Amfexa

Patient Information Leaflet

Amfexa 5 mg tablets, 10 mg tablets, 20 mg tablets

desamfetamine sulfate
Please read this leaflet carefully before your child starts taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms are the same, as it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Amfexa is and what it is used for

What Amfexa is
Amfexa tablets contain the active substance desamfetamine sulfate.
Amfexa is a psychostimulant. It enhances the activity of certain parts of the brain. This medicine
can help improve attention span, concentration, and reduce impulsive behaviour.

What it is used for
Amfexa is used for the treatment of attention deficit hyperactivity disorder (ADHD).

• It is used in children and adolescents aged between 6 and 17 years.
• It is not indicated for all children with ADHD.
• It is used only when another medicine called methylphenidate has not been sufficiently effective.
• It must be used as part of a treatment programme that usually includes psychological, educational, and social interventions.

Treatment with Amfexa should be initiated and used only under the supervision of a specialist in childhood or adolescent behavioural disorders.
Contact your doctor if you do not observe any improvement or if you notice a worsening of symptoms in your child after one month. The doctor may decide that a different treatment is necessary.

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMFEXA

Do not use Amfexa if your child:

• is allergic (hypersensitive) to dexamfetamine or to other amphetamine-containing compounds, or to any of the other components of Amfexa (listed in section 6)
• has a thyroid problem
• has high pressure in the eyes (glaucoma)
• has a tumour of the adrenal gland (pheochromocytoma)
• has an eating disorder, lacks appetite, or refuses to eat (e.g. anorexia nervosa)
• has very high blood pressure or narrowing of blood vessels, which may cause pain in arms and legs
• has advanced arteriosclerosis
• has previously had heart problems, such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or was born with a heart defect
• has previously had a problem with blood vessels in the brain, such as stroke, swelling and weakening of a part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
• has mental health problems such as:
  • a psychopathic or borderline personality disorder
  • altered thoughts or perceptions or schizophrenia
  • signs of a severe mood disorder such as: suicidal thoughts, severe depression, mania, or mood swings (from manic to depressed, so-called bipolar disorder)
• is taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) – see section “Other medicines and Amfexa”
• has abused alcohol, prescription medicines, or street drugs
• has Tourette’s syndrome or other motor or verbal tics
• has repeated, difficult-to-control movements of any part of the body or repeats sounds and words
• has porphyria.

Do not use this medicine if any of the above conditions apply to your child. If you have any doubts, consult your doctor or pharmacist before using Amfexa, as the medicine may worsen these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before using Amfexa if your child:

• has a blood or liver disease or kidney problems
• has an unstable personality
• has previously had seizures (epileptic fits, convulsions, epilepsy) or abnormal brain test results (EEG)
• is female and has started menstruating (see section “Pregnancy and breastfeeding”)
• has high blood pressure
• has a heart condition not listed in the section “Do not use Amfexa if your child”
• has a mental health condition not listed in the section “Do not use Amfexa if your child”. This may include general mood swings, unusual aggression, hallucinations, delirium, paranoia, agitation and anxiety, feelings of guilt, or depression.

Before starting treatment, inform your doctor or pharmacist if any of these situations apply to your child. This is because the medicine may worsen these conditions. Your doctor will want to monitor the medicine’s effects on your child.

Checks your doctor will perform before using Amfexa

These checks are necessary to determine whether this medicine is suitable for your child. Your doctor will ask you about:

• any other medicines your child is taking
• whether there have been any cases of unexplained sudden death in your family
• any other medical problems (e.g. heart problems) affecting you or your family
• how your child is feeling, for example whether they feel in a good or bad mood, if they have had unusual thoughts, or if they have experienced these feelings before
• whether there is a family history of “tics” (repeated, difficult-to-control movements of any part of the body or repetition of sounds and words)
• any history of mental health or behavioural problems in you or other family members.

Your doctor will assess whether your child is at risk of mood swings (from manic to depressed, so-called “bipolar disorder”). They will review your child’s mental health history and check whether anyone in the family has a history of suicide, bipolar disorder, or depression.

It is important that you provide as much information as possible. This will help the doctor decide whether Amfexa is the right medicine for your child. The doctor may decide that further medical tests are needed before your child starts taking this medicine.

Effect on weight/growth

Amfexa may cause weight reduction in some children and adolescents.

• A failure to gain weight may occur.
• The doctor will carefully monitor your child’s height, weight, and eating habits.
• If your child is not growing as expected, the doctor may temporarily interrupt treatment with Amfexa.

Surgery

Inform your doctor if your child is due to undergo surgery. Amfexa should not be taken on the day of surgery if a certain type of anaesthetic is to be used. This is because a sudden increase in blood pressure may occur during the operation.

Drug testing

This medicine may give a positive result in tests designed to detect drug use. For people engaged in sports: using the medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Drug interactions/laboratory tests

This medicine may interfere with the results of laboratory tests.

Children and adolescents

Amfexa is not indicated for the treatment of ADHD in children under 6 years of age or in adults. It is not known whether it is safe or beneficial for these individuals.

Other medicines and Amfexa

Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those not requiring a prescription.

Monoamine oxidase inhibitors (MAOIs)

Your child must not use this medicine if they are taking a medicine called a “monoamine oxidase inhibitor” (MAOI) used for depression, or if they have taken an MAOI within the last 14 days. Taking an MAOI together with dexamfetamine may cause a sudden increase in blood pressure.

If your child is taking other medicines, this medicine may affect their effectiveness or may cause side effects. If your child is taking any of the following medicines, consult your doctor or pharmacist before using Amfexa:

• other medicines for depression, e.g. tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs)
• medicines for severe mental health problems, e.g. phenothiazines and haloperidol
• medicines for epilepsy, e.g. anticonvulsants such as phenobarbital, phenytoin, primidone, and ethosuximide
• medicines used to help with alcohol withdrawal, e.g. disulfiram
• medicines used to lower or raise blood pressure, e.g. guanethidine, clonidine, reserpine, or alpha-methyldopa, or beta-blockers such as propranolol
• certain cough and cold remedies containing medicines that may affect blood pressure. It is important to consult a pharmacist before purchasing any of these products
• medicines that thin the blood to prevent clotting, e.g. coumarin anticoagulants
• any medicine containing glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, sodium bicarbonate, acetazolamide, or thiazides
• any of the following medicines: beta-blockers, antihistamines, lithium, noradrenaline, morphine, or meperidine.

If you have any doubts about whether the medicines your child is taking are included in the list above, ask your doctor or pharmacist before giving this medicine to your child.

Amfexa and alcohol

Alcohol should not be consumed while taking this medicine. Remember that some foods and some medicines contain alcohol.

Pregnancy and breastfeeding

Available data on the use of Amfexa during the first three months of pregnancy do not indicate an increased risk of congenital malformations in the baby, but there may be an increased risk of pre-eclampsia (a condition usually occurring after 20 weeks of pregnancy, characterised by high blood pressure and protein in the urine) and premature birth. Newborns exposed to amphetamine during pregnancy may show withdrawal symptoms (behavioural changes, including excessive crying, unstable or irritable mood, hyperexcitability, and marked fatigue).

If your daughter is pregnant, suspects she may be pregnant, is planning a pregnancy, or is breastfeeding, consult your doctor or pharmacist before using this medicine.

• Your doctor will discuss contraception with you.
• If your daughter is pregnant, she may need to stop taking the medicine.
• This medicine may pass into human breast milk. Therefore, your doctor will decide whether your daughter should discontinue breastfeeding or stop taking this medicine.

Driving and using machines

Your child may experience dizziness, difficulty focusing, or blurred vision while taking this medicine. If this occurs, it may be dangerous to perform activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

Amfexa contains isomalt (E953)

If your doctor has diagnosed your child with an intolerance to certain sugars, contact them before giving this medicine to your child.

3. HOW TO TAKE AMFEXA

How much Amfexa to take
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
The usual recommended dose ranges between 5 mg and 20 mg.

• Your doctor usually starts treatment with a low dose, one 5 mg tablet. The dose will then be gradually increased by one 5 mg tablet at weekly intervals, as needed.
• The maximum daily dose is 20 mg (in rare cases, 40 mg may be required).
• Your doctor will decide whether to administer Amfexa once or twice daily, based on how symptoms evolve at different times of the day.

How to take Amfexa
This medicine is for oral use.
Your child should take Amfexa tablets with a glass of water, preferably during or immediately after meals. Amfexa tablets should be taken at the same time relative to meals. In general, the last dose should not be administered too late after lunch to avoid sleep-onset disturbances.
The tablets have a scored line and can be divided if necessary. The score line is intended to facilitate breaking the tablet if difficulty swallowing the whole tablet occurs, and not for dividing it into equal doses. To divide the tablet, place it on a hard surface with the smooth side, bearing the cross-shaped score, facing downwards, then gently press with your index finger at the center of the upper side. The tablet will split into four parts.
If you do not notice any improvement in your child, inform your doctor, who may decide that a different treatment is needed.

Long-term treatment
Your doctor will determine the duration of treatment. If your child takes this medicine for more than one year, your doctor should interrupt the treatment for a short period, for example during school holidays. This will help determine whether the medicine is still necessary.

Incorrect use of Amfexa
If Amfexa is not used correctly, it may cause abnormal behavior. This could also mean that your child may start to become dependent on the medicine. Inform your doctor if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
This medicine is intended only for your child. Do not give it to others, even if their symptoms appear similar.

If your child takes more Amfexa than he/she should
Call a doctor or an ambulance immediately and inform them of how much Amfexa has been taken. Show the doctor the packaging or this leaflet. An overdose of these tablets can be very serious.
Signs of overdose may include: excitement, hallucinations, seizures leading to coma, irregular and rapid heartbeat, and reduced breathing.

If your child forgets to take Amfexa
Do not give a double dose to make up for the missed dose. If your child forgets a dose, wait until the next scheduled dose.

If your child stops taking Amfexa
If your child suddenly stops taking this medicine, he/she may experience extreme tiredness, depression, mood disturbances, agitation, sleep disturbances, increased appetite, or involuntary movements. Your doctor may wish to gradually reduce the daily dose before stopping it completely. Talk to your doctor before discontinuing Amfexa.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. Your doctor will discuss these side effects with you.

Stop using Amfexa and contact a doctor immediately or go to the emergency room if the following symptoms occur:

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

Other adverse reactions

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

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

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

• angina pectoris
• difficulty with visual acuity and focusing, blurred vision, pupil dilation
• reduced growth in height during prolonged use in children
• fatigue
• skin rash, hives

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

• reduction in red blood cells, which may cause pale skin, weakness or shortness of breath, changes in blood cell counts (leucopenia, thrombocytopenia, thrombocytopenic purpura)
• cardiac arrest
• Tourette’s syndrome
• abnormal liver function, ranging from increased liver enzymes to hepatic coma
• muscle cramps
• seizures, 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), recurrent skin rashes occurring at the same site each time the medicine is taken (fixed drug eruption)
• inflammation and/or blockage of blood vessels in the spinal cord and brain (cerebral vasculitis)

Not known: frequency cannot be estimated based on available data

• heart muscle disease (cardiomyopathy), heart attack, sudden death
• inflammation of parts of the large intestine due to reduced blood supply (ischaemic colitis), diarrhoea
• chest pain, increased body temperature, allergic reactions
• disturbance in the body's acid-base balance (acidosis)
• difficulty controlling movements (ataxia), dizziness, abnormal or altered sense of taste, difficulty concentrating, hyperreflexia, stroke, trembling (tremor)
• confusion, dependence, dysphoria, emotional instability, euphoria, altered performance in cognitive tests, altered libido, nightmares, obsessive-compulsive behaviour, panic states, paranoia, restlessness
• kidney damage
• impotence
• sweating, hair loss
• circulatory failure
• numbness, tingling, and colour change (from white to blue, then red) in the fingers of the hands and feet when exposed to cold (Raynaud’s phenomenon)

Reporting of adverse reactions
If your child experiences any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMFEXA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Return any unused tablets to the pharmacist.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Amfexa contains:

• The active substance is dexamfetamine sulfate.
• Amfexa 5 mg: One tablet contains 5 mg of dexamfetamine sulfate.
  Amfexa 10 mg: One tablet contains 10 mg of dexamfetamine sulfate.
  Amfexa 20 mg: One tablet contains 20 mg of dexamfetamine sulfate.
• The other excipients are: isomalt (E953), see section 2; magnesium stearate; crospovidone in the 5 mg tablets; yellow iron oxide (E 172) in the 10 mg tablets; red iron oxide (E 172) in the 20 mg tablets.

Description of the appearance of Amfexa and pack contents:
Amfexa 5 mg tablets
White, round, clover-shaped tablets with a cross-shaped score line on the upper side and a cross-shaped score line with an impressed "S" on each quarter of the lower side.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Pack sizes: 20, 28, 30, 40, 50, 56, 98 or 100 tablets
Boxes containing tablets packaged in PVC/PE/PVdC blisters with aluminium foil lidding.

Amfexa 10 mg tablets
Yellow, round, clover-shaped tablets with a cross-shaped score line on the upper side and a cross-shaped score line with an impressed "M" on each quarter of the lower side.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Pack sizes: 20, 28, 30, 40, 48, 50 or 56 tablets
Boxes containing tablets packaged in PVC/PVdC blisters with aluminium foil lidding.

Amfexa 20 mg tablets
Reddish, round, clover-shaped tablets with a cross-shaped score line on the upper side and a cross-shaped score line with an impressed "L" on each quarter of the lower side.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Pack sizes: 20, 28, 30, 40 or 56 tablets
Boxes containing tablets packaged in PVC/PVdC blisters with aluminium foil lidding.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Philla 5 mg/10 mg/20 mg
Belgium: Attentin 5 mg/10 mg/20 mg
Denmark: Attentin 5 mg/10 mg/20 mg
Estonia: Tentin 5 mg/10 mg/20 mg
Finland: Attentin 5 mg/10 mg/20 mg
France: Tentin 5 mg/10 mg/20 mg
Iceland: Attentin 5 mg/10 mg/20 mg
Italy: Amfexa 5 mg/10 mg/20 mg
Luxembourg: Attentin 5 mg/10 mg/20 mg
Norway: Attentin 5 mg/10 mg/20 mg
Poland: Tentin 5 mg/10 mg/20 mg
Portugal: Tentin 5 mg/10 mg/20 mg
Spain: Tentin 5 mg/10 mg/20 mg
Sweden: Attentin 5 mg/10 mg/20 mg
United Kingdom (Northern Ireland): Amfexa 5 mg/10 mg/20 mg tablets

This patient information leaflet is also available in formats suitable for blind and visually impaired persons.