Package Leaflet: Information for the User

Elvanse 50mg Hard Capsules

Lisdexamfetamine dimesylate

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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Elvanse is and what it is used for

2.What you need to know before you start taking Elvanse

3.How to take Elvanse

4.Possible side effects

5.Storage of Elvanse

6.Contents of the pack and other information

What is Elvanse

Elvanse contains the active ingredient lisdexamfetamine dimesylate that acts on brain activity. It helps to improve attention, concentration, and reduce impulsivity.

Elvanse is a long-acting medication that acts gradually over 13 hours.

What is it used for

Elvanse is part of a comprehensive treatment program for "attention deficit hyperactivity disorder" (ADHD)

in children and adolescents aged 6 to 18 years in whom previous treatment with methylphenidate has been inadequate for ADHD.

• in adults who have had ADHD since childhood. If they have not received treatment for ADHD previously, their doctor will check if they have had ADHD since childhood before prescribing Elvanse.

You should inform your doctor if you do not feel better or feel worse after a month of treatment. Elvanse is not recommended for all patients with ADHD and the decision to use this medication is based on a thorough medical evaluation.

Elvanse is not indicated for the treatment of ADHD in children under 6 years of age as its safety and efficacy in such young individuals is unknown.

How Elvanse works

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

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

• psychological therapy
• educational therapy
• social therapy
• behavioral therapy
• occupational 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. Children and adolescents with ADHD may have difficulties learning and doing homework. They struggle to behave well at home, school, and other places.

ADHD does not affect a person's intelligence.

Do not take Elvanse:

• if you are allergic to lisdexamfetamine, other compounds, or any of the other components of this medication (listed in section6);
• if you are taking a medication called “monoamine oxidase inhibitor” (MAOI) that is used for depression or if you have taken an MAOI in the last 14days;
• if you have thyroid problems;
• if you feel exceptionally elated, 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, cardiac disease, or heart birth defects;
• if you have high or very high blood pressure or narrowed blood vessels;
• if you have elevated intraocular pressure (glaucoma).

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Elvanse if:

• 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 heartbeats (visible on an electrocardiogram), or if you have a disease or are taking a treatment that makes you prone to arrhythmias or sodium imbalances;
• you have a heart problem not included in the section “Do not take Elvanse”;
• you have a history of stroke;
• you have a mental health problem, among others:

• rapid mood swings (manic-depressive states, known as “bipolar disorder”);
• starts behaving aggressively or hostilely, or if these behaviors worsen;
• sees, hears, or feels things that are not real (hallucinations);
• believes things that are not real (delusions);
• feels excessively suspicious (paranoia);
• feels agitated, anxious, or tense;
• feels depressed or guilty.

Or if you are a woman who may become pregnant, plans to become pregnant, or is pregnant (see the section “Pregnancy and breastfeeding”).

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

If not used correctly, Elvanse may cause abnormal behavior and dependence on the medication. Inform your doctor if you or your child have ever abused alcohol, prescription medications, or drugs. Do not give this medication to anyone, even if they seem to have similar symptoms.

Elvanse 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 Elvanse

These checks are made to decide if Elvanse is the right medication for you. Your doctor will ask you about:

• other medications you are taking;

• if there is a family history of sudden and 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” (an uncontrollable and repeated tremor of any part of your body or the repetition of sounds and words);
• any mental health or behavioral problem 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 Elvanse is the right medication for you. Your doctor may decide that further tests are needed before you start taking this medication.

Effect on weight

• Elvanse may cause weight loss in some patients.
• It may also cause no weight gain in children and adolescents.
• If the patient is a child or adolescent, your doctor will closely monitor weight, height, and eating habits.
• If you do not grow as expected or lose weight, your doctor may interrupt Elvanse treatment.
• In adult patients, your doctor will monitor weight and eating habits.

Use of Elvanse with other medications

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

Do not take Elvanse if:

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

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

• medications for severe mental health problems;
• medications used to raise or lower blood pressure;
• medications used during surgery, such as analgesics;
• remedies for cough and cold. 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 (for example, 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.

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 plan to become pregnant, consult your doctor before using this medication.

Elvanse 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 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 20 weeks 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.

Driving and operating machinery

You may feel dizzy, have trouble focusing, or see blurry when taking Elvanse. If this happens, it is dangerous to engage in activities such as driving, operating machinery, riding a bike, horseback riding, or climbing trees.

Elvanse contains sodium

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

How much to take

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

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

The maximum daily dose is 70 mg.

How to take Elvanse

• Take Elvanse in the morning before breakfast. It can be taken with or without food.

• There are two ways to take Elvanse:

or Swallow the capsule whole with a glass of water.

or 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 lump and mix Elvanse and the yogurt, water, or orange juice well. Take all the yogurt or drink all the water or orange juice immediately after mixing with Elvanse. Do not store 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 take each day.
• The recommended starting dose is 30 mg. Your doctor may increase the dose to 50 mg or 70 mg later. The maximum daily dose is 70 mg.
• If you have any kidney problems, your doctor may reduce the dose.
• If you are an elderly person, your doctor will study your blood pressure and cardiovascular status before starting and during treatment (see section 2 “Do not take Elvanse” and the section “Warnings and precautions”). Your doctor may also need to 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 feel better after 1 month of treatment

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

Abuse of Elvanse

• If you use Elvanse incorrectly, 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 Elvanse than you should

In case of overdose or accidental ingestion, consult a doctor, pharmacist, or call the Toxicology 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, see, feel, or hear 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), high or low blood pressure, circulatory collapse, attacks, and coma may also occur.

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).

Stopping treatment with Elvanse

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 while you are on Elvanse treatment

Your doctor will perform some tests

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

• After starting: your doctor will perform tests at least every 6 months, and even more often.

You will also be tested when you change doses. These tests will include:

-appetite control,

-height and weight measurement,

-blood pressure and pulse measurement,

-checking if you have had mood, emotional state, or any other abnormal feelings or if these issues have worsened while taking Elvanse.

Long-term treatment

Elvanse does not need to be taken forever. If you take Elvanse for more than a year, your doctor should interrupt the treatment for a short 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 this medication, ask your doctor or pharmacist.

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

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

Frequent (may affect up to 1 in 10 people)

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

Less frequent (may affect up to 1 in 100 people)

• Feeling more excited, active, or uninhibited than normal (mania)
• Allergic reaction (hypersensitivity)

Unknown frequency (cannot be estimated from available data)

• 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 movements and difficulty controlling them from any part of the body or repetition of sounds and words (tics)
• Seizures (convulsions)
• Abnormal heart rhythm, potentially fatal (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 skin (angioedema) or severe skin rash with large blisters on the skin and mucous membranes (Stevens-Johnson syndrome)
• Lack of air or swelling of the legs (signs of heart muscle disease)*

*The following serious side effects have a different frequency in children and adolescents compared to adults.

• Seeing, feeling, or hearing things that are not real is less frequent in children and adolescents
• Lack of air or swelling of the legs (signs of heart muscle disease) is less frequent in adolescents

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

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

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

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

Frequent (may affect up to 1 in 10 people)

• Feeling agitated, nervous, anxious, depressed, irritable, or having sudden mood swings
• Feeling more tired* or restless
• Inability to achieve or maintain an erection or changes in sexual desire
• Feeling dizzy
• Uncontrolled tremors, twitching, or being more active than normal
• Repetitive movements and difficulty controlling them from any part of the body, or repetition of sounds and words (tics)
• Fast or irregular heartbeat (tachycardia)
• High blood pressure*
• Difficulty breathing
• Nausea, vomiting, or diarrhea
• Constipation
• Weight loss*
• Excessive sweating
• Stomach pain
• Grinding of teeth

Less frequent (may affect up to 1 in 100 people)

• Fever*
• Talking non-stop
• Feeling depressed, worried, sad, or anxious (dysphoria)
• Feeling too happy or excited (euphoria)
• Picking at the skin excessively
• Uncontrolled tremors or twitching
• Feeling more drowsy than normal
• Itching, skin rash*or red, elevated areas of the skin that itch (urticaria)
• Blurred vision
• Metals taste or changes in sense of taste (dysgeusia)
• Fainting
• Nasal bleeding

Unknown frequency (cannot be estimated from available data)

• Excessive dilation of the pupils*
• Aggression
• Poor blood circulation that causes the hands and feet to become numb and pale (Raynaud's phenomenon)*

*The following side effects have a different frequency in children and adolescents compared to adults.

• Weight loss is very frequent in children and adolescents
• Stomach pain is very frequent in children
• Fever is frequent in children and adolescents
• Feeling more drowsy than normal is frequent in children and adolescents
• Skin rash is frequent in children
• High blood pressure is less frequent in children and adolescents
• Poor blood circulation that causes the hands and feet to become numb and pale (Raynaud's phenomenon) is less frequent in children
• Excessive dilation of the pupils is less frequent in children and adolescents

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above 25°C.

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

Store this medication in a safe and inaccessible place for other people. It may cause serious harm to individuals for whom it was not prescribed.

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if the capsules 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 SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Elvanse

The active ingredient is lisdexamfetamine dimesylate.

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

The other components are :

• Hard capsule content:microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

•Hard capsule coating:gelatin, black ink (shellac and iron oxide black (E172)).

•Colorants of the hard capsule coating:titanium dioxide (E171) and brilliant blue FCF (E133).

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

Dublín 2, D02 HW68, Ireland

E-mail: [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

Dublín 2, D02 HW68

Ireland

or

Takeda GmbH,

Plant Oranienburg, Lehnitzstrasse 70-98,

16515 Oranienburg

Germany

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Takeda Farmacéutica España S.A.

Calle Albacete, 5, planta 9ª,

Edificio Los Cubos

28027 Madrid

Spain

Tel: +34 91 790 42 22

This medicinal product is authorized in the Member States of the European Economic Area and inUnited Kingdom (Northern Ireland)with the following names:

GermanyElvanse

AustriaElvanse

BelgiumElvanse

DenmarkElvanse

SpainElvanse

FinlandElvanse

NetherlandsElvanse

IrelandTyvense

LuxembourgElvanse

NorwayElvanse

PortugalElvanse

SwedenElvanse

United Kingdom (Northern Ireland) Elvanse

Last review date of this leaflet:12/2023.

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