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MEDIKINET XL 60 MG MODIFIED-RELEASE CAPSULE HARD

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Erstellt am:
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24.11.2017
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Mockup_GI Medikinet XL 5 10 20 30 40 50 60 capsules GB
282 x 742 mm
■ Schwarz

Mockup_GI Medikinet XL 5 10 20 30 40 50 60 capsules GB.qxp_20070124 BPZ UK XL Variation 24.11.17 14:12 Seite 1

Package Leaflet: Information for the user

Medikinet®
Medikinet®
Medikinet®
Medikinet®
Medikinet®
Medikinet®
Medikinet®

XL
XL
XL
XL
XL
XL
XL

5 mg modified-release capsules, hard
10 mg modified-release capsules, hard
20 mg modified-release capsules, hard
30 mg modified-release capsules, hard
40 mg modified-release capsules, hard
50 mg modified-release capsules, hard
60 mg modified-release capsules, hard

Methylphenidate hydrochloride

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












The name of your medicine is Medikinet® XL, it contains the active substance
‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used
in the leaflet.

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 you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Read section 4 for more information.

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. What you need to know before you or your child takes 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

✂ 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 aged 6 years and over and in adults.
• it is used only after treatments have been tried which do not involve medication e. g. counselling
and behavioural therapy and which have been insufficient.
MEDIKINET® XL is not for use as a treatment for ADHD in children under 6 years of age.

How it works

MEDIKINET® XL improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention span and 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 doctor,
specialised in the treatment of ADHD, such as an expert paediatrician, a child and adolescent psychiatrist or a psychiatrist. A careful examination by this doctor is required. If you as an adult have
not been treated before, the doctor will perform tests to confirm that you have been affected by
ADHD since childhood. 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.

Patients can have ADHD in varying degrees with symptoms including:
• lack of concentration
• restlessness
• hyperactivity
• impulsivity
• emotional instability
• disorganised thinking

This is shown by, for example:
• difficulty concentrating
• forgetfulness
• talking too much
• difficulties in planning and carrying out tasks to completion
• „blindfold actions“
• impatience

ADHD does not affect the intelligence of a child or young person.

What you need to know before you or your child takes
Medikinet® XL

2.

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 ‘Other medicines and MEDIKINET® XL’
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:
feeling like killing yourself
severe depression, where you feel very sad, worthless and hopeless
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)



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 you 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.

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 below)
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. 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 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 and 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 behavioural 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.

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.

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. Tell your doctor if you or your child is taking medicines to treat:
• depression
• mental health problems
• epilepsy
• blood pressure problems
• cough and colds. Some remedies 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 she 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.

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

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.

Dosage

Use in children

The maximum daily dose is 60 mg.






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.
MEDIKINET® XL should not be taken too late in the morning as it may cause disturbances in
sleep.

Use in adults

For adults who have taken MEDIKINET® XL before







if you have already taken MEDIKINET® XL as a child or adolescent, the same daily dosage
(mg/day) can be used; your doctor will check regularly to see if any adjustment is required
adult patients may require a higher daily dosage but the doctor will aim to give you the lowest
dose that is effective
the maximum daily dose is based among other things on your body weight (see below)

For adults who have not taken MEDIKINET® XL before
The recommended starting dose is 10 mg daily.








your doctor will increase your dose in increments of 10 mg daily, depending on how well you
tolerate the medicine and how effective it is
the aim should be the lowest dose that is effective for you
the maximum daily dose is based among other things on your body weight (see below)
your doctor will decide the maximum daily dose for you
the daily dose is 1 mg per kg body weight, up to a maximum of 80 mg of methylphenidate daily

Things your doctor will do when you or your child is undergoing 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 for children
- measuring weight for adults
- 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.

Method of Administration

The medicinal product is intended for oral use.

Children take MEDIKINET® XL in the morning with or after breakfast.
Adults take MEDIKINET® XL with or after breakfast and lunch.

MEDIKINET® XL is a form of methylphenidate with “controlled release“ action which releases the
drug gradually over a prolonged period of time. Taking the capsule with or after meals is very important in order for their action to be delayed.

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• 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.

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.

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The capsules may be swallowed whole with a drink of water. Alternatively, you can open the capsules, sprinkle the contents onto a small amount (tablespoon) of applesauce or yoghurt and take it
immediately. 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 at least once per year for a short time. In case
of children 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.

If you or your child takes more MEDIKINET® XL than you should

If you or your child takes too much of the 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:
Very common: may affect more than 1 in 10 people
• uneven heartbeat (palpitations)

Common: may affect up to 1 in 10 people
• mood changes or mood swings or changes in personality
• thinking about or feeling like killing yourself

Uncommon: may affect up to 1 in 100 people
• 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), temporary lack of adequate blood and oxygen
(ischemia) 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 whether 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.

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
• decreased appetite
• feeling agitated, feeling depressed or lack of feeling or emotion
• dry mouth
• feeling sick















influenza like illness
loss of energy / feeling weak
feeling thristy
increases in blood thyroid stimulating hormone levels
pain in the area of mouth and throat
nose bleeding
heart discomfort
dry eye
higher pressure inside the eye than normal
stress with partner / family
breast pain
hot flush / flushing
ringing in the ears (tinnitus)

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.
• Your doctor will carefully watch you or your child’s height and weight, and 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 tYellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store. 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 this medicine after the expiry date which is stated on the blister and the box after “EXP”.
The expiry date refers to the last day of that month.

Do not store above 30 °C.
Store in the original package in order to protect from moisture.

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 to protect the environment.
6.

Contents of the pack and other information

What MEDIKINET® XL contains:
The active substance is: methylphenidate hydrochloride

MEDIKINET® XL 5 mg modified-release capsules, hard
Each modified-release capsule, hard contains 5 mg methylphenidate hydrochloride equivalent to
4.35 mg methylphenidate.

MEDIKINET® XL 10 mg modified-release capsules, hard
Each modified-release capsule, hard contains 10 mg methylphenidate hydrochloride equivalent to
8.65 mg methylphenidate.
MEDIKINET® XL 20 mg modified-release capsules, hard
Each modified-release capsule, hard contains 20 mg methylphenidate hydrochloride equivalent to
17.30 mg methylphenidate.
MEDIKINET® XL 30 mg modified-release capsules, hard
Each modified-release capsule, hard contains 30 mg methylphenidate hydrochloride equivalent to
25.95 mg methylphenidate.
MEDIKINET® XL 40 mg modified-release capsules, hard
Each modified-release capsule, hard contains 40 mg methylphenidate hydrochloride equivalent to
34.60 mg methylphenidate.
MEDIKINET® XL 50 mg modified-release capsules, hard
Each modified-release capsule, hard contains 50 mg methylphenidate hydrochloride equivalent to
43.25 mg methylphenidate.
MEDIKINET® XL 60 mg modified-release capsules, hard
Each modified-release capsule, hard contains 60 mg methylphenidate hydrochloride equivalent to
51.90 mg methylphenidate.

The other ingredients are:
Capsule content:
Sugar spheres (containing sucrose and maize starch), Methacrylic acid-ethylacrylate-copolymer
(1:1), Talc, Triethyl citrate, Poly(vinyl alcohol), Macrogol 3350, Polysorbate 80, Sodium hydroxide,
Sodium laurilsulfate, Simeticone, Silica colloidal anhydrous, Methylcellulose, Sorbic acid, Indigo
carmine, aluminium lake (E 132)

Capsule shell:
Gelatin, Titanium dioxide (E 171), Sodium laurilsulfate, Purified water

additional in the capsule shell of MEDIKINET® XL 10 mg /- 20 mg:
Erythrosine (E 127), Patent blue V (E 131)

additional in the capsule shell of MEDIKINET® XL 30 mg /- 40 mg /- 50 mg /- 60 mg:
Erythrosine (E 127), Iron oxide black (E 172), Indigo carmine (E 132)

What MEDIKINET® XL looks like and contents of the pack:

MEDIKINET® XL 5 mg modified-release capsules, hard
White opaque capsule body/white opaque capsule cap (15.9 mm) containing white and blue pellets.

Common: may affect up to 1 in 10 people
• joint pain
• high temperature (fever)
• unusual hair loss or thinning
• feeling unusually sleepy or drowsy
• itching, rash or raised red itchy rashes (hives), excessive sweating
• cough, sore throat or nose and throat irritation
• high blood pressure or other changes, fast heart beat (tachycardia) or irregular heart beat (arrhythmia)
• feeling dizzy, movements which you cannot control, being unusually active
• feeling aggressive, emotional unstable, anxious, irritable, behaving abnormally, feeling restless,
problems sleeping
• not having or showing much emotion or interest
• stomach pain, diarrhoea, stomach discomfort and being sick, vomiting
• lack of appetite/not willing to eat
• reduced weight and height gain during long use in children, losing weight
• shaking or trembling
• blurred vision
• muscle pain
• increased levels of bilirubin in the blood

Uncommon: may affect up to 1 in 100 people
• constipation
• chest discomfort, extra sound during heart beat
• blood in the urine
• double vision
• muscle twitching
• shortness of breath or chest pain
• increases in liver test results (seen in a blood test)
• anger, feeling tearful, excessive awareness of surroundings, feeling very calm or sleepy

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
• redness of the skin, red raised skin rash
• pain resulting from not enough blood flow to the heart
• problems/changes in the menses

MEDIKINET® XL 10 mg modified-release capsules, hard
White opaque capsule body/mauve opaque capsule cap (15.9 mm) containing white and blue pellets.

MEDIKINET® XL 20 mg modified-release capsules, hard
Mauve opaque capsule body/mauve opaque capsule cap (15.9 mm) containing white and blue pellets.

MEDIKINET® XL 30 mg modified-release capsules, hard
Light grey opaque capsule body/dark violet opaque capsule cap (15.9 mm) containing white and
blue pellets.

MEDIKINET® XL 40 mg modified-release capsules, hard
Grey opaque capsule body/dark violet opaque capsule cap (18.0 mm) containing white and blue pellets.
MEDIKINET® XL 50 mg modified-release capsules, hard
Violet opaque capsule body/dark violet opaque capsule cap (18.0 mm) containing white and blue
pellets.

MEDIKINET® XL 60 mg modified-release capsules, hard
Dark violet opaque capsule body/dark violet opaque capsule cap (19.4 mm) containing white and
blue pellets.
Pack sizes:

MEDIKINET® XL 5 mg modified-release capsules, hard
Boxes containing 20, 30 or 50 modified-release capsules, hard packed in blisters made of
PVC/PVdC aluminium foil.

MEDIKINET® XL 10 mg /- 20 mg /- 30 mg /- 40 mg modified-release capsules, hard
Boxes containing 20, 28, 30 or 50 modified-release capsules, hard packed in blisters made of
PVC/PVdC aluminium foil.

MEDIKINET® XL 50 mg /- 60 mg modified-release capsules, hard
Boxes containing 20, 28, 30, 40 modified-release capsules, hard packed in blisters made of
PVC/PVdC aluminium foil.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany

This medicinal product is authorised in the Member States of the EEA under the following
names:

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, 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, sad/dark thoughts
• 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
• erectile dysfunction
• prolonged erections, sometimes painful, or an increased number of erections
• excessive uncontrolled talking
• tension
• grind your teeth during sleep
• ADHD symptoms may come back or unwanted effects such as depression may appear after stop
of medication
• tingling sensation
• problems with language and speeking
• retching
• disturbance in attention



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 apple sauce or yoghurt
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
• 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.

403006062809

Erstellt am:
Art.-Nr.:
Art.-Bez.:
Größe:
Farbe:

24.11.2017
00000000000
Mockup_GI Medikinet XL 5 10 20 30 40 50 60 capsules GB
282 x 742 mm
■ Schwarz

Mockup_GI Medikinet XL 5 10 20 30 40 50 60 capsules GB.qxp_20070124 BPZ UK XL Variation 24.11.17 14:12 Seite 2

Germany:

Medikinet® retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hartkapseln mit veränderter Wirkstofffreisetzung
Austria:
Medikinet® retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hartkapseln mit veränderter Wirkstofffreisetzung
Denmark:
Medikinet® CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Spain:
Medikinet® 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg cápsulas duras de
liberación modificada
Finland:
Medikinet® CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Iceland:
Medikinet® CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg hart hylki
með breyttan losunarhraða
Luxembourg:
Medikinet® retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hartkapseln mit veränderter Wirkstofffreisetzung
Netherlands:
Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg capsule met
gereguleerde afgifte, hard
Norway:
Medikinet® 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg Kapsel med
modifisert frisetting, hard
Poland:
Medikinet® CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Sweden:
Medikinet® 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg Kapsel med
modifierad frisättning, hård
United Kingdom: Medikinet® XL 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg modifiedrelease capsule, hard
This leaflet was last revised in 11/2017.

• Your heart beating faster than usual
• When you are a boy, having pain at your penis or seeing different behaviour of your
penis.

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 capsules the next time. Just take
one capsule 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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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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