Concerta XL (Methylphenidate)
How does it work?
Concerta XL tablets contain the active ingredient methylphenidate hydrochloride, which is a type of medicine called a stimulant. It is used to treat attention deficit hyperactivity disorder (ADHD) in children. (NB. Methylphenidate tablets are also available without a brand name, ie as the generic medicine.)
Stimulants are related to amphetamines, which might make them seem an odd choice for treating hyperactive children, because stimulants increase 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 natural chemicals that are found in the brain. In particular, it increases the activity of chemicals called dopamine and noradrenaline in areas of the brain that play a part in controlling attention and behaviour. These areas seem to be underactive in children with ADHD. It is thought increasing the activity of these chemicals improves the function of these underactive parts of the brain. We still dont fully understand how stimulants work in children with ADHD, and they dont work for everyone. But they can be very useful at helping some children to learn to control their behaviour.
Concerta XL tablets are a prolonged-release formulation of methylphenidate that only needs to be taken once a day. The tablets are designed to release a small amount of the medicine immediately, as the outer layer of the tablet dissolves. The rest of the medicine is then released gradually from a special membrane inside the tablet over the rest of the day, giving effects that last for up to 12 hours.
Concerta XL tablets must be swallowed whole. They must not be chewed, broken or crushed, as this would stop the prolonged-release action from working and cause all the medicine to be released at once.
What is it used for?
- Attention deficit hyperactivity disorder (ADHD).
Methylphenidate is not used for all children with ADHD. It is used as part of a comprehensive treatment programme for ADHD that includes psychotherapy and behavioural management techniques, and is only used in children in whom these treatments have proved to be insufficient on their own. It should only be used under the supervision of a specialist in childhood behavioural disorders, and only after the severity of the child's symptoms has been thoroughly assessed.
The medicine can be continued into adolescence and adulthood if ADHD symptoms continue and you are still benefiting from the medicine.
How do I take it?
- The usual starting dose of Concerta XL is one 18mg tablet daily. Your doctor may increase this to either one 27mg or one 36mg tablet daily, depending on the response to the medicine. The maximum daily dosage of Concerta XL is 54mg.
- Concerta XL tablets should be taken once a day in the morning. They can be taken either with or without food.
- The tablets should be swallowed whole with a drink. They must not be chewed, broken or crushed.
- If you forget to take your tablet in the morning you should not take it later in the day, because this may cause problems with sleeping during the night. Instead, leave out the forgotten dose and just take your next dose as usual the following morning. Dont take a double dose to make up for a missed dose.
- If symptoms have not improved after one month of taking this medicine your doctor may decide to stop treatment. Where symptoms have improved, the medicine should be stopped from time to time, usually at least once a year, so that the 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. When stopping treatment, the medicine should be withdrawn gradually, following the instructions given by your doctor.
- Concerta XL 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 your stools. This is normal and nothing to worry about.
- This medicine may cause dizziness, drowsiness and visual disturbances. If affected, you should avoid activities that could be potentially hazardous, such as climbing trees, riding bikes or horses, driving or operating machinery.
- You should not drink alcohol while taking this medicine.
- Children should have their height, weight and appetite checked before starting this medicine and then regularly every six months as long as treatment is continued. 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 checked before starting treatment and then at least every six months and after any dose changes, particularly if your child has existing high blood pressure.
- 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.
Use with caution in
- People with marked anxiety, agitation or tension.
- People with a personal or family history of involuntary muscle spasms (twitches or tics).
- People with a personal or family history of Tourette's syndrome (characterised by involuntary repetition of speech, in particular obscene or vulgar words).
- People with a personal or family history of psychiatric illness.
- People with a history of alcohol or drug abuse.
- High blood pressure (hypertension).
Not to be used in
- Children under six years of age.
- People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days.
- People with a history of severe depression or thoughts of suicide.
- People with a history of mania.
- Type 1 bipolar disorder that is not well controlled.
- People with a history of other severe mood disorders.
- People with a history of psychotic symptoms (having abnormal thoughts or visions or hearing abnormal sounds).
- People with a history of schizophrenia.
- People with a psychopathic or borderline personality disorder.
- Anorexia nervosa.
- People with very high blood pressure (hypertension).
- People with disease involving the heart and blood vessels (cardiovascular disease), including structural abnormalities in the heart, irregular heartbeats (arrhythmias), heart failure, angina or recent heart attack.
- People who have had 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).
- As Concerta XL tablets must be swallowed whole, this form of methylphenidate is not appropriate for people who have difficulty swallowing or who have any unusual narrowing in the stomach or intestines.
- Concerta XL tablets contain lactose and are not suitable for people 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 or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, 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 further medical advice from your doctor.
- If you are having sex it is important to use an effective method of contraception to avoid getting pregnant while you are taking this medicine. If think you could be pregnant or want to plan a pregnancy it is important to talk to your doctor straight away.
- This medicine may pass into breast milk and could have harmful effects on a nursing infant. It should not be taken by mothers who are breastfeeding. Seek further medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or 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)
- Difficulty sleeping (insomnia).
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.
- Abnormal behaviour.
- 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).
- Decreased sex drive and difficulty getting an erection.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Abnormal involuntary movements (twitching or tics).
- Psychotic disorders.
- Suicidal thoughts.
- Chest pain.
- Double or blurred vision.
- Shortness of breath.
- 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. Your doctor may want to do blood tests from time to time to make sure there are no problems with your blood cells.
- Liver problems. 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. Tell your doctor if you experience any of these symptoms while taking this medicine.
- Inflammation of the arteries in the brain (cerebral arteritis).
- Heart attack.
- Convulsions (fits).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
You should tell your doctor what medicines your child is already taking before they start treatment with this medicine. This includes medicines bought without a prescription and herbal medicines. Likewise, once treatment has started you should always check with your doctor or pharmacist before using any new medicines, to make sure the combination is safe.
If this medicine is taken within 14 days of taking a monoamine oxidase inhibitor antidepressant (MAOI, eg tranylcypramine, phenelzine, isocarboxazid, moclobemide) there may be a risk of a dangerous rise in blood pressure (hypertensive crisis). For this reason methylphenidate should not be taken by people who have taken an MAOI in the previous 14 days.
Check with your pharmacist before giving cough and cold remedies to children taking methylphenidate, as these types of medicines sometimes contain ingredients that may affect blood pressure, and could be unsuitable to use in combination with methylphenidate.
Methylphenidate may increase the blood levels of the following medicines:
- the antiepileptic medicines fosphenytoin, phenytoin, primidone and phenobarbital
- tricyclic antidepressants, eg imipramine.
Children taking any of these medicines may need to have their doses reduced by the doctor.
Methylphenidate opposes the effect of the blood pressure lowering medicine guanethidine.
Other medicines containing the same active ingredient
Methylphenidate tablets are also available without a brand name, ie as the generic medicine.