MEDIKINET XL 40MG MODIFIED-RELEASE CAPSULES HARD

Active substance: METHYLPHENIDATE HYDROCHLORIDE

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: Information for the user
Package Leaflet: Information for the user

Medikinet® XL 40mg modified-release capsules, hard
(methylphenidate hydrochloride)

Important things you need to know about your medicine

This medicine is used to treat ADHD
 The full name for ADHD is „Attention Deficit Hyperactivity Disorder‟.
 The medicine helps with your brain activity. It can help improve your
attention, help you concentrate, and make you less impulsive.
 You need to have other treatments for ADHD as well as this medicine.
Read Section 1 for more information.
Before you take this medicine, talk to your doctor if:
 You have heart, circulation, or mental health problems - you may not
be able to take this medicine.
 You are taking any other medicines - this is because methylphenidate
can affect how other medicines work.
Read Section 2 for more information.
While taking this medicine:
 See your doctor regularly. This is because your doctor will want to
check how the medicine is working.
 Do not stop taking the medicine without first talking to your doctor.
 Your doctor may stop your medicine to see if it is still needed, if you
take it for more than a year.
 The most common side effects are feeling nervous, not being able to
sleep or having a headache.
Read Sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
 Your mood and how you feel changes.
 You feel any problems with your heart.
Read Section 4 for more information.
The rest of this leaflet includes more detail and other important
information on the safe and effective use of this medicine.
 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
 If any of the side effects worry you, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.
The leaflet has been written in sections:
– Sections 1 to 6 are for parents and carers (sometimes called „your
guardians‟).
– The last section is a special section for a child or young person to
read.
However, all sections are written as though the child or young person
taking the medicine is reading them.
The sections are:
1) What Medikinet XL is and what it is used for.
2) Before you take Medikinet XL.
3) How to take Medikinet XL.
4) Possible side effects.
5) How to store Medikinet XL.
6) Further information.
Information for children and young people
Now read the rest of this leaflet before you start taking this
medicine.

1) WHAT MEDIKINET XL IS AND WHAT IT IS USED FOR
What it is used for
Medikinet 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.
Medikinet XL is not for use as a treatment for ADHD in children under 6
years of age or in adults. It is not known if it is safe or of benefit in these
people.
How it works
Medikinet XL improves the activity of certain parts of the brain which are
under-active. 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.
Medikinet XL treatment must only be initiated by, and used under the
supervision of, a specialist in childhood and/or adolescent behavioural
disorders. Although there is no cure for ADHD, it can be managed using
treatment programmes.
About ADHD
Children and young people with ADHD find it:
 hard to sit still and
 hard 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) BEFORE YOU TAKE MEDIKINET XL
Do not take Medikinet XL if:
 you are allergic (hypersensitive) to methylphenidate or any of the other
ingredients of Medikinet XL (listed in Section 6)
 you have a thyroid problem
 you have increased pressure in your eye (glaucoma)
 you have a tumour of your adrenal gland (phaeochromocytoma)
 you have an eating problem when you do not feel hungry or want to
eat - such as „anorexia nervosa‟
 you have very high blood pressure or narrowing of the blood vessels,
which can cause pain in the arms and legs
 you 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
 you 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)
 you 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:

Information for children and young people
This info is to help you learn the main things about your medicine called
Medikinet XL.
If you don‟t enjoy reading, someone like your mum, dad or carer
(sometimes called „your guardian‟) can read it to you and answer any
questions.
It may help if you read small bits at a time.
Why have I been given this medicine?
This medicine can help children and young people with „ADHD‟.
 ADHD can make you:
– run about too much
– not be able to pay attention
– act quickly without thinking about what will happen next (impulsive).
 It affects learning, making friends and how you think about yourself. It
is not your fault.
While you are taking this medicine
 as well as taking this medicine you will also get help with ways to cope
with your ADHD such as talking to ADHD specialists.
 this medicine should help you. But it does not cure ADHD.
 you will need to go to your doctor several times a year for check ups.
This is to make sure the medicine is working and that you are growing
and developing OK.

feeling like killing yourself
depression, where you feel very sad, worthless and
hopeless
mania, where you feel unusually excitable, over-active, and
un-inhibited.
 you have a history of pronounced lack of gastric acid (anacidity of the
stomach) with a pH value above 5.5
 are taking medicines to reduct secretion of gastric acid or to treat
excessive acidity of the stomach (H2 receptor blocker or antacid
treatment)
Do not take methylphenidate if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before you take
methylphenidate. This is because methylphenidate can make these
problems worse.


severe

Check with your doctor or pharmacist before treatment if:
 you have liver or kidney problems
 you have had fits (seizures, convulsions, epilepsy) or any abnormal
brain scans (EEGs)
 you have ever abused or been dependent on alcohol, prescription
medicines or street drugs
 you are a girl and have started your periods (see the „Pregnancy and
breast-feeding‟ section below)
 you have hard-to-control, repeated twitching of any parts of the body or
you repeat sounds and words
 you have high blood pressure
 you have a heart problem which is not in the „Do not take‟ section
above
 you 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.
Tell your doctor or pharmacist if any of the above apply to you before
starting treatment. This is because methylphenidate can make these
problems worse. Your doctor will want to monitor how the medicine
affects you.
Checks that your doctor will make before you start taking
methylphenidate
These checks are to decide if methylphenidate 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 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.
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.
Your doctor may decide that other medical tests are needed before you
start taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Do not take methylphenidate 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 methylphenidate may cause a sudden increase in
your blood pressure.
If you are taking other medicines, methylphenidate 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
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.
 Medikinet XL must not be taken together with H2 receptor blockers or
antacids which are used to reduce gastric acid secretion or to
counteract excessive acidity in the stomach, as this could lead to a
faster release of the total amount of active substance.
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
methylphenidate.
Having an operation
Tell your doctor if you are going to have an operation. You should not take
methylphenidate 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.
Drug testing
This medicine may give a positive result when testing for drug use. This
includes testing used in sport.
Taking methylphenidate 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
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 with you
 pregnant or think you 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 or 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.
Important information about some of the ingredients of Medikinet XL
This medicine contains sucrose (a type of sugar). If you have been told by
your doctor that you cannot tolerate or digest some sugars, talk to your
doctor before taking this medicine.



The name of your medicine is Medikinet® XL 40mg modified-release
capsules, hard, it contains the active substance „methylphenidate
hydrochloride‟. The name „methylphenidate‟ will also be used in this
leaflet.
Your medicine will also be referred to as Medikinet XL in this leaflet.
Medikinet XL are also available in other strengths.

 if you take the medicine for more than one year, your doctor may stop
your medicine to see if it is still needed. This will probably happen in a
school holiday.
 if you take this medicine more than once a day, you may have to
remember to take it at school or college. You or your mum, dad or
carer will need to find out what the school rules are about this.
 do not drink alcohol. Alcohol may make the side effects of this medicine
worse.
 if you are having sex, please talk to your doctor about contraception.
Girls must tell their doctor straight away if they think they may be
pregnant. We do not know how this medicine affects unborn babies.
Some people cannot have this medicine
You cannot have this medicine if:
 you have a problem with your heart
 you feel very unhappy, depressed or have a mental illness.

3) HOW TO TAKE MEDIKINET XL
How much to take
Always take Medikinet XL 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 60 mg.
 Medikinet XL is a “modified release” form of methylphenidate
hydrochloride which releases the medicine gradually over a time
period corresponding to the school day. Methylphenidate
hydrochloride tablets have a shorter period of effect and therefore
normally have to be taken at breakfast and lunchtime.
 If the effect of the capsules wears off too early in the late afternoon or
evening, your doctor may evaluate a small additional dose of
methylphenidate can be taken in the evening. For this short acting
methylphenidate hydrochloride tablets are suitable.
How to take
The medicinal product is intended for oral use.
Take Medikinet XL in the morning with or after breakfast. This is very
important in order to obtain sufficiently prolonged action. The capsules
may be swallowed whole with a drink of water.
Alternatively, you can open the capsules, sprinkle the capsule contents
onto a small amount (tablespoon) of applesauce and take it
immediately. Do not store for future use.
The capsules and the capsule contents must not be crushed or chewed.
If you do not feel better after 1 month of treatment
If you do not feel better, tell your doctor. He may decide you need a
different treatment.
Not using Medikinet XL properly
If Medikinet 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.
If you take more Medikinet 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 and dry nose and mouth.
If you forget to take Medikinet 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 Medikinet 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 Medikinet XL.
Things your doctor will do when you are on treatment
Your doctor will do some tests
 before you start - to make sure that Medikinet XL is 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 your appetite
– measuring height and weight
– measuring blood pressure and heart rate
– checking whether you have any problems with your mood, state of
mind or any other unusual feelings. Or if these have got worse
while taking Medikinet XL.

Other side effects include the following, if they get serious, please
tell your doctor or pharmacist:
Very common (affects more than 1 in 10 people)
 headache
 feeling nervous
 not being able to sleep.
Common (affects less than 1 in 10 people)
 joint pain
 dry mouth
 high temperature (fever)
 unusual hair loss or thinning
 feeling unusually sleepy or drowsy
 loss of appetite or decreased appetite
 itching, rash or raised red itchy rashes (hives)
 cough, sore throat or nose and throat irritation
 high blood pressure, fast heart beat (tachycardia)
 feeling dizzy, movements which you cannot control, being unusually
active
 feeling aggressive, agitated, anxious, depressed, irritable and
abnormal behaviour
 Stomach pain, diarrhoea, feeling sick, stomach discomfort and being
sick. These usually occur at the beginning of treatment and may be
reduced by taking the medicine with food.
Uncommon (affects less than 1 in 100 people)
 constipation
 chest discomfort
 blood in the urine
 shaking or trembling
 double vision or blurred vision
 muscle pain, muscle twitching
 shortness of breath or chest pain
 increases in liver test results (seen in a blood test)
 anger, feeling restless or tearful, excessive awareness of
surroundings, problems sleeping.
Rare (affects less than 1 in 1,000 people)
 changes in sex drive
 feeling disorientated
 dilated pupils, trouble seeing
 swelling of the breasts in men
 excessive sweating, redness of the skin, red raised skin rash
Very rare (affects less than 1 in 10,000 people)
 heart attack
 sudden death
 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
 Suicidal attempt, 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‟).
Other side effects (how often they happen is not known)
 migraine
 very high fever
 slow, fast or extra heart beats
 a major fit („grand mal convulsions‟)
 believing things that are not true, confusion
 severe stomach pain, often with feeling and being sick
 problems with the blood vessels of the brain (stroke, cerebral
arteritis or cerebral occlusion).
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.

Long-term treatment
Medikinet XL does not need to be taken for ever. If you take Medikinet
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 any of the side effects worry you, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.

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

Like all medicines, methylphenidate 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.

 Keep out of the sight and reach of children.
 Do not use Medikinet XL after the expiry date which is stated on the
label. The expiry date refers to the last day of that month.
 Do not store above 30°C.
 Store in the original packaging in order to protect from moisture.
 If your capsules become discoloured or show any sign of
deterioration, return them to your pharmacist
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Some side effects could be serious. If you have any of the side
effects below, see a doctor straight away:

6) FURTHER INFORMATION

4) POSSIBLE SIDE EFFECTS

Common (affects less than 1 in 10 people)
 uneven heartbeat (palpitations)
 mood changes or mood swings or changes in personality
Uncommon (affects less than 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 (affects less than 1 in 1,000 people)
 feeling unusually excited, over-active and un-inhibited (mania)
Very rare (affects less than 1 in 10,000 people)
 heart attack
 fits (seizures, convulsions epilepsy)
 skin peeling or purplish red patches
 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
 Paralysis or problems with movement and vision, difficulties in
speech (these can be signs of problems with the blood vessels in
your 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.
Other side effects (how often they happen is not known)
 unwanted thoughts that keep coming back
 unexplained fainting, chest pain, shortness of breath (these can be
signs of heart problems)
If you have any of the side effects above, see a doctor straight away.

Some people need to talk to their doctor before they start having
this medicine
You need to talk to your doctor if:
 you have epilepsy (fits)
 you are pregnant or breastfeeding
 You have a lack of gastric acid or take medicines for binding gastric
acid.
 you are taking other medicines – your doctor needs to know about all
the medicines you are taking.
How do I take my medicine (capsules)?
 Swallow your medicine with water with or after a meal.
 If you have problems to swallow the capsules, the capsules may be
opened, the capsule contents sprinkled onto a small amount
(tablespoon) of applesauce and taken immediately. The capsules
and the capsule contents must not be crushed or chewed.
 Your doctor will tell you how many times a day you should take your
medicine
 Do not stop taking the medicine without talking to your doctor first.
Possible side effects
Side effects are the unwanted things that can happen when you take a
medicine. If any of the following happen, tell an adult you trust straight
away. They can then talk to your doctor. The main things that could
affect you are:
 Feeling worried or nervous
 Feeling dizzy, or getting head aches
 Being very depressed and unhappy or wanting to hurt yourself

5) HOW TO STORE MEDIKINET XL

What Medikinet XL contains
The active ingredient is methylphenidate hydrochloride.
Medikinet XL 40mg modified-release capsules, hard contain 40mg of
methylphenidate hydrochloride.
The other ingredients are:
 Capsule contents: Sucrose, Maize starch, Methacrylic acidethylacrylate-copolymer (1:1),Talc, Triethyl citrate, Polyvinyl alcohol,
Macrogol 3350, Polysorbate 80, Sodium hydroxide, Sodium
laurilsulfate, Simeticone, Silica colloidal anhydrous, Methylcellulose,
Sorbic acid, Indigo carmine aluminium salt (E 132)
 Capsule shell: Gelatin, Erythrosine (E 127), Titanium dioxide
(E 171), Sodium laurilsulfate, Purified water, Iron oxide (E172),
Indigo Carmine (E132)
What Medikinet XL looks like and contents of the pack
Opaque dark violet - grey modified-release capsule, hard, which
contains white and blue pellets.
The medicinal product is available in blister strips containing 30
capsules.
Manufacturer
Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37. 58638
Iserlohn, Germany. Procured from within the EU by the Product
Licence holder: MPT Pharma Ltd, Westgate Business park, Unit 5-7
Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by XXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXX
PLPI: 33532/0382 Medikinet® XL 40mg modified-release capsules,
hard
Medikinet® is a trademark of
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
POM

Leaflet dated: 29th November 2012

Leaflet code: xxxxx

CD

 Having different moods than usual, not being able to get to sleep
 Skin rashes, bruising easily, getting out of breath
 The medicine can also make you feel sleepy. If you feel sleepy, it is
important not to do outdoor sports like riding a horse or bike,
swimming or climbing trees. You could hurt yourself and others.
 Your heart beating faster than usual.
If you feel unwell in any way while you are taking your medicine
please tell an adult you trust straight away.
Other things to remember
 make sure you keep your medicine in a safe place, so that no one
else takes it, especially younger brothers or sisters.
 the medicine is special for you - do not let anyone else have it. It
may help you, but it could hurt someone else.
 if you forget to take your medicine don’t take two tablets the next
time. Just take one tablet at the next normal time.
 if you do take too much medicine, tell your mum, dad or carer right
away.
 it is important not to take too much medicine or you will get ill.
 don‟t stop taking your medicine until your doctor says it‟s OK.
Who should I ask if there is anything I don’t understand?
Your mum, dad, carer, doctor, nurse or pharmacist will be able to help
you.

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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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