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 undesirable effects, including any undesirable effects not listed in this leaflet, they should inform 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 undesirable 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 the lack of information on its efficacy and safety in this patient group. In adults, this medicine is used to treat ADHD, provided that 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 subside.

About ADHD

Children and adolescents with ADHD exhibit:

• 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 undesirable 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 outflow (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)

Atofab should not be taken 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 thoughts or behaviors of suicide
• 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 are not there), believing in untrue things, or being suspicious
• have a state of mania (excitement or excessive stimulation that leads to 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 difficulty controlling repetitive movements of any part of the body or repeating words or sounds

If any of the above conditions occur, the patient should consult a doctor or pharmacist before starting to take Atofab. 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 whether 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 talk to the patient if they are taking any other medicines, if there have been cases of sudden death from an unknown cause in the patient's family, or if the patient or their family members have had 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 whether 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 whether 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 its increase.

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 undesirable effects. The patient should consult their 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, such as imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine
• certain cough or cold medicines that contain substances that affect blood pressure. It is essential to check with the pharmacist when any of these medicines are used

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

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

In case of doubts about whether the medicines being taken are listed above, the patient 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 child or pass into breast milk.

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

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

Driving and operating machinery

After taking Atofab, the patient may experience drowsiness, sleepiness, or dizziness. The patient should be careful when driving a car or operating machinery until they know how Atofab affects them. If drowsiness, sleepiness, or dizziness occurs, the patient should not drive or operate machinery.

3. How to take Atofab

• This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their 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 drowsiness or malaise occurs 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 every day at the same time will help 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 total initial 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 total initial 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:

• Atofab treatment 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 activities

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 growth and body weight in children and adolescents
• measuring blood pressure and heart rate
• checking for any problems or whether undesirable 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 whether 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 their doctor or the nearest hospital and inform them about the number of capsules taken. The most common symptoms of overdose are: gastrointestinal symptoms, drowsiness, dizziness, nausea, and abnormal behavior.

Missing a dose of Atofab

If a dose is missed, it should be taken as soon as possible. However, a double dose should not be taken within 24 hours. A double dose should not be taken to make up for a missed dose.

Stopping Atofab treatment

After stopping Atofab, no undesirable effects usually occur, but ADHD symptoms may return. The patient should consult their doctor before stopping the medicine. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

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

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

• perceived or real rapid heartbeat, arrhythmia
• thoughts or behaviors of suicide
• feeling aggressive
• 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 rashes on the skin)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or being suspicious

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

• thoughts or behaviors of suicide (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 undesirable effects, such as:

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or being suspicious

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

• liver damage

The patient should stop taking Atofab and immediately consult their 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 under the ribs, which occurs when pressed (tenderness to pressure)
• unjustified nausea
• fatigue
• itching
• flu-like symptoms

Other reported undesirable effects are listed below. If symptoms worsen, the patient should consult their 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 undesirable effects

If undesirable effects occur, including any undesirable effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Undesirable 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. Undesirable effects can also be reported to the marketing authorization holder. By reporting undesirable 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 not visible and inaccessible to children. Do not use this medicine after the expiry date stated on the packaging and blister pack 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:cornstarch, 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:cornstarch, 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:cornstarch, 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:cornstarch, 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 a non-transparent white cap with a black print "10" and a non-transparent 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 a non-transparent yellow cap with a black print "18" and a non-transparent 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 a non-transparent blue cap with a black print "25" and a non-transparent 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 a non-transparent blue cap with a black print "40" and a non-transparent 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. Pack sizes: 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

To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland, Tel: 022/ 636 52 23; 636 53 02, biuro@gl-pharma.pl

Date of last revision of the leaflet: 16.11.2021