Medikinet (methylphenidate)

How does it work?

Medikinet tablets and Medikinet XL capsules 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 under active parts of the brain. We still don't fully understand how stimulants work in children with ADHD, and they don't work for everyone. But they can be very useful at helping some children to learn to control their behaviour.

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.

Medikinet tablets are immediate release tablets. They start working within about 30 to 60 minutes of taking a dose, and the effects wear off about three to four hours later. This means they usually need to be taken two to three times a day, ie a dose at breakfast and at lunchtime, with some children also needing a dose in the early evening as well.

Medikinet XL capsules are a modified release form of methylphenidate. The capsules are designed to release 50 per cent of the methylphenidate immediately, giving an initial dose of medicine for the morning. The remaining 50 per cent of the dose is released gradually through the afternoon. This means the capsules provide enough medicine to cover the school day, without your child needing to take a dose at lunchtime. This mimics the effect of taking a morning and lunchtime dose of Medikinet tablets.

Medikinet XL capsules should be swallowed whole with liquid and not crushed or chewed, as this would stop the modified release action from working. For children who cannot swallow the capsules whole, the contents of the capsule can be sprinkled onto a spoonful of soft food that doesn't need chewing, such as apple sauce. This should be given immediately and followed with a drink. The sprinkled capsule contents should not be crushed or chewed, as this will stop the modified release action from working. The opened capsule contents should not be stored for later use.

Medikinet tablets may be broken or crushed for children who cannot swallow them whole.

What is it used for?

Attention deficit hyperactivity disorder.

Warning!

This medicine may cause drowsiness and dizziness. If affected, children should avoid activities that could be potentially hazardous, such as operating machinery 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 discontinued. Where symptoms have improved, the medicine should be stopped from time to time, so that the child's condition can be assessed. 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 should have their weight and height regularly monitored. If your child is not growing or gaining weight satisfactorily, your doctor may suggest breaks from the medicine to allow growth to catch up. Blood pressure and pulse should also be monitored regularly, particularly in children with high blood pressure, and children should also have periodic blood tests to make sure there are no disturbances in the normal composition of their blood.

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.

You should also tell your doctor if any other symptoms or side effects are experienced during treatment. Children and adolescents taking this medicine should be encouraged to report any new or worsening distressing thoughts or feelings, anxiety, irritability, 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

Epilepsy.

High blood pressure .

History of alcohol or drug abuse.

History of psychotic illness.

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).

Severe depression.

Children who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days.

Current psychotic symptoms, eg abnormal thoughts or visions or hearing abnormal sounds.

Current drug or alcohol dependence.

Anorexia nervosa.

Glaucoma.

Overactive thyroid gland .

Irregular heart beats (arrhythmias).

Severe angina pectoris - chest pain.

Medikinet 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.

Medikinet XL capsules contain sucrose and may not be suitable for children with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

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 medical advice from your doctor.

There is no information available about the safety of this medicine during breastfeeding. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.

Side effects

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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Nervousness.

Difficulty in sleeping (insomnia).

Decreased appetite.

Headache.

Drowsiness.

Dizziness.

Abdominal pain.

Nausea and vomiting.

Dry mouth.

Increased heart rate.

Awareness of your heartbeat (palpitations).

Rise in blood pressure.

Skin reactions such as rash or itching.

Pain in the joints (arthralgia).

Hair loss (alopecia).

Weight loss or delayed growth with prolonged use.

Abnormal involuntary movements (twitching or tics).

Emotional highs and lows.

Irritability.

Depression.

Disturbances in the composition of the blood.

Liver problems.

The side effects listed above may not include all of the side effects reported by the drug'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.

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