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MATORIDE XL 54 MG PROLONGED-RELEASE TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Matoride XL 18 mg Prolonged-release Tablets
Matoride XL 36 mg Prolonged-release Tablets
Matoride XL 54 mg Prolonged-release Tablets
methylphenidate hydrochloride
Read all of this leaflet carefully before you start 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4
What is in this leaflet
1. What Matoride XL is and what it
is used for
2. What you need to know before
you take Matoride XL
3. How to take Matoride XL
4. Possible side effects
5. How to store Matoride XL
6. Contents of the pack and other
information

1

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.

What Matoride XL is and
what it is used for

What it is used for
Methylphenidate is used to treat
‘Attention Deficit Hyperactivity
Disorder’ (ADHD).
• It is used in children, 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 is not for use as
a treatment for ADHD in children
under 6 years of age or in adults.
When treatment was started at a
younger age, it might be
appropriate to continue taking
Matoride XL when you become
an adult. Your doctor will advise
you about this.

It is important that you provide as
much information as you can. This
will help your doctor decide if
Matoride XL is the correct medicine
for you. Your doctor may decide that
other medical tests are needed
before you start taking this
medicine.
Other medicines and Matoride XL
Tell your doctor if you are taking,
have recently taken or might take
any other medicines.
Do not take Matoride XL 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
Matoride XL may cause a sudden
increase in your blood pressure.

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
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.

If you are taking other medicines,
Matoride XL 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 Matoride XL:
• 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

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.

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 Matoride XL.

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.

Having an operation
Tell your doctor if you are going to
have an operation. You should not
take Matoride XL 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.

ADHD does not affect the intelligence
of a child or young person.

2

What you need to know
before you take
Matoride XL

Drug testing
This medicine may give a positive
result when testing for drug use.
This includes testing used in sport.
Matoride XL with alcohol
Do not drink alcohol while taking this
medicine. Alcohol may make the
side effects of this medicine worse.
Remember that some foods and
medicines contain alcohol.

Do not take Matoride XL if you
• 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 your
eye (glaucoma)
• have a tumour of your adrenal
gland (phaeochromocytoma)
• have an eating problem when you
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 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 taking medicines known as
monoamine oxidase inhibitors
(MAOIs) for depression, or have
taken MAOIs in the last 14 days
• 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,
overactive, and uninhibited

Pregnancy, breast-feeding and
contraception
If you are pregnant or
breast-feeding, think you may be
pregnant or are planning to have
a baby, ask your doctor for advice
before taking this medicine.
It is not known if Methylphenidate
will affect an unborn baby. Tell your
doctor or pharmacist before using
Methylphenidate if you are:
• having sex.
Your doctor will discuss
contraception.
• pregnant or may be pregnant
Your doctor will decide whether
you should take Methylphenidate.
• breast-feeding or planning to
breast-feed It is possible that
Methylphenidate is passed into
human breast milk.
Therefore, your doctor will decide
whether you should breast-feed
while taking Methylphenidate.
Driving and using machines
You may feel dizzy, have problems
focusing 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.

Do not take Matoride XL if any of the
above apply to you. If you are not
sure, talk to your doctor or
pharmacist before you take Matoride
XL. This is because Matoride XL can
make these problems worse.

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

Warnings and precautions
Talk to your doctor or pharmacist if
you are not sure whether it is safe
for you to drive while taking this
medicine.

Talk to your doctor before taking
Matoride XL if you:
• have liver or kidney problems
• have a problem with swallowing
or swallowing whole tablets
• have a narrowing or blockage of
your gut or food-pipe
• have had fits (seizures,
convulsions, epilepsy) or any
abnormal brain scans (EEGs)
• have ever abused or been
dependent on alcohol,
prescription medicines or street
drugs
• are a girl and have started having
periods (see the ‘Pregnancy,
breast-feeding and contraception’
section below)
• have hard-to-control, repeated
twitching of any parts of the body
or you repeat sounds and words
• have high blood pressure
• have a heart problem which is not
in the ‘Do not take’ section above
• 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

Matoride XL contains lactose
This medicine contains lactose (a
type of sugar). If you have an
intolerance to some sugars, talk to
your doctor before taking this
medicine.

3

How much to take
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
• Your doctor will usually start
treatment with a low dose and
increase it gradually as required.
• The maximum daily dose is 54 mg.
• You should take Matoride XL
once each day in the morning
with a glass of water. The tablet
may be taken with or without
food.
• The tablet should be swallowed
whole and not chewed, broken, or
crushed. A small round hole is
visible on one side of the tablet.
• The tablet does not dissolve
completely after all of the drug
has been released and
sometimes the tablet shell may
appear in your stools. This is
normal.
In some patients Matoride XL may
cause sleeplessness. To avoid
difficulty in falling asleep, it should
not be taken too late in the morning
unless the doctor recommends
otherwise.

Tell your doctor or pharmacist if any
of the above apply to you before
starting treatment. This is because
Matoride XL can make these
problems worse. Your doctor will
want to monitor how the medicine
affects you.

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.

Checks that your doctor will make
before you start taking Matoride XL
These checks are to decide if
Matoride XL 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

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How to take Matoride XL

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

Continued on the next page >>

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If you take more Matoride XL than
you should
If you take too much medicine, talk
to a doctor or call an ambulance
straight away. Tell them how much
has been taken.
Signs of overdose may include:
• being sick
• feeling agitated
• shaking
• increased uncontrolled
movements
• muscle twitching
• fits (may be followed by coma)
• feeling very happy
• being confused
• seeing, feeling or hearing things
that are not real (hallucinations)
• sweating
• flushing
• headache
• high fever
• changes in heart beat (slow, fast
or uneven)
• high blood pressure
• dilated pupils
• dry nose and mouth

Rare, may affect up to 1 in 1,000
people
• feeling disorientated or confused
• trouble seeing or double vision
• swelling of the breasts in men
• excessive sweating, redness of
the skin, red raised skin rash
Very rare, may affect up to 1 in
10,000 people
• muscle cramps
• small red marks on the skin
• inflammation or blocked arteries
in the brain
• abnormal liver function including
liver failure and coma
• changes in test results including
liver and blood tests
• abnormal thinking, lack of feeling
or emotion, doing things over and
over again, being obsessed with
one thing
• fingers and toes feeling numb,
tingling and changing colour (from
white to blue, then red) when
cold (‘Raynaud’s phenomenon’)
Not known: frequency cannot be
estimated from the available data
• migraine
• dilated pupils
• very high fever
• slow, fast or extra heart beats
• a major fit (‘grand mal
convulsions’)
• believing things that are not true
• severe stomach pain, often with
feeling and being sick

If you forget to take Matoride XL
Do not take a double dose to make
up for a forgotten dose. If you forget
a dose, wait until it is time for the
next dose.
If you stop taking Matoride XL
If you suddenly stop taking this
medicine, the ADHD symptoms may
come back or unwanted effects such
as depression may appear. Your
doctor may want to gradually reduce
the amount of medicine taken each
day, before stopping it completely.
Talk to your doctor before stopping
Matoride XL.

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.

Things your doctor will do when
you are on treatment
• Your doctor will do some tests
- before you start to make sure
that Matoride XL are 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 appetite
- measuring height and weight
- measuring blood pressure
and heart rate
- checking whether you have
any problems with mood,
state of mind or any other
unusual feelings.
Or if these have got worse
while taking Matoride XL.

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

• Long-term treatment
Matoride XL does not need to be
taken for ever. If you take
Matoride XL for more than a year,
your doctor should stop treatment
for a short time, this may happen
during a school holiday. This will
show if the medicine is still
needed.

5

Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the
expiry date which is stated on carton
and label after EXP. The expiry date
refers to the last day of that month.

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

4

How to store
Matoride XL

This medicine does not require any
special storage conditions before
first opening the bottle. After
opening, the product should be
stored below 25°C.

Possible side effects

The tablets can be stored for 6
months in the bottle after the first
opening.

Like all medicines, this medicine 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.

The pack contains drying plug. This
plug is used to keep the tablets dry
and should not be eaten.
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.

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

6

Uncommon, may affect up to 1 in
100 people
• thinking about or feeling like
killing yourself
• seeing, feeling or hearing things
that are not real, these are signs
of psychosis.
• uncontrolled speech and body
movements (Tourette’s)
• signs of allergy such as rash,
itching or hives on the skin,
swelling of the face, lips, tongue
or other parts of the body,
shortness of breath, wheezing or
trouble breathing

Contents of the pack
and other information

What Matoride XL contains
The active substance is
methylphenidate hydrochloride.
18 mg
Each tablet contains contain 18 mg
of methylphenidate hydrochloride.
36 mg
Each tablet contains 36 mg of
methylphenidate hydrochloride.
54 mg
Each tablet contains 54 mg of
methylphenidate hydrochloride.

Rare, may affect up to 1 in 1,000
people
• feeling unusually excited,
overactive and uninhibited
(mania)
Very rare, may affect up to 1 in
10,000 people
• heart attack
• sudden death
• suicidal attempt
• fits (seizures, convulsions
epilepsy)
• skin peeling or purplish red
patches
• inflammation or blocked arteries
in the brain
• muscle spasms which you cannot
control affecting your eyes, head,
neck, body and nervous system
due to a temporary lack of blood
supply to the brain
• decrease in number of blood cells
(red cells, white cells and platelets)
which can make you more likely
to get infections, and make you
bleed and bruise more easily
• a sudden increase in body
temperature, very high blood
pressure and severe convulsions
(‘Neuroleptic Malignant
Syndrome’)
It is not certain that this side effect
is caused by methylphenidate or
other drugs that may be taken in
combination with methylphenidate.
Not known: frequency cannot be
estimated from the available data
• unwanted thoughts that keep
coming back
• unexplained fainting, chest pain,
shortness of breath (these can be
signs of heart problems)
• paralysis or problems with
movement and vision, difficulties
in speech (these can be signs of
problems with the blood vessels
in your brain)

The other ingredients are:
• drug layer: polyethylene oxide,
succinic acid, povidone (K 25),
butylhydroxytoluene, stearic acid
• push layer: polyethylene oxide,
sodium chloride, povidone (K 25),
butylhydroxytoluene, iron oxide
red (E 172), stearic acid
• membrane layer: cellulose
acetate, poloxamer 188
• drug coat: hypromellose,
succinic acid
• film coat: film coating mixture:
white (lactose monohydrate,
hypromellose, titanium dioxide (E
171), macrogol 4000
In addition in 18 mg prolonged
release tablets:
Iron oxide yellow (E 172)
In addition in 54 mg prolonged
release tablets:
Iron oxide red (E 172)
Iron oxide yellow (E 172)
What Matoride XL looks like and
contents of the pack
[18 mg]
Light yellow film-coated tablet of
round shape (diameter 8mm) with a
delivery orifice (visible small round
hole) on one side.
[36 mg]
White film-coated tablet of round
shape (diameter 10mm) with a
delivery orifice (visible small round
hole) on one side.
[54 mg]
Red film-coated tablet of round
shape (diameter 10mm) with a
delivery orifice (visible small round
hole) on one side.

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

The medicine is available in bottles
containing 28 tablets, 30 tablets, or
multipacks of 60 tablets (2 packs of
30 tablets) or multipack of 90 tablets
(3 packs of 30 tablets).

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

Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Sandoz Ltd,
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
United Kingdom.

Common, may affect up to 1 in 10
people
• joint pain
• blurred vision
• tension headache
• dry mouth, thirst
• trouble falling asleep
• high temperature (fever)
• decreased interest in sex
• unusual hair loss or thinning
• muscle tightness, muscle cramps
• loss of appetite or decreased
appetite
• inability to develop or maintain an
erection
• itching, rash or raised red itchy
rashes (hives)
• feeling unusually sleepy or
drowsy, feeling tired
• clenching or grinding your teeth,
feeling of panic
• tingling feeling, prickling, or
numbness of the skin
• increased alanine
aminotransferase (liver enzyme)
level in your blood
• cough, sore throat or nose and
throat irritation, upper respiratory
tract infection; sinus infection
• high blood pressure, fast heart
beat (tachycardia)
• dizziness (vertigo), feeling weak,
movements which you cannot
control, being unusually active
• feeling aggressive, agitated,
anxious, depressed, irritable,
tense, jittery and abnormal
behaviour
• upset stomach or indigestion,
stomach pain, diarrhoea, feeling
sick, stomach discomfort and
being sick

Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
or
Lek Pharmaceuticals d.d.,
Verovskova 57,
1526 Ljubljana,
Slovenia.
This leaflet was last revised in
06/2015.

Uncommon, may affect up to 1 in
100 people
• dry eyes
• constipation
• chest discomfort
• blood in the urine
• listlessness
• shaking or trembling
• increased need to pass urine
• muscle pain, muscle twitching
• shortness of breath or chest pain
• feeling hot
• increases in liver test results
(seen in a blood test)
• anger, feeling restless or tearful,
excessive awareness of
surroundings, problems sleeping
• tiredness, lack of energy
• talking too much

draft: 44043297, 44043299,
44060083
laetus code: 0000
mat.no.: 00000000

0000000
SZ00000LT000

Artwork Proof Box
Ref: V010: Addition of 90s pack size
Proof no.
005.0

Date prepared:
23/06/2015

Colours:
Black
Dimensions: 110 x 810 mm

Font size:
7.5pt
Fonts:
Helvetica

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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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