Atomoxetine medice

Poland
Brand name Atomoxetine medice
Form tablets, film-coated
Active substance / Dosage
atomoxetine hydrochloride · 100 mg
Prescription type Prescription only
ATC code
N06BA09
Registration number 100397939
Manufacturer Medice Arzneimittel Puetter GmbH & Co. KG

Table of Contents

Package leaflet: Information for the patient

Atomoxetine Medice, 10 mg, film-coated tablets
Atomoxetine Medice, 18 mg, film-coated tablets
Atomoxetine Medice, 25 mg, film-coated tablets
Atomoxetine Medice, 40 mg, film-coated tablets
Atomoxetine Medice, 60 mg, film-coated tablets
Atomoxetine Medice, 80 mg, film-coated tablets
Atomoxetine Medice, 100 mg, film-coated tablets
Atomoxetine
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
The medicine should always be taken exactly as described in this patient information leaflet or as directed by the
physician or pharmacist.

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

Table of contents

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

What this medicine is used for
Atomoxetine Medice contains atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). It is used:

  • in children over 6 years of age
  • in adolescents
  • in adults

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

This 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 particularly severe and interfere with work or social functioning, and when symptoms were already present during childhood.

How this medicine works
Atomoxetine 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 daily life. Children and adolescents with ADHD may have problems with learning and completing homework. They may also find it difficult to behave appropriately at home, at school, and 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 result in problems:

  • at work,
  • in interpersonal relationships,
  • related to low self-esteem,
  • in learning.

2. Important information before using Atomoxetine Medice

When not to use Atomoxetine Medice:

  • if the patient is allergic to atomoxetine or to any of the other ingredients of this medicine (listed in section 6);
  • if the patient has taken a monoamine oxidase inhibitor (MAOI) within the last two weeks, e.g. phenelzine. MAOIs are sometimes used in the treatment of depression and other mental disorders. Taking Atomoxetine Medice together with an MAOI may cause severe adverse reactions or may be life-threatening. Also, at least 14 days should elapse 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 if heart rate and/or blood pressure increase (which may be caused by taking Atomoxetine Medice);
  • if the patient has severe diseases of the blood vessels in the brain—such as stroke, swelling and weakening of a blood vessel (aneurysm), narrowing or blockage of a blood vessel;
  • if the patient has a tumour of the adrenal gland (pheochromocytoma).

Do not take Atomoxetine Medice if any of the above conditions apply. If the patient is unsure, they should speak to a doctor or pharmacist before starting treatment with 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 treatment with Atomoxetine Medice, discuss with a doctor or pharmacist if the patient has:

  • suicidal thoughts or behaviours;
  • heart diseases (including heart defects) or rapid heart rate. Atomoxetine Medice may increase heart rate (pulse). Cases of sudden death have been reported 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 patients with low blood pressure;
  • sudden changes in blood pressure or heart rhythm;
  • cardiovascular disorders or history of stroke;
  • liver diseases. A dose reduction of the medicine may be necessary;
  • psychotic reactions, including hallucinations (hearing voices or seeing things that are not real), belief in false ideas, or suspiciousness;
  • manic state (excitement or excessive activation causing unusual behaviour) and agitation;
  • feelings of aggression;
  • unfriendly and hostile attitude;
  • history of epilepsy or seizures for any reason. Atomoxetine Medice may increase the frequency of seizures;
  • unusual mood changes (mood swings) or feelings of deep sadness;
  • uncontrollable, repetitive movements of any part of the body or repetition of sounds or words.

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

Examinations the doctor will perform before the patient starts taking 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 treatment with Atomoxetine Medice and during treatment, and 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 has been a family history of sudden unexplained death;
  • the patient or any family members have other medical conditions (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 treatment with this medicine.

Atomoxetine Medice and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to use. This also includes medicines available without a prescription. The doctor will decide whether it is safe to take Atomoxetine Medice 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 in 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. If taking any of the following medicines, talk to a doctor or pharmacist before starting treatment with Atomoxetine Medice:

  • 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 remedies containing substances that affect blood pressure. It is important to check this with a pharmacist when purchasing any of these medicines;
  • certain medicines used in the treatment of mental 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 injectable salbutamol (a medicine used in the treatment of 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 salt levels;
  • medicines used in the prevention and treatment of malaria;
  • certain antibiotics (such as erythromycin and moxifloxacin).

If in doubt whether the medicines being taken are included in the above list, ask a doctor or pharmacist before starting treatment with Atomoxetine Medice.

Pregnancy and breastfeeding

It is not known whether this medicine may 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 have a child,
  • is planning to start breastfeeding,
  • she 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 a car or operating machinery until they know how they react to Atomoxetine Medice. If fatigue, drowsiness or dizziness occur, 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, immediately rinse with water and seek medical help. Wash hands and any other body parts 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; this means the medicine is considered "sodium-free".

3. How to use Atomoksetyna Medice

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a 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 Atomoksetyna Medice once daily, the doctor may recommend switching to twice-daily dosing.
  • Tablets must not be divided, crushed, or chewed; they should be swallowed whole, with or between meals.
  • Taking the medicine at the same time each day will help with remembering to take it.

What dose to use
Children and adolescents (aged 6 years and older):
The doctor will determine the appropriate dose of Atomoksetyna Medice based on the patient's body weight. Treatment will usually start with a lower dose before increasing it to the dose appropriate for the patient's body weight.

  • Body weight up to 70 kg: the initial total daily dose is approximately 0.5 mg per kg 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 kg of body weight per day.
  • Body weight over 70 kg: the initial total 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 a doctor may prescribe is 100 mg.

Adults:

  • Treatment with Atomoksetyna Medice should begin 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 mg to 100 mg per day. The maximum daily dose a doctor may prescribe is 100 mg. In case of liver disease, the doctor may prescribe a lower dose.

Taking more Atomoksetyna Medice than recommended
Seek immediate medical advice from a doctor or go to the nearest hospital, and inform them of the number of tablets taken. The most commonly reported symptoms following overdose include gastrointestinal symptoms, drowsiness, dizziness, tremor, and unusual behaviour.

If you miss a dose of Atomoksetyna Medice
If a dose is missed, 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 Atomoksetyna Medice
After stopping Atomoksetyna Medice, withdrawal symptoms usually do not occur, but ADHD symptoms may return. Talk to your doctor before stopping the medicine.

During treatment, your doctor will carry out the following checks:

The doctor will perform examinations

  • before starting treatment – to ensure that Atomoksetyna Medice is safe and beneficial for the patient;
  • during treatment – examinations will be carried out at least every 6 months, though likely more frequently, and also when the dose is changed. These will include:
  • monitoring of growth and body weight in children and young people
  • measurement of blood pressure and heart rate
  • checking for any problems or whether any adverse effects have worsened during treatment with Atomoksetyna Medice.

Long-term treatment
Atomoksetyna Medice does not need to be taken for life. After one year of treatment with Atomoksetyna Medice, the doctor will evaluate the treatment results 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone gets them.
Although some people experience adverse reactions, Atomoxetine Medice helps most people. Your doctor will inform you about possible adverse reactions.
Some adverse reactions may be serious. If any of the following adverse reactions occur, contact your doctor immediately:
Uncommon ( may occur in less than 1 in 100 treated patients )

  • palpitations or actual increased heart rate, heart rhythm disturbances,
  • suicidal thoughts or tendencies,
  • feelings of aggression,
  • hostility or irritability,
  • mood swings or changes in mood,
  • severe allergic reactions, which may include:
  • swelling of the face or throat,
  • difficulty breathing,
  • urticaria (small itchy skin rashes),
  • seizures,
  • psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in false things or suspiciousness.

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

  • suicidal thoughts or tendencies (may occur in up to 1 in 100 treated patients).
  • mood swings or changes in mood (may occur in up to 1 in 10 treated patients).
    In adults, the risk of adverse reactions is reduced (may occur in up to 1 in 1,000 treated patients), such as:
  • seizures,
  • psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in false things or suspiciousness. Rare ( may occur in up to 1 in 1,000 treated patients ):
  • liver damage.

Stop taking Atomoxetine Medice and contact your doctor immediately if any of the following symptoms occur:

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

Other reported adverse reactions are listed below. If symptoms worsen, contact your doctor or pharmacist.

Very common adverse reactions (may occur in more than 1 in 10 treated patients)
Children and adolescents aged over 6 yearsAdults
  • headache,
  • abdominal pain,
  • decreased appetite (lack of hunger sensation),
  • 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 hunger sensation),
  • difficulty falling asleep, staying asleep, and early awakening,
  • increased blood pressure,
  • increased heart rate (pulse),
Common adverse reactions (may occur in no more than 1 in 10 treated patients)
Children and adolescents aged over 6 yearsAdults
  • irritability or agitation,
  • sleep disturbances, including early awakening,
  • depression,
  • feeling of sadness or hopelessness,
  • anxiety,
  • tics,
  • dilated pupils (dark center of the eye),
  • dizziness,
  • constipation,
  • loss of appetite,
  • gastric discomfort, indigestion,
  • swollen, red, or itchy skin,
  • rash,
  • lethargy,
  • chest pain,
  • fatigue,
  • decreased body weight,
  • agitation,
  • decreased interest in sex,
  • sleep disturbance,
  • depression,
  • feeling of sadness or hopelessness,
  • anxiety,
  • dizziness,
  • persistent taste disturbance or altered taste,
  • tremor,
  • tingling or numbness in hands or feet,
  • drowsiness, somnolence, feeling of fatigue,
  • constipation,
  • abdominal pain,
  • indigestion,
  • flatulence,
  • vomiting,
  • hot flushes or sudden reddening of the skin,
  • perceived or actual increased heart rate,
  • swollen, red, or itchy skin,
  • increased sweating,
  • rash,
  • urinary difficulties, such as inability to urinate, 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, tremor,
  • feeling of thirst,
  • decreased body weight.
Uncommon adverse reactions (may occur in less than 1 in 100 treated patients)
Children and adolescents aged over 6 yearsAdults
  • fainting,
  • tremor,
  • migraine,
  • blurred vision,
  • abnormal skin sensations such as burning, pricking, itching, or tingling,
  • tingling or numbness in hands or feet,
  • seizures (convulsions),
  • perceived or actual increased heart rate (QT interval prolongation),
  • shortness of breath,
  • increased sweating,
  • skin itching,
  • lack of strength or energy,
  • anxiety,
  • tics,
  • fainting,
  • migraine,
  • blurred vision,
  • heart rhythm disturbances (QT interval prolongation),
  • feeling of coldness in fingers of hands and feet,
  • 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 aged over 6 yearsAdults
  • poor blood circulation causing numbness and paleness of fingers in hands and feet (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 in hands and feet (Raynaud's phenomenon),
  • prolonged and painful erection.

Effect on growth
In some children, growth (weight and height) may be slowed after starting treatment with Atomoxetine Medice. However, during long-term treatment, children achieve appropriate weight and height for their age group.
The doctor will monitor the child's growth and 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 reactions 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, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atomoksetyna Medice

Keep this 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 mentioned month.
No special storage instructions apply for this medicine.
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 pack and other information

What Atomoksetyna Medice 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg film-coated tablets contain
The active substance is atomoxetine in the form of hydrochloride.
Each film-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 Atomoksetyna Medice looks like and contents of the pack
Atomoksetyna Medice 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg film-coated tablets are white, oval, film-coated tablets, marked with "10", "18", "25", "40", "60", "80", or "100" respectively on one side.
Atomoksetyna Medice 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg film-coated tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes of 7, 14, 28, 35, 49, 56 or 84 film-coated tablets are available.
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]

The medicine is authorised in EEA countries 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 filmomhulde tabletten
Denmark audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg filmovertrukne tabletter
Germany Agakalin 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Filmtabletten
Iceland audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg filmuhúðaðar töflur
Luxembourg Agakalin 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Filmtabletten
Norway Audalis
Poland Atomoksetyna Medice
Spain audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg comprimidos recubiertos con película EFG
Sweden Audalis 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg filmdragerade tabletter
United Kingdom Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg film-coated tablets (Northern Ireland)