Atomoksetina Medice

Package 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 package leaflet carefully before taking the medicine, as it contains important information for you.

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

• Keep this package 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package 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 the active substance atomoxetine and is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in:
children over 6 years old,
adolescents,
adults. The medicine is used as part of a comprehensive treatment programme, which includes psychological, educational, and social measures.

• Children under 6 years old: The medicine is not used to treat ADHD in children under 6 years old, as it is not known if it is safe and effective in this age group.
• Adults: Atomoxetine Medice is used to treat ADHD in adults who have had symptoms of the disorder since childhood.

How does it work?

Atomoxetine Medice increases the levels of the chemical noradrenaline in the brain. Noradrenaline is a chemical that is naturally produced by the body. It helps improve attention and reduce impulsivity and hyperactivity in patients with ADHD. The medicine does not have a stimulating effect and is not addictive. It may take a few weeks for the medicine to start working.

About ADHD

Children and adolescents with ADHD have difficulty:
sitting still and remaining seated,
focusing their attention. It is not their fault that they have difficulty with these tasks. Many children and adolescents have problems with these tasks, but for those with ADHD, these problems interfere with their daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving at home, in school, and in other settings. ADHD does not affect a child's or adolescent's intelligence.

• Difficulty sitting still and remaining seated
• Difficulty focusing their attention

Adults with ADHD have difficulty with all of the above tasks, but for adults, this may mean problems with:
work,
relationships,
self-esteem,
learning.

• Work
• Relationships
• Self-esteem
• Learning

2. Important information before taking Atomoxetine Medice

When not to take Atomoxetine Medice:

• If you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
• If you have taken a medicine called a monoamine oxidase inhibitor (MAOI), such as phenelzine, within the last 2 weeks. MAOIs are sometimes used to treat depression and other mental health conditions. Taking Atomoxetine Medice with 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 you have an eye problem called narrow-angle glaucoma (increased pressure in the eye).
• If you have severe heart problems that may get worse with an increase in heart rate and/or blood pressure (which may be caused by taking Atomoxetine Medice).
• If you have severe blood vessel problems in the brain, such as a stroke, swelling, or weakness of a blood vessel (aneurysm), narrowing, or blockage of a blood vessel.
• If you have a tumour of the adrenal gland (phaeochromocytoma).

Do not take Atomoxetine Medice if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Atomoxetine Medice, as the medicine may make these conditions worse.

Warnings and precautions

Both adults and children should be aware of the following warnings and precautions.
Talk to your doctor or pharmacist before taking Atomoxetine Medice if you have:
thoughts of suicide or suicidal behaviour,
heart problems (including heart defects) or an irregular heartbeat. Atomoxetine Medice may increase your 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,
heart or blood vessel problems, or a history of stroke,
liver problems. Your doctor may need to reduce your dose,
psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), delusions, or paranoia,
mania (excitement or excessive restlessness),
aggression,
hostility or anger,
a history of epilepsy or seizures for any reason. Atomoxetine Medice may increase the risk of seizures,
mood swings or feelings of sadness,
uncontrollable movements of any part of the body or repeating sounds or words.

Serotonin syndrome
Serotonin syndrome is a potentially life-threatening condition that can occur when taking Atomoxetine Medice with certain other medicines (see section 2, "Atomoxetine Medice with other medicines"). The symptoms of serotonin syndrome can include a combination of the following: confusion, agitation, uncoordinated movements, hallucinations, coma, rapid heartbeat, high body temperature, changes in blood pressure, sweating, flushing, tremors, exaggerated reflexes, nausea, vomiting, and diarrhea. If you suspect serotonin syndrome, seek medical attention immediately.

Treatment with Atomoxetine Medice may cause feelings of aggression, hostility, or violent behavior, or may worsen these symptoms if they were present before treatment. It may also cause unusual changes in behavior or mood (including physical assault, threats, and thoughts of harming others). If you, your family, or friends notice any of these reactions, tell your doctor or pharmacist immediately.

If any of the above applies to you, talk to your doctor or pharmacist before taking Atomoxetine Medice. The medicine may make these conditions worse. Your doctor will monitor how the medicine affects you.

Tests before starting Atomoxetine Medice

These tests are necessary to determine if Atomoxetine Medice is suitable for you.
Your doctor will measure your:
blood pressure and heart rate (pulse) before starting treatment with Atomoxetine Medice and during treatment,
height and weight in children and adolescents during treatment.

Talk to your doctor if you are taking any other medicines or have any other medical conditions.

• if you are taking any other medicines
• if you have a history of sudden death in your family for unknown reasons
• if you have any other medical conditions (such as heart problems) or if they have occurred 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 perform other medical tests before starting treatment with this medicine.

Atomoxetine Medice with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, including those you have bought without a prescription. Your doctor will decide if you can take Atomoxetine Medice with other medicines. In some cases, your doctor may decide to adjust the dose or increase it more slowly.

Do not take Atomoxetine Medice with medicines called 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 may cause side effects. If you are taking any of the following medicines, talk to your doctor or pharmacist before taking Atomoxetine Medice:

• medicines that increase blood pressure or are used to control blood pressure
• antidepressant medicines, such as imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine
• certain cough and cold medicines that contain substances that affect blood pressure
• certain medicines used to treat mental health conditions
• medicines that increase the risk of seizures
• certain medicines that may prolong the action of Atomoxetine Medice in the body (such as quinidine or terbinafine)
• salbutamol (a medicine used to treat asthma) taken by mouth or injection, may cause a feeling of rapid heartbeat, but will not make asthma symptoms worse

The following medicines may increase the risk of an abnormal heart rhythm if taken with Atomoxetine Medice:

• medicines used to control heart rhythm
• medicines that change the levels of salts in the blood
• medicines used to prevent and treat malaria
• certain antibiotics (such as erythromycin and moxifloxacin)

Atomoxetine Medice may affect the action of other medicines or other medicines may affect its action. These include:

• certain antidepressant medicines, opioid painkillers such as tramadol, and medicines used to treat migraine called triptans. These medicines may interact with Atomoxetine Medice, which may lead to a potentially life-threatening condition called serotonin syndrome (see section 2, "Warnings and precautions", "Serotonin syndrome").

If you are unsure if any of 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 an unborn baby or pass into breast milk.

• Do not take this medicine during pregnancy unless your doctor advises you to.
• Avoid taking this medicine while breastfeeding or stop breastfeeding.

If you:

• are pregnant or breastfeeding
• think you may be pregnant or plan to have a baby
• plan to start breastfeeding
• should ask your doctor or pharmacist for advice 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 the medicine 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 may irritate the eye. If atomoxetine comes into contact with the eye, rinse it with water and seek medical attention. Wash your hands and any other parts of your 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 essentially "sodium-free".

3. How to take Atomoxetine Medice

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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 feel unwell while taking Atomoxetine Medice once a day, your doctor may advise you to take it twice a day.
• Do not divide, crush, or chew the tablets. 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 weight. Your doctor will start with a lower dose and increase it to the recommended dose based on your weight.

• Weight up to 70 kg: The total daily starting dose is approximately 0.5 mg per kg of body weight for at least 7 days. Your doctor may then increase the dose to the usual maintenance dose of approximately 1.2 mg per kg of body weight per day.
• Weight over 70 kg: The total daily starting dose is 40 mg for at least 7 days. Your doctor may then increase 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:

• Start with a total daily dose of 40 mg for at least 7 days. Your doctor may then increase 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 problems, your doctor may prescribe a lower dose.

What to do if you take more Atomoxetine Medice than you should

Immediately contact your doctor or the nearest hospital and inform them of the number of tablets you have taken. The most common symptoms of overdose are gastrointestinal symptoms, sleepiness, dizziness, tremors, and abnormal behaviour. Very rarely, serotonin syndrome, a potentially life-threatening condition, has been reported (see section 2, "Warnings and precautions", "Serotonin syndrome").

What to do if you forget to take Atomoxetine Medice

Take the missed dose as soon as you remember. However, do not take a double dose within 24 hours. Do not take more than the total daily dose recommended by your doctor.

What to do if you stop taking Atomoxetine Medice

After stopping Atomoxetine Medice, you may not experience any side effects, but your ADHD symptoms may return. Talk to your doctor before stopping the medicine.

What your doctor will do while you are taking Atomoxetine Medice

Your doctor will perform the following tests:

• before starting treatment to ensure that Atomoxetine Medice is safe and suitable for you
• during treatment, at least every 6 months, but probably more often

These tests will include:

• measuring your height and weight in children and adolescents
• measuring your blood pressure and heart rate (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 one year of treatment with Atomoxetine Medice, your doctor will assess the results of your treatment to determine if you should continue taking 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 find that Atomoxetine Medice helps them. 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:

• rapid or irregular heartbeat, changes in heart rhythm
• thoughts of suicide or suicidal behaviour
• aggression
• hostility or anger
• mood swings or changes in mood
• severe allergic reactions, which can cause:
• swelling of the face or throat
• difficulty breathing
• hives (small, itchy bumps on the skin)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), delusions, or paranoia

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

• thoughts of suicide or suicidal behaviour (may occur in up to 1 in 100 people)
• mood swings or changes in mood (may occur in up to 1 in 10 people)

In adults, there is a lower risk of side effects (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), delusions, or paranoia

Rarely(may occur in 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 urine
• yellowing of the skin or eyes
• pain in the upper right part of the abdomen, which may be 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, Atomoxetine Medice may cause a slowdown in growth (weight and height). However, during long-term treatment, children tend to reach their expected 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 adjust the dose or temporarily stop the medicine.

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide 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 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.
Store in a cool, dry place, below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 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 croscarmellose,
magnesium stearate,
polyvinyl alcohol,
macrogol 4000,
talc,
titanium dioxide (E 171).

What Atomoxetine Medice looks like and contents of the pack

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

Marketing authorisation 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: [email protected]
www.medice.de
Adverse event reporting: +48 (22) 370 21 05

This medicine is authorised in the Member States of the EEA under the following names:

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

Date of last revision of the package leaflet: 01/2025