ATAMAX 100 mg HARD CAPSULES

2. What you need to know before taking Atamax

Do not takeAtamax:

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

Do not take Atamax if any of the above cases apply 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 to take 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 may 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 your blood pressure or heart rate.
• cardiovascular disease or a history of having suffered 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 causes 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 cause an increase in the frequency of seizures.
• mood changes or feelings of unhappiness.
• repeated spasms of difficult-to-control parts 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 determine 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 the 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 wash 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 may need to take any other medication. This includes those purchased without a prescription. Your doctor will decide if you can take Atamax with your other medications, and in some cases, your doctor 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 their proper functioning 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 purchasing these products.
• certain medications used to treat mental disorders
• 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Atamax may cause fatigue, drowsiness, or dizziness. Be careful when driving or using machinery until you know how Atamax affects you. If you feel tired, drowsy, 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 in doubt, consult your doctor or pharmacist again. The recommended dose is once or twice a day (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 a day and feel drowsy or sick, your doctor may change your treatment schedule to twice a day.
• 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 extracted or taken in any other way.
• Taking the medication 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 of age) or an adolescent:

Your doctor will tell you the dose of Atamax you should take and calculate it based on your weight. Normally, your doctor will give you a lower dose at first, before increasing the amount of Atamax you should 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 it 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 it 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 it 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 being treated

Your doctor will perform some tests

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

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

• measurement of height and weight in children and adolescents.
• measurement of 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 forget 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 forgotten doses.

If you stop treatment with Atamax

If you stop taking Atamax, normally no side effects appear, but the symptoms of ADHD may reappear. 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 people 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 regain 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 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 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 you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atamax

• The active ingredient is atomoxetine.

Each hard capsule contains 100 mg of atomoxetine, equivalent to 114.28 mg of atomoxetine hydrochloride.

• The other ingredients are

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

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 No. 1 (length of 19.1 ± 0.4 mm), with a brown opaque cap with '100' printed in black ink and a brown 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 100 mg hard capsules

Greece ATAMA καψ?κιο σκληρ? 100 mg

Germany ATAMA 100 mg hard capsules

Spain Atamax 100 mg hard capsules EFG

Date of the Last Revision of this Leaflet:November 2024

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