Auroxetin

Leaflet accompanying the packaging: information for the user

Auroxetyn, 10 mg, hard capsules

Auroxetyn, 18 mg, hard capsules

Auroxetyn, 25 mg, hard capsules

Auroxetyn, 40 mg, hard capsules

Atomoxetine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Auroxetyn and what is it used for
• 2. Important information before taking Auroxetyn
• 3. How to take Auroxetyn
• 4. Possible side effects
• 5. How to store Auroxetyn
• 6. Contents of the packaging and other information

1. What is Auroxetyn and what is it used for

What this medicine is used for

Auroxetyn contains atomoxetine and is used to treat attention deficit hyperactivity disorder (ADHD). The medicine is used:

• in children over 6 years of age;
• in adolescents;
• in adults. The medicine is used only as part of a comprehensive treatment program that also includes non-pharmacological methods, such as counseling and behavioral therapy.

The medicine should not be used to treat ADHD in children under 6 years of age, as it is not known whether the medicine is effective and safe in these individuals.
In adults, Auroxetyn is used to treat ADHD if the symptoms are very troublesome and disrupt work or social life, and the symptoms of the disease occurred in the patient during childhood.

How this medicine works

Auroxetyn increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical substance naturally produced by the body. It increases concentration and reduces impulsivity and excessive restlessness in patients with ADHD. This medicine is prescribed to help control the symptoms of ADHD. This medicine does not have a stimulating effect and therefore does not cause addiction.
It may take a few weeks from the start of treatment for the symptoms to completely disappear.

About ADHD

Children and adolescents with ADHD exhibit:

• difficulty sitting still in one place and
• difficulty concentrating. It's not their fault that they can't cope with it. Many children and young people struggle with these problems. However, in people with ADHD, this can disrupt daily life. Children and young people with ADHD may have difficulty learning and doing homework. They may have difficulty behaving properly at home, at school, and in other places. ADHD does not affect the intelligence of the child or young person.

Adults with ADHD have difficulty with all the things that children with ADHD have difficulty with, and for adults, this can mean problems:

• at work;
• in interpersonal relationships;
• related to low self-esteem;
• with learning.

2. Important information before taking Auroxetyn

When not to take Auroxetyn:

Auroxetyn should not be taken if any of the above conditions occur.
If the patient is unsure, they should talk to their doctor or pharmacist before starting Auroxetyn, as the medicine may worsen these conditions.

Warnings and precautions

Both adults and children should be aware of the following warnings and precautions.
Before starting Auroxetyn, the patient should discuss with their doctor or pharmacist if they:

• have suicidal thoughts or behaviors;
• have heart disease (including heart defects) or a rapid heart rate. Auroxetyn may increase heart rate (pulse). In patients with heart defects, there have been reports of sudden death;
• have high blood pressure. Auroxetyn may increase blood pressure;
• have low blood pressure. Auroxetyn may cause dizziness or fainting in people with low blood pressure;
• have sudden changes in blood pressure or heart rate;
• have cardiovascular disease or have had a stroke;
• have liver disease. The dose of Auroxetyn may need to be reduced;
• have psychotic reactions, including hallucinations (hearing voices or seeing things that don't exist), believing in untrue things, or being suspicious;
• have a manic state (excitement or excessive stimulation that causes unusual behavior) and stimulation;
• feel aggressive;
• have a hostile or evil (hostile) attitude;
• have a history of epilepsy or seizures for any reason. Auroxetyn may increase the frequency of seizures;
• have a different mood than usual (mood swings) or feel very sad;
• have uncontrollable, repetitive movements of any part of the body or repetition of sounds or words.

If any of the above conditions occur, the patient should talk to their doctor or pharmacist before starting Auroxetyn. Auroxetyn may worsen these conditions. The doctor will monitor how the medicine affects the patient.
Serotonin syndrome
Serotonin syndrome is a life-threatening condition that can occur when taking Auroxetyn with certain other medicines (see section 2 "Auroxetyn and other medicines").
Objective and subjective symptoms of serotonin syndrome may include a combination of the following: disorientation, agitation, lack of coordination and stiffness, hallucinations, coma, rapid heart rate, elevated body temperature, rapid changes in blood pressure, sweating, sudden flushing of the skin, tremors, exaggerated reflexes, nausea, vomiting, and diarrhea.
If serotonin syndrome is suspected, the patient should immediately consult a doctor or go to the nearest hospital emergency department.
Treatment with Auroxetyn may cause feelings of aggression, hostility, or violent behavior, or may worsen these symptoms if they occurred before treatment. It may also cause unusual changes in behavior or mood (including physical assault, threats, and thoughts of harming others). If the patient, their family, and/or friends notice any of these reactions, they should immediately tell their doctor or pharmacist.

Tests to be performed before starting Auroxetyn

These tests are necessary to determine whether Auroxetyn is suitable for the patient.
The doctor will measure:

• the patient's blood pressure and heart rate (pulse) before starting Auroxetyn and during treatment
• the growth and weight of the patient during Auroxetyn treatment, if the patient is a child or adolescent.

The patient should talk to their doctor if:

• they are taking any other medicines
• there is a history of sudden death from an unknown cause in their family
• they have any other diseases (such as heart disease) or if any family members have these diseases.

It is essential to provide the doctor with as much information as possible. This will help the doctor decide whether Auroxetyn is suitable for the patient. The doctor may also order other medical tests that are necessary before starting treatment.

Auroxetyn and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription. The doctor will decide whether Auroxetyn can be taken with other medicines. In some cases, the doctor may decide to modify the dose or increase it more slowly.
Auroxetyn should not be taken with monoamine oxidase inhibitors (MAOIs) used to treat depression. See section 2 "When not to take Auroxetyn".
If the patient is taking other medicines, Auroxetyn may affect their action or may cause side effects. If the patient is taking any of the following medicines, they should talk to their doctor or pharmacist before starting Auroxetyn:

• medicines that increase blood pressure or are used to control blood pressure,
• antidepressants, such as imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine,
• certain cough and cold medicines that contain substances that affect blood pressure. It is essential to check this with the pharmacist when purchasing any of these medicines;
• certain medicines used to treat mental illnesses,
• medicines that increase the risk of seizures,
• certain medicines that may prolong the time Auroxetyn stays in the body (such as quinidine or terbinafine);
• salbutamol (a medicine used to treat asthma) taken orally or by injection, may cause a feeling of rapid heartbeat, but will not worsen asthma symptoms.

Auroxetyn may affect the action of other medicines or other medicines may affect its action. These include:

• certain antidepressants, opioids such as tramadol, and medicines used to treat migraines called triptans. These medicines may interact with Auroxetyn, which can lead to the development of serotonin syndrome, a life-threatening condition. (See section 2 "Warnings and precautions", "Serotonin syndrome").

The following medicines may increase the risk of abnormal heart rhythm if taken with Auroxetyn:

• medicines used to control heart function,
• medicines that change the concentration of salts in the blood,
• medicines used to prevent and treat malaria,
• certain antibiotics (such as erythromycin and moxifloxacin).

If the patient is unsure whether the medicines they are taking are listed above, they should ask their doctor or pharmacist before starting Auroxetyn.

Pregnancy and breastfeeding

It is not known whether this medicine can affect the unborn child or pass into breast milk.

• Auroxetyn should not be taken during pregnancy, unless advised by a doctor.
• Auroxetyn should be avoided during breastfeeding or breastfeeding should be stopped.

If the patient:

• is pregnant or breastfeeding,
• suspects they may be pregnant or plans to have a child,
• plans to start breastfeeding, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

After taking Auroxetyn, the patient may experience fatigue, drowsiness, or dizziness.
The patient should be careful when driving a car or operating machines until they know how Auroxetyn affects them. If the patient experiences fatigue, drowsiness, or dizziness, they should not drive or operate machines.

Important information about the contents of the capsules

Auroxetyn capsules should not be opened, as the contents of the capsule may irritate the eyes.
If the contents of the capsule get into the eye, the patient should immediately rinse it with water and seek medical advice. The patient should also wash their hands and any other parts of the body that have come into contact with the contents of the capsules.

3. How to take Auroxetyn

• This medicine should always be taken as directed by the doctor. It is usually taken once or twice a day (in the morning and late afternoon or early evening).
• Children should not take this medicine without adult supervision.
• If the patient experiences drowsiness or malaise when taking Auroxetyn once a day, the doctor may recommend taking it twice a day.
• The capsules should be swallowed whole, with or without food.
• The capsules should not be opened, their contents should not be poured out, or taken in any other way.
• Taking the medicine every day at the same time will help remember to take it.

What dose to take

Children and adolescents (over 6 years of age)

The doctor will recommend the appropriate dose of Auroxetyn, which will be calculated according to the patient's body weight. The doctor will start treatment with a lower dose before increasing it to the appropriate dose for the patient's body weight.

• Body weight up to 70 kg: the total initial daily dose is approximately 0.5 mg/kg body weight for at least 7 days. The doctor may then recommend increasing the dose to the usual maintenance dose of approximately 1.2 mg/kg body weight per day.
• Body weight over 70 kg: the total initial daily dose is 40 mg for at least 7 days. The doctor may then recommend increasing the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose that the doctor can prescribe is 100 mg.

Adults

• Auroxetyn treatment should be started with a total daily dose of 40 mg for at least 7 days. The doctor may then recommend increasing the dose to the usual maintenance dose of 80-100 mg per day. The maximum daily dose that the doctor can prescribe is 100 mg.

If the patient has liver disease, the doctor may prescribe a lower dose of Auroxetyn.

Taking a higher dose of Auroxetyn than recommended

The patient should immediately contact their doctor or the nearest hospital and inform them of the number of capsules taken. The most commonly reported symptoms after overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and abnormal behavior. Very rarely, serotonin syndrome has also been reported, which is a life-threatening condition. (See section 2. "Warnings and precautions", "Serotonin syndrome").

Missing a dose of Auroxetyn

If a dose is missed, the patient should take it as soon as possible. However, they should not take more than the recommended total daily dose within 24 hours. The patient should not take a double dose to make up for a missed dose.

Stopping Auroxetyn treatment

After stopping Auroxetyn, there are usually no side effects, but the symptoms of ADHD may return. The patient should talk to their doctor before stopping Auroxetyn.

During Auroxetyn treatment, the doctor will perform the following:

The doctor will perform tests

• before starting treatment - to ensure that Auroxetyn is safe and beneficial for the patient;
• during treatment - tests will be performed at least every 6 months, although probably more often.

Tests will also be performed when the dose is changed. They will include:

• measuring the growth and weight of children and young people
• measuring blood pressure and pulse
• checking for any problems or if side effects have worsened while taking Auroxetyn.

Long-term treatment

Auroxetyn does not need to be taken for the rest of your life. After a year of treatment with Auroxetyn, the doctor will assess the treatment results to determine whether the medicine is still needed.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Auroxetyn can cause side effects, although not everybody gets them.
Although some people experience side effects, most people taking Auroxetyn are helped by it.
The doctor will inform the patient about possible side effects.
Some side effects can be serious. If the patient experiences any of the following side effects, they should immediately contact their doctor:
Uncommon(may occur in up to 1 in 100 people)

• perceived or actual rapid heartbeat, arrhythmia;
• suicidal thoughts or behaviors;
• feelings of aggression;
• hostile attitude or anger (hostility);
• mood swings or mood changes;
• severe allergic reactions, the symptoms of which are:
• swelling of the face and throat;
• difficulty breathing;
• hives (small, itchy rashes on the skin).
• seizures;
• psychotic symptoms, including hallucinations (hearing voices or seeing things that don't exist), believing in untrue things, or being suspicious.

In children and young adults under 18 years of age, there is an increased risk compared to

adults of side effects such as:

• suicidal thoughts or behaviors (may occur in up to 1 in 100 people);
• mood swings or mood changes (may occur in up to 1 in 10 people).

In adults, there is a lower risk than in younger patients of side effects

(may occur in up to 1 in 1,000 people) such as:

• seizures;
• psychotic symptoms, including hallucinations (hearing voices or seeing things that don't exist), believing in untrue things, or being suspicious.

Rare(may occur in up to 1 in 1,000 people)

• liver damage.

The patient should stop taking Auroxetyn and immediately contact their doctor if they experience any of the following symptoms:

• dark-colored urine;
• yellowing of the skin or eyes;
• pain in the upper right part of the abdomen, which occurs under pressure (tenderness to pressure);
• unjustified nausea;
• fatigue;
• itching;
• flu-like symptoms.

Other reported side effects are listed below. If the symptoms worsen, the patient should contact their doctor or pharmacist.

Effect on growth

In some children, after starting Auroxetyn, growth (weight and height) may be slowed down. However, during long-term treatment, children achieve normal weight and height for their age group.
The doctor will monitor the child's growth and weight. If the child is not growing or gaining weight as expected, the doctor may decide to change the dose or temporarily stop Auroxetyn.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the
Department of Drug Safety Monitoring
National Institute of Medicines
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Auroxetyn

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the label, carton, and bottle after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Auroxetyn contains

• The active substance is atomoxetine hydrochloride. One hard capsule contains 10 mg of atomoxetine in the form of atomoxetine hydrochloride. One hard capsule contains 18 mg of atomoxetine in the form of atomoxetine hydrochloride. One hard capsule contains 25 mg of atomoxetine in the form of atomoxetine hydrochloride. One hard capsule contains 40 mg of atomoxetine in the form of atomoxetine hydrochloride.
• The medicine also contains: maize starch, sodium lauryl sulfate, simethicone emulsion (30%).

Capsule shell:titanium dioxide (E 171), sodium lauryl sulfate, yellow iron oxide (E 172) (only for 18 mg), indigo carmine (E 132) (only for 25 mg and 40 mg), gelatin, purified water.
Body:titanium dioxide (E 171), sodium lauryl sulfate, indigo carmine (E 132) (only for 40 mg), gelatin, purified water.
Printing ink:shellac (E 904), black iron oxide (E 172).

What Auroxetyn looks like and contents of the pack

Hard capsule.
Auroxetyn, 10 mg, hard capsules
White, opaque hard gelatin capsules, size "5" filled with white or off-white powder, with "AT" printed on the cap and "10" printed on the body, in black ink.
Auroxetyn, 18 mg, hard capsules
Gold-white, opaque hard gelatin capsules, size "4" filled with white or off-white powder, with "AT" printed on the gold cap and "18" printed on the white body, in black ink.
Auroxetyn, 25 mg, hard capsules
Blue-white, opaque hard gelatin capsules, size "4" filled with white or off-white powder, with "AT" printed on the blue cap and "25" printed on the white body, in black ink.
Auroxetyn, 40 mg, hard capsules
Blue, opaque hard gelatin capsules, size "2" filled with white or off-white powder, with "AT" printed on the cap and "40" printed on the body, in black ink.
Auroxetyn is available in blisters, packed in cartons.
Pack sizes: 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw

Manufacturer/importer

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebuggia, BBG 3000
Malta
Generis Farmaceutica, S.A.
Rua João de Deus, 19
Amadora, 2700-487
Portugal

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

Germany:
Atomoxetin PUREN 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg
Hard capsules
Poland:
Auroxetyn
Netherlands:
Atomoxetine HCl Aurobindo 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg, hard capsules
Spain:
Atomoxetina Aurovitas 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg, hard capsules EFG
Date of last revision of the leaflet:11/2024