Konaten

Leaflet accompanying the packaging: information for the user

Konaten, 10 mg, hard capsules

Konaten, 18 mg, hard capsules

Konaten, 25 mg, hard capsules

Konaten, 40 mg, hard capsules

Atomoxetine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Konaten and what is it used for
• 2. Important information before taking Konaten
• 3. How to take Konaten
• 4. Possible side effects
• 5. How to store Konaten
• 6. Contents of the packaging and other information

1. What is Konaten and what is it used for

What is Konaten used for

Konaten contains atomoxetine and is used to treat attention deficit hyperactivity disorder (ADHD). The medicine is used

• in children over 6 years of age
• in young people
• in adults.

The medicine is given only as part of a comprehensive treatment program that also includes non-pharmacological methods, such as group therapy and behavioral therapy. The medicine should not be used to treat ADHD in children under the age of six, as it is not known whether the medicine is effective and safe in these individuals. In adults, Konaten is used to treat ADHD if the symptoms are very troublesome and affect work or social life, and the symptoms of the disease occurred in the patient during childhood.

How Konaten works

Konaten increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical substance produced naturally by the body, which increases concentration and reduces impulsive behavior and excessive restlessness in patients with ADHD. This medicine is prescribed to help control the symptoms of ADHD. This medicine does not have a stimulating effect and does not cause addiction. It may take a few weeks from the start of taking the medicine before the symptoms completely disappear.

About ADHD

Children and young people 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 have such problems. However, in people with ADHD, this can affect daily life. Children and young people with ADHD may have difficulty learning and doing homework. They have trouble behaving properly at home, at school, and in other places. ADHD does not affect the intelligence of the child or young person. In adults with ADHD, similar difficulties occur, as in children with ADHD; however, in adults, this can cause problems:

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

2. Important information before taking Konaten

When not to take Konaten:

• 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 medicine called a monoamine oxidase inhibitor (MAOI), such as phenelzine, in the last 2 weeks. MAOIs are sometimes used to treat depression and other mental illnesses; taking Konaten at the same time as an MAOI can cause serious or life-threatening side effects. After stopping Konaten, you should also wait at least 14 days before starting an MAOI;
• if the patient has an eye disease - narrow-angle glaucoma (increased pressure in the eyeball);
• if the patient has severe heart problems that may worsen with increased heart rate and/or increased blood pressure, which may be caused by taking Konaten;
• if the patient has severe blood vessel problems in the brain - such as stroke, swelling, and weakness of a blood vessel (aneurysm), narrowing, or blockage of a blood vessel;
• if the patient has a tumor of the adrenal gland (pheochromocytoma).

You must not take Konaten if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking Konaten. Konaten may worsen these diseases and actions.

Warnings and precautions

Serotonin syndrome
Serotonin syndrome is a life-threatening condition that can occur when taking Konaten with certain other medicines (see section 2 "Konaten 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, excessive reflexes, nausea, vomiting, and diarrhea. If serotonin syndrome is suspected, you should immediately consult a doctor or go to the nearest hospital emergency department.
Both adults and children should be aware of the following warnings and precautions. Before taking Konaten, you should discuss this with your doctor or pharmacist if you have:

• suicidal thoughts or behaviors;
• heart disease (including heart defects) or rapid heart rate. Konaten may increase heart rate. Cases of sudden death have been reported in patients with heart defects;
• high blood pressure. Konaten may increase blood pressure;
• low blood pressure. Konaten 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 Konaten may need to be reduced;
• psychotic symptoms, including hallucinations (hearing voices or seeing things that do not exist), believing in untrue things, or suspiciousness;
• mania (excitement or excessive stimulation, leading to abnormal behavior) and agitation;
• feeling aggressive;
• hostile and evil (hostile) attitude;
• a history of epilepsy or seizures from any other cause. Konaten may increase the frequency of seizures;
• mood other than usual (mood swings) or feeling very sad;
• difficulty controlling repetitive movements of any part of the body or repeating sounds or words.

Treatment with Konaten 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 immediately tell their doctor or pharmacist.
If any of the above situations apply to you, you should discuss this with your doctor or pharmacist before starting treatment. Konaten may worsen these symptoms. Your doctor will monitor how the medicine affects you.

Examinations that the doctor will perform on the patient before starting Konaten

These examinations are necessary to decide whether Konaten is suitable for the patient.
The doctor will measure

• the patient's blood pressure and heart rate before starting Konaten and during treatment
• the growth and body weight of the patient during treatment with Konaten, if the patient is a child or adolescent

The doctor will discuss with the patient:

• the patient's use of any other medicines
• cases of sudden death from an unknown cause that may have occurred in the family
• the occurrence of any other diseases (such as heart disease) in the patient or their family members.

It is essential that the patient provides the doctor with as much information as possible. This will help the doctor decide whether Konaten is suitable for the patient. Before taking this medicine, the doctor may order other necessary medical tests.

Konaten and other medicines

Konaten 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 called triptans. These medicines may interact with Konaten, which may lead to the occurrence of serotonin syndrome, a life-threatening condition. (See section 2 "Warnings and precautions", "Serotonin syndrome").

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines that are available without a prescription. Your doctor will decide whether you can take Konaten at the same time as other medicines.
In some cases, your doctor may decide to adjust the dose or increase it more slowly.
You must not take Konaten with medicines called monoamine oxidase inhibitors (MAOIs) used in depression. See section 2 "When not to take Konaten".
If you are taking other medicines, Konaten may affect their action or may cause side effects. If you are taking any of the following medicines, you should consult your doctor or pharmacist before taking Konaten:

• medicines that increase blood pressure or are used to control blood pressure;
• antidepressants, such as imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine;
• certain cough and cold medicines that contain substances that affect blood pressure. It is essential to check this with your pharmacist when purchasing any of these medicines;
• certain medicines used to treat mental illnesses;
• medicines known to increase the risk of seizures;
• certain medicines that may prolong the elimination of Konaten from 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 Konaten:

• medicines used to control heart rhythm (heart rate),
• medicines that increase the concentration of electrolytes in the blood,
• medicines used to prevent and treat malaria,
• certain antibiotics (such as erythromycin and moxifloxacin).

If you are unsure whether the medicines you are taking are on the above list, you should ask your doctor or pharmacist before taking Konaten.

Pregnancy and breastfeeding

It is not known whether this medicine can affect the fetus or pass into breast milk.

• You should not take this medicine during pregnancy, unless your doctor advises you to do so.
• You should avoid taking this medicine during breastfeeding or stop breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

After taking Konaten, you may feel tired, sleepy, or dizzy. You should be careful when driving or operating machinery until you know how Konaten affects you. If you feel tired, sleepy, or dizzy, you should not drive or operate machinery.

Important information about the contents of the capsules

You should not open the capsules, as the contents of the capsule may irritate the eyes. If the contents of the capsule get into the eye, you should immediately rinse it with water and seek medical advice. You should also wash your hands and any other parts of the body that have come into contact with the contents of the capsules.

3. How to take Konaten

• This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult 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 the patient experiences sleepiness or malaise when taking Konaten once a day, the doctor may recommend taking the medicine twice a day.
• The capsules should be swallowed whole, with or without food.
• You should not open the capsules, pour out their contents, or take them in any other way.
• Taking the medicine every day at the same time will help you remember to take it.

What dose to take

Children and adolescents (aged 6 and over)

The doctor will recommend the appropriate dose of Konaten, which will be calculated based on the patient's body weight. The doctor will start treatment with a lower dose before increasing it to the dose calculated based on the patient's body weight.

• Body weight up to 70 kg: the total initial daily dose is 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 80 mg per day. The maximum daily dose that the doctor can prescribe is 100 mg.

Adults

• Konaten 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 to 100 mg per day. The maximum daily dose that the doctor can prescribe is 100 mg.

If the patient has liver disease, the doctor may prescribe a lower dose of Konaten.

Taking a higher dose of Konaten than recommended

You should immediately contact your doctor or go to the nearest hospital and inform them of how many capsules you have taken. The most commonly reported symptoms after an overdose were gastrointestinal symptoms, sleepiness, dizziness, tremors, and abnormal 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 Konaten

If you miss a dose, you should take it as soon as possible. However, you should not take a dose that is more than the recommended total daily dose within 24 hours. You should not take a double dose to make up for a missed dose.

Stopping Konaten treatment

After stopping Konaten treatment, no side effects usually occur, but the symptoms of ADHD may return. You should consult your doctor before stopping treatment.

During treatment with Konaten, the doctor will perform the following:

The doctor will perform examinations

• before starting treatment - to ensure that taking Konaten will be 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 the growth and body weight of children and young people
• measuring blood pressure and heart rate
• checking for any problems or whether side effects have worsened while taking Konaten.

Long-term treatment

It is not necessary to take Konaten for the rest of your life. After a year of taking Konaten, the doctor will assess the treatment results and decide whether you should continue taking the medicine.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Konaten can cause side effects, although not everybody gets them. Although some people experience side effects, most people find that Konaten 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, you should immediately contact your doctor.
Uncommon(may affect up to 1 in 100 people)

• perceived or actual rapid heartbeat, arrhythmias
• suicidal thoughts or behaviors
• feeling aggressive
• hostile attitude and anger (hostility)
• mood swings or changes in mood
• severe allergic reactions, the symptoms of which are:
• swelling of the face and throat
• difficulty breathing
• hives (small, itchy rashes on the skin)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that do not exist), believing in untrue things, or suspiciousness.

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

suicidal thoughts or behaviors (uncommon - may affect up to 1 in 100 people):

• mood swings or changes in mood (common - may affect up to 1 in 10 people)

In adults, there is a decreased risk of side effects (rare - may affect up to 1 in 1,000 people) such as:

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that do not exist), believing in untrue things, or suspiciousness.

Rare(may affect up to 1 in 1,000 people)

• liver damage.

You should stop taking Konaten and immediately contact your doctor if you experience any of the following symptoms:

• dark-colored urine
• yellowing of the skin or whites of the eyes
• pain in the upper right part of the abdomen under the ribs, which occurs when pressed (tenderness to pressure)
• unjustified nausea (nausea)
• fatigue
• itching
• flu-like symptoms.

Other reported side effects. If symptoms worsen, you should contact your doctor or pharmacist.

Frequency not known(cannot be estimated from the available data)
only in children and adolescents

• Involuntary grinding of the teeth (bruxism)

Effect on growth

In some children, taking Konaten leads to growth inhibition (body weight and height). However, during long-term treatment, children achieve normal body weight and height for their age group. The doctor will monitor the child's growth and body weight. If the child is not growing or gaining weight as expected, the doctor may decide to change the dose or temporarily stop taking Konaten.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Konaten

The medicine should be stored out of sight and reach of children.
You should not take this medicine after the expiry date stated on the carton after EXP or on the label after the EXP abbreviation. The expiry 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Konaten contains

• The active substance of the medicine is atomoxetine.

Konaten, 10 mg, hard capsules
Each hard capsule contains 10 mg of atomoxetine, which corresponds to 11.43 mg of atomoxetine hydrochloride.
The other ingredients are:
Capsule contents:maize starch, colloidal anhydrous silica, and dimethicone 350
Capsule shell:gelatin, sodium lauryl sulfate, titanium dioxide (E 171)
Konaten, 18 mg, hard capsules
Each hard capsule contains 18 mg of atomoxetine, which corresponds to 20.57 mg of atomoxetine hydrochloride.
The other ingredients are:
Capsule contents:maize starch, colloidal anhydrous silica, and dimethicone 350
Capsule shell:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), yellow iron oxide (E 172)
Konaten, 25 mg, hard capsules
Each hard capsule contains 25 mg of atomoxetine, which corresponds to 28.57 mg of atomoxetine hydrochloride.
The other ingredients are:
Capsule contents:maize starch, colloidal anhydrous silica, and dimethicone 350
Capsule shell:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), indigo carmine (E 132)
Konaten, 40 mg, hard capsules
Each hard capsule contains 40 mg of atomoxetine, which corresponds to 45.71 mg of atomoxetine hydrochloride.
The other ingredients are:
Capsule contents:maize starch, colloidal anhydrous silica, and dimethicone 350
Capsule shell:gelatin, sodium lauryl sulfate, titanium dioxide (E 171), indigo carmine (E 132)

• Printing ink (black) contains: shellac, iron oxide black (E 172), propylene glycol

What Konaten looks like and contents of the pack

Konaten, 10 mg, hard capsules
The hard capsule is size 3 (length 15.7±0.4 mm), with a matte white cap with a black print "10" and a matte white body with a black print "mg".
Konaten, 18 mg, hard capsules
The hard capsule is size 3 (length 15.7±0.4 mm), with a matte deep yellow cap with a black print "18" and a matte white body with a black print "mg".
Konaten, 25 mg, hard capsules
The hard capsule is size 3 (length 15.7±0.4 mm), with a matte blue cap with a black print "25" and a matte white body with a black print "mg".
Konaten, 40 mg, hard capsules
The hard capsule is size 3 (length 15.7±0.4 mm), with a matte blue cap with a black print "40" and a matte blue body with a black print "mg".
Available pack sizes:
Konaten, 10 mg, 18 mg, 25 mg, 40 mg: 28 or 56 capsules in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer

Pharmathen International SA
Industrial Park Sapes, Rodopi Prefecture
Block No 5, Rodopi 69300
Greece
Pharmathen SA
Dervenakion 6
Pallini Attiki 15351
Greece
Glenmark Pharmaceuticals s.r.o.
Fibichova 143,
566 17 Vysoké Mýto
Czech Republic

For more information, please contact the local representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw

Date of last revision of the leaflet: 10/2024