Package leaflet: information for the patient

Atomoksetyna Medice, 10 mg, film-coated tablets
Atomoksetyna Medice, 18 mg, film-coated tablets
Atomoksetyna Medice, 25 mg, film-coated tablets
Atomoksetyna Medice, 40 mg, film-coated tablets
Atomoxetine
Please read carefully the entire leaflet before taking the medicine, as it contains important information for the patient.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Atomoksetyna Medice is and what it is used for
Important information before taking Atomoksetyna Medice
How to take Atomoksetyna Medice
Possible side effects
How to store Atomoksetyna Medice
Contents of the pack and other information

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

What this medicine is used for
Atomoksetyna Medice contains the active substance atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). This medicine is used:

in children over 6 years of age
in adolescents
in adults

Atomoksetyna Medice is only used as part of a comprehensive treatment programme, which may also include non-pharmacological interventions such as counselling and behavioural therapy.

Atomoksetyna Medice 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, Atomoksetyna Medice is used to treat ADHD when symptoms are particularly severe and impair work or social functioning, and when symptoms were already present during childhood.

How this medicine works
Atomoksetyna Medice increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical naturally produced by the body. It improves concentration and reduces impulsiveness and excessive motor activity in patients with ADHD. This medicine is prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and therefore does not cause dependence.
It may take several weeks after starting treatment before symptoms improve.

About ADHD
Children and adolescents with ADHD may have:

difficulty sitting still and
difficulty concentrating.
It is not their fault that they struggle with these issues. Many children and young people have such problems. However, in individuals with ADHD, these difficulties may interfere with everyday life. Children and adolescents with ADHD may have problems with learning and completing homework. They may find it difficult to behave appropriately at home, at school, or in other settings. ADHD does not affect a child's or teenager's intelligence.

Adults with ADHD have difficulties similar to those experienced by children with ADHD, but in adults these may lead to problems:

at work,
in interpersonal relationships,
related to low self-esteem,
in academic performance.

2. Important information before using Atomoxetine Medice

When not to use 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) within the past two weeks, e.g. phenelzine. MAOIs are sometimes used in the treatment of depression and other psychiatric disorders. Taking Atomoxetine Medice together with an MAOI may cause severe adverse reactions or pose a risk to life. Also, at least 14 days should be waited after stopping Atomoxetine Medice before starting an MAOI.
if the patient has a disease of the eye – narrow-angle glaucoma (increased pressure in the eye).
if the patient has severe heart disorders which may worsen due to increased heart rate and/or increased blood pressure (which may be caused by taking Atomoxetine Medice).
if the patient has severe cerebrovascular diseases such as stroke, cerebral edema, aneurysm (weakening of a blood vessel wall), narrowing or blockage of blood vessels.
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 consult a 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 a doctor or pharmacist if the patient has:

suicidal thoughts or behaviors;
heart diseases (including structural heart defects) or rapid heart rate. Atomoxetine Medice may increase heart rate (pulse). Cases of sudden death have been reported in patients with structural heart defects;
high blood pressure. Atomoxetine Medice may increase blood pressure;
low blood pressure. Atomoxetine Medice may cause dizziness or fainting in individuals with low blood pressure;
sudden changes in blood pressure or heart rhythm;
cardiovascular disorders or history of stroke;
liver disease. A dose reduction of the medicine may be necessary;
psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), false beliefs, or suspiciousness;
manic state (excitement or excessive activation leading to abnormal behavior) and agitation;
feelings of aggression;
unfriendly and hostile attitude;
history of epilepsy or seizures from any cause. Atomoxetine Medice may increase the frequency of seizures;
mood changes (mood swings) or feelings of profound sadness;
uncontrollable, repetitive movements of any part of the body or repetitive sounds or words.

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening condition and may occur when Atomoxetine Medice is taken together 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, psychomotor agitation, lack of coordination and muscle rigidity, hallucinations, coma, increased heart rate, elevated body temperature, rapid changes in blood pressure, sweating, sudden flushing of the skin, tremor, exaggerated reflexes, nausea, vomiting, and diarrhea. If serotonin syndrome is suspected, seek immediate medical attention or go to the nearest hospital emergency department.

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, making threats, or thoughts of harming others). If the patient, their family, and/or friends notice any of these reactions, they should immediately inform the doctor or pharmacist.

If any of the above conditions apply, discuss them with a doctor or pharmacist before starting Atomoxetine Medice. The medicine may worsen these conditions. The doctor will monitor how the medicine affects the patient.

Examinations the doctor will perform before starting Atomoxetine Medice

These examinations are necessary to determine whether Atomoxetine Medice is suitable for the patient.

The treating doctor will measure:

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

Talk to the doctor if:

the patient is taking any other medicines;
there is a family history of unexplained sudden death;
the patient or any family members have any other diseases (such as heart diseases).

It is important to provide the doctor with as much information as possible. This will help the doctor decide whether Atomoxetine Medice is appropriate for the patient. The doctor may also order additional medical tests before starting this medicine.

Atomoxetine Medice and other medicines

Tell the doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription. The doctor will decide whether Atomoxetine Medice can be taken together 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 for depression. See section 2, "When not to use Atomoxetine Medice."

If the patient is taking other medicines, Atomoxetine Medice may affect their action or may cause adverse effects. Before starting Atomoxetine Medice, talk to a doctor or pharmacist if the patient is taking any of the following:

medicines that increase blood pressure or are used to control blood pressure;
antidepressants, e.g. imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine;
certain cough or cold medicines containing substances affecting blood pressure. It is important to check this with a pharmacist when purchasing any of these medicines;
certain medicines used to treat psychiatric disorders;
medicines that increase the risk of seizures;
certain medicines that may prolong the presence of Atomoxetine Medice in the body (such as quinidine or terbinafine);
oral or injected salbutamol (a medicine used to treat asthma) may cause a sensation of rapid heartbeat, but will not worsen asthma symptoms.

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

medicines used to control heart rhythm;
medicines that alter blood electrolyte levels;
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 antidepressants, opioids such as tramadol, and migraine medicines known as triptans. These medicines may interact with Atomoxetine Medice, potentially leading to serotonin syndrome, a potentially life-threatening condition. (See section 2, "Warnings and precautions", "Serotonin syndrome").

If in doubt whether the medicines being taken are listed above, ask the 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 use this medicine during pregnancy unless advised by a doctor.
Avoid using this medicine during breastfeeding or discontinue breastfeeding.

If the patient:

is pregnant or breastfeeding,
suspects she may be pregnant or is planning to become pregnant,
is planning to start breastfeeding,
should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

After taking Atomoxetine Medice, fatigue, drowsiness, or dizziness may occur. The patient should exercise caution when driving or operating machinery until they know how they react to Atomoxetine Medice. If fatigue, drowsiness, or dizziness occurs, do not drive or operate machinery.

Important information about the ingredients of the tablets

Do not split the tablets, as atomoxetine may irritate the eye. If atomoxetine comes into contact with the eye, immediately rinse with water and seek medical help. Hands and any other body parts 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, meaning the medicine is considered "sodium-free".

3. How to take Atomoxetine Medice

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The medicine is usually taken once or twice daily (in the morning and late afternoon, or early evening).

Children should not take this medicine without adult supervision.
If drowsiness or feeling unwell occurs while taking Atomoxetine Medice once daily, your doctor may recommend taking the medicine twice daily.
Do not divide, crush, or chew the tablets. Swallow them whole, with or between meals.
Taking the medicine at the same time each day will help you remember to take it.

What dose to take
Children and adolescents (aged 6 years and older):
Your doctor will prescribe the appropriate dose of Atomoxetine Medice based on the patient's body weight. Treatment will start with a lower dose, which your doctor may later increase to the dose appropriate 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, your doctor may increase 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, your doctor may increase the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose that a doctor may prescribe is 100 mg.

Adults:

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

If you have liver disease, your doctor may prescribe a lower dose.
Taking more than the recommended dose of Atomoxetine Medice
Contact your doctor or nearest hospital immediately and inform them of the number of tablets taken. The most commonly reported symptoms following overdose include gastrointestinal symptoms, drowsiness, dizziness, tremor, and unusual behavior. Very rarely, serotonin syndrome has been reported, which is a potentially life-threatening condition. (See section 2. Warnings and precautions, Serotonin syndrome).
If you miss a dose of Atomoxetine Medice
If you miss a dose, take it as soon as possible. However, do not take more than the total recommended daily dose within 24 hours. Do not take a double dose to make up for a missed dose.
Stopping treatment with Atomoxetine Medice
Usually, no withdrawal effects occur after stopping Atomoxetine Medice, but ADHD symptoms may return. Talk to your doctor before stopping treatment.
While taking this medicine, your doctor will carry out the following procedures:
Your doctor will conduct examinations

before starting treatment – to ensure that treatment with Atomoxetine Medice is safe and beneficial for the patient;
during treatment – examinations will be performed at least every 6 months, though likely more frequently.

Examinations will also be carried out if the dose is changed. These will include:

measurement of height and body weight in children and young people
measurement of blood pressure and pulse
checking for any problems or whether any side effects have worsened during treatment with Atomoxetine Medice.

Long-term treatment
Atomoxetine Medice does not need to be taken for life. After one year of treatment with Atomoxetine Medice, your doctor will assess the treatment outcomes to determine whether continued use is necessary.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Although some people may experience side effects, for most people, the medicine Atomoxetine
Medice is beneficial. The doctor will inform the patient about possible side effects.
Some side effects may be serious. If any of the following side effects occur, contact a doctor
immediately:
Uncommon ( may occur in less than 1 in 100 treated patients )

perceived or actual rapid heartbeat, irregular heart rhythm,
suicidal thoughts or tendencies,
feelings of aggression,
hostile attitude or anger (hostility),
mood swings or changes in mood,
severe allergic reactions, which may include:
swelling of the face or throat,
difficulty breathing,
hives (small, itchy skin rash),
seizures,
psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), belief in false ideas, or suspiciousness.

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

suicidal thoughts or tendencies (may occur in no more than 1 in 100 treated patients).
mood swings or changes in mood (may occur in no more than 1 in 10 treated patients)

In adults, the risk of side effects is reduced (may occur in no more than 1 in 1,000 treated patients), such as:

seizures,
psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), belief in false ideas, or suspiciousness.

Rare (may occur in no more than 1 in 1,000 treated patients):

liver damage.

Frequency not known:

involuntary teeth grinding (bruxism).

The use of Atomoxetine Medice should be discontinued and medical advice should be
sought immediately if any of the following symptoms occur:

dark-coloured urine,
yellowing of the skin or eyes,
pain in the upper right part of the abdomen under the ribs, tender to pressure (tenderness),
unexplained nausea,
fatigue,
itching,
flu-like symptoms.

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

Very common adverse reactions (may occur in more than 1 in 10 treated patients)
Children and adolescents above 6 years of age	Adults
headache, abdominal pain, decreased appetite (lack of feeling hungry), nausea or vomiting, drowsiness, increased blood pressure, increased heart rate (pulse), In most patients, these symptoms may resolve after some time.	nausea, dry mouth, headache, decreased appetite (lack of feeling hungry), difficulty falling asleep, staying asleep, and early waking, increased blood pressure, increased heart rate (pulse),
Common adverse reactions (may occur in no more than 1 in 10 treated patients)
Children and adolescents above 6 years of age	Adults
irritability or overstimulation, sleep disturbances, including early waking, depression, feelings of sadness or hopelessness, anxiety, tics, dilated pupils (dark center of the eye), dizziness, constipation, loss of appetite, stomach discomfort, indigestion, swollen, red, or itchy skin, rash, lethargy, chest pain, fatigue, decreased body weight,	overstimulation, reduced interest in sex, sleep disturbance, depression, feelings of sadness or hopelessness, anxiety, dizziness, taste disturbances or persistent altered taste, tremor, tingling or numbness of hands or feet, drowsiness, sleepiness, feeling tired, constipation, abdominal pain, indigestion, flatulence with gas release, vomiting, hot flushes or sudden reddening of the skin, palpitations or actual increased heart rate, swollen, red, or itchy skin, increased sweating, rash, urinary difficulties such as inability to pass urine, frequent urination, difficulty initiating urination, pain during urination, prostatitis, groin pain in men, inability to achieve erection, delayed orgasm, difficulty maintaining erection, menstrual cramps, lack of strength or energy, fatigue, lethargy, chills, irritability, restlessness, feeling thirsty, decreased body weight.
Uncommon adverse reactions (may occur in less than 1 in 100 treated patients)
Children and adolescents above 6 years of age	Adults
fainting, tremor, migraine, blurred vision, abnormal skin sensations such as burning, pricking, itching, or tingling, tingling or numbness of hands or feet, seizures (convulsions), palpitations or actual increased heart rate (prolongation of QT interval), shortness of breath, increased sweating, skin itching, lack of strength or energy,	anxiety, tics, fainting, migraine, blurred vision, heart rhythm disorders (prolongation of QT interval), feeling of cold fingers and toes, chest pain, shortness of breath, itchy red blisters on the skin (urticaria), muscle cramps, sudden urge to urinate, abnormal orgasm or its absence, irregular menstruation, ejaculation disorders.
Rare adverse reactions (may occur in less than 1 in 1,000 treated patients)
Children and adolescents above 6 years of age	Adults
poor blood circulation causing numbness and paleness of fingers and toes (Raynaud's phenomenon), urinary difficulties such as frequent urination or difficulty initiating urination, pain during urination, prolonged and painful erection, groin pain in men,	poor blood circulation causing numbness and paleness of fingers and toes (Raynaud's phenomenon), prolonged and painful erection.

Effect on growth
In some children, starting treatment with Atomoxetine Medice may lead to
inhibition of growth (weight and height). However, during long-term treatment, children achieve
normal weight and height appropriate for their age group.
The doctor will monitor the child's growth and body weight. If the child does not grow or gain weight as expected,
the doctor may decide to adjust the dose or temporarily discontinue treatment with Atomoxetine Medice.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather additional information on the safety of the medicine.

5. How to store Atomoksetyna 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 the carton after "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Atomoxetine Medice 10 mg, 18 mg, 25 mg, 40 mg film-coated tablets contain
The active substance is atomoxetine hydrochloride.
Each film-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 film-coated tablets are white, oval film-coated tablets marked with "10", "18", "25", or "40" respectively on one side.
Atomoxetine Medice 10 mg, 18 mg, 25 mg, 40 mg film-coated tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes are 7, 14, 28, 35, 49, 56 or 84 film-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
Tel.: +49 (0) 2371 937-0
Fax: +49 (0) 2371 937-106
E-mail: [email protected]
www.medice.de
Reporting of suspected adverse reactions: +48 (22) 370 21 05

The medicine is authorised in EEA countries under the following names:
Germany Agakalin 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Film Tablets
Poland Atomoxetine Medice

Atomoxetine medice