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

Read the leaflet carefully 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.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 the age of six, 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 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:

Warnings and precautions

Both adults and children should be aware of the following warnings and precautions.
Before starting Atomoxetine Medice, the doctor or pharmacist should be consulted if the patient has:

• 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 the medicine 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 causes 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;
• difficulty controlling, repetitive movements of any part of the body or repeating sounds or words.

If any of the above conditions occur, the doctor or pharmacist should be consulted before starting Atomoxetine Medice. The medicine may worsen these conditions. The doctor will check how the medicine affects the patient.

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

These examinations are necessary to decide 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, and the patient's weight and height during Atomoxetine Medice treatment, if the patient is a child or adolescent.

The doctor should be consulted if:

• the patient is 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 prescribe other medical tests that are necessary before starting this medicine.

Atomoxetine Medice and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, including those that are available without a prescription. The doctor will decide whether 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 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 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 there are any doubts about whether the medicines being taken are on the above list, the doctor or pharmacist should be consulted 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,
• thinks 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 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 there are any doubts, the doctor or pharmacist should be consulted. 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 remember to take it.

What dose to take

Children and adolescents (over 6 years old):

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 kg 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 kg 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:

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

Taking a higher dose of Atomoxetine Medice than recommended

The doctor or the nearest hospital should be contacted immediately and informed about the number of tablets taken. The most commonly reported symptoms after overdose are symptoms from the gastrointestinal tract, sleepiness, dizziness, tremors, and abnormal behavior.

Missing a dose of Atomoxetine Medice

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 Atomoxetine Medice treatment

After stopping Atomoxetine Medice, there are usually no side effects, but ADHD symptoms may return. The doctor should be consulted 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 Atomoxetine Medice is 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 height 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 one's life. After a year of taking Atomoxetine Medice, the doctor will assess the treatment results to determine if the medicine still needs to be taken.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

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 it. The doctor will inform the patient about possible side effects.
Some side effects can be serious. If any of the following side effects occur, the doctor should be contacted 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, 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 the age of 18, there is an increased risk of side effects, such as:

• suicidal thoughts or behaviors (may occur in up to 1 in 100 people).
• mood swings or mood changes (may occur in up to 1 in 10 people) In adults, the risk of side effects is lower (may occur in up to 1 in 1,000 people) such as:
• seizures,
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or suspiciousness.

If any of the following symptoms occur, the medicine should be stopped and the doctor should be contacted immediately:

• dark-colored 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 symptoms worsen, the doctor or pharmacist should be consulted.

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 Atomoxetine Medice.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 expiration date stated on the blister pack and carton after "EXP".
The expiration 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 pharmacist should be asked 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 carboxymethylcellulose,
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: [email protected]

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