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EQUASYM XL 20MG MODIFIED-RELEASE CAPSULES HARD

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Transcript
5







How to store Equasym XL

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not take Equasym XL after the expiry date which is stated on the blister
and carton label and the carton. The expiry date refers to the last day of
that month.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
Medicines should not be disposed of via waste water or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6

Further information

What Equasym XL contains
• Each capsule contains 20mg methylphenidate hydrochloride
corresponding to 17.30mg methylphenidate.
• 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).
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.

Manufacturer and Licence Holder
Manufactured by Shire Pharmaceuticals Limited, Hampshire International
Business Park Chineham, Basingstoke, Hampshire RG24 8EP and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

Equasym ® XL 20mg modified-release capsules, hard
(methylphenidate hydrochloride)

Patient Information Leaflet

Equasym XL is a registered trademark of UCB PHARMA S.A.

Your medicine is called Equasym XL 20mg modified-release capsules, hard
but will be referred to as Equasym XL throughout the rest of this leaflet. The
active substance is ‘methylphenidate hydrochloride’. The name
‘methylphenidate’ will also be used throughout the leaflet. Please note that
the leaflet also contains information about other strengths of Equasym XL.

Leaflet revision date: 09/12/15

Important things you need to know about your medicine

POM

CD

PL 15184/1580

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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.

What Equasym XL looks like and contents of the pack
• The cap is blue, opaque and is imprinted with ‘S544’ in white. The body is
white, opaque imprinted with ‘20mg’ in black.
• Each pack contains 30 modified-release capsules, hard.

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
2
3
4

Page 4

5
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.
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 capsules the next time.
Just take one capsule 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.

Ref:1580/091215/1/F

6

What Equasym XL is and what it is used for
Before you take methylphenidate
How to take Equasym XL
Possible side effects
How to store Equasym XL
Further information

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 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
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:
- 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.

Page 1

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:
• 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 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
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:
- A doctor has prescribed this medicine for you and
- You have taken it according to his or her instructions, or with the
information in this leaflet and
- 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.

Page 2

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.









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

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:







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

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

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

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)

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)

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.

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.

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)

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









Ref:1580/091215/1/B

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.

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.

Page 3

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.

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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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