LISDEXANFETAMINE TEVA 70 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Lisdexanfetamina Teva 30 mg hard capsules EFG

Lisdexanfetamina Teva 50 mg hard capsules EFG

Lisdexanfetamina Teva 70 mg hard capsules EFG

lisdexanfetamine dimesylate

Read the entire package leaflet carefully before you start using this medicine, as it contains important information for you..

• Keep this package leaflet, as you may need to read it again.
• • If you have any further 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Lisdexanfetamina Teva and what is it used for
2. What you need to know before you start using Lisdexanfetamina Teva
3. How to use Lisdexanfetamina Teva
4. Possible side effects

5 Conservation of Lisdexanfetamina Teva

1. Contents of the pack and further information
2. Information for children and adolescents

1. What is Lisdexanfetamina Teva and what is it used for

What is Lisdexanfetamina Teva

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

Lisdexanfetamina Teva is a prolonged-release medicine that acts gradually over 13 hours.

What is it used for

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

• for children and adolescents aged 6 to 18 years in whom previous treatment with methylphenidate has been inadequate for ADHD.
• for adults who have had ADHD since childhood. If you have not received treatment for ADHD before, your doctor will check if you had ADHD as a child before prescribing this medicine.

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

This medicine is not recommended for all patients with ADHD, and the decision to take it is based on a comprehensive medical evaluation.

This medicine is not indicated for the treatment of ADHD in children under 6 years of age, as it is not known whether it is safe or beneficial for such young individuals.

How it works

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

The medicine 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 people with behavioral problems.

About ADHD

People with ADHD have difficulties:

• sitting still
• 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 may have trouble behaving well at home, at school, and in other places.

ADHD does not affect a person's intelligence.

2. What you need to know before you start using Lisdexanfetamina Teva

Do not useLisdexanfetamina Teva

• if you are allergic to lisdexanfetamine 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 heartbeats, chest pain and discomfort, 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 lisdexanfetamine dimesylate if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking this medicine, as it may worsen these problems.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine if:

• you have ever abused prescription medicines or street drugs;
• you have had kidney problems;
• you have had seizures (fits, convulsions, epilepsy) or changes 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 taking a treatment that makes you prone to arrhythmias or changes in sodium levels;
• you have a heart problem not listed in the "Do not use Lisdexanfetamina Teva" section above;
• you have a mental health problem, including:

• sudden mood changes (from manic to depressive states, also known as "bipolar disorder");
• starting to behave aggressively or hostilely or if these behaviors worsen;
• 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 breastfeeding (see "Pregnancy and breastfeeding" section)

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

If this medicine is not used correctly, it can cause abnormal behavior, and the user may start to depend on the medicine. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Do not give this medicine to anyone else, even if the symptoms seem similar.

This medicine 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 perform before you start taking Lisdexanfetamina Teva

These checks are performed to decide if lisdexanfetamine dimesylate 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 unusual thoughts or if you have had these feelings in the past;
• if you have a family history of "tics" (a difficult-to-control and repeated tremor of any part of the body or the repetition of 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 lisdexanfetamine dimesylate is the right medicine for you. Your doctor may decide that other tests need to be performed before you start taking this medicine.

Use in athletes

This medicine contains lisdexanfetamine, which may produce a positive result in doping tests (see references in section 4.4 of the technical sheet).

Effects on weight

• Lisdexanfetamine may cause weight loss in some patients.
• There may also be a lack of weight gain in children and adolescents.
• If you are a child or adolescent, your doctor will closely monitor your height and weight, as well as your diet.
• If you are not growing as expected or if you are losing weight, your doctor may interrupt treatment with lisdexanfetamine.
• In the case of adults, the doctor will monitor your weight and diet.

Other medicines and Lisdexanfetamina Teva

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

DO NOT take this medicine 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. The use of an MAOI with lisdexanfetamine dimesylate 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.

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

• 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 that you consult your pharmacist when purchasing any of these medicines
• medicines that may affect the acidity of the urine, such as vitamin C (ascorbic acid) or sodium bicarbonate (e.g., in medicines for indigestion).

If you are unsure if the medicines you are taking are on the list above, consult your doctor or pharmacist before taking this medicine.

Pregnancy andbreastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Lisdexanfetamine dimesylate is transformed into other substances in the body that can cross the placenta and pass into breast milk.

Available data on the use of this medicine 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 breastfeed if you are taking lisdexanfetamine dimesylate.

Driving and using machines

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

Lisdexanfetamina Teva contains sodium

This medicine contains less than 1mmol of sodium (23 mg) per capsule; this is, essentially "sodium-free".

3. How to take Lisdexanfetamina Teva

How much to take

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

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

How to take Lisdexanfetamina Teva

• Take this medicine in the morning before breakfast. It can be taken with or without food.
• There are two ways to take this medicine:

• 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 this medicine and the yogurt, water, or orange juice well. Take all the yogurt or drink all the water or orange juice immediately after mixing with lisdexanfetamine. 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 what dose of capsules 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 recommended 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 study your blood pressure and cardiovascular status before starting treatment and during treatment (see section 2 "Do not use Lisdexanfetamina Teva" and "Warnings and precautions"). Your doctor may 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.

Incorrect use of Lisdexanfetamina Teva

If this medicine is not used correctly, it can cause abnormal behavior. You may also start to feel that you need the medicine for reasons that are not related to ADHD. Inform your doctor if you have ever had problems with alcohol, prescription medicines, or street drugs.

If you take more Lisdexanfetamina Teva 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 taken.

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. You may also experience nausea, vomiting, diarrhea, and stomach cramps. There may also be changes in heart rhythm (slow, fast, or irregular), high or low blood pressure, circulatory collapse, seizures, and coma.

If you forget to take Lisdexanfetamina Teva

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 Lisdexanfetamina Teva

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

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

What your doctor will do while you are on Lisdexanfetamina Teva treatment

Your doctor will perform some tests

• before starting: to ensure that this medicine is safe and beneficial for you.
• after starting: your doctor will perform tests at least every 6 months, and even more often. Tests will also be performed when changing the 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 this medicine.

Long-term treatment

This medicine does not need to be taken forever. If you take lisdexanfetamine dimesylate for more than a year, your doctor should interrupt treatment for a short period, such as during vacations. 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 occur, consult your doctor immediately:

Frequent (may affect up to 1 in 10 people)

• irregular heartbeats (palpitations)
• chest pain (may 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, delusions (psychotic episodes)
• 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 adverse effects are more frequent in children and/or adolescents than in 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) are infrequent in adolescents.

If you experience any of the above adverse effects, consult your 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 tired* or restless
• inability to achieve or maintain an erection or changes in sexual desire
• feeling dizzy
• uncontrolled tremors, shaking, or being more active than usual
• repeated and uncontrollable spasms of any part of the body or repeating sounds and words (tics)
• rapid or irregular heartbeat (tachycardia) high blood pressure*
• breathing difficulties
• nausea, vomiting, or diarrhea
• constipation
• weight loss*
• excessive sweating
• stomach pain
• grinding teeth

Infrequent (may affect up to 1 in 100 people)

• fever*
• talking excessively
• feeling depressed, worried, sad, or uneasy (dysphoria)
• feeling too happy or excited (euphoria)
• excessive skin picking
• uncontrolled tremors or shaking
• feeling unusually drowsy
• itching, skin rash, or red, raised skin areas that itch (urticaria)
• blurred vision
• high blood pressure
• 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 side effects are more frequent in children and/or adolescents than in adults.

• weight loss is very common in children and adolescents
• stomach pain is very frequent in children
• fever is frequent in children and adolescents
• feeling unusually drowsy 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 Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lisdexanfetamina Teva

Store below 30°C

Keep this medicine out of sight and reach of children.

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

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

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

6. Package Contents and Additional Information

Composition of Lisdexanfetamina Teva

The active ingredient is lisdexanfetamine dimesylate.

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

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

Each 70 mg capsule contains 70 mg of lisdexanfetamine dimesylate, equivalent to 20.8 mg of dexamfetamine.

The other ingredients are:

• Capsule content: microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171), black ink (shellac, propylene glycol, iron oxide black, and potassium hydroxide).
• Capsule shell colorants:

• 30 mg: yellow iron oxide (E172), red iron oxide (E172)
• 50 mg: carmine indigo (E132)
• 70 mg: yellow iron oxide (E172), red iron oxide (E172), carmine indigo (E132)

Appearance of the Product and Package Contents

Plastic bottle with child-resistant closure.

30 mg: White body and orange cap, printed with 'TEV' and '30 mg' in black ink.

50 mg: White body and blue cap, printed with 'TEV' and '50 mg' in black ink.

70 mg: Blue body and orange cap, printed with 'TEV' and '70 mg' in black ink.

Each capsule is approximately 19 mm long and 6 mm wide.

Package sizes: 10, 30, or 100 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

Zagreb 10000

Croatia

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

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:October 2024

1. Information for children and adolescents

This information is to help you understand the main points about your medicine called Lisdexanfetamina Teva.

If you prefer not to read it, someone like your mother, father, or main caregiver can read it to you and answer some questions.

It may help if you read small pieces at a time.

Why has your doctor prescribed this medicine for you?

This medicine can help with your ADHD.

ADHD can make you:

• run too much.

• be unable to pay attention.
• act quickly without thinking about what will happen next (impulsive).

This affects learning, making friends, and how you think about yourself. It's not your fault.

While you are taking this medicine

• Your doctor will agree with you on ways to deal with your ADHD, such as talking to people who can give you advice or teach you different ways of doing things, as well as giving you this medicine. The medicine should help you with your ADHD.
• You will need to visit your doctor several times for check-ups. This is to ensure that this medicine is working and that you are growing and developing well.
• If you take this medicine for more than a year, your doctor may stop the treatment to see if you still need it. This may happen during school vacations.
• Girls should ask their doctor for advice before taking this medicine if they think they may be pregnant or are planning to have a baby.

Some people cannot take this medicine.

You cannot take this medicine if:

• you have heart problems

• you feel unusually excited or hyperactive

Some people need to talk to their doctor before starting to take this medicine.

You need to talk to your doctor if:

• you have seizures
• you are pregnant or breastfeeding
• you are taking other medicines – your doctor needs to know the medicines you are taking
• you have kidney problems

How do I take my medicine (capsules)?

• Swallow the capsule with water. Or open the capsule and dissolve the entire contents in a glass of water or orange juice. Or mix the contents with soft food like yogurt.
• Eat all the yogurt or drink all the water or orange juice directly after mixing.
• Take one capsule each morning. You can take it with or without food. Do not stop taking this medicine without talking to your doctor first.
• If you forget to take your medicine, talk to an adult. DO NOT take 2 capsules to make up for the missed dose.

Possible Adverse Effects

Adverse effects are unwanted things that can happen when you take a medicine. If any of the following occur, talk to an adult directly. They can talk to your doctor. The things that may affect you mainly are:

• feeling that your heart is beating faster than usual or irregular heartbeat
• seeing, feeling, or hearing things that are not real
• feeling unusually excited or hyperactive
• having a severe allergic reaction. This can be seen as feeling dizzy, difficulty breathing, and itching.
• having seizures
• noticing yellowing of the eyes and/or skin
• having skin swelling or severe skin rash with significant blisters on the skin or in other areas

If you feel unwell in any way while taking your medicine, please talk to an adult directly.

Other things to remember

• Make sure to keep your medicine in a safe place, so that no one else can take it.
• The medicine is only for you – DO NOT let anyone else take it. It may help you, but it could harm other people.
• If you forget to take your medicine, do not take 2 capsules the next time. Take only 1 capsule the next time at your usual time
• It is important not to take too much medicine or you may become ill.
• If you take too much medicine, talk to your mother, father, or caregiver directly.
• Do not stop taking your medicine until your doctor tells you to stop taking it.

Who should I ask if there is something I do not understand?

Your mother, father, or caregiver, doctor, nurse, or pharmacist can help you.

Other sources of information

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