Auroxetyn

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Auroxetyn (Atomoxetine HCl Aurobindo 25 mg), 25 mg, hard capsules
Atomoxetinum
Auroxetyn and Atomoxetine HCl Aurobindo 25 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, 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 package 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). The medicine is used:

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

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

This medicine should not be used in the treatment of ADHD in children under 6 years of age, as it is not known whether the medicine is effective and safe in this age group.
In adults, Auroxetyn is used to treat ADHD when symptoms are particularly severe and interfere with work or social functioning, and when the 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 improves 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 show:

• difficulties in sitting still and
• difficulties in 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 problems may interfere with daily life. Children and adolescents with ADHD may have difficulties in learning and completing homework. They may find it hard to behave appropriately at home, at school, and in other settings. ADHD does not affect the intelligence of a child or young person.

Adults with ADHD have difficulties with all the issues that affect 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 past 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. Also, at least 14 days must elapse 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 problems that could 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 diseases such as stroke, cerebral edema, or weakening of a blood vessel (aneurysm), narrowing or blockage of a blood vessel;
• if the patient has a tumour of the adrenal gland (pheochromocytoma).

Auroxetyn must not be taken if any of the above conditions apply.
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, discuss with the doctor or pharmacist if the patient has:

• suicidal thoughts or behaviours;
• heart disease (including structural heart defects) or a rapid heart rate. Auroxetyn may increase heart rate (pulse). Cases of sudden death have been reported in patients with structural heart defects;
• high blood pressure. Auroxetyn may increase blood pressure;
• low blood pressure. Auroxetyn may cause dizziness or fainting in patients with low blood pressure;
• sudden changes in blood pressure or heart rhythm;
• cardiovascular disorders or a history of stroke;
• liver disease. A dose reduction of the medicine may be necessary;
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), believing in false ideas, or suspiciousness;
• manic state (excitement or excessive activation leading to unusual behaviour) or agitation;
• feelings of aggression;
• hostile or unfriendly attitude;
• a 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, the patient should discuss them with their
doctor or pharmacist before starting treatment with Auroxetyn. Auroxetyn may
worsen these conditions. The doctor will monitor how the medicine affects the patient.
Examinations required before starting treatment with Auroxetyn
These examinations are necessary to determine whether Auroxetyn is suitable for the patient.
The treating doctor will measure:

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

Talk to the doctor if:

• the patient is taking any other medicines;
• there has been a case of sudden unexplained death in the family;
• the patient or any family members have other medical conditions (such as heart disease).

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 before starting treatment with 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 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 adverse effects. If taking any of the following medicines, talk to the 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 medicines containing substances that affect blood pressure. It is important to check with the pharmacist when purchasing any of these medicines;
• certain medicines used to treat 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 to treat asthma) may cause a sensation of rapid heartbeat, but will not worsen asthma symptoms.

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

• medicines used to control heart function;
• medicines that alter blood electrolyte levels;
• medicines used to prevent or treat malaria;
• certain antibiotics (such as erythromycin and moxifloxacin).

If in doubt whether any of the medicines being taken are listed above, 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.

• Do not use this medicine during pregnancy unless advised by a doctor.
• Avoid using this medicine during breastfeeding or discontinue breastfeeding.

If the patient:

• is pregnant or breastfeeding,
• suspects she may be pregnant or is planning to become pregnant,
• plans to start breastfeeding, she should consult her 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 occurs, 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 parts of the body that have come into contact with the capsule contents 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 prescribed by your doctor. Usually, the medicine is taken once or twice daily (in the morning and late afternoon, or early evening).
• Children should not take this medicine without adult supervision.
• If drowsiness or general malaise occurs while taking Auroxetyn once daily, your doctor may recommend switching to twice-daily dosing.
• 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 initial total 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 over 70 kg: the initial total 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 with 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 prescribed
Contact your doctor or the nearest hospital immediately 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
After discontinuing Auroxetyn, withdrawal symptoms usually do not occur, but ADHD symptoms may return. Talk to your doctor before stopping the medicine.
While taking this medicine, your doctor will perform the following procedures:
Your doctor will conduct examinations

• before starting treatment – to ensure that taking Auroxetyn will be 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:

• measuring 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 assess the treatment outcomes to determine whether continued use of the medicine is still necessary.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Although some people may experience adverse reactions, Auroxetyn helps most people.
The doctor will inform the patient about possible adverse reactions.
Some adverse reactions may be serious. If any of the following adverse reactions occur,
contact a doctor immediately:
Uncommon (may occur in no more than 1 in 100 people)

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

In children and young adults under 18 years of age, the risk of adverse reactions is higher than in
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 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), belief in false things, or suspiciousness.

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

• liver damage.

Discontinue use of Auroxetyn and contact a doctor immediately if any of the following symptoms occur:

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

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

Effect on growth
In some children, growth (body weight and height) may slow down after starting treatment with Auroxetyn.
However, during long-term treatment, children usually 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 treatment with Auroxetyn.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor,
pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 allows the collection of additional information on the safety of the medicine.

5. How to store Auroxetyn

Keep this medicine out of 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 for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 25 mg of atomoxetine as atomoxetine hydrochloride.
• Other ingredients are: pregelatinized starch, corn starch, simethicone emulsion (30%). Cap: titanium dioxide (E 171), sodium lauryl sulfate, indigotine (E 132), gelatin, purified water. Body: titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water. Printing ink: shellac (E 904), black iron oxide (E 172).

What Auroxetyn looks like and contents of the pack
Blue and white, opaque hard gelatin capsules, size "4", filled with white or off-white powder, printed with "AT" on the blue cap and "25" on the white body, using black ink.
Auroxetyn is available in blisters packed in cardboard boxes.
Pack size: 30 hard capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Netherlands, 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, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Marketing Authorisation number in the Netherlands, country of export: RVG 121290
Parallel Import Licence Number: 229/23

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Czech Republic: AURODEHADE
Germany: Atomoxetin PUREN 25 mg Hartkapseln
Poland: Auroxetyn
Portugal: Atomoxetina Aurovitas
The Netherlands: Atomoxetine HCl Aurobindo 25 mg, harde capsules
Romania: Atomoxetina Aurobindo 25 mg capsule
Spain: Atomoxetina Aurovitas 25 mg capsulas duras EFG