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 a 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 requires the use of 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 have:

• 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 may have difficulty 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 may 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 an adrenal gland tumor (pheochromocytoma).

You must not take Konaten if any of the above situations apply to you. If in doubt, consult a 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 may 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: confusion, restlessness, 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. The 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 Konaten treatment, 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 examinations.

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 medicines used to treat migraines 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. The doctor will decide whether you can take Konaten at the same time as other medicines.
  In some cases, the 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 heart rate, but will not worsen asthma symptoms.

  The following medicines may increase the risk of abnormal heart rhythm if taken at the same time as Konaten:

  • medicines used to control heart rate (heart rhythm),
  • 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 baby, 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 machines until you know how Konaten affects you. If you feel tired, sleepy, or dizzy, you should not drive or operate machines.

  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 your body that have come into contact with the contents of the capsules.

  3. How to take Konaten

  • This medicine should always be taken exactly 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 (6 years of age or older)

  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 kilogram 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 kilogram 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 a doctor or go to the nearest hospital and inform them of how many capsules you have taken. The most commonly reported symptoms after 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 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 discuss this with your doctor before stopping treatment.

  During treatment, 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 one 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 heart rate, heart rhythm disorders
  • suicidal thoughts or tendencies
  • feeling aggressive
  • hostile attitude and anger (hostility)
  • mood swings or mood changes
  • 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 the age of 18, there is an increased risk of side effects, such as:

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

  • mood swings or mood changes (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.

  Very common side effects (may affect more than 1 in 10 people)
  CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD	ADULTS
  headache stomach pain (abdominal pain) decreased appetite (loss of appetite) nausea or vomiting sleepiness increased blood pressure rapid heart rate (tachycardia)	nausea dry mouth headache decreased appetite (loss of appetite) difficulty sleeping, maintaining sleep, and waking up early
  Most patients may experience these symptoms, which may disappear after a while.	increased blood pressure rapid heart rate (tachycardia)

  Common side effects (may affect up to 1 in 10 people)
  CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD	ADULTS
  irritability or restlessness sleep disturbances, including early morning waking depression feeling sad or hopeless anxiety tics dilated pupils (dark center of the eye) dizziness constipation loss of appetite stomach upsets, indigestion swelling, redness, or itching of the skin rash lethargy chest pain fatigue weight loss.	restlessness decreased sexual desire sleep disturbances depression feeling sad or hopeless anxiety dizziness taste disturbances or persistent taste changes tremors tingling or numbness of hands or feet sleepiness, lethargy, feeling tired constipation stomach pain indigestion bloating with gas vomiting hot flashes or sudden flushing perceived or actual rapid heart rate swelling, redness, or itching of the skin increased sweating rash urinary disturbances, such as inability to urinate, frequent urination, or difficulty starting urination, pain during urination prostate inflammation groin pain in men difficulty achieving erection delayed orgasm difficulty maintaining erection menstrual cramps lack of strength or energy fatigue lethargy chills irritability, shakiness feeling thirsty weight loss

  Uncommon side effects (may affect up to 1 in 100 people)
  CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD	ADULTS
  fainting tremors migraine blurred vision abnormal skin sensations, such as burning, tingling, itching, or numbness tingling or numbness of hands or feet seizures perceived or actual rapid heart rate (QT interval prolongation) shortness of breath increased sweating itching of the skin lack of strength or energy	restlessness tics fainting migraine blurred vision heart rhythm disturbances (QT interval prolongation) feeling cold in the fingers and toes chest pain shortness of breath red, itchy rashes on the skin (hives) muscle spasms sudden need to urinate abnormal orgasm or lack of orgasm irregular menstrual periods ejaculation disorders

  Rare side effects (may affect up to 1 in 1,000 people)
  CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD	ADULTS
  poor blood circulation, which causes numbness and paleness of the fingers and toes (Raynaud's disease). urinary disturbances, such as frequent urination or difficulty starting urination, pain during urination prolonged and painful erection groin pain in male children and adolescents	poor blood circulation, which causes numbness and paleness of the fingers and toes (Raynaud's disease) prolonged and painful erection

  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 may cause 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, 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.
  Reporting side effects will help to gather 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 expiry date. 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 required. 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 dimeticone 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 dimeticone 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 dimeticone 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 dimeticone 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 your 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