How does it work?

Concerta XL tablets contain the active ingredientmethylphenidate hydrochloride, which is a type of medicine called a stimulant.It is used to treat attention deficit hyperactivity disorder (ADHD) inchildren. (NB. Methylphenidate tablets are also available without a brand name,ie as thegeneric medicine.)

Stimulants are related to amphetamines, which might make themseem an odd choice for treating hyperactive children, because stimulantsincrease activity in the brain and normally make people more alert and active.However, stimulants at the doses used for ADHD have the opposite effect.

Methylphenidate works by affecting some of the naturalchemicals that are found in the brain. In particular, it increases the activityof chemicals called dopamine and noradrenaline in areas of the brain that playa part in controlling attention and behaviour. These areas seem to beunderactive in children with ADHD. It is thought increasing the activity ofthese chemicals improves the function of these underactive parts of the brain.We still don’t fully understand how stimulants work in children withADHD, and they don’t work for everyone. But they can be very useful athelping some children to learn to control their behaviour.

Methylphenidate is not used for all children with ADHD. It isused as part of a comprehensive treatment programme for ADHD that includespsychotherapy and behavioural management techniques, and is only used inchildren in whom these treatments have proved to be insufficient on their own.It should only be used under the supervision of a specialist in childhoodbehavioural disorders, and only after the severity of the child's symptoms hasbeen thoroughly assessed.

Concerta XL tablets are a prolonged-release formulation ofmethylphenidate. The tablets are designed to be taken once a day, and theygradually release the dose of methylphenidate over the day. Concerta XL tabletsmust be swallowed whole. The tablets must not be chewed, broken or crushed, asthis would stop the prolonged-release action from working and cause all themedicine to be released at once.

What is it used for?

• Attention deficit hyperactivity disorder (ADHD).

Warning!

• Concerta XL tablets must be swallowed whole and not chewed, broken or crushed. The tablets don’t dissolve completely after the medicine has been released in the intestines, and the shell of the tablets may sometimes be visible in the child's stools. This is normal and nothing to worry about.
• This medicine may cause drowsiness and dizziness. If affected, children should avoid activities that could be potentially hazardous, such as operating machinary or riding bikes.
• Alcohol should be avoided while taking this medicine.
• If there has been no improvement in the child's symptoms after one month of treatment with this medicine it should be stopped. Where symptoms have improved, the medicine should be stopped from time to time, usually at least once a year, so that the child's condition can be assessed, and to check if the medicine is still needed. However, in both cases, this medicine must not be stopped suddenly without your doctor's advice, as this could unmask symptoms such as depression and overactivity in the child. When stopping treatment, the medicine should be withdrawn gradually, following the instructions given by your doctor.
• Children taking this medicine for long periods of time should have their height, weight and appetite regularly checked every six months. If your child is not growing or gaining weight satisfactorily, your doctor may suggest breaks from the medicine to allow growth to catch up. Your child's blood pressure and heart rate (pulse) should also be monitored at least every six months and after any dose changes, particularly if your child has existing high blood pressure. Children should also have periodic blood tests to make sure there are no problems with their blood cells.
• If your child experiences any heart palpitations, chest pain when exercising, or shortness of breath, or if they faint for no apparant reason, you should let your doctor know straight away.
• You should also tell your doctor if any other symptoms or side effects are experienced during treatment. In particular, children and adolescents taking this medicine should be encouraged to report any new or worsening distressing thoughts or feelings, anxiety, agitation, irritability, depression, mood changes, or other unusual change in behaviour that they may experience after starting this medicine. If you are worried about your child at any point it is important to talk to your doctor immediately.
• This medicine has very rarely been associated with liver problems. For this reason, parents of children taking this medicine should be aware of the symptoms of liver problems, and inform your doctor if they are experienced during treatment. Symptoms that could indicate liver problems include unexplained itching, nausea and vomiting, right-sided abdominal pain, loss of appetite or flu-like symptoms; yellowing of the skin or eyes (jaundice); or unusually dark urine.

Use with caution in

• Epilepsy.
• High blood pressure (hypertension).
• History of psychiatric illness.
• History of alcohol or drug abuse.

Not to be used in

• Children under six years of age.
• Marked anxiety, agitation or tension.
• Personal or family history of involuntary muscle spasms (twitches or tics).
• Personal or family history of Tourette's syndrome (characterised by involuntary repetition of speech, in particular obscene or vulgar words).
• History of severe depression or thoughts of suicide.
• History of mania.
• Type 1 bipolar disorder that is not well controlled.
• History of other severe mood disorders.
• History of psychotic symptoms (having abnormal thoughts or visions or hearing abnormal sounds).
• History of schizophrenia.
• People with a psychopathic or borderline personality disorder.
• History of anorexia nervosa.
• People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days.
• Children with structural abnormalities in the heart.
• Irregular heart beats (arrhythmias).
• Severe angina pectoris.
• Other disorders of the heart and blood vessels, such as very high blood pressure, heart failure or recent heart attack, unless a heart specialist has been consulted first.
• Disorders of the blood vessels in the brain, such as cerebral aneurysm, vasculitis or stroke.
• Overactive thyroid gland (hyperthyroidism).
• Tumour of the adrenal gland (phaeochromocytoma).
• Glaucoma.
• Breastfeeding.
• Concerta XL tablets contain lactose and may not be suitable for children with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.
• This medicine may pass into breast milk. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.

Label warnings

• This medication is to be swallowed whole, not chewed.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

See the warning section above for more information about some of these side effects.

Very common (affect more than 1 in 10 people)

• Nervousness.
• Difficulty sleeping (insomnia).
• Headache.

Common (affect between 1 in 10 and 1 in 100 people)

• Decreased appetite.
• Reduced weight and height gain with prolonged use in children.
• Rise in blood pressure.
• Increased heart rate.
• Awareness of your heartbeat (palpitations).
• Irregular heartbeats (arrhythmias).
• Emotional highs and lows.
• Depression.
• Irritability.
• Aggression.
• Agitation.
• Anxiety.
• Abnormal behaviour.
• Dizziness.
• Drowsiness.
• Movement disorders (dyskinesias).
• Gut disturbances such as abdominal pain, nausea, vomiting, diarrhoea.
• Dry mouth.
• Skin reactions such as rash or itching.
• Hair loss (alopecia).
• Pain in the joints (arthralgia).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Abnormal involuntary movements (twitching or tics).
• Psychotic disorders.
• Hallucinations.
• Suicidal thoughts.
• Chest pain.
• Double or blurred vision.
• Constipation.
• Shortness of breath.
• Fatigue.
• Blood in the urine.

Very rare (affect less than 1 in 10,000 people)

• Cold hands and feet.
• Disturbances in the normal numbers of blood cells in the blood.
• Liver problems.
• Inflammation of the arteries in the brain (cerebral arteritis).
• Heart attack.
• Convulsions.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

You should tell your doctor what medicines your child is alreadytaking, before starting treatment with this medicine. This includes medicinesbought without a prescription and herbal medicines. Likewise, once treatmenthas started you should always check with your doctor or pharmacist beforegiving any new medicines, to make sure thecombination is safe.

If this medicine is taken within 14 days of taking a monoamineoxidase inhibitor antidepressant (MAOI, eg tranylcypramine, phenelzine,isocarboxazid) there may be a risk of a dangerous rise in blood pressure(hypertensive crisis). For this reason methylphenidate should not be taken bypeople who have taken an MAOI in the previous 14 days.

Check with your pharmacist before giving cough and cold remediesto children taking methylphenidate, as these types of medicines sometimescontain ingredients that may affect blood pressure, and could be unsuitable touse in combination with methylphenidate.

Methylphenidate may increase the blood levels of the followingmedicines:

• antiepileptic medicines, eg phenytoin, primidone, phenobarbital
• medicines to prevent blood clots (anticoagulants) eg warfarin
• phenylbutazone
• tricyclic antidepressants, eg imipramine
• SSRI antidepressants, eg fluoxetine.

Children taking any of these medicines may need to have theirdoses reduced by the doctor.

Other medicines containing the same active ingredient

Methylphenidate tablets are also available without a brand name,ie as thegeneric medicine.