Atomoksetina Medice

Leaflet accompanying the packaging: patient information

Atomoxetine Medice, 10 mg, coated tablets
Atomoxetine Medice, 18 mg, coated tablets
Atomoxetine Medice, 25 mg, coated tablets
Atomoxetine Medice, 40 mg, coated tablets
Atomoxetine

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

Always take the medicine exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

What the medicine is used for

Atomoxetine Medice 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 the treatment of ADHD in children under 6 years old, as it is not known whether it is effective and safe in these individuals.
In adults, Atomoxetine Medice is used to treat ADHD if the symptoms are very troublesome and disrupt work or social life, and also occurred in the patient during childhood.

How the medicine works

Atomoxetine Medice increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical naturally produced by the body. It increases concentration and reduces impulsivity 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 taking the medicine for the symptoms to subside.

About ADHD

Children and adolescents with ADHD exhibit:

• difficulty sitting still in one place and
• difficulty concentrating. It's not their fault that they can't cope with it. Many children and young people struggle with these 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 trouble behaving properly at home, at school, and in other places. ADHD does not affect a child's or adolescent's intelligence.

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

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

2. Important information before taking Atomoxetine Medice

When not to take Atomoxetine Medice:

• 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), such as phenelzine, in the last two weeks. MAOIs are sometimes used to treat depression and other mental illnesses. Taking Atomoxetine Medice 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 Atomoxetine Medice before starting an MAOI.
• if the patient has glaucoma (increased eye pressure).
• 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 Atomoxetine Medice).
• if the patient has severe cerebrovascular problems, 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 Atomoxetine Medice if any of the above conditions apply. If the patient is unsure, they should talk to their doctor or pharmacist before starting Atomoxetine Medice, 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 Atomoxetine Medice, discuss with your doctor or pharmacist if the patient has:

• suicidal thoughts or behaviors;
• heart disease (including heart defects) or rapid heart rate. Atomoxetine Medice may increase heart rate (pulse). In patients with heart defects, sudden death has been reported;
• high blood pressure. Atomoxetine Medice may increase blood pressure;
• low blood pressure. Atomoxetine Medice may cause dizziness or fainting in people with low blood pressure;
• sudden changes in blood pressure or heart rate;
• cardiovascular disease or a history of stroke;
• liver disease. The dose of Atomoxetine Medice may need to be reduced;
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or suspiciousness;
• manic mood (excitement or excessive stimulation that leads to unusual behavior) and stimulation;
• feeling aggressive;
• hostile or evil (hostile) attitude;
• a history of epilepsy or seizures for any reason. Atomoxetine Medice may increase the frequency of seizures,
• abnormal mood (mood swings) or feeling very sad;
• difficult to control, repetitive movements of any part of the body or repetition of sounds or words.

Serotonin syndrome
Serotonin syndrome is a life-threatening condition that can occur when taking Atomoxetine Medice with certain other medicines (see section 2 "Atomoxetine Medice and other medicines"). Objective and subjective symptoms of serotonin syndrome may include a combination of the following: disorientation, agitation, lack of coordination, and stiffness, hallucinations, coma, rapid heart rate, elevated body temperature, rapid changes in blood pressure, sweating, sudden flushing of the skin, tremors, exaggerated reflexes, nausea, vomiting, and diarrhea. If serotonin syndrome is suspected, seek medical attention immediately.
Treatment with Atomoxetine Medice may cause aggression, hostility, or violent behavior, or may worsen these symptoms if they occurred before treatment. It may also cause unusual changes in behavior or mood (including physical assault, threats, and thoughts of harming others). If the patient, their family, and/or friends notice any of these reactions, they should tell their doctor or pharmacist immediately.
If any of the above conditions occur, discuss them with your doctor or pharmacist before starting Atomoxetine Medice. Atomoxetine Medice 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 Medice

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

• the patient's blood pressure and heart rate (pulse) before starting Atomoxetine Medice and during treatment, as well as the patient's growth and weight if the patient is a child or adolescent.

Talk to your doctor if:

• you are taking any other medicines
• there is a history of sudden death from an unknown cause in the patient's family
• the patient has any other diseases (such as heart disease)

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

Atomoxetine Medice and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that do not require a prescription. The doctor will decide whether you can take Atomoxetine Medice with other medicines. In some cases, the doctor may decide to modify the dose or increase it more slowly.
Do not take Atomoxetine Medice with monoamine oxidase inhibitors (MAOIs) used in depression. See section 2 "When not to take Atomoxetine Medice".
If you are taking other medicines, Atomoxetine Medice may affect their action or other medicines may affect its action. These include:

• certain antidepressants, opioids such as tramadol, and migraine medicines called triptans. These medicines may interact with Atomoxetine Medice, which can lead to serotonin syndrome, a life-threatening condition. (See section 2 "Warnings and precautions", "Serotonin syndrome").

If you are unsure whether the medicines you are taking are listed above, ask your doctor or pharmacist before starting Atomoxetine Medice.

Pregnancy and breastfeeding

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 your doctor advises you to.
• Avoid taking this medicine during breastfeeding or stop breastfeeding.

If the patient:

• is pregnant or breastfeeding,
• suspects they may be pregnant or plans to have a child,
• plans to start breastfeeding,
• should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

After taking Atomoxetine Medice, drowsiness, sleepiness, or dizziness may occur. The patient should be cautious when driving a car or operating machinery until they know how Atomoxetine Medice affects them. If drowsiness, sleepiness, or dizziness occurs, do not drive or operate machinery.

Important information about the ingredients of the tablets

Do not divide the tablets, as atomoxetine may irritate the eyes. If atomoxetine comes into contact with the eyes, rinse them immediately with water and seek medical attention. Wash your hands and any other parts of the body that may have come into contact with atomoxetine as soon as possible.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is "sodium-free".

3. How to take Atomoxetine Medice

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your 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 this medicine without adult supervision.
• If sleepiness or malaise occurs when taking Atomoxetine Medice once a day, the doctor may recommend taking the medicine twice a day.
• Do not divide, crush, or chew the tablets and swallow them whole, with or without food.
• Taking the medicine at the same time every day will help you remember to take it.

What dose to take

Children and adolescents (6 years and older):

The doctor will recommend the appropriate dose of Atomoxetine Medice, calculated according to 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 total initial daily dose is approximately 0.5 mg/kg 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/kg 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:

• Start taking Atomoxetine Medice 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 Atomoxetine Medice.

Taking a higher dose of Atomoxetine Medice than recommended

Contact your doctor or the nearest hospital immediately and inform them of the number of tablets taken. The most commonly reported symptoms after an overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and unusual behavior. Very rarely, serotonin syndrome has also been reported, which is a life-threatening condition. (See section 2. Warnings and precautions, Serotonin syndrome).

Missing a dose of Atomoxetine Medice

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

Stopping Atomoxetine Medice

After stopping Atomoxetine Medice, no side effects usually occur, but ADHD symptoms may return. Talk to your doctor before stopping the medicine.

During treatment with Atomoxetine Medice, the doctor will perform the following:

The doctor will perform examinations

• before starting treatment - to ensure that taking Atomoxetine Medice 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 weight in children and young people
• measuring blood pressure and pulse
• checking for any problems or if side effects have worsened while taking Atomoxetine Medice.

Long-term treatment

Atomoxetine Medice does not need to be taken for the rest of your life. After a year of taking Atomoxetine Medice, the doctor will assess the treatment results to determine whether the medicine is still needed.
If you have any further doubts about taking this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atomoxetine Medice can cause side effects, although not everybody gets them.
Although some people experience side effects, most people taking Atomoxetine Medice are helped by the medicine. The doctor will inform the patient about possible side effects.
Some side effects can be serious. If you experience any of the following side effects, contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people)

• perceived or real rapid heartbeat, arrhythmia,
• suicidal thoughts or behaviors,
• feeling aggressive,
• hostile or evil (hostile) attitude,
• mood swings or mood changes,
• severe allergic reactions, whose symptoms are:
• swelling of the face or 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 suspiciousness.

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

• suicidal thoughts or behaviors (may occur in up to 1 in 100 patients).
• mood swings or mood changes (may occur in up to 1 in 10 patients)

In adults, there is a decreased risk of side effects (may occur in up to 1 in 1,000 patients) such as:

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

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

• liver damage.

Frequency not known:

• involuntary grinding of the teeth (bruxism).

Stop taking Atomoxetine Medice and contact your doctor immediately if you 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 side effects are listed below. If symptoms worsen, contact your doctor or pharmacist.

Effect on growth

In some children, after starting Atomoxetine Medice, growth (body weight and height) may be slowed down. However, during long-term treatment, children achieve normal weight and height for their age group.
The doctor will monitor the child's growth and 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 Medice.

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Atomoxetine Medice

Keep the medicine out of sight and reach of children.
Do not take this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Medice 10 mg, 18 mg, 25 mg, 40 mg coated tablets contain

The active substance of the medicine is atomoxetine hydrochloride.
Each coated tablet contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, or 40 mg of atomoxetine.
The other ingredients are:
Calcium hydrogen phosphate,
Microcrystalline cellulose,
Calcium phosphate,
Sodium carmellose,
Magnesium stearate,
Polyvinyl alcohol,
Macrogol 4000,
Talc,
Titanium dioxide (E 171).

What Atomoxetine Medice looks like and what the pack contains

Atomoxetine Medice 10 mg, 18 mg, 25 mg, 40 mg coated tablets are white, oval, coated tablets with the inscription "10", "18", "25", "40" on one side.
Atomoxetine Medice 10 mg, 18 mg, 25 mg, 40 mg coated tablets are packaged in PVC/PVDC/Aluminum blisters.
The available pack sizes are 7, 14, 28, 35, 49, 56, or 84 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
Phone: +49 (0) 2371 937-0
Fax: +49 (0) 2371 937-106
Email: info@medice.de
www.medice.de
Reporting side effects: +48 (22) 370 21 05

The medicine is authorized for marketing in EEA member states under the following names:

Germany
Agakalin 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Filmtabletten
Poland
Atomoksetyna Medice

Date of last revision of the leaflet: 01/2025