Auroxetine

Package leaflet: Information for the user

Auroxetyn, 10 mg, hard capsules
Auroxetyn, 18 mg, hard capsules
Auroxetyn, 25 mg, hard capsules
Auroxetyn, 40 mg, hard capsules
Atomoxetinum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

Leaflet contents

1. What Auroxetyn is and what it is used for
2. What you need to know 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 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 may also include non-pharmacological treatments such as counselling and behavioural therapy.

Auroxetyn should not be used in the treatment of ADHD in children under six 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 improves concentration and reduces impulsiveness 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 difficulties 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 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) in 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 or life-threatening adverse effects. Also, at least 14 days should elapse after discontinuing Auroxetyn before starting an MAOI;
• if the patient has a eye disease called narrow-angle glaucoma (increased pressure in the eye);
• if the patient has severe heart disorders 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, weakening of a blood vessel wall (aneurysm), narrowing or blockage 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 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 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 a history of stroke;
• liver diseases. 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 agitation leading to unusual behavior) and agitation;
• feelings of aggression;
• hostile or unfriendly attitude;
• a history of epilepsy or seizures for any reason. Auroxetyn may increase the frequency of seizures;
• mood different from usual (mood swings) or feelings of profound sadness;
• uncontrollable, repetitive movements of any body part or repetitive sounds or words.

If any of the above conditions apply, the patient should discuss them with a
doctor or pharmacist before starting Auroxetyn. Auroxetyn 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 and other medicines").
Objective and subjective symptoms of serotonin syndrome may include a combination of the following: disorientation, psychomotor agitation, lack of coordination and stiffness, hallucinations, coma, rapid heart rate, elevated body temperature, rapid changes in blood pressure, sweating, sudden skin flushing, tremor, exaggerated reflexes, nausea, vomiting, and diarrhea.
If serotonin syndrome is suspected, seek immediate medical attention or go to the nearest hospital 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 assault, 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.
Tests required before starting Auroxetyn
These tests 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 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 unexplained sudden death;
• the patient or any family members have 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 treatment with this medicine.
Auroxetyn and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken. 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 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 medicines containing substances affecting blood pressure. It is important to check this with the pharmacist when purchasing such 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 to treat 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 potentially life-threatening condition. (See section 2 "Warnings and precautions", "Serotonin syndrome").

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 plans to have a child,
• 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, 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

• This medicine should always be taken exactly 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 feeling unwell 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, pour out their contents, or take them in any other way.
• Taking the medicine at the same time each day 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. Afterwards, 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. Afterwards, 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 begin with a total daily dose of 40 mg for at least 7 days. Afterwards, 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 Auroxetyn than prescribed
Contact your doctor or 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. Serotonin syndrome, a potentially life-threatening condition, has also been reported very rarely. (See section 2. "Warnings and precautions", "Serotonin syndrome").
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.
During treatment, your doctor will carry out the following:
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 carried out if the dose is changed. These will include:

• measuring height and body weight in children and young people
• measuring blood pressure and pulse
• checking whether any problems have occurred 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 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 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 can 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 increased heart rate, arrhythmias;
• suicidal thoughts or tendencies;
• feeling of aggression;
• hostile attitude or anger (hostility);
• mood swings or changes in mood;
• severe allergic reactions, with symptoms such as:
  • swelling of the face and throat;
  • difficulty breathing;
  • urticaria (small itchy skin rash).
• 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, there is an increased risk of adverse reactions
compared to adults, such as:

• 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).

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 ideas, 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 part of the abdomen under the ribs, occurring upon pressure (tenderness);
• 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 be slowed after starting treatment with Auroxetyn. 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 treatment with Auroxetyn.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring of 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, e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product and helps to gather further information on the safety of 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 label, carton, and bottle after: EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions 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. Such 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 10 mg of atomoxetine as atomoxetine hydrochloride. One hard capsule contains 18 mg of atomoxetine as atomoxetine hydrochloride. One hard capsule contains 25 mg of atomoxetine as atomoxetine hydrochloride. One hard capsule contains 40 mg of atomoxetine as atomoxetine hydrochloride.
• Other ingredients are: pregelatinized starch (corn), simethicone emulsion (30%).

Cap: titanium dioxide (E 171), sodium lauryl sulfate, yellow iron oxide (E 172) (only for 18 mg), indigo carmine (E 132) (only for 25 mg and 40 mg), gelatin, purified water.
Body: titanium dioxide (E 171), sodium lauryl sulfate, indigo carmine (E 132) (only for 40 mg), gelatin, purified water.
Printing ink: shellac (E 904), black iron oxide (E 172).

What Auroxetyn looks like and contents of the pack
Hard capsule.

Auroxetyn 10 mg hard capsules
White to off-white, opaque gelatin hard capsules, size "5", filled with white or off-white powder, printed with "AT" on the cap and "10" on the body in black ink.

Auroxetyn 18 mg hard capsules
Golden-white, opaque gelatin hard capsules, size "4", filled with white or off-white powder, printed with "AT" on the golden cap and "18" on the white body in black ink.

Auroxetyn 25 mg hard capsules
Blue-white, opaque gelatin hard capsules, size "4", filled with white or off-white powder, printed with "AT" on the blue cap and "25" on the white body in black ink.

Auroxetyn 40 mg hard capsules
Blue, opaque gelatin hard 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 blisters packed in cardboard cartons.
Pack sizes: 7, 10, 14, 15, 28, 30, 50, 56, 60, 90 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland

Manufacturer/Importer
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebuggia, BBG 3000
Malta

Generis Farmaceutica, S.A.
Rua João de Deus, 19
Amadora, 2700-487
Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Atomoxetin PUREN 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg Hartkapseln
Poland: Auroxetyn
Netherlands: Atomoxetine HCl Aurobindo 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg, harde capsules
Spain: Atomoxetina Aurovitas 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg capsulas duras EFG