Lisdexamfetamine: full package insert, how to take, contraindications, side effects.

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

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

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

What is lisdexamfetamine indicated 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 control symptoms.
2. Binge Eating Disorder (BED) Treatment: Additionally, 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 primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older, helping to improve attention, reduce impulsivity and decrease hyperactivity.

Start of Action

The effects of the medication 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 patients with TCA under 18 years of age.

Composition and formulation

Lisdexamfetamine dimesylate hard capsules are available in strengths 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.

50 mg:

• 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 red disodium 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 are feeling very anxious, tense or agitated.
• Heart Diseases: If you have heart problems.
• Hardening of the Arteries: Known as atherosclerosis.
• High Blood 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.
• Stimulant Allergy: If you have a sensitivity or allergy 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 may cause physical or psychological dependence. Using it without medical advice may be harmful to your health.

Risk of Abuse

Amphetamines, such as lisdexamfetamine dimesylate, should not be misused. Abuse can lead to tolerance, meaning 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 fatigue and depression.

History of alcohol and drug abuse

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

Heart Problems

Your doctor should check for heart problems before starting treatment. During treatment, your doctor may stop your medication periodically to assess your condition.

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

Mental symptoms

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

Attention span while driving

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

Use in the elderly and children

It has not been studied in people over 55 or in children under 6, 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 your dose may need to be adjusted.

Pregnancy and breastfeeding

Pregnancy risk category C: Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Breast-feeding should be discontinued while using this medicine. 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 medicines

If you are taking antidepressants, such as MAOIs, tell your doctor. Lisdexamfetamine dimesylate can interact with other medications and cause serious side effects. Only your doctor can determine whether the doses of other medications need to be adjusted.

Therefore, you should tell your doctor and/or pharmacist about all medications you are taking, including over-the-counter medications, vitamins, and supplements. Avoid starting any new medications without consulting first.

Interactions with laboratory tests and doping

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

This drug can be detected in doping tests.

Allergies to dyes

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

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

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

How and where to store this medicine?

Conservation: Keep the medicine in its original packaging to protect it from light and moisture and store it 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 using, 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.

Instructions for use

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

Avoid taking it in the afternoon or evening, so as not to affect 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 will dissolve completely, a small amount of inactive ingredients may remain in the container.

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

Dosage

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

Prolonged Use

If you are taking a long-term treatment, your doctor will perform regular check-ups to see if the medication is still helping you. It is essential to follow all of your doctor's instructions regarding the time, dose, and duration of treatment. Do not stop taking the medication without first consulting your doctor.

What should I do if I forget to take it?

If you forget to take a dose of lisdexamfetamine dimesylate, take it in the morning as soon as you remember. If you don't remember until the afternoon or evening, you should skip the missed dose, as taking the medicine in the afternoon can 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 “all 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

Patients with ADHD:

• Very common (in 10% or more of patients): Reduced appetite, trouble sleeping, headache, weight loss, dry mouth, agitation, 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, skin picking and hurting, dyskinesia, euphoria, hallucination, blurred vision, pupil dilation, urticaria, chest pain, cardiomyopathy, Raynaud's phenomenon, QT prolongation, and nosebleed.
• Incidence unknown: 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 having an 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, mania of picking and hurting the skin, hives, drowsiness, blurred vision, shortness of breath, fever, Raynaud's phenomenon, QT interval prolongation and nosebleed.
• Unknown incidence: anaphylactic reaction, psychosis (disconnection from reality), hallucinations and aggression. Other effects include dilated pupils, heart problems (such as inflammation and enlargement), eosinophilic hepatitis, swelling of the affected areas, hair loss, Stevens-Johnson syndrome, seizures, reduced blood flow to the intestine and Tourette's syndrome, 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, high blood pressure, sudden death, myocardial infarction.
• Central Nervous System: Psychotic episodes, overstimulation, restlessness, dizziness, insomnia, euphoria, difficulty with intentional movements, dysphoria, depression, tremor, headache, motor and phonic tics, seizures, stroke.
• Gastrointestinal Problems: Dry mouth, unpleasant taste, diarrhea, constipation.
• Allergic Reactions: Hives, skin 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. Inform your doctor immediately if you notice any adverse reactions.

What to do if you use more than the recommended amount?

If someone uses more than the prescribed amount of lisdexamfetamine dimesylate, it is essential to seek immediate medical attention 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 breakdown. After the stimulation phase, fatigue and depression may occur.

In addition, 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 seizures and coma.

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

Download the complete leaflet

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Sources and bibliography:

This article was extracted from the original package insert from the manufacturer EUROFARMA, in July 2024, under the technical supervision of the responsible pharmacist.

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

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