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XENIDATE XL 54 MG PROLONGED-RELEASE TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Package leaflet: Information for the patient

Xenidate XL 54 mg
Prolonged-release Tablets
(methylphenidate hydrochloride)

Read all of this leaflet carefully before you or
your child 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 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 child’s ones.
• 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 Xenidate XL is and what it is used for
2. What you need to know before you or your
child takes Xenidate XL
3. How to take Xenidate XL
4. Possible side effects
5. How to store Xenidate XL
6. Contents of the pack and other information

1. What Xenidate XL is and what it is used for
What Xenidate XL is used for

Xenidate XL is used to treat “attention deficit
hyperactivity disorder” (ADHD):
• it is used in children and young people between
the ages of 6 and 18

Description Xenidate_XL_54mg_30
Component Type Leaflet
Affiliate Item Code 1275777
Superceded Affiliate Item Code 1107608
TrackWise PR No. 1275777
MA No. PL 04569/1419
Packing Site/Printer

Konapharm AG
(Pratteln - CH)

Supplier Code TBC

Pharma Code 2005
SAP No. N/A
Vendor Job No. 491310
Trackwise Proof No. 1
Client Market United Kingdom

• it is used only after trying treatments which do
not involve medicines. Such as counselling and
behavioural therapy.
Xenidate XL is not for use as a treatment for ADHD in
children under 6 years of age or for the initiation of
treatment in adults. When treatment was started at
a younger age, it might be appropriate to continue
taking Xenidate XL when you become an adult. Your
doctor will advise you about this.

How Xenidate XL works

Xenidate XL 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 therapy
• educational therapy
• social therapy.
 ethylphenidate must only be initiated by,
M
and used under the supervision of, a specialist
in childhood/and or adolescent behavioral.
Using medicine in combination with treatment
programmes helps to manage ADHD.

About ADHD

Children and young people with ADHD find it hard:
• to sit still
• 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.

Date: 17 Aug 17
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2. What you need to know before you or your
child take methylphenidate
Do not take methylphenidate 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 Xenidate XL”
• 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:
feeling like killing yourself
severe depression, where you feel very sad,
worthless and hopeless

mania, where you feel unusually excitable, overactive, and uninhibited.

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Do not take methylphenidate 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
methylphenidate. This is because methylphenidate can
make these problems worse.

Warnings and precautions
Talk to your doctor or pharmacist before taking Xenidate
XL if you or your child:
• have liver or kidney problems
• have a problem with swallowing or swallowing whole
tablets
• have a narrowing or blockage of the gut or food-pipe
• have had fits (seizures, convulsions, epilepsy) or any
abnormal brain scans (EEG)
• are 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 Xenidate XL if you or your child …’
• have a mental health problem which is not mentioned
in the section ‘Do not take Xenidate XL 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

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-tocontrol, 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, 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.

Other medicines and Xenidate XL

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 if you or your child:
• 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 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:
• other medicines for depressionmedicines 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 aff ect 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 or your child are taking are included in the list
above, ask your doctor or pharmacist for advice
before taking methylphenidate.
Please tell your doctor or pharmacist if you or your
child are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.

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 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.

Xenidate 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.

Pregnancy, breast-feeding and contraception

• are having sex. Your doctor will discuss contraception
• are pregnant or think 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.

Driving and 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.

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.

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

It is not known if methylphenidate will affect an
unborn baby. Tell your doctor or pharmacist before
using methylphenidate if you or your daughter:

Xenidate XL contains sucrose
If you or your child have been told by your doctor
that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3. How to take Xenidate XL
Before you or your child start treatment, at every change
of dose and then at least every 6 months or 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.
Dose adjustment
Careful dose adjustment is necessary at the start of
treatment with methylphenidate. The dose should be
started at the lowest possible dose and increased as
recommended by your doctor.

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 54 mg
• you or your child should take Xenidate XL once each
day in the morning with a glass of water. The tablet
can be divided into equal doses. The tablet must not
be chewed or crushed. The tablet may be taken with
or without food.

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

Xenidate XL does not need to be taken forever. If you or
your child take Xenidate XL for more than a year, your

Description Xenidate_XL_54mg_30
Component Type Leaflet
Affiliate Item Code 1275777
Superceded Affiliate Item Code 1107608
TrackWise PR No. 1275777
MA No. PL 04569/1419
Packing Site/Printer

Konapharm AG
(Pratteln - CH)

Supplier Code TBC

Pharma Code 2005
SAP No. N/A
Vendor Job No. 491310
Trackwise Proof No. 1
Client Market United Kingdom

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 Xenidate XL properly

If Xenidate XL is not used properly, this may cause
abnormal behavior. It may also mean that you or your
child start to depend on the medicine. Tell your doctor if
you or your child have 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 Xenidate XL than
you 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.
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 take Xenidate XL

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 Xenidate XL

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

Date: 17 Aug 17
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each day, before stopping it completely. Talk to your
doctor before stopping Xenidate XL.
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 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):

• uneven heartbeat (palpitations)
• mood changes or mood swings or changes in
personality.

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.

Rare (may affect up to 1 in 1,000 people):

• feeling unusually excited, over-active and uninhibited
(mania).

Very rare (may affect up to 1 in 10,000 people):
• heart attack
• sudden death

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• suicidal attempt
• fits (epileptic seizures, convulsions, epilepsy)
• skin peeling or purplish red patches
• inflammation or blocked arteries in the brain
• muscle spasms which cannot be controlled 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)
• prolonged erections, sometimes painful, or an
increased number of erections.

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 a lack of weight gain or height growth
• your doctor will carefully watch your or your child’s
height and weight, as well as how well you or your
child are eating
• if you or your child are not growing as expected, then
treatment with methylphenidate may be stopped for
a short time.

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.

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 painful 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.

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, talking too much,
excessive awareness of surroundings, problems sleeping.

Rare (may affect up to 1 in 1,000 people):

• 
feeling disorientated, confusion
• 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
• 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, temporary low mood
• 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
• diluted pupils

• very high fever
• slow, fast or extra heart beats
• a major fit (‘grand mal convulsion’)
• believing things that are not true
• severe stomach pain, often with feeling and being sick.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. 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. How to store Xenidate XL
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 bottle label and the carton box after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage
conditions. However, the prolonged-release tablets
should be stored in the original, child-resistant container.
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. Contents of the pack and other information
What Xenidate XL contains
• The active substance is methylphenidate
hydrochloride. Each prolonged-release tablet contains
54 mg methylphenidate hydrochloride equivalent to
46.70 mg methylphenidate.
• The other ingredients are:

Sugar spheres (sucrose, maize starch),
hypromellose, talc, ethylcellulose,
hydroxypropylcellulose, triethyl citrate,
hypromellose acetate succinate, carmellose
sodium, microcrystalline cellulose, magnesium
stearate, colloidal anhydrous silica, hydrochloric
acid (pH adjustment).
Tablet Titanium dioxide (E171), polyvinyl alcohol,
coating: macrogol 3350, talc, iron oxide red (E172),
hydrochloric acid (pH adjustment).
Tablet
core:

What Xenidate XL looks like and contents of
the pack
Xenidate XL 54 mg prolonged-release tablets are reddish
to red, oblong, biconvex tablets of 13.3 x 6.4 mm with
break scores on both sides. The tablet can be divided
into equal doses.
The prolonged-release tablets are available in bottles
with child-resistant screw caps.
Pack sizes:
28 or 30 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK.

Manufacturer
Develco Pharma GmbH, Grienmatt 27,
79650 Schopfheim, Germany
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Generics [UK] Limited
Station Close, Potters Bar, EN6 1TL, UK.
This leaflet was last revised in 08/2017

1275777

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