Elvanse

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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. This 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 aged 6 to 18 years, 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 been present since childhood.

If there is no improvement or the patient feels worse after one month of treatment, they should consult their doctor. Elvanse is not recommended for all patients with ADHD. The decision to use it is made based on a thorough medical assessment. Elvanse should not be given to children with ADHD under the age of 6, as it is not known whether it is safe and effective in 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 in conjunction 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
• concentrating

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 you are allergic to lisdexamfetamine, other amphetamine compounds, or any of the other ingredients of this medicine (listed in section 6)
• if you are taking or have taken in the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOIs)
• if you have been diagnosed with a thyroid disease
• if you feel agitated, highly active, or lack restraint
• if you have 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 you have high blood pressure or narrowed blood vessels
• if you have been diagnosed with glaucoma (high pressure in the eye)

In these cases, you should not take Elvanse. If you have any doubts, you should consult your doctor or pharmacist before treatment. This is because treatment may worsen the mentioned symptoms.

Warnings and precautions

Before starting treatment with Elvanse, you should discuss it with your doctor or pharmacist if:

• you have ever abused drugs or substances
• you have kidney problems
• you have had seizures (epilepsy) or abnormal EEG results
• you have had uncontrolled muscle contractions or involuntarily repeated sounds or words
• you have been diagnosed with high blood pressure
• you or your family members have had heart rhythm disorders (visible on an electrocardiogram) or diseases treated with medicines that cause heart rhythm disorders, or mineral imbalance in the body
• you have been diagnosed with other heart problems beyond those mentioned above in the "When not to take Elvanse" section
• you have had a stroke
• you have mental health problems, such as:
• severe mood swings (bipolar affective disorder, where mood swings from mania to depression)
• aggression or hostility 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"). You should tell your doctor or pharmacist before treatment if you have experienced any of these symptoms. This is because treatment may worsen the mentioned symptoms. The doctor will monitor the effect of the medicine on you. Improper use of Elvanse may lead to behavioral disorders, and the patient taking the medicine may become dependent on it. If you have abused alcohol, prescription drugs, or illegal psychoactive substances, or are addicted to them, you should inform your doctor. You should not give the medicine to other people - even if they have similar symptoms. In some patients, Elvanse may cause heart rhythm disorders. If you experience palpitations or irregular heartbeat during treatment, you should immediately inform your doctor. The risk of heart problems may increase with the dose. Therefore, you should take the prescribed dose.

Before starting treatment, the doctor will examine you

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

• Are you taking any other medicines?
• Has anyone in your family died suddenly for unknown reasons?
• Do you or any of your family members have other health problems (e.g., heart disease)?
• How do you feel: are you happy or sad, do you currently or have you had unusual thoughts in the past?
• Do you or any of your family members have "nervous tics," i.e., uncontrollable, repetitive movements or sounds?
• Have you or any of your family members ever had a mental illness or behavioral disorder? The doctor will conduct a mental health interview and may ask if there have been any suicide attempts, bipolar affective disorder (severe mood swings from depression to mania), or depression in your family.

It is essential that you answer the doctor's questions in detail and honestly. This will allow the doctor to ensure that treatment with Elvanse is suitable for you. 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 weight is lost, the doctor may stop Elvanse treatment.
• In the case of adult patients, the doctor will monitor growth and appetite.

Elvanse and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take in the future. When not to take Elvanse:

• If you are taking or have taken MAOIs in the last 14 days. Taking Elvanse and MAOIs may cause a sudden increase in blood pressure. Your doctor or pharmacist can tell you which medicines are MAOIs.

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

• medicines used 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 may increase blood pressure, so you should consult a pharmacist before buying them
• medicines that change the acidity of urine, such as vitamin C (ascorbic acid) or sodium bicarbonate (e.g., in antacids).

If you are unsure or if the medicine is not on the above list, you should consult your doctor or pharmacist before taking Elvanse.

Tests for detecting illegal substances

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. The body breaks down Elvanse into substances that can pass through the placenta and into breast milk in breastfeeding women. Available data on the use of Elvanse in the first three months of pregnancy do not indicate an increased risk of congenital malformations 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 (tremors, 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 operating machinery

During treatment with Elvanse, patients may experience blurred vision or dizziness. In such cases, driving, operating machinery, and, for example, 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 the medicine is considered "sodium-free".

3. How to take Elvanse

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your 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 with a spoon. After mixing, eat the yogurt or drink the water or orange juice immediately. Do not delay taking the medicine. After drinking the medicine, a white residue may remain on the walls of the container or glass. However, this should not be a concern, as it does not contain the active substance.

Dose

• The doctor will inform you which dose to take daily.
• The recommended starting dose is 30 mg, but the doctor may decide to start treatment with a dose of 20 mg. Later, the doctor may increase the dose. The maximum daily dose is 70 mg.
• If you have kidney disease, the doctor may reduce the dose.
• If you are elderly, the doctor will monitor your blood pressure and cardiovascular system (see section 2 "When not to take Elvanse" and "Warnings and precautions") before starting treatment and during treatment. The doctor may also consider it necessary to reduce the dose.
• You should not reduce the dose yourself or take part of the capsules. You should always take the whole contents of the capsule. You should not take less than one capsule per day.

If you do not feel better after 1 month of treatment

If you do not feel better, you should tell your doctor. The doctor may then change the treatment.

If you take Elvanse incorrectly

If you take Elvanse incorrectly, you may experience behavioral disorders or become dependent on the medicine. Therefore, you should inform your doctor if you have ever had a problem 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 you take too much of the medicine, you should immediately consult your doctor or call an ambulance. You should tell the medical staff what dose you took. Symptoms of overdose may include restlessness, tremors, increased uncontrolled movements, 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 be observed.

Missing a dose of Elvanse

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

Stopping Elvanse treatment

If you stop taking Elvanse, ADHD symptoms may return. You should not stop treatment without consulting your doctor. You should not suddenly stop taking the medicine 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 will be safe and beneficial for you.
• During treatment, the doctor will order control tests every 6 months or more often, as well as after each dose change. Control tests may include:
• assessing your appetite
• measuring your growth and weight
• measuring your 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 your 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 you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Sometimes, serious side effects may occur. If you experience any of the following symptoms, you should consult your doctor as soon as possible:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• excessive restlessness, excessive activity, lack of restraint (mania)
• allergic reactions (hypersensitivity)

Frequency not known: cannot be estimated from the 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 (tics)
• 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 feet (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 feet (signs of heart disease) in adolescents is uncommon

If you experience any of these symptoms, you should consult your doctor as soon as possible.

Other side effects may also occur. If they worsen, you should tell your 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)

• restlessness, agitation, anxiety, depression, irritability, 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 rapid 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 changes (hives)
• blurred vision
• metallic taste or changes in taste (taste disorders)
• fainting
• nosebleeds

Frequency not known: cannot be estimated from the 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Elvanse

Do not store above 25°C. The medicine should be stored 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 you notice that the capsules are damaged. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Elvanse contains

• The active substance of Elvanse 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, opaque body and an opaque cap of the same color, with "S489" and "20 mg" printed in black ink. The 30 mg capsules have a white, opaque body and a pink, opaque cap, with "S489" and "30 mg" printed in black ink. The 40 mg capsules have a white, opaque body and a green-blue, opaque cap, with "S489" and "40 mg" printed in black ink. The 50 mg capsules have a white, opaque body and a blue, opaque cap, with "S489" and "50 mg" printed in black ink. The 60 mg capsules have a turquoise, opaque body and a turquoise, opaque cap, with "S489" and "60 mg" printed in black ink. The 70 mg capsules have a blue, opaque body and a pink, opaque cap, with "S489" and "70 mg" printed in black ink. The pack sizes are 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

• Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 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

• Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 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 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 may make it easier to understand the text.

Why did the doctor prescribe this medicine?

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

• be overly active
• have trouble concentrating
• 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, for example, by talking to people who can help and teaching you how to cope with the symptoms of the disease.
• The medicine should reduce the ADHD symptoms that you have been diagnosed with.
• You will visit the doctor for check-ups. The doctor will then 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 child should consult their 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 restlessness 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 and drink water. You can also open the capsule and mix the powder with water or orange juice. The powder can also be mixed with yogurt or another soft food.
• After mixing, eat the yogurt or drink the water or orange juice immediately.
• 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 an adult. If you forget to take a capsule, DO NOT take 2 capsules at once (a double dose of the medicine).

Possible side effects

Side effects are unpleasant symptoms that may occur during treatment. If you notice any of the following symptoms, tell an adult quickly. The adult may discuss them with your doctor. The most important side effects:

• rapid or irregular heartbeat
• seeing, feeling, or hearing non-existent things
• excessive unusual restlessness 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 in other areas

If you feel unwell during treatment, tell an adult quickly.

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 may harm other people.
• 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 this may harm you.
• If you take too much medicine, tell your mom, dad, or caregiver immediately.
• Do not stop taking the medicine unless your doctor tells you to.

Who can you ask if you do not understand something?

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