ATAMAX 80 mg HARD CAPSULES

Introduction

Package Leaflet:information for the user

Atamax 80 mg hard capsules EFG

atomoxetine

Read all of this leaflet carefully before you start 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, 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 signs of illness 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 is Atamax and what is it used for
2. What you need to know before you take Atamax
3. How to take Atamax
4. Possible side effects
5. Storage of Atamax
6. Contents of the pack and other information

1. What is Atamax and what is it used for

What is it used for

Atamax 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 comprehensive treatment programme including psychological, educational, and social measures.

It is not used to treat ADHD in children under 6 years old because the safety and efficacy of the medication in this age group have not been established.

In adults, this medication 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 during childhood.

How it works

This medication 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 medication has been prescribed to help control the symptoms of ADHD. This medication is not a stimulant and therefore does not cause addiction.

It may take a few weeks from the start of treatment with this medication for the symptoms to improve completely.

About ADHD

Children and adolescents with ADHD find it:

• difficult to sit still
• difficult to concentrate

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

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

• work
• relationships
• low self-esteem
• education

2. What you need to know before you take Atamax

Do not takeAtamax:

• if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
• if you have taken a medicine called a monoamine oxidase inhibitor (MAOI), such as phenelzine, within the last 2 weeks. MAOIs are sometimes used for depression and other mental health conditions; taking Atamax with an MAOI could cause serious or life-threatening side effects. You should also wait at least 14 days after stopping MAOI treatment before taking Atamax.
• if you have an eye problem called narrow-angle glaucoma (increased pressure in the eye).
• if you have serious heart problems that may get worse with an increase in heart rate and/or blood pressure, as this may be an effect of Atamax.
• if you have serious blood vessel problems in the brain, such as stroke, inflammation, and weakening of a blood vessel (aneurysm), or narrowed or blocked blood vessels.
• if you have a tumor of the adrenal gland (pheochromocytoma).

Do not take Atamax if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medication. The reason is that this medication 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 treatment with Atamax if you have:

• Serotonin syndrome

Serotonin syndrome is a potentially life-threatening situation that can occur when taking Atamax in combination with other medications (see section 2 "Other medications and Atamax"). The signs and symptoms of serotonin syndrome can include a combination of the following: confusion, restlessness, lack of coordination, and stiffness, hallucinations, coma, rapid heartbeat, increased body temperature, rapid changes in blood pressure, sweating, flushing, tremors, hyperactive 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 Atamax 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 your 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.
• suicidal thoughts or attempted suicide.
• heart problems (including heart defects) or an increased heart rate. Atamax may increase your heart rate (pulse). There have been reports of sudden death in patients with heart defects.
• high blood pressure. Atamax may increase your blood pressure.
• low blood pressure. Atamax 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 having had a stroke (cerebrovascular accident).
• liver problems. You may need a lower dose.
• psychotic symptoms, including hallucinations (hearing voices or seeing unreal things), believing things that are not true, or being suspicious.
• mania (feeling elated or overexcited, which leads to unusual behavior) and agitation.
• aggression.
• feeling of dislike and anger (hostility).
• history of epilepsy or if you have had seizures for any other reason. Atamax may increase the frequency of seizures.
• different moods than usual (mood swings) or feeling unhappy.
• repeated spasms that are difficult to control of any part of the body or repetition of sounds and words.

Consult your doctor or pharmacist if you have any of the symptoms mentioned above before starting treatment. The reason is that Atamax may make these problems worse. Your doctor will want to monitor how the medication affects you.

Tests that your doctor will perform before you start taking Atamax

These tests are to decide if Atamax is the right medication for you.

Your doctor will measure your:

• blood pressure and heart rate (pulse) before and while you are taking Atamax
• weight and height if you are a child or adolescent while you are taking Atamax

Your doctor will ask you about:

• other medications you are taking
• if you have a family history of sudden death
• any other medical problems (such as heart problems) that you or your family may have

It is essential that you provide all the information you can. This will help your doctor decide if Atamax is the right medication for you. Your doctor may decide that other medical tests are necessary before starting treatment with this medication.

Important information about the contents of the capsules

Do not open Atamax capsules because the contents of the capsule can irritate the eye. If the contents of the capsules come into contact with the eye, you should immediately rinse the affected eye with water and consult a doctor. The hands and any other part of the body that may have come into contact with the contents of the capsule should also be washed as soon as possible.

Other medications andAtamax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. This includes those bought without a prescription. Your doctor will decide if you can take Atamax with your other medications and, in some cases, may need to adjust your dose or increase your dose more slowly.

Do not take Atamax with medications called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 "Do not take Atamax".

If you are taking other medications, Atamax may affect how they work or cause side effects.

If you are taking any of the following medications, check with your doctor or pharmacist before taking Atamax.

Atamax may be affected by or affect other medications. These include:

• certain antidepressants, opioids such as tramadol, and medications used to treat migraines called triptans. These medications may interact with Atamax and cause serotonin syndrome, a potentially life-threatening situation. (See section 2, Warnings and precautions, Serotonin syndrome).
• medications that increase blood pressure or are used to control blood pressure
• medications such as antidepressants, for example, imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine
• certain cough and cold remedies that contain medications that can affect blood pressure. It is essential to check with your pharmacist when buying these products.
• certain medications used to treat mental health conditions
• medications known to increase the risk of seizures
• certain medications that make Atamax stay in the body longer than usual

(such as quinidine and terbinafine)

• salbutamol (a medication for the treatment of asthma) when taken orally or injected may cause a feeling that your heart is racing, but this will not worsen your asthma.

The medications described below may increase the risk of abnormal heart rhythm when taken with Atamax:

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

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

Pregnancy and breastfeeding

There are no data available on whether this medication can affect the fetus or pass into breast milk.

• This medication should not be taken during pregnancy, unless your doctor recommends it.
• You should avoid taking this medication 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, consult your doctor or pharmacist before using this medication.

Driving and using machines

Atamax may cause drowsiness, sleepiness, or dizziness. Be careful when driving or using machinery until you know how Atamax affects you. If you feel drowsy, sleepy, or dizzy, you should not drive or use machinery.

Atamax contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Atamax

• Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended dose is once or twice daily (morning and late afternoon or early evening).
• Children should not take this medication without the help of an adult.
• If you are taking Atamax once daily and feel drowsy or unwell, your doctor may change your treatment schedule to twice daily.
• Oral administration.
• 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 or taken in any other way.
• Taking the medication at the same time each 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 Atamax to take and will calculate it based on your weight. Normally, your doctor will start with a lower dose, and then increase the amount of Atamax you take according to your body weight.

• Body weight up to 70 kg: 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 and per day.
• Body weight over 70 kg: 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 that your doctor will prescribe is 100 mg.

Adults

• Treatment with Atamax 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 80-100 mg per day. The maximum daily dose that your doctor will prescribe is 100 mg.

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

What your doctor will do while you are taking Atamax

Your doctor will perform some tests

• before you start - to make sure Atamax is safe and will benefit you.
• after you have started - the tests will be done at least every 6 months, although they may be more frequent.

The tests will also be done 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 Atamax.

Long-term treatment

Atamax does not need to be taken indefinitely. If you take Atamax for more than a year, your doctor should review your treatment to check if the medication is still necessary.

If you take moreAtamaxthan you shouldcontact your doctor or the emergency department of the nearest hospital immediately and tell them how many capsules you have taken. The most commonly reported symptoms after an overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and abnormal behavior. Very rarely, serotonin syndrome, a potentially life-threatening situation, has also been reported. (See section 2, Warnings and precautions, Serotonin syndrome).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Atamax

If you miss a dose, take another as soon as possible, but do not take an amount that exceeds 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 Atamax

If you stop taking Atamax, you will not normally experience any side effects, but the symptoms of ADHD may return. You should talk to your doctor before stopping treatment.

If you have any doubts about the use of this medication, 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 consider that Atamax 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
• suicidal thoughts or feelings
• feeling aggressive
• feeling of hostility or anger
• mood swings or changes in mood
• severe allergic reaction with symptoms of:
• swelling of the face and throat
• difficulty breathing
• hives (itchy, raised, red patches)
• 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 adolescents under 18 years have a higher risk of suffering from adverse effects such as:

• suicidal thoughts or feelings (may affect up to 1 in 100 people)
• mood swings or changes in mood (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 (such as 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 Atamax and contact your doctor immediately if you experience any of the following adverse effects:

• dark urine
• yellowing of the skin and eyes
• abdominal pain when pressed (tenderness) in the upper right part of the abdomen, just below the ribs
• unexplained nausea
• fatigue
• itching
• feeling of having a cold

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

Effects on Growth

Some children experience decreased growth (weight and height) when they start taking Atamax. However, with long-term treatment, children recover the expected weight and height for their age group. Your doctor will monitor your child's height and weight over time. If your child is not growing or gaining weight as expected, your doctor may change the dose of Atamax or decide to temporarily suspend treatment with Atamax.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this prospectus. 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 Atamax

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging and on the blister pack after the abbreviation "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Atamax

• The active ingredient is atomoxetine.

Each hard capsule contains 80 mg of atomoxetine, equivalent to 91.42 mg of atomoxetine hydrochloride.

• The other ingredients are

Capsule content:pregelatinized corn starch, anhydrous colloidal silica, and dimeticone.

Capsule shell:gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and purified water.

• Printing ink (black) composed of: Shellac Glaze-45% (20% esterified) in ethanol, black iron oxide (E172), and propylene glycol.

Appearance of the Product and Package Contents

Hard gelatin capsule containing white powder, size 2 (length of 17.6 ± 0.4 mm), with a brown opaque cap with '80' printed in black ink and a white opaque body with 'mg' printed in black ink.

Atamax is presented in blister packs in a cardboard box.

Available in packs of 7, 14, 28, and 56 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS RUBIÓ, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal

Barcelona – Spain

Manufacturer:

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

or

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

This medicine is authorized in the Member States of the European Economic Area with the following names:

Austria Atomoxetin Pharmathen 80 mg hard capsules

Greece ATAMA καψ?κιο σκληρ? 80 mg

Germany ATAMA 80 mg hard capsules

Spain Atamax 80 mg hard capsules EFG

Date of the last revision of this prospectus:November 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/)