Document: leaflet MAH BRAND_PLPI 20636-2746 change

• leaflet MAH BRAND_PLPI 20636-2746
• leaflet MAH GENERIC_PL 04569-1498

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PATIENT INFORMATION LEAFLET

Medikinet® 20 mg tablets

(methylphenidate hydrochloride)

The name of your medicine is Medikinet, it contains the active substance ‘methylphenidate hydrochloride'. The name ‘methylphenidate' will also be used in this leaflet. Also available in other strengths.

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 is and what it is used for

2.    What you need to know before you take 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.

1. What Medikinet is and what it is used for What it is used for

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.

How it works

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.

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.

Information for children and young people

This info is to help you learn the main things about your medicine called Medikinet®.

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.

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 take Medikinet Do not take Medikinet 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 uninhibited.

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 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 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. This is because 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 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.

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.

•    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.

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

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 a MAOI in the last 14 days. Taking a 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.

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 Medikinet with food and drink

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

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

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

Medikinet contains lactose

If you or your child has been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicinal product.

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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.

3.    How to take Medikinet How much to take

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.

Your doctor will do some tests

•    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.

How to take

The medicinal product is intended for oral use.

You or your child should swallow 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

If you or your child does not feel better, tell your doctor. They may decide a different treatment is needed.

Long-term 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.

Not using Medikinet properly

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.

If you or your child takes more Medikinet 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

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

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.

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.

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.

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.

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

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 25 °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.

If the medicines become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

6.    Contents of the pack and other information What Medikinet contains:

The active substance is: methylphenidate hydrochloride 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

What Medikinet looks like and contents of the pack Medikinet 20 mg tablets

White, round tablets with notched breakline on both sides and embossed with ‘L' on both halves.

Pack sizes: 30 tablets

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

Manufacturer and Product Licence Holder

Manufactured by Medice Arzneimittel Putter GmbH & Co. KG Kuhloweg 37, 58638 Iserlohn, Germany.

Procured from within the EU by Product Licence holder:

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

| POM | | PL 20636/2746

Leaflet issue and revision date (Ref): 02.04.16[2]

Medikinet is a trademark of Medice Arzneimittel Putter GmbH & Co. KG

PATIENT INFORMATION LEAFLET

Methylphenidate Hydrochloride 20 mg tablets

The name of your medicine is Methylphenidate Hydrochloride 20 mg tablets, it contains the active substance ‘methylphenidate hydrochloride'. The name ‘methylphenidate' or Methylphenidate tablets will also be used in this leaflet. Also available in other strengths.

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 Methylphenidate tablets is and what it is used for

2.    What you need to know before you take Methylphenidate tablets

3.    How to take Methylphenidate tablets

4.    Possible side effects

5.    How to store Methylphenidate tablets

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 Methylphenidate tablets is and what it is used for What it is used for

Methylphenidate tablets 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.

Methylphenidate tablets 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

Methylphenidate tablets 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.

Methylphenidate tablets 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.

Information for children and young people

This info is to help you learn the main things about your medicine called Methylphenidate tablets.

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.

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 take Methylphenidate tablets Do not take Methylphenidate tablets 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 Methylphenidate tablets'

•    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 uninhibited.

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 Methylphenidate tablets 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 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. This is because 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 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

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.

•    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.

or your child. Your doctor may decide that other medical tests are needed before you or your child start taking this medicine.

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 Methylphenidate tablets

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 a MAOI in the last 14 days. Taking a 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.

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 tablets with food and drink

Taking Methylphenidate tablets with food may help to stop stomach pains, feeling sick or being sick.

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

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

Methylphenidate tablets contains lactose

If you or your child has been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicinal product.

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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.

3.    How to take Methylphenidate tablets How much to take

You or your child should always take Methylphenidate tablets 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.

Your doctor will do some tests

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

How to take

The medicinal product is intended for oral use.

You or your child should swallow Methylphenidate 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

If you or your child does not feel better, tell your doctor. They may decide a different treatment is needed.

Long-term treatment

Methylphenidate tablets does not need to be taken for ever. If you or your child takes Methylphenidate tablets 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 Methylphenidate tablets properly

If Methylphenidate tablets 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 Methylphenidate tablets 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 Methylphenidate tablets

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 Methylphenidate tablets

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 Methylphenidate tablets.

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.

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.

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.

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 Methylphenidate tablets

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 25 °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.

If the medicines become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

6.    Contents of the pack and other information What Methylphenidate tablets contains:

The active substance is: methylphenidate hydrochloride Methylphenidate tablets 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

What Methylphenidate tablets looks like and contents of the pack Methylphenidate tablets 20 mg tablets

White, round tablets with notched breakline on both sides and embossed with ‘L' on both halves.

Pack sizes: 30 tablets

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

Manufacturer and Product Licence Holder

Manufactured by Medice Arzneimittel Putter GmbH & Co. KG Kuhloweg 37, 58638 Iserlohn, Germany.

Procured from within the EU by Product Licence holder:

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

| POM | | PL 20636/2746

Leaflet issue and revision date (Ref): 02.04.16[2]

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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.