Auroxetin

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

Atomoxetine

Read all of this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Auroxetyn is and what it is used for
• 2. Before you take 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 Auroxetyn is used for

Auroxetyn contains atomoxetine and is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in:

• children over 6 years old;
• adolescents;
• adults. Auroxetyn is used as part of a comprehensive treatment programme, which includes psychological, educational, and social measures.

Auroxetyn should not be used to treat ADHD in children under 6 years old, as its safety and efficacy have not been established in this age group.

In adults, Auroxetyn is used to treat ADHD when the symptoms are very troublesome and affect their work or social life, and when the symptoms have been present since childhood.

How Auroxetyn works

Auroxetyn increases the levels of noradrenaline in the brain. Noradrenaline is a chemical that is naturally produced by the body. It helps improve attention and reduce impulsivity and hyperactivity in patients with ADHD. Auroxetyn is not a stimulant and does not have the same effects as stimulants. It may take a few weeks for Auroxetyn to start working.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and;
• focusing their attention. It is not their fault, and they should not be blamed for it. Many children and adolescents have these problems, but in those with ADHD, it can affect their daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may also have difficulty behaving at home, in school, and in other settings. ADHD does not affect a child's intelligence.

Adults with ADHD have the same problems as children with ADHD, and these can affect:

• work;
• relationships;
• self-esteem;
• learning.

2. Before you take Auroxetyn

Do not take Auroxetyn:

• if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6);
• if you have taken a monoamine oxidase inhibitor (MAOI) in the last 2 weeks. MAOIs are sometimes used to treat depression and other mental health conditions. Taking Auroxetyn with an MAOI can cause serious side effects or be life-threatening. You should also wait at least 14 days after stopping Auroxetyn before starting an MAOI;
• if you have an eye problem called narrow-angle glaucoma (increased pressure in the eye);
• if you have severe heart problems that may get worse if your heart rate or blood pressure increases (e.g., heart defects, heart failure);
• if you have had a heart attack or stroke;
• if you have a tumor of the adrenal gland (pheochromocytoma).

Do not take Auroxetyn if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Auroxetyn.

Warnings and precautions

Both children and adults should be aware of the following warnings and precautions.

Before taking Auroxetyn, tell your doctor if you have:

• thoughts of suicide or suicidal behavior;
• heart problems (including heart defects) or an increased heart rate. Auroxetyn may increase your heart rate;
• high blood pressure. Auroxetyn may increase your 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;
• heart or blood vessel problems, or if you have had a stroke;
• liver problems. Your doctor may need to reduce your dose;
• psychotic symptoms, including hallucinations (hearing or seeing things that are not there), delusions, or paranoia;
• mania or hypomania (excitement or excessive restlessness that causes unusual behavior);
• aggression;
• hostility or aggression;
• a history of seizures or epilepsy. Auroxetyn may increase the risk of seizures;
• mood swings or feeling unusually sad;
• uncontrollable movements, such as twitching or repeating sounds or words.

If any of the above apply to you, tell your doctor or pharmacist before taking Auroxetyn. Auroxetyn may make these conditions worse.

Tests before taking Auroxetyn

These tests are needed to decide if Auroxetyn is suitable for you.

• Your doctor will measure your blood pressure and heart rate before and during treatment with Auroxetyn;
• Your doctor will measure your height and weight during treatment with Auroxetyn if you are a child or adolescent.

Tell your doctor if you are taking any other medicines, if you have a family history of sudden death, or if you have any other medical conditions.

It is essential to provide your doctor with as much information as possible. This will help your doctor decide if Auroxetyn is suitable for you.

Auroxetyn and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, including those you have bought without a prescription.

Auroxetyn may interact with other medicines, including:

• 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 with your pharmacist when buying any of these medicines;
• certain medicines used to treat mental health conditions;
• medicines that increase the risk of seizures;
• certain medicines that may prolong the time Auroxetyn stays in your body (such as quinidine or terbinafine);
• salbutamol (a medicine used to treat asthma) taken orally or by injection, may cause a rapid heart rate, but will not make asthma symptoms worse.

Auroxetyn may affect the way other medicines work, or other medicines may affect the way Auroxetyn works.

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

• medicines used to control heart rate;
• medicines that change the levels of salts in your blood;
• medicines used to prevent or treat malaria;
• certain antibiotics (such as erythromycin and moxifloxacin).

If you are unsure whether any of your medicines are on this list, ask your doctor or pharmacist before taking Auroxetyn.

Pregnancy and breastfeeding

It is not known if Auroxetyn can affect an unborn baby or pass into breast milk.

• Do not take Auroxetyn during pregnancy unless your doctor advises you to;
• Do not take Auroxetyn while breastfeeding or stop breastfeeding.

If you are pregnant, think you may be pregnant, or plan to become pregnant, or if you are breastfeeding, or plan to breastfeed, ask your doctor or pharmacist for advice before taking Auroxetyn.

Driving and using machines

Auroxetyn may cause drowsiness, dizziness, or fainting. Be careful when driving or operating machinery until you know how Auroxetyn affects you.

Important information about the ingredients of Auroxetyn

Do not open Auroxetyn capsules, as the contents may irritate your eyes. If the contents of the capsule get into your eye, rinse it with water and seek medical advice. Also, wash your hands and any other parts of your body that have come into contact with the capsule contents.

3. How to take Auroxetyn

• Always take Auroxetyn exactly as your doctor has told you. Auroxetyn is usually taken once or twice a day (in the morning and late afternoon or early evening).
• Children should not take Auroxetyn without adult supervision.
• If you are taking Auroxetyn once a day and experience drowsiness or discomfort, your doctor may advise you to take it twice a day.
• Swallow the capsules whole with water, with or without food.
• Do not open the capsules or sprinkle the contents on food.
• Taking Auroxetyn at the same time each day will help you remember to take it.

What dose to take

Children and adolescents (aged 6 and over)

Your doctor will prescribe the right dose of Auroxetyn for you, based on your body weight. Your doctor will start with a lower dose and increase it as needed.

• Body weight up to 70 kg: the total daily dose is approximately 0.5 mg per kg of body weight for at least 7 days. Your doctor may then increase 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 daily dose is 40 mg for at least 7 days. Your doctor may then increase the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose is 100 mg.

Adults

• Start with a total daily dose of 40 mg for at least 7 days. Your doctor may then increase the dose to the usual maintenance dose of 80-100 mg per day. The maximum daily dose is 100 mg.

If you have liver problems, your doctor may prescribe a lower dose.

If you take more Auroxetyn than you should

Contact your doctor or the nearest hospital immediately if you take more Auroxetyn than you should. The most common symptoms of overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and abnormal behavior. Rarely, serotonin syndrome, a life-threatening condition, may occur (see section 2, "Warnings and precautions", "Serotonin syndrome").

If you forget to take Auroxetyn

If you forget to take a dose, take it as soon as you remember. However, do not take more than your total daily dose in 24 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Auroxetyn

After stopping Auroxetyn, your ADHD symptoms may return. Talk to your doctor before stopping Auroxetyn.

While taking Auroxetyn, your doctor will

Perform tests

• before starting treatment to ensure Auroxetyn is safe and suitable for you;
• during treatment, at least every 6 months, but probably more often.

Tests will also be performed when your dose is changed. These tests will include:

• measuring your height and weight if you are a child or adolescent;
• measuring your 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 one year of treatment with Auroxetyn, your doctor will assess the benefits and risks of continuing treatment.

4. Possible side effects

Like all medicines, Auroxetyn can cause side effects, although not everybody gets them.

Some side effects can be serious. If you experience any of the following, contact your doctor immediately:

• rapid or irregular heartbeat, abnormal heart rhythm;
• suicidal thoughts or behavior;
• aggression;
• hostility or aggression;
• mood swings or changes in mood;
• severe allergic reactions, which can cause:
• swelling of the face and throat;
• difficulty breathing;
• hives (small, itchy bumps on the skin).
• seizures;
• psychotic symptoms, including hallucinations (hearing or seeing things that are not there), delusions, or paranoia.

In children and adolescents under 18 years, the risk of side effects such as

suicidal thoughts or behavior and mood swings or changes in mood is higher(may affect up to 1 in 100 people) than in adults.

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

In adults, the risk of side effects such as

seizures and psychotic symptoms, including hallucinations (hearing or seeing things that are not there), delusions, or paranoia is lower(may affect up to 1 in 1,000 people) than in children and adolescents.

• seizures;
• psychotic symptoms, including hallucinations (hearing or seeing things that are not there), delusions, or paranoia.

Rare(may affect up to 1 in 1,000 people)

• liver damage.

Stop taking Auroxetyn and contact your doctor immediately if you experience any of the following:

• dark-colored urine;
• yellowing of the skin or eyes;
• pain in the upper right part of the abdomen, which may be tender to the touch;
• unexplained nausea;
• fatigue;
• itching;
• flu-like symptoms.

Other side effects that have been reported

Effect on growth

In some children, Auroxetyn may cause a decrease in growth (weight and height). However, during long-term treatment, children tend to reach their expected weight and height for their age group.

Your doctor will monitor your child's growth and weight. If your child is not growing or gaining weight as expected, your doctor may adjust the dose or temporarily stop Auroxetyn.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly to the national reporting system via the contact details below.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Auroxetyn

Keep Auroxetyn out of the sight and reach of children.

Do not use Auroxetyn after the expiry date stated on the label, carton, or bottle after EXP. The expiry date refers to the last day of the month.

There are no special storage instructions for Auroxetyn.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Auroxetyn contains

• The active substance is atomoxetine hydrochloride. Each hard capsule contains 10 mg, 18 mg, 25 mg, or 40 mg of atomoxetine as atomoxetine hydrochloride.
• The other ingredients are maize starch, silicon dioxide, sodium lauryl sulfate, and simethicone emulsion (30%).

Capsule shell: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, and purified water.

Body:titanium dioxide (E 171), sodium lauryl sulfate, indigo carmine (E 132) (only for 40 mg), gelatin, and purified water.

Printing ink:shellac (E 904), iron oxide (E 172).

What Auroxetyn looks like and contents of the pack

Hard capsule.

Auroxetyn, 10 mg, hard capsules

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

Auroxetyn, 18 mg, hard capsules

Gold and white, opaque hard gelatin capsules, size 4, filled with a white or off-white powder, with "AT" printed on the gold cap and "18" printed on the white body with black ink.

Auroxetyn, 25 mg, hard capsules

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

Auroxetyn, 40 mg, hard capsules

Blue, opaque hard gelatin capsules, size 2, filled with a white or off-white powder, with "AT" printed on the cap and "40" printed on the body with black ink.

Auroxetyn is available in blisters, packed in cartons.

Available 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 Warszawa

Manufacturer

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 Member States of the European Economic Area 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

Date of last revision of the leaflet:11/2024