Dexamfetamine Sulfate 1 mg/ ml Oral Solution

• Keep this leaflet.You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Throughout this leaflet Dexamfetamine Sulfate 1 mg/ml Oral Solution will be referred to as ‘Dexamfetamine Solution’.

1. What Dexamfetamine Solution is and what it is used for
2.What you need to know before you take Dexamfetamine Solution
3. How to take Dexamfetamine Solution
4. Possible side effects
5. How to store Dexamfetamine Solution
6. Contents of the pack and other information.

• are allergic (hypersensitive) to dexamfetamine or other amfetamine compounds or any of the other ingredients of this medicine (listed in Section 6)
• have a thyroid problem
• have increased pressure in the eyes (glaucoma)
• have a tumour of the adrenal gland (phaeochromocytoma)
• have an eating problem, do not feel hungry or do not want to eat (e.g. anorexia nervosa)
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have advanced arteriosclerosis
• have ever had heart problems -such as a heart attack, uneven heartbeat, pain and discomfort in the chest, heart failure, heart disease, or were born with a heart problem
• have 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)
• have mental health problems such as:
  • a psychopathic or borderline personality disorder
  • abnormal thoughts or visions or schizophrenia
  • signs of a severe mood disorder like:
    • suicidal feelings
    • severe depression
    • mania
• are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) -see ‘Other medicines and Dexamfetamine Solution’ section below
• have ever abused alcohol, prescription medicines, or street drugs or anyone in your family has Tourette’s syndrome or other motor or verbal tics
• have hard-to-control, repeated twitching of any parts of the body or repeats sounds and words
• have porphyria.

If any of the above applies to you do not take Dexamfetamine Solution and talk to your doctor or pharmacist.This is because this medicine can make these problems worse.

Talk to your doctor before taking Dexamfetamine Solution if you or your child:

• have a disease of the blood or liver, or kidney problems
• are hyperexcitable or has an unstable personality
• have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)
• are female and have started having periods (see ‘Pregnancy and breast-feeding’ section below)
• have high blood pressure
• have a heart problem which is not in the ‘Do not take’ section above
• have a mental health problem which is not in the ‘Do not take’ section above. This may include mood swings, unusual aggression, hallucinations, delusions, paranoia, agitation and anxiety, feelings of guilt or depression.

Tell your doctor or pharmacist if any of the above applies to you or your child before starting treatment. This is because this medicine can make these problems worse. Your doctor will want to monitor how the medicine affects you or your child.

These checks are to decide if this is the correct medicine for you or your child. Your doctor will talk to you about:

• any other medicines you or your child are 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 are 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 other family members have ever had.

Your doctor will discuss whether you or your child are at risk of having mood swings (from being manic to being depressed -called ‘bipolar disorder’). They will check your child’s mental health history, and check if any of your family has 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 Dexamfetamine Solution 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.

Dexamfetamine Solution may cause reduced weight in some children and adolescents.

• There may be a lack of weight gain.
• Your doctor will carefully watch the height and weight of your child, as well as how well your child is eating.
• If your child is not growing as expected, then your doctor may stop treatment with Dexamfetamine Solution for a short time.

Tell your doctor if you or your child are going to have an operation.

Dexamfetamine Solution 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.

This medicine may interfere with your laboratory test results. This includes testing used in sports.

Dexamfetamine Solution is not for use as a treatment for ADHD in children under 6 years of age, and adults. It is not known if it is safe or of benefit for these people.

Dexamfetamine Solution is not for use as a treatment for narcolepsy in children and adolescents. It is not known if it is safe or of benefit to them.

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.

Do not use this medicine if you or your child are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have taken a MAOI in the last 14 days. Taking a MAOI with dexamfetamine may cause a sudden increase in blood pressure.

If you or your child are taking other medicines, this medicine may affect how well they work or may cause side effects. If you or your child are taking any of the following medicines, check with your doctor or pharmacist before using Dexamfetamine Solution:

• other medicines for depression, e.g. tricyclic antidepressants and selective serotonin reuptake inhibitors
• medicines for severe mental health problems, e.g. phenothiazines and haloperidol
• medicines for epilepsy, e.g. anticonvulsants like phenobarbital, phenytoin, primidone and ethosuximide
• medicinal products that help to give up alcohol, e.g. disulfiram
• medicines used to reduce or increase blood pressure, e.g. guanethidine, clonidine, reserpine, or alpha-methyltyrosine, or beta-blockers such as propranolol
• 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, e.g. coumarin anticoagulants
• any medicines that contain glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, sodium bicarbonate, acetazolamide, thiazides
• any of the following medicines: beta-blockers, antihistamines, lithium, noradrenaline, morphine and meperidine.

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

Alcohol must not be consumed while taking this medicine.

Remember that some foods and medicines contain alcohol.

Available data from the use of Dexamfetamine Solution during the first three months of pregnancy do not indicate increased risk of congenital malformation in the child, but may increase the risk for pre-eclampsia (a condition usually occurring after 20 weeks of pregnancy characterized by high blood pressure and protein in the urine) and preterm birth. Newborns exposed to amphetamine during pregnancy may experience withdrawal symptoms (changes in behavior including excessive crying, unstable or irritable mood, hyperexcitability and pronounced exhaustion).

If you or your daughter are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• Your doctor will discuss contraception.
• If you or your daughter are pregnant you/she may have to stop taking this medicine.
• It is possible that this medicine is passed into human breast milk. Therefore, your doctor will decide whether you or your daughter should stop breast-feeding or stop taking this medicine.

You or your child may feel dizzy, have problems focusing, or have blurred vision when taking this medicine.

If so, it may be dangerous to do things such as drive, use machines, ride a bike or horse, or climb trees.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains 0.6 mg benzoic acid in each ml. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

For narcolepsy in adults:

• The usual starting dose is 10 mg a day in divided doses.
• Your doctor may increase your dose each week up to a maximum of 60 mg a day if necessary.

For narcolepsy in the elderly:

• The usual starting dose is 5 mg a day.
• Your doctor may increase your dose by 5 mg each week.

For ADHD in children aged 6 years and over:

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The normal recommended dose is between 5 mg and 20 mg.

• Your doctor will usually start treatment with a low dose of 5 mg of Dexamfetamine Solution. This will be increased gradually by 5 mg at weekly intervals, as required.
• The maximum daily dose is 20 mg (in rare cases, 40 mg may be needed).

The medicinal product is intended for oral use.

Your child should take Dexamfetamine Solution with a drink of water, preferably with or immediately after meals.

Dexamfetamine Solution should be taken at the same time in relation to the meals. The last dose should, in general, not be given too late after lunch in order to prevent disturbances in falling asleep.

If your child does not feel better, tell your doctor. They may decide a different treatment is needed.

Your doctor will decide how long the treatment is given. If you or your child takes this medicine for more than a year, your doctor should stop treatment for a short time, e.g. during a holiday period. This will show if the medicine is still needed.

If Dexamfetamine Solution is not used properly, it 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 have 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.

Your doctor will check the height and weight of your child whilst they are taking Dexamfetamine Solution.

If you or your child take more solution than you should, you might experience excitement, hallucinations, convulsions leading to coma, irregular and rapid heartbeat and reduced breathing.

1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the bottle and any remaining solution with you so that people can see what you have taken.
3. Do this even if you feel well.

If you or your child forget to take a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.

Do not take a double dose to make up for a forgotten dose.

Do not stop taking Dexamfetamine Solution without first talking to your doctor.

Suddenly stopping taking Dexamfetamine Solution can lead to extreme tiredness and depression, mood disorders, agitation, sleep disturbances, increased appetite, or involuntary movements. Your doctor may want to gradually reduce the amount of medicine taken each day, before stopping it completely. Your doctor will stop the treatment gradually.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRAYellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is dexamfetamine sulfate.

The other ingredients are benzoic acid (E210), citric acid monohydrate (E330), disodium phosphate dihydrate, liquid maltitol (E965), hypromellose, orange tangerine flavour and purified water (See end of Section 2 for further information on liquid maltitol and benzoic acid).

Dexamfetamine Solution is a clear colourless solution which smells of orange/tangerine.

Dexamfetamine Solution is available in a 150 ml brown glass bottle.

This medicinal product is authorised in the Member States of the EEA and United Kingdom (Northern Ireland) under the following names:

Norway: Dexamfetamine Taw Pharma

Iceland: Dexamfetamine Taw Pharma

United Kingdom: Dexamfetamine Sulfate 1 mg/ml Oral Solution