EQUASYM XL 20 MG MODIFIED RELEASE CAPSULES HARD

Active substance: METHYLPHENIDATE HYDROCHLORIDE

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Package Leaflet: Information for the user

Equasym® XL,

10 mg, 20 mg and 30 mg

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.

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 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

• 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.

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.

While taking this medicine:

About ADHD

• 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.

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.

Before you take this medicine, talk to your doctor if:

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
■ Further information
Information for children and young people

Now read the rest of this leaflet before you start taking this medicine.

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’.

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:
– a ‘psychopathic’ or ‘borderline personality’ problem
– abnormal thoughts or visions or an illness called ‘schizophrenia’
– signs of a severe mood problem like:
o feeling like killing yourself
o severe depression, where you feel very sad, worthless and hopeless
o 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.
• 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.

Check with your doctor or pharmacist before treatment if:

Having an operation

• 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.

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.

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

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 methylphenidate.

Driving or using machines
You may feel dizzy, have problems focussing or have blurred vision when taking methylphenidate.
If these happen it may be dangerous to do things such as drive, use machines, ride a bike or
horse or climb trees.

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.

3


How to take Equasym XL

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:
• 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.

• 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.

• This medicine should help you.

Some people cannot have this medicine

• 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.

You cannot have this medicine if:
• you have a problem with your heart
• you feel very unhappy, depressed or have a mental illness.

• 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.

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.



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.

• Do not drink alcohol. Alcohol may make the side effects of this medicine worse.

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.

500391-‘393-‘394-’398-’399-’400/PILC2/3585/sb/br

modified-release capsules, hard
Methylphenidate hydrochloride

Some people need to talk to their doctor before they start having this
medicine

• 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.

You need to talk to your doctor if:
• you have epilepsy (fits)
• you are pregnant or breastfeeding

500391-’393-’394-’398-’399-’400/PILC2/3585/sb/br
Version 2

Package Leaflet: Information for the user

Equasym® XL,

10 mg, 20 mg and 30 mg

modified-release capsules, hard
Methylphenidate hydrochloride

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.

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:

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.

Common (affects less than 1 in 10 people)
• uneven heartbeat (palpitations)
• mood changes or mood swings or changes in personality

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.

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

If you take more Equasym XL than you should

Rare (affects less than 1 in 1,000 people)
• feeling unusually excited, over-active and un-inhibited (mania)

If you take too much medicine, talk to a doctor or call an ambulance straight away. Tell them
how much has been taken.

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

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

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)

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 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.

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

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.
• 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
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.

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’).

6


Further information

What Equasym XL contains
The active substance is methylphenidate hydrochloride
• Each 10 mg capsule contains 10 mg of methylphenidate hydrochloride corresponding to
8.65 mg of methylphenidate.
• Each 20 mg capsule contains 20 mg of methylphenidate hydrochloride corresponding to
17.30 mg of methylphenidate.
• Each 30 mg capsule contains 30 mg of methylphenidate hydrochloride corresponding to
25.94 mg of methylphenidate.
The other ingredients are:
• Capsule content: Sugar spheres (sucrose and maize starch), povidone K29 to K32, Opadry
Clear YS-1-7006 (hypromellose, macrogol 400 and macrogol 8000), ethylcellulose aqueous
dispersion and dibutyl sebacate.
• Capsule shell: Gelatin, Titanium dioxide (E171) and Indigo carmine aluminium salt (E132).
The 10 mg capsule also contains yellow iron oxide (E172) and the 30 mg capsule also contains
red iron oxide (E172).
• White printing ink: shellac, propylene glycol, sodium hydroxide, povidone K16 and titanium
dioxide (E171)
• Black ink contains shellac glaze 45% (20% esterified) in ethanol, propylene glycol, ammonium
hydroxide 28% and iron oxide black.

What Equasym XL looks like and contents of the pack
Modified-release capsules, hard
The 10 mg modified-release capsules, hard have a dark green opaque cap imprinted with
“S544” in white and white opaque body imprinted with “10 mg” in black.
The 20 mg modified-release capsules, hard have a blue opaque cap imprinted with “S544” in
white and white opaque body imprinted with “20 mg” in black.
The 30 mg modified-release capsules, hard have a reddish-brown opaque cap imprinted with
“S544” in white and white opaque body imprinted with “30 mg” in black.

Other side effects (how often they happen is not known)
Pack sizes: 10, 28, 30, 60 or 100 modified-release capsules, hard.
• migraine
Not all pack sizes may be marketed.
• very high fever
• slow, fast or extra heart beats
Marketing Authorisation Holder and Manufacturer
• a major fit (‘grand mal convulsions’)
Shire Pharmaceuticals Ireland Limited, 5 Riverwalk, Citywest Business Campus, Dublin 24,
• believing things that are not true, confusion
Ireland.
• severe stomach pain, often with feeling and being sick
• problems with the blood vessels of the brain (stroke, cerebral arteritis or cerebral
Manufacturer:
occlusion)
Shire Pharmaceuticals Limited, Hampshire International Business Park, Chineham, Basingstoke,
Hampshire, RG24 8EP, United Kingdom. Tel. Nr.: 0800 055 6614; e-mail: medinfoglobal@shire.
Effects on growth
When used for more than a year, methylphenidate may cause reduced growth in some children. com
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.

This medicinal product is authorised in the Member States of the EEA
under the following names:

Austria:
Equasym Retard
Denmark:
Equasym Depot
Finland:
Equasym Retard
France:
Quasym LP
Germany:
Equasym Retard
Iceland:
Equasym Depot
Ireland:
Equasym XL
5 How to store Equasym XL
Netherlands:
Equasym XL
Equasym Depot
Make sure you keep your medicine in a safe place, so that no one else takes it, especially Norway:
Sweden:
Equasym Depot
younger brothers or sisters.
Do not use Equasym XL after the expiry date which is stated on the blister and the carton after United Kingdom: Equasym XL
EXP. The expiry date refers to the last day of that month.
This leaflet was last approved in 07/2011.
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 or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.



Other things to remember

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, 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.

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

500391-‘393-‘394-’398-’399-’400/PILC2/3585/sb/br

500391-’393-’394-’398-’399-’400/PILC2/3585/sb/br
Version 2

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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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