20 mg, 30 mg, 40 mg, 50 mg 60 mg, 70 mg capsules, hard 
lisdexamfetamine dimylate

Important information about your medicine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

This medicine is used to treat ADHD:

  • ADHD stands for Attention Deficit Hyperactivity Disorder (attention deficit hyperactivity disorder).
  • This drug has a positive effect on brain activity. It can help improve attention, concentration and reduce impulsive behavior.
  • You will also need another type of treatment for ADHD (such as talk therapy and behavioral therapy) in addition to this medicine.

More information can be found in section 1.

Before you start taking this medicine, tell your doctor if you

  • have problems with your heart, circulation, or mental health problems – you may not be able to use this medicine
  • taking other medicines. The reason for this is that Elvanse may affect the effectiveness of other medicines.

More information can be found in section 2.

When you take this medicine:

  • Go to regular doctor’s appointments. This is important because your doctor needs to check how the medicine works.
  • Do not stop taking this medicine without first discussing it with your doctor.
  • If you are taking this medicine for more than a year, your doctor may stop treatment to see if it is still needed.
  • The most common side effects are decreased appetite, weight loss, insomnia, dry mouth, and headaches.

More information can be found in sections 3 and 4.

Contact a doctor immediately if any of the following occur:

  • Your mood (how you feel) changes.
  • You’re having heart problems.

More information can be found in section 4.

The rest of this leaflet contains more detailed information about the medicine and how to use it safely and effectively.

  • Save 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

The package leaflet is divided into different sections:

  • Sections 1 to 6 are for parents and carers (sometimes called your guardians).
  • The last section is especially aimed at children and young people.

However, all sections are written with the child or young person taking the medicine in mind.

In this leaflet you will find information about: 
1. What Elvanse is and what it is used for 
2. What you need to know before taking Elvanse 
3. How to take Elvanse 
4. Possible side effects 
5. How to store Elvanse 
6. Contents of the packaging and other information 

1. What Elvanse is and what it is used for

What Elvanse is

Elvanse contains the active substance lisdexamfetamine dimesylate which has a positive effect on brain activity. It helps to improve attention, concentration and reduce impulsive behavior.

Elvanse is a long-acting drug that works gradually over a 13-hour period.

What it is used for

Elvanse is used in the treatment of ADHD (Attention Deficit Hyperactivity Disorder, ie attention deficit hyperactivity disorder). It is used

  • in children and adolescents between 6 and 18 years of age who have previously been treated with the drug methylphenidate without sufficient effect on ADHD. You can continue to take Elvanse until adulthood if your doctor thinks you may benefit from the 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 to treat ADHD in children under 6 years of age. The safety and benefits of treatment have not been established in this patient population.

How it works

Elvanse improves the activity in certain areas of the brain, which are underactive. The drug can help to improve attention, concentration and reduce impulsive behavior.

The drug is given as part of a treatment program that usually consists of:

  • psychological treatment (psychotherapy)
  • training
  • social therapy.

It is only prescribed by doctors who have experience in treating people with behavioral problems.

About ADHD

People with ADHD have difficulty:

  • sit still
  • concentrate.

It is not their own fault that they can not do these things. ADHD can cause problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, or elsewhere.

ADHD does not affect the intelligence of children or adolescents.

2. What you need to know before taking 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 currently taking so-called monoamine oxidase inhibitors ( MAOIs ) to treat depression, or have done so for the past 14 days
  • if you have thyroid problems
  • if you feel unusually elated, overactive, or uninhibited
  • if you have or have had heart problems, such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or have a congenital heart problem
  • if you have high or very high blood pressure or have narrowing of the blood vessels
  • if you have increased pressure in the eye ( glaucoma ).

Do not take Elvanse if any of the above apply to you. If you have any further questions, ask your doctor or pharmacist before taking Elvanse. This is because Elvanse can exacerbate these problems.

Warnings and cautions

Talk to your doctor before using Elvanse if you

  • have ever abused prescription drugs or narcotics
  • have had kidney problems
  • have had seizures (seizures, convulsions, epilepsy ) or abnormal findings when measuring brain activity ( EEC )
  • have started menstruating (see section “Pregnancy, breast-feeding and fertility” below)
  • have difficult-to-control repeated twitches in any part of the body or repeat sounds and words
  • have high blood pressure
  • previously had an irregular heartbeat or if an irregular heartbeat is present in the family (can be seen on an ECG ), or if you have an illness and/or receive a treatment that allows you to have irregular heartbeats or salt imbalance
  • have a heart problem that is not mentioned in the above section “Do not take Elvanse”
  • have a mental problem. Examples of such mental problems can be:
    • mood swings (from being manic to being depressed, so-called “bipolar disorder”)
    • exhibits aggressive or hostile behavior, or aggravated aggression
    • see, hear or feel things that do not exist (hallucinations)
    • believe in things that are not real (delusions)
    • feels unusually suspicious ( paranoid )
    • feeling upset, anxious, or tense
    • feeling depressed or have feelings of guilt

If any of the above applies to you, tell your doctor or pharmacist before starting treatment. The reason for this is that Elvanse can exacerbate these problems. Your doctor will want to follow up on how the medicine affects you.

Elvanse may cause heart rhythm disturbances in some patients. If you experience palpitations or irregular heartbeats during treatment, tell your doctor immediately. The risk of heart problems can increase if the dose is increased. Therefore, the recommended dosage should be followed.

Checks that the doctor will do before starting treatment with Elvanse

These checks are needed to determine if Elvanse is a suitable medicine for you. Your doctor will talk to you about the following:

  • if you are taking any other medicine
  • if there have been any sudden unexplained deaths in the family
  • if there is any other medical condition (such as heart problems) in you or other people in your family
  • how you feel, e.g. if you are elated or depressed, have strange thoughts or if you have had any such feelings in the past
  • if there have been “tics” within the family (difficult to control repeated twitches in any part of the body or repetition of sounds and words)
  • if you or any other family member has or has had a problem related to mental health or behavioral disorder. Your previous mental health will be checked. It will also check if someone in your family has committed suicide in the past, has bipolar disorder (mood swings from being manic to becoming depressed), or depression.

You must provide as much information as you can. This will help your doctor decide if Elvanse is a suitable medicine for you. Your doctor may decide that more medical tests are needed before you can 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

  • currently taking so-called monoamine oxidase inhibitors ( MAOIs ) for the treatment of depression, or have done so for the past 14 days. Taking MAOIs with Elvanse may lead to a sudden increase in blood pressure. Doctors or pharmacists can tell you if you are taking a medicine that belongs to the group of MAO inhibitors.

Elvanse and some other medicines may affect each other. If you are taking any of the following medicines, you must consult your doctor or pharmacist before taking Elvanse:

  • medicines for serious mental problems
  • medicines for high or low blood pressure
  • drugs used in surgery, e.g. analgesic
  • certain cough medicines and cold medicines that can affect blood pressure. It is important to consult the pharmacy staff before buying any such product.
  • drugs that can affect the acidity of the urine, such as vitamin C ( ascorbic acid ) or sodium bicarbonate (found, for example, in medicines for indigestion).

If you are not sure if any of the medicines you are taking are included in the list above, ask your doctor or pharmacist for advice before taking Elvanse.

Drug tests

This medicine may give positive results in drug abuse tests. This also applies to tests performed at sports events.

Pregnancy, breastfeeding, 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. 

Your body breaks down Elvanse into various substances that can pass through the placenta and turn into breast milk. Available data from the use of Elvanse during the first three months of pregnancy do not indicate an increased risk of congenital malformations in the baby but may increase the risk of preeclampsia (a condition that usually occurs after the 20th week of pregnancy and is characterized by high blood pressure and protein in the urine) as well as premature birth. Newborns exposed to amphetamines during pregnancy may experience withdrawal symptoms (tremors, irritability, tense muscles). You should not use this medicine during pregnancy unless your doctor has told you to. You should not use this medicine while breast-feeding. The effect of Elvanse on fertility is not known.

Driving and using machines

You may feel dizzy, have trouble focusing, or have blurred vision when using Elvanse. If this happens, it can be dangerous to e.g. drive a car or other vehicle, using machines, cycle, riding, or climbing trees.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Elvanse contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

3. How to take Elvanse

How much medicine to take?

Always take this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.

Elvanse has been prescribed for you only. Do not give it to anyone else, even if they show signs of illness similar to yours.

How to take Elvanse

  • Take Elvanse in the morning before breakfast. Elvanse can be taken regardless of the meal.
  • You can take Elvanse in two ways:
    • Swallow the capsule whole with a glass of water
    • open the capsule and empty the contents of
      • soft foods such as yogurt
      • a glass of water or orange juice. Use a spoon to break up any lumps and mix Elvanse with yogurt, water, or orange juice until well blended. Eat or drink the whole mixture one with yogurt, water, or juice directly. Do not save mixture one. Do not worry if there is a coating left in the glass or container – this is not the active substance.

Dose

  • Your doctor will tell you what strength to take each day.
  • The recommended dose at the beginning of treatment is 30 mg, but your doctor may decide to start with 20 mg. The doctor may later need to increase the dose one. The maximum daily dose is 70 mg.
  • If you have kidney problems, your doctor may reduce your dose.
  • Do not divide the capsule but use the entire contents. Take no less than one capsule per day.

If you do not feel better after a month of treatment

Tell your doctor if you do not feel better. Your doctor may decide to use another treatment.

Not using Elvanse properly

  • If Elvanse is not used properly, it can lead to abnormal behavior. It may also start to feel like you need the medicine for a purpose other than treating ADHD. Tell your doctor if you have ever had problems with alcohol, prescription drugs, or drugs.

If you take more Elvanse than you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Talk about how many capsules it is.

Signs of overdose may include the following: restlessness, tremors, increased uncontrolled movements, muscle twitching, rapid breathing, confusion, the tendency to aggression, seeing, feeling, or hearing things that do not exist (hallucinations), panic disorder, high fever, or muscle breakdown. Fatigue and depression can be sequelae. Changes in heart rate (slow, fast, or uneven), high or low blood pressure, circulatory collapse, seizures, and coma can be seen. Nausea or vomiting, diarrhea, 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 miss a dose, wait until the next day. Avoid taking Elvanse in the afternoon as the medicine may cause sleep disturbances (insomnia).

If you stop taking Elvanse

If you suddenly stop taking this medicine, symptoms of ADHD may return.

Do not stop taking this medicine without first discussing it with your doctor. Do not stop treatment suddenly or on your own.

Checks when starting treatment with Elvanse

The doctor will do some checks

  • before starting treatment. This is to ensure that Elvanse is safe and that it will be useful.
  • after starting treatment. Checks will be made at least every six months, but possibly more often. They will also be done when dose one is changed. The controls include the following:
    • control of appetite
    • measurement of height and weight
    • measurement of blood pressure and heart rate
    • control of mood, mood, or other unusual feelings or if these feelings have deteriorated during the time Elvanse has been taken.

Long-term treatment

Elvanse does not have to be taken forever. If you have been taking Elvanse for more than a year, your doctor should stop treatment for a short time. This can be done during a school holiday. This is to check if the medicine is still needed.

If you have any further questions on the use of this product, 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 can be serious. If you get any of the side effects listed below, contact your healthcare provider immediately:

Common (may affect up to 1 in 10 patients)

  • irregular heartbeat (palpitations)
  • chest pain (may be a sign of heart problems).

Uncommon (may affect up to 1 in 100 people)

  • see, feel, or hear things that do not exist (hallucinations)
  • feel unusually elated, overactive, or uninhibited (mania)
  • allergic reaction (hypersensitivity)
  • shortness of breath or bone swelling (signs of heart muscle disease).

No known frequency (cannot be calculated from the available data)

  • signs of a severe allergic reaction: severe drop in blood pressure, shortness of breath, and hives/itching ( anaphylactic reaction )
  • see, feel, or hear things that do not exist, paranoia and delusions (psychotic episodes)
  • seizures (seizures)
  • abnormal heart rhythm, life-threatening irregular heart rhythm (can be seen on ECG ). See Section 2, Warnings and Precautions
  • allergic hepatitis with possible yellowing of the eyes and/or skin ( eosinophilic hepatitis )
  • swelling of the skin ( angioedema ) or a severe rash with blisters on the skin and mucous membranes ( Stevens-Johnson syndrome ).

If you get any of the side effects listed above, contact your healthcare provider immediately.

The other side effects are listed below. If they become serious, consult a doctor or pharmacist:

Very common (may affect more than 1 in 10 people)

  • decreased appetite
  • weight loss
  • insomnia
  • dry mouth
  • abdominal pain
  • headache.

Common (may affect up to 1 in 10 patients)

  • feeling excited, shaky, anxious, depressed, aggressive, irritated, or having mood swings
  • abnormal drowsiness, fatigue, or restlessness
  • inability to get or maintain an erection or changes in sexual drive
  • dizziness
  • uncontrollable twitching or sharp movements, tremors, tremors, or hyperactivity
  • rapid or irregular heartbeat ( tachycardia )
  • difficulty breathing
  • nausea, vomiting, or diarrhea
  • constipation
  • high temperature (fever) or excessive sweating
  • rash
  • gnashing of teeth.

Uncommon (may affect up to 1 in 100 people)

  • excessive talkativeness
  • feeling depressed, anxious, low, or restless ( dysphoria )
  • feeling overly elated or hurried ( euphoria )
  • forced withdrawal of skin
  • uncontrolled twitching or sharp movements
  • itching, rash, or a raised red itchy rash ( hives )
  • dimsyn
  • the greatly dilated pupil is
  • poor blood circulation that causes fingers and toes to become numb and pale (Raynaud’s phenomenon)
  • high blood pressure
  • metallic taste in the mouth or taste changes ( dysgeusia )
  • fainting.

Effects on weight

Elvanse can cause weight loss in some children and adolescents.

  • Failure to gain weight may occur.
  • Your doctor will closely monitor your progress in terms of height and weight and how well you eat.
  • If you do not grow as expected, your doctor may stop taking Elvanse for a short time.

5. 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 can and carton after EXP. The expiration date is the last day of the specified month.

Do not use this medicine if the capsules look damaged in any way.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is lisdexamfetamine dimesylate.

One 20 mg capsule contains 20 mg of lisdexamfetamine dimesylate, equivalent to 5.9 mg of dexamphetamine.

One 30 mg capsule contains 30 mg of lisdexamfetamine dimesylate, equivalent to 8.9 mg of dexamphetamine.

One 40 mg capsule contains 40 mg of lisdexamfetamine dimesylate, equivalent to 11.9 mg of dexamphetamine.

One 50 mg capsule contains 50 mg of lisdexamfetamine dimesylate, equivalent to 14.8 mg of dexamphetamine.

One 60 mg capsule contains 60 mg of lisdexamfetamine dimesylate, equivalent to 17.8 mg of dexamphetamine.

One 70 mg capsule contains 70 mg of lisdexamfetamine dimesylate, equivalent to 20.8 mg of dexamphetamine.

Other ingredients are:

  • Capsule contents: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
  • Capsule shell: gelatin and black ink (shellac and black iron oxide E172).
  • Dyes in the capsule shell: titanium dioxide (E171)
    • The 20 mg capsule also contains yellow iron oxide (E172)
    • The 30 mg capsule also contains erythrosine (E127)
    • The 40 mg capsule also contains brilliant blue FCF (E133), black iron oxide (E172), and yellow iron oxide (E172)
    • The 50 mg capsule also contains brilliant blue FCF (E133)
    • The 60 mg capsule also contains brilliant blue FCF (E133)
    • The 70 mg capsule also contains brilliant blue FCF (E133) and erythrosine (E127)

What the medicine looks like and the contents of the pack

Capsules, hard

The 20 mg capsules are opaque with an ivory white base and an ivory white top, marked with “S489” and “20 mg” in black ink.

The 30 mg capsules are opaque with a white base and a pink top, marked with “S489” and “30 mg” in black ink.

The 40 mg capsules are opaque with a white base and a blue/green top, marked with “S489” and “40 mg” in black ink.

The 50 mg capsules are opaque with a white base and blue top, marked with “S489” and “50 mg” in black ink.

The 60 mg capsules are opaque with a turquoise base and a turquoise top, marked with “S489” and “60 mg” in black ink.

The 70 mg capsules are opaque with a blue base and a pink top, marked with “S489” and “70 mg” in black ink.

Pack sizes: 28 or 30 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

Ireland

Tel: +44 (0) 1256 894 959

Email: medinfoEMEA@shire.com

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder :

Takeda Pharma AB

Vasagatan 7, 6 tr

111 20 Stockholm

Muhammad Nadeem

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