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CONCERTA XL 27MG TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Assessed against UK
PIL dated March 2015
P18577

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By kariri at 9:04 am, Apr 06, 2016

Package Leaflet: Information for the user

Concerta® XL 27mg Tablets
(methylphenidate hydrochloride)

The name of your medicine is Concerta XL 27mg. 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. This product is also available in other
strengths.

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. See section 4.

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 pack 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
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:

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 foodpipe

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 Concerta XL

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-tocontrol, 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 monohydrate

This medicine contains lactose monohydrate (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
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.

Not using Concerta XL properly

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

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.
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. 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.

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.

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.

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)























joint pain
blurred vision
tension headache
dry mouth, thirst
trouble falling asleep
high temperature (fever)
problems with sex drive
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.












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

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)












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.

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





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)

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.

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.
PL No: 21828/0641

POM

CD

Leaflet revision and issue date (Ref): 05.04.16
Concerta® XL is a registered trademark of Alza Corporation.
P18577

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’).

Uncommon (may affect up to 1 in 100 people)




What Concerta XL looks like and contents of the
pack

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

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

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

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.

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.






What Concerta XL contains

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

Common (may affect up to 1 in 10 people)



6. Contents of the pack and other
information









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, 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.

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.

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.

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

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.

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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