Concerta XL 54mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Methylphenidate hydrochloride
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
N06BA04
INN (International Name):
Methylphenidate hydrochloride
Dosage:
54mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
Schedule 2 (CD)
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 04040000

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

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 are taking other medicines – your doctor needs to know about all the medicines you are

taking.

Package Leaflet: Information for the user

Concerta

®

XL 54 mg Prolonged Release Tablets

Methylphenidate hydrochloride

The name of your medicine is Concerta XL 54mg Prolonged release tablets. However they will be referred to

as Concerta XL throughout this leaflet. Concerta XL contains the active substance ‘methylphenidate

hydrochloride’. The name ‘methylphenidate’ will also be used in this leaflet. This product is 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 only. Do not pass it on to others. It may harm them, even if their

signs of illness 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.

The sections are:

1 What Concerta XL is and what it is used for

2 What you need to know before you take Concerta XL

3 How to take Concerta XL

4 Possible side effects

5 How to store Concerta XL

6 Contents of the packet and other information

Information for children and young people

Now read the rest of this leaflet before you start taking this medicine because it contains

important information for you.

1

What Concerta XL is and what it is used for

What it is used for

Concerta 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.

Concerta XL is not for use as a treatment for ADHD in children under 6 years of age or for the initiation of

treatment in adults. When treatment was started at a younger age, it might be appropriate to continue taking

Concerta XL when you become an adult.

Your doctor will advise you about this.

How it works

Concerta 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.

It is prescribed only by doctors who have experience in children or young people's behaviour problems.

Although there is no cure for ADHD, it can be managed using treatment programmes.

About ADHD

Children and young people with ADHD find it:

hard to sit still and

hard to concentrate.

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

Many children and young people struggle to do these things. However, with ADHD they can cause problems

with everyday life. Children and young people with ADHD may have difficulty learning and doing homework.

They find it hard to behave well at home, at school or in other places.

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

2

What you need to know before you take Concerta XL

Do not take Concerta XL if:

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

you have a thyroid problem

you have increased pressure in your eye (glaucoma)

you have a tumour of your adrenal gland (phaeochromocytoma)

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

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

legs

you have ever had heart problems - such as a heart attack, uneven heartbeat, pain and discomfort in the

chest, heart failure, heart disease or were born with a heart problem

you have had a problem with the blood vessels in your 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)

you are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine

oxidase inhibitor)- see ‘Other medicines and Concerta XL’

Information for children and young people

you have 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. If you are not sure, talk to your doctor or

pharmacist before you take methylphenidate. This is because methylphenidate can make these problems

worse.

Warnings and precautions

Talk to your doctor before taking Concerta XL if:

you have liver or kidney problems

you have a problem with swallowing or swallowing whole tablets

you have a narrowing or blockage of your gut or food-pipe

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

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

you are a girl and have started your periods (see the ‘Pregnancy, breast-feeding and contraception’ section

below)

you have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words

you have high blood pressure

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

you have 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’)

feeling aggressive or hostile

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 before starting treatment. This is because

methylphenidate can make these problems worse. Your doctor will want to monitor how the medicine affects

you.

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.

Checks that your doctor will make before you start taking Concerta XL

These checks are to decide if methylphenidate is the correct medicine for you. Your doctor will talk to you

about:

any other medicines you are 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 are feeling, such as feeling high or low, having strange thoughts or if you have 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 other family members have ever had. Your doctor will

discuss whether you are at risk of having mood swings (from being manic to being depressed - called

‘bipolar disorder’). They will check your 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. Your doctor may decide that other medical tests are needed

before you start taking this medicine.

Other medicines and Concerta XL

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Do not take methylphenidate if you:

are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have taken an

MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in your blood

pressure.

Tell your doctor or pharmacist if you are taking any of the following medicines for depression or anxiety:

tricyclic antidepressant

selective serotonin reuptake inhibitor (SSRI)

serotonin and norepinephrine reuptake inhibitor’ (SNRI).

Taking methylphenidate with these type of medicine could cause a life threatening increase of ‘serotonin’ in

the brain (serotonin syndrome), which may lead to feeling confused or restless, sweating, shivering, muscle

jerks or fast heart beat. If you develop these side effects, see a doctor straight away.

If you are taking other medicines, methylphenidate may affect how well they work or may cause side effects. If

you are taking any of the following medicines, check with your doctor or pharmacist before taking

methylphenidate:

medicines for severe mental health problems

medicines for Parkinson’s disease (such as levodopa)

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 are taking are included in the list above, ask your

doctor or pharmacist before taking methylphenidate.

Please tell you doctor or pharmacist if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription.

Having an operation

Tell your doctor if you are going to have an operation. You should not take methylphenidate on the day of your

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.

Drug testing

This medicine may give a positive result when testing for drug use. This includes testing used in sport.

Concerta XL 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, breast-feeding and contraception

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your

doctor for advice before taking this medicine. 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 are:

having sex. Your doctor will discuss contraception with you

pregnant or think you may be pregnant. Your doctor will decide whether you should take methylphenidate.

breast-feeding or planning to breast-feed. Methylphenidate passes into breast milk. Therefore, your doctor

will decide whether you should breast-feed while taking methylphenidate.

Driving and using machines

You 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.

Concerta XL contains lactose

This medicine contains lactose (a type of sugar). If you have been told by your doctor that

you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

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How do I take my medicine?

swallow your medicine with water.

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 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.

3

How to take Concerta XL

How much to take

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are

not sure.

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

the maximum daily dose is 54 mg.

you should take Concerta XL once each day in the morning with a glass of water. The tablet should be

swallowed whole and not chewed, broken, or crushed. The tablet may be taken with or without food.

The tablet does not dissolve completely after all of the drug has been released and sometimes the tablet shell

may appear in your stools. This is normal.

If you do not feel better after 1 month of treatment

If you do not feel better, tell your doctor. They may decide you need a different treatment.

Not using Concerta XL properly

If Concerta XL is not used properly, this may cause abnormal behaviour. It may also mean that you start to

depend on the medicine. Tell your doctor if you have 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 take more Concerta XL than you should

If you take 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 forget to take Concerta XL

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

dose.

If you stop taking Concerta XL

If you suddenly stop taking this medicine, the 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 Concerta XL.

Things your doctor will do when you are on treatment

Your doctor will do some tests

before you start - to make sure that Concerta XL is safe and will be of benefit.

after you start - 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 your appetite

measuring height and weight

measuring blood pressure and heart rate

checking whether you have any problems with your mood, state of mind or any other unusual feelings. Or

if these have got worse while taking Concerta XL.

Long-term treatment

Concerta XL does not need to be taken for ever. If you take Concerta 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.

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

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Although some

people get side effects, most people find that methylphenidate helps 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

sudden death

suicidal attempt

fits (seizures, convulsions epilepsy)

skin peeling or purplish red patches

inflammation or blocked arteries in the brain

temporary paralysis or problems with movement and vision, difficulties in speech (these can be signs of

problems with the blood vessels in your brain)

muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system

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 the available data)

unwanted thoughts that keep coming back

unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)

paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems with

the blood vessels in your brain)

prolonged erections, sometimes painful or an increased number of erections.

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

blurred vision

tension headache

dry mouth, thirst

trouble falling asleep

high temperature (fever)

problems with sex drive

unusual hair loss or thinning

muscle tightness, muscle cramps

loss of appetite or decreased appetite

inability to develop or maintain an erection

itching, rash or raised red itchy rashes (hives)

feeling unusually sleepy or drowsy, feeling tired

excessive teeth grinding (bruxism)

feeling of panic

tingling feeling, prickling, or numbness of the skin

increased alanine aminotransferase (liver enzyme) level in your blood

cough, sore throat or nose and throat irritation; upper respiratory tract infection; sinus infection

high blood pressure, fast heart beat (tachycardia)

dizziness (vertigo), feeling weak, movements which you cannot control, being unusually active

feeling aggressive, agitated, anxious, depressed, irritable, tense, jittery and abnormal behaviour

upset stomach or indigestion, stomach pain, diarrhoea, feeling sick, stomach discomfort and being sick.

Uncommon (may affect up to 1 in 100 people)

dry eyes

constipation

chest discomfort

blood in the urine

listlessness

shaking or trembling

increased need to pass urine

muscle pain, muscle twitching

shortness of breath or chest pain

feeling hot

increases in liver test results (seen in a blood test)

anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, problems

sleeping.

Rare (may affect up to 1 in 1,000 people)

feeling disorientated or confused

trouble seeing or double vision

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)

muscle cramps

small red marks on the skin

abnormal liver function including sudden liver failure and coma

changes in test results – including liver and blood tests

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 the available data)

migraine

dilated pupils

very high fever

slow, fast or extra heart beats

a major fit (‘grand mal convulsions’)

believing things that are not true

severe stomach pain, often with feeling and being sick

inability to control the excretion of urine (incontinence)

spasm of the jaw muscles that makes it difficult to open the mouth (trismus).

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 your height and weight, as well as how well you are eating.

if you are not growing as expected, then your treatment with methylphenidate may be stopped for a short

time.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not

listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects, you can help provide more information on the safety of this medicine.

5

How to store Concerta XL

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last

day of that month.

Keep the bottle tightly closed in order to protect from moisture. Do not store above 30°C.

The pack contains one or two silica gel pouches. These pouches are used to keep the tablets dry and should

not be eaten.

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.

6

Contents of the packet and other information

What Concerta XL contains

The active substance is methylphenidate hydrochloride.

Each prolonged release tablet contains 54mg of methylphenidate hydrochloride.

The other ingredients are:

butylhydroxytoluene (E321), cellulose acetate, hypromellose (E464), phosphoric acid 85%, poloxamer 188,

macrogol 200 000 and 7000 000, povidone K29-32, sodium chloride, stearic acid, succinic acid, iron oxide

black (E172), iron oxide yellow (E172) and iron oxide red (E172).

Film coat: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, iron oxide yellow

(E172), and iron oxide red (E172).

Clear coat: carnauba wax, hypromellose (E464), macrogol 400.

Printing ink: iron oxide black (E172), hypromellose (E464) and propylene glycol.

What Concerta XL looks like and contents of the pack

Concerta XL 54mg Prolonged Release Tablets are brown-red capsule shaped tablets marked 'alza 54' in black

The plastic bottle has a plastic child-resistant closure with one or two desiccant pouches enclosed.

The medicinal product is available in bottles containing 30 prolonged-release tablets.

Manufacturer:

The manufacturer is Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium and Procured

from within the EU and repackaged in the UK by the Product Licence holder, CD Pharma Ltd, 4 Cairn Court,

East Kilbride, G74 4NB

Concerta XL 54mg Prolonged Release Tablets

PL: 20492/0608

Date of preparation: 22

May 2020

Blind or partially sighted? Is this leaflet hard to see or

read?

Call 01355 204 448 to obtain a leaflet in a format

suitable for you.

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Concerta XL 54 mg prolonged-release tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

One prolonged-release tablet contains 54 mg of methylphenidate hydrochloride.

Excipients with known effect: contains 7.6 mg of lactose.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Prolonged-release tablet

Capsule-shaped brownish-red tablet with “alza 54” printed on one side in

black ink.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Attention-Deficit/Hyperactivity Disorder (ADHD)

Concerta XL is indicated as part of a comprehensive treatment programme for Attention

Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over when

remedial measures alone prove insufficient. Treatment must be under the supervision of a

specialist in childhood behavioural disorders.

Diagnosis should be made according to the

current DSM criteria or ICD guidelines and should be based on a complete history

and evaluation of the patient

. Diagnosis cannot be made solely on the presence of one or

more symptom.

The specific aetiology of this syndrome is unknown, and there is no single diagnostic test.

Adequate diagnosis requires the use of medical and specialised psychological, educational,

and social resources.

A comprehensive treatment programme typically includes psychological, educational and

social measures as well as pharmacotherapy and is aimed at stabilising children with a

behavioural syndrome characterised by symptoms which may include chronic history of short

attention span, distractibility, emotional lability, impulsivity, moderate to severe

hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be

impaired.

Concerta XL treatment is not indicated in all children with ADHD and the decision to use the

drug must be based on a very thorough assessment of the severity and chronicity of the child’s

symptoms in relation to the child’s age.

Appropriate educational placement is essential, and psychosocial intervention is generally

necessary. Where remedial measures alone prove insufficient, the decision to prescribe a

stimulant must be based on rigorous assessment of the severity of the child's symptoms. The

use of methylphenidate should always be used in this way according to the licensed indication

and according to prescribing/diagnostic guidelines.

4.2

Posology and method of administration

Treatment must be initiated under the supervision of a specialist in childhood and/or

adolescent behavioural disorders.

Pre-treatment screening

Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s

cardiovascular status including blood pressure and heart rate. A comprehensive history should

document concomitant medications, past and present co-morbid medical and psychiatric

disorders or symptoms, family history of sudden cardiac/unexplained death and accurate

recording of pre-treatment height and weight on a growth chart (see sections 4.3 and 4.4).

Ongoing monitoring

Growth, psychiatric and cardiovascular status should be continuously monitored (see also

section 4.4).

Blood pressure and pulse should be recorded on a centile chart at each adjustment of

dose and then at least every 6 months;

Height, weight and appetite should be recorded at least 6 monthly with maintenance of

a growth chart;

Development of de novo or worsening of pre-existing psychiatric disorders should be

monitored at every adjustment of dose and then at least every 6 months and at every

visit.

Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.

Posology

Dose titration

Careful dose titration is necessary at the start of treatment with Concerta XL. Dose titration

should be started at the lowest possible dose. A 27 mg dosage strength is available for those

who wish to prescribe between the 18 mg and 36 mg dosages.

Other strengths of this medicinal product and other methylphenidate-containing products may

be available.

The dosage may be adjusted in 18 mg increments. In general, dosage adjustment may proceed

at approximately weekly intervals.

The maximum daily dosage of Concerta XL is 54 mg.

Patients New to Methylphenidate: Clinical experience with Concerta XL is limited in these

patients (see section 5.1). Concerta XL may not be indicated in all children with ADHD

syndrome. Lower doses of short-acting methylphenidate formulations may be considered

sufficient to treat patients new to methylphenidate. Careful dose titration by the physician in

charge is required in order to avoid unnecessarily high doses of methylphenidate. The

recommended starting dose of Concerta XL for patients who are not currently taking

methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg

once daily.

Patients Currently Using Methylphenidate: The recommended dose of Concerta XL for

patients who are currently taking methylphenidate three times daily at doses of 15 to

45 mg/day is provided in Table 1. Dosing recommendations are based on current dose

regimen and clinical judgement.

TABLE 1

Recommended Dose Conversion from Other Methylphenidate Hydrochloride Regimens,

where available, to Concerta XL

Previous Methylphenidate Hydrochloride Daily Dose

Recommended Concerta XL Dose

5 mg Methylphenidate three times daily

18 mg once daily

10 mg Methylphenidate three times daily

36 mg once daily

15 mg Methylphenidate three times daily

54 mg once daily

If improvement is not observed after appropriate dosage adjustment over a one-month period,

the drug should be discontinued.

Long-term (more than 12 months) use in children and adolescents

The safety and efficacy of long-term use of methylphenidate has not been systematically

evaluated in controlled trials. Methylphenidate treatment should not and need not, be

indefinite. Methylphenidate treatment is usually discontinued during or after puberty. The

physician who elects to use methylphenidate for extended periods (over 12 months) in

children and adolescents with ADHD should periodically re-evaluate the long-term

usefulness of the medicinal product for the individual patient with trial periods off medication

to assess the patient’s functioning without pharmacotherapy. It is recommended that

methylphenidate is de-challenged at least once yearly to assess the child’s condition

(preferable during times of school holidays). Improvement may be sustained when the

medicinal product is either temporarily or permanently discontinued.

Dose reduction and discontinuation

Treatment must be stopped if the symptoms do not improve after appropriate dosage

adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious

adverse events occur, the dosage should be reduced or discontinued.

Adults

In adolescents whose symptoms persist into adulthood and who have shown clear benefit

from treatment, it may be appropriate to continue treatment into adulthood. However, start of

treatment with Concerta XL in adults is not appropriate (see sections 4.4 and 5.1).

Elderly

Methylphenidate should not be used in the elderly. Safety and efficacy has not been

established in this age group.

Children under 6 years of age

Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy

in this age group has not been established.

Method of administration

Concerta XL must be swallowed whole with the aid of liquids, and must not be chewed,

divided, or crushed (see section 4.4).

Concerta XL may be administered with or without food (see section 5.2).

Concerta XL is taken once daily in the morning.

4.3

Contraindications

Hypersensitivity to methylphenidate or to any of the excipients listed in section 6.1

Glaucoma

Phaeochromocytoma

During treatment with non-selective, irreversible monoamine oxidase (MAO)

inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to the risk

of hypertensive crisis (see section 4.5)

Hyperthyroidism or Thyrotoxicosis

Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal

tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia,

psychopathic/borderline personality disorder

Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that

is not well-controlled)

Pre-existing cardiovascular disorders including severe hypertension, heart failure,

arterial occlusive disease, angina, haemodynamically significant congenital heart

disease, cardiomyopathies, myocardial infarction, potentially life-threatening

arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)

Pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities

including vasculitis or stroke

4.4

Special warnings and precautions for use

Methylphenidate treatment is not indicated in all children with ADHD and the decision to use

the drug must be based on a very thorough assessment of the severity and chronicity of the

child’s symptoms in relation to the child’s age.

Long-term use (more than 12 months) in children and adolescents

The safety and efficacy of long-term use of methylphenidate has not been systematically

evaluated in controlled trials. Methylphenidate treatment should not and need not, be

indefinite. Methylphenidate treatment is usually discontinued during or after puberty. Patients

on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according

to the guidance in sections 4.2 and 4.4. for cardiovascular status, growth, appetite,

development of de novo or worsening of pre-existing psychiatric disorders. Psychiatric

disorders to monitor for are described below, and include (but are not limited to) motor or

vocal tics, aggressive or hostile behaviour, agitation, anxiety, depression, psychosis, mania,

delusions, irritability, lack of spontaneity, withdrawal and excessive perseveration.

The physician who elects to use methylphenidate for extended periods (over 12 months) in

children and adolescents with ADHD should periodically re-evaluate the long-term usefulness

of the medicinal product for the individual patient with trial periods off medication to assess

the patient’s functioning without pharmacotherapy. It is recommended that methylphenidate

is de-challenged at least once yearly to assess the child’s condition (

preferably during times of

school holidays). Improvement may be sustained when the medicinal product is either

temporarily or permanently discontinued.

Use in adults

Safety and efficacy have not been established for the initiation of treatment in adults or the

routine continuation of treatment beyond 18 years of age. If treatment withdrawal has not

been successful when an adolescent has reached 18 years of age continued treatment into

adulthood may be necessary. The need for further treatment of these adults should be

reviewed regularly and undertaken annually.

Use in the elderly

Methylphenidate should not be used in the elderly. Safety and efficacy has not been

established in this age group.

Use in children under 6 years of age

Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy

in this age group has not been established.

Cardiovascular status

Patients who are being considered for treatment with stimulant medications should have a

careful history (including assessment for a family history of sudden cardiac or unexplained

death or malignant arrhythmia) and physical exam to assess for the presence of cardiac

disease, and should receive further specialist cardiac evaluation if initial findings suggest such

history or disease. Patients who develop symptoms such as palpitations, exertional chest pain,

unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during

methylphenidate treatment should undergo a prompt specialist cardiac evaluation.

Analyses of data from clinical trials of methylphenidate in children and adolescents with

ADHD showed that patients using methylphenidate may commonly experience changes in

diastolic and systolic blood pressure of over 10 mmHg relative to controls. The short- and

long-term clinical consequences of these cardiovascular effects in children and adolescents

are not known. The possibility of clinical complications cannot be excluded as a result of the

effects observed in the clinical trial data especially when treatment during

childhood/adolescence is continued into adulthood. Caution is indicated in treating

patients whose underlying medical conditions might be compromised by increases in

blood pressure or heart rate. See section 4.3 for conditions in which methylphenidate

treatment in contraindicated.

Cardiovascular status should be carefully monitored. Blood pressure and pulse should

be recorded on a centile chart at each adjustment of dose and then at least every

6 months.

The use of methylphenidate is contraindicated in certain pre-existing cardiovascular disorders

unless specialist paediatric cardiac advice has been obtained (see section 4.3).

Sudden death and pre-existing structural cardiac abnormalities or other serious cardiac

disorders

Sudden death has been reported in association with the use of stimulants of the central

nervous system at usual doses in children, some of whom had structural cardiac abnormalities

or other serious heart problems. Although some serious heart problems alone may carry an

increased risk of sudden death, stimulant products are not recommended in children or

adolescents with known structural cardiac abnormalities, cardiomyopathy, serious heart

rhythm abnormalities, or other serious cardiac problems that may place them at increased

vulnerability to the sympathomimetic effects of a stimulant medicine.

Misuse and cardiovascular events

Misuse of stimulants of the central nervous system may be associated with sudden death and

other serious cardiovascular adverse events.

Cerebrovascular disorders

See section 4.3 for cerebrovascular conditions in which methylphenidate treatment is

contraindicated. Patients with additional risk factors (such as a history of cardiovascular

disease, concomitant medications that elevate blood pressure) should be assessed at every

visit for neurological signs and symptoms after initiating treatment with methylphenidate.

Cerebral vasculitis appears to be a very rare idiosyncratic reaction to methylphenidate

exposure. There is little evidence to suggest that patients at higher risk can be identified and

the initial onset of symptoms may be the first indication of an underlying clinical problem.

Early diagnosis, based on a high index of suspicion, may allow the prompt withdrawal of

methylphenidate and early treatment. The diagnosis should therefore be considered in any

patient who develops new neurological symptoms that are consistent with cerebral ischemia

during methylphenidate therapy. These symptoms could include severe headache, numbness,

weakness, paralysis, and impairment of coordination, vision, speech, language or memory.

Treatment with methylphenidate is not contraindicated in patients with hemiplegic cerebral

palsy.

Psychiatric disorders

Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account

when prescribing stimulant products. In the case of emergent psychiatric symptoms or

exacerbation of pre-existing psychiatric disorders, methylphenidate should not be given

unless the benefits outweigh the risks to the patient.

Development or worsening of psychiatric disorders should be monitored at every

adjustment of dose, then at least every 6 months, and at every visit; discontinuation of

treatment may be appropriate.

Exacerbation of pre-existing psychotic or manic symptoms

In psychotic patients, administration of methylphenidate may exacerbate symptoms of

behavioural disturbance and thought disorder.

Emergence of new psychotic or manic symptoms

Treatment-emergent psychotic symptoms (visual/tactile/auditory hallucinations and

delusions) or mania in children and adolescents without prior history of psychotic illness or

mania can be caused by methylphenidate at usual doses. If manic or psychotic symptoms

occur, consideration should be given to a possible causal role for methylphenidate, and

discontinuation of treatment may be appropriate.

Aggressive or hostile behaviour

The emergence or worsening of aggression or hostility can be caused by treatment with

stimulants. Aggression has been reported in patients treated with methylphenidate (see

section 4.8). Patients treated with methylphenidate should be closely monitored for the

emergence or worsening of aggressive behaviour or hostility at treatment initiation, at every

dose adjustment and then at least every 6 months and every visit. Physicians should evaluate

the need for adjustment of the treatment regimen in patients experiencing behaviour changes

bearing in mind that upwards or downwards titration may be appropriate. Treatment

interruption can be considered.

Suicidal tendency

Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be

evaluated immediately by their physician. Consideration should be given to the exacerbation

of an underlying psychiatric condition and to a possible causal role of methylphenidate

treatment. Treatment of an underlying psychiatric condition may be necessary and

consideration should be given to a possible discontinuation of methylphenidate.

Tics

Methylphenidate is associated with the onset or exacerbation of motor and verbal tics.

Worsening of Tourette’s syndrome has also been reported. Family history should be assessed

and clinical evaluation for tics or Tourette’s syndrome in children should precede use of

methylphenidate. Patients should be regularly monitored for the emergence or worsening of

tics during treatment with methylphenidate. Monitoring should be at every adjustment of

dose and then at least every 6 months or every visit.

Anxiety, agitation or tension

Anxiety, agitation and tension have been reported in patients treated with methylphenidate

(see section 4.8). Methylphenidate is also associated with the worsening of pre-existing

anxiety, agitation or tension, and anxiety led to discontinuation of methylphenidate in some

patients. Clinical evaluation for anxiety, agitation or tension should precede use of

methylphenidate and patients should be regularly monitored for the emergence or

worsening of these symptoms during treatment, at every adjustment of dose and then at

least every 6 months or every visit.

Forms of bipolar disorder

Particular care should be taken in using methylphenidate to treat ADHD in patients with

comorbid bipolar disorder (including untreated Type I Bipolar Disorder or other forms of

bipolar disorder) because of concern for possible precipitation of a mixed/manic episode in

such patients. Prior to initiating treatment with methylphenidate, patients with comorbid

depressive symptoms should be adequately screened to determine if they are at risk for

bipolar disorder; such screening should include a detailed psychiatric history, including a

family history of suicide, bipolar disorder, and depression. Close ongoing monitoring is

essential in these patients (see above ‘Psychiatric Disorders’ and section 4.2). Patients

should be monitored for symptoms at every adjustment of dose, then at least every

6 months and at every visit.

Growth

Moderately reduced weight gain and growth retardation have been reported with the long-

term use of methylphenidate in children.

The effects of methylphenidate on final height and final weight are currently unknown and

being studied.

Growth should be monitored during methylphenidate treatment: height, weight and

appetite should be recorded at least 6 monthly with maintenance of a growth chart.

Patients who are not growing or gaining height or weight as expected may need to have their

treatment interrupted.

Seizures

Methylphenidate should be used with caution in patients with epilepsy. Methylphenidate may

lower the convulsive threshold in patients with prior history of seizures, in patients with prior

EEG abnormalities in absence of seizures, and rarely in patients without a history of

convulsions and no EEG abnormalities. If seizure frequency increases or new-onset seizures

occur, methylphenidate should be discontinued.

Priapism

Prolonged and painful erections have been reported in association with methylphenidate

products, mainly in association with a change in the methylphenidate treatment regimen.

Patients who develop abnormally sustained or frequent and painful erections should seek

immediate medical attention.

Use with serotonergic medicinal products

Serotonin syndrome has been reported following coadministration of methylphenidate with

serotonergic medicinal products. If concomitant use of methylphenidate with a serotonergic

medicinal product is warranted, prompt recognition of the symptoms of serotonin syndrome is

important. These symptoms may include mental-status changes (e.g. agitation, hallucinations,

coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia),

neuromuscular abnormalities (e.g. hyperreflexia, incoordination, rigidity), and/or

gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Methylphenidate must be

discontinued as soon as possible if serotonin syndrome is suspected.

Abuse, misuse and diversion

Patients should be carefully monitored for the risk of diversion, misuse and abuse of

methylphenidate.

Methylphenidate should be used with caution in patients with known drug or alcohol

dependency because of a potential for abuse, misuse or diversion.

Chronic abuse of methylphenidate can lead to marked tolerance and psychological

dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur,

especially in response to parenteral abuse.

Patient age, the presence of risk factors for substance use disorder (such as co-morbid

oppositional-defiant or conduct disorder and bipolar disorder), previous or current substance

abuse should all be taken into account when deciding on a course of treatment for ADHD.

Caution is called for in emotionally unstable patients, such as those with a history of drug or

alcohol dependence, because such patients may increase the dosage on their own initiative.

For some high-risk substance abuse patients, methylphenidate or other stimulants may not be

suitable and non-stimulant treatment should be considered.

Withdrawal

Careful supervision is required during drug withdrawal, since this may unmask depression as

well as chronic over-activity. Some patients may require long-term follow up.

Careful supervision is required during withdrawal from abusive use since severe depression

may occur.

Fatigue

Methylphenidate should not be used for the prevention or treatment of normal fatigue states.

Excipients: galactose intolerance

This medicinal product contains lactose: patients with rare hereditary problems of galactose

intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take

this medicine.

Choice of methylphenidate formulation

The choice of formulation of methylphenidate-containing product will have to be decided by

the treating specialist on an individual basis and depends on the intended duration of effect.

Drug screening

This product contains methylphenidate which may induce a false positive laboratory test for

amphetamines, particularly with immunoassay screen test.

Renal or hepatic insufficiency

There is no experience with the use of methylphenidate in patients with renal or hepatic

insufficiency.

Haematological effects

The long-term safety of treatment with methylphenidate is not fully known. In the event of

leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of

serious renal or hepatic disorders, discontinuation of treatment should be considered.

Potential for gastrointestinal obstruction

Because the Concerta XL tablet is nondeformable and does not appreciably change in shape

in the gastrointestinal (GI) tract, it should not ordinarily be administered to patients with pre-

existing severe GI narrowing (pathologic or iatrogenic) or in patients with dysphagia or

significant difficulty in swallowing tablets. There have been rare reports of obstructive

symptoms in patients with known strictures in association with the ingestion of drugs in

nondeformable prolonged-release formulations.

Due to the prolonged-release design of the tablet, Concerta XL should only be used in patients

who are able to swallow the tablet whole. Patients should be informed that Concerta XL must

be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or

crushed. The medication is contained within a nonabsorbable shell designed to release the

drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be

concerned if they occasionally notice in their stool something that looks like a tablet.

4.5

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interaction

It is not known how methylphenidate may effect plasma concentrations of concomitantly

administered drugs. Therefore, caution is recommended at combining methylphenidate with

other drugs, especially those with a narrow therapeutic window.

Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant extent.

Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on

methylphenidate pharmacokinetics. Conversely, the d- and l- enantiomers of methylphenidate

do not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.

However, there are reports indicating that methylphenidate may inhibit the metabolism of

coumarin anticoagulants, anticonvulsants (e.g. phenobarbital, phenytoin, primidone), and

some antidepressants (tricyclics and selective serotonin reuptake inhibitors). When starting or

stopping treatment with methylphenidate, it may be necessary to adjust the dosage of these

drugs already being taken and establish drug plasma concentrations (or for coumarin,

coagulation times).

Pharmacodynamic interactions

Anti-hypertensive drugs

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.

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