Elvanse

Package Leaflet: Information for the Patient

Elvanse, 20 mg, Hard Capsules

Elvanse, 30 mg, Hard Capsules

Elvanse, 40 mg, Hard Capsules

Elvanse, 50 mg, Hard Capsules

Elvanse, 60 mg, Hard Capsules

Elvanse, 70 mg, Hard Capsules

Lisdexamfetamine dimesylate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Elvanse and what is it used for
• 2. Important information before taking 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 adolescents

1. What is Elvanse and what is it used for

What is Elvanse

Elvanse contains lisdexamfetamine dimesylate. It is a substance that helps regulate brain function. It facilitates focus and reduces restlessness. Elvanse acts gradually and for a long time - for 13 hours.

What is Elvanse used for

Elvanse is used to treat Attention Deficit Hyperactivity Disorder (ADHD) as part of a comprehensive treatment program:

• in children and adolescents from 6 to 18 years old, if previous treatment with methylphenidate did not reduce ADHD symptoms;
• in adults who have had ADHD since childhood. Before prescribing Elvanse to a person who has not been previously treated for ADHD, the doctor will determine if the disorder has existed since childhood.

If there is no improvement or the patient feels worse after one month of treatment, they should consult a doctor. Elvanse is not recommended for all patients with ADHD. The decision to use it is made based on a thorough medical assessment. Elvanse is not given to children with ADHD under 6 years old, as it is not known if it is safe and beneficial for such young people.

How does Elvanse work

Elvanse improves the functioning of certain parts of the brain with reduced activity. This can facilitate concentration and reduce restlessness. The medicine is used with other treatment methods:

• psychotherapy
• educational programs
• developing social skills
• behavioral therapy
• occupational therapy

The medicine should only be prescribed by doctors experienced in treating behavioral disorders.

ADHD

Patients with ADHD have problems with:

• staying in one place
• focusing attention

ADHD is not the patient's fault, but it can cause problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving well at home, school, or other places. ADHD does not affect intelligence.

2. Important information before taking Elvanse

When not to take Elvanse

• if the patient is allergic to lisdexamfetamine, other amphetamine compounds, or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking or has taken in the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOIs)
• if the patient has been diagnosed with a thyroid disease
• if the patient feels agitated, highly active, or has no inhibitions
• if the patient has ever had heart problems, such as a heart attack, irregular heartbeat, chest pain, or heart failure, or other heart problems or congenital heart defects
• if the patient has high blood pressure or narrowed blood vessels
• if the patient has been diagnosed with glaucoma (high pressure in the eye)

In these cases, do not take Elvanse. If the patient has any doubts, they should consult a doctor or pharmacist before treatment. This is because treatment may worsen the mentioned symptoms.

Warnings and precautions

Before starting treatment with Elvanse, the patient should discuss it with a doctor or pharmacist if:

• the patient has ever abused drugs or addictive substances
• the patient has kidney problems
• the patient has had seizures (epilepsy) or abnormal EEG results
• the patient has had uncontrolled muscle contractions or involuntarily repeated sounds or words
• the patient has been diagnosed with high blood pressure
• there have been heart rhythm disorders (visible on an electrocardiogram) or diseases treated with drugs that cause heart rhythm disorders, or mineral salt imbalance in the patient or their family
• the patient has other heart problems beyond those mentioned above in the "When not to take Elvanse" section
• the patient has had a stroke
• the patient has mental health problems, such as:
• severe mood swings (bipolar affective disorder, where mood swings from mania to depression)
• feeling aggressive or hostile, or increased aggression
• seeing, hearing, or feeling non-existent things (hallucinations)
• believing in untrue things (delusions)
• strong suspicion (paranoia)
• agitation, anxiety, or increased tension
• depression or feelings of guilt

This also applies to women who are able to become pregnant, plan to become pregnant, or are breastfeeding (see "Pregnancy and breastfeeding"). The patient should tell the doctor or pharmacist before treatment if they have experienced any of these symptoms. This is because treatment may worsen the mentioned symptoms. The doctor will monitor the patient's response to the medicine. Misuse of Elvanse can lead to behavioral disorders, and the patient taking the medicine may become dependent on it. If the patient has abused alcohol, prescription drugs, or illegal psychoactive substances, or is addicted to them, they should inform the doctor. Do not give the medicine to other people - even if they have similar symptoms. In some patients, Elvanse may cause heart rhythm disorders. If irregular heartbeat occurs during treatment, the patient should immediately inform the doctor. The risk of heart problems may increase with the dose. Therefore, the prescribed dose should be taken.

Before starting treatment, the doctor will examine the patient

The doctor will perform the examinations listed below and decide if treatment with Elvanse is suitable. The doctor will ask:

• Is the patient taking other medicines?
• Has anyone in the patient's family died suddenly for unknown reasons?
• Does the patient or anyone in their family have other health problems (e.g., heart disease)?
• How does the patient feel: are they happy or sad, do they currently or have they had unusual thoughts in the past?
• Does the patient or anyone in their family have "tics" (involuntary repetition of words or movements)?
• Has the patient or anyone in their family had mental health problems or behavioral disorders? The doctor will conduct a mental health interview and may ask if there have been suicidal attempts, bipolar affective disorder (severe mood swings from depression to mania), or depression in the patient's family.

It is essential for the patient to answer the doctor's questions honestly and in detail. This will allow the doctor to ensure that treatment with Elvanse is suitable for the patient. Before treatment, the doctor may order additional tests.

Weight changes

• Elvanse may cause weight loss in some patients.
• Children and adolescents may not gain weight.
• In the case of children and adolescents, the doctor will closely monitor growth, weight, and appetite.
• If the growth rate is not as expected or if there is weight loss, the doctor may stop Elvanse treatment.
• In adult patients, the doctor will monitor growth and appetite.

Elvanse and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take in the future. When not to take Elvanse:

• If the patient is taking or has taken MAOIs in the last 14 days. Taking Elvanse and MAOIs can cause a sudden increase in blood pressure. The doctor or pharmacist can tell the patient which medicines are MAOIs.

Elvanse and some other medicines may interact with each other. Before starting treatment with Elvanse, the patient should consult a doctor or pharmacist if they are taking:

• medicines for severe mental illnesses
• medicines that increase or decrease blood pressure
• medicines used during surgical procedures, such as painkillers
• cold and cough medicines. Some of these medicines can increase blood pressure, so the patient should consult a pharmacist before buying them
• medicines that change urine acidity, such as vitamin C (ascorbic acid) or sodium bicarbonate (e.g., in antacids).

If the patient is unsure or if the medicine is not on the above list, they should consult a doctor or pharmacist before treatment.

Tests for detecting illegal substances

This medicine may cause a positive result in tests for detecting illegal substances.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult a doctor before taking this medicine. The body breaks down Elvanse into substances that can pass through the placenta and into breast milk. Available data on the use of Elvanse in the first three months of pregnancy do not indicate an increased risk of birth defects in the child, but may increase the risk of pre-eclampsia (a condition that usually occurs after the 20th week of pregnancy, characterized by high blood pressure and protein in the urine) and premature birth. Newborns exposed to amphetamine during pregnancy may experience withdrawal symptoms (shaking, irritability, increased muscle tone). This medicine should not be used during pregnancy unless clearly prescribed by a doctor; during treatment, breastfeeding should be avoided.

Driving and using machines

During treatment with Elvanse, patients may experience blurred vision or dizziness. In such cases, driving, operating machinery, and activities such as horse riding, cycling, or climbing trees may be dangerous.

Elvanse contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Elvanse

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult a doctor or pharmacist. Elvanse has been prescribed for a specific patient and should not be given to others, even if they have similar symptoms.

How to take Elvanse

• Elvanse should be taken in the morning before breakfast. It can be taken with or without food.
• Elvanse can be taken in two ways: either swallow the whole capsule with water or open the capsule and pour the contents into yogurt or another soft food, or a glass of water or orange juice. Mix the Elvanse with yogurt, water, or orange juice thoroughly with a spoon. After mixing, the patient should immediately eat the yogurt or drink the water or orange juice. Do not delay taking the medicine. After drinking the medicine, a white residue may remain on the container or glass. However, this should not be a concern, as it does not contain the active substance.

Dose

• The doctor will inform the patient which dose to take daily.
• The recommended starting dose is 30 mg, but the doctor may decide to start with a 20 mg dose. Later, the doctor may increase the dose. The maximum daily dose is 70 mg.
• If the patient has kidney disease, the doctor may reduce the dose.
• If the patient is elderly, the doctor will monitor blood pressure and cardiovascular assessment (see section 2 "When not to take Elvanse" and "Warnings and precautions") before starting treatment and during treatment. The doctor may also consider reducing the dose.
• Do not reduce doses or take partial capsules on your own. Always take the entire contents of the capsule. Do not take less than one capsule per day.

If the patient does not feel better after 1 month of treatment

If the patient does not feel better, they should tell the doctor. The doctor may then change the treatment.

If the patient takes Elvanse incorrectly

If the patient takes Elvanse incorrectly, they may experience behavioral disorders or become dependent on the medicine. Therefore, the patient should inform the doctor if they have ever had problems with abuse or dependence on alcohol, prescription drugs, or illegal psychoactive substances. Do not give the medicine to other people - even if they have similar symptoms.

Taking a higher dose of Elvanse than recommended

If the patient takes too much of the medicine, they should immediately consult a doctor or call an ambulance. The patient should tell the medical staff what dose they took. Symptoms of overdose may include: restlessness, shaking, increased uncontrolled movements, minor muscle contractions, rapid breathing, confusion, aggression, and hallucinations. Later, fatigue and depression may occur. Patients may experience nausea, vomiting, diarrhea, or abdominal cramps. In some cases, changes in heart rhythm (fast, slow, or irregular heartbeat), low or high blood pressure, circulatory collapse, seizures, and coma may occur.

Missing a dose of Elvanse

Do not take a double dose to make up for a missed dose. If the patient forgets to take a dose, they should wait and take the next dose the following day. Do not take the medicine in the afternoon, as it may cause insomnia or disrupt sleep.

Stopping Elvanse treatment

If the patient stops taking Elvanse, ADHD symptoms may return. Do not stop treatment without consulting a doctor. Do not stop taking the medicine abruptly on your own.

Control tests during Elvanse treatment

The doctor will perform certain tests during Elvanse treatment

• Before starting treatment, the doctor will check if the treatment is safe and beneficial for the patient.
• During treatment, the doctor will schedule control tests every 6 months or more frequently, as well as after each dose change. Control tests may include:
• assessing the patient's appetite
• measuring the patient's growth and weight
• measuring the patient's blood pressure and pulse
• checking for mood, thinking, or feeling disorders and if they have worsened during Elvanse treatment

Long-term treatment

Treatment with Elvanse will not be necessary for the rest of the patient's life. If treatment is needed for more than a year, the doctor may recommend a short break in treatment (e.g., during vacations). This will help determine if the medicine is still necessary. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Elvanse can cause side effects, although not everybody gets them. The doctor will discuss possible side effects with the patient.

Serious side effects may occur. If any of the following symptoms appear, the patient should immediately consult a doctor:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• excessive stimulation, excessive activity, lack of inhibitions (mania)
• allergic reactions (hypersensitivity)

Rare (frequency cannot be estimated from available data)

• severe allergic reactions with a sudden drop in blood pressure, shortness of breath, and itching/hives (anaphylactic reaction)
• seeing, feeling, or hearing non-existent things*, paranoia, and delusions (psychotic symptoms)
• worsening of Tourette's syndrome, characterized by uncontrollable, repetitive movements or sounds
• seizures (convulsions)
• heart rhythm disorders, life-threatening irregular heartbeat (visible on an electrocardiogram). See section 2 "Warnings and precautions"
• allergic liver damage, which may be accompanied by yellowing of the eyes and/or skin (eosinophilic hepatitis)
• skin swelling (angioedema) or severe rash with blisters on the skin and mucous membranes (Stevens-Johnson syndrome)
• shortness of breath or swelling of the legs (signs of heart disease)*

* The frequency of the following serious side effects is different in children and/or adolescents than in adults.

• seeing, feeling, or hearing non-existent things in children and/or adolescents is uncommon
• shortness of breath or swelling of the legs (signs of heart disease) in adolescents is uncommon

If any of these symptoms appear, the patient should immediately consult a doctor.

Other side effects may also occur. If they worsen, the patient should tell their doctor or pharmacist.

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

• decreased appetite
• sleeping problems
• dry mouth
• headache

Common (may affect up to 1 in 10 people)

• stimulation, irritability, anxiety, depression, or mood swings
• feeling tired* or restlessness
• difficulty achieving or maintaining an erection or changes in libido
• dizziness
• uncontrolled muscle contractions, involuntary movements, or tremors
• uncontrolled, repetitive muscle contractions or involuntary repetition of sounds or words (tics)
• irregular or fast heartbeat (tachycardia)
• high blood pressure*
• shortness of breath
• nausea, vomiting, or diarrhea
• constipation
• weight loss*
• excessive sweating
• abdominal pain
• teeth grinding

Uncommon (may affect up to 1 in 100 people)

• fever*
• logorrhea
• feeling depressed, anxious, low, or restless (dysphoria)
• feeling happy and excited (euphoria)
• frequent "skin picking"
• uncontrolled muscle contractions or sudden body movements
• excessive sleepiness
• itching, rash*, or red itchy skin (hives)
• blurred vision
• metallic taste or changes in taste (taste disorders)
• fainting
• nosebleeds

Rare (frequency cannot be estimated from available data)

• pupil dilation*
• aggression
• poor blood circulation, causing numbness and paleness of fingers and toes (Raynaud's phenomenon)*

* The frequency of the following side effects is different in children and/or adolescents than in adults.

• weight loss is common in children and adolescents
• abdominal pain is very common in children
• fever is common in children and adolescents
• excessive sleepiness is common in children and adolescents
• rash is common in children
• high blood pressure is uncommon in children and adolescents
• poor blood circulation, causing numbness and paleness of fingers and toes (Raynaud's phenomenon), is uncommon in children
• pupil dilation is uncommon in children and adolescents

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Elvanse

Do not store above 25°C. The medicine should be kept out of sight and reach of children. The medicine should be stored in a safe place, inaccessible to other people. Taking the medicine by people it was not prescribed for may have serious health consequences. Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated. Do not use this medicine if the capsules are damaged. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Elvanse contains

• The active substance is lisdexamfetamine dimesylate

Each 20 mg capsule contains 20 mg of lisdexamfetamine dimesylate, which corresponds to 5.9 mg of dexamfetamine. Each 30 mg capsule contains 30 mg of lisdexamfetamine dimesylate, which corresponds to 8.9 mg of dexamfetamine. Each 40 mg capsule contains 40 mg of lisdexamfetamine dimesylate, which corresponds to 11.9 mg of dexamfetamine. Each 50 mg capsule contains 50 mg of lisdexamfetamine dimesylate, which corresponds to 14.8 mg of dexamfetamine. Each 60 mg capsule contains 60 mg of lisdexamfetamine dimesylate, which corresponds to 17.8 mg of dexamfetamine. Each 70 mg capsule contains 70 mg of lisdexamfetamine dimesylate, which corresponds to 20.8 mg of dexamfetamine.

• Other ingredients are:
• Capsule contents: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), and magnesium stearate (E 572)
• Capsule shell: gelatin, titanium dioxide (E 171)
• The 20 mg capsule also contains yellow iron oxide (E 172)
• The 30 mg capsule also contains erythrosine (E 127)
• The 40 mg capsule also contains brilliant blue FCF (E 133), black iron oxide (E 172), and yellow iron oxide (E 172)
• The 50 mg capsule also contains brilliant blue FCF (E 133)
• The 60 mg capsule also contains brilliant blue FCF (E 133)
• The 70 mg capsule also contains brilliant blue FCF (E 133) and erythrosine (E 127)
• Printing ink: shellac (E 904); potassium hydroxide (E 525); black iron oxide (E 172); propylene glycol (E 1520); concentrated ammonia solution (E 527)

What Elvanse looks like and contents of the pack

Hard capsules. The 20 mg capsules have an ivory-colored body and an ivory-colored cap with "S489" and "20 mg" printed in black ink. The 30 mg capsules have a white body and a pink cap with "S489" and "30 mg" printed in black ink. The 40 mg capsules have a white body and a green-blue cap with "S489" and "40 mg" printed in black ink. The 50 mg capsules have a white body and a blue cap with "S489" and "50 mg" printed in black ink. The 60 mg capsules have a turquoise body and a turquoise cap with "S489" and "60 mg" printed in black ink. The 70 mg capsules have a blue body and a pink cap with "S489" and "70 mg" printed in black ink. Pack sizes: 28 or 30 capsules, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, e-mail: medinfoEMEA@takeda.com

• 50 – 58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

Manufacturer

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

• 50 – 58 Baggot Street Lower, Dublin 2, Ireland

Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

• 50 – 58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

Takeda GmbH, Lehnitzstrasse 70-98, Oranienburg, Brandenburg, 16515, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Elvanse

Belgium: Elvanse

Denmark: Elvanse

Estonia: Elvanse

Finland: Elvanse

Spain: Elvanse

Ireland: Tyvense

Luxembourg: Elvanse

Netherlands: Elvanse

Germany: Elvanse

Norway: Elvanse

Poland: Elvanse

Portugal: Elvanse

Sweden: Elvanse

United Kingdom (Northern Ireland): Elvanse

Date of last revision of the package leaflet: 11/2024

7. Information for children and adolescents

This leaflet will help you understand the most important information about Elvanse. If you cannot read the leaflet yourself, ask your parents, grandparents, or another caregiver to read it to you and explain it. Reading short sections can make it easier to understand the text.

Why did the doctor prescribe this medicine?

This medicine is used to treat ADHD, a condition you have been diagnosed with. Children and adolescents with ADHD may:

• be overly active
• have trouble focusing
• act very quickly and without thinking (be impulsive).

ADHD affects learning in school, making new friends, and thinking about yourself. It is not your fault that you have ADHD.

Treatment

• The doctor will prescribe the medicine and tell you how to deal with ADHD, such as talking to people who can help and teaching you how to cope with the symptoms of the condition.
• The medicine should reduce the ADHD symptoms you have been diagnosed with.
• You will visit the doctor for check-ups. The doctor will check if the medicine is working and if you are growing and developing well.
• If treatment is needed for more than a year, the doctor may recommend a short break in treatment (e.g., during vacations). This will help determine if the medicine is still necessary.
• Girls who think they may be pregnant or plan to have a baby should consult a doctor before taking this medicine.

Some children should not take this medicine

You should not take this medicine if:

• you have heart problems
• you have problems with excessive stimulation or very high activity

Sometimes you should talk to your doctor before treatment

Tell your doctor if:

• you have had seizures
• you are pregnant or breastfeeding
• you are taking other medicines - you must tell your doctor about these medicines.
• you have kidney problems.

How to take the medicine (capsules)

• You can swallow the whole capsule with water. You can also open the capsule and mix the powder with a glass of water or orange juice. The powder can also be mixed with yogurt or another soft food.
• After mixing, you should immediately eat the yogurt or drink the water or orange juice.
• Take one capsule daily in the morning. The medicine can be taken with or without food.
• If you want to stop treatment, first ask your doctor.
• If you forget to take a capsule, tell a grown-up. If you forget to take a capsule, DO NOT take 2 capsules at once (double dose).

Possible side effects

Side effects are unpleasant symptoms that can occur during treatment. If you notice any of the following symptoms, tell a grown-up right away. The grown-up can discuss them with the doctor. The most important side effects:

• fast or irregular heartbeat
• seeing, feeling, or hearing non-existent things
• excessive unusual stimulation or very high activity
• severe allergic reaction; you may feel dizzy, short of breath, and itchy
• seizures
• yellowing of the eyes and/or skin
• swollen skin or severe rash with blisters on the skin and mucous membranes

If you feel unwell during treatment, tell a grown-up right away.

Other important things

• Keep the medicine in a safe place. No one else should take this medicine.
• This medicine is for you. DO NOT let anyone else take it. The medicine may be good for you, but it can harm others.
• If you forget to take a capsule, do not take 2 capsules later. Just take 1 capsule the next day.
• Do not take more capsules than you should, as it may harm you.
• If you take too much medicine, tell your mom, dad, or caregiver right away.
• Do not stop taking the medicine without consulting your doctor.

Who can you ask if you do not understand something?

Ask your mom, dad, caregiver, doctor, nurse, or pharmacist for help.