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DEXAMFETAMINE SULFATE 1MG/ML ORAL SOLUTION

Active substance(s): DEXAMFETAMINE SULFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dexamfetamine Sulfate 1mg/ml Oral Solution
Dexamfetamine Sulfate
(This medicine will be referred to as Dexamfetamine Oral Solution in this leaflet)

D02766

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet

The leaflet has been written in
sections:
• Sections 1 to 6 are for patients or
parents/carers of a child taking the
medicine
• The last section is a special section for
a child or young person with ADHD to
read
However, all sections are written as
though the person taking the medicine is
reading them.

The sections are:
1. What Dexamfetamine Oral Solution is
and what it is used for
2. What you need to know before you
take Dexamfetamine Oral Solution
3. How to take Dexamfetamine Oral
Solution
4. Possible side effects
5. How to store Dexamfetamine Oral
Solution
6. Contents of the pack and other
information

1. What Dexamfetamine Oral
Solution is and what it is used
for
Dexamfetamine Oral Solution contains the
active substance Dexamfetamine Sulfate.
Dexamfetamine Oral Solution 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 norepinephrine in areas
of the brain that play a part in controlling
attention and behaviour.
Dexamfetamine Oral Solution is used:
• To treat narcolepsy (being unable to
stop yourself falling asleep)
• In children, to treat ‘Attention Deficit
Hyperactivity Disorder’ (ADHD)

2. What you need to
know before you take
Dexamfetamine Oral Solution
Do not take Dexamfetamine Oral
Solution if:
• you are allergic to Dexamfetamine
Sulfate or any of the other ingredients
of this medicine (see ‘Important
information about some of the
ingredients’ later in this section, and
section 6)
• you are allergic to any medicines acting
on the nervous system including
methylphenidate, pemoline or
ephedrine
• you suffer from problems with your
heart, circulation or blood pressure
• you are taking, or have recently stopped
taking (within the last 14 days), a type
of medicine called Monoamine Oxidase
Inhibitors (MAOIs) which is used to treat
depression
• you have a history of drug or alcohol
abuse
• you suffer from an overactive thyroid
• you are unusually or excessively
excitable (unless it is part of your ADHD)
• you suffer from glaucoma (increased
pressure in the eye)
• you suffer from a blood disorder known
as porphyria
• you suffer from Tourette’s syndrome
(tics), which causes you to make
uncontrollable movements or sounds,
or other similar disorders
• you are pregnant, likely to become
pregnant or are breast-feeding
Warnings and precautions
Talk to your doctor or pharmacist before
taking Dexamfetamine Oral Solution if:
• you suffer from high blood pressure
• you have a family history of involuntary
muscle spasms known as dystonias. If
you start experiencing these muscle
spasms you should stop taking
Dexamfetamine Oral Solution.
• you suffer from epilepsy
• you suffer from problems with your
kidneys
• you have an eating problem when you
do not feel hungry or do not want to
eat, such as ‘anorexia nervosa’

• you have mental health problems such
as:
- mood swings (from being manic
to being depressed - called ‘bipolar
disorder’)
- feeling aggressive or hostile, or your
aggression gets worse
- seeing, hearing or feeling things that
are not real (hallucinations)
- believing things that are not true
(delusions)
- severe depression, where you feel very
sad, worthless and hopeless
- mania, where you feel unusually
excitable, over-active, and un-
inhibited
If any of the above applies to you, please
consult your doctor before taking this
medicine.
Taking other medicines and
Dexamfetamine Oral Solution
Tell your doctor if you are taking, have
recently taken or might take any other
medicines, including medicines obtained
without a prescription and herbal
medicines.
Tell your doctor if you are taking any of the
following:
• lithium (used to treat bipolar disorder)
• alpha-methyltyrosine (used to treat a
tumour of the adrenal gland known as
phaeochromocytoma)
• disulfiram (used in the treatment of
alcoholism)
• medicines used to treat depression
known as tricyclic antidepressants, such
as amitryptyline and imipramine
• medicines used to treat depression
known as monoamine oxidase inhibitors
(MAOIs), such as phenelzine and
moclobemide. Tell your doctor if you are
currently taking MAOIs or if you have
taken them within the last 14 days.
• medicines used to treat high blood
pressure, such as propranolol, atenolol
and guanethidine
• medicines used to treat certain mental
disorders known as phenothiazines,
such as chlorpromazine, fluphenazine
and haloperidol
• medicines used to treat epilepsy,
such as phenobarbital, phenytoin and
ethosuxamide
• morphine (used to treat severe pain)
• meperidine (used to treat moderate to
severe pain)
• clonidine (used to treat high blood
pressure)
• reserpine (used to treat mental
problems or high blood pressure)
• ascorbic acid (vitamin C)
• glutamic acid hydrochloride (found in
food supplements)
• ammonium chloride (an ingredient in
some cough medicines)
• sodium acid phosphate (used to treat
too high calcium levels or too low
phosphate levels in the body)
• thiazides (used to treat high blood
pressure or fluid retention)

If you have any doubts about whether this
medicine is suitable for you please discuss
this with your doctor.
Dexamfetamine Oral Solution with
alcohol
Do not drink alcohol while taking this
medicine. Alcohol may make the side
effects of this medicine worse. Remember
that some foods and medicines contain
alcohol.
Pregnancy and breast-feeding
Dexamfetamine Oral Solution must not
be taken until you have spoken to your
doctor for advice if you are pregnant, think
you may be pregnant or are planning to
have a baby, or are breast feeding.
Dexamfetamine passes into breast milk;
therefore your doctor will decide whether
you should breast-feed while taking
Dexamfetamine Oral Solution.
Driving and using machines
You may feel drowsy or dizzy, have
problems focussing, or have blurred vision
when taking Dexamfetamine Oral Solution.
If these happen, it may be dangerous to do
things such as drive, use machines, ride a
bike or horse or climb trees.
This medicine can affect your ability to
drive and operate machinery as it may
make you sleepy or dizzy.
• Do not drive while taking this medicine
until you know how it affects you.
• It is an offence to drive if this medicine
affects your ability to drive.
• However, you would not be committing
an offence if:
• The medicine has been prescribed to
treat a medical or dental problem and
• You have taken it according to the
instructions given by the prescriber
or in the information provided with the
medicine and
• It was not affecting your ability to drive
safely
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.
Important information about some of
the ingredients
Dexamfetamine Oral Solution contains the
following ingredients:
• Liquid maltitol (a type of sugar). If you
have been told by your doctor that you
cannot tolerate or digest some sugars,
talk to your doctor before taking this
medicine.
• Methyl hydroxybenzoate sodium (E219)
and propyl hydroxybenzoate sodium
(E217). These may cause an allergic
reaction which could occur even if
you have been taking Dexamfetamine
Oral Solution for a while, or if you have
stopped taking it.
Continued overleaf

Information for children and
young people with ADHD
This information is to help you learn the main things about your
medicine called Dexamfetamine Oral Solution.
If you don’t enjoy reading, someone like your mum, dad or carer
(sometimes called ‘your guardian’) can read it to you and answer
any questions. It may help if you read small bits at a time.

Why have I been given this medicine?

This medicine can help children and young people with ‘ADHD’.
• ADHD can make you:
- run about too much
- not be able to pay attention
- act quickly without thinking about what will happen next
(impulsive).
• It affects learning, making friends and how you think about
yourself. It is not your fault.

While you are taking this medicine

• as well as taking this medicine, you will also get help with ways
to cope with your ADHD such as talking to ADHD specialists
• this medicine should help you. But it does not cure ADHD
• you will need to go to your doctor several times a year for checkups. This is to make sure the medicine is working and that you
are growing and developing OK
• do not drink alcohol. Alcohol may make the side effects of this
medicine worse
• if you are having sex, please talk to your doctor about
contraception. Girls must tell their doctor straight away if they
think they may be pregnant. We do not know how this medicine
affects unborn babies

Some people cannot have this medicine

You cannot have this medicine if:
• you have a problem with your heart
• you feel very unhappy, depressed or have a mental illness

Some people need to talk to their doctor before
they start having this medicine

You need to talk to your doctor if:
• you have epilepsy (fits)
• you are pregnant or breastfeeding
• you are taking other medicines – your doctor needs to know
about all the medicines you are taking
Continued overleaf

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Information for children and
young people with ADHD (continued)
How do I take my medicine?

• your doctor will tell you how much of your medicine you need
to take, how you should take it and how many times a day you
should take it
• do not stop taking the medicine without talking to your doctor
first

Possible side effects

Side effects are the unwanted things that can happen when you
take a medicine. If any of the following happen, tell an adult you
trust straight away. They can then talk to your doctor.
The main things that could affect you are:
• feeling worried or nervous
• feeling dizzy, or getting headaches
• being very depressed and unhappy or wanting to hurt yourself
• having different moods than usual, not being able to get to
sleep or sleeping too much
• skin rashes, bruising easily, getting out of breath
• the medicine can also make you feel sleepy. If you feel sleepy, it
is important not to do outdoor sports like riding a horse or bike,
swimming or climbing trees. You could hurt yourself and others
• your heart beating faster than usual
If you feel unwell in any way while you are taking your
medicine, please tell an adult you trust straight away.

Other things to remember

• make sure you keep your medicine in a safe place so that no one
else takes it, especially younger brothers or sisters
• the medicine is special for you - do not let anyone else have it. It
may help you, but it could hurt someone else
• if you forget to take your medicine don’t take two doses the next
time. Just take the next dose at the next normal time
• if you do take too much medicine, tell your mum, dad or carer
right away
• it is important not to take too much medicine or you will get ill
• don’t stop taking your medicine until your doctor says it’s OK

Who should I ask if there is anything I don’t
understand?

Your mum, dad, carer, doctor, nurse or pharmacist will be able to
help you.

3. How to take Dexamfetamine
Oral Solution
Always take Dexamfetamine Oral Solution
exactly as your doctor has told you. Check
with your doctor or pharmacist if you are
not sure.
For narcolepsy in:
Adults:
The usual starting dose is 10mg (10ml
of the solution) a day, split into separate
doses. Your doctor may gradually increase
your dose up to a maximum of 60mg
(60ml of the solution) per day.
Elderly:
The usual starting dose is 5mg (5ml of the
solution) a day. Your doctor may gradually
increase your dose by 5mg (5ml of the
solution) each week.
For ADHD in children:
Your child’s treatment will be specific
to them. The doctor will prescribe the
appropriate dose; therefore the following
doses are for guidance only.
Aged 3-5: The usual starting dose is 2.5mg
(2.5ml of the solution) a day. Your child’s
doctor may gradually increase their dose
by 2.5mg (2.5ml of the solution) each
week.
Aged 6 years and over: The usual starting
dose is 5-10mg (5-10ml of the solution)
a day. Your child’s doctor may gradually
increase their dose up to a maximum
of 20mg (20ml of the solution) per day,
although for older children, the doctor
may prescribe 40mg (40ml of the solution)
or more a day.
Things your child’s doctor will do when
they are on treatment:
Your child’s doctor will do some tests
• before your child starts - to make sure
that Dexamfetamine Oral Solution is
safe and will be of benefit to them
• after they start, and when the dose is
changed. Tests will include
- checking their appetite
- measuring height and weight
- measuring blood pressure and heart
rate
- checking whether your child has
any problems with their mood, state
of mind or any other unusual
feelings, or if these have got worse
while taking this medicine.
If you take more Dexamfetamine Oral
Solution than you should
If you take too much medicine, talk to a
doctor or call an ambulance straight away.
Tell them how much has been taken.

Signs of overdose may include: shaking;
increased uncontrolled movements;
fits (may be followed by coma); seeing,
feeling or hearing things that are not
real (hallucinations); high fever; changes
in heart beat (slow, fast or uneven);
confusion; aggressive behaviour; dilated
pupils and chest pains.
If you forget to take Dexamfetamine
Oral Solution
Do not take a double dose to make up for
a forgotten dose. If you forget a dose, wait
until it is time for the next dose and simply
take it as normal.
If you stop taking Dexamfetamine Oral
Solution
Do not stop taking this medicine without
first talking to your doctor.
Do not suddenly stop taking
Dexamfetamine Oral Solution as this can
lead to extreme tiredness and depression.
You may notice the following effects
(withdrawal effects) when you stop taking
Dexamfetamine Oral Solution: sleep
disturbances (vivid dreams, nightmares,
inability to sleep, excessive sleeping);
feeling restless or agitated; unusual
tiredness or weakness; increased appetite;
general feeling of unhappiness; cravings.
If you experience symptoms when you
stop treatment, contact your doctor.
When stopping Dexamfetamine Oral
Solution, your doctor may want to
gradually reduce the amount of medicine
you take each day, before stopping it
completely - this should help reduce the
chance of withdrawal effects.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If any of the following symptoms occur,
contact your doctor or nearest accident
and emergency department immediately.
These could be symptoms of a serious
allergic reaction.
• sudden wheeziness and tightness of the
chest
• swelling of the eyelids, face, lips or
throat
• skin lumps or hives
• skin rash (red spots), itchiness
• high fever
• collapse

Other side effects that may occur include:
Effects on the nervous system
• restlessness, irritability or difficulty
sleeping
• nightmares and panic attacks
• nervousness
• confusion, believing things that are not
true (delusions)
• aggressive behaviour or abnormal
moods
• dizziness
• headache
• impaired vision or enlarged pupils
• changes in sexual drive and ability
• dry mouth, loss of appetite
• sweating
• fits, tremor, twitches, excessive reflex
reactions
• lack of coordination of muscle
movements
• mental disorders including mood
disorders and schizophrenia
• distortion of the sense of taste
Effects on the heart and circulation
• fast heartbeat, palpitations
• chest pain
• changes in blood pressure (with possible
bleeding in the brain)
• damaged heart muscle following long
term use
• heart attack
• cardiac arrest (when the heart suddenly
stops pumping blood around the body)
• stroke
• increased acidity in the blood
Effects on the stomach
• stomach pain and cramps
• feeling sick (nausea)
• diarrhoea
Other effects
• kidney damage
• slowed growth in children
• muscular pains
• inflammation and injury of the large
intestine
• weight loss
• damaged skeletal muscle tissue
• hair loss from the head or body
• abnormal facial movements
• hyperactivity
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.

5. How to store Dexamfetamine
Oral Solution
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date (EXP) which is stated on the carton
and bottle. The expiry date refers to the
last day of that month.
Do not store your medicine above 25°C.
Once you have opened the bottle you are
advised to dispose of it after 30 days.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6. Contents of the pack and
other information
What Dexamfetamine Oral Solution
contains
The active substance is dexamfetamine
sulfate.
1millilitre (ml) of Dexamfetamine Oral
Solution contains 1milligram (mg) of
dexamfetamine sulfate.
The other ingredients are: quinoline
yellow (E104), methyl hydroxybenzoate
sodium (E219), propyl hydroxybenzoate
sodium (E217), lemon flavour no.1
(contains propylene glycol E1520),
carmellose sodium (E466), saccharin
sodium, liquid maltitol, hydrochloric acid,
sodium hydroxide and purified water.
What Dexamfetamine Oral Solution
looks like and contents of the pack
Dexamfetamine Oral Solution is a clear
yellow liquid, supplied in a glass bottle
with a child-proof cap. Each bottle
contains 500ml of the solution.
Marketing Authorisation Holder and
Manufacturer
Martindale Pharmaceuticals, Bampton
Road, Harold Hill, Essex RM3 8UG, UK
Product Licence No:
PL 00156/0034
This leaflet was last revised in 08/2013
If this leaflet is difficult to see or
read, please contact the marketing
authorisation holder for help.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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