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 Medice, 60 mg, coated tablets
Atomoxetine Medice, 80 mg, coated tablets
Atomoxetine Medice, 100 mg, coated tablets
Atomoxetine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

The medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 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 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 pack 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 substance 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 such problems. However, in people with ADHD, this can disrupt daily life. Children and young people 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 interpersonal 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, edema, 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). You should not take Atomoxetine Medice if any of the above conditions occur. 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, the patient should discuss the following with their doctor or pharmacist:

• suicidal thoughts or behaviors;
• heart disease (including heart defects) or rapid heart rate. Atomoxetine Medice may increase heart rate (pulse). There have been reports of sudden death in patients with heart defects;
• 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 excitement (excitement or excessive stimulation that causes unusual behavior) and excitement;
• 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;
• 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 talk to their 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 if 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, and the patient's weight and height during Atomoxetine Medice treatment, if the patient is a child or adolescent.

The patient should talk to their doctor if they are

• taking any other medicines
• have a history of sudden death in the family for unknown reasons
• have any other diseases (such as heart disease) or if they have 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 if Atomoxetine Medice is right for the patient. The doctor may also order other medical tests before starting this medicine.

Atomoxetine Medice and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that do not require a prescription. The doctor will decide if Atomoxetine Medice can be taken with other medicines. In some cases, the doctor may decide to modify the dose or increase it more slowly.
Atomoxetine Medice should not be taken with monoamine oxidase inhibitors (MAOIs) used in depression. See section 2 "When not to take Atomoxetine Medice".
If the patient is taking other medicines, Atomoxetine Medice may affect their action or cause side effects. If the patient is taking any of the following medicines, they should talk to their doctor or pharmacist before starting Atomoxetine Medice:

• 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 the pharmacist when buying any of these medicines;
• certain medicines used to treat mental illnesses,
• medicines that increase the risk of seizures,
• certain medicines that may prolong the time Atomoxetine Medice 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 with Atomoxetine Medice:

• medicines used to control heart rhythm,
• medicines that change the level 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 on the above list, they should ask their doctor or pharmacist before starting Atomoxetine Medice.

Pregnancy and breastfeeding

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

• The medicine should not be taken during pregnancy, unless the doctor recommends it.
• The medicine should be avoided during breastfeeding or breastfeeding should be stopped. If the patient:
• is pregnant or breastfeeding,
• suspects they may be pregnant or plans to have a baby,
• plans to start breastfeeding
• should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

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

Important information about the ingredients of the tablets

Do not divide the tablets because atomoxetine can irritate the eyes. If atomoxetine comes into contact with the eyes, they should be rinsed immediately with water and medical help should be sought. Hands and any other parts of the body that may have come into contact with atomoxetine should be washed as soon as possible.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Atomoxetine Medice

This medicine should always be taken exactly as directed by the doctor or pharmacist. If the patient is unsure, they 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 this medicine without adult supervision.
• If the patient experiences sleepiness or malaise when taking Atomoxetine Medice once a day, the doctor may recommend taking the medicine twice a day.
• The tablets should not be divided, crushed, or chewed and should be swallowed whole, with or without food.
• 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 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 per kilogram of body weight for at least 7 days. The doctor may then 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. The doctor may then 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:

• Atomoxetine Medice treatment should be started with a total daily dose of 40 mg for at least 7 days. The doctor may then 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 Atomoxetine Medice.

Taking a higher dose of Atomoxetine Medice than recommended

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

Missing a dose of Atomoxetine Medice

If a dose is missed, the patient should take it as soon as possible. However, they should not take 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 Atomoxetine Medice treatment

After stopping Atomoxetine Medice, there are usually no side effects, but ADHD symptoms may return. The patient should talk to their 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 more frequently. Examinations will also be performed when the dose is changed. They will include:
• measuring the patient's height and weight
• 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 the patient's life. After one year of taking Atomoxetine Medice, the doctor will assess the treatment results to determine if the medicine is still needed.
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 Medice can cause side effects, although not everyone gets them.
Although some people experience side effects, most people taking Atomoxetine Medice are helped by it. The doctor will inform the patient about possible side effects.
Some side effects can be serious. If the patient experiences any of the following side effects, they should immediately contact their doctor:
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, the symptoms of which 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 people treated).
• mood swings or mood changes (may occur in up to 1 in 10 people treated) In adults, the risk of side effects is lower (may occur in up to 1 in 1,000 people treated) 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.

The patient should stop taking Atomoxetine Medice and immediately contact their doctor if they experience any of the following symptoms:

• dark urine,
• yellowing of the skin or eyes,
• pain in the upper right part of the abdomen under the ribs, which is tender to the touch,
• 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 Atomoxetine Medice, growth (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 Atomoxetine Medice.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell 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, PL-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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Atomoxetine Medice

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the blister pack and carton after "EXP".
The expiry date refers to the last day of the month stated.
There are no special precautions for storing 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 pack and other information

What Atomoxetine Medice 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg coated tablets contain

The active substance of the medicine is atomoxetine in the form of hydrochloride.
Each coated tablet contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine.
The other ingredients are:
Calcium hydrogen phosphate,
Microcrystalline cellulose,
Calcium phosphate,
Sodium croscarmellose,
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, 60 mg, 80 mg, 100 mg coated tablets are white, oval, coated tablets with the inscription "10", "18", "25", "40", "60", "80", "100" on one side.
Atomoxetine Medice 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 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
Tel.: +49 (0) 2371 937-0
Fax: +49 (0) 2371 937-106
Email: info@medice.de

The medicine is authorized in EU member states under the following names:

Austria
audalis 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Filmtabletten
Netherlands
audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg film-coated tablets
Denmark
audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg film-coated tablets
Germany
Agakalin 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Filmtabletten
Iceland
audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg film-coated tablets
Luxembourg
Agakalin 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Filmtabletten
Norway
Audalis
Poland
Atomoksetyna Medice
Spain
audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg coated tablets EFG
Sweden
Audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg film-coated tablets
United Kingdom
Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg film-coated tablets (Northern Ireland)

Date of last revision of the leaflet: 02/2021