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EQUASYM XL 50 MG MODIFIED-RELEASE CAPSULES HARD

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Equasym® XL 40 mg, 50 mg and 60 mg modified-release capsules, hard
Methylphenidate hydrochloride
The name of your medicine is Equasym XL, it contains the active substance ‘methylphenidate
hydrochloride’. The name ‘methylphenidate’ will also be used in this leaflet.

Important things you need to know about your medicine
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 as well as this medicine.
Read Section 1 for more information.
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.
You are taking any other medicines - this is because methylphenidate can affect how other medicines
work.
Read Section 2 for more information.
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.
Your doctor may stop your medicine to see if it is still needed, if you take it for more than a year.
The most common side effects are feeling nervous, not being able to sleep or having a headache.
Read Sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
Your mood and 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 on the safe and effective
use of 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.
If any of the side effects worry you, or if you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist.
The leaflet has been written 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 Equasym XL is and what it is used for
2.
Before you take methylphenidate
3.
How to take Equasym XL
4.
Possible side effects
5.
How to store Equasym XL
6.
Contents of the pack and other information
1

Information for children and young people
Now read the rest of this leaflet before you start taking this medicine.

1.

What Equasym XL is and what it is used for

What it is used for
Equasym XL is used to treat ‘attention deficit hyperactivity disorder’ (ADHD).
it is used in children and young people between the ages of 6 and 18.
it is used only after trying treatments which do not involve medicines. Such as counseling and
behavioural therapy.
Equasym XL is not for use as a treatment for ADHD in children under 6 years of age or in adults. It is not
known if it is safe or of benefit in these people.
How it works
Equasym XL improves the activity of certain parts of the brain which are under-active. The medicine can
help improve attention (attention span), concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually includes:
psychological
educational and
social therapy
It is prescribed only by doctors who have experience in children or young people’s behaviour problems.
ADHD can be managed using treatment programmes.
About ADHD
Children and young people with ADHD find it:
Hard to sit still and
Hard to concentrate
It is not their fault that they cannot do these things.
Many children and young people struggle to do these things. However, with ADHD they 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.

Before you take methylphenidate

Do not take methylphenidate if:
you are allergic (hypersensitive) to methylphenidate or any of the other ingredients of Equasym XL
(listed in Section 6)
you have a thyroid problem
you have increased pressure in your eye (glaucoma)
you have a tumour of your adrenal gland (phaeochromocytoma)
you have an eating problem when you do not feel hungry or want to eat - such as ‘anorexia nervosa’
you have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms
and legs
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
you have had a problem with the blood vessels in your brain - such as a stroke, swelling and
weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of
the blood vessels (vasculitis)
you have mental health problems such as:
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a ‘psychopathic’ or ‘borderline personality’ problem
abnormal thoughts or visions or an illness called ‘schizophrenia’
signs of a severe mood problem like:
- feeling like killing yourself
- severe depression, where you feel very sad, worthless and hopeless
- mania, where you feel unusually excitable, over-active, and un-inhibited.
Do not take methylphenidate if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before you take methylphenidate. This is because methylphenidate can make these problems
worse.
Check with your doctor or pharmacist before treatment if:
you have liver or kidney problems
you have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)
you have ever abused or been dependent on alcohol, prescription medicines or street drugs
you are a girl and have started your periods (see the ‘Pregnancy, breast-feeding and contraception’
section below)
you have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words
you have high blood pressure
you have a heart problem which is not in the ‘Do not take’ section above
you have a mental health problem which is not in the ‘Do not take’ section above. Other mental health
problems include:
mood swings (from being manic to being depressed - called ‘bipolar disorder’)
starting to be aggressive or 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 apply to you before starting treatment. This is because
methylphenidate 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 methylphenidate
These checks are to decide if methylphenidate is the correct medicine for you. Your doctor will talk to 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 high or low, 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 discuss whether you are at risk of having mood swings (from being manic to being depressed called ‘bipolar disorder’). They will check your mental health history, and check if any of your family
have a history of suicide, bipolar disorder or depression.
It is important that you provide as much information as you can. This will help your doctor decide if
methylphenidate is the correct medicine for you. Your doctor may decide that other medical tests are needed
before you start taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Do not take methylphenidate if you:

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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 methylphenidate may cause a sudden
increase in your blood pressure.

If you are taking other medicines, methylphenidate may affect how well they work or may cause side effects.
If you are taking any of the following medicines, check with your doctor or pharmacist before taking
methylphenidate:
other medicines for depression
medicines for severe mental health problems
medicines for epilepsy
medicines used to reduce or increase blood pressure
some cough and cold remedies which contain medicines that can affect blood pressure. It is important
to check with your pharmacist when you buy any of these products
medicines that thin the blood to prevent blood clots
If you are in any doubt about whether any medicines you are taking are included in the list above, ask your
doctor or pharmacist before taking methylphenidate.
Having an operation
Tell your doctor if you are going to have an operation. You should not take methylphenidate on the day of
your surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise in
blood pressure during the operation.
Drug testing
This medicine may give a positive result when testing for drug use. This includes testing used in sport.
Taking methylphenidate with alcohol
Do not drink alcohol whilst taking this medicine. Alcohol may make the side effects of this medicine worse.
Remember that some foods and medicines contain alcohol.
Pregnancy, breast-feeding and contraception
It is not known if methylphenidate will affect an unborn baby. Tell your doctor or pharmacist before using
methylphenidate if you are:
having sex. Your doctor will discuss contraception with you
pregnant or think you may be pregnant. Your doctor will decide whether you should take
methylphenidate
breast-feeding or planning to breast-feed. It is possible that methylphenidate is passed into human
breast milk. Therefore, your doctor will decide whether you should breast-feed while taking
methylphenidate.
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 may 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.
Important information about some of the ingredients of Equasym XL
This medicine contains sucrose (a type of sugar). If you have been told by your doctor that you cannot
tolerate or digest some sugars, talk to your doctor before taking this medicine.
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3.

How to take Equasym XL

How much to take
Always take Equasym XL exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
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Equasym XL is a “modified release” form of methylphenidate which releases the medicine gradually
over a time period corresponding to the school day (8 hours). It is intended to take the place of the
same total daily dose of traditional (immediate release) methylphenidate taken at breakfast and
lunchtime.
If you are already taking traditional (immediate release) methylphenidate, your doctor may prescribe
an equivalent dose of Equasym XL instead.
If you have not taken methylphenidate before, your doctor will normally start treatment with
traditional (immediate release) methylphenidate tablets. If your doctor feels it is necessary
methylphenidate treatment may be started with Equasym XL 10 mg once daily before breakfast.
Your doctor will usually start treatment with a low dose and increase it gradually as required.
The maximum daily dose is 60 mg.

How to take
Equasym XL should be given in the morning before breakfast. The capsules may be swallowed whole
with a drink of water, or alternatively, may be opened and the capsule contents sprinkled onto a small
amount (tablespoon) of applesauce and taken immediately and not stored for future use. If the
medicine is taken with soft food, some fluids, e.g. water, should be taken afterwards.
If you do not feel better after 1 month of treatment
If you do not feel better, tell your doctor. They may decide you need a different treatment.
Not using Equasym XL properly
If Equasym XL is not used properly, this may cause abnormal behaviour. It may also mean that you start to
depend on the medicine. Tell your doctor if you have ever abused or been dependent on alcohol, prescription
medicines or street drugs.
This medicine is only for you. Do not give this medicine to anyone else, even if their symptoms seem
similar.
If you take more Equasym XL than you should
If you take too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has
been taken.
Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements,
muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or
hearing things that are not real (hallucinations or psychosis), sweating, flushing, headache, high fever,
changes in heart beat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.
If you forget to take Equasym XL
Do not take a double dose to make up for a forgotten dose. If you forget a dose, wait until it is time for the
next dose.
If you stop taking Equasym XL
If you suddenly stop taking this medicine, the ADHD symptoms may come back or unwanted effects such as
depression may appear. Your doctor may want to gradually reduce the amount of medicine taken each day,
before stopping it completely. Talk to your doctor before stopping Equasym XL.
Things your doctor will do when you are on treatment
5

Your doctor will do some tests
before you start - to make sure that Equasym XL is safe and will be of benefit.
after you start - they will be done at least every 6 months, but possibly more often. They will also be
done when 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 Equasym XL.
Long-term treatment
Equasym XL does not need to be taken for ever. If you take Equasym XL for more than a year, your doctor
should stop treatment for a short time, this may happen during a school holiday. This will show if the
medicine is still needed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, methylphenidate can cause side effects, but not everybody gets them. Although some
people get side effects, most people find that methylphenidate helps them. Your doctor will talk to you about
these side effects.
Some side effects could be serious. If you have any of the side effects below, see a doctor straight away:
Common (affects less than 1 in 10 people)
uneven heartbeat (palpitations)
mood changes or mood swings or changes in personality
Uncommon (affects less than 1 in 100 people)
thinking about or feeling like killing yourself
seeing, feeling, or hearing things that are not real, these are signs of psychosis
uncontrolled speech and body movements (Tourette’s)
signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other
parts of the body, shortness of breath, wheezing or trouble breathing
Rare (affects less than 1 in 1,000 people)
feeling unusually excited, over-active and un-inhibited (mania)
Very rare (affects less than 1 in 10,000 people)
heart attack
fits (seizures, convulsions, epilepsy)
skin peeling or purplish red patches
muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system due to a temporary lack of blood supply to the brain
paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems
with the blood vessels in your brain)
decrease in number of blood cells (red cells, white cells and platelets) which can make you more likely
to get infections, and make you bleed and bruise more easily
a sudden increase in body temperature, very high blood pressure and severe convulsions (‘Neuroleptic
Malignant Syndrome’). It is not certain that this side effect is caused by methylphenidate or other
drugs that may be taken in combination with methylphenidate
Other side effects (how often they happen is not known)
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unwanted thoughts that keep coming back
unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)

If you have any of the side effects above, see a doctor straight away.
Other side effects include the following, if they get serious, please tell your doctor or pharmacist:
Very common (affects more than 1 in 10 people)
headache
feeling nervous
not being able to sleep
Common (affects less than 1 in 10 people)
joint pain
dry mouth
high temperature (fever)
unusual hair loss or thinning
feeling unusually sleepy or drowsy
loss of appetite or decreased appetite
itching, rash or raised red itchy rashes (hives)
cough, sore throat or nose and throat irritation
high blood pressure, fast heart beat (tachycardia)
feeling dizzy, movements which you cannot control, being unusually active
feeling aggressive, agitated, anxious, depressed, irritable and abnormal behaviour
grinding of the teeth
Uncommon (affects less than 1 in 100 people)
constipation
chest discomfort
blood in the urine
shaking or trembling
double vision or blurred vision
muscle pain, muscle twitching
shortness of breath or chest pain
increases in liver test results (seen in a blood test)
anger, feeling restless or tearful, excessive awareness of surroundings, problems sleeping
Rare (affects less than 1 in 1,000 people)
changes in sex drive
feeling disorientated
dilated pupils, trouble seeing
swelling of the breasts in men
excessive sweating, redness of the skin, red raised skin rash
Very rare (affects less than 1 in 10,000 people)
heart attack
sudden death
muscle cramps
small red marks on the skin
inflammation or blocked arteries in the brain
abnormal liver function including liver failure and coma
changes in test results – including liver and blood tests
suicidal attempt, abnormal thinking, lack of feeling or emotion, doing things over and over again,
being obsessed with one thing
fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold
(‘Raynaud’s phenomenon’)
Other side effects (how often they happen is not known)
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migraine
very high fever
slow, fast or extra heart beats
a major fit (‘grand mal convulsions’)
believing things that are not true, confusion
severe stomach pain, often with feeling and being sick
problems with the blood vessels of the brain (stroke, cerebral arteritis or cerebral occlusion)

Effects on growth
When used for more than a year, methylphenidate may cause reduced growth in some children. This affects
less than 1 in 10 children.
There may be lack of weight gain or height growth.
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 treatment with methylphenidate may be stopped for a
short time.
If any of the side effects worry you, or if you notice any side effects not listed in this leaflet, tell your doctor
or pharmacist.

5.

How to store Equasym XL

Make sure you keep your medicine in a safe place, so that no one else takes it, especially younger brothers or
sisters.
Do not use Equasym XL after the expiry date which is stated on the blister and the carton after EXP. The
expiry date refers to the last day of that month.
Store below 25°C.
Do not use Equasym XL if the capsules look damaged in any way.
Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Equasym XL contains
The active substance is methylphenidate hydrochloride.
Each 40 mg capsule contains 40 mg of methylphenidate hydrochloride corresponding to 34.59 mg of
methylphenidate.
Each 50 mg capsule contains 50 mg of methylphenidate hydrochloride corresponding to 43.24 mg of
methylphenidate.
Each 60 mg capsule contains 60 mg of methylphenidate hydrochloride corresponding to 51.89 mg of
methylphenidate.
The other ingredients are:
Capsule content: Sugar spheres (sucrose and maize starch), povidone K29 to K32, Opadry Clear YS1-7006 (hypromellose, macrogol 400 and macrogol 8000), ethylcellulose aqueous dispersion and
dibutyl sebacate
Capsule shell: Gelatin, Titanium dioxide (E171). The 40 mg capsule also contains yellow iron oxide
(E172) and the 50 mg capsule also contains indigo carmine (E132) and red iron oxide (E172)
White printing ink: shellac, propylene glycol, sodium hydroxide, povidone K16 and titanium dioxide
(E171)

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Black ink contains shellac glaze 45% (20% esterified) in ethanol, propylene glycol, ammonium
hydroxide 28% and iron oxide black (E172)

What Equasym XL looks like and contents of the pack
Modified-release capsules, hard
The 40 mg modified-release capsules, hard have a yellow ivory opaque cap imprinted with “S544” in black
and a white opaque body imprinted with “40 mg” in black.
The 50 mg modified-release capsules, hard have a purple opaque cap imprinted with “S544” in white and a
white opaque body imprinted with “50 mg” in black.
The 60 mg modified-release capsules, hard have a white opaque cap imprinted with “S544” in black and a
white opaque body imprinted with “60 mg” in black.
Pack sizes: 28 or 30 modified-release capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Shire Pharmaceuticals Ireland Limited
5 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
Shire Pharmaceuticals Limited
Hampshire International Business Park
Chineham, Basingstoke,
Hampshire RG24 8EP
United Kingdom
UK Tel.-Nr.: 0800 055 6614
e-mail: Medinfoglobal@shire.com
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium
Denmark
Finland
France
Germany
Ireland
Italy
Luxembourg
Netherlands
Norway
Portugal
Spain
United Kingdom

Equasym XR
Equasym Depot
Equasym Retard
Quasym
Equasym Retard
Equasym XL
Equasym
Equasym XR
Equasym XL
Equasym Depot
Quasym
Equasym
Equasym XL

This leaflet was last revised in 02/2014

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7. Information for children and young people
This info is to help you learn the main things about your medicine called Equasym XL.
If you don’t enjoy reading, someone like your mum, dad or carer (sometimes called ‘your guardian’) can
read it to you and answer any questions.
It may help if you read small bits at a time.
Why have I been given this medicine?
This medicine can help children and young people with ‘ADHD’.
ADHD can make you:
run about too much
not be able to pay attention
act quickly without thinking about what will happen next (impulsive).
It affects learning, making friends and how you think about yourself. It is not your fault.
While you are taking this medicine
As well as taking this medicine you will also get help with ways to cope with your ADHD such as
talking to ADHD specialists.
This medicine should help you.
You will need to go to your doctor several times a year 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 it is still
needed. This will probably happen in a school holiday.
Do not drink alcohol. Alcohol may make the side effects of this medicine worse.
Girls must tell their doctor straight away if they think they may be pregnant. We do not know how this
medicine affects unborn babies. If you are having sex, please talk to your doctor about contraception.
Some people cannot have this medicine
You cannot have this medicine if:
you have a problem with your heart
you feel very unhappy, depressed or have a mental illness.
Some people need to talk to their doctor before they start having this medicine
You need to talk to your doctor if:
you have epilepsy (fits)
you are pregnant or breastfeeding
you are taking other medicines – your doctor needs to know about all the medicines you are taking.
How do I take my medicine (capsules)?
Swallow your medicine with water and food.
Your doctor will tell you how many times a day you should take your medicine
Do not stop taking the medicine without talking to your doctor first.
Possible side effects
Side effects are the unwanted things that can happen when you take a medicine. If any of the following
happen, tell an adult you trust straight away. They can then talk to your doctor. The main things that could
affect you are:
Feeling worried or nervous
Feeling dizzy, or getting headaches
Being very depressed and unhappy or wanting to hurt yourself
Having different moods than usual, not being able to get to sleep
Skin rashes, bruising easily, getting out of breath

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The medicine can also make you feel sleepy. If you feel sleepy, it is important not to do outdoor sports
like riding a horse or bike, swimming or climbing trees. You could hurt yourself and others.
Your heart beating faster than usual.

If you feel unwell in any way while you are taking your medicine please tell an adult you trust straight
away.
Other things to remember
Make sure you keep your medicine in a safe place, so that no one else takes it, especially younger
brothers or sisters.
The medicine is special for you - do not let anyone else have it. It may help you, but it could hurt
someone else.
If you forget to take your medicine don’t take two tablets the next time. Just take one tablet at the next
normal time.
If you do take too much medicine, tell your mum, dad or carer right away.
It is important not to take too much medicine or you will get ill.
Don’t stop taking your medicine until your doctor says it’s OK.
Who should I ask if there is anything I don’t understand?
Your mum, dad, carer, doctor, nurse or pharmacist will be able to help you.

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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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