Elvanse Adults 50 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Elvanse Adult 50 mg hard capsules

lisdexamfetamine dimesylate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Elvanse Adult is and what it is used for
2. What you need to know before taking Elvanse Adult
3. How to take Elvanse Adult
4. Possible side effects
5. How to store Elvanse Adult
6. Contents of the pack and other information

1. What Elvanse Adults is and what it is used for

What Elvanse Adults is

Elvanse Adults contains the active substance lisdexamfetamine dimesylate, which acts on brain activity. It helps improve attention, concentration, and reduce impulsivity.

Elvanse Adults is a prolonged-action medicine that gradually works over 14 hours.

What it is used for

Elvanse Adults is part of a comprehensive treatment programme for attention deficit hyperactivity disorder (ADHD) in adults who have had ADHD since childhood. If you have not previously received treatment for ADHD, your doctor will check whether you had ADHD since childhood before prescribing Elvanse Adults.

You should inform your doctor if you do not feel better or if you feel worse after one month of treatment.

Elvanse Adults is not recommended for all patients with ADHD, and the decision to use this medicine should be based on a thorough medical evaluation.

For children and adolescents aged 6 to 17 years, another medicine containing lisdexamfetamine dimesylate is available. Elvanse Adults is not indicated for the treatment of ADHD in children under 6 years of age, as it is unknown whether it is safe or beneficial for such young individuals.

How Elvanse Adults works

Elvanse Adults improves the activity of certain parts of the brain that have low activity. The medicine may help improve attention, concentration, and reduce impulsive behaviour.

The medicine is administered as part of a treatment programme that usually includes:

• psychological therapy
• educational therapy
• behavioural therapy
• occupational therapy
• social therapy

It can only be prescribed by doctors experienced in treating people with behavioural problems.

About ADHD

People with ADHD have difficulties with:

• staying seated
• concentrating

These individuals are not to blame for being unable to do these things. However, ADHD can cause problems in daily life. People with ADHD may have difficulties working, learning, and socializing, and may have low self-esteem.

ADHD does not affect a person's intelligence.

2. What you need to know before starting Elvanse Adults

DO NOT take Elvanse Adults

• if you are allergic to lisdexamfetamine, to other amphetamine compounds, or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking a medicine called a “monoamine oxidase inhibitor” (MAOI) used for depression, or if you have taken an MAOI within the last 14 days;
• if you have thyroid problems;
• if you feel unusually elated, more active, or less inhibited than normal;
• if you have or have ever had heart problems, such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or congenital heart defects;
• if you have high or very high blood pressure, or narrowing of the blood vessels;
• if you have increased intraocular pressure (glaucoma);
• if you have a condition called phaeochromocytoma (a rare tumor usually growing in the adrenal glands located above the kidneys).

Do not take Elvanse Adults if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Elvanse Adults, as it may worsen these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Elvanse Adults if:

• you have ever abused prescription medicines or drugs;

• you have had kidney problems;

• you have had seizures (fits, convulsions, epilepsy) or abnormalities in the electroencephalogram (EEG);

• you have had uncontrollable tremors in any part of the body or repeat sounds and words;

• you have high blood pressure;

• you have a personal or family history of irregular heartbeat (visible on an electrocardiogram), or if you have a medical condition or are taking treatment that makes you prone to arrhythmias or sodium disturbances;

• you have a heart problem not listed in the section above “Do not take Elvanse Adults”;

• you have a history of stroke;

• you have a mental health condition, including but not limited to:

• sudden mood swings (from manic to depressive states, known as “bipolar disorder”);

• you start behaving aggressively or hostilely, or these behaviors worsen;

• you see, hear, or feel things that are not real (hallucinations);

• you believe things that are not true (delusions);

• you feel more suspicious than usual (paranoia);

• you feel restless, anxious, or tense;

• you feel depressed or guilty.

Or if you are a woman of childbearing potential, planning to become pregnant, or are pregnant (see section “Pregnancy, breastfeeding, and fertility”).

Inform your doctor or pharmacist if any of the above conditions apply to you before starting treatment. Elvanse Adults may worsen these conditions. Your doctor will want to monitor how the medicine affects you.

If Elvanse Adults is not used properly, it may cause abnormal behavior and lead to dependence on the medicine. Inform your doctor if you have ever abused alcohol, prescription medicines, or drugs, or if you have ever been dependent on any of these substances. Do not give this medicine to anyone else, even if their symptoms seem similar.

Elvanse Adults may cause heart rhythm disturbances in some patients. If you experience palpitations or irregular heartbeat during treatment, you must inform your doctor immediately. The risk of heart problems may increase when the dose is raised. Therefore, the recommended dose should be followed.

Checks your doctor will perform before you start taking Elvanse Adults

These checks are made to determine whether Elvanse Adults is the right medicine for you. Your doctor will ask you about:

• other medicines you are taking;
• whether there is a family history of unexplained sudden death;
• any other medical problems you or your family members have had (such as heart problems);
• how you feel, whether you feel happy or sad, if you have strange thoughts, or if you have had such feelings in the past;
• whether there is a family history of “tics” (repeated, difficult-to-control tremors in any part of the body or repetition of sounds and words);
• any mental health or behavioral problems you or your family members have had. Your doctor will review your mental health history and check whether anyone in your family has a history of suicide, bipolar disorder (mood swings from manic to depressive states), or depression.

It is important to provide as much information as possible. This will help your doctor decide whether Elvanse Adults is the right medicine for you. Your doctor may decide that further tests are needed before you start taking this medicine.

Effects on weight

Elvanse Adults may cause weight loss in some people.

Your doctor will monitor your weight and whether you are eating properly. If you are losing weight, your doctor may temporarily interrupt your treatment with Elvanse Adults.

Using Elvanse Adults with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

DO NOT take Elvanse Adults if:

• you are taking a medicine called a “monoamine oxidase inhibitor” (MAOI) used for depression, or if you have taken an MAOI within the last 14 days. Using an MAOI together with Elvanse Adults may cause a sudden increase in blood pressure. Your doctor or pharmacist can tell you whether you are taking a medicine that is an MAOI.

Elvanse Adults may interact with other medicines. If you are taking any of the following medicines, consult your doctor or pharmacist before taking Elvanse Adults:

• medicines for serious mental health conditions;
• medicines used to raise or lower blood pressure;
• medicines used during surgery, such as analgesics;
• cough and cold remedies. Some of these medicines may affect blood pressure, so it is important to consult your pharmacist when purchasing such medicines;
• medicines that may affect the acidity of urine, such as vitamin C (ascorbic acid) or sodium bicarbonate (e.g., in medicines for indigestion).

If you are unsure whether your medicines are included in the list above, consult your doctor or pharmacist before taking Elvanse Adults.

Doping control and use in athletes

Patients should be advised that this medicine may result in a positive outcome in drug testing.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Elvanse Adults is converted in the body into substances that can cross the placenta and pass into breast milk. Available data on the use of Elvanse Adults during 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 and is characterized by high blood pressure and protein in the urine) and premature birth. Newborns exposed to amphetamines during pregnancy may experience withdrawal symptoms (tremor, irritability, hypertonia). You should not use this medicine during pregnancy unless specifically instructed by your doctor, nor should you breastfeed while taking Elvanse Adults.

Driving and using machines

You may feel dizzy, have difficulty focusing your vision, or experience blurred vision when taking Elvanse Adults. If this happens, it is dangerous to carry out activities such as driving or operating machinery.

Elvanse adults contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Elvanse Adults

How much to take

Follow exactly the instructions provided by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Elvanse Adults is intended only for you. Do not give this medicine to anyone else, even if they have similar symptoms.

How to take Elvanse Adults

• Take Elvanse Adults in the morning before breakfast. It may be taken with or without food.
• There are two ways to take Elvanse Adults:
  • Swallow the capsule whole with a glass of water.
  • Open the capsule and empty the contents into:
    • a soft food such as yoghurt
    • a glass of water or orange juice

Use a spoon to break up any lumps and mix Elvanse Adults thoroughly with the yoghurt, water, or orange juice until well blended. Consume all of the yoghurt or drink all of the water or orange juice immediately after mixing with Elvanse Adults. Do not store it. Do not be concerned if a film remains in the glass or container; this is not the active substance.

Dosage

• Your doctor will tell you which capsule to take each day.
• The recommended starting dose at the beginning of treatment is 30 mg. Your doctor may increase the dose if necessary. The maximum daily dose is 70 mg.
• If you have any kidney problems, your doctor may reduce your dose.
• If you are an elderly patient, your doctor will evaluate your blood pressure and cardiovascular status before starting treatment and during treatment (see section 2 “Do NOT take Elvanse Adults” and “Warnings and precautions”). Your doctor may also reduce your dose.
• Do not divide the capsule dose; take the entire contents of the capsule. Do not take less than the full content of one capsule per day.

If you do not feel better after 1 month of treatment

If you do not feel better, inform your doctor. You may require a different treatment.

If you misuse Elvanse Adults

If you misuse Elvanse Adults, you may experience abnormal behavior or develop dependence on the medicine. Therefore, inform your doctor if you have ever abused alcohol, prescription medicines, or drugs, or if you have had dependence on any of these substances.

If you take more Elvanse Adults than you should

In case of overdose or accidental ingestion, contact a doctor, pharmacist, or call the Toxicology Information Service at 915620420 immediately, stating the medicine and the amount ingested.

Signs of overdose may include:

• restlessness, tremors, increased uncontrolled movements, muscle twitching, rapid breathing, confusion, tendency to fight or argue, seeing, feeling, or hearing things that are not real (hallucinations), panic state, high fever, or muscle collapse. This may be followed by feelings of fatigue and depression;
• nausea, vomiting, diarrhoea, and stomach cramps may also occur;
• changes in heart rate (slow, fast, or irregular), high or low blood pressure, circulatory collapse, seizures, and coma may also occur;
• headache, confusion, seizures, and visual disturbances may also occur.

If you forget to take Elvanse Adults

Do not take a double dose to make up for missed doses. If you forget a dose, wait until the next day. Avoid taking the dose in the afternoon to prevent sleep disturbances (insomnia).

If you stop taking Elvanse Adults

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

Do not stop taking the medicine without first consulting your doctor. You must not stop taking the medicine suddenly or on your own.

What your doctor will do while you are on Elvanse Adults treatment

Your doctor will perform certain tests

• Before starting: to ensure that Elvanse Adults is safe and beneficial for you.

• After starting: your doctor will perform tests at least every 6 months, and even more frequently. Tests will also be performed when your dose is changed. These tests will include:

• monitoring of appetite,

• measurement of weight,

• measurement of blood pressure and pulse,

• checking whether you have experienced any mood problems, changes in mood, or any other unusual feelings, or whether these issues have worsened while taking Elvanse Adults.

Long-term treatment

Elvanse Adults does not need to be taken indefinitely. If you take Elvanse Adults for more than one year, your doctor should interrupt treatment for a brief period, such as during holidays. This allows assessment of whether you still need the medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Your doctor will inform you about these adverse effects.

Some adverse effects may be serious. If you experience any of the following adverse effects, contact your doctor immediately:

Frequent (may affect up to 1 in 10 adults)

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

Uncommon (may affect up to 1 in 100 adults)

• feeling more excited, active, or uninhibited than normal (mania)
• allergic reaction (hypersensitivity)

Frequency not known (cannot be estimated from available data)

• seeing, feeling, or hearing things that are not real (hallucinations)
• severe allergic reaction characterized by a sharp drop in blood pressure, difficulty breathing, and hives/itching (anaphylactic reaction)
• seeing, feeling, or hearing things that are not real, paranoia, and delusions (psychotic episodes)
• worsening of Tourette’s disorder, with symptoms such as repeated, difficult-to-control body jerks or repetition of sounds and words (tics)
• seizures (convulsive fits)
• abnormal heartbeat, potentially life-threatening irregular heartbeat (observed on an electrocardiogram). See section 2, “Warnings and precautions”
• allergic liver injury detectable by yellowing of the eyes and/or skin (eosinophilic hepatitis)
• swelling of the face, tongue, or throat; difficulty swallowing; hives and breathing difficulties (angioedema) or severe skin rash, with or without blisters, affecting the skin and mucous membranes, or skin irritation, ulcers, or swelling of the mouth, throat, eyes, nose, and around the genitals (Stevens-Johnson syndrome)
• shortness of breath or leg swelling (signs of heart muscle disease)

If you experience any of the adverse effects listed above, contact your doctor immediately.

Other adverse effects include the following. If they become severe, inform your doctor or pharmacist:

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

• decreased appetite
• difficulty sleeping
• dry mouth
• headache

Frequent (may affect up to 1 in 10 adults)

• feeling restless, nervous, anxious, or irritable
• feeling more tired or restless than normal
• inability to achieve or maintain an erection or changes in sex drive
• feeling dizzy
• uncontrolled spasms, jerks, and tremors or being more active than normal
• repeated and difficult-to-control tremors or jerks in any part of the body or repetition of sounds and words (tics)
• mood changes
• high blood pressure, rapid or irregular heartbeat (tachycardia)
• breathing difficulty
• nausea or diarrhea
• constipation
• weight loss
• excessive sweating
• stomach pain
• teeth grinding

Uncommon (may affect up to 1 in 100 adults)

• talking non-stop
• feeling depressed, worried, sad, or uneasy (dysphoria)
• feeling overly happy or excited (euphoria)
• excessive skin picking
• uncontrolled tremors or jerks
• feeling sleepier than normal
• itching, skin rash, or raised red itchy areas of skin (urticaria)
• blurred vision
• high temperature (fever)
• vomiting
• metallic taste or changes in taste sensation (dysgeusia)
• fainting
• nosebleeds

Frequency not known (cannot be estimated from available data)

• excessive dilation of the pupils
• aggression
• poor blood circulation causing the fingers of the hands and feet to become numb and turn pale (Raynaud’s phenomenon)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Elvanse Adults

Do not store above 25°C.

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe place where others cannot access it. It may cause serious harm to people for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if the capsules show any sign of damage.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Elvanse Adults

The active substance is lisdexamfetamine dimesylate.

Each 50 mg hard capsule contains 50 mg of lisdexamfetamine dimesylate, equivalent to 14.8 mg of dexamfetamine.

The other components are:

• Capsule contents: microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E572)
• Capsule coating: gelatin, titanium dioxide (E171)
• Each 50 mg hard capsule also contains brilliant blue FCF (E133)
• Printing ink: shellac (E904), potassium hydroxide (E525), black iron oxide (E172), propylene glycol (E1520), and concentrated ammonia solution (E527)

Description of the product and contents of the pack

Hard capsules.

The 50 mg capsules have an opaque white body and an opaque blue cap, printed with “S489” and “50 mg” in black ink.

Pack sizes: 28, 30 or 90 capsules. Only certain 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: [email protected]

Manufacturer:

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

or

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

or

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Takeda Farmacéutica España S.A.
Calle Albacete, 5, 9th floor,
Edificio Los Cubos
28027 Madrid
Spain
Tel: +34 91 790 42 22

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Austria Elvanse Erwachsene

Denmark Aduvanz

Finland, Germany, Iceland Elvanse Adult

Norway Aduvanz

Spain Elvanse Adultos

Sweden Elvanse Vuxen

United Kingdom (Northern Ireland) Elvanse Adult

Date of last review of this leaflet: 12/2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).