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ELVANSE 70 MG CAPSULES HARD

Active substance(s): LISDEXAMFETAMINE DIMESYLATE

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11821Vx
Elvanse PIL UK MultiS 28ct 14121503573122
N/A
454616A02
N/A
1
685 x 300mm
19-12-14

PMS 7447

Black

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Package leaflet: Information for the user

TBC

Elvanse 30 mg capsules, hard
Elvanse 50 mg capsules, hard
Elvanse 70 mg capsules, hard
Lisdexamfetamine dimesylate

Regulatory Responsible Person Approval:
Signature:
Marketing Responsible Person Approval:
Signature:

This medicine is subject to additional monitoring. This will allow quick identification of new safety
information. You can help by reporting any side effects you may get. See the end of section 4 for
how to report side effects.
Important things you need to know about your medicine
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

GFW-045 00

Wingdings-Regular

This medicine is used to treat ADHD:
• The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’.
• The medicine helps with your brain activity. It can help improve your attention, help you
concentrate, and make you less impulsive.
• You need to have other treatments for ADHD (such as counselling and behavioural therapy) as
well as this medicine.

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Read Section 1 for more information.

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Before you take this medicine, talk to your doctor if you:
• have heart, circulation, or mental health problems - you may not be able to take this medicine.
• are taking any other medicines - this is because Elvanse can affect how other medicines work.

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Read Section 2 for more information.

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While taking this medicine:
• See your doctor regularly. This is because your doctor will want to check how the medicine is
working.
• Do not stop taking the medicine without first talking to your doctor.
• If you take your medicine for more than a year, your doctor may stop your medicine to see if it is
still needed.
• The most common side effects are decreased appetite, weight loss, being unable to sleep, dry
mouth or headache.
Read Sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
• Your mood or how you feel changes.
• You feel any problems with your heart.
Read Section 4 for more information.
The rest of this leaflet includes more detail and other important information to help you use
this medicine safely and effectively.
Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
The leaflet is in sections:
• Sections 1 to 6 are for parents and carers (sometimes called ‘your guardians’).
• The last section is a special section for a child or young person to read.
However, all sections are written as though the child or young person taking the medicine is reading
them.
The sections are:
1. What Elvanse is and what it is used for
2. What you need to know before you take Elvanse
3. How to take Elvanse

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

4. Possible side effects
5. How to store Elvanse
6. Contents of the pack and other information
7. Information for children and young people
1. What Elvanse is and what it is used for
What Elvanse is
Elvanse contains the active substance lisdexamfetamine dimesylate which helps with your brain
activity. It helps improve your attention, helps you concentrate and makes you less impulsive.
Elvanse is a long acting medicine which works gradually over a 13 hour time period.
What it is used for
Elvanse is a treatment for ‘attention deficit hyperactivity disorder’ (ADHD). It is used:
• in children and young people between the ages of 6 and 18 who have previously taken a
methylphenidate treatment that inadequately treated their ADHD. You may continue to take
Elvanse into adulthood if your doctor thinks you are benefiting from treatment.
You must talk to a doctor if you do not feel better or if you feel worse after one month of treatment.
Elvanse is not used as a treatment for ADHD in children under 6 years of age because it is not
known if it is safe or of benefit in such young people.
How it works
Elvanse improves the activity of certain parts of the brain which are under-active. The medicine can
help improve attention, concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually includes the following:
• psychological therapy
• educational therapy
• social therapy
It is prescribed only by doctors who have experience in treating people with behaviour problems.
About ADHD
People with ADHD find it hard to:
• sit still
• concentrate
It is not their fault that they cannot do these things. However, ADHD can cause problems with
everyday life. Children and young people with ADHD may have difficulty learning and doing
homework. They find it hard to behave well at home, at school or in other places.
ADHD does not affect the intelligence of a child or young person.
2. What you need to know before you take Elvanse
Do NOT take Elvanse:
• if you are allergic to lisdexamfetamine or any of the other ingredients of this medicine (listed in
Section 6)
• if you are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or
have taken an MAOI in the last 14 days
• if you have a thyroid problem
• if you feel unusually excited, over-active, or un-inhibited
• if you have ever had heart problems - such as a heart attack, uneven heartbeat, pain and
discomfort in the chest, heart failure, heart disease or were born with a heart problem
• if you have high or very high blood pressure or narrowing of the blood vessels
• if you have increased pressure in your eye (glaucoma)
Do not take Elvanse if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before you take Elvanse. This is because Elvanse can make these problems worse.
Why has the doctor given me this medicine?
This medicine can help your ‘ADHD’.
ADHD can make you:
• run about too much
• be unable to pay attention
• 
act quickly without thinking about what will happen next (impulsive).
It affects learning, making friends and how you think about yourself. It is not your fault.
While you are taking this medicine
• As well as giving you this medicine, your doctor will arrange for you to learn ways to cope with
your ADHD such as talking to people who can give you tips or teach you different ways to do
things.

Warnings and precautions
Talk to your doctor or pharmacist before using Elvanse treatment if you have:
• ever abused prescription medicines or street drugs
• had kidney problems
• had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)
• started your periods – girls only (see the ‘Pregnancy, breast-feeding’ section)
• hard-to-control and repeated twitching of any parts of the body or you repeat sounds and words
• high blood pressure
• a heart problem which is not in the ‘Do not take’ section above
• a mental health problem. These may include:
- mood swings (from being manic to being depressed - called ‘bipolar disorder’)
- starting to be aggressive or unfriendly (hostile), or your aggression gets worse
- seeing, hearing or feeling things that are not there (hallucinations)
- believing things that are not true (delusions)
- feeling unusually suspicious (paranoia)
- feeling agitated, anxious or tense
- feeling depressed or guilty
Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This
is because Elvanse can make these problems worse. Your doctor will want to monitor how the
medicine affects you.
Checks that your doctor will make before you start taking Elvanse
These checks are to decide if Elvanse is the correct medicine for you. Your doctor will ask you about:
• any other medicines you are taking
• whether there is any family history of sudden unexplained death
• any other medical problems (such as heart problems) you or your family may have
• how you are feeling, such as feeling happy or sad, having strange thoughts, or if you have had any
of these feelings in the past
• whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the
body or repeating sounds and words)
• any mental health or behaviour problems you or other family members have ever had. Your doctor
will check your mental health history, and check if any of your family have a history of suicide,
bipolar disorder (mood swings from being manic to being depressed) or depression.
It is important that you provide as much information as you can. This will help your doctor decide if
Elvanse is the correct medicine for you. Your doctor may decide that other medical tests are needed
before you start taking this medicine.
Other medicines and Elvanse
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do NOT take Elvanse if you:
• are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have
taken an MAOI in the last 14 days. Taking an MAOI with Elvanse may cause a sudden increase in
your blood pressure. Your doctor or pharmacist will be able to tell you if are taking a medicine that
is an MAOI.
Elvanse and some other medicines can affect each other. If you are taking any of the following
medicines, check with your doctor or pharmacist before taking Elvanse:
• medicines for severe mental health problems
• medicines used to reduce or increase blood pressure
• medicines used during surgery such as painkillers
• cough and cold remedies. Some of these contain medicines that can affect blood pressure so it is
important to check with your pharmacist when you buy any of these products
• medicines that can affect the acidity of your urine, such as vitamin C (ascorbic acid) or sodium
bicarbonate (for example in medicines for indigestion)
• The medicine should help your ADHD.
• You will need to go to your doctor several times for check ups. This is to make sure the medicine
is working and that you are growing and developing OK.
• If you take the medicine for more than one year, your doctor may stop your medicine to see if you
still need it. This will probably happen in a school holiday.
• Girls must ask their doctor for advice before taking this medicine if they think they may be
pregnant, or are planning to have a baby.
Some people cannot have this medicine
You cannot have this medicine if you:
• have a problem with your heart
• feel unusually excited or over-active

If you are unsure about whether the medicines you are taking are in the list above, ask your doctor or
pharmacist before taking Elvanse.
Drug testing
This medicine may give a positive result when testing for drug use. This includes testing used in sport.
Pregnancy, breast-feeding and fertility
It is not known if Elvanse will affect an unborn baby. Your body breaks down Elvanse into other
substances which can cross the placenta and enter breast milk. If you are pregnant, think you may
be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
You should not use this medicine during pregnancy unless explicitly advised by your doctor, or
breast feed while taking Elvanse. The effect of Elvanse on fertility is unknown.
Driving or using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy, or you may have
problems focusing or have blurred vision. If these happen it will be dangerous to do things such as
drive, use machines, ride a bike or horse or climb trees.
• 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:
o A doctor has prescribed this medicine for you and
o You have taken it according to his or her instructions, or with the information in this leaflet and
o 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.
3. How to take Elvanse
How much to take
Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Elvanse is only for you. Do not give this medicine to anyone else, even if their symptoms seem similar.
The maximum daily dose is 70 mg.
How to take Elvanse
• Take Elvanse in the morning before breakfast. It can be taken with or without food.
• There are two ways to take Elvanse:
o 
Swallow the capsule whole with a drink of water
o Open the capsule and empty the contents into:
§ Soft food such as yogurt
§ A glass of water or orange juice
Use a spoon to break up any bits and stir the Elvanse and yogurt, water or orange juice until they
are completely mixed together. Eat all the yogurt or drink all the water or orange juice immediately
after mixing with Elvanse. Do not store it. Do not worry if there is a film left in the glass or container
afterwards – this is not the active ingredient.
Dose
• Your doctor will tell you what strength of capsule to take (Elvanse 30 mg, 50 mg or 70 mg capsule)
each day.
• The recommended dose at the start of treatment is 30 mg. Later on your doctor may increase this
to 50 mg or 70 mg.
• If you have any kidney related problems your doctor may reduce the dose.
• Do not split the dose of a capsule; take the entire contents of the capsule. Do not take anything
less than one capsule per day.
If you do not feel better after 1 month of treatment
If you do not feel better, tell your doctor. You may need a different treatment.
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Some people need to talk to their doctor before they start taking this medicine
You need to talk to your doctor if you:
• have fits
• are pregnant or breastfeeding
• are taking other medicines – your doctor needs to know about all the medicines you are taking
• have bad kidney problems.
How do I take my medicine (capsules)?
• Swallow your capsule with water. Or open the capsule and dissolve all of the contents in a glass of
water or orange juice. Or mix the contents into soft food like yogurt.
• Eat all the yogurt or drink all the water or orange juice straight away after mixing.
• Take one capsule each morning. You can take it with or without food.

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11821Vx
Elvanse PIL UK MultiS 28ct 14121503573122
N/A
454616A02
N/A
1
685 x 300mm
19-12-14

PMS 7447

Black

Technical Info

Profile

1st AW Person Approval:
Submission Mock-up

Print at Risk

Shire Final Proof

Printer’s Proof

2nd AW Person Approval:
Submission Mock-up

Print at Risk

Shire Final Proof

Printer’s Proof

Regulatory Responsible Person Approval:
Signature:
Marketing Responsible Person Approval:

Package leaflet: Information for the user

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Elvanse 30 mg capsules, hard
Elvanse 50 mg capsules, hard
Elvanse 70 mg capsules, hard
Lisdexamfetamine dimesylate

Signature:

Not using Elvanse properly
• If Elvanse is not used properly, it may cause abnormal behaviour. You may also start to feel like
you need the medicine for reasons other than helping with your ADHD. Tell your doctor if you have
ever had a problem with alcohol, prescription medicines or street drugs
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If you take more Elvanse than you should
If you take too much medicine, talk to a doctor or call an ambulance straight away. Tell them how
much you have taken.

Wingdings-Regular

Signs of overdose may include: restlessness, shaking, increased uncontrolled movements, muscle
twitching, fast breathing, being confused, an inclination to fight or quarrel, seeing, feeling or hearing
things that are not real (hallucinations), panicked state, high fever or muscle breakdown. Tiredness
and depression may follow. Changes in heart beat (slow, fast or uneven), high or low blood pressure,
circulatory collapse, fits and coma may be seen. Being or feeling sick, diarrhoea and stomach
cramps may also occur.

Smallest point sized used:

If you forget to take Elvanse

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Do not take a double dose to make up for a forgotten dose. If you forget a dose, wait until the next
day. Avoid taking it in the afternoon because of the possibility of sleep disturbances (insomnia).

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If you stop taking Elvanse
If you stop taking this medicine, ADHD symptoms may come back.
Do not stop taking the medicine without first talking to your doctor. You should not suddenly stop
taking this medicine on your own.
Things your doctor will do when you take Elvanse
Your doctor will do some tests
• before you start - to make sure that Elvanse is safe for you and will be of benefit to you.
• after you start - your doctor will do tests at least every 6 months, but possibly more often. The
tests will also be done if the dose is changed. These tests will include:
- checking your appetite
- measuring height and weight
- measuring blood pressure and heart rate
- checking whether you have any problems with your mood, state of mind or any other unusual
feelings, or if these have got worse while taking Elvanse.
Long-term treatment
Elvanse does not need to be taken forever. If you take Elvanse for more than a year, your doctor
should stop treatment for a short time; this may happen during a holiday. This will show if you still
need the medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your
doctor will talk to you about these side effects.
Some side effects could be serious. If you get any of the side effects below, see a doctor
straight away:
Common (may affect up to 1 in 10 people)
• uneven heartbeat (palpitations)

Uncommon (may affect up to 1 in 100 people)
• seeing, feeling, or hearing things that are not real (hallucinations)
• feeling unusually excited, over-active, or un-inhibited (mania)
• allergic reaction (hypersensitivity)
Not known: frequency cannot be estimated from the available data
• severe allergic reaction characterised by a sharp drop in blood pressure, difficulty breathing, and
hives/itching (anaphylactic reaction)
• seeing or feeling or hearing things that are not real, paranoia, delusions (psychotic episodes)
• fits (seizures)
• allergic liver injury seen as possible yellowing of the eyes and/or skin (eosinophilic hepatitis)
• swelling of the skin (angioedema) or serious skin rash seen as severe blisters of the skin and
mucous membranes (Stevens- Johnson syndrome)
• breathlessness or swelling of the legs (signs of heart muscle disease)

Possible side effects
Side effects are the unwanted things that can happen when you take a medicine. If any of the
following happen, tell an adult straight away. They can then talk to your doctor. The main things that
could affect you are if you:
• feel your heart beating faster than usual or uneven heart beat
• see, feel, or hear things that are not real
• feel unusually excited or over-active
• have a severe allergic reaction. This may be seen as feeling dizzy, difficulty breathing, and itching

Marketing Authorisation Holder and Manufacturer

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:
Shire Pharmaceutical Contracts Limited
Hampshire International Business Park
Chineham, Basingstoke,
Hampshire RG24 8EP
United Kingdom

5. How to store Elvanse
Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
The expiry date refers to the last day of that month.

If you have any of the side effects above, see a doctor straight away.

Do not use this medicine if the capsules look damaged in any way.

Other side effects include the following. If they get serious, please tell your doctor or
pharmacist:

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

Very common (may affect more than 1 in 10 people)
• decreased appetite
• weight loss
• being unable to sleep
• dry mouth
• headache
Common (may affect up to 1 in 10 people)
• feeling agitated, jittery, anxious, aggressive, irritable or have mood swings
• feeling unusually sleepy, tired or restlessness
• unable to get or keep an erection or changes in sex drive
• feeling dizzy
• uncontrolled twitching, jerking, shaking, trembling or being unusually active
• high blood pressure, fast or uneven heart beat (tachycardia)
• difficulty breathing
• feeling or being sick or diarrhoea
• constipation
• stomach pains
• high temperature (fever) or excessive sweating
• rash
• grinding of the teeth
Uncommon (may affect up to 1 in 100 people)
• talking excessively
• feeling depressed, anxious, low, or uneasy (dysphoria)
• feeling excessively happy or excited (euphoria)
• excessive picking of the skin
• uncontrolled twitching or jerking of the body
• itching, rash or raised red itchy rashes (urticaria)
• blurred vision
• excessive widening of the pupils of the eyes
• poor blood circulation which makes the toes and fingers go numb and pale (Raynaud’s
phenomenon)
Effects on weight
Elvanse may cause reduced weight in some children and adolescents.
• There may be lack of weight gain.
• Your doctor will carefully watch your height and weight, as well as how well you are eating.
• If you are not growing as expected, then your doctor may stop treatment with Elvanse for a short time.

• Do not stop taking the medicine without talking to your doctor first.
• If you forget to take your medicine, tell an adult. You must NOT take 2 capsules to make up for the
dose you forgot.

Reporting of side effects

6. Contents of the pack and other information
What Elvanse contains
The active substance is Lisdexamfetamine dimesylate.

Each 70 mg capsule contains 70 mg Lisdexamfetamine dimesylate, corresponding to 20.8 mg of
dexamfetamine
The other ingredients are:

This leaflet was last revised in 01/2015

Each 50 mg capsule contains 50 mg Lisdexamfetamine dimesylate, corresponding to 14.8 mg of
dexamfetamine

• Capsule content: microcrystalline cellulose, croscarmellose sodium, magnesium stearate
• Capsule shell: gelatin, black ink (shellac and black iron oxide E172)
• Capsules shell colourants: titanium dioxide (E171)
- The 30 mg capsule also contains erythrosine (E127)
- The 50 mg capsule also contains brilliant blue FCF (E133)
- The 70 mg capsule also contains brilliant blue FCF (E133) and erythrosine (E127)

Elvanse
Elvanse
Elvanse
Tyvense
Elvanse
Elvanse
Elvanse
Elvanse

What Elvanse looks like and contents of the pack
Capsules, hard
The 30 mg capsules have a white opaque body and pink opaque cap, printed ‘S489’ and ’30mg’ in
black ink.
The 50 mg capsules have a white opaque body and blue opaque cap, printed ‘S489’ and ’50mg’ in
black ink.
The 70 mg capsules have a blue opaque body and pink opaque cap, printed ‘S489’ and ’70mg’ in
black ink.
Pack sizes: 28 or 30 capsules. Not all pack sizes may be marketed.

• It is important not to take too much medicine or you will get ill.
• If you take too much medicine, tell your mum, dad or carer right away.
• Don’t stop taking your medicine until your doctor says it’s OK to stop.

If you feel unwell in any way while you are taking your medicine please tell an adult straight
away.

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

• Make sure you keep your medicine in a safe place, so that no one else takes it.
• The medicine is just for you - do NOT let anyone else have it. It may help you, but it could hurt
someone else.
• If you forget to take your medicine don’t take 2 capsules the next time. Just take 1 capsule at the
next normal time.

This medicinal product is authorised in the Member States of the EEA under the following
names:
Denmark
Finland
Germany
Ireland
Norway
Spain
Sweden
United Kingdom

Each 30 mg capsule contains 30 mg Lisdexamfetamine dimesylate, corresponding to 8.9 mg of
dexamfetamine.

• have fits
• notice yellowing of the eyes and/or skin
• have swelling of the skin or bad skin rash like blisters of the skin or other areas

Other things to remember

Manufacturer:
Shire Pharmaceuticals Limited
Hampshire International Business Park
Chineham, Basingstoke,
Hampshire RG24 8EP
United Kingdom
Tel. Number: 0800 055 6614
e-mail: medinfouk@shire.com

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

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Source: Medicines and Healthcare Products Regulatory Agency

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

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