostility
Some people may get other side
effects of DEXAMPHETAMINE.
Your doctor may
lower the dose to help control serious side
effects and decide on necessary tests to monitor
any of the above problems.
Check with your
doctor as soon as possible if you have any
problems while taking DEXAMPHETAMINE even if you
do not think the problems are connected with the
medicine or are not listed in this leaflet.
After using DEXAMPHETAMINE
Storage
Keep it where children cannot reach it. A
locked cupboard at least one-and-a-half metres
above the ground is a good place to store
medicines.
Keep DEXAMPHETAMINE in a cool
dry place where the temperature stays below
25°C and protect from light. Do not store it,
or any other medicines, in a bathroom or near a
sink.
Do not leave it in the car or on
window sills. Heat and dampness can destroy some
medicines. Do not take DEXAMPHETAMINE if the
tablets do not look quite right.
Keep your
tablets in the plastic bottle they were provided
in until it is time to take them.
Disposal
If your doctor tells you to
stop taking the tablets OR they have passed their
expiry date, ask your pharmacist what to do with
any left over.
Product description
What it looks like
DEXAMPHETAMINE 5mg
tablet is a white round flat tablet, scored on one
side with D5 on the other.
Ingredients
Each DEXAMPHETAMINE tablet contains 5mg of the
active ingredient, dexamphetamine (present as
dexamphetamine sulfate).
The excipients or
other non-active ingredients are povidone,
lactose, starch-wheat, and magnesium stearate. The
tablets do not contain a colouring agent.
DEXAMPHETAMINE does contain lactose and very
low levels of gluten. It does not contain
tartrazine or any other azo dye.
Sponsor or
Supplier
Sigma Pharmaceuticals (Australia) Pty
Ltd (A.C.N. 004 118 594)
96 Merrindale
Drive
Croydon Victoria 3136
Australia
Telephone: 03 - 9839 2800
The Australian
Registration Number for DEXAMPHETAMINE 5mg tablet
is AUST R 19684
This leaflet was prepared
in August 1996 and updated in January 1997, March
2006 and June 2006.