Atofab

Package leaflet: Information for the patient

Atofab, 10 mg, hard capsules
Atofab, 18 mg, hard capsules
Atofab, 25 mg, hard capsules
Atofab, 40 mg, hard capsules
Atomoxetine
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Atofab is and what it is 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 package and other information

1. What Atofab is and what it is used for

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

• in children over 6 years of age
• in adolescents
• in adults

Atofab is used only as part of a comprehensive treatment programme, which should also include non-pharmacological approaches such as counselling and behavioural therapy.
This medicine is not intended for use in children under 6 years of age due to lack of information on efficacy and safety in this patient group.
In adults, this medicine is used to treat ADHD when symptoms are particularly severe and interfere with work or social functioning, and when symptoms of the disorder were already present during childhood.

How this medicine works
This medicine increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical substance naturally produced by the body, which enhances concentration and reduces impulsiveness and excessive motor activity in patients with ADHD. This medicine is prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and therefore does not cause dependence.
It may take several weeks after starting treatment before symptoms improve.

About ADHD
Children and adolescents with ADHD show:

• difficulty remaining still and seated in one place,
• difficulty concentrating. It is not their fault that they struggle with this. Many children and young people have such problems. However, in individuals with ADHD, these difficulties may interfere with daily life. Children and young people with ADHD may have difficulties with learning and completing homework. They may find it hard to behave appropriately at home, at school, and in other settings. ADHD does not affect a child's or young person's intelligence.

Adults with ADHD have difficulties with all the issues that affect children with ADHD, but in adults these may lead to problems:

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

2. Important information before using 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) medicine within the last 2 weeks, such as phenelzine. MAOIs are sometimes used in the treatment of depression and other psychiatric disorders. Taking Atofab together with an MAOI may cause severe adverse reactions or pose a life-threatening risk. Also, at least 14 days should be waited after stopping this medicine before starting an MAOI;
• if the patient has a disease of the eye called narrow-angle glaucoma (increased pressure in the eye);
• if the patient has severe heart disorders which may worsen due to an increased heart rate and/or increased blood pressure, which may be caused by taking Atofab;
• if the patient has severe cerebrovascular diseases such as stroke, cerebral edema, weakening of a blood vessel wall (aneurysm), narrowing or blockage of a blood vessel;
• if the patient has a tumour of the adrenal gland (pheochromocytoma).

Atofab must not be taken if any of the above conditions apply. If the patient is unsure, they should speak to a doctor or pharmacist before starting treatment with this medicine, as the medicine may worsen these conditions.

Warnings and precautions

Both children and adult patients should be informed of the following warnings and precautions. Before starting treatment with Atofab, discuss with a doctor or pharmacist if the patient has:

• suicidal thoughts or behaviours;
• heart diseases (including heart defects) or a fast heart rate. Atofab may increase heart rate (pulse). Cases of sudden death have been reported in patients with heart defects;
• high blood pressure. Atofab may increase blood pressure;
• low blood pressure. Atofab may cause dizziness or fainting in people who have low blood pressure;
• sudden changes in blood pressure or heart rhythm;
• cardiovascular disorders or a history of stroke;
• liver disease. A dose reduction may be necessary;
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not real), false beliefs, or suspiciousness;
• a manic state (excitement or excessive activation leading to abnormal behaviour) or agitation;
• feelings of aggression;
• hostile or negative (adverse) attitude;
• a history of epilepsy or seizures from any cause. Atofab may increase the frequency of seizures;
• mood different from usual (mood swings) or feelings of deep sadness;
• uncontrollable, repetitive movements of any part of the body or repetition of sounds or words.

If any of the above conditions apply, discuss them with a doctor or pharmacist before starting treatment with Atofab. Atofab may worsen these conditions. The doctor will monitor how the medicine affects the patient.

Examinations the doctor will perform before starting Atofab treatment

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

• the patient’s blood pressure and heart rate (pulse) before starting Atofab and during treatment;
• the patient’s height and body weight during treatment with Atofab, if the patient is a child or adolescent.

The doctor will discuss with the patient:

• any other medicines currently or recently taken;
• any family history of unexplained sudden death;
• any other diseases (such as heart disorders) in the patient or their family members.

It is important to provide the doctor with as much information as possible. This will help the doctor decide whether Atofab is appropriate for the patient. The doctor may also order additional medical tests required before starting treatment with this medicine.

Important information about capsule contents

Atofab capsules must not be opened, as their contents may irritate the eyes. If the capsule contents come into contact with the eye, rinse immediately with water and contact a doctor. Hands and any other body parts that have come into contact with the capsule contents should be washed immediately.

Atofab and other medicines

Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. The doctor will decide whether the patient can take Atofab together with other medicines. In some cases, the doctor may decide to modify the dose or increase it more slowly.

Atofab must not be used together with monoamine oxidase inhibitor (MAOI) medicines used in depression. See section 2 “When not to take Atofab”.

If the patient is taking other medicines, Atofab may affect their action or may cause adverse effects.

Talk to a doctor or pharmacist before starting Atofab if 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 or cold medicines containing substances affecting blood pressure. It is important to check with a pharmacist which of these medicines have been taken;
• certain medicines used in the treatment of psychiatric disorders;
• medicines that increase the risk of seizures;
• certain medicines that may prolong the presence of Atofab in the body (such as quinidine or terbinafine);
• oral or injectable salbutamol (a medicine used in the treatment of asthma) may cause a sensation of rapid heartbeat, but will not worsen asthma symptoms.

The following medicines may increase the risk of abnormal heart rhythm if taken together with Atofab:

• medicines used to control heart function;
• medicines that alter blood electrolyte concentrations;
• medicines used to prevent or treat malaria;
• certain antibiotics (such as erythromycin and moxifloxacin).

If in doubt whether the medicines being taken are included in the above list, ask a doctor or pharmacist before starting Atofab.

Pregnancy and breastfeeding

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

• This medicine should not be used during pregnancy unless advised by a doctor.
• This medicine should be avoided during breastfeeding or breastfeeding should be discontinued.

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

After taking Atofab, the patient may experience fatigue, drowsiness, or dizziness. The patient should exercise caution when driving a car or operating machinery until they know how Atofab affects them. If fatigue, drowsiness, or dizziness occurs, the patient should not drive or operate mechanical devices.

3. How to take Atofab

• This medicine should always be taken as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Usually, the medicine is taken once or twice daily (in the morning and late afternoon or early evening).
• Children should not take this medicine without adult supervision.
• If drowsiness or malaise occurs during once-daily treatment with Atofab, your doctor may recommend taking the medicine twice daily.
• Capsules should be taken orally.
• Swallow the capsules whole, with or without food.
• Do not open the capsules, sprinkle out the contents, or take them in any other way.
• Taking the medicine every day at the same time will help you remember to take it.

What dose should be used
Children and adolescents (6 years and older):
Your doctor will determine the appropriate dose of Atofab based on the patient's body weight.
Treatment will be started with a lower dose of Atofab before increasing it to the amount appropriate for the patient's body weight.

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

Adults:

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

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

During treatment, your doctor will perform the following procedures
Your doctor will carry out examinations

• Before starting treatment – to ensure that taking Atofab is safe and beneficial for the patient;
• After starting treatment – examinations will be performed at least every 6 months, although more frequent monitoring is likely.

Examinations will also be performed if the dose is changed. These will include:

• Measurement of height and body weight in children and adolescents
• Measurement of blood pressure and pulse
• Checking for any problems or worsening of adverse effects during treatment with Atofab.

Long-term treatment
Atofab does not need to be taken for life. After one year of treatment with Atofab, your doctor will assess the treatment outcomes to determine whether continued use of the medicine is necessary.

Taking more than the recommended dose of Atofab
If you take more than the recommended dose, contact your doctor or nearest hospital immediately and inform them of the number of capsules taken. The most commonly reported symptoms following overdose are gastrointestinal symptoms, drowsiness, dizziness, tremor, and unusual behavior.

Missing a dose of Atofab
If you miss a dose, take it as soon as possible. However, do not take a dose larger than the total recommended daily dose within 24 hours. Do not take a double dose to make up for a missed dose.

Stopping Atofab
After discontinuing Atofab, adverse effects usually do not occur, but ADHD symptoms may return. Talk to your doctor before stopping the medicine.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Although some people experience side effects, most patients find that Atofab
has helped them. Your doctor will inform you about possible side effects.
Some side effects may be serious. If you experience any of the following side effects,
seek medical advice immediately.

Not common (may occur in less than 1 in 100 people):

• palpitations or actual increased heart rate, heart rhythm disorders
• suicidal thoughts or behaviour
• feeling of aggression
• hostile attitude or anger (hostility)
• mood swings or changes in mood
• severe allergic reactions, including:
  • swelling of the face and throat
  • difficulty breathing
  • urticaria (small itchy skin rashes)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), belief in false ideas, or suspiciousness

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

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

In adults, there is a reduced risk (may occur in less than 1 in 1,000 people)
of the following side effects:

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), belief in false ideas, or suspiciousness

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

• liver damage

You must stop taking Atofab and contact your doctor immediately if you experience any of the following symptoms:

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

Other reported side effects are listed below. If symptoms worsen, you should
contact your doctor or pharmacist.

Effect on growth
In some children, growth (body weight and height) may slow down after starting treatment with Atofab. However, during long-term treatment, children achieve normal body weight and height appropriate for their age group. The doctor will monitor the child's growth and body weight. If the child does not grow or gain weight as expected, the doctor may decide to adjust the dose or temporarily discontinue treatment with Atofab.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further collection of information on the safety of the medicinal product.

5. How to store Atofab

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister pack following:
EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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 atomoxetine hydrochloride.

• Other ingredients are:
  Contents of the capsule: pregelatinized 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 atomoxetine hydrochloride.

• Other ingredients are:
  Contents of the capsule: pregelatinized 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 atomoxetine hydrochloride.

• Other ingredients are:
  Contents of the capsule: pregelatinized 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 atomoxetine hydrochloride.

• Other ingredients are:
  Contents of the capsule: pregelatinized 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 packaging
Atofab 10 mg, hard capsules
White powder in a hard gelatin capsule of size 3 (length 15.7±0.4 mm), with an opaque white cap printed in black with the mark '10' and an opaque white body printed in black with the mark 'mg'.

Atofab 18 mg, hard capsules
White powder in a hard gelatin capsule of size 3 (length 15.7±0.4 mm), with an opaque yellow cap printed in black with the mark '18' and an opaque white body printed in black with the mark 'mg'.

Atofab 25 mg, hard capsules
White powder in a hard gelatin capsule of size 3 (length 15.7±0.4 mm), with an opaque blue cap printed in black with the mark '25' and an opaque white body printed in black with the mark 'mg'.

Atofab 40 mg, hard capsules
White powder in a hard gelatin capsule of size 3 (length 15.7±0.4 mm), with an opaque blue cap printed in black with the mark '40' and an opaque blue body printed in black with the mark 'mg'.

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

Marketing Authorisation 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

For further information, please contact the marketing authorisation holder's representative:
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
[email protected]