Atamax 10 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Atamax 10 mg hard capsules EFG

atomoxetine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Atamax is and what it is used for
2. What you need to know before taking Atamax
3. How to take Atamax
4. Possible side effects
5. How to store Atamax
6. Contents of the pack and other information

1. What Atamax is and what it is used for

What it is used for

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

• in children from the age of 6 years
• in adolescents
• in adults

It is used only as part of a comprehensive treatment programme for the condition, which must also include non-drug treatments such as counselling or behavioural therapy.

It is not used for the treatment of ADHD in children under 6 years of age, because it is not known whether the medicine is effective or safe in this population.

In adults, this medicine is used for the treatment of ADHD when symptoms are particularly problematic and affect work or social life, and when symptoms of the disorder were present during childhood.

How it works

This medicine increases the amount of noradrenaline in the brain. Noradrenaline is a naturally produced chemical that enhances attention and reduces impulsivity 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 several weeks after starting treatment with this medicine before symptoms improve fully.

About ADHD

Children and adolescents with ADHD find it:

• difficult to sit still
• difficult to concentrate

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

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

• work
• relationships
• low self-esteem
• education

2. What you need to know before starting to take Atamax

Do not take Atamax:

• if you are allergic to atomoxetine or to any of the other ingredients of this medicine (listed in section 6).
• if you have taken a type of medicine called monoamine oxidase inhibitors (MAOIs) within the last two weeks, for example phenelzine. MAOIs are sometimes used for depression and other mental disorders; taking Atamax together with an MAOI could cause serious or life-threatening side effects. You must also wait at least 14 days after stopping this medicine before taking an MAOI.
• if you have a type of eye disease called narrow-angle glaucoma (increased pressure in your eye).
• if you have serious heart problems that could worsen due to 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 your brain, such as 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 apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine. The reason is that this medicine may worsen these conditions.

Warnings and precautions

Both adults and children should consider 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 condition that may occur when Atamax is taken in combination with other medicines (see section 2 “Other medicines and Atamax”). Signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, lack of coordination and rigidity, 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 nearest hospital emergency department if you think you are experiencing serotonin syndrome.

• Treatment with Atamax may make you feel aggressive, hostile, or violent; or may 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 suicide attempts.
• heart problems (including heart defects) or 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 who have low blood pressure.
• problems with sudden changes in your blood pressure or heart rate.
• cardiovascular disease or history of 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, leading to unusual behavior) and agitation.
• aggression.
• feelings 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 different from usual (mood changes) or feeling unhappy.
• repeated, difficult-to-control muscle spasms in any part of the body or repeated sounds and words.

Consult your doctor or pharmacist if you have any of the symptoms listed above before starting treatment. The reason is that Atamax may worsen these problems. 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 determine whether 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
• 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 whether Atamax is the right medicine for you. Your doctor may decide that additional medical tests are needed before starting treatment with this medicine.

Important information about the capsule contents

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

Other medicines and Atamax

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This includes medicines obtained without a prescription. Your doctor will decide whether 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 for depression. See section 2 “Do not take Atamax”.

If you are taking other medicines, Atamax may affect how they work or cause adverse 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:

• certain antidepressants, opioids such as tramadol, and migraine medicines called triptans. These medicines may interact with Atamax and cause serotonin syndrome, a potentially life-threatening condition. (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
• certain cough and cold remedies containing medicines that may affect blood pressure. It is important to check with your pharmacist when purchasing these products.
• certain medicines used to treat mental disorders
• medicines known to increase the risk of seizures
• certain medicines that cause Atamax to remain in the body longer than normal

(such as quinidine and terbinafine)

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

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

• medicines used to control heart rhythm
• medicines that alter blood electrolyte levels
• medicines for the prevention and treatment of malaria
• certain antibiotic medicines (such as erythromycin and moxifloxacin).

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

Pregnancy and breastfeeding

There are no data on whether this medicine may affect the fetus or 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 use of machines

Atamax may cause tiredness, drowsiness, or dizziness. Be cautious if driving or operating 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; this is essentially “sodium-free.”

3. How to take Atamax

• Follow exactly the dosing instructions for this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended dose is once or twice daily (in the morning and late afternoon or early evening).
• Children must not take this medicine without the help of an adult.
• If you are taking Atamax once daily and experience drowsiness or feel unwell, your doctor may change your treatment schedule to twice daily.
• For oral administration.
• The capsules must be swallowed whole, with or without food.
• The capsules must not be opened, and the contents must not be removed or taken in any other way.
• Taking the medicine at the same time each day may help you remember to take it.

How much to take

If you are a child (from 6 years of age) or adolescent:

Your doctor will determine the dose of Atamax you should take, based on your body weight. Usually, your doctor will start with a lower dose before increasing the amount of Atamax 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 whether to increase it to the usual maintenance dose of 1.2 mg per kg of body weight 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 whether to increase it to the usual maintenance dose of 80 mg per day. The maximum daily dose your doctor will prescribe is 100 mg.

Adults

• Treatment with Atamax should begin with a total daily dose of 40 mg for at least 7 days. Your doctor will then decide whether to increase it to the usual maintenance dose of 80 mg–100 mg per day. The maximum daily dose your doctor will prescribe is 100 mg.

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

What your doctor will do during your treatment

Your doctor will perform certain tests

• Before you start treatment – to ensure that Atamax is safe and will benefit you.
• After you have started treatment – tests will be performed 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:

• Measurement of height and weight in children and adolescents.
• Measurement of blood pressure and heart rate.
• Checking whether you have any problems or whether 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 one year, your doctor must review your treatment to determine whether the medicine is still necessary.

If you take more Atamax than you should

Contact your doctor or the nearest hospital emergency department immediately and inform them how many capsules you have taken. The most commonly reported symptoms following an overdose are gastrointestinal symptoms, drowsiness, dizziness, tremor, and abnormal behavior. Very rarely, serotonin syndrome, a potentially life-threatening condition, has also been reported. (See section 2, Warnings and precautions, Serotonin syndrome).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atamax

If you miss a dose, take it as soon as possible, but do not exceed the total daily dose within 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, adverse effects usually do not occur, but symptoms of ADHD may reappear. You should speak with your doctor before stopping treatment.

If you have any 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 everyone experiences them. Although some people experience adverse effects, most find that Atamax helps them. Your doctor will discuss these adverse effects with you.

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

Uncommon (may affect up to 1 in 100 people)

• feeling or having a very fast heartbeat, irregular heartbeat
• suicidal thoughts or feelings
• feeling aggressive
• feelings of dislike and anger (hostility)
• mood changes or mood swings
• severe allergic reaction with symptoms such as:
• swelling of the face and throat
• difficulty breathing
• hives (rash/small raised reddish itchy eruptions)
• seizures
• psychotic symptoms including hallucinations (hearing voices or seeing things that are not real), believing things that are not true, or being suspicious.

Children and adolescents under 18 years of age have a higher risk of experiencing adverse 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 have a lower risk (may affect up to 1 in 1,000 people) of experiencing adverse effects such as:

• seizures
• psychotic symptoms including hallucinations (such as hearing voices or seeing things that are not real), 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 any of the following adverse effects occur:

• dark urine
• yellowing of the skin or eyes
• stomach pain when pressed (tenderness) in the upper right side of the abdomen, just below the ribs
• unexplained nausea
• tiredness
• itching
• feeling as if you have caught a cold

Other reported adverse effects have been the following. If any of these worsen, consult your doctor or pharmacist.

Adverse effects very common (may affect more than 1 in 10 people)
CHILDREN over 6 years and ADOLESCENTS	ADULTS
headache stomach pain decreased appetite (loss of hunger) feeling unwell sleepiness increased blood pressure increased heart rate (pulse) These effects may disappear after some time in most patients.	feeling of discomfort dry mouth headache decreased appetite (loss of hunger) difficulty falling asleep, staying asleep, or waking up early increased blood pressure increased heart rate (pulse)

Adverse reactions common (may affect up to 1 in 10 people)
CHILDREN over 6 years and ADOLESCENTS	ADULTS
irritability and restlessness sleep problems including waking up early depression feeling of sadness or hopelessness feeling of anxiety tics dilated pupils (the black center of the eye) dizziness constipation loss of appetite stomach pain, indigestion skin swelling, redness, and itching skin rash feeling of sluggishness (lethargy) chest pain fatigue weight loss	sensation of restlessness decreased sexual appetite sleep disturbance depression feeling of sadness or hopelessness feeling of anxiety dizziness unusual or persistent altered taste tremor sensation of numbness or tingling in hands and feet numbness, drowsiness, feeling of fatigue constipation stomach pain indigestion gas (flatulence) malaise flushing or hot flashes feeling or having a very rapid heartbeat skin swelling, redness, and itching increased sweating skin rash urinary problems such as inability to urinate, frequency, difficulty starting to urinate, pain during urination inflammation of the prostate gland (prostatitis) groin pain in men difficulty achieving an erection delayed orgasm difficulty maintaining an erection menstrual cramps lack of strength or energy fatigue sensation of sluggishness (lethargy) chills feeling irritable or nervous feeling thirsty weight loss

Uncommon adverse effects (may affect up to 1 in 100 people)
CHILDREN over 6 years and ADOLESCENTS	ADULTS
fainting tremors migraine blurred vision abnormal skin sensations such as burning, prickling, itching, or tingling tingling or numbness in hands and feet seizures (fits) feeling or having a very fast heartbeat (QT interval prolongation) difficulty breathing increased sweating itching of the skin lack of strength or energy	agitation tics fainting migraine blurred vision irregular heartbeat (QT interval prolongation) feeling cold in fingers of hands and feet chest pain shortness of breath itchy, raised red rash (hives) muscle cramps urgent need to urinate absence or abnormality of orgasms irregular menstruation absence of ejaculation

Adverse reactions rare (may affect up to 1 in 1,000 people)
CHILDREN over 6 years and ADOLESCENTS	ADULTS
numb and pale fingers and toes due to poor blood circulation (Raynaud's phenomenon) problems with urination such as difficulty passing urine or passing urine frequently, pain when urinating prolonged and painful erections groin pain in men	numb and pale fingers and toes due to poor blood circulation (Raynaud's phenomenon) prolonged and painful erections

Adverse reactions of unknown frequency

CHILDREN over 6 years and ADOLESCENTS

Involuntary teeth grinding (bruxism)

Effects on growth

Some children experience reduced growth (weight and height) when starting Atamax. However, with long-term treatment, children regain 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 adjust the dose of Atamax or decide to temporarily discontinue treatment with Atamax.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide 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 expiry date stated on the packaging and blister after the abbreviation “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atamax

• The active substance is atomoxetine.

Each hard capsule contains 10 mg of atomoxetine, equivalent to 11.43 mg of atomoxetine hydrochloride.

• The other components are

Capsule contents: Pregelatinized corn starch, anhydrous colloidal silica, and dimethicone.

Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), 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 contents of the container

Hard gelatin capsule containing white powder, size No. 3 (length 15.7±0.4 mm), with an opaque white cap printed with '10' in black ink and an opaque white body printed with 'mg' in black ink.

Atamax is presented in blister packs within a cardboard box.

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

Only certain 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Atomoxetin Pharmathen 10 mg Hard Capsules

Greece ATAMA καψ?κιο σκληρ? 10 mg

Germany ATAMA 10 mg Hard Capsules

Spain Atamax 10 mg hard capsules EFG

Date of the most recent review of this product information: November 2024

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