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XENIDATE XL 54 MG PROLONGED-RELEASE TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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TBC

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 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 child’s ones.
• I f 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.
• 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,
• educational, and
• social therapy
Methylphenidate must only be initiated by,
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, 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. What you need to know before you or your
child takes 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, unevenheartbeat, 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,
over-active, and uninhibited
TBC

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),
• 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 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 Xenidate XL

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.

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:

Having an operation

Tell your doctor if you are or your child is 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.

• 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.

Drug testing/anti-doping testing

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 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 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.

Do not drink alcohol while taking this medicine.
Alcohol may make the side effects of this medicine
worse. Remember that some foods and medicines
contain alcohol.

If you 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 is taking or has recently taken any other
medicines, including medicines obtained without
a prescription.

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

Xenidate XL with alcohol

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 or your daughter:
• is having sex. Your doctor will discuss contraception
• is pregnant or think might be pregnant. Your
doctor will decide whether methylphenidate
should be taken.
• is 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
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking
this medicine.

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
(or half tablet) must not be chewed or crushed.
The tablet may be taken with or without food.

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 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 hasbeen 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 do not feel better after
1 month of treatment

If you or your child forget to take Xenidate XL

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

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.

Long-term treatment

If you or your child stop taking Xenidate XL

Xenidate XL does not need to be taken forever. If you
or your child takes Xenidate 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.

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 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.

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 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,
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,
• 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).

Common (may affect up to 1 in 10 people)


















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 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.






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,

15 Jul 2015

14:32
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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, excessive
talkativeness, 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,
• 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 convulsions’),
believing things that are not true,
severe stomach pain, often with feeling and
being sick.

Reporting of side effects

The other ingredients are:

5. How to store Xenidate XL

Tablet coating: Titanium dioxide (E171),
hypromellose, macrogol (6000), talc, iron oxide, red
(E172)], hydrochloric acid (pH adjustment).

Keep this medicine out of the sight and reach
of children.

What Xenidate XL looks like and contents of
the pack

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.

Xenidate XL 54 mg 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

Do not use this medicine if you notice that the tablet
is damaged.

Marketing Authorisation Holder

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.

Manufacturer

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.

Tablet core: Sugar spheres (sucrose, maize starch),
hypromellose, talc, ethylcellulose,
hydroxypropylcellulose, triethyl citrate, hypromellose
acetate succinate, carmellose sodium, cellulose,
microcrystalline, magnesium stearate, silica, colloidal
anhydrous, hydrochloric acid (pH adjustment).

The prolonged-release tablets are available in bottles
This medicine does not require any special
with child-resistant screw caps.
storage conditions. However, the prolonged-release
tablets should be stored in the original,
Pack sizes: 28 or 30 prolonged-release tablets
child-resistant container.
Not all pack sizes may be marketed.

6. Contents of the pack and other information

Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK.
Develco Pharma GmbH, Grienmatt 42, 79650
Schopfheim, Germany.
Gerard Laboratories, 35-36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland

What Xenidate XL contains
Xenidate XL 54 mg prolonged-release tablets:
• The active substance is methylphenidate
hydrochloride. Each prolonged-release tablet
contains 54 mg methylphenidate hydrochloride
equivalent to 46.70 mg methylphenidate.

This leaflet was last revised in 05/2015

666331

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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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