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.

• 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.

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.

What is in this leaflet:

1. What MEDIKINET is and what it is used for
2. What you need to know before you or your child takes MEDIKINET
3. How to take MEDIKINET
4. Possible side effects
5. How to store MEDIKINET
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.

MEDIKINET 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 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.

MEDIKINET 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 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.

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.

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’
• 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.

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.

Talk to your doctor before taking MEDIKINET if you or your child

• has liver or kidney problems
• has problems with swallowing or swallowing whole tablets
• 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 (tics)
• 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.

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.

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.

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.

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.

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.

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 MEDIKINET with food may help to stop stomach pains, feeling sick or being sick.

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.

Available data do not suggest an increased risk of overall birth defects, whilst a small increase in the risk of malformations of the heart when used during the first three months of pregnancy could not be ruled out. Your doctor will be able to give you more information about this risk. 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.

You or your child may feel dizzy, feel drowsy, have problems focussing or have blurred vision, have hallucinations or other side effects in the central nervous system 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.

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 medicine.

You or your child should always take MEDIKINET 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.

• Your doctor will usually start treatment with a low dose of 5 mg methylphenidate once or twice daily at breakfast and lunch and increase it gradually as required.
• Your doctor will tell you what strength of tablet to take each day.
• The last dose should, in general, not be given within 4 hours before bedtime in order to prevent disturbances in falling asleep.

• before you or your child starts - to make sure that MEDIKINET 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.

The medicinal product is intended for oral use.

You or your child should swallowed MEDIKINET tablets with a drink of water. If needed the tablets can be divided into halves. Take the tablets with or after a meal.

If you or your child does not feel better after 1 month of treatment, tell your doctor. Your doctor may decide that you or your child need a different treatment.

MEDIKINET does not need to be taken for ever. If you or your child takes MEDIKINET 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 MEDIKINET 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.

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

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. You may need medical treatment.

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, dry nose and mouth, muscle spasms, red-brown urine which could be possible signs of abnormal breakdown of muscles (rhabdomyolysis).

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 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.

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.

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.

The active substance is: methylphenidate hydrochloride

MEDIKINET 5 mg tablets

Each tablet contains 5 mg methylphenidate hydrochloride equivalent to 4.35 mg methylphenidate.

MEDIKINET 10 mg tablets

Each tablet contains 10 mg methylphenidate hydrochloride equivalent to 8.65 mg methylphenidate.

MEDIKINET 20 mg tablets

Each tablet contains 20 mg methylphenidate hydrochloride equivalent to 17.30 mg methylphenidate.

The other ingredients are:

Microcrystalline cellulose, Pregelatinised maize starch, Calcium hydrogen phosphate dihydrate, Lactose monohydrate, Magnesium stearate

MEDIKINET 5 mg tablets

Tablet (white, round) embossed with ”S”. The tablets can be divided into halves.

Pack sizes: 20, 28, 30, 50 or 56 tablets

Boxes containing tablets packed in blisters made of PVC/PE/PVdC aluminium foil.

MEDIKINET 10 mg tablets

Tablet (white, round) embossed with ”M”. The tablets can be divided into halves.

Pack sizes: 20, 28, 30, 50, 56, 98 or 100 tablets

Boxes containing tablets packed in blisters made of PVC/PVdC aluminium foil.

MEDIKINET 20 mg tablets

Tablet (white, round) embossed with ”L”. The tablets can be divided into halves.

Pack sizes: 30, 50 or 56 tablets

Boxes containing tablets packed in blisters made of PVC/PVdC aluminium foil.

Not all pack sizes may be marketed.

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

Germany: Medikinet 5 mg, 10 mg, 20 mg Tabletten

Denmark: Medikinet 5 mg, 10 mg, 20 mg

Finland: Medikinet 5 mg, 10 mg, 20 mg

Iceland: Medikinet 5 mg, 10 mg, 20 mg tafla

Luxembourg: Medikinet 5 mg, 10 mg, 20 mg

Netherlands: Medikinet 5 mg, 10 mg, 20 mg

Norway: Medikinet 5 mg, 10 mg, 20 mg

Poland: Medikinet 5 mg, 10 mg, 20 mg

Spain: Medicebran 5 mg, 10 mg, 20 mg

Sweden: Medikinet 5 mg, 10 mg, 20 mg

United Kingdom: Medikinet 5 mg, 10 mg, 20 mg tablets

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.

• 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.
• 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.

You cannot have this medicine if:

• you have a problem with your heart
• you feel very unhappy, depressed or have a mental illness.

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.

• Swallow your medicine with water with or after a meal.
• 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.

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.
• 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.

• 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.

Your mum, dad, carer, doctor, nurse or pharmacist will be able to help you.