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

Please read this leaflet carefully before taking the medicine, as it contains important information for you.

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

Why is Elvanse used

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 one month of treatment, consult your 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 function of some 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 you are allergic to lisdexamfetamine 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, very 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 the above cases, do not take Elvanse. If you have doubts, consult your doctor or pharmacist before treatment. This should be done because treatment may worsen the mentioned symptoms. The doctor will monitor the medicine's effect on you.

Warnings and precautions

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

• you have ever abused medicines or addictive substances
• you have kidney problems
• you have had seizures (epilepsy) or abnormal EEG results
• you have started menstruating - only for girls (see "Pregnancy and breastfeeding")
• you have had uncontrolled muscle contractions or involuntarily repeated sounds or words
• you have been diagnosed with high blood pressure
• you or a family member have had heart rhythm disorders (visible on an electrocardiogram) or diseases treated with medicines that cause heart rhythm disorders, or mineral salt imbalance in the body
• you have been diagnosed with other heart problems beyond those mentioned above in "When not to take Elvanse"
• you have mental health problems, such as:
• severe mood swings (bipolar disorder, with 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)
• severe suspicion (paranoia)
• agitation, anxiety, or increased tension
• depression or feelings of guilt.

Tell your doctor or pharmacist before treatment if you have experienced any of these symptoms. This should be done because treatment may worsen the mentioned symptoms. The doctor will monitor the medicine's effect on you. In some patients, Elvanse may cause heart rhythm disorders. If heart palpitations or irregular heartbeat occur during treatment, inform your doctor immediately. The risk of heart problems may increase with the dose. Therefore, use the prescribed dose.

Before starting treatment, the doctor will examine you

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

• Are you taking any other medicines?
• Has anyone in your family died suddenly for unknown reasons?
• Do you or a family member have other health problems (e.g., heart disease)?
• How do you feel: are you happy or sad, do you currently or have you had strange thoughts?
• Do you or a family member have "tics" (involuntarily repeating words or body movements)?
• Do you or a family member have a history of mental illness or behavioral disorders? 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 your family.

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

Elvanse and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and any medicines you plan to take in the future. When not to take Elvanse:

• If you are taking or have 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. Your doctor or pharmacist may tell you 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, consult your doctor or pharmacist if you 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 consult your pharmacist before purchasing
• 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, consult your doctor or pharmacist before treatment.

Tests detecting the presence of illegal substances

This medicine may cause a positive result in tests for the presence of illegal substances.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, consult your 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 congenital malformations 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). Do not take this medicine during pregnancy unless your doctor has explicitly recommended it; during treatment, do not breastfeed.

Driving and using machines

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

Recommended dose

Always take the medicine as recommended by your doctor. If you have doubts, 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

• Take Elvanse 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. Immediately after mixing, 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. Do not worry, 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. Your doctor will tell you which dose to take daily.
• It is recommended to start treatment with a dose of 30 mg. Then, your doctor may increase the dose to 50 mg or 70 mg. The maximum dose is 70 mg per day.
• If you have been diagnosed with kidney disease, your doctor may reduce the dose.
• Do not reduce the dose yourself or take part of the capsules. Always take the whole contents of the capsule. Do 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, tell your doctor. The doctor may then change the treatment.

Incorrect use of Elvanse

• If you do not take Elvanse correctly, behavioral disorders may occur. Sometimes, patients may feel that they need the medicine for reasons other than ADHD. If you have ever had a problem with alcohol, prescription medicine, or illegal substance addiction, tell your doctor.

Taking a higher dose of Elvanse than recommended

If you take too much of the medicine, immediately consult your doctor or call an ambulance. Tell the medical staff what dose you took. Overdose symptoms may include: anxiety, shaking, increased uncontrolled movements, minor muscle contractions, rapid breathing, confusion, aggression, and hallucinations (seeing, hearing, or feeling non-existent things), panic attacks, high fever, or muscle damage (muscle breakdown). Later, fatigue and depression may occur. Sometimes, changes in heart rhythm (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

Do not take a double dose to make up for a missed dose. If you miss a dose, 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 you stop taking Elvanse, ADHD symptoms may return. Do not stop treatment without consulting your doctor. Do 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, and after each dose change. Control tests may include:
• assessing your appetite
• measuring your height and weight
• measuring your blood pressure and pulse
• checking for mood, thinking, or feeling disorders and whether 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, your doctor may recommend a short break in treatment (e.g., during holidays). This will help determine if the medicine is still necessary. If you have any further doubts about using this medicine, consult 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 discuss possible side effects with you.

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

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 non-existent things (hallucinations)
• excessive excitement, excessive activity, or lack of restraint (mania)
• allergic reactions (hypersensitivity)
• shortness of breath or swelling of the legs (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 non-existent things, 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 you experience any of these symptoms, consult your doctor immediately.

Other side effects may also occur. If they worsen, tell your doctor or pharmacist.

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

• decreased appetite
• weight loss
• sleeping problems
• dry mouth
• abdominal pain
• headache

Common (may affect up to 1 in 10 people)

• agitation, irritability, anxiety, depression, aggression, mood swings
• excessive sleepiness, fatigue, or restlessness
• difficulty achieving or maintaining an erection or changes in libido
• dizziness
• uncontrolled muscle contractions, involuntary movements, or muscle 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, or uneasy (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

Weight changes

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

• Children may not gain weight.
• During treatment, your doctor will monitor your appetite, height, and weight.
• If growth is slow, your doctor may temporarily stop Elvanse treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, 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. Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the bottle and carton after "EXP". "EXP" means 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. Ask your 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 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 carmellose, 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 "S489" and "30 mg" printed in ink. The 50 mg capsules have a white opaque body and blue opaque cap with "S489" and "50 mg" printed in ink. The 70 mg capsules have a blue opaque body and pink opaque cap with "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: medinfoEMEA@takeda.com

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 it.

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 attention
• 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

• Your doctor will prescribe the medicine and tell you how to cope 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 have regular check-ups with your doctor. 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, your doctor may stop it and check if you still need it. The doctor may do this during holidays.
• Girls who may be pregnant or plan to become pregnant must 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 excessive excitement 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. Immediately after mixing, eat the yogurt or drink the water or orange juice.
• Take one capsule daily in the morning. You can take the medicine with or without 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 (double dose).

Possible side effects

Side effects are unpleasant 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 non-existent things
• excessive unusual excitement 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 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 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 mother, father, or caregiver immediately.
• Do not stop taking the medicine unless your doctor recommends it.

Who can you ask if you do not understand something?

Ask your mother, father, caregiver, doctor, nurse, or pharmacist in the pharmacy for help.