Patient leaflet - Lisdexamfetamine Dimesylate Sandoz 20 mg hard capsules
what it is used for
What Lisdexamfetamine Capsules are
Lisdexamfetamine Capsules 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. Lisdexamfetamine Capsules are
a long acting medicine which works gradually over a 13 hour
time period.
What it is used for
Lisdexamfetamine Capsules are 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
Lisdexamfetamine Capsules.
You must talk to a doctor if you do not feel better or if you
feel worse after one month of treatment. Lisdexamfetamine
Capsules are not recommended for all patients with ADHD
and the decision to use this medicine is based on a thorough
medical evaluation.
Lisdexamfetamine Capsules are 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 Capsules 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 Capsules
Do NOT take Lisdexamfetamine Capsules
if you are allergic to lisdexamfetamine, other amfetamine
compounds or any of the other ingredients of this medicine
(listed in section 6)
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
- if you have a thyroid problem
- if you feel unusually excited, over-active, or un-inhibited
if 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
if you have high or very high blood pressure or narrowing
of the blood vessels
- if 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 Lisdexamfetamine Capsules if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before you take Lisdexamfetamine Capsules.
This is because Lisdexamfetamine Capsules 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 history of stroke
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
Capsules can make these problems worse. Your doctor will
want to monitor how the medicine affects you.
If Lisdexamfetamine Capsules are 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.
Lisdexamfetamine Capsules 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 Capsules
These checks are to decide if Lisdexamfetamine Capsules are
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 Capsules are 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 Capsules 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 Capsules.
- For adults, your doctor will watch your weight, as well as how well you are eating.
Other medicines and Lisdexamfetamine Capsules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do NOT take Lisdexamfetamine Capsules if you:
- are taking a medicine called ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have taken an MAOI in the last 14 days. Taking an MAOI with Lisdexamfetamine Capsules may cause a sudden increase in your blood pressure. Your doctor or pharmacist will be able to tell you if you are taking a medicine that is an MAOI.
Lisdexamfetamine Capsules 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 Capsules :
- 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 Capsules.
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 Lisdexamfetamine Capsules into other substances which can cross the placenta and enter breast milk. Available data from the use of Lisdexamfetamine Capsules 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 Capsules.
Driving and using machines
The 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 , ride a bike or horse or climb trees.
- 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 Capsules and sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3 How to take Lisdexamfetamine Capsules
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 Capsules are only for you. Do not give this medicine to anyone else, even if their symptoms seem similar. How to take Lisdexamfetamine Capsules
Take Lisdexamfetamine Capsules in the morning before breakfast. It can be taken with or without food.
There are two ways to take Lisdexamfetamine Capsules:
- 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 Capsules 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 Lisdexamfetamine Capsules. 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.
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- 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 Capsules ’ 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.
If you are not using Lisdexamfetamine Capsules properly
- If you use Lisdexamfetamine Capsules improperly, 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 Capsules 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.
Headache, confusion, seizures and visual changes may
also occur.
If you forget to take Lisdexamfetamine Capsules
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 Capsules
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 Capsules
Your doctor will do some tests
- before you start - to make sure that Lisdexamfetamine Capsules are 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 Lisdexamfetamine Capsules. Long-term treatment
Lisdexamfetamine Capsules does not need to be taken forever. If you take Lisdexamfetamine Capsules 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 or repeating sounds and words (tics)
- 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 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
- 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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in 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 Capsules
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 store above 25°C
Do not use this medicine after the expiry date which is stated on the bottle or blister 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.
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 protect the environment.
6 Contents of the pack and other information
What Lisdexamfetamine Capsules contains
The active substance is lisdexamfetamine dimesylate 20 mg capsules: Each capsule contains 20 mg of lisdexamfetamine dimesylate, equivalent to 5.9 mg of dexamfetamine.
30 mg capsules: Each capsule contains 30 mg of lisdexamfetamine dimesylate, equivalent to 8.9 mg of dexamfetamine.
40 mg capsules: Each capsule contains 40 mg of lisdexamfetamine dimesylate, equivalent to 11.9 mg of dexamfetamine.
50 mg capsules: Each capsule contains 50 mg of lisdexamfetamine dimesylate, equivalent to 14.8 mg of dexamfetamine.
60 mg capsules: Each capsule contains 60 mg of lisdexamfetamine dimesylate, equivalent to 17.8 mg of dexamfetamine.
70 mg capsules: Each capsule contains 70 mg of lisdexamfetamine dimesylate, equivalent to 20.8 mg of dexamfetamine.
- The other ingredients are pregelatinised maize starch, croscarmellose sodium, Silica, colloidal anhydrous and magnesium stearate
- The capsule shells contain gelatin and black ink (consisting of shellac glaze in ethanol (~45%) (E904), iron oxide, black (E172), propylene glycol (E1520) and ammonium hydroxide (E527))
The colourants in the capsule shells are:
20 mg:
Cap: titanium dioxide (E171), yellow iron oxide (E172) Body: titanium dioxide (E171), yellow iron oxide (E172) 30 mg:
Cap: titanium dioxide (E171), erythrosin FD&C red 3 (E127) Body: titanium dioxide (E171)
40 mg:
Cap: titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), brilliant blue FCF – FD&C blue 1 (E133) Body: titanium dioxide (E171)
50 mg:
Cap: titanium dioxide (E171), brilliant blue FCF – FD&C blue 1 (E133)
Body: titanium dioxide (E171)
60 mg:
Cap: titanium dioxide (E171), brilliant blue FCF – FD&C blue 1 (E133)
Body: titanium dioxide (E171), brilliant blue FCF – FD&C blue 1 (E133)
70 mg:
Cap: titanium dioxide (E171), erythrosin FD&C red 3 (E127) Body: titanium dioxide (E171), brilliant blue FCF – FD&C blue 1 (E133)
What Lisdexamfetamine Capsules looks like and contents of the pack
20 mg hard capsule: Opaque ivory body and opaque ivory cap, 18 mm, marked ’20 mg’ on the body and ‘LDA’ on the cap in black ink.
30 mg hard capsule: Opaque white body and opaque pink cap, 18 mm, marked ’30 mg’ on the body and ‘LDA’ on the cap in black ink.
40 mg hard capsule: Opaque white body and opaque blue green cap, 18 mm, marked ’40 mg’ on the body and ‘LDA’ on the cap in black ink.
50 mg hard capsule: Opaque white body and opaque blue cap, 18 mm, marked ’50 mg’ on the body and ‘LDA’ on the cap in black ink.
60 mg hard capsule: Opaque aqua blue body and opaque aqua blue cap, 18 mm, marked ’60 mg’ on the body and ‘LDA’ on the cap in black ink.
70 mg hard capsule: Opaque blue body and opaque pink cap, 18 mm, marked ’70 mg’ on the body and ‘LDA’ on the cap in black ink.
Lisdexamfetamine Capsules are avaliable in Al/PVC/Al/OPA blister packs containing 28, 30, 90 or 120 hard capsules or plastic bottle with desiccant and closed with a child-resistant plastic cap containing 28, 30, 90, 100 or 120 hard capsules Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Sandoz Limited
Maxis 1
Western Road
Bracknell
United Kingdom
RG12 1RF
Manufacturer(s)
Coripharma ehf.
Reykjavikurvegur 78 - 80
IS-220 Hafnarfjordur
ICELAND
Lek d.d.
LEK farmacevtska družba d.d.
Verovškova ulica 57
1526, Ljubljana
Slovenia
This leaflet was last revised in 03/2026
7 Information for children and young people
This information is to help you learn the main things about your medicine called Lisdexamfetamine Capsules.
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
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.
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