DEXAMFETAMINE SULPHATE 5MG TABLETS

Active substance: DEXAMPHETAMINE SULPHATE

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Artwork
Notes

Dexamfetamine Tablets 5mg

PIL Code

A1000315

Date started

PIL

Version

A1000315/2

AW/V

Finished size: 2pp - 180mm high x 300mm wide

31.01.2014

v1 - 31.01.2014

Author

Side 1

Read all of this leaflet
carefully before you start
taking this medicine.

Patient Information Leaflet: Dexamfetamine Sulphate 5 mg Tablets

Product

• 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. Do
not pass it on to others.
It may harm them, even
if their symptoms are the
same as yours.
In this leaflet:
1. What Dexamfetamine
is for
2. Before you take
Dexamfetamine
3. How to take
Dexamfetamine
4. Possible side effects
5. How to store
Dexamfetamine
6. Further information.

1. What Dexamfetamine is 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 is used:
• To treat narcolepsy (being
unable to stop yourself falling
asleep)
• In children, to treat attention
deficit hyperactivity disorder
(ADHD).
Dexamfetamine may seem an
odd treatment for hyperactive
children, as stimulants
normally make people more
active.
However, at the doses
recommended for children with
ADHD, Dexamfetamine
can have the opposite effect,
helping some children to learn
to control their behaviour.

2. Before you take Dexamfetamine
Do not take Dexamfetamine if:
• You are allergic to the active
ingredient dexamphetamine

• You are allergic to any of the
other ingredients of
Dexamfetamine (these are
listed in Section 6)
• You are allergic to any
medicines acting on the
nervous system including
methylphenidate, pemoline
or ephedrine
• You are taking medicines
called monoamine oxidase
inhibitors (MAOIs) for
depression or if you have
taken them within the last
2 weeks
• You have ever abused alcohol
or drugs
• You have a medical condition
called Gilles de la Tourette
syndrome or similar
movement disorders
(dystonias) which cause
twitching
• You have porphyria, a disease
of the blood
• You have any problems with
your heart or blood pressure
• You have hardening of the
arteries
• You have problems with your
eyesight as a result of
increased pressure in your
eyes (i.e. glaucoma)
• You are hyperexcitable
• You have an overactive
thyroid gland
• You are pregnant, likely to
become pregnant or are
breast feeding.
If any of the above applies to
you do not take Dexamfetamine
and talk to your doctor or
pharmacist.

Check with your doctor before
taking Dexamfetamine if:
• You have problems with your
kidneys
• You have epilepsy
• You have an unstable
personality
• Anyone in your family has a
movement disorder
(dystonias) which cause
twitching.
Tell your doctor before taking
Dexamfetamine if you are
taking any of the following
medicines:
• Medicines for depression
including:
- Those called monoamine
oxidase inhibitors (MAOIs)
such as Phenelzine or if
you have taken them
within the last 2 weeks
- Those called tricyclic
anti-depressants (e.g.
imipramine)
- Lithium
• Drugs to lower blood
pressure (e.g. guanethidine or
α-methyltyrosine)
• Medicines to help you give up
alcohol (e.g. disulfiram)
• Beta-blockers such as
propranolol
• Phenothiazines used to control
anxiety
• Medicines for epilepsy
such as ethosuximide,
phenobarbital and phenytoin
• Haloperidol used for mental
illness
• Morphine for the treatment of
severe pain

• Norepinephrine (used to
increase the rate of
contractions)
• Meperidine (used to treat
moderate to severe pain)
• Clonidine (used to treat high
blood pressure)
• Reserpine (used as
antipsychotic and
antihypertensive drug)
• Ascorbic acid (used as
antioxidant properties)
• Glutamic Acid HCL
• Ammonium chloride
• Sodium acid phosphate
• Thiazides (used to treat
hypertension and oedema)
• Chlorpromazine (used as
antipsychotic drug)
• Any other medicine, including
medicines obtained without a
prescription.
If any of the above applies to
you, tell your doctor before
taking Dexamfetamine.
Pregnancy and breast-feeding
Do not take Dexamfetamine
whilst you are pregnant,
particularly during the first
three months of pregnancy.
Do not take Dexamfetamine if
you are breast-feeding.
Driving and using machines
Dexamfetamine may cause
dizziness and affect your vision.
If this happens to you, do not
drive or use machinery.
The medicine can affect your
ability to drive 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.
Warnings about the ingredients
in Dexamfetamine
Dexamfetamine contains
lactose and sucrose.
If you have an intolerance to
some sugars, talk with your
doctor before taking
Dexamfetamine.

3. How to take Dexamfetamine
Always take Dexamfetamine
exactly as your doctor has told you.
Important:
Your doctor will choose the
dose that is right for you. Your
dose will be shown clearly on
the label that your pharmacist
puts on your medicine. If it
does not, or you are not sure,
ask your doctor or pharmacist.

Product
Artwork
Notes

Dexamfetamine Tablets 5mg

PIL Code

A1000315

Date started

31.01.2014

PIL

Version

A1000315/2

AW/V

v1 - 31.01.2014

Finished size: 2pp - 180mm high x 300mm wide

Author

Side 2

If you need to break the tablets
in half, your doctor or
pharmacist will show you how
to do this.
For narcolepsy in adults:
• The usual starting dose is 10 mg
(2 x 5 mg tablets) a day twice a
day (i.e. 1 tablet in the morning
and 1 in the evening)
• Your doctor may increase
your dose each week up to a
maximum of 60 mg (12 x 5
mg tablets) a day if necessary.
For narcolepsy in the elderly:
• The usual starting dose is
5 mg (1 x 5 mg tablet) a day
• Your doctor may increase
your dose by 5 mg (1 x 5 mg
tablet) each week.
For ADHD in children aged
3-5 years:
• The usual starting dose is
2.5 mg (half of a 5 mg
tablet) a day
• Your doctor may increase
the dose by 2.5 mg (half of a
5 mg tablet) each week.
For ADHD in children aged
6 years and over:
• The usual starting dose is
5-10 mg (1-2 x 5 mg tablets)
a day
• Your doctor may increase
the dose by 5 mg (1 x 5 mg
tablet) each week
• The maximum dose is
usually 20 mg (4 x 5 mg
tablets) a day, although for
older children your doctor
may prescribe 40 mg (8 x 5
mg tablets) or more a day.

Medical check-ups in children
Your doctor will check the
height and weight of your child
whilst they are taking Dexamfetamine.
If you take more
Dexamfetamine than you
should
If you take too much
immediately go to the nearest
hospital casualty department or
your doctor. Taking too many
tablets can be very serious.
Symptoms of overdose include
excitement, hallucinations,
convulsions leading to coma,
irregular and rapid heartbeat
and reduced breathing.
If you forget to take
Dexamfetamine
Do not take a double dose to
make up for missed dose.
Simply take the next dose as
planned.
Stopping Dexamfetamine
Do not stop taking
Dexamfetamine without first
talking to your doctor.
Do not suddenly stop taking
Dexamfetamine as this can
lead to extreme tiredness and
depression. Your doctor will
stop your treatment gradually.
If you have any further
questions about the use of this
medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines
Dexamfetamine can cause side

effects, although not everybody gets them.
• Seek immediate medical
help if you have any
unexplained rise in body
temperature.
• Talk to your doctor as soon
as possible if you start
experiencing twitches.
Dexamfetamine can cause the
following side-effects:
Effects on the nervous system:
• Sleeplessness and restlessness
• Nightmares and panic attacks
• Nervousness
• Confusion and delirium
• Delusions
• Aggression and irritability
• Happiness
• Dizziness
• Headache
• Impaired vision
• Widening of the pupils
• Altered sexual drive and
ability
• Dry mouth
• Lack of appetite
• Sweating
• Convulsions
• Tremor and twitches
• Excessive reflex reactions.
• Lack of coordination of
muscle movements
• Abnormal moods
• Loss of contact with reality
• Mental disorders including
mood disorders and
schizophrenia
• Distortion of the sense of
taste
Effects on the heart and
circulation
• Fast heartbeat, palpitations

• Chest pains
• Changes in blood pressure
(with possible bleeding into
the brain)
• Damaged heart muscle
following long term use
• Fatal heart and circulatory
system collapse (after a very
high temperature, upset salt
and water balance and
transient hyperactivity).
• Heart Attack
• Cardiovascular collapse
• Stroke
• Increased acidity in the blood.
Effects on the stomach
• Stomach pain
• Stomach cramps
• Feeling sick
• Diarrhoea
• Nausea.
Other effects:
• Kidney damage
• Paralysis
• Slowed growth in children
• Muscular pains.
• Hypersensitivity
• Serious allergic reaction
• Inflammation and injury of
the large intestine
• Weight loss
• Damaged skeletal muscle
tissue
• Skin rash
• Loss of hair from the head
or body
• Rapid swelling
• Abnormal facial movements
• Abnormal movements
• Movement disorder
• Difficulty moving or
coordinating part of the body

Becoming dependent on your
medicine
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 Dexamfetamine.
With increasing doses and
dependence, mental instability
and behavioural changes can
occur.
If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor
or pharmacist.

5. How to store Dexamfetamine
Keep out of the reach and sight
of children.
Do not use Dexamfetamine
after the expiry date on the
carton. The expiry date refers
to the last day of that month.
Medicines should not be
disposed of via wastewater or
household waste. Return any
medicine you no longer need to
your pharmacist.

6. Further information
What Dexamfetamine contains
The active substance is
dexamfetamine sulphate 5 mg.
The other ingredients are stearic
acid, acacia powder, lactose,
light liquid paraffin, maize
starch, sucrose, purified talc
and purified water.

What Dexamfetamine looks
like
Dexamfetamine is a white
tablet.
Dexamfetamine comes in
blister strip of 28 tablets in a
carton. Not all pack sizes may
be marketed.
Marketing Authorisation
Holder:
Auden Mckenzie (Pharma
Division) Ltd., Mckenzie House,
Bury Street, Ruislip, Middlesex,
HA4 7TL, UK
Manufacturer:
Recipharm Limited,
Vale of Bardsley,
Ashton-under-Lyne,
OL7 9RR, UK.

This leaflet was last updated
February 2014.

If this leaflet is difficult
to see or read or you
would like it in a
different format, please
contact:
Auden Mckenzie
(Pharma Division) Ltd.,
Mckenzie House,
Bury Street,
Ruislip, Middlesex,
HA4 7TL, UK

Auden Mckenzie

A1000315/2

Artwork
Notes

Dexamfetamine Tablets 5mg

PIL Code

A1000318

Date started

31.01.2014

PIL

Version

A1000318/2

AW/V

v1 - 31.01.2014

Finished size: 2pp - 180mm high x 300mm wide

Author

Side 1

Read all of this leaflet
carefully before you start
taking this medicine.

Patient Information Leaflet: Dexamfetamine Sulphate 5 mg Tablets

Product

• 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. Do
not pass it on to others.
It may harm them, even
if their symptoms are the
same as yours.
In this leaflet:
1. What Dexamfetamine
is for
2. Before you take
Dexamfetamine
3. How to take
Dexamfetamine
4. Possible side effects
5. How to store
Dexamfetamine
6. Further information.

1. What Dexamfetamine is 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 is used:
• To treat narcolepsy (being
unable to stop yourself falling
asleep)
• In children, to treat attention
deficit hyperactivity disorder
(ADHD).
Dexamfetamine may seem an
odd treatment for hyperactive
children, as stimulants
normally make people more
active.
However, at the doses
recommended for children with
ADHD, Dexamfetamine
can have the opposite effect,
helping some children to learn
to control their behaviour.

2. Before you take Dexamfetamine
Do not take Dexamfetamine if:
• You are allergic to the active
ingredient dexamphetamine

• You are allergic to any of the
other ingredients of
Dexamfetamine (these are
listed in Section 6)
• You are allergic to any
medicines acting on the
nervous system including
methylphenidate, pemoline
or ephedrine
• You are taking medicines
called monoamine oxidase
inhibitors (MAOIs) for
depression or if you have
taken them within the last
2 weeks
• You have ever abused alcohol
or drugs
• You have a medical condition
called Gilles de la Tourette
syndrome or similar
movement disorders
(dystonias) which cause
twitching
• You have porphyria, a disease
of the blood
• You have any problems with
your heart or blood pressure
• You have hardening of the
arteries
• You have problems with your
eyesight as a result of
increased pressure in your
eyes (i.e. glaucoma)
• You are hyperexcitable
• You have an overactive
thyroid gland
• You are pregnant, likely to
become pregnant or are
breast feeding.
If any of the above applies to
you do not take Dexamfetamine
and talk to your doctor or
pharmacist.

Check with your doctor before
taking Dexamfetamine if:
• You have problems with your
kidneys
• You have epilepsy
• You have an unstable
personality
• Anyone in your family has a
movement disorder
(dystonias) which cause
twitching.
Tell your doctor before taking
Dexamfetamine if you are
taking any of the following
medicines:
• Medicines for depression
including:
- Those called monoamine
oxidase inhibitors (MAOIs)
such as Phenelzine or if
you have taken them
within the last 2 weeks
- Those called tricyclic
anti-depressants (e.g.
imipramine)
- Lithium
• Drugs to lower blood
pressure (e.g. guanethidine or
α-methyltyrosine)
• Medicines to help you give up
alcohol (e.g. disulfiram)
• Beta-blockers such as
propranolol
• Phenothiazines used to control
anxiety
• Medicines for epilepsy
such as ethosuximide,
phenobarbital and phenytoin
• Haloperidol used for mental
illness
• Morphine for the treatment of
severe pain

• Norepinephrine (used to
increase the rate of
contractions)
• Meperidine (used to treat
moderate to severe pain)
• Clonidine (used to treat high
blood pressure)
• Reserpine (used as
antipsychotic and
antihypertensive drug)
• Ascorbic acid (used as
antioxidant properties)
• Glutamic Acid HCL
• Ammonium chloride
• Sodium acid phosphate
• Thiazides (used to treat
hypertension and oedema)
• Chlorpromazine (used as
antipsychotic drug)
• Any other medicine, including
medicines obtained without a
prescription.
If any of the above applies to
you, tell your doctor before
taking Dexamfetamine.
Pregnancy and breast-feeding
Do not take Dexamfetamine
whilst you are pregnant,
particularly during the first
three months of pregnancy.
Do not take Dexamfetamine if
you are breast-feeding.
Driving and using machines
Dexamfetamine may cause
dizziness and affect your vision.
If this happens to you, do not
drive or use machinery.
The medicine can affect your
ability to drive 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.
Warnings about the ingredients
in Dexamfetamine
Dexamfetamine contains
lactose and sucrose.
If you have an intolerance to
some sugars, talk with your
doctor before taking
Dexamfetamine.

3. How to take Dexamfetamine
Always take Dexamfetamine
exactly as your doctor has told
you.
Important:
Your doctor will choose the
dose that is right for you. Your
dose will be shown clearly on
the label that your pharmacist
puts on your medicine. If it
does not, or you are not sure,
ask your doctor or pharmacist.

Product
Artwork
Notes

Dexamfetamine Tablets 5mg

PIL Code

A1000318

Date started

31.01.2014

PIL

Version

A1000318/2

AW/V

v1 - 31.01.2014

Finished size: 2pp - 180mm high x 300mm wide

Author

Side 2

If you need to break the tablets
in half, your doctor or
pharmacist will show you how
to do this.
For narcolepsy in adults:
• The usual starting dose is 10 mg
(2 x 5 mg tablets) a day twice a
day (i.e. 1 tablet in the morning
and 1 in the evening)
• Your doctor may increase
your dose each week up to a
maximum of 60 mg (12 x 5
mg tablets) a day if necessary.
For narcolepsy in the elderly:
• The usual starting dose is
5 mg (1 x 5 mg tablet) a day
• Your doctor may increase
your dose by 5 mg (1 x 5 mg
tablet) each week.
For ADHD in children aged
3-5 years:
• The usual starting dose is
2.5 mg (half of a 5 mg
tablet) a day
• Your doctor may increase
the dose by 2.5 mg (half of a
5 mg tablet) each week.
For ADHD in children aged
6 years and over:
• The usual starting dose is
5-10 mg (1-2 x 5 mg tablets)
a day
• Your doctor may increase
the dose by 5 mg (1 x 5 mg
tablet) each week
• The maximum dose is
usually 20 mg (4 x 5 mg
tablets) a day, although for
older children your doctor
may prescribe 40 mg (8 x 5
mg tablets) or more a day.

Medical check-ups in children
Your doctor will check the
height and weight of your child
whilst they are taking Dexamfetamine.
If you take more
Dexamfetamine than you
should
If you take too much
immediately go to the nearest
hospital casualty department or
your doctor. Taking too many
tablets can be very serious.
Symptoms of overdose include
excitement, hallucinations,
convulsions leading to coma,
irregular and rapid heartbeat
and reduced breathing.
If you forget to take
Dexamfetamine
Do not take a double dose to
make up for missed dose.
Simply take the next dose as
planned.
Stopping Dexamfetamine
Do not stop taking
Dexamfetamine without first
talking to your doctor.
Do not suddenly stop taking
Dexamfetamine as this can
lead to extreme tiredness and
depression. Your doctor will
stop your treatment gradually.
If you have any further
questions about the use of this
medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines
Dexamfetamine can cause side

effects, although not everybody gets them.
• Seek immediate medical
help if you have any
unexplained rise in body
temperature.
• Talk to your doctor as soon
as possible if you start
experiencing twitches.
Dexamfetamine can cause the
following side-effects:
Effects on the nervous system:
• Sleeplessness and restlessness
• Nightmares and panic attacks
• Nervousness
• Confusion and delirium
• Delusions
• Aggression and irritability
• Happiness
• Dizziness
• Headache
• Impaired vision
• Widening of the pupils
• Altered sexual drive and
ability
• Dry mouth
• Lack of appetite
• Sweating
• Convulsions
• Tremor and twitches
• Excessive reflex reactions.
• Lack of coordination of
muscle movements
• Abnormal moods
• Loss of contact with reality
• Mental disorders including
mood disorders and
schizophrenia
• Distortion of the sense of
taste
Effects on the heart and
circulation
• Fast heartbeat, palpitations

• Chest pains
• Changes in blood pressure
(with possible bleeding into
the brain)
• Damaged heart muscle
following long term use
• Fatal heart and circulatory
system collapse (after a very
high temperature, upset salt
and water balance and
transient hyperactivity).
• Heart Attack
• Cardiovascular collapse
• Stroke
• Increased acidity in the blood.
Effects on the stomach
• Stomach pain
• Stomach cramps
• Feeling sick
• Diarrhoea
• Nausea.
Other effects:
• Kidney damage
• Paralysis
• Slowed growth in children
• Muscular pains.
• Hypersensitivity
• Serious allergic reaction
• Inflammation and injury of
the large intestine
• Weight loss
• Damaged skeletal muscle
tissue
• Skin rash
• Loss of hair from the head
or body
• Rapid swelling
• Abnormal facial movements
• Abnormal movements
• Movement disorder
• Difficulty moving or
coordinating part of the body

Becoming dependent on your
medicine
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 Dexamfetamine.
With increasing doses and
dependence, mental instability
and behavioural changes can
occur.
If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor
or pharmacist.

5. How to store Dexamfetamine
Keep out of the reach and sight
of children.
Do not use Dexamfetamine
after the expiry date on the
carton. The expiry date refers
to the last day of that month.
Medicines should not be
disposed of via wastewater or
household waste. Return any
medicine you no longer need to
your pharmacist.

6. Further information
What Dexamfetamine contains
The active substance is
dexamfetamine sulphate 5 mg.
The other ingredients are stearic
acid, acacia powder, lactose,
light liquid paraffin, maize
starch, sucrose, purified talc
and purified water.

What Dexamfetamine looks
like
Dexamfetamine is a white
tablet.
Dexamfetamine comes in
blister strip of 28 tablets in a
carton. Not all pack sizes may
be marketed.
Marketing Authorisation
Holder:
Auden Mckenzie (Pharma
Division) Ltd., Mckenzie
House, Bury Street, Ruislip,
Middlesex, HA4 7TL, UK
Manufacturer:
Tiofarma BV
Benjamin Franklinstraat 9
3261 LW Oud-Beijereland
Netherlands

This leaflet was last updated
February 2014.

If this leaflet is difficult
to see or read or you
would like it in a
different format, please
contact:
Auden Mckenzie
(Pharma Division) Ltd.,
Mckenzie House,
Bury Street,
Ruislip, Middlesex,
HA4 7TL, UK

Auden Mckenzie

A1000318/2

Expand view ⇕

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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