Auroxetine

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
Atomoxetinum
Auroxetyn and Atomoxetine HCl Aurobindo 40 mg are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Auroxetyn is and what it is 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 Auroxetyn is and what it is used for

What this medicine is used for
Auroxetyn contains atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). This medicine is indicated for:

• children over 6 years of age;
• adolescents;
• adults.

Auroxetyn should only be used as part of a comprehensive treatment programme, which may also include non-pharmacological interventions such as counselling and behavioural therapy.

Auroxetyn should not be used in the treatment of ADHD in children under six years of age, as its efficacy and safety have not been established in this age group.
In adults, Auroxetyn is used to treat ADHD when symptoms are particularly severe and impair work or social functioning, and when symptoms of the disorder were already present during childhood.

How this medicine works
Auroxetyn increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical naturally produced by the body. It enhances concentration and reduces impulsivity and excessive motor activity in patients with ADHD. This medicine is prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and therefore does not cause dependence.
It may take several weeks after starting treatment before symptoms fully improve.

About ADHD
Children and adolescents with ADHD may experience:

• difficulty remaining still and sitting quietly in one place, and
• difficulty concentrating.

It is not their fault that they struggle with these issues. Many children and young people have such problems. However, in individuals with ADHD, these difficulties may interfere with daily life. Children and adolescents with ADHD may have problems with learning and completing homework. They may find it difficult to behave appropriately at home, at school, and in other settings. ADHD does not affect a child's or young person's intelligence.

Adults with ADHD experience similar difficulties as children with ADHD, and for adults this may lead to problems:

• at work;
• in interpersonal relationships;
• related to low self-esteem;
• in 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) within the last 2 weeks, e.g. phenelzine. MAOIs are sometimes used in the treatment of depression and other psychiatric disorders. Taking Auroxetyn together with an MAOI may cause severe adverse reactions or may be life-threatening. At least 14 days should also be waited after stopping Auroxetyn before starting an MAOI;
• if the patient has a condition of the eye called narrow-angle glaucoma (increased pressure in the eye);
• if the patient has severe heart disorders which may worsen due to an increased heart rate and/or increased blood pressure (which may be caused by taking Auroxetyn);
• if the patient has severe cerebrovascular disorders such as stroke, cerebral edema, aneurysm (weakening of a blood vessel wall), stenosis or occlusion of a blood vessel;
• if the patient has a tumor of the adrenal gland (pheochromocytoma).

Auroxetyn must not be taken if any of the above conditions apply.
If the patient is unsure, they should consult a 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 Auroxetyn, discuss with a doctor or pharmacist if the patient has:

• suicidal thoughts or behaviors;
• heart diseases (including congenital heart defects) or rapid heart rate. Auroxetyn may increase heart rate (pulse). Cases of sudden death have been reported in patients with heart defects;
• high blood pressure. Auroxetyn may increase blood pressure;
• low blood pressure. Auroxetyn may cause dizziness or fainting in individuals with low blood pressure;
• sudden changes in blood pressure or heart rhythm;
• cardiovascular disorders or history of stroke;
• liver disorders. A dose reduction may be necessary;
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not real), false beliefs, or suspiciousness;
• manic state (excitement or excessive arousal leading to unusual behavior) or agitation;
• feelings of aggression;
• unfriendly and hostile (adverse) attitude;
• history of epilepsy or seizures for any reason. Auroxetyn may increase the frequency of seizures;
• unusual mood changes (mood swings) or feelings of profound sadness;
• uncontrollable, repetitive movements of any body part or repetition of sounds or words.

If any of the above conditions apply, discuss them with a doctor or pharmacist before starting
Auroxetyn. The medicine may worsen these conditions. The doctor will monitor how the medicine affects the patient.

Tests required before starting Auroxetyn

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

• the patient’s blood pressure and heart rate (pulse) before starting Auroxetyn and during treatment;
• the patient’s height and body weight during treatment with Auroxetyn, if the patient is a child or adolescent.

Discuss with the doctor if:

• the patient is taking any other medicines;
• there has been a family history of unexplained sudden death;
• the patient or family members have any other disorders (such as heart diseases).

It is important to provide the doctor with as much information as possible. This will help the doctor decide whether Auroxetyn is appropriate for the patient. The doctor may also order additional medical tests required before starting this medicine.

Auroxetyn and other medicines

Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. The doctor will decide whether Auroxetyn can be taken together with other medicines. In some cases, the doctor may decide to modify the dose or increase it more slowly.

Auroxetyn must not be used together with monoamine oxidase inhibitors (MAOIs) used in the treatment of depression. See section 2 “When not to take Auroxetyn”.

If the patient is taking other medicines, Auroxetyn may affect their action or may cause adverse effects. If taking any of the following medicines, discuss with a doctor or pharmacist before starting Auroxetyn:

• medicines that increase blood pressure or are used to control blood pressure;
• antidepressants, e.g. imipramine, venlafaxine, mirtazapine, fluoxetine or paroxetine;
• certain cough or cold remedies containing substances affecting blood pressure. It is important to check this with a pharmacist when purchasing any of these medicines;
• certain medicines used in the treatment of psychiatric disorders;
• medicines that increase the risk of seizures;
• certain medicines that may prolong the time Auroxetyn remains in the body (such as quinidine or terbinafine);
• oral or injectable salbutamol (a medicine used in asthma treatment) may cause a sensation of rapid heartbeat but will not worsen asthma symptoms.

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

• medicines used to control heart function;
• medicines that alter blood electrolyte levels;
• medicines used in the prevention and treatment of malaria;
• certain antibiotics (such as erythromycin and moxifloxacin).

If in doubt whether a medicine is included in the above list, ask the doctor or pharmacist before starting Auroxetyn.

Pregnancy and breastfeeding

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

• This medicine should not be used during pregnancy unless advised by a doctor.
• This medicine should be avoided during breastfeeding or breastfeeding should be discontinued.

If the patient:

• is pregnant or breastfeeding,
• suspects she may be pregnant or is planning to become pregnant,
• is planning to start breastfeeding, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

After taking Auroxetyn, fatigue, drowsiness, or dizziness may occur.
The patient should exercise caution when driving or operating machinery until they know how they react to Auroxetyn. If fatigue, drowsiness, or dizziness occur, the patient should not drive or operate machinery.

Important information about capsule contents

Do not open Auroxetyn capsules, as the capsule contents may irritate the eyes.
If the capsule contents come into contact with the eye, rinse immediately with water and seek medical advice. Hands and any other body parts that have come into contact with the capsule contents should also be washed immediately.

3. How to take Auroxetyn

• This medicine should always be taken as prescribed by your doctor. Usually, the medicine is taken once or twice daily (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 drowsiness or feeling unwell occurs while taking Auroxetyn once daily, your doctor may recommend switching to twice-daily administration.
• Capsules should be swallowed whole, with or between meals.
• Do not open the capsules, sprinkle out the contents, or take them in any other way.
• Taking the medicine every day at the same time will help you remember to take it.

What dose to take
Children and adolescents (aged 6 years and older)
Your doctor will determine the appropriate dose of Auroxetyn based on the patient's body weight.
Treatment will be started with a lower dose before increasing it to the dose appropriate 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. Then, your doctor may recommend increasing the dose to the usual maintenance dose of approximately 1.2 mg per kg of body weight per day.
• Body weight greater than 70 kg: the total initial daily dose is 40 mg for at least 7 days. Then, your doctor may recommend increasing the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose that a doctor may prescribe is 100 mg.

Adults

• Treatment with Auroxetyn should be initiated at a total daily dose of 40 mg for at least 7 days. Then, your doctor may recommend increasing the dose to the usual maintenance dose of 80 mg to 100 mg per day. The maximum daily dose that a doctor may prescribe is 100 mg.

In case of liver disease, your doctor may prescribe a lower dose.
Taking more Auroxetyn than recommended
Seek immediate medical advice from your doctor or the nearest hospital and inform them of the number of capsules taken. The most commonly reported symptoms following overdose include gastrointestinal symptoms, drowsiness, dizziness, tremor, and unusual behavior.
If you miss a dose of Auroxetyn
If you miss a dose, take it as soon as possible. However, do not take more than the total recommended daily dose within 24 hours. Do not take a double dose to make up for a missed dose.
Stopping Auroxetyn
Usually, no adverse effects occur after stopping Auroxetyn, but ADHD symptoms may return. Talk to your doctor before stopping the medicine.
While taking Auroxetyn, your doctor will perform the following procedures:
Your doctor will conduct examinations

• before starting treatment – to ensure that taking Auroxetyn is safe and beneficial for the patient;
• during treatment – examinations will be performed at least every 6 months, though likely more frequently.

Examinations will also be performed if the dose is changed. These will include:

• monitoring height and body weight in children and young people
• measuring blood pressure and pulse
• checking for any problems or whether any adverse effects have worsened during treatment with Auroxetyn.

Long-term treatment
Auroxetyn does not need to be taken for life. After one year of treatment with Auroxetyn, your doctor will evaluate the treatment outcomes to determine whether continued use of the medicine is necessary.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Although some people may experience adverse reactions, Auroxetyn helps most people.
Your doctor will inform you about possible adverse reactions.
Some adverse reactions may be serious. If any of the following adverse reactions occur, contact your doctor immediately:

Uncommon (may occur in no more than 1 in 100 people)

• perceived or actual rapid heartbeat, heart rhythm disturbances;
• suicidal thoughts or behaviour;
• feelings of aggression;
• hostility or anger;
• mood swings or changes in mood;
• severe allergic reactions, which may include:
  • swelling of the face and throat;
  • difficulty breathing;
  • hives (small, itchy skin rash).
• seizures;
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), false beliefs, or suspicion.

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

• suicidal thoughts or behaviour (may occur in no more than 1 in 100 people);
• mood swings or changes in mood (may occur in no more than 1 in 10 people).

In adult patients, the risk of the following adverse reactions is lower than in younger patients (may occur in no more than 1 in 1,000 people), such as:

• seizures;
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), false beliefs, or suspicion.

Rare (may occur in no more than 1 in 1,000 people)

• liver damage.

Stop taking Auroxetyn and contact your doctor immediately if any of the following symptoms occur:

• dark-coloured urine;
• yellowing of the skin or eyes;
• pain in the upper right part of the abdomen below the ribs, tender to pressure (tenderness);
• unexplained nausea;
• fatigue;
• itching;
• flu-like symptoms.

Other reported adverse reactions are listed below. If symptoms worsen, contact your doctor or pharmacist.

Effect on growth
In some children, initiation of Auroxetyn treatment may lead to growth inhibition (body weight and height). However, during long-term treatment, children achieve body weight and height appropriate for their age group.
The doctor will monitor the child's growth and body weight. If the child does not grow or gain weight as expected, the doctor may decide to adjust the dose or temporarily discontinue Auroxetyn treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 adverse reactions helps to provide more information on the safety of using the medicine.

5. How to store Auroxetyn

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Auroxetyn contains

• The active substance is atomoxetine hydrochloride. One hard capsule contains 40 mg of atomoxetine as atomoxetine hydrochloride.
• Other ingredients are: pregelatinized maize starch, simethicone emulsion (30%). Cap: titanium dioxide (E 171), sodium lauryl sulfate, indigo carmine (E 132), gelatin, purified water. Body: titanium dioxide (E 171), sodium lauryl sulfate, indigo carmine (E 132), gelatin, purified water. Printing ink: shellac (E 904), black iron oxide (E 172).

What Auroxetyn looks like and contents of the pack
Hard capsule.
Blue, opaque hard gelatin capsules, size "2", filled with white or off-white powder, printed with "AT" on the cap and "40" on the body in black ink.
Auroxetyn is available in PVC/PE/PVDC/Aluminium blister packs in cardboard cartons.
Pack sizes: 30 hard capsules.
For more detailed information, please 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
The 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
Poland

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

Netherlands Marketing Authorization Number: RVG 121293
Parallel Import License Number: 165/23

This medicinal product is authorized for sale in the European Economic Area (EEA) under the following names:
Czech Republic: AURODEHADE
Germany: Atomoxetin PUREN 40 mg Hartkapseln
Poland: Auroxetyn
Portugal: Atomoxetina Aurovitas
The Netherlands: Atomoxetine HCl Aurobindo 40 mg harde capsules
Romania: Atomoxetina Aurobindo 40 mg capsule
Spain: Atomoxetina Aurovitas 40 mg capsulas duras EFG