Elvanse 20mg, 40mg and 60mg Capsules - Consumer Medicine Information
|Condition:||ADHD (Attention Deficit Hyperactivity Disorder), Binge Eating Disorder|
|Ingredients:||lisdexamfetamine dimesylate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, gelatin, black ink (shellac and black iron oxide E172)|
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.
People with ADHD find it hard to:
- sit still
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.
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 Contents of the Pack and Other Information)
- 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, breast-feeding’ section)
- hard-to-control and repeated twitching of any parts of the body or you repeat sounds and words
- high blood pressure
- 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.
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.
This medicine may give a positive result when testing for drug use. This includes testing used in sport.
Pregnancy, Breast-feeding and Fertility
It is not known if Elvanse will affect an unborn baby. Your body breaks down Elvanse into other substances which can cross the placenta and enter breast milk. 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. 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 or 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.
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:
- 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 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.
- 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.
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 heart beat (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.
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.
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)
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)
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)
- 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)
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
Common (may affect up to 1 in 10 people)
- feeling agitated, jittery, anxious, 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
- high blood pressure, fast or uneven heart beat (tachycardia)
- difficulty breathing
- feeling or being sick or diarrhoea
- stomach pains
- high temperature (fever) or excessive sweating
- 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)
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.
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). By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Elvanse
Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
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.
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.
Contents of the Pack and Other Information
What Elvanse Contains
The active substance is Lisdexamfetamine dimesylate.
Each 20 mg capsule contains 20 mg Lisdexamfetamine dimesylate, corresponding to 5.9 mg of dexamfetamine.
Each 40 mg capsule contains 40 mg Lisdexamfetamine dimesylate, corresponding to 11.9 mg of dexamfetamine
Each 60 mg capsule contains 60 mg Lisdexamfetamine dimesylate, corresponding to 17.8 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)
- The 20 mg capsule also contains yellow iron oxide (E172)
- The 40 mg capsule also contains brilliant blue FCF (E133), black iron oxide E172 and yellow iron oxide (E172)
- The 60 mg capsule also contains brilliant blue FCF (E133)
What Elvanse Looks Like and Contents of the Pack
The 20 mg capsules have an ivory opaque body and an ivory opaque cap, printed ‘S489’ and ’20mg’ in black ink.
The 40 mg capsules have a white opaque body and blue/green opaque cap, printed ‘S489’ and ’40mg’ in black ink.
The 60 mg capsules have an aqua blue opaque body and an aqua blue opaque cap, printed ‘S489’ and ’60mg’ in black ink.
Pack sizes: 28 or 30 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Shire Pharmaceutical Contracts Limited
Hampshire International Business Park
Chineham, Basingstoke, Hampshire RG24 8EP United Kingdom
Shire Pharmaceuticals Limited
Hampshire International Business Park
Hampshire RG24 8EP
Tel. Number: 0800 055 6614
This Medicinal Product is Authorised in the Member States of the EEA Under the Following Names