Auroxetin

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Auroxetyn (Atomoxetine HCl Aurobindo 25 mg), 25 mg, hard capsules

Atomoxetine
Auroxetyn and Atomoxetine HCl Aurobindo 25 mg are different trade names for the same medicine.

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 pack and other information

1. What is Auroxetyn and what is it used for

What is this medicine 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 patients.
In adults, Auroxetyn is used to treat ADHD if the symptoms are very troublesome and interfere with work or social life, and the symptoms of the disease occurred in the patient during childhood.

How the 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. The medicine is prescribed to help control ADHD symptoms. 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 have:

• 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:

• if the patient is allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has taken a monoamine oxidase inhibitor (MAOI), such as phenelzine, in the last 2 weeks. MAOIs are sometimes used to treat depression and other mental illnesses. Taking Auroxetyn with an MAOI can cause serious side effects or be life-threatening. It is also necessary to wait at least 14 days after stopping Auroxetyn before starting an MAOI;
• if the patient has glaucoma (increased pressure in the eye);
• if the patient has severe heart problems that may worsen with increased heart rate and/or increased blood pressure (which may be caused by taking Auroxetyn);
• if the patient has severe blood vessel problems in the brain - such as stroke, swelling, and weakness of a blood vessel (aneurysm), narrowing, or blockage of a blood vessel;
• if the patient has a tumor of the adrenal gland (pheochromocytoma).

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 treatment with 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 treatment with Auroxetyn, the patient should discuss the following 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). There have been reports of sudden death in patients with heart defects;
• 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 are not there), 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 treatment with Auroxetyn. Auroxetyn may worsen these conditions. The doctor will monitor how the medicine affects the patient.

Tests to be performed before starting treatment with Auroxetyn

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

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

The patient should talk to their doctor if they:

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

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

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 if 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 in depression. See section 2 "When not to take Auroxetyn".
If the patient is taking other medicines, Auroxetyn may affect their action or cause side effects. If the patient is taking any of the following medicines, they should talk to their doctor or pharmacist before starting treatment with 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.

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

• medicines used to control heart rate,
• 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 on the above list, they should ask their doctor or pharmacist before starting treatment with Auroxetyn.

Pregnancy and breastfeeding

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

• The medicine should not be taken during pregnancy, unless the doctor recommends it.
• The medicine should be avoided during breastfeeding or breastfeeding should be stopped.

If the patient:

• is pregnant or breastfeeding,
• thinks they may be pregnant or plans to have a baby,
• 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 feel tired, sleepy, or dizzy.
The patient should be careful when driving a car or operating machines until they know how Auroxetyn affects them. If the patient feels tired, sleepy, or dizzy, they should not drive or operate machines.

Important information about the contents of the capsules

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

3. How to take Auroxetyn

Auroxetyn is available in the following strengths: 10 mg, 18 mg, 25 mg, 40 mg.

• 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 (6 years of age or older)

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

• Body weight up to 70 kg: the total initial daily dose is approximately 0.5 mg per kg of 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 per kg of 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

• Treatment with Auroxetyn 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 doctor or the nearest hospital should be contacted immediately and informed about the number of capsules taken. The most commonly reported symptoms after overdose are symptoms from the gastrointestinal tract, drowsiness, dizziness, tremors, and unusual behavior.

Missing a dose of Auroxetyn

If a dose is missed, it should be taken as soon as possible. However, a dose higher than the recommended total daily dose should not be taken within 24 hours. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Auroxetyn

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

During treatment with Auroxetyn, 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 body 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 if 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 contact their doctor immediately:
Uncommon(may occur in less than 1 in 100 people)

• felt or real rapid heartbeat, irregular heartbeat;
• suicidal thoughts or behaviors;
• aggressive feelings;
• 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 are not there), believing in untrue things, or being suspicious.

In children and young adults under 18 years of age, there is an increased risk of side effects compared to adults, such as:

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

In adults, there is a lower risk of side effects compared to younger patients

(may occur in less than 1 in 1,000 people) such as:

• seizures;
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or being suspicious.

Rare(may occur in less than 1 in 1,000 people)

• liver damage.

The patient should stop taking Auroxetyn and contact their doctor immediately 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 under the ribs, which occurs when pressed (tenderness to pressure);
• unexplained 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 treatment with Auroxetyn, growth (body 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Auroxetyn

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 pack and other information

What Auroxetyn contains

• The active substance is atomoxetine hydrochloride. One hard capsule contains 25 mg of atomoxetine in the form of atomoxetine hydrochloride.
• The medicine also contains: maize starch, sodium lauryl sulfate, indigo carmine (E132), gelatin, and purified water. Cap:titanium dioxide (E171), sodium lauryl sulfate, indigo carmine (E132), gelatin, and purified water. Body:titanium dioxide (E171), sodium lauryl sulfate, gelatin, and purified water. Printing ink:shellac (E904), iron oxide black (E172).

What Auroxetyn looks like and what the pack contains

Blue and 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 is available in blisters, packaged in cardboard boxes.
Pack size: 30 hard capsules.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Aurobindo Pharma B.V.
Baarnsche Dijk 1
3741 LN Baarn
Netherlands

Manufacturer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
BBG 3000, Birzebbugia
Malta
Generis-Farmaceutica, S.A.
Rua Joao de Deus, n° 19
2700-487, Venda Nova, Amadora
Portugal

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 121290

Parallel import authorization number: 229/23

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

Czech Republic:

AURODEHADE

Germany:

Atomoxetin PUREN 25 mg Hartkapseln

Poland:

Auroxetyn

Portugal:

Atomoxetina Aurovitas

Netherlands:

Atomoxetine HCl Aurobindo 25 mg, hard capsules

Romania:

Atomoxetina Aurobindo 25 mg capsules

Spain:

Atomoxetina Aurovitas 25 mg capsules EFG

Date of approval of the leaflet: 12.10.2023

[Information about the trademark]