Product Information for the User

Elvanse Adults 50mg Hard Capsules

Lisdexamfetamine dimesilate

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

• Keep this leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know beforestartingtotakeElvanse Adults

3.How to take Elvanse Adults

4.Possible side effects

5.Storage of Elvanse Adults

6.Contents of the pack and additional information

What isElvanse Adults

ElvanseAdultscontains the active ingredient lisdexanfetamina dimesilato that acts on brain activity. It helps to improve attention, concentration, and reduce impulsivity.

ElvanseAdultsis a long-acting medication that acts gradually over 14hours.

What is it used for

Elvanse Adults is part of an integrated treatment program for attention deficit hyperactivity disorder (ADHD) in adults who have had ADHD since childhood. If you have not received previous treatment forADHD, your doctor will check if you have had ADHD since childhood before prescribing ElvanseAdults.

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

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

For children and adolescents aged 6 to 17years, there is another medication available that contains lisdexanfetamina dimesilato. ElvanseAdultsis not indicated for the treatment of ADHD in children under 6years of age, as its safety and efficacy in such young individuals are unknown.

How Elvanse Adults works

ElvanseAdultsimproves the activity of certain parts of the brain that are underactive. The medication may help improve attention, concentration, and reduce impulsive behavior.

The medication is administered as part of a treatment program that usually includes:

• psychological therapy
• educational therapy
• behavioral therapy
• occupational therapy
• social therapy

It can only be prescribed by doctors who have experience in treating individuals with behavioral 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 relating, and have low self-esteem.

ADHD does not affect a person's intelligence.

Do not take ElvanseAdults

• if you are allergic to lisdexamfetamine, other amphetamine compounds, or any of the other components of this medication (listed in section6);
• if you are taking a medication called “monoamine oxidase inhibitor” (MAOI) used for depression or if you have taken an MAOI in the last 14days;
• if you have thyroid problems;
• if you feel exceptionally excited, more active, or more uninhibited than normal;
• if you have or have had any heart problems, such as a heart attack, irregular heartbeats, chest pain and discomfort, heart failure, heart disease, or birth heart problems;
• if you have high or very high blood pressure or narrowed blood vessels;
• if you have elevated eye pressure (glaucoma).

Do not take ElvanseAdultsif you present any of the circumstances indicated above. If you are unsure, consult your doctor or pharmacist before taking Elvanse Adults, as it may worsen these problems.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment withElvanseAdultsif:

• you have ever abused prescription medications or drugs;
• you have kidney problems;
• you have had seizures (crises, convulsions, epilepsy) or altered electroencephalogram (EEG);

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

• you have high blood pressure;
• you have a family or medical history of irregular heartbeat (visible on an electrocardiogram), or if you have a disease or are undergoing treatment that makes you prone to arrhythmias or sodium imbalances;
• you have a heart problem not included in the section above “Do not take Elvanse Adults”;
• you have a history of stroke;
• you have a mental health problem, including:

• rapid mood changes (manic-depressive disorder);
• you become aggressive or hostile, or these behaviors worsen;
• you see, hear, or feel things that are not real (hallucinations);
• you believe things that are not real (delusions);
• you feel more suspicious than normal (paranoia);
• you feel agitated, anxious, or tense;
• you feel depressed or guilty.

Or if you are a fertile woman, intend to become pregnant, or are pregnant (see the section “Pregnancy, breastfeeding, and fertility”).

Inform your doctor or pharmacist if you present any of the circumstances indicated above before starting treatment. ElvanseAdultsmay worsen these problems. Your doctor will want to monitor how the medication affects you.

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

Elvanse Adults may cause cardiac arrhythmias in some patients. If you experience palpitations or irregular heartbeats during treatment, you must inform your doctor immediately. The risk of cardiac problems may increase with increased dosage. Therefore, you should follow the recommended dosage.

Checks your doctor will make before you start taking ElvanseAdults

These checks are made to decide if ElvanseAdultsis the correct medication for you. Your doctor will ask you about:

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

It is essential to provide as much information as possible. This will help your doctor decide if ElvanseAdultsis the correct medication for you. Your doctor may decide that further tests are needed before you start taking this medication.

Effects on weight

Elvanse Adults may cause weight loss in some people.

Your doctor will monitor your weight, as well as whether you are eating well. If you are losing weight, your doctor may interrupt your treatment with Elvanse Adults for a brief period.

Use ofElvanseAdultswith other medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

Do not take ElvanseAdultsif:

• you are taking a medication called “monoamine oxidase inhibitor” (MAOI) used for depression or have taken an MAOI in the last 14days. The use of an MAOI with ElvanseAdultsmay cause a sudden increase in blood pressure. Your doctor or pharmacist may tell you if you are taking a medication that is an MAOI.

ElvanseAdultsmay interact with other medications. If you take any of the following medications, consult your doctor or pharmacist before taking ElvanseAdults:

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

If you are unsure if the medications you take are on the above list, consult your doctor or pharmacist before taking Elvanse Adults.

Control of doping and use in athletes

Patients should be warned that this medication may produce a positive result in drug tests.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Elvanse Adults in the body is transformed into other substances that can cross the placenta and pass into breast milk.The 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 preeclampsia (a condition that usually occurs after 20weeks of pregnancy and is characterized by high blood pressure and protein in the urine) and premature birth. Newborns exposed to amphetamine during pregnancy may exhibit withdrawal symptoms (tremors, irritability, hypertonia).Do not use this medication during pregnancy unless your doctor explicitly tells you to, and do not breastfeed while taking Elvanse Adults.

Driving and operating machines

You may feel dizzy, have trouble focusing, or see blurry when taking Elvanse Adults. If this happens, it is dangerous to engage in activities such as driving or operating machines.

Elvanse Adults contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially “sodium-free”.

How much to take

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again..

ElvanseAdultsis only for you. Do not give this medication to anyone else, even if they have similar symptoms.

How to take Elvanse Adults

• Take ElvanseAdultsin the morning before breakfast. It can 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 yogurt
    • a glass of water or orange juice

Use a spoon to break up any lumps and mix ElvanseAdultswell with the yogurt, water, or orange juice until everything is well mixed. Take all the yogurt or drink all the water or orange juice immediately after mixing with ElvanseAdults. Do not save it. Do not worry if there is a film left in the glass or container; it is not the active ingredient.

Dose

• Your doctor will tell you which capsule to takeeach day.
• The recommended starting dose is 30mg. 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 the dose.
• If you are an elderly patient, your doctor will evaluate your blood pressure and cardiovascular status before starting treatment and during treatment (see section2 “Do not take Elvanse Adults” and “Warnings and precautions”. Your doctor may also reduce the dose.
• Do not divide the dose of a capsule, take the entire contents of the capsule. Do not take less than the contents of a capsule per day.

If you do not get better after 1month of treatment

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

Abuse of Elvanse Adults

• If you use ElvanseAdultsincorrectly, you may experience abnormal behavior or develop dependence on the medication. Therefore,inform your doctor if you have ever abused alcohol, prescription medications, or drugs, or if you have had dependence on any of these substances.

Take more ElvanseAdultsthan you should

In case of overdose or accidental ingestion, consult a doctor, pharmacist, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

The signs of overdose may include:restlessness, tremors, increased uncontrolled movements, muscle tremors, 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. You may then feel tired and depressed. Nausea, vomiting, diarrhea, and stomach cramps may also occur. Changes in heart rhythm (slow, fast, or irregular) may also occur, as well as high or low blood pressure, circulatory collapse, seizures, and coma.

Missed dose

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

Discontinuing treatment with Elvanse Adults

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

Do not stop taking the medication without consulting your doctor. Do not stop taking the medication suddenly or on your own.

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

Your doctor will perform some tests

• Before starting: to ensure that ElvanseAdultsis safe and beneficial for you.
• After starting: your doctor will perform tests at least every 6months, and even more often. They will also be performed when you change doses. These tests will include:

• appetite control,
• weight measurement,
• blood pressure and pulse measurement,
• checking if you have had mood, mood, or any other abnormal feelings or if these have worsened while taking ElvanseAdults.

Long-term treatment

ElvanseAdultsdoes not need to be taken forever. If you take ElvanseAdultsfor more than a year, your doctor should interrupt the treatment for a brief period, such as during vacations. This allows you to see if you still need the medication.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. Your doctor will inform you about these side effects.

Some side effects may be serious. If any of the following side effects occur, seek medical attention immediately:

Frequent (may affect up to 1 in 10 adults)

• Irregular heartbeats (palpitations)
• Chest pain (may be a sign of heart problems)

Poorly frequent (may affect up to 1 in 100 adults)

• Feeling overly excited, active, or uninhibited (mania)
• Allergic reaction (hypersensitivity)

Unknown frequency (cannot be estimated from available data)

• Seeing, feeling, or hearing things that are not real (hallucinations)
• Severe allergic reaction characterized by a sudden drop in blood pressure, difficulty breathing, and urticaria/hives (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 repetitive, uncontrollable movements of a part of the body or repetition of sounds and words (tics)
• Seizures (convulsions)
• Abnormal heart rhythm, potentially fatal irregular heartbeat (observed on an electrocardiogram). See section 2, "Warnings and precautions"
• Allergic liver injury that can be detected by yellowing of the eyes and/or skin (eosinophilic hepatitis)
• Swelling of the face, tongue, or throat; difficulty swallowing; urticaria, and respiratory difficulties (angioedema) or severe skin rash, with or without blisters, on the skin and mucous membranes or skin irritation, ulcers, or swelling of the mouth, throat, eyes, nose, and around the genitals (Stevens-Johnson syndrome)
• Lack of air or swelling of the legs (signs of heart muscle disease)

If you experience any of the above side effects, seek medical attention immediately.

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

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

• Loss of appetite
• Inability to sleep
• Dry mouth
• Headache

Frequent (may affect up to 1 in 10 adults)

• Feeling agitated, nervous, anxious, or irritable
• Feeling overly tired or restless
• Inability to achieve or maintain an erection or changes in sexual desire
• Feeling dizzy
• Uncontrolled spasms, tremors, or shaking or being overly active
• Repetitive, uncontrollable movements or repetition of sounds and words (tics)
• Changes in mood
• High blood pressure, rapid or irregular heartbeat (tachycardia)
• Difficulty breathing
• Nausea or diarrhea
• Constipation
• Weight loss
• Excessive sweating
• Stomach pain
• Bruxism

Poorly frequent (may affect up to 1 in 100 adults)

• Talking nonstop
• Feeling depressed, worried, sad, or anxious (dysphoria)
• Feeling overly happy or excited (euphoria)
• Picking at the skin excessively
• Uncontrolled tremors or shaking
• Feeling excessively sleepy
• Hives, skin rash, or red, elevated patches on the skin that itch (urticaria)
• Blurry vision
• Fever
• Vomiting
• Metals taste or changes in taste (dysgeusia)
• Loss of consciousness
• Nasal bleeding

Unknown frequency (cannot be estimated from available data)

• Excessive dilation of the pupils
• Aggression

• Poor blood circulation causing numbness and paleness of the hands and feet (Raynaud's phenomenon)

Reporting side effects

If you experienceany type of side effect, consultyour doctororpharmacist,even if it is a possibleside effect that does not appear in this prospectus.You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 25°C.

Keepthis medicationout of the sight and reach of children.

Store this medication in a safe place, where other people cannot access it. It may cause serious harm to individuals who have not been prescribed it.

Do not usethis medicationafter the expiration date that appears on the bottle and on the box afterCAD. The expiration date is the last day of the month indicated.

Do not use this medication if thecapsules show any type of damage.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose ofthe containers and medications you no longerneed. By doing so, you will help protect the environment.

Composition ofElvanseAdults

The active ingredient is lisdexanfetamine dimesilate.

Each hard capsule contains 50 mg of lisdexanfetamine dimesilate, which is equivalent to 14.8 mg of dexanfetamine.

The other components are:

• Hard capsule content: microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E572)
• Hard capsule coating: gelatin, titanium dioxide (E171)
• Each hard capsule of 50 mg also contains Brilliant Blue FCF (E133)
• Ink for printing: shellac (E904), potassium hydroxide (E525), iron oxide black (E172) and propylene glycol (E1520) and concentrated ammonia solution (E527)

Appearance of the product and contents of the package

Hard capsules.

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

Package size: 28 or 30 capsules. Some package sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower Dublin 2, D02 HW68

Ireland

Email: [email protected]

Responsible 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Takeda Farmacéutica España S.A.

Calle Albacete, 5, planta 9ª,

Edificio Los Cubos

28027 Madrid

Spain

Phone: +34 91 790 42 22

This medicine is authorized in the member states of theEconomic Area and inUnited Kingdom (Northern Ireland)with the following names:

AustriaElvanse Erwachsene

DenmarkAduvanz

Finland, Germany, IcelandElvanse Adult

NorwayAduvanz

SpainElvanse Adultos

SwedenElvanse Vuxen

United Kingdom (Northern Ireland) Elvanse Adult

Date of the last review of thisleaflet: 11/2024

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).