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EQUASYM XL 30MG MODIFIED-RELEASE HARD CAPSULES

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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S1669 LEAFLET Equasym XL 20140530

What Equasym XL looks like and contents of the pack

Very rare (affects less than 1 in 10,000 people)

Equasym XL capsules have a reddish-brown opaque cap imprinted
with “S544” in white and white opaque body imprinted with “30 mg”
in black.



heart attack



sudden death



muscle cramps



small red marks on the skin



Product Licence holder

inflammation or blocked arteries in the brain



abnormal liver function including liver failure and coma



changes in test results – including liver and blood tests

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



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’).

S1669 LEAFLET Equasym XL 20140530

PACKAGE LEAFLET: INFORMATION FOR THE USER

EQUASYM XL 30mg
MODIFIED-RELEASE HARD CAPSULES
(methylphenidate hydrochloride)

Equasym XL capsules are available in packs of 30 capsules.

This product is manufactured by Shire Pharmaceuticals Limited,
Hampshire International Business Park, Chineham, Basingstoke,
Hampshire, RG24 8EP, United Kingdom.
CD

The active substance is ‘methylphenidate hydrochloride'. The name
‘methylphenidate' will also be used in this leaflet.
Please note that other strengths (10mg and 20mg) are also
available for Equasym XL Modified-release Hard Capsules.

Manufacturer

POM

Your medicine is known as Equasym XL 30mg Modified-release
Hard Capsules but will be referred to as Equasym XL throughout
the following leaflet.

PL No: 19488/1669

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

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.

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:

Other side effects (how often they happen is not known)

Leaflet revision date: 30 May 2014



migraine



very high fever

Equasym is a registered trademark of Shire Pharmaceuticals Ltd,
UK.



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



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

problems with the blood vessels of the brain (stroke, cerebral
arteritis or cerebral occlusion)



You have heart, circulation, or mental health problems - you
may not be able to take this medicine.

About ADHD



You are taking any other medicines - this is because
methylphenidate can affect how other medicines work.



hard to sit still and



hard to concentrate.

S1669 LEAFLET Equasym XL 20140530



Read Section 1 for more information.

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.

Read Section 2 for more information.
While taking this medicine:

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:
www.mhra.gov.uk/yellowcard.



Do not store above 25°C.



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 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

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.

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.

Children and young people with ADHD find it:

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)



Read Section 4 for more information.

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

The rest of this leaflet includes more detail and other important
information on the safe and effective use of this medicine.



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:

Talk to your doctor straight away if any of the following
happen:

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.



Read Sections 3 and 4 for more information.

By reporting side effects, you can help provide more information on
the safety of this medicine.



You need to have other treatments for ADHD as well as this
medicine.





Your mood and how you feel changes.



You feel any problems with your heart.



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.

-

What Equasym XL contains
-

The active substance is methylphenidate hydrochloride. Each 30mg
capsule contains 30mg of methylphenidate hydrochloride
corresponding to 25.94mg of methylphenidate.


The last section is a special section for a child or young person
to read.

The sections are:
1. What Equasym XL is and what it is used for

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.

2. Before you take methylphenidate

Capsule shell: gelatin, titanium dioxide (E171), indigo carmine
aluminium salt (E132) and red iron oxide (E172).



White printing ink: shellac, propylene glycol, sodium
hydroxide, povidone K16 and titanium dioxide (E171).

5. How to store Equasym XL

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

Information for children and young people

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.

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.

3. How to take Equasym XL





abnormal thoughts or visions or an illness called
‘schizophrenia’

Sections 1 to 6 are for parents and carers (sometimes called
‘your guardians’).

However, all sections are written as though the child or young
person taking the medicine is reading them.

The other ingredients are:

a ‘psychopathic’ or ‘borderline personality’ problem

-

The leaflet has been written in sections:
6. Further information

-

4. Possible side effects
6. Further information
Now read the rest of this leaflet before you start taking this
medicine.

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

Information for children and young people

Why have I been given this medicine?

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

This info is to help you learn the main things about your medicine
called Equasym XL.

o

This medicine can help children and young people with ‘ADHD’.

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.


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

If you do not feel better after 1 month of treatment

Rare (affects less than 1 in 1,000 people)



you have liver or kidney problems
you have had fits (seizures, convulsions, epilepsy) or any
abnormal brain scans (EEGs)

If you do not feel better, tell your doctor. They may decide you need
a different treatment.






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.

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)



heart attack



fits (seizures, convulsions, epilepsy)

This medicine may give a positive result when testing for drug use.
This includes testing used in sport.

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.



skin peeling or purplish red patches



This medicine is only for you. Do not give this medicine to anyone
else, even if their symptoms seem similar.

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

Drug testing

you have hard-to-control, repeated twitching of any parts of the
body or you repeat sounds and words



you have high blood pressure

Taking methylphenidate with alcohol



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:

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.

mood swings (from being manic to being depressed - called
‘bipolar disorder’)

It is not known if methylphenidate will affect an unborn baby. Tell
your doctor or pharmacist before using methylphenidate if you are:

starting to be aggressive or hostile, or your aggression gets
worse



having sex. Your doctor will discuss contraception with you

-

seeing, hearing or feeling things that are not there
(hallucinations)



pregnant or think you may be pregnant. Your doctor will decide
whether you should take methylphenidate.

-

believing things that are not true (delusions)



-

feeling unusually suspicious (paranoia)

-

feeling agitated, anxious or tense

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.

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)



Pregnancy, breast-feeding and contraception

-

-

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.

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.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.


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



Do not drive while taking this medicine until you know how it
affects you.

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

Other side effects (how often they happen is not known)

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.



unwanted thoughts that keep coming back



unexplained fainting, chest pain, shortness of breath (these can
be signs of heart problems)

If you stop taking Equasym XL

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

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

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.



It is an offence to drive if this medicine affects your ability to
drive.





before you start - to make sure that Equasym XL is safe and will
be of benefit.

However, you would not be committing an offence if:



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.

Common (affects less than 1 in 10 people)

these tests will include:
-

o

The medicine has been prescribed to treat a medical or
dental problem and

o

You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine
and

o



joint pain



dry mouth



high temperature (fever)

checking your appetite



unusual hair loss or thinning

-

measuring height and weight

feeling unusually sleepy or drowsy

-

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.



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)

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.

feeling dizzy, movements which you cannot control, being
unusually active



feeling aggressive, agitated, anxious, depressed, irritable and
abnormal behaviour



grinding of the teeth



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.
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.


Do not take methylphenidate if you:


Very rare (affects less than 1 in 10,000 people)
Not using Equasym XL properly



-

feeling unusually excited, over-active and un-inhibited (mania)







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


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 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 have any further questions on the use of this product, ask
your doctor or pharmacist.

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

Common (affects less than 1 in 10 people)



increases in liver test results (seen in a blood test)



uneven heartbeat (palpitations)





mood changes or mood swings or changes in personality

anger, feeling restless or tearful, excessive awareness of
surroundings, problems sleeping

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:

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)


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

S1669 LEAFLET Equasym XL 20140530

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.

Some people cannot have this medicine

How do I take my medicine (capsules)?

Possible side effects

You cannot have this medicine if:

Swallow your medicine with water and food.



This medicine should help you.





you have a problem with your heart



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 feel very unhappy, depressed or have a mental illness.

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.

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:








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.



Feeling worried or nervous



Feeling dizzy, or getting headaches

You need to talk to your doctor if:



Being very depressed and unhappy or wanting to hurt yourself



you have epilepsy (fits)





you are pregnant or breastfeeding

Having different moods than usual, not being able to get to
sleep



you are taking other medicines – your doctor needs to know
about all the medicines you are taking.



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.

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

 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.

Expand view ⇕

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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