• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your specialist or pharmacist.
• This medicine has been prescribed for your child and/or adolescent only. Do not pass it on to others. It may harm them, even if their signs of illness are the same.
• If your child and/or adolescent gets any side effects, talk to your specialist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Amfexa tablets contain the active substance dexamfetamine sulfate.

Amfexa is a psychostimulant. It improves activity in parts of the brain. This medicine can help to improve attention span, concentration, and reduce impulsive behaviour.

Amfexa tablets are used to treat attention-deficit/hyperactivity disorder (ADHD).

• it is used in children and adolescents aged 6-17 years.
• it is not indicated in all children and adolescents with ADHD.
• it is used only after when another medicine called methylphenidate was not sufficiently effective.
• It should be used as part of a treatment programme which typically includes psychological, educational and social measures.

Treatment with Amfexa tablets must only be initiated by and used under the supervision of a specialist in childhood or adolescent behavioural disorders.

You must talk to a specialist if your child and/or adolescent does not feel better or if they feel worse after a month. The specialist may decide that a different treatment is needed.

• is allergic (hypersensitive) to dexamfetamine or other amfetamine compounds or any of the other ingredients of Amfexa tablets (listed in section 6)
• has a thyroid problem
• has increased pressure in the eyes (glaucoma)
• has a tumour of the adrenal gland (phaeochromocytoma)
• has an eating problem, does not feel hungry or does not want to eat (e.g. anorexia nervosa)
• has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• has advanced arteriosclerosis
• has ever had heart problems - such as a heart attack, uneven heartbeat, pain and discomfort in the chest, heart failure, heart disease, or was born with a heart problem
• has 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)
• has 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
    • mood swings (from being maniac to being depressed, called bipolar disorder)
• is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) – see the ‘Other medicines and Amfexa tablets’ section below
• has ever abused alcohol, prescription medicines, or street drugs
• has Tourette’s syndrome or other motor or verbal tics
• has hard-to-control, repeated twitching of any parts of the body or repeats sounds and words
• has porphyria.

Do not use this medicine if any of the above applies to your child and/or adolescent. If you are not sure, talk to your specialist or pharmacist before you use Amfexa tablets. This is because this medicine can make these problems worse.

Talk to your specialist or pharmacist before taking Amfexa tablets if your child and/or adolescent:

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

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

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

• any other medicines your child and/or adolescent is 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 your child and/or adolescent is feeling, such as feeling high or low, having strange thoughts or if your child and/or adolescent 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 specialist will discuss whether your child and/or adolescent is at risk of having mood swings (from being manic to being depressed - called ‘bipolar disorder’). They will check your child and/or adolescent’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 specialist decide if Amfexa tablets are the correct medicine for your child and/or adolescent. Your specialist may decide that other medical tests are needed before they start taking this medicine.

Amfexa Tablets may cause reduced weight in some child and/or adolescentren and adolescents.

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

Tell your specialist if your child and/or adolescent is going to have an operation. Amfexa tablets 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 give a positive result when testing for drug use.

This medicine may interfere with your laboratory test results.

Amfexa tablets are 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.

Tell your specialist or pharmacist if your child and/or adolescent is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription.

Monoamine oxidase inhibitors

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

If your child and/or adolescent is taking other medicines, this medicine may affect how well they work or may cause side effects. If your child and/or adolescent is taking any of the following medicines, check with your specialist or pharmacist before using Amfexa tablets:

• 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 your child and/or adolescent is taking are included in the list above, ask your specialist 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 Amfexa tablets during the first three months of pregnancy do not indicate increased risk of congenital malformation in the child and/or adolescent, 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. New-borns exposed to amfetamine during pregnancy may experience withdrawal symptoms (changes in behaviour including excessive crying, unstable or irritable mood, hyperexcitability and pronounced exhaustion).

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

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

Your child and/or adolescent may feel dizzy, have problems focussing, 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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your specialist or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

If you have been told by your specialist that your child and/or adolescent cannot tolerate some sugars, talk to your specialist before using this medicinal product.

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

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

• Your specialist will usually start treatment with a low dose of one tablet. This will be increased gradually by one tablet at weekly intervals, as required.
• The maximum daily dose is 20 mg (in rare cases, 40 mg may be needed).
• Your specialist will decide the need of giving Amfexa once or twice daily based on the course of symptoms at different times of the day.

The medicinal product is intended for oral use.

The tablet should be taken with a drink of water, preferably with or immediately after meals. Amfexa tablets 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.

The tablets have a score line and can be divided, if needed. The score line is only there to help you break the tablet if there is difficulty swallowing it whole and not to divide into equal doses. To split it, place the tablet on a solid surface with the cross-scored, smooth side downwards and then push carefully with your index finger at the centre of its top side. The tablet then breaks into four parts.

If your child and/or adolescent does not feel better, tell your specialist. They may decide a different treatment is needed.

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

If Amfexa Tablets is not used properly, it may cause abnormal behaviour. It may also mean that your child and/or adolescent starts to depend on the medicine. Tell your specialist if your child and/or adolescent has ever abused or been dependent on alcohol, prescription medicines or street drugs.

This medicine is only for your child and/or adolescent. Do not give this medicine to anyone else, even if their symptoms seem similar.

Talk to a specialist or call an ambulance straight away. Tell them how much has been taken. Show the package or this leaflet to the specialist. Overdosage of these tablets can be very serious.

Signs of overdose may include: excitement, hallucinations, convulsions leading to coma, irregular and rapid heartbeat, and reduced breathing.

Do not use a double dose to make up for a forgotten dose. If your child and/or adolescent forgets a dose, wait until it is time for the next dose.

If your child and/or adolescent suddenly stops taking this medicine, this can lead to extreme tiredness, depression, mood disorders, agitation, sleep disturbances, increased appetite, or involuntary movements. Your specialist may want to gradually reduce the amount of medicine taken each day, before stopping it completely. Talk to your specialist before stopping Amfexa Tablets.

• hallucinations, psychosis/psychotic reactions, suicidal behaviour (very rare: may affect up to 1 in 10,000 people)
• serious allergic reactions causing swelling of the face, tongue or throat; difficulty swallowing; hives and breathing difficulties (angioedema/ anaphylaxis) (Not known: frequency cannot be estimated from the available data)
• abnormal muscle breakdown with symptoms such as inexplicable muscle pains, muscle cramps or muscle weakness (rhabdomolysis) (Not known: frequency cannot be estimated from the available data)

Other side effects

Very common: may affect more than 1 in 10 people

• decreased appetite, reduced weight gain and weight loss during prolonged use in children
• difficulty in sleeping
• nervousness

Common: may affect up to 1 in 10 people

• irregular or increased heartbeat, a more noticeable heartbeat
• abdominal pain and/or cramps, nausea, vomiting, dry mouth
  These effects usually occur at the beginning of treatment and may be alleviated by taking the medicine with meals.
• changes in blood pressure and heart rate (usually increases)
• joint pain
• A feeling of dizziness or “spinning”, jerky or involuntary movements, headache, hyperactivity
• abnormal behaviour, aggression, excitation, anorexia, anxiety, depression, irritability

Rare: may affect up to 1 in 1,000 people

• angina pectoris
• difficulties in visual sharpening and focus, blurred vision, dilation of the pupils
• reduced height increase during prolonged use in children
• fatigue
• rash, hives

Very rare: may affect up to 1 in 10,000 people

• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness, changes in blood cell counts (leukopenia, thrombocytopenia, thrombocytopenic purpura)
• cardiac arrest
• Tourette’s syndrome
• abnormal liver function ranging from hepatic enzyme elevations to hepatic coma
• muscle cramps
• convulsions, involuntary movements (choreoathetoid movements), bleeding inside the skull (intracranial haemorrhage)
• suicide, tics, worsening of pre-existing tics
• itchy red skin lesions (erythema multiforme) or scaly skin patches (exfoliative dermatitis), recurring rash, which happens in the same place each time the medicine is taken (fixed drug eruption)
• inflammation of the blood vessels of the spinal cord and brain (cerebral vasculitis) and/or occlusion

Not known: frequency cannot be estimated from the available data

• heart muscle disease (cardiomyopathy), heart attack
• inflammation of parts of the large intestine when the blow flow is reduced (ischaemic colitis), diarrhoea
• chest pain, growth retardation during prolonged use, increased body temperature, allergic reactions, sudden death
• disturbance of the acid-base balance of the body (acidosis)
• difficulty in controlling movements (ataxia), dizziness, abnormal or impaired sense of taste, concentration difficulties, hyperreflexia, stroke, shaking (tremor)
• confusion, dependence, dysphoria, emotional instability, euphoria, impaired cognitive test performance, altered libido, night terrors, obsessive-compulsive behaviour, panic states, paranoia, restlessness
• renal damage
• impotence
• sweating, hair loss
• circulatory failure
• Fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold (Raynaud’s phenomenon).

If you get any side effects, talk to your specialist or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow 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
  Amfexa 10 mg:
  One tablet contains 10 mg dexamfetamine sulfate
  Amfexa 20 mg: One tablet contains 20 mg dexamfetamine sulfate
• The other ingredients are:
  isomalt (E953)
  magnesium stearate
  iron oxide, yellow (E 172) in Amfexa 10 mg
  iron oxide, red (E 172) in Amfexa 20 mg

Amfexa 10 mg tablets

Yellow, round, cloverleaf-shaped tablets with a notched, cross-scored line on the top side and a cross-scored line embossed with “M” on each quarter on the rear side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Pack sizes: 20, 28, 30, 48 or 50 tablets

Amfexa 20 mg tablets

Reddish, round, cloverleaf-shaped tablets with a notched, cross-scored line on the top side and a cross-scored line embossed with “L” on each quarter on the rear side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Pack sizes: 20, 28 or 30 tablets

Boxes containing tablets packed in blisters made of PVC/PVdC aluminium foil

Not all pack sizes may be marketed.