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DEXAMFETAMINE SULPHATE 5MG TABLETS

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ARTWORK INFORMATION:

APPROVED FOR
SUBMISSION:

PRODUCT:

Dexamfetamine 5 mg Tablets

LICENCE:

PL 17507/0188

ITEM / SIZE:

Generic package leaflet / 180 mm (h) x 300 mm (w) [flat]

ID CODE:

A1000315/3

VERSION:

1; 08/03/2015

INK:

Black

Patient Information Leaflet: Dexamfetamine Sulphate 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.

A1000315_3 V1 Dexamfet Tabs (Reci) PIL.indd 1

APPROVED BY
HEALTH AUTHORITY:

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 antidepressants (e.g. imipramine)
-L
 ithium
• 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.

08/05/2015 10:58

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.

A1000315_3 V1 Dexamfet Tabs (Reci) PIL.indd 2

If you take more Dexamfet­
amine 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 Dexamfet­
amine 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 Dexamfet­
amine 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.

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.

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.

Marketing Authorisation
Holder:
Auden Mckenzie (Pharma
Division) Ltd.,
Mckenzie House,
Bury Street,
Ruislip, Middlesex,
HA4 7TL, UK

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.

Manufacturer:
Recipharm Limited,
Vale of Bardsley,
Ashton-under-Lyne,
OL7 9RR, UK
This leaflet was last updated May
2015.

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

A1000315/3

08/05/2015 10:58

ARTWORK INFORMATION:

APPROVED FOR
SUBMISSION:

PRODUCT:

Dexamfetamine 5 mg Tablets

LICENCE:

PL 17507/0188

ITEM / SIZE:

Generic package leaflet / 180 mm (h) x 300 mm (w) [flat]

ID CODE:

A1000318/3

VERSION:

1; 08/03/2015

INK:

Black

Patient Information Leaflet: Dexamfetamine Sulphate 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.

A1000318_3 V1 Dexamfet Tabs (Tio) PIL.indd 1

APPROVED BY
HEALTH AUTHORITY:

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 antidepressants (e.g. imipramine)
-L
 ithium
• 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.

08/05/2015 10:59

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.

A1000318_3 V1 Dexamfet Tabs (Tio) PIL.indd 2

If you take more Dexamfet­
amine 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 Dexamfet­
amine 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 Dexamfet­
amine 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.

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.

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.

Marketing Authorisation
Holder:
Auden Mckenzie (Pharma
Division) Ltd.,
Mckenzie House,
Bury Street,
Ruislip, Middlesex,
HA4 7TL, UK

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.

Manufacturer:
Tiofarma BV
Benjamin Franklinstraat 9
3261 LW Oud-Beijereland
Netherlands
This leaflet was last updated May
2015.

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

A1000318/3

08/05/2015 10:59

Expand Transcript

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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