Concerta Prolonged Release Tablets (Methylphenidate Hydrochloride)

Concerta XL18 mg Prolonged Release Tablets, Concerta XL36 mg Prolonged Release Tablets, Concerta XL54 mg Prolonged Release Tablets, Methylphenidate Hydrochloride

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 XLis 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

Concerta XLimproves 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.

Before you or your child takes methylphenidate

Do not take methylphenidate if you or your child:

• is allergic (hypersensitive) to methylphenidate or any of the other ingredients of Concerta XL
• 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 Taking other medicines
• has mental health problems such as:

– a ‘psychopathic’ or ‘borderline personality’ problem

– abnormal thoughts or visions or an illness called ‘schizophrenia’

– signs of a severe mood problem like:

feeling like killing yourself

• severe depression, where you feel very sad, worthless and hopeless o  mania, where you feel unusually excitable, over-active, and un-inhibited. Do not take methylphenidate if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before you or your child takes methylphenidate. This is because methylphenidate can make these problems worse.

Take special care with Concerta XL if: 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 or your child 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 yours 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.

Taking other medicines

Do not take methylphenidate if you or your child:

• is taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or has taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in blood pressure.

If you or your child is taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you or your child is taking any of the following medicines, check with your doctor or pharmacist before taking methylphenidate:

• other medicines for depression
• medicines for severe mental health problems
• medicines for epilepsy
• medicines used to reduce or increase blood pressure
• some cough and cold remedies which contain medicines that can affect blood pressure. It is important to check with your pharmacist when you buy any of these products
• medicines that thin the blood to prevent blood clots.

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

Please tell your doctor or pharmacist if you or your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

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.

Drug testing

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

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 or 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.

Important information about some of the ingredients of Concerta XL

This medicine contains lactose (a type of sugar). If you or your child has an intolerance to some sugars, talk to your doctor before taking this medicine.

How to take Concerta XL

How much to take

You or your child should always take Concerta XL exactly as your doctor has told you. You should 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 or your child 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 the stools. This is normal.

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.

Not using Concerta XL properly

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

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

If you or your child takes more Concerta 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 Concerta 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 Concerta 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 Concerta XL.

Things your doctor will do when you or your child is on treatment

Your doctor will do some tests

• before you or your child starts – to make sure that Concerta 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 Concerta XL.

Long-term treatment

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

Possible side effects

Like all medicines, methylphenidate can cause side effects, but 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 or your child has any of the side effects below, see a doctor straight away:

Common

(affects less than 1 in 10 people)

• uneven heartbeat (palpitations)
• mood changes or mood swings or changes in personality

Uncommon

(affects less than 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

(affects less than 1 in 1,000 people)

• feeling unusually excited, over-active and un-inhibited (mania)

Very rare

(affects less than 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
• 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
• 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.

Other side effects

(how often they happen is not known)

• 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)

If you or your child has 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

(affects more than 1 in 10 people)

• headache
• feeling nervous
• not being able to sleep.

Common

(affects less than 1 in 10 people)

• joint pain
• dry mouth
• high temperature (fever)
• unusual hair loss or thinning
• feeling unusually sleepy or drowsy, feeling tired
• 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

(affects less than 1 in 100 people)

• constipation
• chest discomfort
• blood in the urine
• shaking or trembling
• 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

(affects less than 1 in 1,000 people)

• changes in sex drive
• 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

(affects less than 1 in 10,000 people)

• muscle cramps
• small red marks on the skin
• abnormal liver function including 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’).

Other side effects

(how often they happen is not known)

• 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

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 or your child’s height and weight, as well as how well you or your child is eating.
• if you or your child is not growing as expected, then treatment with methylphenidate may be stopped for a short time.

If any of the side effects worry you, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How to store Concerta XL

Keep out of the reach and sight of children.

Do not use Concerta 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.

Keep the bottle tightly closed to protect from moisture.

The pack contains one or two pouches. These pouches are used to keep the tablets dry and should not be eaten.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Concerta XL contains

The active substance is methylphenidate hydrochloride

• Concerta XLcontain 18 mg of methylphenidate hydrochloride.
• Concerta XLcontain 36 mg of methylphenidate hydrochloride.
• Concerta XLcontain 54 mg of methylphenidate hydrochloride.

The other ingredients are:

• butylhydroxytoluene (E321), cellulose acetate 398-10, hypromellose 3 cp, phosphoric acid concentrated, poloxamer 188, polyethylene oxides 200K and 7000K, povidone K29-32, sodium chloride, stearic acid, succinic acid, black iron oxide (E172), ferric oxide yellow (E172), and ferric oxide red (E172, 54 mg tablet only).
• Film coat: hypromellose 15cp, lactose monohydrate, titanium dioxide (E171), triacetin, ferric oxide yellow (El72, 18 mg and 54 mg tablets only), ferric oxide red (E172, 54 mg tablet only) and stearic acid (18 mg tablet only).
• Clear coat: carnauba wax, hypromellose 6cp, macrogol 400.
• Printing Ink: black iron oxide (El72), hypromellose 6cp, isopropyl alcohol, propylene glycol and purified water.

What Concerta XL looks like and contents of the pack

Concerta XL is available in three strengths: 18 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
• 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 tablets. Not all pack sizes may be marketed.