ELVANSE ADULTS 30 mg HARD CAPSULES

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

What isElvanse Adult

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

Elvanse Adult is a prolonged-release medicine that acts gradually over 14 hours.

What is it used for

Elvanse Adult 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 been treated for ADHD, your doctor will check if you had ADHD as a child before prescribing Elvanse Adult for you.

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

Elvanse Adult 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 Adult is not indicated for the treatment of ADHD in children under 6 years of age, as it is not known if it is safe or effective for such young patients.

How Elvanse Adult works

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

The medicine is given 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 who have experience in treating people with behavioural problems.

About ADHD

People with ADHD have difficulty:

• sitting still
• concentrating

These people are not to blame for not being able to do these things. However, ADHD can cause problems in daily life. People with ADHD may have difficulty working, learning, and relating to others, and have low self-esteem.

ADHD does not affect a person's intelligence.

2. What you need to know before you take Elvanse Adult

Do not take ElvanseAdult

• if you are allergic to lisdexamfetamine, other amphetamine compounds, or 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 in the last 14 days;
• if you have thyroid problems;
• if you feel exceptionally agitated, more active, or more uninhibited than usual;
• if you have or have had heart problems, such as a heart attack, irregular heartbeats, chest pain, heart failure, heart disease, or congenital heart problems;
• if you have high or very high blood pressure or narrowing of the blood vessels;
• if you have high eye pressure (glaucoma).

Do not take Elvanse Adult if you have any of the above conditions. If you are not sure, consult your doctor or pharmacist before taking Elvanse Adult, as it may worsen these problems.

Warnings and precautions

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

• you have ever abused prescription medicines or drugs;
• you have had kidney problems;
• you have had seizures (fits, convulsions, epilepsy) or changes in your electroencephalogram (EEG);

• you have had tremors that are difficult to control in any part of your body or if you repeat sounds and words;

• you have high blood pressure;
• you have a family history of irregular heartbeat (visible on an electrocardiogram) or if you have a condition or are taking a treatment that makes you prone to arrhythmias or changes in sodium levels;
• you have a heart problem not listed in the section above “Do not take Elvanse Adult”;
• you have had a stroke;
• you have a history of mental health problems or behaviour, including:

• sudden mood changes (from manic to depressive states, known as “bipolar disorder”);
• you start to behave aggressively or hostilely or if these behaviours 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 usual (paranoia);
• you feel agitated, anxious, or tense;
• you feel depressed or guilty.

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

Tell your doctor or pharmacist if you have any of the above conditions before starting treatment. Elvanse Adult may worsen these problems. Your doctor will want to monitor how the medicine affects you.

If Elvanse Adult is not used properly, it can cause abnormal behaviour and the user may become dependent on the medicine. Tell your doctor if you have ever had problems with alcohol, prescription medicines, or drugs, or if you have been dependent on any of these substances. Do not give this medicine to anyone else, even if their symptoms seem similar.

Elvanse Adult may cause heart rhythm disorders in some patients. If you experience palpitations or irregular heartbeats during treatment, you should inform your doctor immediately. The risk of heart problems may increase with increasing dose. Therefore, you should follow the recommended dose.

Checks that your doctor will make before you start taking ElvanseAdult

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

• other medicines you are taking;
• if there is a family history of sudden unexplained death;
• any other medical problem (such as heart problems) that 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 repeated movement of any part of the body or the repetition of sounds and words);
• any mental health or behaviour problems that 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 changes from manic to depressive states), or depression.

It is important that you provide as much information as possible. This will help your doctor decide if Elvanse Adult is the right medicine for you. Your doctor may decide that other tests need to be done before you start taking this medicine.

Effects on weight

Elvanse Adult 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 treatment with Elvanse Adult for a short period.

UsingElvanseAdultwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Elvanse Adult if:

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

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

• medicines for severe mental health problems
• medicines used to increase or decrease blood pressure
• medicines used during surgery, such as painkillers
• cough and cold remedies. Some of these medicines may affect blood pressure, so it is important to consult your pharmacist when purchasing any of these medicines
• medicines that may affect urine acidity, such as vitamin C (ascorbic acid) or sodium bicarbonate (e.g. in medicines for indigestion).

If you are not sure if the medicines you are taking are on the list above, consult your doctor or pharmacist before taking Elvanse Adult.

Doping control and use in athletes

Patients should be warned that this medicine may produce a positive result in doping tests.

Pregnancy and breastfeeding

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

Elvanse Adult is transformed in the body into other substances that can cross the placenta and pass into breast milk. Available data on the use of Elvanse Adult 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 amphetamine during pregnancy may exhibit withdrawal symptoms (tremor, irritability, muscle hypertonia). You should not use this medicine during pregnancy unless your doctor explicitly tells you to, nor breastfeed if you are taking Elvanse Adult.

Driving and using machines

You may feel dizzy, have problems fixing your gaze, or see blurry when taking Elvanse Adult. If this happens, it is dangerous to perform activities such as driving or using machines.

Elvanse Adult 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 Adult

How much to take

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

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

How to take Elvanse Adult

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

Use a spoon to dissolve any lumps and mix Elvanse Adult 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 Adult. Do not store it. Do not worry if a film remains 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 if necessary. The maximum daily dose is 70 mg.
• If you have kidney problems, your doctor may reduce the dose.
• If you are an elderly patient, your doctor will assess your blood pressure and cardiovascular status before starting treatment and during treatment (see section 2 “Do not take Elvanse Adult” 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 one capsule per day.

If you do not feel better after 1month of treatment

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

If you misuse Elvanse Adult

• If you use Elvanse Adult incorrectly, you may experience abnormal behaviour or become dependent on the medicine. Therefore, tell your doctor if you have ever had problems with alcohol, prescription medicines, or drugs.

If you take more ElvanseAdultthan you should

In case of overdose or accidental ingestion, consult a doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

Signs of overdose may include: restlessness, tremors, increased uncontrolled movements, muscle tremors, rapid breathing, confusion, tendency to fight or argue, seeing, hearing, or feeling things that are not real (hallucinations), panic state, high fever, or muscle collapse. You may then feel tired and depressed. You may also experience nausea, vomiting, diarrhea, and stomach cramps. There may also be changes in heart rate (slow, fast, or irregular), high or low blood pressure, circulatory collapse, seizures, and coma.

If you forget to take Elvanse Adult

Do not take a double dose to make up for forgotten doses. If you forget a dose, wait until the next day. Avoid taking the dose in the afternoon due to the possibility of sleep disorders (insomnia).

If you stop taking Elvanse Adult

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

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

What your doctor will do while you are taking Elvanse Adult

Your doctor will perform some tests

• Before starting: to make sure Elvanse Adult is safe and effective for you.
• After starting: your doctor will perform tests at least every 6 months, and even more often. Tests will also be performed when you change dose. These tests will include:

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

Long-term treatment

Elvanse Adult does not need to be taken forever. If you take Elvanse Adult for more than a year, your doctor should interrupt treatment for a short period, such as during holidays. This allows your doctor to see if 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 all people suffer from them. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If any of the following adverse effects appear, go to the doctor immediately:

Frequent (may affect up to 1 in 10 adults)

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

Infrequent (may affect up to 1 in 100 adults)

• feeling more excited, active, or uninhibited than usual (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 delirium (psychotic episodes)
• worsening of Tourette's disorder, with signs such as repeated and uncontrollable twitching of some part of the body or repetition of sounds and words (tics)
• seizures (convulsions)
• abnormal heartbeat, potentially life-threatening irregular heartbeat (observed on an electrocardiogram). See section 2, "Warnings and Precautions".
• allergic liver injury that can be detected by the yellow color 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, 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)
• shortness of breath or swelling of the legs (signs of heart muscle disease)

If you experience any of the above adverse effects, go to the doctor immediately.

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

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

• decreased appetite
• inability to sleep
• dry mouth
• headache

Frequent (may affect up to 1 in 10 adults)

• feeling agitated, nervous, anxious, or irritable
• feeling more tired or restless than usual
• inability to achieve or maintain an erection or changes in sexual desire
• feeling dizzy
• spasms, twitching, and uncontrolled tremors or being more active than usual
• repeated and uncontrollable twitching in any part of the body or repetition of sounds and words (tics)
• mood changes
• high blood pressure, rapid or irregular heartbeat (tachycardia)
• breathing difficulties
• nausea or diarrhea
• constipation
• weight loss
• excessive sweating
• stomach pain
• teeth grinding

Infrequent (may affect up to 1 in 100 adults)

• talking non-stop
• feeling depressed, worried, sad, or uneasy (dysphoria)
• feeling too happy or excited (euphoria)
• excessive skin picking
• uncontrolled tremors or twitching
• feeling more sleepy than usual
• itching, skin rash, or red, elevated skin areas that itch (urticaria)
• blurred vision
• high temperature (fever)
• vomiting
• metal taste or changes in taste (dysgeusia)
• fainting
• nosebleeds

Frequency not known (cannot be estimated from available data)

• excessive dilation of the pupils
• aggressiveness

• poor blood circulation that causes the fingers and toes to become numb and pale (Raynaud's phenomenon)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Elvanse Adult

Do not store above 25°C.

Keep this medicine out of sight and reach of children.

Store this medicine in a safe place where others cannot access it. It can cause serious harm to people who have not been prescribed it.

Do not use this medicine after the expiration date shown on the bottle and carton after EXP. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Elvanse Adult

The active ingredient is lisdexamfetamine dimesylate.

Each 30 mg hard capsule contains 30 mg of lisdexamfetamine dimesylate, equivalent to 8.9 mg of dexamfetamine.

The other ingredients are:

• Capsule content: microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E572)
• Capsule shell: gelatin, titanium dioxide (E171)
• Each 30 mg hard capsule also contains erythrosine (E127)
• Printing ink: shellac (E904), potassium hydroxide (E525), black iron oxide (E172), propylene glycol (E1520), and concentrated ammonia solution (E527).

Product Appearance and Package Contents

Hard capsules.

The 30 mg capsules have a white opaque body and a pink opaque cap, with the imprint "S489" and "30 mg" in black ink.

Package size: 28 or 30 capsules. Only some package 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

Email: [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

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, 9th floor,

Edificio Los Cubos

28027 Madrid

Spain

Phone: +34 91 790 42 22

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under 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 revision of this leaflet: 11/2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).