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CONCERTA XL 18 MG PROLONGED RELEASE TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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S1759 LEAFLET Concerta 18mg 20161110

6



increased need to pass urine

What Concerta XL contains



muscle pain, muscle twitching



The active substance is methylphenidate hydrochloride. Each tablet
contains 18mg of methylphenidate hydrochloride.

shortness of breath or chest pain



feeling hot



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



anger, feeling restless or tearful, talking too much, excessive
awareness of surroundings, problems sleeping.

Rare (may affect up to 1 in 1,000 people)

Contents of the pack and other information

The other ingredients are:




butylhydroxytoluene (E321), cellulose acetate 398-10,
hypromellose 3cp, phosphoric acid concentrated, poloxamer
188, polyethylene oxides 200k MW and 7000k MW, povidone
K29-32, sodium chloride, stearic acid, succinic acid, iron oxide
black (E172), iron oxide yellow (E172)
Film coat: hypromellose 15cp, lactose monohydrate, titanium
dioxide (E171), triacetin, iron oxide yellow (E172) and stearic
acid.

S1759 LEAFLET Concerta 18mg 20161110

PACKAGE LEAFLET: INFORMATION FOR THE USER
Concerta® XL 18 mg Prolonged Release Tablets
(methylphenidate hydrochloride)
®

The name of your medicine is Concerta XL 18 mg Prolonged
Release Tablets, but will be referred to as Concerta XL throughout
the following leaflet.
The active substance is ‘methylphenidate hydrochloride'. The name
‘methylphenidate' will also be used in this leaflet.

1

What Concerta XL is and what it is used for

What it is used for
Concerta 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.

Please note that other strengths (36 and 54mg) are also available
for Concerta XL Prolonged Release Tablets.

Concerta XL is not for use as a treatment for ADHD in children
under 6 years of age or for the initiation of treatment in adults.
When treatment was started at a younger age, it might be
appropriate to continue taking Concerta XL when you become an
adult. Your doctor will advise you about this.



feeling disorientated or confused



trouble seeing or double vision



Clear coat: carnauba wax, hypromellose 6cp, macrogol 400.

Important things you need to know about your medicine

How it works



swelling of the breasts in men



This medicine is used to treat ADHD



excessive sweating, redness of the skin, red raised skin rash.

Printing Ink: iron oxide black (E172), hypromellose 6cp,
isopropyl alcohol, propylene glycol and purified water.

Concerta XL improves the activity of certain parts of the brain which
are under-active.



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.

Very rare (may affect up to 1 in 10,000 people)

What Concerta XL looks like and contents of the pack



muscle cramps



small red marks on the skin

Capsule-shaped yellow tablet with 'alza 18' printed on one side in
black ink.



abnormal liver function including sudden liver failure and coma



changes in test results – including liver and blood tests



Product Licence holder

abnormal thinking, lack of feeling or emotion, doing things over
and over again, being obsessed with one thing

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



fingers and toes feeling numb, tingling and changing colour
(from white to blue, then red) when cold (‘Raynaud’s
phenomenon’).

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



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

Manufacturer



This product is manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, 2340, Beerse, Belgium.

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

Read Section 2 for more information.

Not known (frequency cannot be estimated from the available
data)


migraine



dilated pupils



very high fever



slow, fast or extra heart beats



a major fit (‘grand mal convulsions’)



believing things that are not true



severe stomach pain, often with feeling and being sick

Concerta XL tablets are available in bottle packs of 30 tablets.

POM

CD

PL 19488/1759

Leaflet revision date: 10 November 2016
®

Concerta is a registered trademark of Alza Corporation.
S1759 LEAFLET Concerta 18mg 20161110

Effects on growth

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.



Read Section 1 for more information.

While taking this medicine:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Keep the bottle tightly closed in order
to protect from moisture.



Do not use this medicine after the expiry date which is stated on
the label. The expiry date refers to the last day of that month.



The pack contains one or two silica gel pouches. These
pouches are used to keep the tablets dry and should not be
eaten.





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 wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment

educational and



social therapy.

It is prescribed only by doctors who have experience in children or
young people's behaviour problems. Although there is no cure for
ADHD, it 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.

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.

ADHD does not affect the intelligence of a child or young person.



The most common side effects are feeling nervous, not being
able to sleep or having a headache.

2



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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

By reporting side effects you can help provide more information on
the safety of this medicine.
How to store Concerta XL

psychological





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

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.



See your doctor regularly. This is because your doctor will want
to check how the medicine is working.

Read Section 4 for more information.

Reporting of side effects

The medicine is given as part of a treatment programme, which
usually includes:



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

if you are not growing as expected, then your treatment with
methylphenidate may be stopped for a short time.

5

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

Read Sections 3 and 4 for more information.

When used for more than a year, methylphenidate may cause
reduced growth in some children. This affects less than 1 in 10
children.




The medicine can help improve attention (attention span),
concentration and reduce impulsive behaviour.

What you need to know before you take Concerta XL

Do not take Concerta XL if:


you are allergic to methylphenidate or any of the other
ingredients of this medicine (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 are currently taking or have taken within the last 14 days an
antidepressant (known as a monoamine oxidase inhibitor)- see
‘Other medicines and Concerta XL’



you have mental health problems such as:

The leaflet has been written in sections:

-

a ‘psychopathic’ or ‘borderline personality’ problem

-

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

-

abnormal thoughts or visions or an illness called
‘schizophrenia’

-

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

-

signs of a severe mood problem like:
o

feeling like killing yourself

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

o

severe depression, where you feel very sad, worthless
and hopeless

The sections are:

o

mania, where you feel unusually excitable, over-active,
and un-inhibited.

1

What Concerta XL is and what it is used for

2

What you need to know before you take Concerta XL

3

How to take Concerta XL

4

Possible side effects

5

How to store Concerta XL

6

Contents of the packet and other information

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.

Information for children and young people
Now read the rest of this leaflet before you start taking this
medicine because it contains important information for you.

Other things to remember





make sure you keep your medicine in a safe place, so that no
one else takes it, especially younger brothers or sisters.
the medicine is special for you - do not let anyone else have
it. It may help you, but it could hurt someone else.
if you forget to take your medicine don’t take two tablets the
next time. Just take one tablet at the next normal time.
if you do take too much medicine, tell your mum, dad or carer
right away.



it is important not to take too much medicine or you will get ill.



don’t stop taking your medicine until your doctor says it’s OK.

Who should I ask if there is anything I don’t understand?
Your mum, dad, carer, doctor, nurse or pharmacist will be able to
help you.

Information for children and young people
This info is to help you learn the main things about your medicine
called Concerta XL.

Why have I been given this medicine?
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.

Warnings and precautions
Talk to your doctor before taking Concerta XL if:



you have liver or kidney problems
you have a problem with swallowing or swallowing whole
tablets



you have a narrowing or blockage of your gut or food-pipe



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

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.
Please tell you doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

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)



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



you have high blood pressure

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



you have a heart problem which is not in the ‘Do not take’
section above

Concerta XL with alcohol



you have a mental health problem which is not in the ‘Do not
take’ section above.

fits (seizures, convulsions epilepsy)



skin peeling or purplish red patches



inflammation or blocked arteries in the brain



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



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

Drug testing



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.

If you take more Concerta 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),
sweating, flushing, headache, high fever, changes in heart beat
(slow, fast or uneven), high blood pressure, dilated pupils and dry
nose and mouth.

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

Pregnancy, breast-feeding and contraception



unwanted thoughts that keep coming back

If you stop taking Concerta XL

If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before
taking this medicine.



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 Concerta XL.

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



paralysis or problems with movement and vision, difficulties in
speech (these can be signs of problems with the blood vessels
in your brain)

- believing things that are not true (delusions)

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

- feeling unusually suspicious (paranoia)



having sex. Your doctor will discuss contraception with you

- feeling agitated, anxious or tense



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

Things your doctor will do when you are on treatment



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.



before you start - to make sure that Concerta 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:

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)

Driving and using machines

Other medicines and Concerta XL
Tell your doctor if you are taking, have recently taken or might take
any other medicines.
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.

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. But it does not cure ADHD.



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.



if you are having sex, please talk to your doctor about
contraception. Girls must tell their doctor straight away if they
think they may be pregnant. We do not know how this medicine
affects unborn babies.

Your doctor will do some tests

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.



checking your appetite
measuring height and weight



measuring blood pressure and heart rate



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.




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 Concerta 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 (may affect more than 1 in 10 people)


headache



feeling nervous



not being able to sleep.

Common (may affect up to 1 in 10 people)


joint pain



blurred vision



tension headache



dry mouth, thirst



trouble falling asleep

Long-term treatment



high temperature (fever)

Concerta XL does not need to be taken for ever. If you take
Concerta 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.



problems with sex drive



unusual hair loss or thinning



muscle tightness, muscle cramps

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

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



loss of appetite or decreased appetite



inability to develop or maintain an erection

It was not affecting your ability to drive safely

4



itching, rash or raised red itchy rashes (hives)



feeling unusually sleepy or drowsy, feeling tired



clenching or grinding your teeth, feeling of panic



tingling feeling, prickling, or numbness of the skin



increased alanine aminotransferase (liver enzyme) level in your
blood

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; upper
respiratory tract infection; sinus infection

Common (may affect up to 1 in 10 people)



high blood pressure, fast heart beat (tachycardia)

How much to take



uneven heartbeat (palpitations)



Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.



mood changes or mood swings or changes in personality

dizziness (vertigo), feeling weak, movements which you cannot
control, being unusually active





your doctor will usually start treatment with a low dose and
increase it gradually as required.

Uncommon (may affect up to 1 in 100 people)

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



thinking about or feeling like killing yourself





the maximum daily dose is 54 mg.





upset stomach or indigestion, stomach pain, diarrhoea, feeling
sick, stomach discomfort and being sick.

you should take Concerta XL once each day in the morning with
a glass of water. The tablet should be swallowed whole and not
chewed, broken, or crushed. The tablet may be taken with or
without food.

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



However, you would not be committing an offence if:
o

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.





Not known (frequency cannot be estimated from the available
data)

Checks that your doctor will make before you start taking
Concerta XL



suicidal attempt

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

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.

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.



sudden death



Other mental health problems include:

- feeling depressed or guilty.



heart attack



If you forget to take Concerta XL

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





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.

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



Very rare (may affect up to 1 in 10,000 people)

If Concerta 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.

Having an operation





Not using Concerta XL properly

o

o

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

Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
Concerta XL contains lactose
This medicine contains lactose (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 Concerta XL

Like all medicines, this medicine can cause side effects, although
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.

Uncommon (may affect up to 1 in 100 people)


dry eyes



constipation



chest discomfort



blood in the urine

Rare (may affect up to 1 in 1,000 people)



listlessness





shaking or trembling

The tablet does not dissolve completely after all of the drug has
been released and sometimes the tablet shell may appear in your
stools. This is normal.
If you do not feel better after 1 month of treatment

Possible side effects

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

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

S1759 LEAFLET Concerta 18mg 20161110

How do I take my medicine?

Possible side effects

Some people cannot have this medicine



swallow your medicine with water.

You cannot have this medicine if:



your doctor will tell you how many times a day you should take
your medicine

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:



do not stop taking the medicine without talking to your doctor
first



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:



feeling worried or nervous



feeling dizzy, or getting head aches



being very depressed and unhappy or wanting to hurt yourself



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



you have epilepsy (fits)





skin rashes, bruising easily, getting out of breath

you are pregnant or breastfeeding





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

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.

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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