Auroxetyn

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging 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
medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for you.

• 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 other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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:

• 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.

Auroxetyn 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 or 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 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 impulsiveness and excessive motor activity in patients with ADHD. This medicine is prescribed to help manage 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 everyday 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 the same 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 past 2 weeks, such as 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 pose a life-threatening risk. Also, at least 14 days must elapse after stopping Auroxetyn before starting an MAOI;
• if the patient has a disease of the eye—narrow-angle glaucoma (increased pressure in the eye);
• if the patient has severe heart disorders that may worsen due to increased heart rate and/or elevated blood pressure (which may result from taking Auroxetyn);
• if the patient has severe cerebrovascular diseases—such as stroke, cerebral edema, aneurysm (weakening of a blood vessel), 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 treatment with 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 diseases or history of stroke;
• liver diseases. A dose reduction may be necessary;
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), false beliefs, or suspiciousness;
• manic episodes (excitement or excessive agitation leading to unusual behavior) and agitation;
• feelings of aggression;
• hostile or unfriendly attitude;
• a history of epilepsy or seizures from any cause. 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 a
doctor or pharmacist before starting Auroxetyn. The medicine may worsen these conditions.
The doctor will monitor how the medicine affects the patient.
Serotonin syndrome
Serotonin syndrome is a potentially life-threatening condition and may occur when
Auroxetyn is taken together with certain other medicines (see section 2 “Auroxetyn with other medicines”).
Objective and subjective symptoms of serotonin syndrome may include a combination of the following:
disorientation, psychomotor agitation, lack of coordination and muscle rigidity, hallucinations,
coma, rapid heart rate, elevated body temperature, rapid fluctuations in blood pressure,
sweating, sudden flushing of the skin, tremor, exaggerated reflexes, nausea, vomiting, and diarrhea.
If serotonin syndrome is suspected, seek immediate medical attention or go to the nearest emergency department.
Treatment with Auroxetyn may cause feelings of aggression, hostility, or violent behavior, or may worsen these symptoms if they were present before treatment. It may also cause unusual changes in behavior or mood (including physical attacks, threats, or thoughts of harming others). If the patient, their family, and/or friends notice any of these reactions, they should inform the doctor or pharmacist immediately.
Examinations required before starting Auroxetyn
These tests are necessary to determine whether Auroxetyn is suitable for the patient.
The treating doctor will monitor:

• 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.

Consult a doctor if:

• the patient is taking any other medicines;
• there is a family history of sudden unexplained death;
• the patient or their family members have any other medical conditions (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 before starting this medicine.
Auroxetyn with other medicines
Inform 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 adjust the dose or increase it more gradually.
Auroxetyn must not be taken 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. Before starting Auroxetyn, consult a doctor or pharmacist if the patient is taking any of the following:

• medicines that increase blood pressure or are used to control blood pressure;
• antidepressants, such as imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine;
• certain cough or cold medicines containing substances that affect blood pressure. It is important to verify 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 presence of Auroxetyn in the body (such as quinidine or terbinafine);
• oral or injectable salbutamol (a medicine used in the treatment of asthma) may cause a sensation 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 migraine medicines called triptans. These medicines may interact with Auroxetyn, potentially leading to 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
concurrently 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 medicines being taken are listed above, consult a 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 have a baby;
• plans 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 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, immediately rinse the eye 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

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 malaise occurs when taking Auroxetyn once daily, your doctor may recommend taking the medicine twice daily.
• Capsules should be swallowed whole, with or without food.
• 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.
The doctor will start treatment 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, the 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 total initial daily dose is 40 mg for at least 7 days. Then, the 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, the 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, the doctor may prescribe a lower dose.
Taking more than the recommended dose of Auroxetyn
Contact your 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, drowsiness, dizziness, tremor, and unusual behavior. Very rarely, serotonin syndrome has been reported, which is a potentially life-threatening condition. (See section 2. "Warnings and precautions", "Serotonin syndrome").
Missing a dose of Auroxetyn
If you miss a dose, take it as soon as possible. However, do not take a dose larger 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 stopping Auroxetyn, withdrawal symptoms usually do not occur, but ADHD symptoms may return. Talk to your doctor before stopping the medicine.
During treatment, your doctor will carry out the following procedures:
Your doctor will perform 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:

• measurement of height and body weight in children and young people;
• measurement of blood pressure and pulse;
• checking for any problems or whether any adverse reactions 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 the medicine should still be continued.
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 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)

• palpitations or actual increased heart rate, heart rhythm disorders;
• suicidal thoughts or tendencies;
• feelings of aggression;
• hostile behaviour 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 ideas, or suspiciousness.

In children and young adults under 18 years of age, the risk of adverse reactions such as the following is higher than in adults:

• suicidal thoughts or tendencies (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).

Adults have a lower risk of adverse reactions compared to 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 ideas, or suspiciousness.

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 side of the abdomen under 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.

Adverse reactions occurring with frequency: unknown (cannot be determined from
available data)
CHILDREN and ADOLESCENTS aged above 6 years

• Involuntary teeth grinding (bruxism).

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 achieve normal 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 effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 the medicinal product.

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 conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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 as atomoxetine hydrochloride.
• Other ingredients: pregelatinized maize 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
Hard capsule.
Blue and white, opaque gelatin hard capsules, size "4", filled with white or almost white powder, printed with "AT" on the blue cap and "25" on the white body, using black ink.
Auroxetyn is available in blisters made of PVC/PE/PVDC-Aluminium, packed in cardboard boxes.
Pack sizes: 10, 30, 50 or 60 hard capsules.
For more detailed information about the medicine, please contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in the Netherlands, country of export:
Aurobindo Pharma B.V.
Baarnsche Dijk 1
3741 LN Baarn, The Netherlands

Manufacturers:
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorization Number in the Netherlands, country of export: RVG 121290
Parallel Import Authorization Number: 361/25

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