RITALIN 10MG TABLETS

Active substance: METHYLPHENIDATE HYDROCHLORIDE

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Do not take this medicine after the expiry date
shown on the carton or blister label. If your
doctor tells you to stop taking the medicine, take
any remaining medicine back to the pharmacist
for safe disposal. Only keep this medicine if your
doctor tells you to.
If your medicine becomes discoloured or shows
any signs of deterioration, ask your pharmacist
who will advise 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.

6. Further information
What Ritalin contains
The active substance is methylphenidate
hydrochloride. Each Ritalin tablet contains 10 mg
of methylphenidate hydrochloride.
The other ingredients are: calcium phosphate
(E341), lactose, wheat starch, gelatin,
magnesium stearate (E470b), talc (E553b).
What Ritalin looks like and contents of the
pack
Ritalin Tablets are available in one strength: 10
mg. Ritalin is a white, round tablet, marked A and
B with a scoremark on one side and CG on the
other side.
Ritalin comes in blister packs of 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Novartis
Pharma B.V, Raapopseweg 1, 6824 DP ARNHEM,
The Netherlands and is procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you

POM

CD

PL 15184/1331 - Ritalin 10mg Tablets
Ritalin is a registered trademark of Novartis AG.
Leaflet revision date: 10/07/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Information for children and young people
with ADHD
This info is to help you learn the main things about
your medicine called Ritalin.






your doctor may stop your medicine to see if it is
still needed. This will probably happen in a
school holiday.
If you take this medicine more than once a day,
you may have to remember to take it at school
or college. You or your mum, dad or carer will
need to find out what the school rules are about
this.
Do not drink alcohol. Alcohol may make the side
effects of this medicine worse.
Girls must tell their doctor straight away if they
think they may be pregnant. We do not know
how this medicine affects unborn babies. If you
are having sex, please talk to your doctor about
contraception.

Some people cannot have this medicine
You cannot have this medicine if:
• you have a problem with your heart
• you feel very unhappy, depressed or have a
mental illness.
Some people need to talk to their doctor before
they start having this medicine
You need to talk to your doctor if:
• you have epilepsy (fits)
• you are pregnant or breastfeeding
• you are taking other medicines – your doctor
needs to know about all the medicines you are
taking.

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 or being sick, or having tummy pains.
These may only happen when you first start
taking the medicine. It is best to take the
medicine with food
• 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.
Other things to remember

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.








place, so that no one else takes it, especially
younger brothers or sisters.
The medicine is special for you – do not let any
one 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.

Ref: 1331/100713/1/F

Ritalin ® 10mg Tablets
(methylphenidate hydrochloride)
The name of your medicine is Ritalin, 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:

How do I take my medicine (tablets)?
• 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.

• Make sure you keep your medicine in a safe
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.

PATIENT INFORMATION LEAFLET

• If you take the medicine for more than one year,

• 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects worry you, or if you
notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.
The leaflet has been written in sections:
– Sections 1 to 6 are for parents and carers
(sometimes called ‘your guardians’).
– The last section is a special section for a child or
young person to read.
However, all sections are written as though the
child or young person taking the medicine is
reading them.
Your medicine is called Ritalin 10mg Tablets but
will be referred to as Ritalin throughout the rest of
this leaflet.
The sections are:
1. What Ritalin is and what it is used for
2. Before you take methylphenidate
3. How to take Ritalin
4. Possible side effects
5. How to store Ritalin
6. Further information
Information for children and young people
Now read the rest of this leaflet before you
start taking this medicine.
1. What Ritalin is and what it is used for
What it is used for
Ritalin 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.
Ritalin is not for use as a treatment for ADHD in
children under 6 years of age or in adults. It is not
known if it is safe or of benefit in these people.

How it works
Ritalin 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. Before you take methylphenidate
Do not take methylphenidate if:
• you are allergic (hypersensitive) to
methylphenidate or any of the other ingredients
of Ritalin (listed in Section 6)
• you have a thyroid problem
• you have increased pressure in your eye
(glaucoma)
• you have a tumour of your adrenal gland
(phaeochromocytoma)
• you have an eating problem when you do not
feel hungry or want to eat - such as ‘anorexia
nervosa’
• you have very high blood pressure or narrowing
of the blood vessels, which can cause pain in
the arms and legs.
• you have ever had heart problems - such as a
heart attack, uneven heartbeat, pain and
discomfort in the chest, heart failure, heart
disease or were born with a heart problem
• you have had a problem with the blood vessels
in your brain – such as a stroke, swelling and
weakening of part of a blood vessel (aneurysm),
narrow or blocked blood vessels, or
inflammation of the blood vessels (vasculitis)
• you have mental health problems such as:
– a ‘psychopathic’ or ‘borderline personality’
problem
– abnormal thoughts or visions or an illness called
‘schizophrenia’
– signs of a severe mood problem like:
• feeling like killing yourself
• severe depression, where you feel very sad,
worthless and hopeless
• mania, where you feel unusually excitable,
over-active, and un-inhibited.
Do not take methylphenidate if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before you take
methylphenidate. This is because methylphenidate
can make these problems worse.
Check with your doctor or pharmacist before
treatment if:
• you have liver or kidney problems
• you have had fits (seizures, convulsions,
epilepsy) or any abnormal brain scans (EEGs)
• you have ever abused or been dependent on
alcohol, prescription medicines or street drugs
• you are a girl and have started your periods
(see the ‘Pregnancy, breast-feeding and
contraception’ section below)
• you have hard-to-control, repeated twitching of
any parts of the body or you repeat sounds and
words
• you have high blood pressure
• you have a heart problem which is not in the ‘Do
not take’ section above

• you have a mental health problem which is not in
the ‘Do not take’ section above. Other mental
health problems include:
– mood swings (from being manic to being
depressed – called ‘bipolar disorder’)
– starting to be aggressive or hostile, or your
aggression gets worse
– seeing, hearing or feeling things that are not
there (hallucinations)
– believing things that are not true (delusions)
– feeling unusually suspicious (paranoia)
– feeling agitated, anxious or tense
– feeling depressed or guilty.
Tell your doctor or pharmacist if any of the above
apply to you before starting treatment. This is
because methylphenidate can make these
problems worse. Your doctor will want to monitor
how the medicine affects you.
Checks that your doctor will make before you
start taking methylphenidate
These checks are to decide if methylphenidate is
the correct medicine for you. Your doctor will talk
to you about:
• any other medicines you are taking
• whether there is any family history of sudden
unexplained death
• any other medical problems (such as heart
problems) you or your family may have
• how you are feeling, such as feeling high or low,
having strange thoughts or if you have had any
of these feelings in the past
• whether there is a family history of ‘tics’
(hard to control, repeated twitching of any parts
of the body or repeating sounds and words)
• any mental health or behaviour problems you or
other family members have ever had. Your
doctor will discuss whether you are at risk of
having mood swings (from being manic to being
depressed – called ‘bipolar disorder’). They will
check your mental health history, and check if
any of your family have a history of suicide,
bipolar disorder or depression.
It is important that you provide as much
information as you can. This will help your doctor
decide if methylphenidate is the correct medicine
for you. Your doctor may decide that other medical
tests are needed before you start taking this
medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Do not take methylphenidate if you:
• are taking a medicine called a ‘monoamine
oxidase inhibitor’ (MAOI) used for depression, or
have taken an MAOI in the last 14 days. Taking
an MAOI with methylphenidate may cause a
sudden increase in your blood pressure.
If you are taking other medicines, methylphenidate
may affect how well they work or may cause side
effects. If you are taking any of the following
medicines, check with your doctor or pharmacist
before taking methylphenidate:
• other medicines for depression
• medicines for severe mental health problems
• medicines for epilepsy
• medicines used to reduce or increase blood
pressure
• some cough and cold remedies which contain
medicines that can affect blood pressure. It is
important to check with your pharmacist when
you buy any of these products
• medicines that thin the blood to prevent blood
clots.
If you are in any doubt about whether any
medicines you are taking are included in the list
above, ask your doctor or pharmacist before
taking methylphenidate.
Having an operation
Tell your doctor if you are going to have an
operation. You should not take methylphenidate on
the day of your surgery if a certain type of
anaesthetic is used. This is because there is a
chance of a sudden rise in blood pressure during
the operation.
Drug testing
This medicine may give a positive result when
testing for drug use. This includes testing used in
sport.

Taking methylphenidate with food and drink
Taking methylphenidate with food may help to stop
stomach pains, feeling sick or being sick.
Taking methylphenidate with alcohol
Do not drink alcohol while taking this medicine.
Alcohol may make the side effects of this medicine
worse. Remember that some foods and medicines
contain alcohol.

If you stop taking Ritalin
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
Ritalin.

Pregnancy, breast-feeding and contraception
It is not known if methylphenidate will affect an
unborn baby. Tell your doctor or pharmacist before
using methylphenidate if you are:
• having sex. Your doctor will discuss
contraception with you.
• pregnant or think you may be pregnant. Your
doctor will decide whether you should take
methylphenidate.
• breast-feeding or planning to breast-feed. It is
possible that methylphenidate is passed into
human breast milk.
Therefore, your doctor will decide whether you
should breast-feed while taking
methylphenidate.

Things your doctor will do when you are on
treatment
Your doctor will do some tests
• before you start – to make sure that Ritalin 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 Ritalin.

Driving or 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.

Long-term treatment
Ritalin does not need to be taken for ever. If you
take Ritalin 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.

Important information about some of the
ingredients of Ritalin
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.

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

This medicine contains wheat starch. If you have
chronic fatty diarrhoea (but not coeliac disease),
you should not take Ritalin.
3. How to take Ritalin
How much to take
Always take Ritalin 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 60 mg.
• take Ritalin once or twice daily (e.g. at breakfast
or/and lunchtime).
• the tablets should be swallowed with a drink of
water.
• you can break the tablets to make it easier to
swallow.
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.

4. Possible side effects
Like all medicines, methylphenidate can cause
side effects, but not everybody gets them.
Although some people get side effects, most
people find that methylphenidate helps them.
Your doctor will talk to you about these side
effects.
Some side effects could be serious. If you
have any of the side effects below, see a
doctor straight away:
Common (affects less than 1 in 10 people)
• uneven heartbeat (palpitations)
• mood changes or mood swings or changes in
personality
Uncommon (affects less than 1 in 100 people)

• thinking about or feeling like killing yourself
• 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 (affects less than 1 in 1,000 people)
Not using Ritalin properly
If Ritalin 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 Ritalin 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 Ritalin
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.

Other side effects include the following, if they
get serious, please tell your doctor or
pharmacist:
Very common (affects more than 1 in 10
people)
• headache
• feeling nervous
• not being able to sleep
Common (affects less than 1 in 10 people)

• joint pain
• dry mouth
• high temperature (fever)
• unusual hair loss or thinning
• feeling unusually sleepy or drowsy
• loss of appetite or decreased appetite
• itching, rash or raised red itchy rashes (hives)
• cough, sore throat or nose and throat irritation
• high blood pressure, fast heart beat
(tachycardia)

• feeling dizzy, movements which you cannot
control, being unusually active

• feeling aggressive, agitated, anxious, depressed,
irritable and abnormal behaviour

• stomach pain, diarrhoea, feeling sick, stomach
discomfort and being sick . These usually occur
at the beginning of treatment and may be
reduced by taking the medicine with food.
Uncommon (affects less than 1 in 100 people)

• constipation
• chest discomfort
• blood in the urine
• shaking or trembling
• double vision or blurred vision
• muscle pain, muscle twitching
• shortness of breath or chest pain
• increases in liver test results (seen in a blood
test)

• anger, feeling restless or tearful, excessive
awareness of surroundings, problems sleeping.
Rare (affects less than 1 in 1,000 people)

• changes in sex drive
• feeling disorientated
• dilated pupils, trouble seeing
• swelling of the breasts in men
• excessive sweating, redness of the skin, red
raised skin rash
Very rare (affects less than 1 in 10,000 people)

• heart attack
• sudden death
• muscle cramps
• small red marks on the skin
• inflammation or blocked arteries in the brain
• abnormal liver function including liver failure and
coma

• changes in test results – including liver and
blood tests

• suicidal attempt, abnormal thinking, lack of


• feeling unusually excited, over-active and
un-inhibited (mania)
Very rare (affects less than 1 in 10,000 people)
• heart attack
• fits (seizures, convulsions epilepsy)
• skin peeling or purplish red patches
• muscle spasms which you cannot control
affecting your eyes, head, neck, body and
nervous system-due to a temporary lack of
blood supply to the brain
• paralysis or problems with movement and vision,
difficulties in speech (these can be signs of
problems with the blood vessels in your brain)
• decrease in number of blood cells (red cells,
white cells and platelets) which can make you
more likely to get infections, and make you
bleed and bruise more easily
• a sudden increase in body temperature, very
high blood pressure and severe convulsions
(‘Neuroleptic Malignant Syndrome’). It is not
certain that this side effect is caused by
methylphenidate or other drugs that may be
taken in combination with methylphenidate.
Other side effects (how often they happen is
not known)
• unwanted thoughts that keep coming back
• unexplained fainting, chest pain, shortness of
breath (these can be signs of heart problems)
If you have any of the side effects above, see a
doctor straight away.

feeling or emotion, doing things over and over
again, being obsessed with one thing
fingers and toes feeling numb, tingling and
changing colour (from white to blue, then red)
when cold (‘Raynaud’s phenomenon’)

Other side effects (how often they happen is
not known):
• migraine
• very high fever
• slow, fast or extra heart beats
• a major fit (‘grand mal convulsions’)
• believing things that are not true, confusion
• severe stomach pain, often with feeling and
being sick
• problems with the blood vessels of the brain
(stroke, cerebral arteritis or cerebral occlusion).
• erectile dysfunction
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.
If any of the side effects worry you, or if you notice
any side effects not listed in this leaflet, tell your
doctor or pharmacist.
5. How to store Ritalin





KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 25°C.
Store in the original package.
Ref: 1331/100713/1/B

If any of the side effects worry you, or if you notice
any side effects not listed in this leaflet, tell your
doctor or pharmacist.
5. How to store Methylphenidate
hydrochloride









KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 25°C.
Store in the original package.
Do not take this medicine after the expiry date
shown on the carton or blister label. If your
doctor tells you to stop taking the medicine, take
any remaining medicine back to the pharmacist
for safe disposal. Only keep this medicine if your
doctor tells you to.
If your medicine becomes discoloured or shows
any signs of deterioration, ask your pharmacist
who will advise 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.

6. Further information
What Methylphenidate hydrochloride contains
The active substance is methylphenidate
hydrochloride.
Each Methylphenidate hydrochloride tablet
contains 10 mg of methylphenidate hydrochloride.
The other ingredients are: calcium phosphate
(E341), lactose, wheat starch, gelatin,
magnesium stearate (E470b), talc (E553b).
What Methylphenidate hydrochloride looks like
and contents of the pack
Methylphenidate hydrochloride Tablets are
available in one strength: 10 mg. Methylphenidate
hydrochloride is a white, round tablet, marked A
and B with a scoremark on one side and CG on
the other side.
Methylphenidate hydrochloride comes in blister
packs of 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Novartis
Pharma B.V, Raapopseweg 1, 6824 DP ARNHEM,
The Netherlands and is procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you

POM

CD

PL 15184/1331 - Methylphenidate hydrochloride
10mg Tablets
Leaflet revision date: 10/07/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Information for children and young people
with ADHD
This info is to help you learn the main things about
your medicine called Methylphenidate
hydrochloride.
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.
• If you take this medicine more than once a day,
you may have to remember to take it at school
or college. You or your mum, dad or carer will
need to find out what the school rules are about
this.
• Do not drink alcohol. Alcohol may make the side
effects of this medicine worse.
• Girls must tell their doctor straight away if they
think they may be pregnant. We do not know
how this medicine affects unborn babies. If you
are having sex, please talk to your doctor about
contraception.



Some people cannot have this medicine
You cannot have this medicine if:
• you have a problem with your heart
• you feel very unhappy, depressed or have a
mental illness.
Some people need to talk to their doctor before
they start having this medicine
You need to talk to your doctor if:
• you have epilepsy (fits)
• you are pregnant or breastfeeding
• you are taking other medicines – your doctor
needs to know about all the medicines you are
taking.
How do I take my medicine (tablets)?
• 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 or being sick, or having tummy pains.
These may only happen when you first start
taking the medicine. It is best to take the
medicine with food
• 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.
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 any
one 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.

PATIENT INFORMATION LEAFLET

Ref: 1331/100713/2/F

Methylphenidate hydrochloride 10mg Tablets
The name of your medicine is Methylphenidate
hydrochloride, it contains the active substance
‘methylphenidate hydrochloride’. The name
‘methylphenidate’ will also be used in this leaflet.

Methylphenidate hydrochloride is not for use as a
treatment for ADHD in children under 6 years of
age or in adults. It is not known if it is safe or of
benefit in these people.

Important things you need to know about your
medicine

How it works
Methylphenidate hydrochloride 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.

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

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

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.

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.

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.

Do not take methylphenidate if:
• you are allergic (hypersensitive) to
methylphenidate or any of the other ingredients
of Methylphenidate hydrochloride (listed in
Section 6)
• you have a thyroid problem
• you have increased pressure in your eye
(glaucoma)
• you have a tumour of your adrenal gland
(phaeochromocytoma)
• you have an eating problem when you do not
feel hungry or want to eat - such as ‘anorexia
nervosa’
• you have very high blood pressure or narrowing
of the blood vessels, which can cause pain in
the arms and legs.
• you have ever had heart problems - such as a
heart attack, uneven heartbeat, pain and
discomfort in the chest, heart failure, heart
disease or were born with a heart problem
• you have had a problem with the blood vessels
in your brain – such as a stroke, swelling and
weakening of part of a blood vessel (aneurysm),
narrow or blocked blood vessels, or
inflammation of the blood vessels (vasculitis)
• you have mental health problems such as:
– a ‘psychopathic’ or ‘borderline personality’
problem
– abnormal thoughts or visions or an illness called
‘schizophrenia’
– signs of a severe mood problem like:
• feeling like killing yourself
• severe depression, where you feel very sad,
worthless and hopeless
• mania, where you feel unusually excitable,
over-active, and un-inhibited.

The rest of this leaflet includes more detail and
other important information on the safe and
effective use of this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects worry you, or if you
notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.
The leaflet has been written in sections:
– Sections 1 to 6 are for parents and carers
(sometimes called ‘your guardians’).
– The last section is a special section for a child or
young person to read.
However, all sections are written as though the
child or young person taking the medicine is
reading them.
Your medicine is called Methylphenidate
hydrochloride 10mg Tablets but will be referred to
as Methylphenidate hydrochloride throughout the
rest of this leaflet.
The sections are:
1. What Methylphenidate hydrochloride is and
what it is used for
2. Before you take methylphenidate
3. How to take Methylphenidate hydrochloride
4. Possible side effects
5. How to store Methylphenidate hydrochloride
6. Further information
Information for children and young people
Now read the rest of this leaflet before you
start taking this medicine.
1. What Methylphenidate hydrochloride is and
what it is used for
What it is used for
Methylphenidate hydrochloride 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.

ADHD does not affect the intelligence of a child or
young person.
2. Before you take methylphenidate

Do not take methylphenidate if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before you take
methylphenidate. This is because methylphenidate
can make these problems worse.
Check with your doctor or pharmacist before
treatment if:
• you have liver or kidney problems
• you have had fits (seizures, convulsions,
epilepsy) or any abnormal brain scans (EEGs)
• you have ever abused or been dependent on
alcohol, prescription medicines or street drugs
• you are a girl and have started your periods
(see the ‘Pregnancy, breast-feeding and
contraception’ section below)
• you have hard-to-control, repeated twitching of
any parts of the body or you repeat sounds and
words

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

• you have a mental health problem which is not in
the ‘Do not take’ section above. Other mental
health problems include:
– mood swings (from being manic to being
depressed – called ‘bipolar disorder’)
– starting to be aggressive or hostile, or your
aggression gets worse
– seeing, hearing or feeling things that are not
there (hallucinations)
– believing things that are not true (delusions)
– feeling unusually suspicious (paranoia)
– feeling agitated, anxious or tense
– feeling depressed or guilty.
Tell your doctor or pharmacist if any of the above
apply to you before starting treatment. This is
because methylphenidate can make these
problems worse. Your doctor will want to monitor
how the medicine affects you.
Checks that your doctor will make before you
start taking methylphenidate
These checks are to decide if methylphenidate is
the correct medicine for you. Your doctor will talk
to you about:
• any other medicines you are taking
• whether there is any family history of sudden
unexplained death
• any other medical problems (such as heart
problems) you or your family may have
• how you are feeling, such as feeling high or low,
having strange thoughts or if you have had any
of these feelings in the past
• whether there is a family history of ‘tics’
(hard to control, repeated twitching of any parts
of the body or repeating sounds and words)
• any mental health or behaviour problems you or
other family members have ever had. Your
doctor will discuss whether you are at risk of
having mood swings (from being manic to being
depressed – called ‘bipolar disorder’). They will
check your mental health history, and check if
any of your family have a history of suicide,
bipolar disorder or depression.
It is important that you provide as much
information as you can. This will help your doctor
decide if methylphenidate is the correct medicine
for you. Your doctor may decide that other medical
tests are needed before you start taking this
medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Do not take methylphenidate if you:
• are taking a medicine called a ‘monoamine
oxidase inhibitor’ (MAOI) used for depression, or
have taken an MAOI in the last 14 days. Taking
an MAOI with methylphenidate may cause a
sudden increase in your blood pressure.
If you are taking other medicines, methylphenidate
may affect how well they work or may cause side
effects. If you are taking any of the following
medicines, check with your doctor or pharmacist
before taking methylphenidate:
• other medicines for depression
• medicines for severe mental health problems
• medicines for epilepsy
• medicines used to reduce or increase blood
pressure
• some cough and cold remedies which contain
medicines that can affect blood pressure. It is
important to check with your pharmacist when
you buy any of these products
• medicines that thin the blood to prevent blood
clots.
If you are in any doubt about whether any
medicines you are taking are included in the list
above, ask your doctor or pharmacist before
taking methylphenidate.
Having an operation
Tell your doctor if you are going to have an
operation. You should not take methylphenidate on
the day of your surgery if a certain type of
anaesthetic is used. This is because there is a
chance of a sudden rise in blood pressure during
the operation.

Drug testing
This medicine may give a positive result when
testing for drug use. This includes testing used in
sport.
Taking methylphenidate with food and drink
Taking methylphenidate with food may help to stop
stomach pains, feeling sick or being sick.
Taking methylphenidate with alcohol
Do not drink alcohol while taking this medicine.
Alcohol may make the side effects of this medicine
worse. Remember that some foods and medicines
contain alcohol.
Pregnancy, breast-feeding and contraception
It is not known if methylphenidate will affect an
unborn baby. Tell your doctor or pharmacist before
using methylphenidate if you are:
• having sex. Your doctor will discuss
contraception with you.
• pregnant or think you may be pregnant. Your
doctor will decide whether you should take
methylphenidate.
• breast-feeding or planning to breast-feed. It is
possible that methylphenidate is passed into
human breast milk.
Therefore, your doctor will decide whether you
should breast-feed while taking
methylphenidate.
Driving or using machines
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.
Important information about some of the
ingredients of Methylphenidate hydrochloride
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.
This medicine contains wheat starch. If you have
chronic fatty diarrhoea (but not coeliac disease),
you should not take Methylphenidate
hydrochloride.
3. How to take Methylphenidate hydrochloride

If you forget to take Methylphenidate
hydrochloride
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.

Other side effects (how often they happen is
not known)
• unwanted thoughts that keep coming back
• unexplained fainting, chest pain, shortness of
breath (these can be signs of heart problems)

If you stop taking Methylphenidate
hydrochloride
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
Methylphenidate hydrochloride.

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

Things your doctor will do when you are on
treatment
Your doctor will do some tests
• before you start – to make sure that
Methylphenidate hydrochloride 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
Methylphenidate hydrochloride.
Long-term treatment
Methylphenidate hydrochloride does not need to
be taken for ever. If you take Methylphenidate
hydrochloride 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, Methylphenidate hydrochloride
can cause side effects, but not everybody gets
them. Although some people get side effects, most
people find that methylphenidate helps them.
Your doctor will talk to you about these side
effects.

How much to take
Always take Methylphenidate hydrochloride
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 60 mg.
• take Methylphenidate hydrochloride once or
twice daily (e.g. at breakfast or/and lunchtime).
• the tablets should be swallowed with a drink of
water.
• you can break the tablets to make it easier to
swallow.

Some side effects could be serious. If you
have any of the side effects below, see a
doctor straight away:
Common (affects less than 1 in 10 people)
• uneven heartbeat (palpitations)
• mood changes or mood swings or changes in
personality

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.

• uncontrolled speech and body movements

Not using Methylphenidate hydrochloride
properly
If Methylphenidate hydrochloride 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 Methylphenidate
hydrochloride 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.

Uncommon (affects less than 1 in 100 people)

• thinking about or feeling like killing yourself
• feeling, or hearing things that are not real, these
are signs of psychosis



(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 (affects less than 1 in 1,000 people)
• feeling unusually excited, over-active and
un-inhibited (mania)
Very rare (affects less than 1 in 10,000 people)
• heart attack
• fits (seizures, convulsions epilepsy)
• skin peeling or purplish red patches
• muscle spasms which you cannot control
affecting your eyes, head, neck, body and
nervous system-due to a temporary lack of
blood supply to the brain
• paralysis or problems with movement and vision,
difficulties in speech (these can be signs of
problems with the blood vessels in your brain)
• decrease in number of blood cells (red cells,
white cells and platelets) which can make you
more likely to get infections, and make you
bleed and bruise more easily
• a sudden increase in body temperature, very
high blood pressure and severe convulsions
(‘Neuroleptic Malignant Syndrome’). It is not
certain that this side effect is caused by
methylphenidate or other drugs that may be
taken in combination with Methylphenidate
hydrochloride.

Other side effects include the following, if they
get serious, please tell your doctor or
pharmacist:
Very common (affects more than 1 in 10
people)
• headache
• feeling nervous
• not being able to sleep
Common (affects less than 1 in 10 people)

• joint pain
• dry mouth
• high temperature (fever)
• unusual hair loss or thinning
• feeling unusually sleepy or drowsy
• loss of appetite or decreased appetite
• itching, rash or raised red itchy rashes (hives)
• cough, sore throat or nose and throat irritation
• high blood pressure, fast heart beat
(tachycardia)

• feeling dizzy, movements which you cannot
control, being unusually active

• feeling aggressive, agitated, anxious, depressed,
irritable and abnormal behaviour

• stomach pain, diarrhoea, feeling sick, stomach
discomfort and being sick . These usually occur
at the beginning of treatment and may be
reduced by taking the medicine with food.
Uncommon (affects less than 1 in 100 people)

• constipation
• chest discomfort
• blood in the urine
• shaking or trembling
• double vision or blurred vision
• muscle pain, muscle twitching
• shortness of breath or chest pain
• increases in liver test results (seen in a blood
test)

• anger, feeling restless or tearful, excessive
awareness of surroundings, problems sleeping.
Rare (affects less than 1 in 1,000 people)

• changes in sex drive
• feeling disorientated
• dilated pupils, trouble seeing
• swelling of the breasts in men
• excessive sweating, redness of the skin, red
raised skin rash
Very rare (affects less than 1 in 10,000 people)

• heart attack
• sudden death
• muscle cramps
• small red marks on the skin
• inflammation or blocked arteries in the brain
• abnormal liver function including liver failure and
coma

• changes in test results – including liver and
blood tests

• suicidal attempt, abnormal thinking, lack of


feeling or emotion, doing things over and over
again, being obsessed with one thing
fingers and toes feeling numb, tingling and
changing colour (from white to blue, then red)
when cold (‘Raynaud’s phenomenon’)

Other side effects (how often they happen is
not known):
• migraine
• very high fever
• slow, fast or extra heart beats
• a major fit (‘grand mal convulsions’)
• believing things that are not true, confusion
• severe stomach pain, often with feeling and
being sick
• problems with the blood vessels of the brain
(stroke, cerebral arteritis or cerebral occlusion).
• erectile dysfunction
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 hydrochloride
may be stopped for a short time.
Ref: 1331/100713/2/B

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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