Document: leaflet MAH BRAND_PLPI 20492-0481 change

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• leaflet MAH BRAND_PLPI 20492-0481

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Package Leaflet: Information for the user

Medikinet® XL 5 mg modified-release capsules, hard

methylphenidate hydrochloride

The name of your medicine is Medikinet® XL 5mg modified-release capsules, hard but will be referred to as Medikinet® XL throughout this leaflet. Medikinet® XL contains the active substance ‘methylphenidate hydrochloride'. The name ‘methylphenidate' will also be used in this leaflet. This medicine is also available in other strengths.

Important things you need to know about your medicine

What Medikinet® XL is and what it is used for

What it is used for

Medikinet® XL is used to treat ‘attention deficit hyperactivity disorder' (ADHD).

•    It is used in children and young people between the ages of 6 and 18.

•    It is used only after trying treatments which do not involve medicines. Such as counselling and behavioural therapy.

Medikinet® XL is not for use as a treatment for ADHD in children under 6 years of age or in adults.

It is not known if it is safe or of benefit in these people.

How it works

Medikinet® XL improves the activity of certain parts of the brain which are under-active.

The medicine can help improve attention (attention span), concentration and reduce impulsive behaviour.

The medicine is given as part of a treatment programme, which usually includes:

•    psychological

•    educational and

•    social therapy.

Medikinet^® XL treatment must only be initiated by, and used under the supervision of, a specialist in childhood and/or adolescent behavioural disorders. Although there is no cure for ADHD, it can be managed using treatment programmes.

About ADHD

Children and young people with ADHD find it:

•    hard to sit still and

•    hard to concentrate.

It is not their fault that they cannot do these things.

Many children and young people struggle to do these things. However, with ADHD they can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places.

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

What you need to know before you take Medikinet® XL

Do not take Medikinet® XL

If you or your child

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

•    has a thyroid problem

•    has increased pressure in the eye (glaucoma)

•    has a tumour of the adrenal gland (phaeochromocytoma)

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

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

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

•    has had a problem with the blood vessels in the brain - such as a stroke, swelling and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood vessels (vasculitis)

•    is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) - see ‘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: o feeling like killing yourself

o severe depression, where you feel very sad, worthless and hopeless o mania, where you feel unusually excitable, over-active, and un-inhibited.

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

•    is taking medicines to reduce secretion of gastric acid or to treat excessive acidity of the stomach (H2 receptor blocker or antacid treatment).

Do not take methylphenidate if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before you or your child takes methylphenidate. This is because methylphenidate can make these problems worse.

Warnings and precautions

Talk to your doctor before taking Medikinet® XL if you or your child

•    has liver or kidney problems

•    has problems with swallowing or swallowing whole tablets

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

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

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

•    is female and has started having periods (see the ‘Pregnancy and breast-feeding' section 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.

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 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.

Medikinet® XL must not be taken together with H₂ receptor blockers or antacids which are used to reduce gastric acid secretion or to counteract excessive acidity in the stomach, as this could lead to a faster release of the total amount of active substance.

If you are in any doubt about whether any medicines you or your child is taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.

Having an operation

Tell your doctor if you or your child is going to have an operation. Methylphenidate should not be taken on the day of surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise in blood pressure during the operation.

Taking methylphenidate with alcohol

Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol.

Pregnancy and breast-feeding

It is not known if methylphenidate will affect an unborn baby. Tell your doctor or pharmacist before using methylphenidate if you or your daughter:

•    is having sex. Your doctor will discuss contraception.

•    is pregnant or think might be pregnant. Your doctor will decide whether methylphenidate should be taken.

•    is breast-feeding or planning to breast-feed. It is possible that methylphenidate is passed into human breast milk. Therefore, your doctor will decide whether you or your daughter should breast-feed while taking methylphenidate.

Driving and using machines

You or your child may feel dizzy, have problems focussing or have blurred vision when taking methylphenidate. If these happen it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

•    The medicine has been prescribed to treat a medical or dental problem and

•    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

•    It was not affecting your ability to drive safely

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

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.

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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.

•    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.

How to take Medikinet® XL

How much to take

You or your child should always take Medikinet® XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The maximum daily dose is 60 mg.

•    Your doctor will usually start treatment with a low dose and increase it gradually as required.

•    Your doctor will tell you what strength of capsule to take each day.

•    Do not split the dose of a capsule; take the entire contents of the capsule.

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

Your doctor will do some tests

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

•    after you or your child starts - they will be done at least every 6 months, but possibly more often.

They will also be done when the dose is changed.

•    these tests will include:

-    checking appetite

-    measuring height and weight

-    measuring blood pressure and heart rate

-    checking problems with mood, state of mind or any other unusual feelings. Or if these have got worse while taking Medikinet® XL.

How to take

The medicinal product is intended for oral use.

Take Medikinet® XL in the morning with or after breakfast. This is very important in order to obtain sufficiently prolonged action. The capsules may be swallowed whole with a drink of water.

Alternatively, you can open the capsules, sprinkle the capsule contents onto a small amount (tablespoon) of applesauce or yoghurt and take it immediately. In this case food should be eaten as well, of course. Do not store for future use.

The capsules and the capsule contents must not be crushed or chewed.

If you or your child does not feel better after 1 month of treatment

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

Medikinet® XL does not need to be taken for ever. If you or your child takes Medikinet® XL for more than a year, your doctor should stop treatment for a short time, this may happen during a school holiday. This will show if the medicine is still needed.

Not using Medikinet® XL properly

If Medikinet® XL is not used properly, this may cause abnormal behaviour. It may also mean that you or your child starts to depend on the medicine. Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines or street drugs.

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

If you or your child takes too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken.

Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart beat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.

If you or your child forgets to take Medikinet® XL

Do not take a double dose to make up for a forgotten dose. If you or your child forgets a dose, wait until it is time for the next dose.

If you or your child stops taking Medikinet® XL

If you or your child suddenly stops taking this medicine, ADHD symptoms may come back or unwanted effects such as depression may appear. Your doctor may want to gradually reduce the amount of medicine taken each day, before stopping it completely. Talk to your doctor before stopping Medikinet® XL.

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

4B 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.

51 How to store Medikinet® XL

Keep this medicine out of the sight and reach of children.

Do not use Medikinet® XL after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store the medicine in the original packaging in order to protect from moisture.

If your medicine becomes discoloured or shows any signs of deterioration consult your pharmacist who will advise you what to do.

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.

Further information

What Medikinet^® XL contains

The active substance is methylphenidate hydrochloride

Each modified-release capsule contains 5 mg methylphenidate hydrochloride, corresponding to 4.35mg methylphenidate.

The other ingredients are:

•    In the capsule content: Sucrose, Maize starch, Methacrylic acid-ethylacrylate copolymer 1:1, Talc, Triethyl citrate, Polyvinyl alcohol, Macrogol 3350, Polysorbate 80, Sodium hydroxide, Sodium laurilsulfate, Simeticone, Colloidal anhydrous silica, Indigo carmine aluminium lake (E132), Methylcellulose and Sorbic acid.

•    In the capsule shell: Gelatine, Titanium dioxide (E171) and Sodium laurilsulfate What Medikinet^® XL looks like and contents of the pack

Each pack contains 30 white, opaque capsules with no markings containing white and blue pellets.

Manufacturer:

The manufacturer is Medice Arzneimittel Putter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany and procured from within the EU and repackaged in the UK by the Parallel Import Product Licence holder, CD Pharma Ltd, Unit 3, Manor Point, Manor Way, Borehamwood, Herts. WD6 1EE.

Medikinet XL 5mg modified-release capsules, hard PL No. 20492/0481

Date of preparation: 21^st August 2015

How do I take my medicine (capsules)?

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

•    If you have problems to swallow the capsules, the capsules may be opened, the capsule contents sprinkled onto a small amount (tablespoon) of applesauce 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.

•    Your heart beating faster than usual.

If you feel unwell in any way while you are taking your medicine please tell an adult you trust

straight away.

Other things to remember

•    make sure you keep your medicine in a safe place, so that no one else takes it, especially younger brothers or sisters.

•    the medicine is special for you - do not let anyone else have it. It may help you, but it could hurt someone else.

•    if you forget to take your medicine don’t take two 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.