Auroxetin

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Auroxetyn (Atomoxetine HCl Aurobindo 40 mg), 40 mg, hard capsules

Atomoxetine
Auroxetyn and Atomoxetine HCl Aurobindo 40 mg are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• 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 old;
• 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 old, 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 does this medicine work

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 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 trouble behaving properly at home, at school, and in other places. ADHD does not affect a child's or young person's intelligence.

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 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:

• suicidal thoughts or behaviors;
• heart disease (including heart defects) or rapid heart rate. Auroxetyn may increase heart rate (pulse). There have been reports of sudden death in patients with heart defects;
• high blood pressure. Auroxetyn may increase blood pressure;
• low blood pressure. Auroxetyn may cause dizziness or fainting in people with low blood pressure;
• sudden changes in blood pressure or heart rate;
• cardiovascular disease or a history of stroke;
• liver disease. The dose of Auroxetyn may need to be reduced;
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or suspiciousness;
• manic mood state (excitement or excessive stimulation that causes unusual behavior) and stimulation;
• feeling aggressive;
• hostile or evil (hostile) attitude;
• a history of epilepsy or seizures for any reason. Auroxetyn may increase the frequency of seizures;
• mood changes or feeling very sad;
• difficulty controlling, repetitive movements of any part of the body or repeating 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 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) or a family history of such diseases.

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, including those that do not require 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 to treat 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,
• suspects 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 or operating machinery until they know how Auroxetyn affects them. If the patient feels tired, sleepy, or dizzy, they should not drive or operate machinery.

Important information about the contents of the capsules

Auroxetyn capsules should not be opened, as the contents 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

• 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).
• Auroxetyn is available in the following strengths: 10 mg, 18 mg, 25 mg, 40 mg.
• Children should not take this medicine without adult supervision.
• If the patient experiences sleepiness 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, the contents should not be spilled, or taken in any other way.
• Taking the medicine at the same time every day will help remember to take it.

What dose to take

Children and adolescents (6 years and 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, before increasing it 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 mg to 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 more Auroxetyn than recommended

The patient should contact their doctor or the nearest hospital immediately and inform them of the number of capsules taken. The most commonly reported symptoms after overdose are gastrointestinal symptoms, sleepiness, 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 greater than the total recommended daily dose should not be taken within 24 hours. A double dose should not be taken to make up for a missed dose.

Stopping Auroxetyn treatment

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

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 heart rate
• 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 find that Auroxetyn helps them.
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 affect up to 1 in 100 people)

• perceived or real rapid heartbeat, irregular heartbeat;
• suicidal thoughts or behaviors;
• feeling aggressive;
• hostile or evil (hostile) attitude;
• mood swings or mood changes;
• severe allergic reactions, whose symptoms 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 suspiciousness.

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

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

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

(may affect up to 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 suspiciousness.

Rare(may affect up to 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 is tender to the touch;
• 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 body weight. If the child is not growing or gaining weight as expected, the doctor may decide to change the dose or temporarily stop Auroxetyn treatment.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this 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 storage instructions.
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 40 mg of atomoxetine in the form of atomoxetine hydrochloride.
• The medicine also contains: maize starch, silicon dioxide, sodium starch glycolate, hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide (E 171), indigo carmine (E 132), yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), and water.

What Auroxetyn looks like and contents of the pack

Hard capsule.
Blue, opaque hard gelatin capsules, size 2, filled with a white or almost white powder, with "AT" printed on the cap and "40" printed on the body, in black ink.
Auroxetyn is available in PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 30 hard capsules.
For more detailed information, the patient should contact the marketing authorization holder or the 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, Birzebuggia
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 121293

Parallel import authorization number: 165/23

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

Czech Republic:
AURODEHADE
Germany:
Atomoxetin PUREN 40 mg hard capsules
Poland:
Auroxetyn
Portugal:
Atomoxetina Aurovitas
Netherlands:
Atomoxetine HCl Aurobindo 40 mg hard capsules
Romania:
Atomoxetina Aurobindo 40 mg capsules
Spain:
Atomoxetina Aurovitas 40 mg hard capsules EFG

Date of leaflet approval: 22.08.2023

[Information about the trademark]