Elvanse

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Elvanse, 30 mg, hard capsules

Elvanse, 50 mg, hard capsules

Elvanse, 70 mg, hard capsules

Lisdexamfetamine dimesylate

Important information about the medicine

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 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 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). The medicine is used:

• in children and adolescents from 6 to 18 years old, if previous treatment with methylphenidate did not reduce ADHD symptoms. If the doctor believes the medicine is helping, it can be continued after reaching adulthood.

If there is no improvement or the patient feels worse after a month of treatment, they should consult their doctor. Elvanse is not given to children with ADHD under 6 years old, as it is not known whether it is safe and beneficial for such young people.

How does the medicine work?

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

• psychotherapy
• educational programs
• developing social skills.

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 the intelligence of children or young people.

2. Important information before taking Elvanse

When not to take Elvanse

• if the patient is allergic to lisdexamfetamine 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 lacks restraint
• 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 the above cases, Elvanse should not be taken. If the patient has doubts, they should consult their doctor or pharmacist before treatment with Elvanse. This should be done because treatment may worsen the listed symptoms. The doctor will monitor the patient's response to the medicine.

Warnings and precautions

Before starting treatment with Elvanse, the patient should discuss it with their 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 started menstruating - only in the case of girls (see "Pregnancy and breastfeeding")
• 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 medicines that cause heart rhythm disorders, or mineral imbalance in the body in the patient's history or family
• the patient has been diagnosed with other heart problems beyond those listed above in "When not to take Elvanse"
• the patient has mental problems, such as:
• severe mood swings (bipolar disorder, where mood swings from mania to depression)
• feeling aggressive or hostile or increased aggression
• seeing, hearing, or feeling things that do not exist (hallucinations)
• believing in untrue things (delusions)
• severe suspicion (paranoia)
• agitation, anxiety, or increased tension
• depression or feelings of guilt.

The patient should tell their doctor or pharmacist if they have experienced any of these symptoms. This should be done because treatment may worsen the listed symptoms. The doctor will monitor the patient's response to the medicine. In some patients, Elvanse may cause heart rhythm disorders. If palpitations or irregular heartbeat occur during treatment, the patient should immediately inform their doctor. The risk of heart problems may increase with the dose. Therefore, the prescribed dose should be used.

Before starting treatment, the doctor will examine the patient

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

• Is the patient taking any 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 strange thoughts?
• Has the patient or anyone in their family ever had "tics" (involuntarily repeating words or movements)?
• Has the patient or anyone in their family ever had a mental illness or behavioral disorder? The doctor will conduct a mental health interview and may ask if there have been any 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 in detail and honestly. This will allow the doctor to ensure that treatment with Elvanse is suitable for the patient. Before treatment, the doctor may order additional tests.

Elvanse and other medicines

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

• If the patient is taking or has taken in the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOIs). Taking Elvanse and monoamine oxidase inhibitors may cause a sudden increase in blood pressure. The doctor or pharmacist may tell the patient which medicines belong to the group of monoamine oxidase inhibitors.

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

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

If the patient is in doubt or if the medicine is not on the above list, they should consult their doctor or pharmacist before treatment with Elvanse.

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 child, they should consult their doctor before taking this medicine. The body breaks down Elvanse into substances that may 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 20 weeks 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 operating machinery

During treatment with Elvanse, patients may experience blurred vision or dizziness. In such cases, driving vehicles, 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

Recommended dose

The medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their 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 other soft food
• a glass of water or orange juice. Mix the Elvanse with yogurt, water, or orange juice with a spoon. After mixing, the patient should immediately eat the yogurt or drink the water or orange juice. The medicine should not be delayed. After drinking the medicine, a white residue may remain on the walls of the container or glass. However, this should not cause concern, as it does not contain the active substance.

Dose

• Elvanse is available in capsules containing 30 mg, 50 mg, or 70 mg of the medicine. The doctor will tell the patient which dose to take daily.
• Treatment should be started with a dose of 30 mg. Then, the doctor may increase the dose to 50 mg or 70 mg. The maximum dose is 70 mg per day.
• If the patient has kidney disease, the doctor may reduce the dose.
• The patient should not reduce the dose themselves or take part of the capsules. They should always take the whole contents of the capsule. The patient should 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 their doctor. The doctor may then change the treatment.

Incorrect use of Elvanse

• If the patient does not use Elvanse correctly, behavioral disorders may occur. Sometimes, patients may feel like they need the medicine for reasons other than ADHD. If the patient has ever had a problem with addiction to alcohol, prescription drugs, or illegal substances, they should tell their doctor.

Taking a higher dose of Elvanse than recommended

In case of taking too much of the medicine, the patient should immediately consult their doctor or call an ambulance. The patient should tell the medical staff what dose they took. Symptoms of overdose may include: anxiety, shaking, increased uncontrolled movements, minor muscle contractions, rapid breathing, confusion, aggression, and hallucinations, panic attacks, high fever, or muscle damage (breakdown). Later, fatigue and depression may occur. Sometimes, changes in heart rate (fast, slow, or irregular heartbeat) are observed, as well as low or high blood pressure, circulatory collapse, seizures, and coma. Patients may experience nausea, diarrhea, or abdominal cramps.

Missing a dose of Elvanse

The patient should 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. The patient should not take the medicine in the afternoon, as it may cause insomnia or disrupt sleep.

Stopping treatment with Elvanse

If the patient stops treatment, ADHD symptoms may return. The patient should not stop treatment without consulting their doctor. They should not suddenly stop taking the medicine on their own.

Control tests during treatment with Elvanse

The doctor will perform certain tests during treatment with Elvanse

• Before starting treatment, the doctor will check if the treatment will be safe and beneficial for the patient.
• 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 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 whether they have worsened during treatment with Elvanse.

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 using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Sometimes, serious side effects may occur. If any of the following symptoms appear, the patient should immediately consult their 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)

• seeing, feeling, or hearing things that do not exist (hallucinations)
• excessive unusual excitement or very high activity (mania)
• allergic reactions (hypersensitivity)
• shortness of breath or swelling of the feet (signs of heart problems)

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 things that do not exist, paranoia, delusions (psychotic symptoms)
• seizures (convulsions)
• heart rhythm disorders, life-threatening irregular heartbeat (observed 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)

If any of these symptoms appear, the patient should immediately consult their 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
• weight loss
• sleep problems
• dry mouth
• abdominal pain
• headache

Common (may affect up to 1 in 10 people)

• agitation, irritability, anxiety, depression, aggression, or mood swings
• excessive sleepiness, fatigue, or restlessness
• difficulty achieving or maintaining an erection or changes in libido
• dizziness
• uncontrolled muscle contractions, involuntary movements, or tremors
• irregular or rapid heartbeat (tachycardia)
• shortness of breath
• nausea, vomiting, or diarrhea
• constipation
• fever or excessive sweating
• rash
• teeth grinding

Uncommon (may affect up to 1 in 100 people)

• logorrhea
• feeling depressed, anxious, low, or restless (dysphoria)
• feeling happy and excited (euphoria)
• frequent "picking at skin"
• uncontrolled muscle contractions or sudden body movements
• itching, rash, or red itchy patches (hives)
• blurred vision
• pupil dilation
• poor blood circulation, causing numbness and paleness of fingers and toes (Raynaud's phenomenon)
• high blood pressure
• metallic taste or changes in taste (taste disorders)
• fainting

Changes in weight

Elvanse may sometimes cause weight loss or slow down weight gain in children or adolescents.

• Children may not gain weight.
• During treatment, the doctor will monitor the patient's appetite, growth, and weight.
• If growth is slow, the doctor may temporarily stop treatment with Elvanse.

Reporting side effects

If side effects occur, including any side effects 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 stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the bottle and carton after "Expiry date (EXP)". "Expiry date (EXP)" means 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Elvanse contains

The active substance is lisdexamfetamine dimesylate. Each 30 mg capsule contains 30 mg of lisdexamfetamine dimesylate, which corresponds to 8.9 mg of dexamfetamine. Each 50 mg capsule contains 50 mg of lisdexamfetamine dimesylate, which corresponds to 14.8 mg of dexamfetamine. Each 70 mg capsule contains 70 mg of lisdexamfetamine dimesylate, which corresponds to 20.8 mg of dexamfetamine. Other ingredients:

• capsule contents: microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• capsule shell: gelatin, ink (shellac and iron oxide black E 172)
• capsule shell colorants: titanium dioxide (E 171)
• The 30 mg capsule also contains erythrosine (E 127)
• The 50 mg capsule contains brilliant blue FCF (E 133)
• The 70 mg capsule contains brilliant blue FCF (E 133) and erythrosine (E 127)

What Elvanse looks like and contents of the pack

Hard capsules. The 30 mg capsules have a white opaque body and pink opaque cap with the inscription "S489" and "30 mg" printed in ink. The 50 mg capsules have a white opaque body and blue opaque cap with the inscription "S489" and "50 mg" printed in ink. The 70 mg capsules have a blue opaque body and pink opaque cap with the inscription "S489" and "70 mg" printed in ink. Pack sizes: 28 or 30 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza

• 50 – 58 Baggot Street Lower Dublin 2, D02 Y754 Ireland Tel: +800 6683 8470 e-mail: [email protected]

Manufacturer/importer

Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza

• 50 – 58 Baggot Street Lower Dublin 2 Ireland

Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza

• 50 – 58 Baggot Street Lower Dublin 2, D02 Y754 Ireland

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 Finland Elvanse Spain Elvanse Ireland Tyvense Luxembourg Elvanse Netherlands Elvanse Germany Elvanse Norway Elvanse Poland Elvanse Portugal Elvanse Czech Republic Elvanse Sweden Elvanse United Kingdom (Northern Ireland) Elvanse

Date of last revision of the leaflet: 04/2022

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 its contents. 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 focusing attention
• act very quickly and without thinking (be impulsive).

ADHD affects learning in school, making new friends, and thinking about oneself. 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 teach 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 have follow-up appointments with your doctor. 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 interrupt it and check if you still need it. The doctor may do this during vacations.
• Girls who may be pregnant or plan to become pregnant should consult their doctor before treatment.

Some children should not take this medicine

You should not take this medicine if:

• you have heart problems
• you have problems with severe agitation 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 yogurt or other soft food, or with a glass of water or orange juice. 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 on an empty stomach or with breakfast.
• If you want to stop treatment, first ask your doctor.
• If you forget to take the medicine, tell an adult. If you forget to take the medicine, DO NOT take 2 (two) capsules at once (a double dose of the medicine).

Possible side effects

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

• rapid or irregular heartbeat
• seeing, feeling, or hearing things that do not exist
• excessive unusual excitement or very high activity
• severe allergy; 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 immediately.

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 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 it 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 in the pharmacy for help.