Atofab

Leaflet included in the packaging: patient information

Atofab, 10 mg, hard capsules
Atofab, 18 mg, hard capsules
Atofab, 25 mg, hard capsules
Atofab, 40 mg, hard capsules
Atomoxetine
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Atofab and what is it used for
• 2. Important information before taking Atofab
• 3. How to take Atofab
• 4. Possible side effects
• 5. How to store Atofab
• 6. Contents of the packaging and other information

1. What is Atofab and what is it used for

Atofab contains atomoxetine and is used to treat attention deficit hyperactivity disorder (ADHD). The medicine is used:

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

The medicine is used only as part of a comprehensive treatment program that also includes non-pharmacological methods, such as counseling and behavioral therapy. The medicine is not intended for use in children under 6 years old due to lack of information on its effects and safety in this patient group. In adults, this medicine is used to treat ADHD if the symptoms are very troublesome and disrupt work or social life, and the symptoms of the disease occurred in the patient during childhood.

How the medicine works

The medicine increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical substance naturally produced by the body, which increases concentration and reduces impulsiveness and excessive restlessness in patients with ADHD. The medicine is prescribed to help control ADHD symptoms. This medicine does not have a stimulating effect and therefore does not cause addiction. It may take a few weeks from the start of treatment for the symptoms to disappear.

About ADHD

Children and adolescents with ADHD have:

• difficulty sitting still in one place
• difficulty concentrating. It's not their fault that they can't cope with it. Many children and young people struggle with such problems. However, in people with ADHD, this can disrupt daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have difficulty behaving properly at home, at school, and in other places. ADHD does not affect a child's or young person's intelligence.

Adults with ADHD have difficulty with all the things that children with ADHD struggle with, but for adults, this can mean problems:

• at work
• in human relationships
• related to low self-esteem
• with learning

2. Important information before taking Atofab

When not to take Atofab:

• if the patient is allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6)
• if the patient has taken a monoamine oxidase inhibitor (MAOI) in the last 2 weeks, e.g. phenelzine. MAOIs are sometimes used to treat depression and other mental illnesses. Taking Atofab at the same time as an MAOI can cause serious side effects or be life-threatening. You should also wait at least 14 days after stopping this medicine before starting to take an MAOI
• if the patient has an eye disease - glaucoma with a narrow angle of the anterior chamber (increased pressure in the eye)
• if the patient has severe heart problems that may worsen with increased heart rate and/or increased blood pressure, which may be caused by taking Atofab
• if the patient has severe vascular problems in the brain - such as stroke, swelling, and weakness of a blood vessel (aneurysm), narrowing or blockage of a blood vessel
• if the patient has a tumor of the adrenal gland (pheochromocytoma)

Do not take Atofab if any of the above conditions occur. If the patient is unsure, they should consult a doctor or pharmacist before starting to take this medicine, as the medicine may worsen these conditions.

Warnings and precautions

Both children and adult patients should be informed about the following warnings and precautions. Before starting to take Atofab, the patient should discuss this with their doctor or pharmacist if they:

• have suicidal thoughts or behaviors
• have heart problems (including heart defects) or a rapid heart rate. Atofab may increase heart rate. There have been reports of sudden death in patients with heart defects
• have high blood pressure. Atofab may increase blood pressure
• have low blood pressure. Atofab may cause dizziness or fainting in people with low blood pressure
• have sudden changes in blood pressure or heart rate
• have cardiovascular or cerebrovascular problems or have had a stroke
• have liver problems. The dose of Atofab may need to be reduced
• have psychotic reactions, including hallucinations (hearing voices or seeing things that don't exist), delusions, or suspiciousness
• have a manic state (excitement or excessive stimulation that causes unusual behavior) and agitation
• feel aggressive
• have a hostile or evil attitude
• have a history of seizures or convulsions from any other cause. Atofab may increase the frequency of seizures
• have an unusual mood or feeling of great sadness
• have uncontrollable, repetitive movements of any part of the body or repetition of words or sounds

If any of the above conditions occur, the patient should consult a doctor or pharmacist before taking the medicine. Atofab may worsen these conditions. The doctor will monitor how the medicine affects the patient.

Examinations that the doctor will perform before starting to take Atofab

These examinations are necessary to determine if Atofab is suitable for the patient. The doctor will:

• measure the patient's blood pressure and heart rate before starting to take Atofab and during treatment
• measure the growth and body weight of the patient during treatment if the patient is a child or adolescent

The doctor will also discuss with the patient:

• if they are taking any other medicines
• if there have been any cases of sudden death from an unknown cause in the patient's family
• if the patient or their family members have any other diseases (such as heart problems)

It is essential to provide the doctor with as much information as possible. This will help the doctor decide if Atofab is suitable for the patient. The doctor may also order other medical tests that are necessary before starting to take this medicine.

Important information about the contents of the capsules

Atofab capsules should not be opened, as their contents may irritate the eyes. If the contents of the capsule come into contact with the eye, it should be rinsed immediately with water and medical attention should be sought. Hands and other parts of the body that have come into contact with the contents of the capsules should be washed immediately.

Atofab and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This also applies to medicines that are available without a prescription. The doctor will decide if the patient can take Atofab at the same time as other medicines. In some cases, the doctor may decide to modify the dose or slow down the increase in dose.

Atofab should not be taken with monoamine oxidase inhibitors (MAOIs) used to treat depression. See section 2 "When not to take Atofab". If the patient is taking other medicines, Atofab may affect their action or cause side effects. The patient should consult a doctor or pharmacist before starting to take Atofab if they are taking any of the following medicines:

• medicines that increase blood pressure or are used to control blood pressure
• antidepressants, e.g. imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine
• certain cough and cold medicines that contain substances that affect blood pressure. It is essential to check with a pharmacist when any of these medicines are used
• certain medicines used to treat mental illnesses
• medicines that increase the risk of seizures
• certain medicines that may prolong the time Atofab stays in the body (such as quinidine or terbinafine)
• salbutamol (a medicine used to treat asthma) taken orally or by injection may cause a feeling of rapid heartbeat, but it will not worsen asthma symptoms

The following medicines may increase the risk of abnormal heart rhythm if taken at the same time as Atofab:

• medicines used to control heart function
• medicines that change the concentration of salts in the blood
• medicines used to prevent and treat malaria
• certain antibiotics (such as erythromycin and moxifloxacin)

If the patient is unsure whether the medicines they are taking are listed above, they should ask their doctor or pharmacist before starting to take Atofab.

Pregnancy and breastfeeding

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

• Atofab should not be taken during pregnancy unless a doctor recommends it.
• Atofab should be avoided during breastfeeding or breastfeeding should be stopped.

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

After taking Atofab, the patient may feel tired, sleepy, or dizzy. The patient should be careful when driving a car or operating machines until they know how Atofab affects them. If the patient feels tired, sleepy, or dizzy, they should not drive or operate machinery.

3. How to take Atofab

• This medicine should always be taken as directed by a doctor or pharmacist. If the patient is unsure, they should consult a doctor or pharmacist. The medicine is usually taken once or twice a day (in the morning and late afternoon or early evening).
• Children should not take the medicine without adult supervision.
• If the patient experiences sleepiness or feels unwell when taking Atofab once a day, the doctor may recommend taking the medicine twice a day.
• The capsules should be taken orally.
• The capsules should be swallowed whole, with or without food.
• The capsules should not be opened, their contents should not be poured out, or taken in any other way.
• Taking the medicine at the same time every day will help the patient remember to take it.

What dose to take

Children and adolescents (6 years and older):

The doctor will recommend the appropriate dose of Atofab, calculated according to the patient's body weight. The doctor will start treatment with a lower dose of Atofab before increasing it to the appropriate dose for the patient's body weight.

• Body weight up to 70 kg: the initial total daily dose is approximately 0.5 mg per kilogram of body weight for at least 7 days. Then, the doctor may recommend increasing the dose to the usual maintenance dose of approximately 1.2 mg per kilogram of body weight per day.
• Body weight over 70 kg: the initial total daily dose is 40 mg for at least 7 days. Then, the doctor may recommend increasing the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose that the doctor can prescribe is 100 mg.

Adults:

• Treatment with Atofab should be started with a total daily dose of 40 mg for at least 7 days. Then, the doctor may recommend increasing the dose to the usual maintenance dose of 80-100 mg per day. The maximum daily dose that the doctor can prescribe is 100 mg.

If the patient has liver disease, the doctor may prescribe a lower dose of Atofab.

During treatment, the doctor will perform the following actions

The doctor will perform examinations

• before starting treatment - to ensure that taking Atofab will be safe and beneficial for the patient
• after starting treatment - examinations will be performed at least every 6 months, although probably more often

Examinations will also be performed when the dose is changed. They will include:

• measuring the growth and body weight of children and adolescents
• measuring blood pressure and heart rate
• checking for any problems or if side effects have worsened while taking Atofab

Long-term treatment

Atofab does not need to be taken for the rest of your life. After a year of treatment with Atofab, the doctor will assess the treatment results to determine if the medicine should be continued.

Taking a higher dose of Atofab than recommended

In case of taking a higher dose of Atofab than recommended, the patient should immediately contact a doctor or the nearest hospital and inform them about the number of capsules taken. The most common symptoms of overdose are: gastrointestinal symptoms, sleepiness, dizziness, and abnormal behavior.

Missing a dose of Atofab

If a dose is missed, the patient should take it as soon as possible. However, they should not take a double dose within 24 hours. They should not take a higher dose than the recommended total daily dose to make up for the missed dose.

Stopping treatment with Atofab

After stopping Atofab, there are usually no side effects, but ADHD symptoms may return. The patient should consult a doctor before stopping the medicine. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Atofab can cause side effects, although not everybody gets them. Although some people experience side effects, most patients think that Atofab helps them. The doctor will inform the patient about side effects. Some side effects can be serious. If the patient experiences any of the following side effects, they should immediately consult a doctor.

Uncommon(may occur in less than 1 in 100 people):

• perceived or real rapid heartbeat, arrhythmia
• suicidal thoughts or behaviors
• aggressive feelings
• hostile or evil attitude
• mood swings or mood changes
• severe allergic reactions, the symptoms of which are:
• swelling of the face and throat
• difficulty breathing
• hives (small, itchy blisters on the skin)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that don't exist), delusions, or suspiciousness

In children and adolescents under 18 years of age, there is an increased risk of side effects, such as:

• suicidal thoughts or behaviors (may occur in less than 1 in 100 people)
• mood swings or mood changes (may occur in less than 1 in 10 people)

In adults, the risk is lower(may occur in less than 1 in 1,000 people) of side effects, such as:

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that don't exist), delusions, or suspiciousness

Rare(may occur in less than 1 in 1,000 people):

• liver damage

The patient should stop taking Atofab and immediately consult a doctor if they experience any of the following symptoms:

• dark-colored urine
• yellowing of the skin or eyes
• pain in the upper right part of the abdomen, which occurs when pressed (tenderness to pressure)
• unexplained nausea
• fatigue
• itching
• flu-like symptoms

Other reported side effects are listed below. If the symptoms worsen, the patient should consult a doctor or pharmacist.

Effect on growth

In some children, after starting to take Atofab, growth (body weight and height) may be slowed down. However, during long-term treatment, children achieve normal body weight and height for their age group. The doctor will monitor the child's growth and body weight. If the child is not growing or gaining weight as expected, the doctor may decide to change the dose or temporarily stop taking Atofab.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Atofab

The medicine should be stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atofab contains

The active substance is atomoxetine. Atofab, 10 mg, hard capsules: Each hard capsule contains 10 mg of atomoxetine in the form of 11.43 mg of atomoxetine hydrochloride.

• Other ingredients are: Contents of the capsule:corn starch, colloidal anhydrous silica, dimethicone
• (350) Capsule shell:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), purified water

Atofab, 18 mg, hard capsules: Each hard capsule contains 18 mg of atomoxetine in the form of 20.57 mg of atomoxetine hydrochloride.

• Other ingredients are: Contents of the capsule:corn starch, colloidal anhydrous silica, dimethicone
• (350) Capsule shell - body:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), purified water Capsule shell - cap:gelatin, sodium lauryl sulfate, iron oxide yellow (E 172), purified water

Atofab, 25 mg, hard capsules: Each hard capsule contains 25 mg of atomoxetine in the form of 28.57 mg of atomoxetine hydrochloride.

• Other ingredients are: Contents of the capsule:corn starch, colloidal anhydrous silica, dimethicone
• (350) Capsule shell - body:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), purified water Capsule shell - cap:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), indigo carmine (E 132), purified water

Atofab, 40 mg, hard capsules: Each hard capsule contains 40 mg of atomoxetine in the form of 45.71 mg of atomoxetine hydrochloride.

• Other ingredients are: Contents of the capsule:corn starch, colloidal anhydrous silica, dimethicone
• (350) Capsule shell:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), indigo carmine (E 132), purified water

Printing ink (black): shellac, iron oxide black (E 172), propylene glycol

What Atofab looks like and contents of the pack

Atofab, 10 mg, hard capsules: White powder in a hard gelatin capsule, size 3 (length 15.7±0.4 mm), with an opaque white cap with a black print "10" and an opaque white body with a black print "mg".

Atofab, 18 mg, hard capsules: White powder in a hard gelatin capsule, size 3 (length 15.7±0.4 mm), with an opaque yellow cap with a black print "18" and an opaque white body with a black print "mg".

Atofab, 25 mg, hard capsules: White powder in a hard gelatin capsule, size 3 (length 15.7±0.4 mm), with an opaque blue cap with a black print "25" and an opaque white body with a black print "mg".

Atofab, 40 mg, hard capsules: White powder in a hard gelatin capsule, size 3 (length 15.7±0.4 mm), with an opaque blue cap with a black print "40" and an opaque blue body with a black print "mg".

Atofab is packaged in PVC/PE/PCTFE/Aluminum or PA/Aluminum/PVC/Aluminum blisters in a cardboard box. The pack sizes are 7, 10, 14, 28, 30, and 56 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Manufacturer

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria, Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1, 8502 Lannach, Austria, Pharmathen International S.A, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece, Pharmathen S.A., Dervenakion 6, Pallini 15351, Attiki, Greece