Atomoxetine Neuropharma

PATIENT INFORMATION LEAFLET

Information leaflet accompanying the packaging: information for the user

Atomoxetine NeuroPharma, 10 mg, hard capsules

Atomoxetine NeuroPharma, 18 mg, hard capsules

Atomoxetine NeuroPharma, 25 mg, hard capsules

Atomoxetine NeuroPharma, 40 mg, hard capsules

Atomoxetine NeuroPharma, 60 mg, hard capsules

Atomoxetine NeuroPharma, 80 mg, hard capsules

Atomoxetine NeuroPharma, 100 mg, hard capsules

Atomoxetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Atomoxetine NeuroPharma and what is it used for

What is Atomoxetine NeuroPharma used for

Atomoxetine NeuroPharma contains the active substance atomoxetine and is used to treat attention deficit hyperactivity disorder (ADHD). The medicine is used

• in children over 6 years of age
• 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. In adults, Atomoxetine NeuroPharma is used to treat ADHD if the symptoms are very troublesome and disrupt work or social life, and the symptoms of the disease were present in the patient's childhood.

How Atomoxetine NeuroPharma works

The medicine increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical substance naturally produced by the body. It increases concentration and reduces impulsiveness and excessive restlessness in patients with ADHD. The medicine is prescribed to help control ADHD symptoms.

About ADHD

Children and adolescents with ADHD exhibit:

• difficulty sitting still in one place and
• difficulty concentrating. It is not their fault that they cannot 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 problems learning and doing homework. They 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 everything that children with ADHD have difficulty with, but for adults, this can mean problems:

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

2. Important information before taking Atomoxetine NeuroPharma

When not to take Atomoxetine NeuroPharma

Do not take Atomoxetine NeuroPharma 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 adults and children should be aware of the following warnings and precautions. Before starting to take Atomoxetine NeuroPharma, the patient should discuss with their doctor or pharmacist if they have:

• suicidal thoughts or behaviors;
• heart problems (including heart defects) or rapid heart rate. Atomoxetine NeuroPharma may increase heart rate (pulse). In patients with heart defects, there have been reports of sudden death;
• high blood pressure. Atomoxetine NeuroPharma may increase blood pressure;

low blood pressure. Atomoxetine NeuroPharma may cause dizziness or fainting in people with low blood pressure;

• sudden changes in blood pressure or heart rate;
• cardiovascular problems or a history of stroke;
• liver problems. The dose of the medicine may need to be reduced;
• psychotic reactions, including hallucinations (hearing voices or seeing things that do not exist), believing in untrue things, or being suspicious;
• manic mood state (excitement or excessive stimulation that causes unusual behavior) and stimulation;
• feeling aggressive;
• hostile or evil (hostile) attitude;
• a history of epilepsy or seizures for any reason. Atomoxetine NeuroPharma may increase the frequency of seizures;
• unusual mood or mood swings;
• difficulty controlling repetitive movements of any part of the body or repeating sounds or words.

If any of the above conditions occur, the patient should consult a doctor or pharmacist before starting to take Atomoxetine NeuroPharma. The medicine may worsen these conditions. The doctor will monitor how the medicine affects the patient.

Examinations that the doctor will perform before the patient starts taking Atomoxetine NeuroPharma

NeuroPharma

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

• the patient's blood pressure and heart rate (pulse) before starting to take Atomoxetine NeuroPharma and during treatment
• the growth and body weight of the patient during treatment with Atomoxetine NeuroPharma, if the patient is a child or adolescent.

The patient should consult a doctor if they are:

• taking any other medicines
• have a family history of sudden unexplained death
• have any other diseases (such as heart problems) or a family history of such diseases.

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

Doctor's recommendations during treatment

The doctor will perform examinations

• before starting treatment - to ensure that taking Atomoxetine NeuroPharma will be safe and beneficial for the patient.
• during 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 pulse
• checking for any problems or whether side effects have worsened while taking Atomoxetine NeuroPharma.

Important information about the contents of the capsules

Do not open the capsules of Atomoxetine NeuroPharma, as the contents of the capsule may irritate the eyes. If the contents of the capsule get into the eye, it should be rinsed immediately with water and medical advice should be sought. The hands and other parts of the body that have come into contact with the contents of the capsules should also be washed immediately.

Atomoxetine NeuroPharma 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 includes medicines that are available without a prescription. The doctor will decide whether Atomoxetine NeuroPharma can be taken at the same time as other medicines. In some cases, the doctor may decide to modify the dose or increase it more slowly. Do not take Atomoxetine NeuroPharma with monoamine oxidase inhibitors (MAOIs) used to treat depression. See section 2 "When not to take Atomoxetine NeuroPharma". If the patient is taking other medicines, Atomoxetine NeuroPharma may affect their action or cause side effects. If the patient is taking any of the following medicines, they should consult their doctor or pharmacist before starting to take Atomoxetine NeuroPharma:

• medicines that increase blood pressure or are used to control blood pressure
• antidepressants, such as imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine
• certain cough and cold medicines that contain substances that affect blood pressure. It is essential to check this with a pharmacist when purchasing any of these medicines
• certain medicines used to treat mental illnesses
• medicines that increase the risk of seizures
• certain medicines that may prolong the period during which Atomoxetine NeuroPharma 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 will not worsen asthma symptoms.

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

• 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)

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 Atomoxetine NeuroPharma

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. It is not known whether this medicine can affect the unborn child or pass into breast milk.

• Do not take this medicine during pregnancy, unless the doctor recommends it.
• Avoid taking this medicine during breastfeeding or stop breastfeeding.

Driving and using machines

After taking Atomoxetine NeuroPharma, the patient may experience fatigue, drowsiness, or dizziness. The patient should be careful when driving a car or operating machines until they know how they react to Atomoxetine NeuroPharma. If the patient experiences fatigue, drowsiness, or dizziness, they should not drive or operate machines.

3. How to take Atomoxetine NeuroPharma

Take this medicine always exactly as the doctor or pharmacist has told you. If the patient is unsure, they should consult their doctor or pharmacist.

What dose to take

Adults

• The treatment with Atomoxetine NeuroPharma 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.

In case of liver disease, the doctor may prescribe a lower dose of the medicine.

• The capsules are usually taken once or twice a day (in the morning and late afternoon or early evening). Taking the medicine at the same time every day can help remember to take it.
• If the patient experiences drowsiness or nausea after taking Atomoxetine NeuroPharma once a day, the doctor may change the treatment schedule to twice a day.

Children and adolescents (over 6 years of age)

The doctor will recommend the appropriate dose of Atomoxetine NeuroPharma, which will be calculated based on the patient's body weight. The doctor will start treatment with a lower dose before increasing it to the dose suitable 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.

Children under 6 years of age:

Atomoxetine NeuroPharma should not be used in children under 6 years of age to treat attention deficit hyperactivity disorder (ADHD), as its action and safety in this age group have not been established. The way to take the medicine

• Oral administration.
• The capsules should be swallowed whole, with or without food.
• The capsules should not be opened or removed or taken in any other way.
• Children should not take this medicine without adult supervision.

Duration of treatment

It may take several weeks from the start of treatment for all symptoms to disappear. Atomoxetine NeuroPharma does not need to be taken for the rest of your life. After one year of treatment with Atomoxetine NeuroPharma, the doctor will assess the treatment results to determine whether the medicine should be continued.

Taking a higher dose of Atomoxetine NeuroPharma than recommended

The patient should immediately contact their doctor or the nearest hospital and inform them about the number of capsules taken. The most commonly reported symptoms after overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and abnormal behavior.

Missing a dose of Atomoxetine NeuroPharma

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

Stopping treatment with Atomoxetine NeuroPharma

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

4. Possible side effects

Like all medicines, Atomoxetine NeuroPharma can cause side effects, although not everybody gets them. The doctor will inform the patient about possible side effects. Some side effects may be serious. If the patient experiences any of the following side effects, they should contact their doctor immediately.Uncommon(may affect up to 1 in 100 people)

• perceived or actual rapid heartbeat, arrhythmia
• suicidal thoughts or behaviors
• feeling aggressive
• hostile or evil (hostile) 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 do not exist), believing in untrue things, or being suspicious.

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

suicidal thoughts or behaviors (uncommon - may affect up to 1 in 100 people)

• mood swings or mood changes (common - may affect up to 1 in 10 people)

In adults, there is a decreased risk of side effects (rare - may affect up to 1 in 1,000 people) such as:

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

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

• -liver damage.

The patient should stop taking Atomoxetine NeuroPharma and contact their doctor immediately 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 worsens with pressure (tenderness to pressure)
• unexplained nausea
• fatigue
• itching
• flu-like symptoms.

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

Effect on growth

In some children, after starting to take Atomoxetine NeuroPharma, 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 Atomoxetine NeuroPharma.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Atomoxetine NeuroPharma

Store the medicine out of sight and reach of children. Do not take 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 storage instructions for the 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 Atomoxetine NeuroPharma contains

• The active substance of the medicine is atomoxetine.
• Atomoxetine NeuroPharma, 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: Capsule contents: Cornstarch, silicon dioxide, and dimethicone (350). Capsule (shell): Gelatin, sodium lauryl sulfate, and titanium dioxide (E 171)
• Atomoxetine NeuroPharma, 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: Capsule contents: Cornstarch, silicon dioxide, and dimethicone (350). Capsule (shell): Gelatin, sodium lauryl sulfate, titanium dioxide (E 171), and yellow iron oxide (E 172)
• Atomoxetine NeuroPharma, 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: Capsule contents: Cornstarch, silicon dioxide, and dimethicone (350). Capsule (shell): Gelatin, sodium lauryl sulfate, titanium dioxide (E 171), and indigo carmine (E 132)
• Atomoxetine NeuroPharma, 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: Capsule contents: Cornstarch, silicon dioxide, and dimethicone (350). Capsule (shell): Gelatin, sodium lauryl sulfate, titanium dioxide (E 171), and indigo carmine (E 132)
• Atomoxetine NeuroPharma, 60 mg, hard capsules Each hard capsule contains 60 mg of atomoxetine in the form of 68.57 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: Cornstarch, silicon dioxide, and dimethicone (350). Capsule (shell): Gelatin, sodium lauryl sulfate, titanium dioxide (E 171), indigo carmine (E 132), and yellow iron oxide (E 172)
• Atomoxetine NeuroPharma, 80 mg, hard capsules Each hard capsule contains 80 mg of atomoxetine in the form of 91.42 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: Cornstarch, silicon dioxide, and dimethicone (350). Capsule (shell): Gelatin, sodium lauryl sulfate, titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172)
• Atomoxetine NeuroPharma, 100 mg, hard capsules Each hard capsule contains 100 mg of atomoxetine in the form of 114.28 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: Cornstarch, silicon dioxide, and dimethicone (350). Capsule (shell): Gelatin, sodium lauryl sulfate, titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172)
• Printing ink (black) consisting of: Shellac - 45% (20% esterified) in ethanol, black iron oxide (E 172), propylene glycol

What Atomoxetine NeuroPharma looks like and what the pack contains

Atomoxetine NeuroPharma, 10 mg, hard capsules
hard gelatin capsule, size 3 (length 15.7±0.4 mm), white opaque cap with black printing "10" and white opaque body with black printing "mg", containing white powder.
Atomoxetine NeuroPharma, 18 mg, hard capsules
hard gelatin capsule, size 3 (length 15.7±0.4 mm), intense yellow opaque cap with black printing "18" and white opaque body with black printing "mg", containing white powder.
Atomoxetine NeuroPharma, 25 mg, hard capsules
hard gelatin capsule, size 3 (length 15.7±0.4 mm), blue opaque cap with black printing "25" and white opaque body with black printing "mg", containing white powder.
Atomoxetine NeuroPharma, 40 mg, hard capsules
hard gelatin capsule, size 3 (length 15.7±0.4 mm), blue opaque cap with black printing "40" and blue opaque body with black printing "mg", containing white powder.
Atomoxetine NeuroPharma, 60 mg, hard capsules
hard gelatin capsule, size 2 (length 17.6±0.4 mm), blue opaque cap with black printing "60" and intense yellow opaque body with black printing "mg", containing white powder.
Atomoxetine NeuroPharma, 80 mg, hard capsules
hard gelatin capsule, size 2 (length 17.6±0.4 mm), brown opaque cap with black printing "80" and white opaque body with black printing "mg", containing white powder.
Atomoxetine NeuroPharma, 100 mg, hard capsules
hard gelatin capsule, size 1 (length 19.1±0.4 mm), brown opaque cap with black printing "100" and brown opaque body with black printing "mg", containing white powder.
Atomoxetine NeuroPharma is available in blisters in a cardboard box.
Pack sizes:
Atomoxetine NeuroPharma 10 mg, 18 mg, 100 mg: 7, 14, 28, and 56 hard capsules.
Atomoxetine NeuroPharma 25 mg, 40 mg, 60 mg, 80 mg: 7, 14, 28, 56, and 98 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

Manufacturers

Pharmathen SA, Dervenakion 6, 15351 Pallini Attiki, Greece
Pharmathen International SA, Industrial Park Sapes, Rodopi Prefecture, Block no. 5, 69300 Rodopi,
Greece
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764 Langenfeld, Germany

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

Germany:
Atomoxetin-neuraxpharm 10 mg Hartkapseln
Atomoxetin-neuraxpharm 18 mg Hartkapseln
Atomoxetin-neuraxpharm 25 mg Hartkapseln
Atomoxetin-neuraxpharm 40 mg Hartkapseln
Atomoxetin-neuraxpharm 60 mg Hartkapseln
Atomoxetin-neuraxpharm 80 mg Hartkapseln
Atomoxetin-neuraxpharm 100 mg Hartkapseln
Poland:
Atomoxetine NeuroPharma
United Kingdom: Atomoxetine neuraxpharm 10 mg hard capsules
Atomoxetine neuraxpharm 18 mg hard capsules
Atomoxetine neuraxpharm 25 mg hard capsules
Atomoxetine neuraxpharm 40 mg hard capsules
Atomoxetine neuraxpharm 60 mg hard capsules
Atomoxetine neuraxpharm 80 mg hard capsules
Atomoxetine neuraxpharm 100 mg hard capsules
Date of last revision of the leaflet:May 2020