DEXAMFETAMINE SULFATE 5MG TABLETS
Active substance(s): DEXAMPHETAMINE SULFATE
- PDF options:
- View fullscreen
- Download PDF
PDF Transcript
Patient Information Leaflet: Dexamfetamine Sulfate 5 mg Tablets
carefully before you start
taking this medicine.
•
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.
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
(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 antidepressants (e.g. imipramine)
- Lithium
• Drugs to lower blood
pressure (e.g. guanethidine or
α-methyltyrosine)
• Medicines to help you give up
• 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)
approved for print/date
AAAI5798
Pregnancy and breast-feeding
Do not take Dexamfetamine
whilst you are pregnant,
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
colours/plates
Dexamfetamine 5 mg Tablet PIL - UK
item no:
• 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.
1. black
dimensions: 300 x 180
print proof no: 8
pharmacode:
origination date: 14.12.15
min pt size: 4pt
originated by:
R.Paul
revision date:
18.05.2016
Technical Approval
revised by:
R.P
date sent: 14.12.15
supplier:
IL/Tiofarma BV
technically app. date: 14.01.2016
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile
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.
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 Dexamfetyour 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
•
• 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
•
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
•
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.
item no:
approved for print/date
please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
also report side effects directly
via the Yellow Card Scheme
(Website: www.mhra.gov.uk/
yellowcard). By reporting side
effects you can help provide more
information on the safety of this
medicine.
5. How to store Dexamfetamine
Keep out of the sight and reach 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 sulfate 5 mg.
The other ingredients are stearic
acid, acacia powder, lactose, light
print proof no: 8
pharmacode:
origination date: 14.12.15
min pt size: 4pt
originated by:
R.Paul
revision date:
18.05.2016
Technical Approval
revised by:
R.P
date sent: 14.12.15
supplier:
IL/Tiofarma BV
technically app. date: 14.01.2016
Marketing Authorisation
Holder:
Auden Mckenzie (Pharma
Division) Ltd.,
Whiddon Valley, Barnstaple,
North Devon,
EX32 8NS, UK
Manufacturer:
Tiofarma BV
Benjamin Franklinstraat 9
3261 LW Oud-Beijereland
Netherlands
This leaflet was last updated
March 2016.
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.,
Whiddon Valley,
Barnstaple, North Devon,
EX32 8NS, UK
AAAI5798
1. black
dimensions: 300 x 180
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.
water.
colours/plates
Dexamfetamine 5 mg Tablet PIL - UK
AAAI5798
If any of the side effects gets
serious, or if you notice any side
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile
Patient Information Leaflet: Dexamfetamine Sulfate 5 mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
• 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Dexamfetamine
Keep out of the sight and reach 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 sulfate 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 (PharmaDivision) Ltd.,
Whiddon Valley, Barnstaple,
North Devon,
EX32 8NS, UK
Manufacturer:
Recipharm Limited,
Vale of Bardsley,
Ashton-under-Lyne,
OL7 9RR, UK
This leaflet was last updated March 2016.
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.,
Whiddon Valley,
Barnstaple, North Devon,
EX32 8NS, UK
carefully before you start
taking this medicine.
•
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.
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
(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 antidepressants (e.g. imipramine)
- Lithium
• Drugs to lower blood
pressure (e.g. guanethidine or
α-methyltyrosine)
• Medicines to help you give up
• 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)
approved for print/date
AAAI5798
Pregnancy and breast-feeding
Do not take Dexamfetamine
whilst you are pregnant,
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
colours/plates
Dexamfetamine 5 mg Tablet PIL - UK
item no:
• 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.
1. black
dimensions: 300 x 180
print proof no: 8
pharmacode:
origination date: 14.12.15
min pt size: 4pt
originated by:
R.Paul
revision date:
18.05.2016
Technical Approval
revised by:
R.P
date sent: 14.12.15
supplier:
IL/Tiofarma BV
technically app. date: 14.01.2016
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile
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.
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 Dexamfetyour 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
•
• 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
•
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
•
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.
item no:
approved for print/date
please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
also report side effects directly
via the Yellow Card Scheme
(Website: www.mhra.gov.uk/
yellowcard). By reporting side
effects you can help provide more
information on the safety of this
medicine.
5. How to store Dexamfetamine
Keep out of the sight and reach 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 sulfate 5 mg.
The other ingredients are stearic
acid, acacia powder, lactose, light
print proof no: 8
pharmacode:
origination date: 14.12.15
min pt size: 4pt
originated by:
R.Paul
revision date:
18.05.2016
Technical Approval
revised by:
R.P
date sent: 14.12.15
supplier:
IL/Tiofarma BV
technically app. date: 14.01.2016
Marketing Authorisation
Holder:
Auden Mckenzie (Pharma
Division) Ltd.,
Whiddon Valley, Barnstaple,
North Devon,
EX32 8NS, UK
Manufacturer:
Tiofarma BV
Benjamin Franklinstraat 9
3261 LW Oud-Beijereland
Netherlands
This leaflet was last updated
March 2016.
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.,
Whiddon Valley,
Barnstaple, North Devon,
EX32 8NS, UK
AAAI5798
1. black
dimensions: 300 x 180
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.
water.
colours/plates
Dexamfetamine 5 mg Tablet PIL - UK
AAAI5798
If any of the side effects gets
serious, or if you notice any side
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile
Patient Information Leaflet: Dexamfetamine Sulfate 5 mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
• 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Dexamfetamine
Keep out of the sight and reach 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 sulfate 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 (PharmaDivision) Ltd.,
Whiddon Valley, Barnstaple,
North Devon,
EX32 8NS, UK
Manufacturer:
Recipharm Limited,
Vale of Bardsley,
Ashton-under-Lyne,
OL7 9RR, UK
This leaflet was last updated March 2016.
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.,
Whiddon Valley,
Barnstaple, North Devon,
EX32 8NS, UK
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
