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CONCERTA XL 27MG TABLETS

Active substance: METHYLPHENIDATE HYDROCHLORIDE

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Package Leaflet: Information for the user
Concerta® XL 27mg Tablets
(methylphenidate hydrochloride)
The name of your medicine is Concerta XL 27mg Tablets. However
they will be referred to as Concerta XL throughout this leaflet. It
contains the active substance ‘methylphenidate hydrochloride’.
The name ‘methylphenidate’ will also be used in this leaflet.

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.



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.


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 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.

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 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
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.

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.
Concerta XL is not for use as a treatment for ADHD in children
under 6 years of age or for 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.

How it works

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

2. What you need to know before you take
methylphenidate
Do not take methylphenidate 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 Taking other medicines

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.


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)

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.

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.


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.
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.

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.

Concerta XL 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

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

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:

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

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

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.

Page 1 of 2

Information for children and young people

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

While you are taking this medicine





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.






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.

Page 1 of 2

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.

3. How to take Concerta XL
How much to take

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

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

the maximum daily dose is 54 mg.

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.
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

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

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


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

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












Not using Concerta XL properly

heart attack
sudden death
suicidal attempt
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
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 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.

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

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




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.

unwanted thoughts that keep coming back
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)

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.

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

If you forget to take Concerta 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 Concerta 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 Concerta XL.
If you have any further questions on the use of this medicine, ask
your doctor.

Things your doctor will do when you are on
treatment
Your doctor will do some tests





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:

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 Concerta XL.

Long-term treatment

Concerta XL does not need to be taken forever. 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.

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

4. Possible side effects
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.

Some side effects could be serious. If you have any
of the side effects below, see a doctor straight
away:
Common (may affect up to 1 in 10 people)



uneven heartbeat (palpitations)
mood changes or mood swings or changes in personality

Uncommon (may affect up to 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

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
high temperature (fever)
decreased interest in sex
unusual hair loss or thinning
muscle tightness, muscle cramps
loss of appetite or decreased appetite
inability to develop or maintain an erection
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
cough, sore throat or nose and throat irritation; upper
respiratory tract infection; sinus infection
high blood pressure, fast heart beat (tachycardia)
dizziness (vertigo), feeling weak, movements which you
cannot control, being unusually active
feeling aggressive, agitated, anxious, depressed, irritable,
tense, jittery and abnormal behaviour
upset stomach or indigestion, stomach pain, diarrhoea,
feeling sick, stomach discomfort and being sick.

Uncommon (may affect up to 1 in 100 people)













dry eyes
constipation
chest discomfort
blood in the urine
listlessness
shaking or trembling
increased need to pass urine
muscle pain, muscle twitching
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)





feeling disorientated or confused
trouble seeing or double vision
swelling of the breasts in men
excessive sweating, redness of the skin, red raised skin
rash.

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

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.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. 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.

5. How to store Concerta XL
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
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.
Keep the bottle tightly closed in order to protect from moisture.
The pack contains one or two silica gel pouches. These pouches
are used to keep the tablets dry and should not be eaten.
If your medicine becomes discoloured or shows any signs of
deterioration consult your pharmacist who will advise you what to
do.
If your doctor decides to stop the treatment, return any leftover
medicine to the pharmacist. Only keep it if your doctor tells you
to.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

6. Contents of the packet and other
information
What Concerta XL contains

The active substance is methylphenidate hydrochloride.
Each tablet contains 27mg methylphenidate hydrochloride
The other ingredients are:

Butylhydroxytoluene (E321), cellulose acetate,
hypromellose (E464), phosphoric acid 85%,
macrogol 200 K and 7000 K, poloxamer 188,
povidone K29-32, sodium chloride, stearic acid, succinic
acid, black iron oxide (E172), yellow iron oxide (E172),
red iron oxide (E172).

Film coat: iron oxide black (E172), hypromellose (E464),
lactose monohydrate, titanium dioxide (E171), triacetin.
Clear coat: carnauba wax, hypromellose (E464),

macrogol 400.
Printing ink: black iron oxide (E172), hypromellose

(E464), propylene glycol.

What Concerta XL looks like and contents of the
pack
Concerta XL are capsule shaped grey tablets printed with alza 27
printed in black ink.
Your medicine is available in bottles containing 30 prolongedrelease tablets.

Manufacturer:

Manufactured by: JANSSEN PHARMACEUTICA N.V.,
Turnhoutseweg 30, 2340 Beerse, Belgium
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
CD
POM
PL No: 21828/0641
Leaflet revision and issue date (Ref): 16.03.15
Concerta® XL is a registered trademark of Johnson and Johnson.

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







muscle cramps
small red marks on the skin
abnormal liver function including liver failure and coma
changes in test results – including liver and blood tests
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’).

Page 2 of 2

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

You




need to talk to your doctor if:
you have epilepsy (fits)
you are pregnant or breastfeeding
you are taking other medicines – your doctor needs to know
about all the medicines you are taking.

How do I take my medicine?




swallow your medicine with water.
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.

Other things to remember

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 head aches

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.
Page 2 of 2








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.

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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