RITALIN TABLETS 10MG

Active substance: METHYLPHENIDATE HYDROCHLORIDE

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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.
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’
Information for children and young people with ADHD
This info is to help you learn the main things about your
medicine called Ritalin.
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.

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-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.
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 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.
31529-ST 13A/B-GB
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Colour:
LEAFLET RITALIN TAB
10 MG. GB
Product:

Presentation Type: GB

1
No of Colour:
31529-ST 10A/B-UK
Replaced No.:

Tel: + 91-44-4228 4888
Fax: + 91-44-4228 4899

T Number:

n.a.

Hurix Systems Private Limited



31529-ST 13A/B-GB

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.

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.

Material No.:

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.

Typesetting Order/CTM-Owner: 649827/Gonzalez Conde R.

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.

Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

Important things you need to know about
your medicine

Approval Box and Ready for Print Box only to be used
in case AWF is not used.

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

Hurix House,
New No. 34, Old No. 10,
Taylors Road,
Kilpauk, Chennai-600 010.

Methylphenidate






Ritalin, 10 mg tablets



Package Leaflet: Information for the user

• 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.

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.
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.
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.
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.
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 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)
• 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)
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.

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 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
Make sure you keep your medicine in a safe place, so that
no one else takes it, especially younger brothers or sisters.
Do not use Ritalin after the expiry date which is stated on the
label. The expiry date refers to the last day of that month.
Do not store above 25°C.
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.
Ritalin tablets contain 10 mg of methylphenidate hydrochloride.
The other ingredients are: calcium phosphate, lactose,
wheat starch, gelatine, magnesium stearate, talc
What Ritalin looks like and contents of the pack
Ritalin Tablets are available in one strength: 10 mg.
The medicinal product is available in blister packs
containing 20, 30, or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, England.
Manufacturer:
Novartis Farmacéutica S.A., Planta de Produccion, Ronda
de Santa Maria 158, 08210 Barberà del Vallès, Barcelona,
Spain.
This leaflet was last revised May 2013

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 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.
Proof 2

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Sridhar
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Proof Date:

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Dimension:

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Smallest font size:
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Technical approval. To be signed by Manufacturing Site.
Code-No.: 1881

Code Type: Laetuscode

Black
Colour:
LEAFLET RITALIN TAB
10 MG. GB

Presentation Type: GB

1
No of Colour:
31529-ST 10A/B-UK

Tel: + 91-44-4228 4888
Fax: + 91-44-4228 4899

n.a.

Product:

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.

Replaced No.:

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.

T Number:

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.



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.

Hurix Systems Private Limited

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.



This medicine contains wheat starch. If you have chronic
fatty diarrhoea (but not coeliac disease), you should not
take Ritalin.

31529-ST 13A/B-GB

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.

Material No.:

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.

Typesetting Order/CTM-Owner: 649827/Gonzalez Conde R.

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

Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

Approval Box and Ready for Print Box only to be used
in case AWF is not used.

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)

Hurix House,
New No. 34, Old No. 10,
Taylors Road,
Kilpauk, Chennai-600 010.

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.

• 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.






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.

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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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