Atomoksetina Medice

Patient Information Leaflet: Information for the Patient

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 is this medicine 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 of age
• in adolescents
• in adults. The medicine is used only as part of a comprehensive treatment program that 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 of age, as its efficacy and safety have not been established in this age group.
In adults, Atomoxetine Medice is used to treat ADHD when symptoms are very troublesome and disrupt work or social life, and have been present since childhood.

How does this medicine work?

Atomoxetine Medice increases the level 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. This 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 after starting treatment for symptoms to improve.

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 difficulty 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:

Do not take Atomoxetine Medice if any of the above conditions apply. If you are unsure, consult your doctor or pharmacist before taking 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 taking Atomoxetine Medice, discuss with your doctor or pharmacist if you

• have thoughts or behaviors of suicide;
• have heart disease (including heart defects) or a rapid heart rate. Atomoxetine Medice may increase heart rate (pulse). There have been reports of sudden death in patients with heart defects;
• have high blood pressure. Atomoxetine Medice may increase blood pressure;
• have low blood pressure. Atomoxetine Medice may cause dizziness or fainting in people with low blood pressure;
• have sudden changes in blood pressure or heart rate;
• have cardiovascular disease or have had a stroke;
• have liver disease. The dose of Atomoxetine Medice may need to be reduced;
• have psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or being suspicious;
• have a manic state (excitement or excessive stimulation that leads to unusual behavior) and stimulation;
• feel aggressive;
• have a hostile or unfriendly attitude;
• have a history of epilepsy or seizures for any reason. Atomoxetine Medice may increase the frequency of seizures,
• have an unusual mood (mood swings) or feeling of great sadness;
• have uncontrollable, 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 feelings of 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 inform their doctor or pharmacist immediately.
If any of the above conditions occur, consult your doctor or pharmacist before taking Atomoxetine Medice. Atomoxetine Medice may worsen these conditions. Your doctor will monitor how the medicine affects you.

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 treatment with 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 in your family from an unknown cause
• you have any other diseases (such as heart disease) or if they occur in your family.

It is essential to provide your doctor with as much information as possible. This will help your doctor decide if Atomoxetine Medice is suitable for you. Your doctor may also prescribe other medical tests that are necessary before starting treatment with this medicine.

Atomoxetine Medice and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those that are available without a prescription. Your doctor will decide if you can take Atomoxetine Medice with other medicines. In some cases, your doctor may decide to modify the dose or increase it more slowly.
Do not take Atomoxetine Medice with monoamine oxidase inhibitors (MAOIs) used to treat 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 if the medicines you are taking are listed above, ask your doctor or pharmacist before taking Atomoxetine Medice.

Pregnancy and breastfeeding

It is not known if this medicine can affect the unborn baby 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 you

• are pregnant or breastfeeding,
• suspect you may be pregnant or plan to have a baby,
• plan to start breastfeeding,
• should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

After taking Atomoxetine Medice, you may feel tired, sleepy, or dizzy. Be careful when driving a car or operating machinery until you know how Atomoxetine Medice affects you. If you feel tired, sleepy, or dizzy, do not drive or operate machinery.

Important information about the ingredients of the tablets

Do not divide the tablets, as atomoxetine can 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 it 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 you experience sleepiness or discomfort when taking Atomoxetine Medice once a day, your doctor may recommend taking it 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):

Your doctor will prescribe the appropriate dose of Atomoxetine Medice based on your body weight. Your doctor will start treatment with a lower dose before increasing it to the dose suitable for your 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, your 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, your doctor may recommend increasing the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose that your doctor can prescribe is 100 mg.

Adults:

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

If you have liver disease, your doctor may prescribe a lower dose of Atomoxetine Medice.

Taking more than the prescribed dose of Atomoxetine Medice

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

Missing a dose of Atomoxetine Medice

If you miss a dose, take it as soon as possible. However, do not take a double dose within 24 hours. Do not take a double dose to make up for a missed dose.

Stopping treatment with Atomoxetine Medice

After stopping Atomoxetine Medice, there are usually no side effects, but ADHD symptoms may return. Consult your doctor before stopping treatment.

During treatment with Atomoxetine Medice, your doctor will

perform the following examinations:

• before starting treatment - to ensure that Atomoxetine Medice is safe and beneficial for you;
• 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

You do not need to take Atomoxetine Medice for the rest of your life. After a year of treatment with Atomoxetine Medice, your doctor will assess the treatment outcome to determine if you still need to take the medicine.
If you have any further questions about taking this medicine, ask 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 it. Your doctor will inform you 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 attitude or anger (hostility),
• 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 being suspicious.

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) and includes:

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

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 is tender to the touch,
• unexplained nausea,
• fatigue,
• itching,
• flu-like symptoms.

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

Effect on growth

In some children, after starting treatment with 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.
Your doctor will monitor your child's growth and weight. If your child is not growing or gaining weight as expected, your doctor may decide to change the dose or temporarily stop treatment with Atomoxetine Medice.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health
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 this medicine.

5. How to store Atomoxetine Medice

Keep the medicine out of the sight and reach of children.
Do not use 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 pack 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 in the form of 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 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 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 pack sizes available 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 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