CONCERTA XL 36 MG PROLONGED RELEASE TABLETS

Active substance: METHYLPHENIDATE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

1974/1975
1976/1978
24.07.14[15]

Concerta® XL 18 mg Prolonged release
tablets
Concerta® XL 36 mg Prolonged release
tablets

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.

(methylphenidate hydrochloride)
This medicine is available using the above name but will be referred to as
Concerta XL. It contains the active substance methylphenidate
hydrochloride. The name methylphenidate will also be used in this leaflet.
Concerta XL is 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.
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 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.
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.

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 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 uninhibited.
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 breastfeed 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.
The 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.
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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.

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.

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.
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.

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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.
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.
If you have any further questions on the use of this product, 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 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.
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
Rare (may affect up to 1 in 1,000 people)
 feeling unusually excited, over-active and un-inhibited (mania)

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.

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)
 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.

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

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:

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

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.
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’).

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.

5. How to Store Concerta XL
Make sure you keep your medicine in a safe place, so that no one else
takes it, especially younger brothers or sisters.

Do not store above 30°C. Store in original container.
Keep the bottle tightly closed to protect from moisture.
The dessicants in the pack (one or two pouches), used to keep the tablets
dry, should not be eaten.
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.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do
6. Further Information
What Concerta XL contains
The active substance is methylphenidate hydrochloride
Concerta XL 18mg Prolonged Release Tablets contain 18mg of
methylphenidate hydrochloride.
Concerta XL 36mg Prolonged Release Tablets contain 36mg of
methylphenidate hydrochloride.
The other ingredients are:
butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 3 cp,
phosphoric acid concentrated, poloxamer 188, polyethylene oxides 200K
and 7000K, povidone K29-32, sodium chloride, stearic acid, succinic acid,
black iron oxide (E172), and ferric oxide yellow (E172).
Film coat: hypromellose 15cp, lactose monohydrate, titanium dioxide
(E171), triacetin, ferric oxide yellow (E172, 18 mg only) and stearic acid
(18 mg tablet only).
Clear coat: carnauba wax, hypromellose 6cp, macrogol 400.
Printing Ink: black iron oxide (E172), hypromellose 6cp, isopropyl
alcohol, propylene glycol and purified water
What Concerta XL looks like and contents of the pack
Concerta XL Prolonged release tablets are available in two strengths:
18mg and 36 mg. Each capsule shaped tablet is individually marked to
aid identification:
- 18 mg: yellow cylinder-shaped tablets marked with 'alza 18' once in
black ink and plain on the other side.
- 36 mg: white cylinder-shaped tablets marked with 'alza 36' once in
black ink and plain on the other side.
The medicinal product is available in bottles containing 28 or 30 tablets
Manufacturer and Product Licence Holder
Manufactured by Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340,
Beerse, Belgium and procured from the EU by Product Licence holder:
Tenolol Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.

POM
CD

Concerta XL 18mg PL No: 30900/1974 & PL No: 30900/1976
Concerta XL 36mg PL No: 30900/1975 & PL No: 30900/1977

Leaflet issue and revision date (Ref): 24.07.14[15]
Concerta is trademark of Alza Corporation, USA

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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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