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MEDIKINET XL 40MG MODIFIED-RELEASE CAPSULES HARD

Active substance: METHYLPHENIDATE HYDROCHLORIDE

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CUSTOMER:

Waymade

PRE-PRESS NO.:

02 1808

PRODUCT:

Medikinet XL 10mg 30mg 40mg caps

ARTWORKER:

DT

DATE OF PROOF:

13/03/14

CODE:

06464/3002 3004 3005G

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.3 - waymade - 13/03/14

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS
DRUG DRIVING

Pg 1

Pg 4

Rare: may affect up to 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: may affect up to 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’).
Not known: frequency cannot be estimated from available data

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)

dry skin.
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 you or your child’s height and weight, as well as how well you or
your child is eating.

If you or your child is not growing as expected, then treatment with methylphenidate may be
stopped for a short time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website:
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 Medikinet XL
Keep this medicine 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 the medicine in the original packaging in order to protect from moisture.
If your medicine becomes discoloured or shows any signs of deterioration consult your pharmacist who will
advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Take any unused or unwanted
medicines back to your pharmacist to dispose of safely. These measures will help to protect the environment.

6. Contents of the pack and other information
What Medikinet XL contains
The active substance is methylphenidate hydrochloride
Each 10mg modified-release capsule contains: 10 mg methylphenidate hydrochloride, corresponding to
8.65mg methylphenidate.
Each 30mg modified-release capsule contains: 30 mg methylphenidate hydrochloride, corresponding to
25.95mg methylphenidate.
Each 40mg modified-release capsule contains: 40 mg methylphenidate hydrochloride, corresponding to
34.60mg methylphenidate.
The other ingredients are:
Capsule content:
sucrose, maize starch, methacrylic acid-ethylacrylate copolymer 1:1, talc, triethyl citrate, polyvinyl alcohol,
macrogol 3350, polysorbate 80, sodium hydroxide, simeticone, silica colloidal anhydrous, methylcellulose and
sorbic acid and indigo carmine (E132).
Capsule shell:
- gelatin, erythrosine (E127), titanium dioxide (E171), sodium laurilsulfate and purified water.
- Medikinet XL 10mg modified-release capsules also contain patent blue V (E131).
- Medikinet XL 30mg modified-release capsules and Medikinet XL 40mg modified-release capsules
also contain Iron II/III oxide (E172) and indigo carmine (E132).
What Medikinet XL looks like and contents of the pack
Each Medikinet XL 10mg modified-release capsule has an unmarked white coloured body and a mauve
coloured cap.
Each Medikinet XL 30mg modified-release capsule has an unmarked light grey coloured body and a dark
purple coloured cap.
Each Medikinet XL 40mg modified-release capsule has an unmarked dark grey coloured body and a dark
purple coloured cap.
Each strength is available in blister packs of 30 modified-release capsules.
POM

CD

PL No: 06464/3002 10mg
PL No: 06464/3004 30mg
PL No: 06464/3005 40mg

Manufacturer
These products are manufactured by: Medice Arzneimittel Pűtter GmbH & Co. KG, Kuhloweg 37, 58638
Iserlohn, Germany and are procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 13.03.2014
Medikinet is a registered trademark of Medice Arzneimittel Pűtter GmbH & Co. KG

Medikinet® XL 10 mg modified-release capsules, hard
Medikinet® XL 30 mg modified-release capsules, har
Medikinet® XL 40 mg modified-release capsules, hard
Methylphenidate hydrochloride

This medicine is known by the above names but will be referred to as Medikinet XL in this leaflet.
Another strength (20mg) is also available.
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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet
1. What Medikinet XL is and what it is used for
2. What you need to know before you or your child take(s) Medikinet XL
3. How to take Medikinet XL
4. Possible side effects
5. How to store Medikinet XL
6. Contents of the pack and other information

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. If you have
been successfully treated with Medikinet XL as an adolescent for ADHD, if your symptoms persist into
adulthood and a need for further therapy has been determined, it might be appropriate to continue taking
Medikinet XL when you become an adult. Your doctor will advise you about this.
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. What you need to know before you or your child take(s) Medikinet XL
Do not take Medikinet XL
If you or your child

is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)

has a thyroid problem

has increased pressure in the eye (glaucoma)

has a tumour of the adrenal gland (phaeochromocytoma)

has an eating problem when you do not feel hungry or want to eat - such as ‘anorexia nervosa’

has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms
and legs

has ever had heart problems - such as a heart attack, uneven heartbeat, pain and discomfort in the
chest, heart failure, heart disease or was born with a heart problem

has had a problem with the blood vessels in the 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)

is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine
oxidase inhibitor) – see ‘Taking other medicines’

has 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:
o feeling like killing yourself
o severe depression, where you feel very sad, worthless and hopeless
o mania, where you feel unusually excitable, over-active, and un-inhibited.

has a history of pronounced lack of gastric acid (anacidity of the stomach) with a pH value above
5.5

is taking medicines to reduce 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 or your child. If you are not sure, talk to your
doctor or pharmacist before you or your child takes methylphenidate. This is because methylphenidate can
make these problems worse.
Warnings and precautions
Talk to your doctor before taking Medikinet XL if you or your child

has liver or kidney problems

has problems with swallowing or swallowing whole tablets

has a narrowing or blockage of the gut or food-pipe

has had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)

has ever abused or been dependent on alcohol, prescription medicines or street drugs

is female and has started having periods (see the ‘Pregnancy and breast-feeding’ section overleaf)

has hard-to-control, repeated twitching of any parts of the body or repeats sounds and words

has high blood pressure

has a heart problem which is not in the ‘Do not take’ section above

has 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 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 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.
Pg 2

CUSTOMER:

Waymade

PRE-PRESS NO.:

02 1808

PRODUCT:

Medikinet XL 10mg 30mg 40mg caps

ARTWORKER:

DT

DATE OF PROOF:

13/03/14

CODE:

06464/3002 3004 3005G

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.3 - waymade - 13/03/14

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS
DRUG DRIVING

Pg 2

Checks that your doctor will make before you 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 is 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 or your child is feeling, such as feeling high or low, having strange thoughts or if you or
your child has 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 your child or other family members have ever had.
Your doctor will discuss whether you or your child is at risk of having mood swings (from being manic to being
depressed - called ‘bipolar disorder’). They will check you or your child’s 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 or your child. Your doctor may decide that other medical tests
are needed before you or your child start taking this medicine.

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 or yoghurt and take it immediately. In this case food should be eaten as well, of course. Do not
store for future use.
The capsules and the capsule contents must not be crushed or chewed.
If you or your child does not feel better after 1 month of treatment
If you or your child does not feel better, tell your doctor. They may decide a different treatment is needed.
Long-term treatment
Medikinet XL does not need to be taken for ever. If you or your child takes 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.
Not using Medikinet XL properly
If Medikinet XL is not used properly, this may cause abnormal behaviour. 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.

Drug testing
This medicine may give a positive result when testing for drug use.
Athletes must be aware that this medicinal product may cause a positive reaction to ‘anti-doping’ tests.
Other medicines and Medikinet XL
Please tell your doctor or pharmacist if you or your child is taking, has recently taken or may take any other
medicines.
Do not take methylphenidate if you or your child:

is taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or has
taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden
increase in blood pressure.
If you or your child is taking other medicines, methylphenidate may affect how well they work or may cause
side effects. If you or your child is 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 acitity 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 or your child is taking are included in the list above,
ask your doctor or pharmacist for advice before taking methylphenidate.
Having an operation
Tell your doctor if you or your child is 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.
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 and breast-feeding
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 or your child 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 or your child takes more Medikinet XL than you should
If you or your child takes 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 forgets to take Medikinet XL
Do not take a double dose to make up for a forgotten dose. If you or your child forgets a dose, wait until it is
time for the next dose.
If you or your child stops taking Medikinet XL
If you or your child suddenly stops taking this medicine, 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.
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, but not everybody gets them. Your doctor will talk to
you about these side effects.
Some side effects could be serious. If you have any of the side effects below, see a doctor straight
away:
Common: may affect up to 1 in 10 people

uneven heartbeat (palpitations)

mood changes or mood swings or changes in personality
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 un-inhibited (mania).
Very rare: may affect up to 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.
Not known: frequency cannot be estimated from available data

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.

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

Other side effects include the following, if they get serious, please tell your doctor or pharmacist:

Medikinet XL contains sucrose
If you or your child has 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 Medikinet XL
How much to take
You or your child should always take Medikinet XL exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The maximum daily dose is 60 mg.





Pg 3

How to take
The medicinal product is intended for oral use.

Your doctor will usually start treatment with a low dose and increase it gradually as required.
Your doctor will tell you what strength of capsule to take each day.
Do not split the dose of a capsule; take the entire contents of the capsule.
Medikinet XL should not be taken too late in the morning as it may cause disturbances in sleep.

Things your doctor will do when you or your child is on treatment
Your doctor will do some tests

before you or your child starts - to make sure that Medikinet XL is safe and will be of benefit.

after you or your child starts - they will be done at least every 6 months, but possibly more often.
They will also be done when the dose is changed.

these tests will include:
- checking appetite
- measuring height and weight
- measuring blood pressure and heart rate
- checking problems with mood, state of mind or any other unusual feelings. Or if these have got
worse while taking Medikinet XL.

Pg 3

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

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.
Uncommon: may affect up to 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.

Pg 4

Expand view ⇕

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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