Elvanse 70 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Elvanse 70mg hard capsules

lisdexamfetamine dimesylate

Read the entire 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Elvanse is and what it is used for
2. What you need to know 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

1. What Elvanse is and what it is used for

What Elvanse is

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

Elvanse is a prolonged-release medicine that gradually works over 13 hours.

What it is used for

Elvanse is part of a comprehensive treatment programme for “attention deficit hyperactivity disorder” (ADHD)

• in children and adolescents aged between 6 and 18 years when previous treatment with methylphenidate has been inadequate for ADHD. They may continue taking it

• 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.

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

Elvanse 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 works

Elvanse 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
• social therapy
• behavioural therapy
• occupational 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. Children and adolescents with ADHD may have difficulties learning and completing homework. They may struggle to behave appropriately at home, at school, and in other settings.

ADHD does not affect a person's intelligence.

2. What you need to know before taking Elvanse

DO NOT take Elvanse:

• 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 tumour usually growing in the adrenal glands located above the kidneys).

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Elvanse 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 family or personal history of irregular heartbeat (visible on an electrocardiogram), or if you have a condition or are receiving 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”;

• you have a history of stroke;

• you have a mental health condition, including:

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

• you start behaving aggressively or hostilely, or these behaviours 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 normal (paranoia);

• you feel restless, anxious, or tense;

• you feel depressed or guilty.

Or if you are a woman who could become pregnant, plan to become pregnant, or are pregnant (see section "Pregnancy and breastfeeding").

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

If not used correctly, Elvanse may cause abnormal behaviour and drug dependence. Inform your doctor if you or your child have abused or been dependent on alcohol, prescription medicines, or drugs. Do not give this medicine to anyone else, even if they seem to have similar symptoms.

Elvanse may cause heart rhythm disorders 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 with higher doses. Therefore, the recommended dose must be followed.

Checks your doctor will make before you start taking Elvanse

These checks are made to decide whether Elvanse 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 (such as heart problems) that you or your family have had;

• how you feel, whether you feel happy or sad, if you have strange thoughts, or if you have had these feelings in the past;

• whether you have a family history of “tics” (repeated, uncontrollable tremors in any part of the body or repetition of sounds and words);

• any mental health or behavioural problems that you or your family 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 is the right medicine for you. Your doctor may decide that further tests are needed before you start taking this medicine.

Effect on weight

• Elvanse may cause weight loss in some patients.
• It may also prevent 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 growth is not as expected or weight loss occurs, your doctor may discontinue treatment with Elvanse.
• In adult patients, the doctor will monitor weight and eating habits.

Taking Elvanse with other medicines

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

DO NOT take Elvanse 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 with Elvanse may 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 may interact with other medicines. If you are taking any of the following medicines, consult your doctor or pharmacist before taking Elvanse:

• medicines for serious mental health conditions;
• medicines used to increase or decrease 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 urine acidity, 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.

Doping control and use in athletes

Patients should be warned that this medicine may result in a positive finding 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 medicine.

Elvanse is converted in the body into substances that can cross the placenta and pass into breast milk.

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 pre-eclampsia (a condition that usually occurs after 20 weeks of pregnancy and is characterised by high blood pressure and protein in the urine) and premature birth. Newborns exposed to amphetamine during pregnancy may experience withdrawal symptoms (tremor, irritability, hypertonia). You should not use this medicine during pregnancy unless explicitly instructed by your doctor, nor should you breastfeed while taking Elvanse.

Driving and using machines

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

Elvanse contains sodium

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

3. How to take Elvanse

How much to take

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

This medicine is for you only. Do not give this medicine to anyone else, even if they 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:

o Swallow the capsule whole with a glass of water.

o 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 well with the yoghurt, water, or orange juice until thoroughly mixed. Take all the yoghurt or drink all the water or orange juice immediately after mixing with Elvanse. Do not store it. Do not worry if a film remains in the glass or container; this is not the active ingredient.

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 later to 50 mg or 70 mg. The maximum daily dose is 70 mg.
• If you have any kidney problems, your doctor may reduce your dose.
• If you are elderly, your doctor will evaluate your blood pressure and cardiovascular status before starting and during treatment (see section 2 “Do not take Elvanse” and section “Warnings and precautions”). Your doctor may also need to reduce your dose.
• Do not split the dose of a capsule; take the entire contents of the capsule. Do not take less than the full capsule content 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.

If you misuse Elvanse

If you misuse Elvanse, 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 than you should

In case of overdose or accidental ingestion, contact a doctor, pharmacist, or call the Toxicology Information Service immediately at phone number 915620420, 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. Fatigue and depression may follow;
• 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

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 due to the risk of sleep disturbances (insomnia).

If you stop taking Elvanse

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

Do not stop taking the medicine without first consulting your doctor. You should not stop taking the medicine 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 frequently.

Tests will also be performed when your dose is changed. These tests will include:

• monitoring of appetite,

• measurement of height and weight,

• measurement of blood pressure and pulse,

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

Long-term treatment

Elvanse does not need to be taken indefinitely. If you take Elvanse 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 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

• severe allergic reaction characterized by a marked 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 signs such as repeated, difficult-to-control body movements or repetition of sounds and words (tics)
• seizures (convulsive fits)
• abnormal heart rhythm, 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 skin (angioedema) or severe skin rash with large blisters on the skin and mucous membranes (Stevens-Johnson syndrome)
• shortness of breath or swelling of the legs (signs of heart muscle disease)*

*The following serious adverse effects occur at different frequencies in children and adolescents compared to adults.

• seeing, feeling, or hearing things that are not real is uncommon in children and adolescents
• shortness of breath or swelling of the legs (signs of heart muscle disease) is uncommon in adolescents

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 people)

• decreased appetite
• difficulty sleeping
• dry mouth
• headache

Common (may affect up to 1 in 10 people)

• feeling restless, nervous, anxious, depressed, irritable, or having sudden mood changes
• feeling more tired* or restless
• inability to achieve or maintain an erection or changes in sex drive
• dizziness
• uncontrollable tremors, shaking, or increased activity
• repeated, difficult-to-control body movements or repetition of sounds and words (tics)
• fast or irregular heartbeat (tachycardia)
• high blood pressure*
• breathing difficulties
• nausea, vomiting, or diarrhea
• constipation
• weight loss*
• excessive sweating
• stomach pain
• teeth grinding

Uncommon (may affect up to 1 in 100 people)

• fever*
• excessive talking
• feeling depressed, worried, sad, or uneasy (dysphoria)
• feeling excessively happy or excited (euphoria)
• excessive skin picking
• uncontrollable tremors or shaking
• feeling more sleepy than usual
• itching, skin rash*, or raised, red, itchy areas of skin (urticaria)
• blurred vision
• 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 numbness and pale color in fingers of hands and feet (Raynaud’s phenomenon)*

*The following adverse effects occur at different frequencies in children and adolescents compared to adults.

• weight loss is very common in children and adolescents
• stomach pain is very common in children
• high temperature (fever) is common in children and adolescents
• feeling more sleepy than normal is common in children and adolescents
• skin rash is common in children
• high blood pressure is uncommon in children and adolescents
• poor blood circulation causing numbness and pale color in fingers of hands and feet (Raynaud’s phenomenon) is uncommon in children
• excessive dilation of the pupils is uncommon in children and adolescents

Reporting of adverse effects

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

5. Storage of Elvanse

Do not store above 25°C.

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

Store this medicine in a safe and inaccessible place for other people. It may seriously harm individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the bottle and the carton, following 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. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Elvanse

The active substance is lisdexamfetamine dimesilate.

Each 70 mg hard capsule contains 70 mg of lisdexamfetamine dimesilate, equivalent to 20.8 mg of dexamfetamine.

The other components are:

• Capsule contents: microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E572).

• Capsule shell: gelatin, titanium dioxide (E171).

  • The 70 mg capsule also contains brilliant blue FCF (E133) and erythrosine (E127).

• Printing ink: shellac (E904), potassium hydroxide (E525), black iron oxide (E172), propylene glycol (E1520), and concentrated ammonia solution (E527).

Appearance of the product and pack contents

Hard capsules.

The 70 mg capsules have an opaque blue body and an opaque pink cap, printed with “S489” and “70 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 more information about this medicinal product, 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 and in the United Kingdom (Northern Ireland) under the following names:

Germany Elvanse
Austria Elvanse
Belgium Elvanse
Denmark Elvanse
Estonia Elvanse
Spain Elvanse
Finland Elvanse
Netherlands Elvanse
Ireland Tyvense
Luxembourg Elvanse
Norway Elvanse
Portugal Elvanse
Sweden Elvanse
United Kingdom (Northern Ireland) Elvanse

Date of the most recent 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/