Patient leaflet - Lisdexamfetamine Dimesylate 10 mg/ml oral solution
1. What Lisdexamfetamine is and what it is used for
What Lisdexamfetamine is
This medicine contains 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 Lisdexamfetamine is used for
Lisdexamfetamine is a part of a comprehensive treatment programme 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 this medicine.
You must talk to a doctor if you do not feel better or if you feel worse after one month of treatment.
This medicine is not recommended for all patients with ADHD and the decision to use this medicine is based on a thorough medical evaluation.
This medicine 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 Lisdexamfetamine 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 Lisdexamfetamine
Do NOT take Lisdexamfetamine if:
you are allergic to lisdexamfetamine, other amfetamine compounds 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)
if you have a condition called phaeochromocytoma (a rare tumour that usually grows in the
adrenal glands which are above your kidneys)
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 taking 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 this medicine is not used properly, it may cause abnormal behaviour and the patient 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) that 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
- This medicine 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 this medicine.
- 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 this medicine.
Drug testing
This medicine may give a positive result when testing for drug use.
Pregnancy and breast-feeding
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 this medicine into other substances, which can cross the placenta and enter breast milk. Available data from the use of lisdexamfetamine dimesylate 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 characterised 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, or breast feed while taking Lisdexamfetamine.
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:
- A doctor has prescribed this medicine for you and
- You have taken it according to his or her instructions, or with the information in this leaflet and
- 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 methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate and propylene glycol.
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’. This medicine contains 100 mg propylene glycol per ml of oral solution.
This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
3. How to take Lisdexamfetamine
Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
- Your doctor will tell you how much to take each day.
- The recommended dose at the start of treatment is 30 mg (3 ml), but your doctor may decide to start you on 20 mg (2 ml). Later on your doctor may increase your dose. The maximum daily dose is 70 mg (7 ml).
- If you have any kidney related problems your doctor may reduce the dose.
How to take Lisdexamfetamine
Take this medicine in the morning before breakfast. It can be taken with or without food.
- This medicine is for oral use only.
Directions for opening the bottle and using the syringe
- 1. Open the bottle: Press downward on the cap and turn it counter-clockwise.
- 2. First time use only: a Press-In Bottle Adapter (PIBA) and an oral syringe are provided. The adapter gets inserted into the neck of the bottle to make it easier to withdraw the solution using the oral syringe. If the PIBA is not already in place, remove the PIBA and oral syringe from the plastic overwrap. With the bottle on a flat surface, insert the PIBA firmly into the bottle neck while keeping the PIBA’s flat surface facing up and pressing on it (see Fig. 1).
- 3. Push the syringe plunger to the bottommost position of the syringe (toward its tip) to remove excess air. Attach the syringe to the PIBA with a slight twisting motion and ensure it is secure. Hold the syringe in place and turn the bottle upside down and gently pull down the plunger to requested dose (see Fig. 2).
- 4. Fill the syringe with the liquid by pulling the syringe plunger down to just beyond the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor. Remove air bubbles from the syringe by pushing the plunger up to the appropriate graduation mark.
- 5. Turn the bottle the right way up. Remove the oral dosing syringe from the bottle by holding onto the bottle and twisting out gently (see Fig. 3)
- 6. Empty the oral syringe into a glass of water, cola drink or fruit juice or directly in the patient’s mouth by sliding the upper ring down and drink it immediately; do not mix the solution with tea for dilution as this may result in modification of the characteristics and effectiveness of the product. Any mixing outside the recommendations is the responsibility of the health care professional or the user.
- 7. After use, the bottle cap must be replaced leaving the adaptor in place.
- 8. Rinse the oral syringe and wash it with cold or warm water after each use and dry it completely before the next use.
The oral syringe has a maximum volume of 8 ml.
Fig. 1
Fig. 2
Fig. 3 Package leaflet: Information for the patient
Lisdexamfetamine dimesylate 10 mg/ml oral solution Important things you need to know about your medicine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is used to treat ADHD:
- The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’.
- The medicine helps with your brain activity. It can help improve your attention, help you concentrate, and make you less impulsive.
- You need to have other treatments for ADHD (such as counselling and behavioural therapy) as well as this medicine. Read Section 1 for more information.
Before you take this medicine, talk to your doctor if you:
- have heart, circulation, or mental health problems - you may not be able to take this medicine.
- are taking any other medicines - this is because this medicine can affect how other medicines work. Read Section 2 for more information.
While taking this medicine:
- See your doctor regularly. This is because your doctor will want to check how the medicine is working.
- Do not stop taking the medicine without first talking to your doctor.
- If you take your medicine for more than a year, your doctor may stop your medicine to see if it is still needed.
- The most common side effects are decreased appetite, weight loss, being unable to sleep, dry mouth or headache. Read Sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
- Your mood or how you feel changes.
- You feel any problems with your heart.
Read Section 4 for more information.
The rest of this leaflet includes more detail and other important information to help you use this medicine safely and effectively.
- 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.
The leaflet is in sections:
- Sections 1 to 6 are for parents and carers (sometimes called ‘your guardians’).
- The last section is a special section for a child or young person to read.
However, all sections are written as though the child or young person taking the medicine is reading them. 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.
If you are not taking Lisdexamfetamine properly
If this medicine is not taken properly, you may experience abnormal behaviour or you could become dependent on the medicine. Therefore please tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs before.
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.
changes in heartbeat (slow, fast or uneven), high or low blood pressure, circulatory collapse, fits
and coma may be seen.
- being or feeling sick, diarrhoea and stomach cramps may also occur.
- headache, confusion, seizures and visual changes may also occur
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 this medicine 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 and delusions (psychotic episodes)
worsening of Tourette´s Disorder with signs such as hard-to-control, repeated twitching of any
parts of the body of repeating sounds and words (tics)
- fits (seizures)
abnormal heart rhythm, life-threatening irregular heart rhythm (seen on an electrocardiogram).
- 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 restlessness
- 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
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 at 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. How to store Lisdexamfetamine
Keep this medicine out of the sight and reach of children.
Store this medicine in a safe storage space, where other people cannot access it. It can cause serious harm to people when it has not been prescribed for them.
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 store above 30°C.
After first opening of the bottle: do not store more than 60 days.
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 contains
- The active substance is lisdexamfetamine dimesylate. Each ml of oral solution contains 10 mg lisdexamfetamine dimesylate, equivalent to 2.95 mg of dexamfetamine.
- The other ingredients are: sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, propylene glycol (E1520), saccharin sodium and purified water.
What Lisdexamfetamine looks like and contents of the pack
The solution is clear and colourless to slightly yellow, in an amber glass bottle or amber brown PET bottle, sealed with a child-proof and tamper evident plastic cap, containing 100 ml oral solution.
A dosing syringe and a plastic plug that is able to fit on the bottle, as well as allow the dosing syringe to fit (Press-In Bottle Adapter), are also provided. The dosing syringe has a volume of 8 ml and the graduations are in steps of 0.1 ml up to the maximum daily dose of 7 ml.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
This leaflet was last revised in 02/2026.
- 7. 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
- Your doctor, your mum, dad or carer will tell you how much oral solution to take each day.
- An adult will also help you or show you how to open the bottle and use the syringe
- The recommended dose at the start of treatment is 3 ml, but your doctor may decide to start you on 2 ml. Later on, your doctor may increase your dose. The maximum daily dose is 7 ml.
- Take one dose 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 doses to make up for the dose you forgot.
Possible side effects
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 doses the next time. Just take 1 dose 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.
This medicine contains sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate and propylene glycol, ingredients that may cause allergic reactions (possibly delayed).
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.
GI1729000-05/UK/0226 50021484/2
Customer Aristo Pharma GmbH
Product Name Lisdexamfetamine 10mg-ml solution PIL
Market United Kingdom (UK)
Language/s English
Ref Code GI1729000-05/UK/0226
Our Ref Lisde-10mg-ml-sol-uk-leaflet-v9_50021484-2-soft-proof
— (** to follow final proof)
Issue 09
Date 06 February 2026
SPECIFICATION DETAILS
Origination 17 June 2024 — (as Issue 01)
Dimensions 360 x 690 mm
Border 11 mm Left, Right, Bottom, Top 13mm
Font details Main title: Frutiger LT Std - 75 Black - 26pt
Sub-titles: Frutiger LT Std - 75 Black — 12pt Body copy: Frutiger LT Std - 55 Roman — 10 pt
Colours Black - K
