ATOMOXETINE AUROVITAS 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Atomoxetine Aurovitas 10 mg hard capsules EFG

Atomoxetine Aurovitas 18 mg hard capsules EFG

Atomoxetine Aurovitas 25 mg hard capsules EFG

Atomoxetine Aurovitas 40 mg hard capsules EFG

Atomoxetine Aurovitas 60 mg hard capsules EFG

Atomoxetine Aurovitas 80 mg hard capsules EFG

Atomoxetine Aurovitas 100 mg hard capsules EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Atomoxetine Aurovitas and what is it used for
2. What you need to know before you take Atomoxetine Aurovitas
3. How to take Atomoxetine Aurovitas
4. Possible side effects
5. Storage of Atomoxetine Aurovitas
6. Contents of the pack and further information

1. What is Atomoxetine Aurovitas and what is it used for

What is it used for

Atomoxetine Aurovitas contains atomoxetine and is used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is used:

• in children from 6 years old
• in adolescents
• in adults

It is used only as part of a complete treatment program for ADHD that may include other treatments such as counseling or behavioral therapy.

It is not used to treat ADHD in children under 6 years old, as it is not known if the medicine works or is safe in this age group.

In adults, atomoxetine is used to treat ADHD when the symptoms are very problematic and affect work or social life, and when symptoms of the disorder were present in childhood.

How it works

Atomoxetine increases the amount of noradrenaline in the brain. This is a naturally occurring chemical that increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. This medicine has been prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and therefore does not cause addiction. It may take a few weeks from the start of treatment with the medicine before the symptoms improve completely.

About ADHD

Children and adolescents with ADHD find it:

• hard to sit still
• hard to concentrate

This is not their fault. Many children and adolescents find these things hard. However, for patients with ADHD, this can cause problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have difficulty behaving well at home, in school, or in other places. ADHD does not affect the intelligence of a child or adolescent.

Adults with ADHD find it hard to do all the things that children find hard, however this may mean that they have problems with:

• work
• relationships
• low self-esteem
• education

2. What you need to know before you take Atomoxetine Aurovitas

Do not take Atomoxetine Aurovitas if:

• You are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
• You have taken a medicine called a monoamine oxidase inhibitor (MAOI), such as phenelzine, in the last two weeks. MAOIs are sometimes used for depression and other mental health conditions; taking atomoxetine with an MAOI could cause serious side effects or be life-threatening. You should also wait at least 14 days after stopping your treatment with atomoxetine before taking an MAOI.
• You have an eye problem called narrow-angle glaucoma (increased pressure in the eye).
• You have serious heart problems that may get worse with an increase in heart rate and/or blood pressure, which may occur with atomoxetine.
• You have serious blood vessel problems in the brain, such as a stroke, an aneurysm (a bulge in a blood vessel that can burst), or narrowed or blocked blood vessels.
• You have a tumor of the adrenal gland (pheochromocytoma).

Do not take atomoxetine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Atomoxetine Aurovitas, as atomoxetine may make these problems worse.

Warnings and precautions

Both adults and children should be aware of the following warnings and precautions. Consult your doctor or pharmacist before starting to take atomoxetine if you have:

• Thoughts or attempts of suicide.
• Heart problems (including heart defects) or an increased heart rate. Atomoxetine may increase your heart rate (pulse). There have been reports of sudden death in patients with heart defects.
• High blood pressure. Atomoxetine may increase your blood pressure.
• Low blood pressure. Atomoxetine may cause dizziness or fainting in people with low blood pressure.
• Problems with sudden changes in blood pressure or heart rate.
• Cardiovascular disease or a history of stroke.
• Liver problems. You may need a lower dose.
• Psychotic symptoms, including hallucinations (hearing voices or seeing things that are not real), believing things that are not true, or being suspicious.
• Mania (feeling elated or overexcited, leading to unusual behavior) and agitation.
• Aggressive feelings.
• Hostile or angry feelings.
• A history of epilepsy or having had seizures for any other reason. Atomoxetine may increase the frequency of seizures.
• Changes in mood (mood swings) or feelings of unhappiness.
• Repetitive movements or sounds that are difficult to control.

Consult your doctor or pharmacist if you have any of the above symptoms before starting treatment, as atomoxetine may make these problems worse. Your doctor will want to monitor how the medicine affects you.

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening condition that may occur when taking atomoxetine with other medicines (see section 2 "Other medicines and Atomoxetine Aurovitas"). The signs and symptoms of serotonin syndrome can include a combination of the following: confusion, agitation, lack of coordination, and stiffness, hallucinations, coma, rapid heartbeat, increased body temperature, rapid changes in blood pressure, sweating, flushing, tremors, overactive reflexes, nausea, vomiting, and diarrhea. Contact a doctor or go immediately to the emergency department of the nearest hospital if you think you are experiencing serotonin syndrome.

Treatment with atomoxetine may make you feel aggressive, hostile, or violent; or worsen these symptoms if they were present before treatment. It may also cause unusual changes in behavior or mood (including physical aggression, threatening behavior, and thoughts of harming others). If you or your family and/or friends notice any of these reactions, talk to your doctor or pharmacist immediately.

Tests that your doctor will perform before you start taking Atomoxetine Aurovitas

These tests are to decide if Atomoxetine Aurovitas is the right medicine for you.

Your doctor will measure your:

• Blood pressure and heart rate (pulse) before and while you are taking atomoxetine.
• Weight and height if you are a child or adolescent while taking atomoxetine.

Your doctor will ask you about:

• Other medicines you are taking.
• A family history of sudden death.
• Any other medical problems (such as heart problems) that you or your family may have.

It is important that you provide all the information you can. This will help your doctor decide if Atomoxetine Aurovitas is the right medicine for you. Your doctor may decide to perform other medical tests before starting treatment with this medicine.

Taking Atomoxetine Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines bought without a prescription. Your doctor will decide if you can take Atomoxetine Aurovitas with other medicines and may need to adjust the dose or increase it more slowly.

Do not take Atomoxetine Aurovitas with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 "Do not take Atomoxetine Aurovitas".

If you are taking other medicines, Atomoxetine Aurovitas may affect how they work or cause side effects. If you are taking any of the following medicines, check with your doctor or pharmacist before taking Atomoxetine Aurovitas:

• Medicines that increase blood pressure or are used to control it.
• Antidepressant medicines, such as imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine.
• Some cough and cold remedies that contain medicines that can affect blood pressure. When buying these products, it is important to check with your pharmacist.
• Some medicines used to treat mental health conditions.
• Medicines known to increase the risk of seizures.
• Medicines that make atomoxetine stay in the body longer than usual (such as quinidine and terbinafine).
• Salbutamol (a medicine for asthma) when taken by mouth or injected, may make you feel like your heart is racing, but this will not make your asthma worse.

Atomoxetine Aurovitas may affect or be affected by other medicines. These include:

• Some antidepressants, opioids such as tramadol, and medicines used to treat migraine called triptans. These medicines may interact with atomoxetine and cause serotonin syndrome, a potentially life-threatening condition. (See section 2, Warnings and precautions, Serotonin syndrome).

The following medicines may increase the risk of an abnormal heart rhythm when taking atomoxetine:

• Medicines used to control heart rhythm.
• Medicines that alter the salt content of the blood.
• Medicines for the prevention and treatment of malaria.
• Some antibiotics (such as erythromycin and moxifloxacin).

If you are not sure if the medicines you are taking are included in the list above, consult your doctor or pharmacist before taking atomoxetine.

Pregnancy, breastfeeding, and fertility

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

• This medicine should not be taken during pregnancy unless your doctor tells you to.
• You should avoid taking this medicine if you are breastfeeding or stop breastfeeding.

If you:

• Are pregnant or breastfeeding,
• Think you may be pregnant or are planning to have a baby,
• Are planning to breastfeed,

consult your doctor or pharmacist before using this medicine.

Driving and using machines

Atomoxetine may make you feel tired, sleepy, or dizzy. Be careful when driving or using machinery until you know how atomoxetine affects you. If you feel tired, sleepy, or dizzy, you should not drive or use machinery.

Important information about some of the ingredients of Atomoxetine Aurovitas

Do not open the capsules of atomoxetine because the contents may irritate your eyes. If the contents of the capsules come into contact with your eyes, rinse them immediately with plenty of water and consult your doctor. If your hands or any other part of your body come into contact with the contents of the capsule, wash them as soon as possible with water.

3. How to take Atomoxetine Aurovitas

• Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. This will usually be once or twice a day (morning and late afternoon or early evening).
• Children should not take this medicine without the help of an adult.
• If you feel sleepy or nauseous when taking atomoxetine once a day, your doctor may change the medicine to twice a day.
• The capsules should be swallowed whole with or without food.
• The capsules should not be opened and the contents of the capsules should not be removed in any way.
• Taking the medicine at the same time every day can help you remember to take it.

How much to take

If you are a child (from 6 years old) or an adolescent:

Your doctor will tell you the dose of atomoxetine to take based on your weight. You will usually start with a low dose before increasing it, based on your weight.

• Up to 70 kg in weight: starting with a total daily dose of 0.5 mg per kg of body weight for at least 7 days. Your doctor will then decide if the dose should be increased to the usual maintenance dose of 1.2 mg per kg of body weight per day.
• Over 70 kg in weight: starting with a total daily dose of 40 mg for at least 7 days. Your doctor will then decide if the dose should be increased to the usual maintenance dose of 80 mg per day. The maximum daily dose is 100 mg.

Adults

• Atomoxetine Aurovitas should be started with a total daily dose of 40 mg for at least 7 days. Your doctor will then decide if the dose should be increased to the usual maintenance dose of 80 mg to 100 mg per day. The maximum daily dose is 100 mg.

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

If you take more Atomoxetine Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken. The most commonly reported symptoms after an overdose are gastrointestinal symptoms, sleepiness, dizziness, tremors, and abnormal behavior. Very rarely, serotonin syndrome, a potentially life-threatening condition, has also been reported. (See section 2, Warnings and precautions, Serotonin syndrome).

If you forget to take Atomoxetine Aurovitas

If you miss a dose, take another as soon as possible, but do not take more than the total daily dose in a 24-hour period. Do not take a double dose to make up for missed doses.

If you stop taking Atomoxetine Aurovitas

If you stop taking atomoxetine, you will not usually get any side effects, but the symptoms of ADHD may come back. You should talk to your doctor before stopping treatment.

What your doctor will do while you are taking Atomoxetine Aurovitas

Your doctor will perform some tests

• Before starting, to make sure atomoxetine is safe and will benefit you.
• After starting, at least every 6 months, although they may be more frequent.

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

• Measuring height and weight in children and adolescents.
• Measuring blood pressure and heart rate.
• Checking if you have any problems or if side effects have worsened while taking atomoxetine.

Long-term treatment

You do not need to take Atomoxetine Aurovitas all the time. If you take atomoxetine for more than a year, your doctor will review your treatment to see if the medicine is still needed.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Although some people suffer from adverse effects, most people consider that atomoxetine helps them. Your doctor will talk to you about these adverse effects.

Some adverse effects could be serious. If you experience any of the following effects, contact your doctor immediately.

Uncommon(may affect up to 1 in 100 people):

• Feeling or having a very fast heart rate, abnormal heart rhythm.
• Thoughts or feelings of suicide.
• Aggressive feelings.
• Feelings of hostility and anger.
• Mood changes.
• Severe allergic reaction with symptoms of:

• Swelling of the face and throat.
• Difficulty breathing.
• Hives (small, itchy, red rashes on the skin).

• Seizures.
• Psychotic symptoms including hallucinations (hearing voices or seeing things that do not exist), believing things that are not true, or being suspicious.

Children and young people under 18 years have a higher risk of suffering from adverse effects such as:

• Thoughts or feelings of suicide (may affect up to 1 in 100 people).
• Mood changes (may affect up to 1 in 10 people).

Adults have a lower risk(may affect up to 1 in 1,000 people) of suffering from adverse effects such as:

• Seizures.
• Psychotic symptoms including hallucinations (hearing voices or seeing things that do not exist), believing things that are not true, or being suspicious.

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

• Liver problems.

Stop treatment with atomoxetine and contact your doctor immediately if you experience any of the following adverse effects:

• Dark urine.
• Yellowish skin and eyes.
• Pain when pressing on the upper right part of the abdomen, just below the ribs.
• Unexplained feeling of discomfort (nausea).
• Fatigue.
• Itching.
• Feeling of starting with a cold.

Other reported adverse effects are as follows. If any of them worsen, consult your doctor or pharmacist.

Effects on Growth

When some children start taking atomoxetine, their growth (weight and height) is reduced. However, with long-term treatment, children recover the weight and height appropriate for their age range. Your doctor will monitor your child's height and weight. If your child is not growing or gaining weight as expected, your doctor may change the dose of atomoxetine or temporarily suspend treatment with atomoxetine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Atomoxetine Aurovitas

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofAtomoxetine Aurovitas

• The active ingredient is atomoxetine hydrochloride.

Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 18 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 25 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 40 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 60 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 80 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 100 mg of atomoxetine.

• The other ingredients are:

The capsules contain: pregelatinized cornstarch, simethicone emulsion (30%).

In the cap:titanium dioxide (E171), sodium lauryl sulfate, yellow iron oxide (E172) (for 18 mg, 80 mg & 100 mg), carmine indigo (E132) (for 25 mg; 40 mg & 60 mg), red iron oxide (E172) (for 80 mg & 100 mg), gelatin, and purified water.

In the body:titanium dioxide (E171), sodium lauryl sulfate, carmine indigo (E132) (only for 40 mg), yellow iron oxide (E172) (for 60 mg & 100 mg), red iron oxide (E172) (only for 100 mg), gelatin, purified water.

Printing ink (black):shellac (E904), black iron oxide (E172).

Appearance of the Product and Package Contents

Hard capsules.

Atomoxetine Aurovitas 10 mg hard capsules EFG

Hard gelatin capsule with the cap and body white opaque, size “5”, filled with white or off-white powder, and with “AT” printed on the white opaque cap and “10” on the white opaque body with black ink.

Atomoxetine Aurovitas 18 mg hard capsules EFG

Hard gelatin capsule with the cap golden opaque and the body white opaque, size “4”, filled with white or off-white powder, and with “AT” printed on the golden opaque cap and “18” on the white opaque body with black ink.

Atomoxetine Aurovitas 25 mg hard capsules EFG

Hard gelatin capsule with the cap blue opaque and the body white opaque, size “4”, filled with white or off-white powder, and with “AT” printed on the blue opaque cap and “25” on the white opaque body with black ink.

Atomoxetine Aurovitas 40 mg hard capsules EFG

Hard gelatin capsule with the cap and body blue opaque, size “2”, filled with white or off-white powder, and with “AT” printed on the blue opaque cap and “40” on the blue opaque body with black ink.

Atomoxetine Aurovitas 60 mg hard capsules EFG

Hard gelatin capsule with the cap blue opaque and the body golden opaque, size “1”, filled with white or off-white powder, and with “AT” printed on the blue opaque cap and “60” on the golden opaque body with black ink.

Atomoxetine Aurovitas 80 mg hard capsules EFG

Hard gelatin capsule with the cap brown opaque and the body white opaque, size “0”, filled with white or off-white powder, and with “AT” printed on the brown opaque cap and “80” on the white opaque body with black ink.

Atomoxetine Aurovitas 100 mg hard capsules EFG

Hard gelatin capsule with the cap and body brown opaque, size “0EL”, filled with white or off-white powder, and with “AT” printed on the brown opaque cap and “100” on the brown opaque body with black ink.

Atomoxetine Aurovitas is available in blister packs.

Package sizes:7, 10, 14, 15, 28, 30, 50, 56, 60, 90, and 100 capsules

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine 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

Spain: Atomoxetina Aurovitas 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg cápsulas duras EFG

Netherlands: Atomoxetine HCl Aurobindo 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg & 100 mg, harde capsules

Poland: Auroxetyn

Date of the last revision of this leaflet: 11/2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)