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What is ASPEN DEXAMFETAMINE

The active ingredient is called dexamfetamine sulfate which belongs to a group of medicines called central nervous system stimulants and is a sympathomimetic amine of the amphetamine group.

It is used to treat a number of medical conditions.

• Hyperkinetic behaviour disorders in children. This behavioural disorder is also known as Attention-deficit Hyperactivity Disorder (ADHD). Not all people with this disorder are hyperactive, which affects the ability to concentrate on tasks for any length of time.

Children suffering from ADHD may have trouble learning or doing school work, and may become aggressive or unmanageable at school or at home. ASPEN DEXAMFETAMINE helps focus attention and shuts out distraction, allowing the child to concentrate.

• Narcolepsy (a sleep disorder). People with narcolepsy have recurring attacks of irresistible day-time sleepiness in spite of a good night’s sleep.

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Before you start to take it

You must tell your doctor if:

1. you are allergic to any other medicines or any foods, dyes or preservatives.

2. you have any other medical conditions or health problems, including:

• suspicion or presence of any cardiac or heart-related abnormalities; irregular heart beats or rate; family history of sudden/cardiac death

• suffer from blood pressure and/or take any medications to treat blood pressure

• angina (chest pain)

• disease of the arteries due to cholesterol deposits

• disorders of the blood vessels in the brain

• epilepsy

• drug dependence or addiction including alcoholism

• suffer from insomnia (an inability to sleep)

• suffer from depression or schizophrenia or another mental illness

• suffer from motor tic or Tourette syndrome (or a family member does)

• kidney problems.

1. you drink alcohol regularly.

Alcohol should not be taken with ASPEN DEXAMFETAMINE.

1. you are pregnant or plan to become pregnant.

Like all medicines, it should not be used during pregnancy, unless your doctor tells you.

1. you are breastfeeding or plan to breastfeed.

ASPEN DEXAMFETAMINE is passed into breast milk. Breast-feeding is not recommended while taking this medicine.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with ASPEN DEXAMFETAMINE. These include:

• drugs which are used to treat depression e.g. tricyclic antidepressants and MAO inhibitors

• drugs used to treat other types of mental illnesses such as schizophrenia e.g. chlorpromazine or manic depressive psychosis e.g. lithium carbonate

• medicines used to treat mental illnesses such as psychotic disorders e.g. haloperidol

• some medicines including Vitamin C and fruit juices which can affect the gastric or urine pH (that is make it acidic or alkaline) may alter the rate of absorption or urinary excretion of ASPEN DEXAMFETAMINE e.g. guanethidine, reserpine, glutamic acid, ammonium chloride, sodium bicarbonate, acetazolamide, some thiazide diuretics

• blood pressure medicines

• some antihistamines

• anti-epileptic medicines e.g. phenytoin

• ethosuximide e.g. Zarontin

• some opioid type analgesics e.g. pethidine

• barbiturates e.g. phenobarbitone.

The above medicines may either reduce the effectiveness of ASPEN DEXAMFETAMINE, reduce its own effectiveness and/or react with this medicine resulting in untoward or sometimes dangerous side effects.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

If you have not told your doctor about any of these things, tell them before you start taking this medicine.

How to take it

How much to take

The dose of ASPEN DEXAMFETAMINE may be different for each person and their medical condition. Your doctor will decide the right dose for you.

The recommended doses for:

Narcolepsy

For children 6 to 12 years one tablet (5 mg) is given daily. The dose may be increased by 5 mg each week until the required response is obtained.

For patients 12 years or older your doctor may start treatment with two tablets (10 mg) daily. The dose may be increased by 10 mg each week until the required response is obtained.

Attention Deficit Disorder

For children over 3 years, your doctor may start treatment with half a tablet (2.5 mg) daily. The dose may be increased by 2.5 mg every week until the required response is obtained up to a maximum of 40 mg (8 tablets) each day taken in two divided doses.