What it is and what it is used for

for

What Lisdexamfetamine is Lisdexamfetamine capsules contain the active substance lisdexamfetamine dimesylate which helps with your brain activity. It helps improve your attention, helps you concentrate and makes you less impulsive. This medicine is a long acting medicine which works gradually over a 13 hour time period. What it is used for Lisdexamfetamine is part of a comprehensive treatment for 'attention deficit hyperactivity disorder' (ADHD)

• for children and young people between the ages of 6 and 18 who have previously taken a methylphenidate treatment that inadequately treated their ADHD.
• for adults who have had ADHD since childhood. If you have not been treated for ADHD before, the doctor will check if you have had ADHD since childhood before prescribing Lisdexamfetamine. You must talk to a doctor if you do not feel better or if you feel worse after one month of treatment. Lisdexamfetamine is not recommended for all patients with ADHD and the decision to use this medicine is based on thorough medical evaluation. Lisdexamfetamine is not used as a treatment for ADHD in children under 6 years of age because it is not known if it is safe or of benefit in such young people. How it works Lisdexamfetamine improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention, concentration and reduce impulsive behaviour. The medicine is given as part of a treatment programme, which usually includes the following:
• psychological therapy

• • • •

educational therapy social therapy behavioural therapy occupational therapy

It is prescribed only by doctors who have experience in treating people with behaviour problems. About ADHD People with ADHD find it hard to:

• sit still
• concentrate It is not their fault that they cannot do these things. However, ADHD can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places. ADHD does not affect the intelligence of a person.

2.

What you need to know before you take it

e Lisdexamfetamine

Do not take Lisdexamfetamine if

• you are allergic to lisdexamfetamine or any of the other ingredients of this medicine (listed in Section 6)
• you are taking a medicine called a 'monoamine oxidase inhibitor' (MAOI) used for depression, or have taken an MAOI in the last 14 days
• you have a thyroid problem
• you feel unusually excited, over-active, or un-inhibited
• you 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
• you have high or very high blood pressure or narrowing of the blood vessels
• you have increased pressure in your eye (glaucoma) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you take this medicine. This is because Lisdexamfetamine can make these problems worse. Warnings and precautions Talk to your doctor or pharmacist before using Lisdexamfetamine treatment if you have:
• ever abused prescription medicines or street drugs
• had kidney problems
• had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)
• hard-to-control and repeated twitching of any parts of the body or you repeat sounds and words
• high blood pressure
• family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances
• a heart problem which is not in the 'Do not take' section above
• a mental health problem. These may include: ⸰ mood swings (from being manic to being depressed – called 'bipolar disorder') ⸰ starting to be aggressive or unfriendly (hostile), or your aggression gets worse ⸰ seeing, hearing or feeling things that are not there (hallucinations) ⸰ believing things that are not true (delusions) ⸰ feeling unusually suspicious (paranoia) ⸰ feeling agitated, anxious or tense ⸰ feeling depressed or guilty

Or if you are a female able to become pregnant, plan to become pregnant or are pregnant (see the "Pregnancy and breast-feeding" section). Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because Lisdexamfetamine can make these problems worse. Your doctor will want to monitor how the medicine affects you. If Lisdexamfetamine is not used properly, it may cause abnormal behaviour and the user may start 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. Do not give this medicine to anyone else even if the symptoms seems similar. This medicine may cause heart rhythm disorders in some patients. If you experience palpitations or irregular heartbeat during the period of treatment, you should inform your doctor immediately. The risk of heart problems may increase with increase of the dose. Therefore, the recommended dosage should be followed. Checks that your doctor will make before you start taking Lisdexamfetamine: These checks are to decide if Lisdexamfetamine is the correct medicine for you. Your doctor will ask you about:

• any other medicines you 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 are feeling, such as feeling happy or sad, having strange thoughts, or if you have 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 check your mental health history, and check if any of your family have a history of suicide, bipolar disorder (mood swings from being manic to being depressed) or depression. It is important that you provide as much information as you can. This will help your doctor decide if Lisdexamfetamine is the correct medicine for you. Your doctor may decide that other medical tests are needed before you start taking this medicine. Effects on weight
• Lisdexamfetamine may cause reduced weight in some patients
• There may also be lack of weight gain in children and adolescents
• If you are a child or adolescent, your doctor will carefully watch your height and weight, as well as how well you are eating.
• If you are not growing as expected or if you are losing weight, your doctor may stop treatment with Lisdexamfetamine
• For adults, your doctor will watch your weight, as well as how well you are eating. Other medicines and Lisdexamfetamine Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not take Lisdexamfetamine if you:
• are taking a medicine called a 'monoamine oxidase inhibitor' (MAOI) used for depression, or have taken an MAOI in the last 14 days. Taking an MAOI with Lisdexamfetamine may cause a sudden increase in your blood pressure. Your doctor or pharmacist will be able to tell you if are taking a medicine that is an MAOI.

This medicine and some other medicines can affect each other. If you are taking any of the following medicines, check with your doctor or pharmacist before taking Lisdexamfetamine:

• medicines for severe mental health problems
• medicines used to reduce or increase blood pressure
• medicines used during surgery such as painkillers
• cough and cold remedies. Some of these contain medicines that can affect blood pressure so it is important to check with your pharmacist when you buy any of these products
• medicines that can affect the acidity of your urine, such as vitamin C (ascorbic acid) or sodium bicarbonate (for example in medicines for indigestion) If you are unsure about whether the medicines you are taking are in the list above, ask your doctor or pharmacist before taking Lisdexamfetamine. Drug testing This medicine may give a positive result when testing for drug use. Pregnancy and breast-feeding Pregnancy If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your body breaks down Lisdexamfetamine into other substances which can cross the placenta and enter breast milk. Available data from the use of Lisdexamfetamine 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 amfetamine during pregnancy may experience withdrawal symptoms (trembling, irritability, tight muscle tone). You should not use this medicine during pregnancy unless explicitly advised by your doctor. Breast-feeding This medicine should not be used during breast-feeding. Driving and using machines This medicine can affect your ability to drive as it may make you sleepy or dizzy, or you may have problems focusing or have blurred vision. If these happen, it will be dangerous to do things such as drive or use machines. • • •

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: o A doctor has prescribed this medicine for you and o You have taken it according to his or her instructions, or with the information in this leaflet and o It was not affecting your ability to drive safely. Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Lisdexamfetamine contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'. Lisdexamfetamine 40 mg capsules contain Allura Red (E129), a colourant which may cause allergic reactions.

3.

How to take Lisdexamfetamine

How much to take Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Lisdexamfetamine is only for you. Do not give this medicine to anyone else, even if their symptoms seem similar.

How to take it

Lisdexamfetamine

• Take Lisdexamfetamine in the morning before breakfast. It can be taken with or without food.
• There are two ways to take this medicine: ⸰ Swallow the capsule whole with a drink of water ⸰ Open the capsule and empty the contents into: • Soft food such as yogurt • A glass of water or orange juice Use a spoon to break up any bits and stir the Lisdexamfetamine and yogurt, water or orange juice until they are completely mixed together. Eat all the yogurt or drink all the water or orange juice immediately after mixing with this medicine. Do not store it. Do not worry if there is a film left in the glass or container afterwards – this is not the active ingredient. Dose
• Your doctor will tell you what strength of capsule to take each day.
• The recommended dose at the start of treatment is 30 mg, but your doctor may decide to start you on 20 mg. Later on your doctor may increase your dose. The maximum daily dose is 70 mg.
• If you have any kidney related problems your doctor may reduce the dose.
• If you are elderly, your doctor will study your blood pressure and cardiovascular status before starting and during treatment (see section 2 "Do not take Lisdexamfetamine" and "Warnings and precautions"). Your doctor may also need to reduce the dose.
• Do not split the dose of a capsule; take the entire contents of the capsule. Do not take anything less than one capsule per day. If you do not feel better after 1 month of treatment If you do not feel better, tell your doctor. You may need a different treatment. Not using Lisdexamfetamine properly If Lisdexamfetamine is not used properly, it may cause abnormal behaviour. You may also start to feel like you need the medicine for reasons other than helping with your ADHD. Tell your doctor if you have ever had a problem with alcohol, prescription medicines or street drugs If you take more Lisdexamfetamine than you should If you take too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much you have taken. Signs of overdose may include: restlessness, shaking, increased uncontrolled movements, muscle twitching, fast breathing, being confused, an inclination to fight or quarrel, seeing, feeling or hearing things that are not real (hallucinations), panicked state, high fever or muscle breakdown. Tiredness and depression may follow. Being or feeling sick, vomiting, diarrhoea and stomach cramps may also occur. Changes in heartbeat (slow, fast or uneven), high or low blood pressure, circulatory collapse, fits and coma may be seen. If you forget to take Lisdexamfetamine Do not take a double dose to make up for a forgotten dose. If you forget a dose, wait until the next day. Avoid taking it in the afternoon because of the possibility of sleep disturbances (insomnia).

If you stop taking Lisdexamfetamine If you stop taking this medicine, ADHD symptoms may come back. Do not stop taking the medicine without first talking to your doctor. You should not suddenly stop taking this medicine on your own. Things your doctor will do when you take Lisdexamfetamine Your doctor will do some tests

• before you start – to make sure that Lisdexamfetamine is safe for you and will be of benefit to you.
• after you start – your doctor will do tests at least every 6 months, but possibly more often. The tests will also be done if the dose is changed. These tests will include: ⸰ checking your appetite ⸰ measuring height and weight ⸰ measuring blood pressure and heart rate ⸰ checking whether you have any problems with your mood, state of mind or any other unusual feelings, or if these have got worse while taking this medicine. Long-term treatment This medicine does not need to be taken forever. If you take Lisdexamfetamine for more than a year, your doctor should stop treatment for a short time; this may happen during a holiday. This will show if you still need the medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will talk to you about these side effects. Some side effects could be serious. If you get any of the side effects below, see a doctor straight away: Common (may affect up to 1 in 10 people)

• uneven heartbeat (palpitations)
• chest pain (may be a sign of heart problems) Uncommon (may affect up to 1 in 100 people)
• feeling unusually excited, over-active, or un-inhibited (mania)
• allergic reaction (hypersensitivity) Not known: frequency cannot be estimated from the available data
• severe allergic reaction characterised by a sharp drop in blood pressure, difficulty breathing, and hives/itching (anaphylactic reaction)
• seeing or feeling or hearing things that are not real, paranoia, delusions (psychotic episodes)
• fits (seizures)
• abnormal heart rhythm, life-threatening irregular heart rhythm (seen on an electrocardiogram). See section 2, Warnings and precautions
• allergic liver injury seen as possible yellowing of the eyes and/or skin (eosinophilic hepatitis)
• swelling of the skin (angioedema) or serious skin rash seen as severe blisters of the skin and mucous membranes (Stevens- Johnson syndrome)
• breathlessness or swelling of the legs (signs of heart muscle disease)* *The following severe side effects have different frequency in children and/or adolescents compared to adults.

• •

seeing, feeling, or hearing things that are not real is uncommon in children and adolescents breathlessness or swelling of the legs (signs of heart muscle disease) is uncommon in adolescents

If you have any of the side effects above, see a doctor straight away. Other side effects include the following. If they get serious, please tell your doctor or pharmacist: Very common (may affect more than 1 in 10 people)

• decreased appetite
• being unable to sleep
• dry mouth
• headache Common (may affect up to 1 in 10 people)
• feeling agitated, jittery, anxious, depressed, irritable or have mood swings
• feeling tired* or restless
• unable to get or keep an erection or changes in sex drive
• feeling dizzy
• uncontrolled twitching, jerking, shaking, trembling or being unusually active
• hard-to-control, repeated twitching of any parts of the body or repeating sounds and words (tics)
• fast or uneven heartbeat (tachycardia)
• high blood pressure*
• difficulty breathing
• feeling or being sick or diarrhoea
• constipation
• weight loss*
• excessive sweating
• stomach pain
• grinding of the teeth Uncommon (may affect up to 1 in 100 people)
• fever*
• talking excessively
• feeling depressed, anxious, low, or uneasy (dysphoria)
• feeling excessively happy or excited (euphoria)
• excessive picking of the skin
• uncontrolled twitching or jerking of the body
• feeling unusually sleepy
• itching, rash* or raised red itchy rashes (urticaria)
• blurred vision
• metallic taste or changes in taste (dysgeusia)
• fainting
• nosebleed Not known: frequency cannot be estimated from the available data
• excessive widening of the pupils*
• aggression
• poor blood circulation which makes the toes and fingers go numb and pale (Raynaud's phenomenon)* *The following side effects have different frequency in children and/or adolescents compared to adults.
• weight loss is very common in children and adolescents

• • • • • • •

stomach pain is very common in children high temperature (fever) is common in children and adolescents feeling unusually sleepy is common in children and adolescents rash is common in children high blood pressure is uncommon in children and adolescents poor blood circulation which makes the toes and fingers go numb and pale (Raynaud's phenomenon) is uncommon in children excessive widening of the pupils of the eyes is uncommon in children and adolescents

Reporting of side effects If you get any side effects, talk to your doctor 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.

5.

Possible side effects

are the unwanted things that can happen when you take a medicine. If any of the following happen, tell an adult straight away. They can then talk to your doctor. The main things that could affect you are if you: feel your heart beating faster than usual or uneven heartbeat

–

see, feel, or hear things that are not real feel unusually excited or over-active have a severe allergic reaction. This may be seen as feeling dizzy, difficulty breathing, and itching have fits notice yellowing of the eyes and/or skin have swelling of the skin or bad skin rash like blisters of the skin or other areas

If you feel unwell in any way while you are taking your medicine, please tell an adult straight away. Other things to remember Make sure you keep your medicine in a safe place, so that no one else takes it. The medicine is just for you – do NOT let anyone else have it. It may help you, but it could hurt someone else. If you forget to take your medicine don't take 2 capsules the next time. Just take 1 capsule at the next normal time. It is important not to take too much medicine or you will get ill. If you take too much medicine, tell your mum, dad or carer right away. Don't stop taking your medicine until your doctor says it's OK to stop. Who should I ask if there is anything I don't understand? Your mum, dad, carer, doctor, nurse or pharmacist will be able to help you.

How to store it

Lisdexamfetamine

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP. The expiry date refers to the last day of that month. Do not use this medicine if the capsules look damaged in any way. Return any unused product to your pharmacy. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Lisdexamfetamine capsules contain The active substance is lisdexamfetamine dimesylate. Each 20 mg capsule contains 20 mg lisdexamfetamine dimesylate, corresponding to 5.9 mg of dexamfetamine Each 30 mg capsule contains 30 mg lisdexamfetamine dimesylate, corresponding to 8.9 mg of dexamfetamine. Each 40 mg capsule contains 40 mg lisdexamfetamine dimesylate, corresponding to 11.9 mg of dexamfetamine. Each 50 mg capsule contains 50 mg lisdexamfetamine dimesylate, corresponding to 14.8 mg of dexamfetamine. Each 60 mg capsule contains 60 mg lisdexamfetamine dimesylate, corresponding to 17.8 mg of dexamfetamine. Each 70 mg capsule contains 70 mg lisdexamfetamine dimesylate, corresponding to 20.8 mg of dexamfetamine. The other ingredients are: Capsule contents: microcrystalline cellulose (E460), croscarmellose sodium (E468), magnesium stearate (E470b) Capsule shell: gelatin (E441), printing ink (shellac, propylene glycol and black iron oxide E172), titanium dioxide (E171) The 30 mg capsule also contains erythrosine (E127) and quinoline yellow (E104)

The 40 mg capsule also contains brilliant blue (E133) and allura red (E129) The 50 mg capsule also contains brilliant blue (E133) The 60 mg capsule also contains brilliant blue (E133) and erythrosine (E127) The 70 mg capsule also contains brilliant blue (E133), erythrosine (E127) and quinoline yellow (E104) What Lisdexamfetamine looks like and contents of the pack Each 20 mg hard capsule has a white cap and white body, "ALV" printed axially on the white cap, "563" printed axially on the white body, all printing in grey ink and containing white to pale yellow powder. Each 30 mg hard capsule has an orange cap and white body, "ALV" printed axially on the orange cap, "564" printed axially on the white body, all printing in grey ink and containing white to pale yellow powder. Each 40 mg hard capsule has a light blue cap and white body, "ALV" printed axially on the light blue cap, "565" printed axially on the white body, all printing in grey ink and containing white to pale yellow powder. Each 50 mg hard capsule has a dark blue cap and white body, "ALV" printed axially on the dark blue cap, "566" printed axially on the white body, all printing in grey ink and containing white to pale yellow powder. Each 60 mg hard capsule has a blue cap and blue body, "ALV" printed axially on the blue cap, "567" printed axially on the blue body, all printing in grey ink and containing white to pale yellow powder. Each 70 mg hard capsule has an orange cap and blue body, "ALV" printed axially on the orange cap, "568" printed axially on the blue body, all printing in grey ink and containing white to pale yellow powder. Capsules are packed in white HDPE bottles, with child-resistant, white (PP) cap and silica gel desiccant canister. Do not swallow the desiccant. Each bottle contains 28, 30 or 100 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Aristo Pharma GmbH Wallenroder Straβe 13435 Berlin Germany

This leaflet was last revised in 06/2025. —————————————————————————————————————————

Information for children and young people This information is to help you learn the main things about your medicine called Lisdexamfetamine. If you don't enjoy reading, someone like your mum, dad or carer (sometimes called 'your guardian') can read it to you and answer any questions. It may help if you read small bits at a time. Why has the doctor given me this medicine? This medicine can help your 'ADHD'. ADHD can make you: run about too much be unable to pay attention act quickly without thinking about what will happen next (impulsive). It affects learning, making friends and how you think about yourself. It is not your fault. While you are taking this medicine As well as giving you this medicine, your doctor will arrange for you to learn ways to cope with your ADHD such as talking to people who can give you tips or teach you different ways to do things. The medicine should help your ADHD. You will need to go to your doctor several times for check ups. This is to make sure the medicine is working and that you are growing and developing OK. If you take the medicine for more than one year, your doctor may stop your medicine to see if you still need it. This will probably happen in a school holiday. Girls must ask their doctor for advice before taking this medicine if they think they may be pregnant or are planning to have a baby. Some people cannot have this medicine You cannot have this medicine if you: have a problem with your heart feel unusually excited or over-active Some people need to talk to their doctor before they start taking this medicine You need to talk to your doctor if you: have fits are pregnant or breastfeeding are taking other medicines – your doctor needs to know about all the medicines you are taking have bad kidney problems. How do I take my medicine (capsules)? Swallow your capsule with water. Or open the capsule and dissolve all of the contents in a glass of water or orange juice. Or mix the contents into soft food like yogurt. Eat all the yogurt or drink all the water or orange juice straight away after mixing. Take one capsule each morning. You can take it with or without food. Do not stop taking the medicine without talking to your doctor first. If you forget to take your medicine, tell an adult. You must NOT take 2 capsules to make up for the dose you forgot. Possible side effects