Concerta XL 18 mg, 36 mg and 54mg prolonged release tablets

Concerta® XL 18 mg Prolonged Release Tablets

Concerta® XL 36 mg Prolonged Release Tablets

Concerta® XL 54 mg Prolonged Release Tablets

Methylphenidate hydrochloride

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

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.

Concerta XL is used to treat ‘attention deficit hyperactivity disorder’ (ADHD).

• it is used in children aged 6 years and over and in adults.
• it is used only after 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.

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, adolescents or adults with behaviour problems. If you are an adult and have not been treated before, the specialist will carry out tests to confirm that you have had ADHD since childhood. Although there is no cure for ADHD, it can be managed using treatment programmes.

Children and adolescents with ADHD find it hard:

• to sit still and
• to concentrate.

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

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

Adults with ADHD often find it hard to concentrate. They often feel restless, impatient and inattentive. They may have difficulty organising their private life and work.

Not all patients with ADHD need to be treated with medicine.

ADHD does not affect intelligence.

• 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’
• 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.

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.

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. For adult patients that are new to Concerta XL, your doctor may refer you to a heart specialist.

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 (see “Do not take Concerta XL”).

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.

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.

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

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.

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.

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.

This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected. There is further information for patients who are intending to drive in Great Britain – go to https://www.gov.uk/drug-driving-law.

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 the daily dose by 18 mg no sooner than once a week if necessary.

The aim should be the lowest dose that is effective for you. Your doctor will decide the maximum daily dose for you or your child..

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.

Use in children aged 6 years and over

• the recommended starting dose of Concerta XL is 18 mg once daily for children who are not currently taking methylphenidate, or for children who are switching from another stimulant to methylphenidate.
• the maximum daily dose is 54 mg.

Use in adults

• the maximum daily dose in adults is 72 mg.

For adults who have taken Concerta XL before:

• if you have already taken Concerta XL as a child or adolescent, the same daily dosage (mg/day) can be used; your doctor will check regularly to see if any adjustment is required.
• adult patients may require a higher daily dosage but the doctor will aim to give you the lowest dose that is effective.

For adults who have not taken Concerta XL before:

• the recommended starting dose is 18 mg daily.

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

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 too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken. Medical treatment might be needed.

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.

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 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.

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.

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

If you have any of the side effects above, see a doctor straight away.

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)
• decreased 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.
• excessive sweating
• weight decreased

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)

• problems with sex drive
• feeling disorientated or confused
• trouble seeing or double vision
• swelling of the breasts in men
• redness of the skin, red raised skin rash
• obsessive-compulsive disorder (OCD) (including irresistible urge to pull out body hair, having repeated unwanted thoughts, feelings, images or urges in your mind (obsessive thoughts), performing repeated behaviours or mental rituals (compulsions))

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
• cold feeling in the arms and legs
• 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
• problems with the blood vessels of the brain (stroke, cerebral arteritis or cerebral occlusion)
• inability to control the excretion of urine (incontinence)
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• stuttering
• nosebleed.

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.

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

The active substance is methylphenidate hydrochloride

• Concerta XL 18mg Prolonged Release Tablets contain 18mg of methylphenidate hydrochloride.
• Concerta XL 36mg Prolonged Release Tablets contain 36mg of methylphenidate hydrochloride.
• Concerta XL 54mg Prolonged Release Tablets contain 54mg of methylphenidate hydrochloride.

The other ingredients are:

• butylhydroxytoluene (E321), cellulose acetate, hypromellose (E464), phosphoric acid concentrated, poloxamer 188, polyethylene oxides 200K and 7000K, povidone K29-32, sodium chloride, stearic acid, succinic acid, iron oxide black (E172), iron oxide yellow (E172), and iron oxide red (E172, 54 mg tablet only).
• Film coat: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, iron oxide yellow (E172, 18 mg and 54 mg tablets only), iron oxide red (E172, 54 mg tablet only) and stearic acid (18 mg tablet only).
• Clear coat: carnauba wax, hypromellose (E464), and macrogol 400.
• Printing Ink: iron oxide black (E172), hypromellose (E464) and propylene glycol.

Concerta XL is available in four strengths: 18 mg, 27 mg, 36 mg and 54 mg. Each capsule shaped tablet is individually marked to aid identification:

• 18 mg: Yellow, with ‘alza 18’ printed on one side in black ink.
• 27 mg: Grey with ‘alza 27’ printed on one side with black ink.
• 36 mg: White with ‘alza 36’ printed on one side in black ink.
• 54 mg: Brownish-red with ’alza 54’ printed on one side in black ink.

The medicinal product is available in bottles containing 28 or 30 prolonged-release tablets. Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Manufacturer:

This medicine is authorised in the Member States of the EEA and in the United Kingdom (Northern Ireland) under the following names:

Austria Concerta 18 mg, 36 mg & 54 mg Retardtabletten;

Belgium Concerta 18 mg, 36 mg & 54 mg tabletten met verlengde afgifte

Bulgaria Concerta 18 mg таблетка с удължено освобождаване

Cyprus Concerta 18 mg, 36 mg, 54 mg Δισκίο παρατεταμένης αποδέσμευσης

Czech Republic Concerta 18 mg, 36 mg, 54 mg tableta s prodlouženým uvolňováním

Denmark Concerta 18 mg, 36 mg, 54 mg Depottabletter

Estonia Concerta 18 mg, 36 mg, 54 mg toimeainet prolongeeritult vabastav tablett

Finland Concerta 18 mg, 36 mg, 54 mg depottabletit

France Concerta LP 18 mg, 36 mg, 54 mg comprimés à libération prolongée

Germany Concerta 18 mg, 36 mg, 54mg Retardtabletten

Greece Concerta 18 mg, 36 mg, 54 mg Δισκίο παρατεταμένης αποδέσμευσης

Iceland Concerta 18 mg, 36 mg & 54 mg forðatöflur

Ireland Concerta XL 18 mg & 36 mg Prolonged-Release Tablets

Lthuania Concerta 18 mg, 36 mg, 54 mg pailginto atpalaidavimo tabletė

Luxembourg Concerta 18 mg, 36 mg & 54 mg comprimés à libération prolongée

Malta Concerta 18 mg, 36 mg, 54 mg pilloli b’rilaxx imtawwal

Netherlands Concerta 18 mg, 36 mg & 54 mg tabletten met verlengde afgifte

Norway Concerta 18 mg, 36 mg & 54 mg depottabletter

Poland Concerta 18 mg, 36 mg Tabletka o przedłużonym uwalnianiu

Portugal Concerta 18 mg, 36 mg & 54 mg comprimidos de libertação prolongada

Romania Concerta 18 mg, 36 mg, 54 mg comprimat cu eliberare prelungită

Slovakia Concerta 18 mg, 36 mg, 54 mg Tableta s predĺženým uvoľňovaním

Slovenia Concerta 18 mg, 36 mg, 54 mg Tablete s podaljšanim sproščanjem

Spain Concerta 18 mg, 36 mg & 54 mg comprimidos de liberación prolongada

Sweden Concerta 18 mg, 36 mg & 54 mg depottabletter

UK (Northern Ireland) Concerta XL 18 mg, 36 mg & 54 mg Prolonged-Release Tablets