Lisdexamfetamine: complete leaflet, how to take, contraindications, side effects.

The information provided here was taken directly from the medicine's original leaflet, ensuring the accuracy and reliability of the data.

This guide was developed to offer a clear and simplified overview of how to use the medicine, its indications, contraindications and necessary care.

Read carefully and, if you have any questions, consult your doctor or pharmacist.

What is lisdexamfetamine recommended for?

1. Treatment of ADHD (Attention Deficit Hyperactivity Disorder): This medication is indicated to help treat Attention Deficit Hyperactivity Disorder (ADHD). It is part of a complete treatment program, which may also include counseling sessions and other therapies to help manage symptoms.
2. Treatment of Binge Eating Disorder (BED): Furthermore, this medication is also recommended for the treatment of Binge Eating Disorder (BED) in adults over 18 years of age, helping to reduce the frequency and episodes of binge eating.

How does lisdexamfetamine work?

Lisdexamfetamine dimesylate is a medication that acts as a central nervous system stimulant.

It is mainly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 and over, helping to improve attention, reduce impulsivity and decrease hyperactivity.

Start of Action

The effects of the medicine begin to be noticed within the first two hours after ingestion.

Limitations of Use

The efficacy and safety of lisdexamfetamine dimesylate are not known for children under 6 years of age with ADHD or for BAD patients under 18 years of age.

Composition and formulation

Lisdexamfetamine dimesylate hard capsules are available in concentrations of 30 mg, 50 mg and 70 mg, and are sold in packs containing 30 hard capsules.

Each lisdexamfetamine dimesylate capsule contains:

30 mg:

• Lisdexamfetamine dimesylate: 30 mg (equivalent to 17.34 mg of lisdexamfetamine)
• Excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide, gelatin, purified water, brilliant blue, erythrosine red disodium, titanium dioxide, quinoline yellow and sunset yellow.

50mg:

• Lisdexamfetamine dimesylate: 50 mg (equivalent to 28.91 mg of lisdexamfetamine)
• Excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide, gelatin, purified water, brilliant blue, erythrosine disodium red and titanium dioxide.

70 mg:

• Lisdexamfetamine dimesylate: 70 mg (equivalent to 40.47 mg of lisdexamfetamine)
• Excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide, gelatin, purified water, titanium dioxide, quinoline yellow and sunset yellow.

When should I not use it?

You should not use this medicine if you have any of the following conditions:

• Use of MAOIs: If you have taken or are taking, in the last 14 days, an antidepressant called a monoamine oxidase inhibitor (MAOI).
• Anxiety and Tension: If you have a lot of anxiety, tension or agitation.
• Heart disease: If you have heart problems.
• Hardening of the Arteries: Known as atherosclerosis.
• High pressure: If your blood pressure is moderate to high.
• Hyperthyroidism: If you have an overactive thyroid.
• Glaucoma: If you have an eye disease called glaucoma.
• History of Drug Abuse: If you have a history of substance abuse.
• Allergy to Stimulants: If you have sensitivity or allergies to other stimulant medications.

Furthermore, This medicine has not been studied in children under 6 years of age or in adults over 55 years of age.

What should I know before using this medicine? (Warnings and Precautions)

Attention: This medicine can cause physical or psychological dependence. Use without medical advice may be harmful to your health.

Risk of Abuse

Amphetamines, such as lisdexamfetamine dimesylate, should not be used inappropriately. Abuse can lead to tolerance, which means you may need larger doses to get the same effect, and psychological dependence.

This can result in abnormal behaviors such as skin problems, difficulty sleeping, irritability, hyperactivity, emotional changes and even psychosis. When the medication is stopped, it can cause withdrawal symptoms such as tiredness and depression.

History of alcohol and drug abuse

It is important to inform the doctor if the patient has a history of alcohol, prescription medication or drug abuse, or if there is such a history in the family.

Heart problems

The doctor must check for heart problems before starting treatment. During treatment, the doctor may stop medication periodically to assess the patient's condition.

It is important to monitor blood pressure, heart rate, height and weight. If signs of heart problems appear, such as chest pain or shortness of breath, see a doctor immediately.

Mental symptoms

If new symptoms or worsening of mental problems appear, such as hallucinations or seeing and/or hearing things that are not there, tell your doctor immediately.

Ability to pay attention when driving

The medicine may affect your ability to drive or operate machinery. Be careful when carrying out activities that require attention.

Use in the elderly and children

It has not been studied in people over 55 years of age or in children under 6 years of age, so efficacy and side effects in these groups have not been confirmed.

Additionally, amphetamines are not recommended for children under 3 years of age.

Kidney problems

Tell your doctor if you have kidney problems, as the dose may need to be adjusted.

Pregnancy and breastfeeding

Risk category C in pregnancy: Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Breastfeeding must be stopped while using the medication. Do not use without medical advice.

Interactions with food

You can take the medicine with or without food, as it does not cause adverse reactions with food.

Interactions with other medications

If you are taking antidepressants, such as MAOIs, tell your doctor. Lisdexamfetamine dimesylate can interact with other medicines and cause serious side effects. Only your doctor can assess whether it is necessary to adjust the doses of other medications.

Therefore, you must inform your doctor and/or pharmacist about all medicines you are using, including over-the-counter medications, vitamins and supplements. Avoid starting any new medication without consulting first.

Interactions with laboratory tests and doping

Amphetamines can significantly increase blood corticosteroid levels, especially at night. Additionally, they can interfere with urine steroid tests.

This medicine can be detected in doping tests.

Allergies to dyes

The dyes present in the capsules may cause allergic reactions in some people. Check out the details:

• 30 mg capsule: contains titanium dioxide, brilliant blue, erythrosine disodium red, quinoline yellow and twilight yellow.
• 50 mg capsule: contains titanium dioxide, brilliant blue and erythrosine disodium red.
• 70 mg capsule: contains titanium dioxide, quinoline yellow and twilight yellow.

Before consuming, check if you are allergic to any of the dyes present in the capsules. If you have any questions or allergy symptoms, consult a doctor.

How and where to store this medicine?

Conservation: Keep the medicine in the original packaging to protect it from light and moisture and store at room temperature, between 15°C and 30°C. Store the medicine out of the reach of children.

Validity: Always check the batch number and manufacturing and expiration dates on the packaging. Do not use the medicine after the expiration date.

Appearance and appearance: Before use, check the appearance of the medicine. If you notice any changes, even within the expiration date, consult a pharmacist.

How should I use it?

The medicine is available in capsules with different concentrations: 30 mg, 50 mg and 70 mg. The dose can be adjusted by your doctor to find the right amount for you.

Instruction for use

The recommendation is to take the medicine once a day, preferably in the morning. Can be taken with or without food.

Avoid taking it in the afternoon or at night to avoid affecting your sleep, as the medicine can cause insomnia.

Taking the capsule

You can swallow the capsules whole with water.

Or if you prefer, you can open the capsule and mix the powder with soft foods, such as yogurt, or liquids, such as water or orange juice. If the powder is compacted, use a spoon to help dissolve the lumps. Consume the entire mixture immediately and do not save it for later. Although the active ingredient dissolves completely, a small amount of inactive ingredients may remain in the container.

Make sure to consume the entire capsule contents and do not take less than the amount of one capsule per day.

Dosage

The recommended starting dose is 30 mg per day, in the morning. Your doctor may increase this dose if necessary, up to the recommended maximum of 70 mg per day.

Prolonged Use

If treatment is prolonged, your doctor will do regular checks to check whether the medicine is still benefiting you. It is essential to follow all your doctor's instructions regarding the time, dose and duration of treatment. Do not stop using the medication without first consulting your doctor.

What should I do when I forget to take it?

If you forget to take your dose of lisdexamfetamine dimesylate, take it in the morning as soon as you remember. If you only remember in the afternoon or evening, you should skip the missed dose, as taking the medicine in the afternoon may affect your sleep.

Do not take a double dose to make up for a missed dose.

If you are on prolonged treatment with high doses and stop using it “at once”, it can cause extreme fatigue and mental depression.

If you have any questions or concerns, consult your pharmacist, doctor or dentist.

Side effects and adverse reactions

ADHD patients:

• Very Common (in 10% or more of patients): Reduced appetite, trouble sleeping, headache, weight loss, dry mouth, restlessness and upper abdominal pain.
• Common (between 1% to less than 10% of patients): Tic, emotional lability, increased psychological and motor activity, aggressiveness, dizziness, depression, irritability, restlessness, nausea, vomiting, diarrhea, skin rash, fever, excessive sweating, shortness of breath, tremor, anxiety, bruxism, drowsiness, constipation , fatigue, accelerated or irregular heartbeat, palpitations, increased blood pressure, difficulty in erection and changes in sexual drive.
• Uncommon (between 0.1% to less than 1% of patients): Hypersensitivity, dysphoria, decreased taste, excessive talking, mania, touching and breaking the skin, dyskinesia, euphoria, hallucination, blurred vision, pupil dilation, urticaria, chest pain, cardiomyopathy, Raynaud's phenomenon, QT prolongation and nosebleeds.
• Unknown incidence: include eosinophilic hepatitis, anaphylactic reactions, psychotic episodes, seizures, angioedema, alopecia and Stevens-Johnson Syndrome. Reduced blood flow to the intestine and Tourette Syndrome, a nervous system disorder characterized by repetitive movements or unwanted sounds, may also occur.

Patients with TCA:

• Very Common (in 10% or more of patients): Reduced appetite, trouble sleeping, headache and dry mouth.
• Common (between 1% to less than 10% of patients): Bruxism, dizziness, agitation, anxiety, tremor, decreased sense of taste, rapid or irregular heartbeat, restlessness, irritability, palpitations, diarrhea, constipation, upper abdominal pain, nausea, vomiting, excessive sweating, skin rash, chest pain, fatigue , nervousness, mood swings, increased blood pressure, weight loss and difficulty in erection.
• Uncommon (between 0.1% to less than 1% of patients): Agitation, excessive talking, decreased sexual desire, tic, hypersensitivity, euphoria, depression, dysphoria, mania, dyskinesia, increased psychological and motor activity, habit of moving and hurting the skin, hives, drowsiness, blurred vision, shortness of breath, fever, Raynaud's phenomenon, QT prolongation and nosebleeds.
• Unknown incidence: anaphylactic reaction, psychosis (disconnection from reality), hallucinations and aggressiveness. Other effects include dilation of the pupils, heart problems (such as inflammation and enlargement), eosinophilic hepatitis, swelling of affected areas, hair loss, Stevens-Johnson Syndrome, seizures, reduced blood flow to the intestine and Tourette's, which causes repetitive movements and sounds.

Effects Related to the Use of Stimulants:

This is a stimulant medication, and with the use of stimulants such as amphetamines, the following adverse reactions have been reported:

• Heart problems: Palpitations, rapid heartbeat, elevated blood pressure, sudden death, myocardial infarction.
• Central Nervous System: Psychotic episodes, overstimulation, restlessness, dizziness, insomnia, euphoria, difficulty in intentional movements, dysphoria, depression, tremor, headache, motor and phonic tics, convulsions, stroke.
• Gastrointestinal Problems: Dry mouth, unpleasant taste, diarrhea, constipation.
• Allergic Reactions: Urticaria, rashes, severe reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
• Hormonal and sexual changes: Impotence and changes in sexual desire.

Attention: This medicine has a new therapeutic indication in the country. Although research indicates acceptable efficacy and safety, unpredictable or unknown adverse effects may occur. Tell your doctor immediately if you notice any adverse reactions.

What to do if I use a larger amount than recommended?

If someone uses more than the indicated amount of lisdexamfetamine dimesylate, it is essential to seek medical attention immediately or go to the hospital. Signs of an acute overdose may include restlessness, tremors, exaggerated reflexes, rapid breathing, confusion, aggression, hallucinations, panic, high fever and muscle destruction. After the stimulation phase, fatigue and depression may occur.

Furthermore, overdose can cause cardiovascular problems, such as changes in heart rhythm, high or low blood pressure and circulatory collapse. Gastrointestinal symptoms such as nausea, vomiting, diarrhea and abdominal cramps may also appear. In severe cases, poisoning can lead to convulsions and coma.

If this happens, seek urgent medical help and, if possible, take the medicine package or leaflet with you. For further guidance, call 0800 722 6001.

Download the full leaflet

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Sources and bibliography:

This article was extracted from the original leaflet from the manufacturer EUROFARMA, in July 2024, under technical supervision of the responsible pharmaceutical company.

To check the leaflet of other brands, you can visit the ANVISA electronic leaflet and search for the manufacturer of your choice.

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