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Package leaflet: Information for the user

Modified-Release Capsules, Hard
(methylphenidate hydrochloride)
Read all of this leaflet carefully before you or your child starts taking this medicine.
Check with your doctor or pharmacist before treatment if:
The name of your medicine is Equasym XL 20mg Modified-Release
Capsules, Hard but will be referred to as ‘Equasym XL’ throughout the
• you have liver or kidney problems
remainder of this leaflet. It contains the active substance
• you have had fits (seizures, convulsions, epilepsy) or any abnormal
‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be
brain scans (EEGs)
used in this leaflet.
• you have ever abused or been dependent on alcohol, prescription
Equasym XL 20mg Modified-Release Capsules, Hard are also available
medicines or street drugs
in other strengths.
• 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
This medicine is used to treat ADHD
• The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’.
• you have a mental health problem which is not in the ‘Do not take’
• The medicine helps with your brain activity. It can help improve your
section above. Other mental health problems include:
attention, help you concentrate, and make you less impulsive.
− mood swings (from being manic to being depressed - called ‘bipolar
• You need to have other treatments for ADHD as well as this medicine.
Read Section 1 for more information.
− starting to be aggressive or hostile, or your aggression gets worse
− seeing, hearing or feeling things that are not there (hallucinations)
Before you take this medicine, talk to your doctor if:
− believing things that are not true (delusions)
• You have heart, circulation, or mental health problems - you may not
− feeling unusually suspicious (paranoia)
be able to take this medicine.
− feeling agitated, anxious or tense
• You are taking any other medicines - this is because methylphenidate
− feeling depressed or guilty.
can affect how other medicines work.
Tell your doctor or pharmacist if any of the above apply to you before
Read Section 2 for more information.
starting treatment. This is because methylphenidate can make these
problems worse. Your doctor will want to monitor how the medicine
While taking this medicine:
affects you.
• See your doctor regularly. This is because your doctor will want to

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
− The last section is a special section for a child or young person to
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) Further information
Information for children and young people
Now read the rest of this leaflet before you start taking this
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 counselling 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
• 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
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.
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
• you have mental health problems such as:
− a ‘psychopathic’ or ‘borderline personality’ problem
− abnormal thoughts or visions or an illness called ‘schizophrenia’
− signs of a severe mood problem like:
ο feeling like killing yourself
ο severe depression, where you feel very sad, worthless and
ο mania, where you feel unusually excitable, over-active, and
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.
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
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.

Checks that your doctor will make before you start taking
These checks are to decide if methylphenidate is the correct medicine for
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
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
Do not take methylphenidate 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 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
• 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
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 while 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
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
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
ο A doctor has prescribed this medicine for you and
ο You have taken it according to his or her instructions, or with the
information in this leaflet and
ο 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.

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.

• 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 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.
• 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 10mg 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
Your doctor will do some tests
• before you start - to make sure that Equasym XL is safe and will be of
• 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.
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
• 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)
• unwanted thoughts that keep coming back
• unexplained fainting, chest pain, shortness of breath (these can be
signs of heart problems)

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
• 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)
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
By reporting side effects, you can help provide more information on the
safety of this medicine.
• Make sure you keep your medicine in a safe place, so that no one else
takes it, especially younger brothers or sisters.
• Keep out of the sight and reach of children.
• 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.
• Do not store above 25oC.
• Return any unused product to your pharmacy.
• If your medicine becomes discoloured, or shows any signs of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
What Equasym XL contains:
Each hard gelatin capsule contains 20 mg methylphenidate
hydrochloride equivalent to 17.30 mg methylphenidate.
The other ingredients are:
Capsule content: Sucrose, Maize starch, Povidone K29 to K32,
Hypromellose, Macrogol 400, Macrogol 8000, Ethylcellulose Aqueous
Dispersion, Dibutyl Sebacate
Capsule shell containing: Gelatin, Titanium dioxide (E171), Indigo
carmine aluminium salt (E132).
White printing ink containing: Shellac, Propylene glycol, Sodium
hydroxide, Povidone K16, Titanium dioxide (E171)
Black printing ink containing: Shellac glaze 45% (20% esterified) in
ethanol, Propylene glycol, Ammonium hydroxide 28%, Black iron oxide
What Equasym XL looks like and contents of the pack
Equasym XL is a Hard gelatin capsule. The capsule has a blue
opaque cap imprinted with “S544” in white and a white opaque body
imprinted with “20 mg” in black.
Equasym XL is available in packs of 30, 60 and 100 capsules.
Manufactured by Shire Pharmaceuticals Ltd., Hampshire
International Business Park, Chineham, Basingstoke RG24 8EP, UK.
Procured from within the EU by the PL Holder: MPT Pharma Ltd,
Westgate Business Park, Unit 5-7 Tintagel way, Aldridge, Walsall,
WS9 8ER.
PL: 33532/0309 EQUASYM XL 20mg Modified-Release Capsules,
Leaflet date: 12th February 2015
Leaflet code: xxxxxxxxxx
Equasym XL® is a registered trademark of Shire Pharmaceuticals Inc.

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

Very common (affects more than 1 in 10 people)
• headache
• feeling nervous
• not being able to sleep.
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
• 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
• 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 side effects include the following, if they get serious, please
tell your doctor or pharmacist:

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
• 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

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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.