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METHYLPHENIDATE HYDROCHLORIDE 5 MG TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Package leaflet: Information for the patient

Methylphenidate
Hydrochloride 5 mg Tablets
Methylphenidate
Hydrochloride 10 mg Tablets
Methylphenidate
Hydrochloride 20 mg Tablets
Read all of this leaflet carefully before you or your child
starts taking this medicine because it contains important
information for you.
• 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 or your child
only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours or your childs.
• If you or your child get any side effects, talk to your doctor
or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet

1. What Methylphenidate Hydrochloride is and what it is used for
2. What you need to know before you or your child takes
Methylphenidate Hydrochloride
3. How to take Methylphenidate Hydrochloride
4. Possible side effects
5. How to store Methylphenidate Hydrochloride
6. Contents of the pack and other information

1. W
 hat Methylphenidate Hydrochloride is and what it
is used for
Methylphenidate Hydrochloride contains the active substance
methylphenidate.
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
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.

How it works

Methylphenidate improves the activity of certain parts of the brain
which are underactive. 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
Methylphenidate Hydrochloride must only be initiated by, and
used under the supervision of, a specialist in childhood/and or
adolescent behavioural disorders. 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
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. W
 hat you need to know before you or your child
takes Methylphenidate Hydrochloride
Do not take Methylphenidate Hydrochloride if you or your child:
are allergic to methylphenidate or any of the other ingredients
• 
of this medicine (listed in section 6)
• 
have a thyroid problem
• 
have increased pressure in the eye (glaucoma)
• 
have a tumour of the adrenal gland (phaeochromocytoma)
• 
have an eating problem when you or your child do not feel
hungry or want to eat - such as “anorexia nervosa”
• 
have very high blood pressure or narrowing of the blood
vessels, which can cause pain in the arms and legs
• 
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

have or 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)
• 
are currently taking or have taken within the last 14 days an
antidepressant known as a monoamine oxidase inhibitor (see
“Other medicines and Methylphenidate Hydrochloride “)
• 
have or have had 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:
o feeling like killing yourself
o severe depression, where you feel very sad, worthless
and hopeless
o mania, where you feel unusually excitable,
over-active, and uninhibited
Do not take Methylphenidate Hydrochloride if any of the above
applies to you or your child. If you are not sure, talk to your doctor
or pharmacist before you or your child take this medicine. This is
because methylphenidate can make these problems worse.

Warnings and precautions

Talk to your doctor or pharmacist before taking Methylphenidate
Hydrochloride if you or your child:
• 
have liver or kidney problems
• 
have had fits (seizures, convulsions, epilepsy) or any abnormal
brain scans (EEG)
• 
is female and have started having periods (see the ‘Pregnancy
and breast-feeding’ section below)
• 
have ever abused or been dependent on alcohol, prescription
medicines or street drugs
• 
have hard-to-control repeated twitching of any parts of the
body or you repeat sounds and words (tics)
• 
have high blood pressure
• 
have a heart problem which is not mentioned in the section ‘Do
not take Methylphenidate Hydrochloride if you or your child:’
• 
have a mental health problem which is not mentioned in the
section ‘Do not take Methylphenidate Hydrochloride if you or
your child’
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 applies to
you or your child, before starting treatment. This is because
methylphenidate can make these problems worse. Your doctor
will want to monitor how the medicine affects you or your child.
Checks that your doctor will make before you or your child start
taking Methylphenidate Hydrochloride
These checks are to decide if methylphenidate is the correct
medicine for you or your child. Your doctor will talk to you about:
• 
any other medicines you or your child are taking,
• 
whether there is any family history of sudden unexplained death,
• 
any other medical problems (such as heart problems) you, your
child or your family may have,
• 
how you or your child are feeling, such as feeling high or low,
having strange thoughts or if you or your child 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 your child or
other family members have or have ever had. Your doctor will
discuss whether you or your child are at risk of having mood
swings (from being manic to being depressed - called ‘bipolar
disorder’). Your doctor will check your or your child’s mental
health history, and check if any of your family has 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 or your child. Your doctor may decide that other
medical tests are needed before you or your child start taking
this medicine.

During treatment

If you or your child take this medicine for longer than 12 months
your doctor may want to monitor heart function, height, weight,
appetite or mental health and may wish you or your child to stop
taking Methylphenidate Hydrochloride to check if treatment is
still necessary.

Tell your doctor if you or your child get any
of the following:
uncontrolled speech or body movements,
• 
• 
any changes or worsening of your mood
or behaviour,
difficulty breathing,
• 
• 
shortness of breath,
chest pain or palpitations (a fast heart beat which feels like
• 
a thumping in the chest), as your doctor may decide to stop
treatment. Your doctor may check for signs of these at every
change of dose, every 6 months or at every visit.

Other medicines and Methylphenidate Hydrochloride

Tell your doctor or pharmacist if you or your child are taking, have
recently taken or might take any other medicines.
Do not take Methylphenidate Hydrochloride if you or your child:
are taking a medicine called a ‘monoamine oxidase inhibitor’
• 
(MAOI) used for depression such as phenelzine or isocarboxazid,
or have taken a MAOI in the last 14 days. Taking a MAOI with
methylphenidate may cause a sudden increase in your or your
child’s blood pressure.
If you or your child are taking other medicines, methylphenidate
may affect how well they work or may cause side effects. If
you or your child are taking any of the following medicines,
check with your doctor or pharmacist before taking
Methylphenidate Hydrochloride:
other medicines for depression such as tricyclic antidepressants
• 
(e.g. amitriptyline clomipramine) or selective serotonin reuptake
inhibitors (SSRIs) (e.g. citalopram, fluoxetine),
medicines for severe mental health problems such as
• 
amisulpride, risperidone, lithium, haloperidol,
DOPA, a medicine used for Parkinson’s disease,
• 
medicines for epilepsy such as phenobarbital, phenytoin,
• 
primidone,
medicines used to reduce or increase blood pressure such
• 
as clonidine,
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 such as
• 
coumarin or warfarin.
If you are in any doubt about whether any medicines you or your
child are taking are included in the list above, ask your doctor or
pharmacist for advice before taking methylphenidate

Having an operation

Tell your doctor if you or your child are going to have an operation.
Methylphenidate should not be taken on the day of a 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/anti-doping testing

This medicine may give a positive result when testing for drug use.
This includes testing used in sport.

Methylphenidate Hydrochloride with food and alcohol

Taking methylphenidate with food may help relieve stomach
pains, feeling sick or vomiting.
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 and breast-feeding

Methylphenidate is present in breast milk. It is not known if
methylphenidate will affect an unborn baby. Tell your doctor or
pharmacist before using methylphenidate if you or your daughter:
• 
are sexually active. Your doctor will discuss contraception
• 
are pregnant or might be pregnant. Your doctor will decide
whether methylphenidate should be taken
are 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 or your daughter should
breast-feed while taking methylphenidate.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.

Driving and using machines

You may feel dizzy, drowsy, have problems focusing or have
blurred or double vision when taking methylphenidate. If these
happen, do not drive, use machines, ride a bike or horse or
climb trees.

3. H
 ow to take Methylphenidate Hydrochloride
Before you or your child start treatment, at every change of dose
and then at least every 6 months or at every visit your doctor will
conduct various tests to make sure that methylphenidate is still
acceptably safe and beneficial. These will include:
measuring blood pressure and heart rate and recording these
• 
on a chart
• 
measuring height, weight and appetite recording these on
a chart
• 
assessing psychiatric symptoms (see section 2 ‘Warnings
and precautions’)

How much to take

You or your child should always take this medicine exactly as your
doctor or pharmacist 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 recommended daily dose is 60 mg
• 
you or your child should take Methylphenidate Hydrochloride
once or twice daily (e.g. at breakfast and/or at lunchtime), with a
glass of water
• 
the score line is only there to help you break the tablet if you
have difficulty swallowing it whole. [10 mg/20 mg only]

If you or your child do not feel better after 1 month of
treatment

If you or your child do not feel better, tell your doctor. They may
decide a different treatment is needed.

Long-term treatment

Methylphenidate Hydrochloride does not need to be taken
forever. If you or your child takes 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.

Not using Methylphenidate Hydrochloride properly

If Methylphenidate Hydrochloride is not used properly, this may
cause abnormal behaviour. It may also mean that you or your child
starts to depend on the medicine. Tell your doctor if you or your
child has ever abused or been dependent on alcohol, prescription
medicines or street drugs.
This medicine is only for you or your child. Do not give this
medicine to anyone else, even if their symptoms seem similar.

If you or your child take more Methylphenidate
Hydrochloride than you or your child should

If you or your child have taken too much medicine, talk to a doctor
or call an ambulance straight away. Tell them how much has been
taken and take the medicine with you.
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 or your child forget to
Methylphenidate Hydrochloride

Do not take a double dose to make up for a forgotten dose. If you
or your child have forgotten a dose, wait until the next dose.

If you or your child stop taking Methylphenidate
Hydrochloride

If you or your child 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 further questions on the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them. Although some people get side effects,
most people find that methylphenidate helps them. Your doctor
will talk to you about these side effects.
Some side effects could be very serious. If you
or your child have any of the side effects below, go immediately
to the nearest hospital emergency department:
Common (may affect up to 1 in 10 people)
uneven heartbeats (arrhythmia) or racing heartbeats that feel
• 
like thumping inside your chest (palpitations)
changes in blood pressure or number of heart beats, usually
• 
an increase
Uncommon (may affect up to 1 in 100 people)
• 
thinking about or feeling like killing yourself
signs of allergic reaction such as rash, itching, blistering, scaling,
• 
redness, peeling of the skin or hives, swelling of the face, ear,
lips, tongue or throat causing difficulty breathing, shortness of
breath or wheezing
Rare (may affect up to 1 in 1,000 people)
• 
heavy or pressing sensation on your chest with chest pain
and shortness of breath on exercise (these may be signs you
have angina)
Very rare (may affect up to 1 in 10,000 people)
sudden chest pain which may spread to the neck or arm, with a
• 
shortness of breath and clammy feeling. These may be signs of
a heart attack
sudden death
• 
• 
attempted suicide (including completed suicide)

fits
• 
• 
muscle spasms which cannot be controlled affecting your eyes,
head, neck, body and nervous system. This may be due to a
temporary lack of blood supply to the brain
sudden collapse, numbness or weakness in the arms or legs,
• 
headache, dizziness or confusion, disturbances in vision,
difficulty swallowing, slurred, mixed up or loss of speech. These
may be signs of a stroke or mini stroke caused by a clot or bleed
affecting blood supply to part of the brain
• 
decrease in number of white blood cells which can make you
more likely to get infections that you may see as fevers, severe
chills or a sore throat
yellowing of the skin and eyes, dark urine, tiredness, fever,
• 
feeling sick (nausea), weakness, drowsiness and stomach pain.
These may be signs of serious liver problems
forgetfulness, poor judgement, a musty or sweet smelling
• 
breath, changes in sleep, worsening of hand movements or
shaking of hands or arms. These are signs of problems with the
brain caused by the liver not working
a sudden increase in body temperature, very high blood
• 
pressure or severe convulsions (‘Neuroleptic Malignant
Syndrome’). It is not certain that this side effect is caused
by methylphenidate or other drugs that may be taken in
combination with methylphenidate
Not known (frequency cannot be estimated from the
available data)
• 
a decrease in the number of other types of blood cell such as
red blood cells or platelets which can cause tiredness, short of
breath, pale skin or cause unexplained bruising or bleeding for
longer than normal
Some side effects could be serious. If you or your child have any
of the side effects below, see a doctor straight away:
Common (may affect up to 1 in 10 people)
feeling aggressive, agitated, anxious, depressed or have a
• 
change in behaviour
• 
weight loss
• 
slower growth. You or your child, on long term treatment, may
grow slower in comparison to others of the same sex and age
(growth retardation)
Uncommon (may affect up to 1 in 100 people)
feeling, or hearing things that are not real or believing things
• 
that are not true. These are signs of psychosis
uncontrolled speech or body movements. If you already have
• 
these signs or Tourette’s syndrome, they may get worse
mood changes or mood swings or changes in personality
• 
Rare (may affect up to 1 in 1,000 people)
• 
feeling unusually excited, over-active or un-inhibited (mania)
Not known (frequency cannot be estimated from the
available data)
• 
difficulty thinking or not thinking clearly

Other possible side effects include the following:
Very common (may affect more than 1 in 10 people)
• 
headache
feeling nervous
• 
• 
not being able to sleep
Common (may affect up to 1 in 10 people)
• 
joint pain
• 
dry mouth
• 
high temperature (fever)
• 
unusual hair loss or thinning
• 
feeling unusually sleepy or drowsy
• 
loss of appetite or decreased appetite
• 
cough, sore throat or blocked, stuffy or runny nose and
throat irritation
• 
high blood pressure
• 
dizziness, movements which you cannot control, being
unusually active
• 
feeling irritable
• 
unstable, quickly changing emotions
• 
stomach pain, diarrhoea, feeling sick (nausea), stomach
discomfort and being sick (vomiting). These usually occur at
the beginning of treatment and may be reduced by taking the
medicine with food
Uncommon (may affect up to 1 in 100 people)
constipation
• 
• 
blood in the urine
• 
heart murmur
• 
tiredness
• 
shaking or trembling
• 
blistering, scaling, redness or peeling of the skin
• 
double or blurred vision
• 
muscle pain or muscle twitching
• 
shortness of breath or chest pain
• 
increases in liver test results which can be seen in a blood test
• 
anger, feeling restless or tearful, excessive awareness of
surroundings or problems sleeping

Rare (may affect up to 1 in 1,000 people)
changes in sex drive
• 
• 
feeling disorientated
• 
dilated pupils, difficulty focussing your sight
• 
swelling of the breasts in men
excessive sweating
• 
Very rare (may affect up to 1 in 10,000 people)
• 
muscle cramps
• 
lack of feeling, emotion, interest or concern
• 
repeating behaviours
• 
over focusing
• 
changes in your blood as seen in a test, such as an increase in an
enzyme called alkaline phosphatase or bilirubin, a low number
of platelets or an abnormal white blood cell level
fingers and toes feeling cold, numb, tingling and changing
• 
colour (from white to blue, then red) when cold (‘Raynaud’s
phenomenon’)
Not known (frequency cannot be estimated from the
available data)
migraine
• 
• 
chest discomfort
• 
confusion
• 
very high fever
• 
slow or extra heart beats
• 
dependence on this medicine
• 
problems getting or maintaining an erection

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

5. H
 ow to store Methylphenidate Hydrochloride
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton box after “EXP”. The expiry date refers to the last day of
that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. C
 ontents of the pack and other information
What Methylphenidate Hydrochloride contains

Methylphenidate Hydrochloride 5 mg tablets
The active substance is methylphenidate hydrochloride. Each
tablet contains 5 mg methylphenidate hydrochloride.
Methylphenidate Hydrochloride 10 mg tablets
The active substance is methylphenidate hydrochloride. Each
tablet contains 10 mg methylphenidate hydrochloride.
Methylphenidate Hydrochloride 20 mg tablets
The active substance is methylphenidate hydrochloride. Each
tablet contains 20 mg methylphenidate hydrochloride.
The other ingredients are microcrystalline cellulose, maize starch,
magnesium stearate and calcium hydrogen phosphate dihydrate.

What Methylphenidate Hydrochloride looks like and
contents of the pack

Methylphenidate Hydrochloride 5 mg tablets are white, round,
flat, tablets marked with “RU” on one side and “5” on the other side.
Methylphenidate Hydrochloride 10 mg tablets are white, round,
flat, scored tablets marked with “RU 10” on one side.
Methylphenidate Hydrochloride 20 mg tablets are white, round,
flat, scored tablets marked with “RU 20” on one side.
Methylphenidate Hydrochloride is available in blisters of 20, 30,
60, [for 5 mg & for 10 mg] 100 tablets or [For 10 mg] 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

Manufacturer

Laboratorios Rubió, S.A., Industria, 29, Pol. Ind. Comte de Sert,
08755 Castellbisbal, Barcelona, Spain.
This leaflet was last revised in January 2016.

776610

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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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