Label:Information for the User

Atamax 80 mg Hard Capsules EFG

atomoxetine

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

For what it is used

Atamaxcontains atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). It is used:

• in children aged 6 years and above
• in adolescents
• in adults

It is used solely as part of the complete treatment of the disease that also requires treatments that do not include medications, such as counseling or behavioral therapy.

It is not used for the treatment of ADHD in children under 6 years old because it is not known if the medication works or is safe in this population.

In adults, this medication is used for the treatment of ADHD when symptoms are very problematic and affect work or social life and when symptoms of the disease have been present since childhood.

How it works

This medication increases the amount of norepinephrine in the brain. This is a naturally produced substance that increases attention and decreases impulsivity and hyperactivity in ADHD patients. This medication has been prescribed to help control ADHD symptoms. This medication is not a stimulant and therefore does not cause addiction.

It may take several weeks since starting treatment with the medication for symptoms to improve completely.

About ADHD

Children and adolescents with ADHD experience:

• difficulty sitting still
• difficulty concentrating

It is not their fault that they cannot do these things. Many children and adolescents find this difficult. However, ADHD can cause problems in daily life for patients with ADHD. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, school, or other places. ADHD does not affect a child's or adolescent's intelligence.

Adults with ADHD experience difficulty doing all the things that children also experience difficulty with, however, this can mean they have problems with:

• work
• relationships
• low self-esteem
• education

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) in the past two weeks, for example phenelzine. MAOIs are sometimes used to treat 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 this medicine before taking an MAOI.
• if you have a condition called narrow-angle glaucoma (increased pressure in your eye).
• if you have severe heart problems that could get worse with an increase in heart rate and/or blood pressure, as this could be an effect of Atamax.
• if you have severe blood vessel problems in your brain, such as a stroke, inflammation, and weakening of part of a blood vessel (aneurysm) or narrow or blocked blood vessels.
• if you have a tumor in your adrenal gland (pheochromocytoma).

Do not take Atamax if you apply any of the above cases. If you are unsure, consult your doctor or pharmacist before taking this medicine. The reason is that this medicine 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 medicines (see section 2 “Other medicines 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 heart rate, 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 nearest hospital emergency department 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, speak with your doctor or pharmacist immediately.
• suicidal thoughts or attempts.
• heart problems (including heart defects) or an increased heart rate. Atamax may increase your heart rate (pulse). Cases of sudden death have been reported 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 had a stroke (cerebral vascular accident).
• 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, which causes unusual behavior) and agitation.
• aggression.
• feeling hostility and anger (hostility).
• history of epilepsy or if you have had seizures for any other reason. Atamax may increase the frequency of seizures.
• unusual mood changes or feeling unhappy.
• repeated spasms of difficult 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 medicine affects you.

Tests your doctor will perform before you start taking Atamax

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

Your doctor will measure your:

-blood pressure and heart rate (pulse) before and during the time you are taking Atamax

-weight and height if you are a child or adolescent during the time you are taking Atamax

Your doctor will ask you about:

-other medicines you are taking

-if you have a family history of sudden death

-any other medical problem (such as heart problems) that you or your family may have

It is important to provide as much information as you can. This will help your doctor decide if Atamax is the right medicine for you. Your doctor may decide that other medical tests are needed before starting treatment with this medicine.

Important information about the contents of the capsules

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

Other medicines andAtamax

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

Do not take Atamax with medicines called MAOIs (monoamine oxidase inhibitors) used to treat depression. See section 2 “Do not take Atamax”.

Atamax may affect the proper functioning of these medicines or cause side effects.

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

Atamax 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 Atamax and cause serotonin syndrome, a potentially life-threatening situation. (See section 2, Warnings and precautions, Serotonin syndrome).
• medicines that increase blood pressure or are used to control blood pressure
• medicines such as antidepressants, for example imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine
• some cough and cold remedies that contain medicines that may affect blood pressure. It is important to check with your pharmacist when you buy this type of product.
• some medicines used to treat mental health conditions
• medicines that are known to increase the risk of seizures
• some medicines that make Atamax stay in the body longer than normal

(such as quinidine and terbinafine)

• salbutamol (a medicine for treating asthma) when taken orally or injected may cause the sensation that your heart is racing, but this will not worsen your asthma.

The medicines listed below may increase the risk of abnormal heart rhythm when taken with Atamax:

• medicines used to control heart rhythm
• medicines that alter the content of salts in the blood
• medicines for the prevention and treatment of malaria
• some antibiotics (such as erythromycin and moxifloxacino).

If you are unsure about whether the medicines you are taking are included in the list above, consult your doctor or pharmacist before taking Atamax.

Pregnancy and breastfeeding

There is no information on whether this medicine can affect the fetus or can pass into breast milk.

• This medicine should not be taken during pregnancy, unless your doctor recommends it.
• 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Atamax may make you feel tired, drowsy, or dizzy. Be careful if you drive or operate machinery until you know how Atamax affects you. If you feel tired, drowsy, or dizzy, you should not drive or operate machinery.

Atamax contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

• Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended dose is one or two times a day (morning and last hour of the afternoon or at first hour of the night).
• Children should not take this medication without the help of an adult.
• If you are taking Atamax once a day and feel drowsy or feel sick, your doctor may change your treatment schedule to two times a day.
• Oral administration.
• The capsules should be swallowed whole, with or without food.
• The capsules should not be opened and the content inside the capsules should not be extracted or taken in any other way.
• Take the medication always at the same hour every day may help you to remember that you should take it.

How much to take

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

Your doctor will indicate the dose of Atamax that you should take and will calculate it according to your weight. Normally, your doctor will administer a lower dose initially, before increasing the amount of Atamax that 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 a minimum of 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 a minimum of 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

• The treatment with Atamax should start with a total daily dose of 40 mg for a minimum of 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 when you are on treatment

Your doctor will do some tests

• before you start - to ensure that 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:

• measurement of height and weight in children and adolescents.
• measurement of blood pressure and heart rate.
• checking if you have any problems or if the 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, the 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 ingested.

If you forgot to take Atamax

If you forget a dose, take another as soon as possible, but do not take a dose that exceeds the total daily dose in a 24-hour period. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Atamax

If you stop taking Atamax, usually no side effects appear, but the ADHD symptoms may reappear. You should talk to your doctor before interrupting the treatment.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Although some people experience side effects, most people find that Atamax helps them. Your doctor will talk to you about these side effects.

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

Rare(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 hostility and anger
• mood changes or mood swings
• severe allergic reaction with symptoms of:
• swelling of the face and throat
• difficulty breathing
• hives (small, itchy, raised bumps)
• convulsions
• psychotic symptoms including hallucinations (hearing voices or seeing things that are not there), believing things that are not true, or being suspicious.

Children and adolescents under 18 years old are at a higher risk of experiencing side effects such as:

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

Adults are at a lower risk(may affect up to 1 in 1,000 people)of experiencing side effects such as:

• convulsions
• psychotic symptoms including hallucinations (such as hearing voices or seeing things that are not there), believing things that are not true, or being suspicious

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

• liver damage

Stop taking Atamax and contact your doctor immediately if you experience any of the following side effects:

• dark urine
• yellowing of the skin and eyes
• abdominal pain when pressing (pain on palpation) in the upper right abdomen, just below the ribs
• unexplained nausea
• fatigue
• itching
• sensation of having caught a cold

Other side effects reported have been the following. 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 appropriate weight and height for their age range. Your doctor will monitor your child's height and weight over time. If your child does not grow or gain weight as expected, your doctor may change the dose of Atamax or decide to temporarily suspend treatment with Atamax.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Atamax

• The active principle isatomoxetine.

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

• The other components are

Content of the capsule:Maize pregelatinized starch, anhydrous colloidal silica, and dimethicone.

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

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

Appearance of the product and contents of the package

Hard gelatin capsule containing white powder, size No. 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 blisters in a cardboard box.

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

LABORATORIOS RUBIÓ, S.A.

Industry, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal

Barcelona – Spain

Responsible 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:

AustriaAtomoxetine Pharmathen 80 mg Hard Capsules

GreeceATAMAκαψ?κιοσκληρ?80 mg

GermanyATAMA 80 mg Hard Capsules

SpainAtamax 80 mg Hard Capsules EFG

Last review date of thesmpleprospect:November 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)