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XENIDATE XL 18 MG PROLONGED-RELEASE TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Package leaflet: Information for the patient

Xenidate XL 18 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_18 mg/30
Component Type Leaflet
Affiliate Item Code 1275662
Superceded Affiliate Item Code 1107598
TrackWise PR No. 1275662
MA No. PL 04569/1417
Packing Site/Printer

Konapharm AG
(Pratteln - CH)

Supplier Code TBC

Pharma Code 2003
SAP No. N/A
Vendor Job No. 491246
Trackwise Proof No. 2
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.
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
• 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: 28 Aug 17
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Sign-offs

v3/Jul 2017

2. What you need to know before you or your
child take methylphenidate

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
Do not take methylphenidate if you or your child: your child take methylphenidate. This is because
• are allergic to methylphenidate or any of the other methylphenidate can make these problems worse.
ingredients of this medicine (listed in section 6)
Warnings and precautions
• have a thyroid problem
Talk to your doctor or pharmacist before taking
• have increased pressure in the eye (glaucoma)
Xenidate XL if you or your child:
• have a tumour of the adrenal gland
• have liver or kidney problems
(phaeochromocytoma)
• have a problem with swallowing or swallowing
• have an eating problem when you or your child
whole tablets
do not feel hungry or want to eat - such as
• have a narrowing or blockage of the gut or
“anorexia nervosa”
food-pipe
• have very high blood pressure or narrowing of the
• have had fits (seizures, convulsions, epilepsy) or
blood vessels, which can cause pain in the arms
any abnormal brain scans (EEG)
and legs
• are female and have started having periods (see
• have ever had heart problems - such as a heart
the ‘Pregnancy and breast-feeding’ section below)
attack, uneven heartbeat, pain and discomfort in
the chest, heart failure, heart disease or were born • have ever abused or been dependent on alcohol,
prescription medicines or street drugs
with a heart problem
• have hard-to-control repeated twitching of any
• have or have had a problem with the blood
parts of the body or you repeat sounds and words
vessels in your brain - such as a stroke, swelling
(tics)
and weakening of part of a blood vessel
• have high blood pressure
(aneurysm), narrow or blocked blood vessels, or
• have a heart problem which is not mentioned in
inflammation of the blood vessels (vasculitis)
the section ‘Do not take Xenidate XL if you or your
• are currently taking or have taken within the
child …’
last 14 days an antidepressant (known as a
• have a mental health problem which is not
monoamine oxidase inhibitor)- see “Other
mentioned in the section ‘Do not take Xenidate XL
medicines and Xenidate XL”
if you or your child …’.
• have or have had mental health problems such as:
Other mental health problems include:
• a ‘psychopathic’ or ‘borderline personality’ problem
• mood swings (from being manic to being
• abnormal thoughts or visions or an illness called
depressed - called ‘bipolar disorder’)
‘schizophrenia’
• starting to be aggressive or hostile, or your
• signs of a severe mood problem like:
aggression gets worse
º feeling like killing yourself
• seeing, hearing or feeling things that are not
º severe depression, where you feel very sad,
there (hallucinations)
worthless and hopeless
• believing things that are not true (delusions)
º mania, where you feel unusually excitable,
• feeling unusually suspicious (paranoia)
over-active, and uninhibited.

• feeling agitated, anxious or tense
• feeling depressed or guilty.

medical tests are needed before you or your child
start taking this medicine.

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.

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.

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.

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.

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

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.

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 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.

Please tell your doctor or pharmacist if you or your child Driving and using machines
You may feel dizzy, have problems focussing or have
are taking or have recently taken any other medicines,
blurred vision when taking methylphenidate. If these
including medicines obtained without a prescription.
happen it may be dangerous to do things such as
Having an operation
drive, use machines, ride a bike or horse or climb trees.
Tell your doctor if you or your child are going to have
The medicine can affect your ability to drive as it may
an operation. Methylphenidate should not be taken
on the day of surgery if a certain type of anaesthetic is make you sleepy or dizzy:
used. This is because there is a chance of a sudden rise • do not drive while taking this medicine until you
know how it affects you
in blood pressure during the operation.
• it is an offence to drive if this medicine affects your
Drug testing/anti-doping testing
ability to drive
This medicine may give a positive result when
• however, you would not be committing an offence if:
testing for drug use.
• the medicine has been prescribed to treat a
This includes testing used in sport.
medical or dental problem and
• you have taken it according to the instructions
Xenidate XL with alcohol
given by the prescriber or in the information
Do not drink alcohol while taking this medicine.
provided with the medicine and
Alcohol may make the side effects of this medicine
• it was not affecting your ability to drive safely.
worse. Remember that some foods and medicines
Talk to your doctor or pharmacist if you are not
contain alcohol.
sure whether it is safe for you to drive while taking
this medicine.
Pregnancy, breast-feeding and contraception
If you are pregnant or breast-feeding, think you may Xenidate XL contains sucrose
be pregnant or are planning to have a baby, ask your If you or your child have been told by your doctor
doctor for advice before taking this medicine.
that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
It is not known if methylphenidate will affect an
unborn baby. Tell your doctor or pharmacist before
3. How to take Xenidate XL
using methylphenidate if you or your daughter:
Before you or your child start treatment, at every
• are having sex. Your doctor will discuss
change of dose and then at least every 6 months or
contraception
every visit your doctor will conduct various tests to
• are pregnant or think might be pregnant. Your
make sure that methylphenidate is still acceptably
doctor will decide whether methylphenidate
safe and beneficial. These will include:
should be taken
• measuring blood pressure and heart rate and
• are breast-feeding or planning to breast-feed. It
recording these on a chart
is possible that methylphenidate is passed into
• measuring height, weight and appetite recording
human breast milk. Therefore, your doctor will
decide whether you or your daughter should
these on a chart
breast-feed while taking methylphenidate.
• 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 (or half tablet) must be swallowed
whole and not chewed, broken or crushed. The
tablet may be taken with or without food.

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.

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.

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.

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 doctor should stop treatment for a short time,
this may happen during a school holiday. This will
show if the medicine is still needed.

If you 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.
Rare (may affect up to 1 in 1,000 people):
Your doctor may want to gradually reduce the
• feeling unusually excited, over-active and
amount of medicine taken each day, before stopping
uninhibited (mania).
it completely. Talk to your doctor before stopping
Very rare (may affect up to 1 in 10,000 people):
Xenidate XL.
• heart attack
If you have any further questions on the use of this
• sudden death
medicine, ask your doctor or pharmacist.
• suicidal attempt
• fits (epileptic seizures, convulsions, epilepsy)
• skin peeling or purplish red patches
• inflammation or blocked arteries in the brain

Description Xenidate XL_18 mg/30
Component Type Leaflet
Affiliate Item Code 1275662
Superceded Affiliate Item Code 1107598
TrackWise PR No. 1275662
MA No. PL 04569/1417
Konapharm AG
(Pratteln - CH)

Supplier Code TBC

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.

4. Possible side effects

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.

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.

Packing Site/Printer

This medicine is only for you or your child. Do not
give this medicine to anyone else, even if their
symptoms seem similar.

Pharma Code 2003
SAP No. N/A
Vendor Job No. 491246
Trackwise Proof No. 2
Client Market United Kingdom

Date: 28 Aug 17
No. of colours
Colours

1

Time: 09:47
Page Count

2/2

Black

Non-Print
Colours

Keyline/Drawing No N/A

Equate CMYK
with

Barcode Info. N/A

Main Font

3D Render ID N/A

Dimensions

Myriad Pro
600 x 150 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v3/Jul 2017

• 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.

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
Not known (frequency cannot be estimated from • muscle tightness, muscle cramps
the available data):
• loss of appetite or decreased appetite
• unwanted thoughts that keep coming back
• inability to develop or maintain an erection
• unexplained fainting, chest pain, shortness of
• itching, rash or raised red itchy rashes (hives)
breath (these can be signs of heart problems)
• feeling unusually sleepy or drowsy, feeling tired
• paralysis or problems with movement and vision,
• clenching or grinding your teeth, feeling of panic
difficulties in speech (these can be signs of
• tingling feeling, prickling, or numbness of the skin
problems with the blood vessels in your brain)
• increased alanine aminotransferase (liver enzyme)
• prolonged erections, sometimes painful, or an
level in your blood
increased number of erections.
• cough, sore throat or painful nose and throat
irritation, upper respiratory tract infection, sinus
Effects on growth
infection
When used for more than a year, methylphenidate
• high blood pressure, fast heart beat (tachycardia)
may cause reduced growth in some children. This
• dizziness (vertigo), feeling weak, movements
affects less than 1 in 10 children:
which you cannot control, being unusually active
• there may be a lack of weight gain or height growth • feeling aggressive, agitated, anxious, depressed,
• your doctor will carefully watch your or your child’s
irritable tense, jittery and abnormal behaviour
height and weight, as well as how well you or your • upset stomach or indigestion, stomach pain,
child are eating
diarrhoea, feeling sick, stomach discomfort and
• if you or your child are not growing as expected,
being sick.
then treatment with methylphenidate may be
stopped for a short time.
Uncommon (may affect up to 1 in 100 people):
• dry eyes
Other side effects include the following. If they
• constipation
get serious, please tell your doctor or pharmacist: • chest discomfort

• The other ingredients are:
• a major fit (‘grand mal convulsion’)
• believing things that are not true
Tablet core:
Sugar spheres (sucrose, maize starch),
• severe stomach pain, often with feeling and being sick.
hypromellose, talc, ethylcellulose,
hydroxypropylcellulose, triethyl
Reporting of side effects
citrate, hypromellose acetate
If you get any side effects, talk to your doctor,
succinate, carmellose sodium,
pharmacist or nurse. This includes any possible side
microcrystalline cellulose, magnesium
effects not listed in this leaflet. You can also report
stearate, colloidal anhydrous silica,
side effects directly via the Yellow Card Scheme at:
hydrochloric acid (pH adjustment).
www.mhra.gov.uk/yellowcard.
Tablet coating: Titanium dioxide (E171), polyvinyl
By reporting side effects you can help provide more
alcohol, macrogol (3350), talc, iron
information on the safety of this medicine.
oxide yellow (E172), hydrochloric acid
Rare (may affect up to 1 in 1,000 people):
(pH adjustment).
• feeling disorientated, confusion
5. How to store Xenidate XL
• trouble seeing or double vision
What Xenidate XL looks like and contents of
• swelling of the breasts in men
Keep this medicine out of the sight and reach of children. the pack
• excessive sweating, redness of the skin, red raised
Xenidate XL 18 mg prolonged-release tablets are
skin rash.
Do not use this medicine after the expiry date
yellowish to yellow, round, biconvex tablets of 6.3 mm.
The prolonged-release tablets are available in bottles
which is stated on the bottle label and the carton
Very rare (may affect up to 1 in 10,000 people):
box after “EXP”. The expiry date refers to the last day with child-resistant screw caps.
• muscle cramps
of that month.
Pack sizes:
• small red marks on the skin
28 or 30 prolonged-release tablets.
• abnormal liver function including liver failure and coma This medicine does not require any special storage
Not all pack sizes may be marketed.
• changes in test results – including liver and blood conditions. However, the prolonged-release tablets
tests
should be stored in the original, child-resistant container. Marketing Authorisation Holder
• abnormal thinking, lack of feeling or emotion,
doing things over and over again, being obsessed Do not throw away any medicines via wastewater or Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK.
with one thing, temporary low mood
household waste. Ask your pharmacist how to throw Manufacturer
• fingers and toes feeling numb, tingling and
away medicines you no longer use. These measures
Develco Pharma GmbH, Grienmatt 27
changing colour (from white to blue, then red)
will help protect the environment.
79650 Schopfheim, Germany
when cold (‘Raynaud’s phenomenon’).
6. Contents of the pack and other information
McDermott Laboratories t/a Gerard Laboratories
Not known (frequency cannot be estimated from
35/36 Baldoyle Industrial Estate, Grange Road
the available data):
What Xenidate XL contains
Dublin 13, Ireland
• migraine
• The active substance is methylphenidate
• diluted pupils
Generics [UK] Limited, Station Close,
hydrochloride. Each prolonged-release tablet
• very high fever
Potters Bar, EN6 1TL, UK.
contains 18 mg methylphenidate hydrochloride
• slow, fast or extra heart beats
equivalent to 15.57 mg methylphenidate.
This leaflet was last revised in 08/2017
1275662










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.

+ Expand Transcript

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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