ELVANSE 40 MG HARD CAPSULES - patient leaflet, side effects, dosage

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 Elvanse 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.

What is in this leaflet

• 1. What Elvanse is and what it is used for

• 2. What you need to know before you take Elvanse

• 3. How to take Elvanse

• 4. Possible side effects

• 5. How to store Elvanse

• 6. Contents of the pack and other information

• 7. Information for children and young people

1. what elvanse is and what it is used for

What Elvanse is

Elvanse 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. Elvanse is a long acting medicine which works gradually over a 13 hour time period.

What it is used for

Elvanse is a treatment for ‘attention deficit hyperactivity disorder’ (ADHD). It is used:

• in children and young people between the ages of 6 and 18 who have previously taken a methylphenidate treatment that inadequately treated their ADHD. You may continue to take Elvanse into adulthood if your doctor thinks you are benefiting from treatment.

You must talk to a doctor if you do not feel better or if you feel worse after one month of treatment.

Elvanse 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

Elvanse 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

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 child or young person.

2. what you need to know before you take elvanse

Do NOT take Elvanse

• if you are allergic to lisdexamfetamine 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)

Do not take Elvanse if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you take Elvanse. This is because Elvanse can make these problems worse.

Warnings and precautions

Talk to your doctor or pharmacist before using Elvanse 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)
• started your periods – girls only (see the ‘Pregnancy, breastfeeding’ section)
• 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

Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because Elvanse can make these problems worse. Your doctor will want to monitor how the medicine affects you.

Elvanse 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 Elvanse

These checks are to decide if Elvanse 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 Elvanse is the correct medicine for you. Your doctor may decide that other medical tests are needed before you start taking this medicine.

Other medicines and Elvanse

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do NOT take Elvanse 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 Elvanse 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.

Elvanse 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 Elvanse:

• 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 Elvanse.

Drug testing

This medicine may give a positive result when testing for drug use. This includes testing used in sport.

Pregnancy, breast-feeding and fertility

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. Available data from the use of Elvanse during the first three months of pregnancy do not indicate increased risk of congenital malformation in the child, but may increase the risk for preeclampsia (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 amphetamine 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 Elvanse. The effect of Elvanse on fertility is unknown.

Driving and using machines

You may feel dizzy, have problems focusing or have blurred vision when taking Elvanse. If these happen it will be dangerous to do things such as drive, 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

7. Information for children and young people

This information is to help you learn the main things about your medicine called Elvanse.

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

^^^turn «................. over

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.

ability to drive

• However, you would not be committing an offence if:

• – The medicine has been prescribed to treat a medical or dental problem and

• – You have taken it according to the instructions given by the

• – prescriber or in the information provided with the medicine and

• – It was not affecting your ability to drive safely talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Elvanse contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‚sodium-free‘.

3. how to take elvanse

How much to take

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.

Elvanse is only for you. Do not give this medicine to anyone else, even if their symptoms seem similar.

How to take Elvanse

• Take Elvanse in the morning before breakfast. It can be taken with or without food.
• There are two ways to take Elvanse:

o Swallow the capsule whole with a drink of water

o 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 Elvanse 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 Elvanse. 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.
• 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 Elvanse properly

• If Elvanse 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 Elvanse 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.

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.

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.

If you forget to take Elvanse

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 Elvanse

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 Elvanse

Your doctor will do some tests

• before you start – to make sure that Elvanse 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 Elvanse.

Long-term treatment

Elvanse does not need to be taken forever. If you take Elvanse 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)

• seeing, feeling, or hearing things that are not real (hallucinations)
• feeling unusually excited, over-active, or un-inhibited (mania)
• allergic reaction (hypersensitivity)
• breathlessness or swelling of the legs (signs of heart muscle disease)

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)

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 heart beat
• 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
• 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)

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
• weight loss
• being unable to sleep
• dry mouth
• stomach pains
• headache

Common (may affect up to 1 in 10 people)

• feeling agitated, jittery, anxious, depressed, aggressive, irritable or have mood swings
• feeling unusually sleepy, 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
• fast or uneven heartbeat (tachycardia)
• difficulty breathing
• feeling or being sick or diarrhoea
• constipation
• high temperature (fever) or excessive sweating
• rash
• grinding of the teeth

Uncommon (may affect up to 1 in 100 people)

• 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
• itching, rash or raised red itchy rashes (urticaria)
• blurred vision
• excessive widening of the pupils of the eyes
• poor blood circulation which makes the toes and fingers go numb and pale (Raynaud’s phe­nomenon)
• high blood pressure
• metallic taste or changes in taste (dysgeusia)
• fainting

Effects on weight

Elvanse may cause reduced weight in some children and adolescents.

• There may be lack of weight gain.
• Your doctor will carefully watch your height and weight, as well as how well you are eating.
• If you are not growing as expected, then your doctor may stop treatment with Elvanse for a short time.
• 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.

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: 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 elvansedo not store above 25°c.

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.

If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist. 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 informationeach capsules contains 40 mg lisdexamfetamine dimesylate, equivalent to 11.9 mg of dexamfetamine.

The other ingredients are:

• Capsule content: microcrystalline cellulose, croscarmellose sodium, magnesium stearate
• Capsule shell: gelatin, black ink (shellac and black iron oxide E172)
• Capsules shell colourants: titanium dioxide (E171), brilliant blue FCF (E133), black iron oxide E172 and yellow iron oxide (E172)

What Elvanse looks like and contents of the pack

The capsules have a white opaque body and blue/green opaque cap, printed ‘S489’ and ‘40 mg’ in black ink.

Available in bottles of 30 capsules.

Product Licence Holder and Manufacturer

Procured from within the EU by the Product Licence holder Orifarm

A/S, Energivej 15, 5260 Odense S, Denmark

Repacked by Orifarm Supply A/S, Energivej 15, 5260 Odense S, Denmark

Manufactured by

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland

Elvanse® 40 mg hard capsules

Leaflet revision date: 13/07/2021

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• 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.