Konaten

Patient Information Leaflet

Konaten, 10 mg, hard capsules
Konaten, 18 mg, hard capsules
Konaten, 25 mg, hard capsules
Konaten, 40 mg, hard capsules
Atomoxetine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Konaten is and what it is used for
2. What you need to know before taking Konaten
3. How to take Konaten
4. Possible side effects
5. How to store Konaten
6. Contents of the pack and other information

1. What Konaten is and what it is used for

What Konaten is used for
Konaten contains atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). Konaten is used:

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

Konaten is given only as part of a comprehensive treatment programme, which also includes non-pharmacological interventions such as group therapy and behavioural therapy.
Konaten should not be used in the treatment of ADHD in children under 6 years of age, as it is not known whether the medicine is effective and safe in this age group.
In adults, Konaten is used to treat ADHD when symptoms are particularly severe and affect work or social functioning, and when symptoms of the disorder were already present during childhood.

How Konaten works
Konaten increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical naturally produced by the body that enhances concentration and reduces impulsive behaviour 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 does not cause dependence.
It may take several weeks after starting treatment before symptoms fully improve.

About ADHD
Children and adolescents with ADHD may experience:

• difficulty staying still in one place 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 trouble learning and completing homework. They may find it difficult to behave appropriately at home, at school, and in other settings. ADHD does not affect a child's or young person's intelligence.
Adults with ADHD experience similar difficulties as children with ADHD; however, in adults, these may lead to problems:

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

2. Important information before using Konaten

When NOT to use 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 known as a monoamine oxidase inhibitor (MAOI) within the last 2 weeks, such as phenelzine. MAOIs are sometimes used to treat depression and other mental disorders; taking Konaten together with an MAOI may cause severe or life-threatening side effects. After stopping treatment with Konaten, at least 14 days must also pass before starting an MAOI;
• if the patient has a disease of the eye—narrow-angle glaucoma (increased pressure in the eyeball);
• if the patient has severe heart disorders that could worsen due to an increased heart rate and/or increased blood pressure, which may be caused by taking Konaten;
• if the patient has severe disorders related to blood vessels in the brain—such as stroke, swelling, weakening of a blood vessel (aneurysm), narrowing or blockage of a blood vessel;
• if the patient has an adrenal gland tumour (pheochromocytoma).

Do not take Konaten if any of the above situations apply to the patient. If in doubt, talk to a doctor or pharmacist before using Konaten.
Konaten may worsen these conditions and effects.

Warnings and precautions

Serotonin syndrome
Serotonin syndrome is a potentially life-threatening condition and may occur when taking Konaten together with certain other medicines (see section 2, "Konaten with other medicines"). Objective and subjective symptoms of serotonin syndrome may include a combination of the following: confusion, psychomotor agitation, lack of coordination and stiffness, hallucinations, coma, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, sweating, sudden flushing of the skin, tremor, exaggerated reflexes, nausea, vomiting, and diarrhoea. If serotonin syndrome is suspected, seek immediate medical attention or go to the nearest hospital emergency department.

Both adults and children should be aware of the following warnings and precautions. Before using Konaten, discuss with a doctor or pharmacist if the patient has:

• suicidal thoughts or behaviours;
• heart disorders (including heart defects) or a fast heart rate. Konaten may increase heart rate (pulse). 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 individuals with low blood pressure;
• sudden changes in blood pressure or heart rhythm (pulse);
• cardiovascular disorders or a history of stroke;
• liver disorders. A dose reduction may be necessary;
• psychotic symptoms, including hallucinations (hearing voices or seeing things that do not exist), false beliefs, or suspiciousness;
• mania (excitement or excessive agitation leading to unusual behaviour) and agitation;
• feelings of aggression;
• hostile and unfriendly (hostile) attitude;
• a history of epilepsy or seizures from any cause. Konaten may increase the frequency of seizures;
• mood changes (mood swings) or feelings of deep sadness;
• uncontrollable, repetitive movements of any part of the body or repetition of sounds or words.

Treatment with Konaten may cause feelings of aggression, hostility, or violent behaviour, or may worsen these symptoms if they were present before treatment. It may also cause unusual changes in behaviour or mood (including physical assault, threats, or thoughts of harming others). If the patient, their family, and/or friends notice any of these reactions, inform the doctor or pharmacist immediately.

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

Examinations the doctor will perform before starting Konaten treatment
These examinations are necessary to determine whether Konaten is suitable for the patient.
The treating doctor will measure:

• the patient’s blood pressure and heart rate (pulse) before starting Konaten and during treatment;
• the height 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:

• any other medicines the patient is taking;
• any family history of sudden unexplained deaths;
• any other disorders (such as heart disorders) in the patient or their family members.

It is important that the patient provides the doctor with as much information as possible. This will help the doctor decide whether Konaten is appropriate for the patient. Before using this medicine, the doctor may order additional necessary medical tests.

Konaten with 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, potentially leading to serotonin syndrome, a life-threatening condition. (See section 2, "Warnings and precautions", "Serotonin syndrome").

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. The doctor will decide whether the patient can take Konaten together with other medicines. In some cases, the doctor may decide to adjust the dose or increase it more slowly.

Do not take Konaten with medicines known as monoamine oxidase inhibitors (MAOIs) used for depression. See section 2, "When NOT to use Konaten".

If the patient is taking other medicines, Konaten may affect their action or may cause side effects. If the patient is taking any of the following medicines, talk to a doctor or pharmacist before using Konaten:

• medicines that increase blood pressure or are used to control blood pressure;
• antidepressants such as imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine;
• certain cough or cold medicines containing substances that affect blood pressure. It is important to check this with a pharmacist when purchasing any of these medicines;
• certain medicines used to treat mental disorders;
• 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);
• 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 Konaten:

• medicines used to control heart rhythm (pulse);
• medicines that increase blood electrolyte levels;
• medicines used to prevent and treat malaria;
• certain antibiotics (such as erythromycin and moxifloxacin).

If in doubt whether the medicines the patient is taking are listed above, ask the doctor or pharmacist before using Konaten.

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

Driving and operating machinery
After taking Konaten, tiredness, drowsiness, or dizziness may occur. The patient should exercise caution when driving or operating machinery until it is known how Konaten affects them. If tiredness, drowsiness, or dizziness occurs, do not drive or operate machinery.

Important information about capsule contents
Do not open the capsules, as the capsule contents may irritate the eyes. If the capsule contents come into contact with the eye, immediately rinse the eye with water and seek medical advice. Wash hands and any other body parts that have come into contact with the capsule contents immediately.

3. How to use Konaten

• This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Usually, the medicine should be taken once or twice daily (in the morning and late afternoon, or early evening).
• Children should not take this medicine without supervision by an adult.
• If drowsiness or feeling unwell occurs while taking Konaten once daily, your doctor may recommend switching to twice-daily dosing.
• Capsules should be swallowed whole, with or between meals.
• Do not open the capsules, pour out their contents, or take them in any other way.
• 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 determine the appropriate dose of Konaten based on the patient's body weight.
Treatment will be started at a lower dose before increasing it to the dose calculated according to body weight.

• Body weight up to 70 kg: the initial total daily dose is 0.5 mg per kg of body weight for at least 7 days. Afterwards, your 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 greater than 70 kg: the initial total daily dose is 40 mg for at least 7 days. Afterwards, your doctor may recommend increasing the dose to the usual maintenance dose of 80 mg per day. The maximum daily dose that a doctor may prescribe is 100 mg.

Adults

• Treatment with Konaten should be initiated at a total daily dose of 40 mg for at least 7 days. Afterwards, your doctor may recommend increasing 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 the patient has liver disease, the doctor may prescribe a lower dose of Konaten.
Taking more than the recommended dose of Konaten
Seek immediate medical advice from your doctor or go to the nearest hospital emergency department and inform them how many capsules have been taken. The most commonly reported symptoms following overdose include gastrointestinal symptoms, drowsiness, dizziness, tremor, and unusual behavior. Serotonin syndrome, a potentially life-threatening condition, has been reported very rarely. (See section 2. Warnings and precautions, Serotonin syndrome).
Missed dose of Konaten
If a dose is missed, take it as soon as possible. However, do not exceed the total recommended daily dose within a 24-hour period. Do not take a double dose to make up for a missed dose.
Stopping Konaten
After stopping Konaten, adverse effects usually do not occur, but symptoms of ADHD may return. Talk to your doctor before discontinuing treatment.
While taking this medicine, your doctor will perform the following checks:
Your doctor will carry out 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, though likely more frequently.

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

• measuring height and body weight in children and adolescents
• measuring blood pressure and pulse
• checking for any problems or whether any adverse effects have worsened during treatment with Konaten.

Long-term treatment
It is not necessary to take Konaten for the rest of your life. After one year of treatment with Konaten, your doctor will assess the treatment outcome and decide whether continued use is still needed.
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 will experience them.
Although some people may experience adverse reactions, Konaten 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 people):

• palpitations or actual sensation of a racing heartbeat, heart rhythm disturbances
• suicidal thoughts or tendencies
• feeling of aggression
• hostile attitude and anger (hostility)
• mood swings or changes in mood
• severe allergic reactions, with symptoms such as:
• swelling of the face and throat
• difficulty breathing
• urticaria (small itchy skin rashes)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not real), false beliefs, or suspicion.

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

• suicidal thoughts or tendencies (uncommon – may occur in less than 1 in 100 people)
• mood swings or changes in mood (common – may occur in less than 1 in 10 people)

In adults, there is a reduced risk of adverse reactions (rare – may occur in less than 1 in 1,000 people) such as:

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not real), false beliefs, or suspicion.

Rare (may occur in less than 1 in 1,000 people):

• liver damage.

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

• dark-coloured urine
• yellowing of the skin or whites of the 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. If symptoms worsen, contact your doctor or pharmacist.

Frequency unknown (cannot be determined from available data)
in children and adolescents only

• Involuntary grinding of teeth (bruxism)

Effect on growth
In some children, treatment with Konaten may result in slowed development (body weight and growth). However, during long-term treatment, children usually achieve normal weight and height 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 Konaten.

Reporting of adverse reactions
If any adverse reactions occur, including any 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, 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 medicinal product.

5. How to store Konaten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: EXP
or on the label after the abbreviation: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Konaten contains

• The active substance is atomoxetine.

Konaten 10 mg, hard capsules
Each hard capsule contains 10 mg of atomoxetine, equivalent to 11.43 mg of atomoxetine
hydrochloride.
The other ingredients are:
Capsule contents: pregelatinized starch, corn starch, colloidal anhydrous silica, and dimethicone
Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171)

Konaten 18 mg, hard capsules
Each hard capsule contains 18 mg of atomoxetine, equivalent to 20.57 mg of atomoxetine
hydrochloride.
The other ingredients are:
Capsule contents: pregelatinized starch, corn starch, colloidal anhydrous silica, and dimethicone
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, equivalent to 28.57 mg of atomoxetine
hydrochloride.
The other ingredients are:
Capsule contents: pregelatinized starch, corn starch, colloidal anhydrous silica, and dimethicone
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, equivalent to 45.71 mg of atomoxetine
hydrochloride.
The other ingredients are:
Capsule contents: pregelatinized starch, corn starch, colloidal anhydrous silica, and dimethicone
Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), indigo carmine (E 132)

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

What Konaten looks like and contents of the pack
Konaten 10 mg, hard capsules
Hard gelatin capsule size 3 (length 15.7±0.4 mm), with a matte white cap printed in black with "10" and a matte white body printed in black with "mg".

Konaten 18 mg, hard capsules
Hard gelatin capsule size 3 (length 15.7±0.4 mm), with a matte deep yellow cap printed in black with "18" and a matte white body printed in black with "mg".

Konaten 25 mg, hard capsules
Hard gelatin capsule size 3 (length 15.7±0.4 mm), with a matte blue cap printed in black with "25" and a matte white body printed in black with "mg".

Konaten 40 mg, hard capsules
Hard gelatin capsule size 3 (length 15.7±0.4 mm), with a matte blue cap printed in black with "40" and a matte blue body printed in black with "mg".

Pack sizes available:
Konaten 10 mg, 18 mg, 25 mg, 40 mg: 28 or 56 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 further information, please contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
Poland