Ritalin 10mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Methylphenidate hydrochloride
Available from:
CST Pharma Ltd
ATC code:
N06BA04
INN (International Name):
Methylphenidate hydrochloride
Dosage:
10mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
Schedule 2 (CD)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04040000; GTIN: 5055946805801

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.

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.

Package Leaflet: Information for the user

Ritalin

®

10mg Tablets

(methylphenidate hydrochloride)

Your medicine is known as Ritalin 10mg Tablets but will

be referred to as Ritalin throughout the following patient

information leaflet.

The active substance of Ritalin is ‘methylphenidate

hydrochloride’. The name ‘methylphenidate’ will also be

used in this leaflet.

Important things you need to know about

your medicine

This medicine is used to treat ADHD

The full name for ADHD is ‘Attention Deficit

Hyperactivity Disorder’.

The medicine helps with your brain activity. It can

help improve your attention, help you concentrate,

and make you less impulsive.

You need to have other treatments for ADHD as well

as this medicine.

Read Section 1 for more information.

Before you take this medicine, talk to your

doctor if:

You have heart, circulation, or mental health

problems - you may not be able to take this medicine.

You are taking any other medicines - this is because

methylphenidate can affect how other medicines work.

Read Section 2 for more information.

While taking this medicine:

See your doctor regularly. This is because your

doctor will want to check how the medicine is

working.

Do not stop taking the medicine without first talking

to your doctor.

Your doctor may stop your medicine to see if it is still

needed, if you take it for more than a year.

The most common side effects are feeling nervous, not

being able to sleep or having a headache.

Read Sections 3 and 4 for more information.

Talk to your doctor straight away if any of the

following happen:

Your mood and how you feel changes.

You feel any problems with your heart.

Read Section 4 for more information.

The rest of this leaflet includes more detail and

other important information on the safe and

effective use of this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

This medicine has been prescribed for you. 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:

What Ritalin is and what it is used for

Before you take methylphenidate

How to take Ritalin

Possible side effects

How to store Ritalin

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:

During treatment, boys and adolescents may

unexpectedly experience prolonged erections. This may

be painful and can occur at any time. It is important to

contact your doctor straight away if your erection lasts

for longer than 2 hours, particularly if this is painful.

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.

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 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.

POM CD

REF: RML61 V2

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.

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.

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.

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.

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.

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)

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)

Prolonged erections, sometimes painful, or an

increased number of erections

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

straight away.

Other side effects include the following, if they get

serious, please tell your doctor or pharmacist:

Very common (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

excessive uncontrolled talking

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.

Reporting of side effects:

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

This includes any possible side effects not listed on this

leaflet. You can also report side effects directly via the Yellow

Card Scheme at: www.mhra.gov.uk/yellowcard or search

for MHRA Yellow Card in the Google Play or Apple App

Store. By reporting side effects, you can help provide more

information on the safety of this medicine.

5. How to store Ritalin

Keep out of the sight and reach of children

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. Store in the original package.

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 tablet contains 10 mg methylphenidate

hydrochloride.

The other ingredients are: calcium phosphate, lactose

monohydrate, wheat starch, gelatin, magnesium stearate

and talc.

What Ritalin looks like and contents of the pack

Ritalin 10 mg tablets are white, round flat tablet with

bevelled edges. One side bears the imprint ‘CG’ the other

side has a score line ‘A’ on one side of the scoreline and

‘B’ on the other side of the scoreline.

Ritalin 10mg Tablets is available in blister packs

containing 30 tablets.

PL No: 41103/0047

This product is manufactured by Novartis Farma S.p.A.,

Via Provinciale Schito 131, 80058 Torre Annunziata NA,

Italy and procured from within the EU and repackaged

by the Product Licence Holder: Community Pharmacy

Supplies Limited, Unit 20/21 Easter Park, Ferry Lane

South, Rainham, Essex RM13 9BP.

Leaflet Revision and issue date 02.10.2017

Ritalin is a registered trademark of Novartis AG

Blind or partially sighted?

Is this leaflet hard to see

or read? Call 01708 528 900

to obtain the leaflet in a

format suitable for you.

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Ritalin

10mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

The active ingredient is Methylphenidate (INN for

-Phenyl-2-piperidineacetic acid

methyl ester hydrochloride).

One tablet contains 10mg methylphenidate hydrochloride.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Tablets.

4.1.

Therapeutic indications

Ritalin is indicated as a part of a comprehensive treatment programme for attention-

deficit hyperactivity disorder (ADHD) in children aged 6 years of age and over when

remedial measures alone prove insufficient. Treatment must be under the supervision

of a specialist in childhood behavioural disorders. Diagnosis should be made according

to DSM criteria or the guidelines in ICD and should be based on a complete history and

evaluation of the patient. Diagnosis cannot be made solely on the presence of one or

more symptom.

The specific aetiology of this syndrome is unknown, and there is no single diagnostic

test. Adequate diagnosis requires the use of medical and specialised psychological,

educational and social resources.

A comprehensive treatment programme typically includes psychological, educational

and social measures as well as pharmacotherapy and is aimed at stabilising children

with a behavioural syndrome characterised by symptoms which may include chronic

history of short attention span, distractibility, emotional lability, impulsivity, moderate

to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or

may not be impaired.

Methylphenidate treatment is not indicated in all children with this syndrome and the

decision to use the drug must be based on a very thorough assessment of the severity

and the chronicity of the child’s symptoms in relation to the child’s age.

Appropriate educational placement is essential, and psychosocial intervention is

generally necessary. Where remedial measures alone prove insufficient, the decision to

prescribe a stimulant must be based on rigorous assessment of the severity of the

child’s symptoms. The use of methylphenidate should always be used in the way

according to the licensed indication and according to the prescribing/diagnostics

guidelines.

4.2

Posology and method of administration

Treatment must be initiated under the supervision of a specialist in childhood

and/or adolescent behavioural disorders

Pre-treatment screening:

Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s

cardiovascular status including blood pressure and heart rate. A comprehensive

history should document concomitant medications, past and present co-morbid

medical and psychiatric disorders or symptoms, family history of sudden

cardiac/unexplained death and accurate recording of pre-treatment height and weight

on a growth chart (see sections 4.3 and 4.4).

Ongoing monitoring:

Growth, psychiatric and cardiovascular status should be continuously monitored (see

section 4.4).

Blood pressure and pulse should be recorded on a centile chart at each

adjustment of dose and then at least every 6 months;

Height, weight and appetite should be recorded at least 6 monthly with

maintenance of a growth chart;

Development of de novo or worsening of pre-existing psychiatric disorders

should be monitored at every adjustment of dose and then at least every 6

months and at every visit.

Patients should be monitored for the risk of diversion, misuse and abuse of

methylphenidate.

Dose titration

Careful dose titration is necessary at the start of treatment with methylphenidate.

Dose titration should be started at the lowest possible dose.

The maximum daily dose is 60mg.

Other strengths of this medicinal product and other methylphenidate containing

products may be available.

Children: (over 6 years). Begin with 5mg once or twice daily (e.g. at breakfast and

lunch), increasing the dose and frequency of administration if necessary by weekly

increments of 5-10mg in the daily dose. Doses above 60mg daily are not

recommended. The total daily dose should be administered in divided doses. Ritalin

is not indicated in children less than 6 years of age.

If the effect of the drug wears off too early in the evening, disturbed behaviour and/or

inability to go to sleep may recur. A small evening dose may help to solve this

problem.

Long term (more than 12 months) use in children and adolescents

The safety and efficacy of long term use of methylphenidate has not been

systematically evaluated in controlled trials. Methylphenidate treatment should not

and need not, be indefinite. Methylphenidate treatment is usually discontinued during

or after puberty. The physician who elects to use methylphenidate for extended

periods (over 12 months) in children and adolescents with ADHD should periodically

re-evaluate the long term usefulness of the drug for the individual patient with trial

periods off medication to assess the patient’s functioning without pharmacotherapy. It

is recommended that methylphenidate is de-challenged at least once yearly to assess

the child’s condition (preferable during school holidays). Improvement may be

sustained when the drug is either temporarily or permanently discontinued.

Dose reduction and discontinuation

Treatment must be stopped if the symptoms do not improve after appropriate dosage

adjustment over a one-month period. If paradoxical aggravation of symptoms or other

serious adverse events occur, the dosage should be reduced or discontinued.

Adults

Ritalin Tablets are not licensed for use in adults with ADHD. Safety and efficacy

have not yet been established in this age group.

Elderly

Methylphenidate should not be used in the elderly. Safety and efficacy has not been

established in this age group.

Children under 6 years of age

Methylphenidate should not be used in children under the age of 6 years. Safety and

efficacy in this age group has not been established.

Hepatic impairment

Ritalin has not been studied in patients with hepatic impairment. Caution should be

exercised in these patients.

Renal impairment

Ritalin has not been studied in patients with renal impairment. Caution should be

exercised in these patients.

4.3

Contraindications

Known sensitivity to methylphenidate or to any of the excipients in Ritalin.

Glaucoma

Phaechromocytoma

During treatment with monoamine oxidase (MAO) inhibitors, or within a minimum

of 14 days of discontinuing those drugs, due to risk of hypertensive crisis (see

section 4.5)

Hyperthyroidism or thyrotoxicosis

Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders,

suicidal tendencies, psychotic symptoms, severe mood disorders, mania,

schizophrenia, psychopathic/borderline personality disorder.

Diagnosis or history of severe and episodic (Type 1) Bipolar (affective) disorder

(that is not well controlled)

Pre-existing cardiovascular disorders including severe hypertension, heart failure,

arterial occlusive disease, angina, haemodynamically significant congenital heart

disease, cardiomyopathies, myocardial infarction, potentially life-threatening

arrhythmias and channelopathies (disorders caused by the dysfunction of ion

channels)

Pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities

including vasculitis or stroke or known risk factors for cerebrovascular disorders

4.4

Special warnings and precautions for use

Methylphenidate treatment is not indicated in all children with ADHD and the

decision to use the drug must be based on a very thorough assessment of the severity

and chronicity of the child’s symptoms in relation to the child’s age.

Long term use (more than 12 months) in children and adolescents

The safety and efficacy of long term use of methylphenidate has not been

systematically evaluated in controlled trials. Methylphenidate treatment should not

and need not be indefinite. Methylphenidate treatment is usually discontinued during

or after puberty. Patients on long-term therapy (i.e. over 12 months) must have careful

ongoing monitoring according to the guidance in section 4.2 and 4.4 for

cardiovascular status, growth, appetite, development of de nevo or worsening of pre-

existing psychiatric disorders. Psychiatric disorders to monitor for are described

below, and include (but are not limited to) motor or vocal tics, aggressive or hostile

behaviour, agitation, anxiety, depression, psychosis, mania, delusions, irritability, lack

of spontaneity, withdrawal and excessive perseveration.

The physician who elects to use methylphenidate for extended periods (over 12

months) in children and adolescents with ADHD should periodically re-evaluate the

long term usefulness of the drug for the individual patient with trial periods off

medication to assess the patient’s functioning without pharmacotherapy. It is

recommended that methylphenidate is de-challenged at least once yearly to assess the

child’s condition (preferably during times of school holidays). Improvement may be

sustained when the drug is either temporary or permanently discontinued.

Use in adults

Ritalin Tablets are not licenced for use in adults with ADHD. Safety and efficacy

have not yet been established in this age group.

Use in the elderly

Methylphenidate should not be used in the elderly. Safety and efficacy has not been

established in this age group.

Use in children under 6 years of age

Methylphenidate should not be used in children under the age of 6 years. Safety and

efficacy in this age group has not been established.

Cardiovascular status

Patients who are being considered for treatment with stimulant medications should

have a careful history (including assessment for a family history of sudden cardiac or

unexplained death or malignant arrhythmia) and physical exam to assess for the

presence of cardiac disease, and should receive further specialist cardiac evaluation if

initial findings suggest such history or disease. Patients who develop symptoms such

as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other

symptoms suggestive of cardiac disease during methylphenidate treatment should

undergo a prompt specialist cardiac evaluation.

Analyses of data from clinical trials of methylphenidate in children and adolescents

with ADHD showed that patients using methylphenidate may commonly experience

changes in diastolic and systolic blood pressure of over 10 mmHg relative to controls.

The short and long term clinical consequences of these cardiovascular effects in

children and adolescents are not known, but the possibility of clinical complications

cannot be excluded as a result of the effects observed in the clinical trial data.

Caution is indicated in treating patients whose underlying medical conditions

might be compromised by increases in blood pressure or heart rate. See section

4.3 for conditions in which methylphenidate treatment is contraindicated.

Cardiovascular status should be carefully monitored. Blood pressure and pulse

should be recorded on centile chart at each adjustment of dose and then at least

every 6 months.

The use of methylphenidate is contraindicated in certain pre-existing cardiovascular

disorders unless specialist paediatric advice has been obtained (see section 4.3

Contraindications).

Sudden death and pre-existing cardiac structural abnormalities or other serious

cardiac disorders

Sudden death has been reported in association with the use of stimulants of the central

nervous system at usual doses in children, some of whom had structural cardiac

abnormalities or other serious heart problems.

Although some serious heart problems alone may carry an increased risk of sudden

death, stimulant products are not recommended in children or adolescents with

known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm

abnormalities, or other serious cardiac problems that may place them at increased

vulnerability to the sympathomimetic effects of a stimulant medicine.

Misuse and cardiovascular events:

Misuse of stimulants of the central nervous system may be associated with sudden

death and other serious cardiovascular adverse events.

Cerebrovascular disorders:

See section 4.3 for cerebrovascular conditions in which methylphenidate treatment is

contraindicated. Patients with additional risk factors (such as a history of

cardiovascular disease, concomitant medications that elevate blood pressure) should

be assessed at every visit for neurological signs and symptoms after initiating

treatment with methylphenidate.

Cerebral vasculitis appears to be very rare idiosyncratic reaction to methylphenidate

exposure. There is little evidence to suggest that patients at higher risk can be

identified and the initial onset of symptoms may be the first indication of an

underlying clinical problem. Early diagnosis, based on a high index of suspicion, may

allow the prompt withdrawal of methylphenidate and early treatment. The diagnosis

should therefore be considered in any patient who develops new neurological

symptoms that are consistent with cerebral ischemia during methylphenidate therapy.

These symptoms could include severe headache, numbness, weakness, paralysis, and

impairment of coordination, vision, speech, language or memory.

Treatment with methylphenidate is not contraindicated in patients with hemiplegic

cerebral palsy

Psychiatric disorders

Co-morbidity of psychiatric disorders in ADHD is common and should be taken into

account when prescribing stimulant products. In the case of emergent psychiatric

symptoms or exacerbation of pre-existing psychiatric disorders, methylphenidate

should not be given unless the benefits outweigh the risks to the patient.

Development or worsening of psychiatric disorders should be monitored at every

adjustment of dose, then at least every 6 months, and at every visit:

discontinuation of treatment may be appropriate.

Exacerbation of pre-existing psychotic or manic symptoms

In psychotic patients, administration of methylphenidate may exacerbate symptoms of

behavioural disturbance and thought disorder.

Emergence of new psychotic or manic symptoms

Treatment-emergent psychotic symptoms (visual/tactile/auditory hallucinations and

delusions) or mania in children and adolescents without prior history of psychotic

illness or mania can be caused by methylphenidate at usual doses. If manic or

psychotic symptoms occur, consideration should be given to a possible causal role for

methylphenidate and discontinuation of treatment may be appropriate.

Aggressive or hostile behaviour

The emergence or worsening of aggression or hostility can be caused by treatment

with stimulants. Patients treated with methylphenidate should be closely monitored

for the emergence or worsening of aggressive behaviour or hostility at treatment

initiation, at every dose adjustment and then least every 6 months and every visit.

Physicians should evaluate the need for adjustment of the treatment regimen in

patients experiencing behavioural changes bearing in mind that upwards or

downwards titration may be appropriate. Treatment interruption can be considered.

Suicidal tendency

Patients with emergent suicidal ideation or behaviour during treatment for ADHD

should be evaluated immediately by their physician. Consideration should be given to

the exacerbation of an underlying psychiatric condition and to a possible causal role

of methylphenidate treatment. Treatment of an underlying psychiatric condition may

be necessary and consideration should be given to a possible discontinuation of

methylphenidate.

Tics

Methylphenidate is associated with the onset or exacerbation of motor and verbal tics.

Worsening of Tourette’s syndrome has also been reported. Family history should be

assessed and clinical evaluation for tics or Tourette’s syndrome in children should

precede use of methylphenidate. Patients should be regularly monitored for the

emergence or worsening of tics during treatment with methylphenidate. Monitoring

should be at every adjustment of dose and then at least every 6 months or every

visit.

Anxiety, agitation or tension

Methylphenidate is associated with the worsening of pre-existing anxiety, agitation or

tension. Clinical evaluation for anxiety, agitation or tension should precede use of

methylphenidate and patients should be regularly monitored for the emergence or

worsening of these symptoms during treatment, at every adjustment of dose and

then at least every 6 months or every visit.

Forms of bipolar disorder

Particular care should be taken in using methylphenidate to treat ADHD in patients

with co morbid bipolar disorder (including untreated type 1 bipolar disorder or other

forms of bipolar disorder) because of concern for possible precipitation of a

mixed/manic episode in such patients. Prior to initiating treatment with

methylphenidate, patients with co morbid depressive symptoms should be adequately

screened to determine if they are at risk for bipolar disorder; such screening should

include a detailed psychiatric history, including a family history of suicide, bipolar

disorder, and depression. Close ongoing monitoring is essential in these patients

(see above ‘Psychiatric Disorders’ and section 4.2). Patients should be monitored

for symptoms at every adjustment of dose, then at least every 6 months and at

every visit.

Priapism

Prolonged and painful erections have been reported in association with

methylphenidate products, mainly in association with a change in the

methylphenidate treatment regimen. Patients who develop abnormally sustained or

frequent and painful erections should seek immediate medical attention.

Growth

Moderately reduced weight gain and growth retardation have been reported with

long-term use of methylphenidate in children.

The effects of methylphenidate on final height and final weight are currently

unknown and being studied.

Growth should be monitored during methylphenidate treatment: height, weight

and appetite should be recorded at least 6 monthly with maintenance of a growth

chart. Patients who are not growing or gaining height or weight as expected may

need to have their treatment interrupted.

Seizures

Methylphenidate should be used with caution in patients with epilepsy.

Methylphenidate may lower the convulsive threshold in patients with prior history of

seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in

patients without a history of convulsions and no EEG abnormalities. If seizure

frequency increases or new-onset seizures occur, methylphenidate should be

discontinued.

Abuse, misuse and diversion

Patients should be carefully monitored for the risk of diversion, misuse and abuse of

methylphenidate.

Methylphenidate should be used with caution in patients with known drug or alcohol

dependency because of a potential for abuse, misuse or diversion.

Chronic abuse of methylphenidate can lead to marked tolerance and psychological

dependence with varying degrees of abnormal behaviour. Frank psychotic episodes

can occur, especially in response to parenteral abuse.

Patient age, the presence of risk factors for substance use disorder (such as co-morbid

oppositional-defiant or conduct disorder and bipolar disorder), previous or current

substance abuse should be taken in to account when deciding on a course of treatment

for ADHD. Caution is called for in emotionally unstable patients, such as those with a

history of drug or alcohol dependence, because such patients may increase the dosage

on their own initiative.

For some high-risk substance abuse patients, methylphenidate or other stimulants may

not be suitable and non-stimulant treatment should be considered.

Withdrawal

Careful supervision is required during withdrawal, since this may unmask depression

as well as chronic over-activity. Some patients may require long-term follow-up.

Careful supervision is required during withdrawal from abusive use since severe

depression may occur.

Fatigue

Methylphenidate should not be used for the prevention or treatment of normal fatigue

states.

Excipients: glactose/sucrose intolerance

This medicinal product contains lactose: patients with rare hereditary problems of

galactose intolerance, the Lapp lactase deficiency or glucose-glactose malabsorption

should not take this medicine.

Choice of methylphenidate formulation

The choice of formulation of methylphenidate-containing product will have to be

decided by the treating specialist on an individual basis and depends on the intended

duration of effect.

Drug screening

This product contains methylphenidate which may induce a false positive laboratory

test for amphetamines, particularly with immunoassay screen test.

Renal or hepatic insufficiency

There is no experience with the use of methylphenidate in patients with renal or

hepatic insufficiency.

Haematological effects

The long-term safety of treatment with methylphenidate is not fully known. In the

event of leucopenia, thrombocytopenia, anaemia or other alterations, including those

indicative of serious renal or hepatic disorders, discontinuation of treatment should be

considered.

Potential for gastrointestinal obstruction

Because Ritalin tablet is nondeformable and does not appreciably change in shape in

the gastrointestinal (GI) tract, it should not ordinarily be administered to patients pre-

existing severe GI narrowing (pathologic or iatrogenic) or in patients with dsyphagia

or significant difficulty in swallowing tablets. There have been rare reports of

obstructive symptoms in patients with known strictures in association with the

ingestion of drugs in nondeformable prolonged-release formulations.

4.5

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interaction

It is not known how methylphenidate may effect plasma concentrations of

concomitantly administered drugs. Therefore, caution is recommended at combining

methylphenidate with other drugs, especially those with narrow therapeutic window.

Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant

extent. Inducers or inhibitors of cytochrome P450 are not expected to have any

relevant impact on methylphenidate pharmacokinetics. Conversely, the d- and I-

enantiomers of methylphenidate do not relevantly inhibit cytochrome P450 1A2, 2C8,

2C9, 2C19, 2D6, 2E1 or 3A.

However, there are reports indicating that methylphenidate may inhibit the

metabolism of coumarin anticoagulants, anticonvulsants (e.g. Phenobarbitol,

phenytoin, primodone), and some antidepressants (tricyclic and selective serotonin

reuptake inhibitors).

When starting and stopping treatment with methylphenidate, it may be necessary to

adjust the dosage of these drugs already being taken and establish drug plasma

concentrations (or for coumarin, coagulation times).

Pharmacodynamics interactions

Anti-hypertensive drugs

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.

Use with drugs that elevate blood pressure

Caution is advised in patients being treated with methylphenidate with other drugs

that can also elevate blood pressure (see also sections on cardiovascular and

cerebrovascular conditions in section 4.4 Warnings and precautions for use).

Because of possible hypertensive crisis, methylphenidate is contraindicated in patients

being treated (currently or within the preceding 2 weeks) with MAO-inhibitors (see

section 4.3 Contraindications).

Use with alcohol

Alcohol may exacerbate the adverse CNS effects of psychoactive drugs, including

methylphenidate. It is therefore advisable for patients to abstain from alcohol during

treatment

Use with anaesthetics

There is a risk of sudden blood pressure and heart rate increase during surgery. If

surgery is planned, methylphenidate treatment should not be used on the day of

surgery.

Use with centrally acting alpha-2agonists (e.g. clonidine)

The long term safety of using methylphenidate in combination with clonidine or other

centrally acting alpha-2 agonists has not been systematically evaluated.

Use with dopaminergic drugs

Caution is recommended when administering methylphenidate with dopaminergic

drugs, including antipsychotics. Because a predominant action of methylphenidate is

to increase extra cellular dopamine levels, methylphenidate may be associated with

pharmacodynamic interactions when co-administered with direct and indirect

dopamine agonists (including DOPA and tricyclic antidepressants) or with dopamine

antagonists including antipsychotics.

4.6

Fertility, pregnancy and lactation

Pregnancy

Data from a cohort study of in total approximately 3,400 pregnancies exposed in the

first trimester do not suggest an increased risk of overall birth defects. There was a

small increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3;

95 % CI, 1.0-1.6) corresponding to 3 additional infants born with congenital cardiac

malformations for every 1000 women who receive methylphenidate during the first

trimester of pregnancy, compared with non-exposed pregnancies.

Cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and

respiratory distress have been reported in spontaneous reports.

Studies in animals have only shown evidence of reproductive toxicity at maternally

toxic doses. (See Section 5.3, Preclinical Safety Data).

Methylphenidate is not recommended for use during pregnancy unless a clinical

decision is made that postponing treatment may pose a greater risk to the pregnancy.

Lactation

Methylphenidate has been found in breast-milk of a women treated with

methylphenidate.

There is one case report of an infant who experienced an unspecified decrease in

weight during the period of exposure but recovered and gained weight after the mother

discontinued treatment with Methylphenidate. A risk to the suckling child cannot be

excluded.

A decision must be made whether to discontinue breast-feeding or to

discontinue/abstain from methylphenidate therapy taking into account the benefit of

breast feeding for the child and the benefit of therapy for the woman.

Fertility

No human data on the effect of methylphenidate on fertility are available.

Methylphenidate did not impair fertility in male or female mice (see Section 5.3

Preclinical Safety Data).

4.7

Effects on Ability to Drive or Use Machines

Ritalin may cause dizziness, drowsiness and visual disturbances including difficulties

with accommodation, diplopia and blurred vision. It may have a moderate influence on

the ability to drive and use machines. Patients should be warned of these possible

effects and advised that if affected, they should avoid potentially hazardous activities

such as driving or operating machinery.

4.8

Undesirable effects

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