ELVANSE 50 mg HARD CAPSULES

2. What you need to know before you take Elvanse

Do not take Elvanse:

• if you are allergic to lisdexamfetamine, other 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 excited, more active, or more uninhibited than usual;
• if you have or have had heart problems, such as a heart attack, irregular heartbeat, chest pain, or heart failure;
• 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 if you have any of the above conditions. If you are not sure, 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 medicines or drugs;
• you have had kidney problems;
• you have had seizures (fits, convulsions, epilepsy) or alterations in the electroencephalogram (EEG);
• you have had tremors that are difficult to control in any part of the 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 undergoing treatment that makes you prone to arrhythmias or sodium disturbances;
• you have a heart problem not listed in the previous section “Do not take Elvanse”;
• you have a history of stroke;
• you have a mental health problem, including:

• sudden mood changes (from manic to depressive states, known as “bipolar disorder”);
• starting to behave aggressively or hostilely or worsening of these behaviors;
• seeing, hearing, or feeling things that are not real (hallucinations);
• believing things that are not real (delusions);
• feeling more suspicious than usual (paranoia);
• feeling agitated, anxious, or tense;
• feeling depressed or guilty.

Or if you are a woman who may become pregnant, plan to become pregnant, or are breast-feeding (see the section “Pregnancy and breast-feeding”).

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

If Elvanse is not used correctly, it can cause abnormal behavior and dependence on the medicine. Inform your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or drugs. Do not give this medicine to anyone, even if they seem to have similar symptoms.

Elvanse can 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 Elvanse

These checks are made to decide if Elvanse 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 sounds and words);
• any mental health or behavioral problem 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 essential that you provide as much information as possible. This will help your doctor decide if Elvanse is the right medicine for you. Your doctor may decide that other tests need to be done before you start taking this medicine.

Effect on weight

• Elvanse may cause weight loss in some patients.
• It may also cause a lack of 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 the child does not grow as expected or loses weight, the doctor may stop treatment with Elvanse.
• In adult patients, the doctor will monitor weight and eating habits.

Using Elvanse with other medicines

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

Do not take Elvanse 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 can cause a sudden increase in blood pressure. Your doctor or pharmacist may tell you if you are taking a medicine that is an MAOI.

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

• 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 essential to consult your pharmacist when purchasing 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.

Doping control and use in athletes

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

Pregnancy and breast-feeding

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

Elvanse 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 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, muscle hypertonia). You should not use this medicine during pregnancy unless your doctor explicitly tells you to, nor breast-feed while taking Elvanse.

Driving and using machines

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

Elvanse contains sodium

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

3. How to take Elvanse

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

Either swallow the capsule whole with a glass of water.

Or 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 and 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 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 to 50 mg or 70 mg later. The maximum daily dose is 70 mg.
• If you have kidney problems, your doctor may reduce the dose.
• If you are an elderly person, your doctor will check 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.

If you misuse Elvanse

• If you use Elvanse incorrectly, 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 been dependent on any of these substances.

If you 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 medicine and the amount ingested.

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

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

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

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

What your doctor will do while you are taking Elvanse

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.

Also, tests will be performed when you change dose. These tests will include:

-appetite control,

-height and 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.

Long-term treatment

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

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

Infrequent (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

• 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 any part of the body or repetition of sounds and words (tics)
• seizures (convulsive crises)
• 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)
• skin swelling (angioedema) or severe skin rash with significant 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 have a different frequency in children and adolescents compared to adults.

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

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 people)

• decreased 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 changes
• 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 usual
• repeated and uncontrollable twitching of any part of the body 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

Infrequent (may affect up to 1 in 100 people)

• fever*
• 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 drowsy than usual
• itching, skin rash*, or red, elevated skin areas that itch (urticaria)
• blurred vision
• metal taste or changes in taste (dysgeusia)
• fainting
• nosebleeds

Frequency not known (cannot be estimated from available data)

• excessive pupil dilation*
• aggression
• poor blood circulation that causes fingers and toes to become numb and pale (Raynaud's phenomenon)*

*The following adverse 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
• high temperature (fever) is frequent in children and adolescents
• feeling more drowsy than usual is frequent in children and adolescents
• skin rash is frequent in children
• high blood pressure is infrequent in children and adolescents
• poor blood circulation that causes fingers and toes to become numb and pale (Raynaud's phenomenon) is infrequent in children
• excessive pupil dilation is infrequent in children and adolescents

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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 can seriously harm people for whom it has not been prescribed.

Do not use this medicine after the expiration date stated on the bottle and carton after CAD. 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 disposed of via wastewater or household waste. Deposit the packaging and medicines that are no longer needed at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Elvanse

The active ingredient is lisdexamfetamine dimesylate.

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

The other ingredients are:

• Capsule content: microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E572).
• Capsule shell: gelatin, titanium dioxide (E171).
• • The 50 mg 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).

Appearance and Package Contents

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. 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:

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 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 Health Products (AEMPS) http://www.aemps.gob.es