Kamaptin

Leaflet accompanying the packaging: information for the user

Kamaptin, 10 mg, hard capsules

Kamaptin, 18 mg, hard capsules

Kamaptin, 25 mg, hard capsules

Kamaptin, 40 mg, hard capsules

Kamaptin, 60 mg, hard capsules

Kamaptin, 80 mg, hard capsules

Kamaptin, 100 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 Kamaptin and what is it used for
• 2. Important information before taking Kamaptin
• 3. How to take Kamaptin
• 4. Possible side effects
• 5. How to store Kamaptin
• 6. Contents of the packaging and other information

1. What is Kamaptin and what is it used for

What is Kamaptin used for

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

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

The medicine is given only as part of a comprehensive treatment program that also includes non-pharmacological methods, such as counseling and behavioral therapy. The medicine should not be used to treat ADHD in children under 6 years of age, as it is not known whether the medicine is effective and safe in these individuals. In adults, Kamaptin is used to treat ADHD if the symptoms are very troublesome and disrupt work or social life, and the symptoms of the disease occurred in the patient during childhood.

How Kamaptin works

Kamaptin increases the concentration of noradrenaline in the brain. Noradrenaline is a chemical substance naturally produced by the body and increases concentration and reduces impulsivity and excessive restlessness in patients with ADHD. This medicine is prescribed to help control ADHD symptoms. This medicine does not have a stimulating effect and therefore 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 adolescents 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 adolescents struggle with such problems. However, in people with ADHD, this can disrupt daily life. Children and adolescents 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 child's or adolescent's intelligence.

Adults with ADHD have difficulty with everything that children with ADHD have difficulty with, but for adults, this can mean problems:

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

2. Important information before taking Kamaptin

When not to take Kamaptin:

• if the patient is allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
• if the patient has taken a monoamine oxidase inhibitor (MAOI), such as phenelzine, in the last 2 weeks. MAOIs are sometimes used to treat depression and other mental illnesses; taking Kamaptin at the same time as an MAOI can cause serious side effects or be life-threatening. You should also wait at least 14 days after stopping Kamaptin before starting an MAOI
• if the patient has eye disease - narrow-angle glaucoma (increased eye pressure)
• 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 Kamaptin
• if the patient has severe cerebrovascular diseases, such as stroke, edema, and weakness of a blood vessel (aneurysm), narrowing or blockage of a blood vessel
• if the patient has an adrenal gland tumor (pheochromocytoma)

You should not take Kamaptin if any of the above conditions occur. If the patient is unsure, they should talk to their doctor or pharmacist before starting to take Kamaptin, as the medicine may worsen these conditions.

Warnings and precautions

Serotonin syndrome
Serotonin syndrome is a life-threatening condition that can occur when taking Kamaptin with certain other medicines (see section 2 "Kamaptin 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 heartbeat, elevated body temperature, rapid changes in blood pressure, sweating, sudden reddening of the skin, tremors, excessive reflexes, nausea, vomiting, and diarrhea.
If serotonin syndrome is suspected, you should immediately see a doctor or go to the nearest emergency room.
Both adults and children should be informed about the following warnings and precautions. Before starting to take Kamaptin, you should discuss this with your doctor or pharmacist if the patient has:

• suicidal thoughts or behaviors.
• heart disease (including heart defects) or rapid heart rate. Kamaptin may increase heart rate (pulse). There have been reports of sudden death in patients with heart defects.
• high blood pressure. Kamaptin may increase blood pressure;
• low blood pressure. Kamaptin 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 Kamaptin may need to be reduced.
• psychotic reactions, including hallucinations (hearing voices or seeing things that don't exist), believing in untrue things, or suspiciousness.
• a state of mania (excitement or excessive stimulation that causes unusual behavior) and agitation.
• feeling aggressive.
• hostile or evil (hostile) attitude.
• a history of epilepsy or seizures for any other reason. Kamaptin may increase the frequency of seizures.
• unusual mood or feeling depressed.
• difficulty controlling repetitive movements of any part of the body or repeating sounds or words.

Treatment with Kamaptin 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 conditions occur, the patient should talk to their doctor or pharmacist before starting to take Kamaptin. Kamaptin may worsen these conditions. The doctor will monitor how the medicine affects the patient.

Examinations that the doctor will perform before the patient starts taking Kamaptin

These examinations are necessary to decide whether Kamaptin is suitable for the patient.
The attending physician will measure:

• the patient's blood pressure and heart rate (pulse) before starting to take Kamaptin and during treatment
• the growth and body weight of the patient during treatment with Kamaptin, if the patient is a child or adolescent. The doctor will discuss with the patient if:
• the patient is taking any other medicines
• there is a history of sudden death from an unknown cause in the patient's family
• the patient has any other diseases (such as heart disease)

It is important to provide the doctor with as much information as possible. This will help the doctor decide whether Kamaptin is suitable for the patient. The doctor may also order other medical tests that are necessary before starting to take this medicine.

Kamaptin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription. The doctor will decide whether Kamaptin can be taken at the same time as other medicines. In some cases, the doctor may decide to modify the dose or increase it more slowly.
Kamaptin should not be taken with monoamine oxidase inhibitors (MAOIs) used to treat depression. See section 2 "When not to take Kamaptin".
If the patient is taking other medicines, Kamaptin may affect their action or may cause side effects. If the patient is taking any of the following medicines, they should talk to their doctor or pharmacist before starting to take Kamaptin:

• medicines that increase blood pressure or are used to control blood pressure
• antidepressants, such as imipramine, venlafaxine, mirtazapine, fluoxetine, or paroxetine
• certain cough and cold medicines that contain substances that affect blood pressure. It is important to check this with the pharmacist when buying any of these medicines
• certain medicines used to treat mental illnesses
• medicines that increase the risk of seizures
• certain medicines that may prolong the period during which Kamaptin stays in 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 at the same time as Kamaptin:

• medicines used to control heart function,
• medicines that change the concentration of salts in the blood,
• medicines used to prevent and treat malaria,
• certain antibiotics (such as erythromycin and moxifloxacin).

If the patient is unsure whether the medicines they are taking are listed above, they should ask their doctor or pharmacist before starting to take Kamaptin.
Kamaptin 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 Kamaptin, which can lead to the development of serotonin syndrome, a life-threatening condition. (See section 2 "Warnings and precautions", "Serotonin syndrome").

Pregnancy and breastfeeding

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

• The medicine should not be taken during pregnancy, unless the doctor recommends it.
• The medicine should be avoided during breastfeeding or breastfeeding should be stopped. If the patient:
• is pregnant or breastfeeding,
• suspects that they may be pregnant or plans to have a child,
• plans to start breastfeeding, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

After taking Kamaptin, drowsiness, sleepiness, or dizziness may occur. The patient should be careful when driving a car or operating machines until they know how Kamaptin affects them. If drowsiness, sleepiness, or dizziness occurs, the patient should not drive or operate machines.

Important information about the contents of the capsules

The Kamaptin capsules should not be opened, as the contents of the capsule may irritate the eyes.
If the contents of the capsule get into the eye, it should be rinsed immediately with water and medical advice should be sought. The hands and other parts of the body that have come into contact with the contents of the capsules should also be washed immediately.

3. How to take Kamaptin

• This medicine should always be taken as directed by the doctor or pharmacist. If the patient is unsure, they should consult their 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 drowsiness or nausea when taking Kamaptin once a day, the doctor may recommend taking the medicine twice a day.
• The capsules should be swallowed whole, with or without food.
• The capsules should not be opened, the contents should not be poured out, or taken in any other way.
• Taking the medicine every day at the same time will help remember to take it.

What dose to take

Children and adolescents (6 years of age and older):

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

• Body weight up to 70 kg: the total initial daily dose is 0.5 mg/kg 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/kg 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 approximately 80 mg per day. The maximum daily dose that the doctor can prescribe is 100 mg.

Adults:

• Treatment with Kamaptin 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 80-100 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 Kamaptin.

Taking a higher dose of Kamaptin than recommended

In case of taking a higher dose of Kamaptin than recommended, the patient should immediately contact their doctor or the nearest hospital and inform them about the number of capsules taken. The most commonly reported symptoms after an overdose are: gastrointestinal symptoms, drowsiness, dizziness, tremors, and unusual behavior. Very rarely, serotonin syndrome has also been reported, which is a life-threatening condition. (See section 2. "Warnings and precautions", "Serotonin syndrome").

Missing a dose of Kamaptin

If a dose is missed, it should be taken as soon as possible. However, a dose greater than the total recommended daily dose should not be taken within 24 hours. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Kamaptin

After stopping Kamaptin, there are usually no side effects, but ADHD symptoms may return. The patient should talk to their doctor before stopping the medicine.

During treatment, the doctor will perform the following actions

The doctor will perform examinations

• before starting treatment - to ensure that taking Kamaptin will be safe and beneficial for the patient;
• after starting 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 adolescents
• measuring blood pressure and pulse
• checking for any problems or whether side effects have worsened while taking Kamaptin.

Long-term treatment

Kamaptin does not need to be taken for the rest of your life. After a year of treatment with Kamaptin, the doctor will assess the treatment results to determine whether the medicine should still be taken.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Kamaptin can cause side effects, although not everybody gets them.
Although some people experience side effects, most patients think that Kamaptin has helped them. The doctor will inform the patient about the side effects.
Some side effects can be serious. If the patient experiences any of the following side effects, they should immediately see a doctor.
Uncommon(may occur in up to 1 in 100 people):

• perceived or real rapid heartbeat, arrhythmia
• suicidal thoughts or behaviors
• feeling aggressive
• hostile or evil (hostile) attitude
• 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 don't exist), believing in untrue things, or suspiciousness

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

• suicidal thoughts or behaviors (may occur in up to 1 in 100 people)
• mood swings or mood changes (may occur in up to 1 in 10 people)

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

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that don't exist), believing in untrue things, or suspiciousness

Rare(may occur in up to 1 in 1,000 people):

• liver damage

The patient should stop taking Kamaptin and immediately contact their doctor if they experience any of the following symptoms:

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

Other reported side effects are listed below. If the symptoms worsen, the patient should contact their doctor or pharmacist.

Frequency not known(cannot be estimated from the available data)

CHILDREN and ADOLESCENTS over 6 years of age

• Involuntary grinding of teeth (bruxism)

Effect on growth

In some children, after starting to take Kamaptin, growth (body weight and height) may be slowed down. 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 Kamaptin.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 the medicine.

5. How to store Kamaptin

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging and blister after the "EXP" abbreviation. The expiry date refers to the last day of the specified month.
The medicine should not be stored at a temperature above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Kamaptin contains

• The active substance of the medicine is atomoxetine in the form of hydrochloride. Each hard capsule of Kamaptin, 10 mg contains atomoxetine hydrochloride equivalent to 10 mg of atomoxetine. Each hard capsule of Kamaptin, 18 mg contains atomoxetine hydrochloride equivalent to 18 mg of atomoxetine. Each hard capsule of Kamaptin, 25 mg contains atomoxetine hydrochloride equivalent to 25 mg of atomoxetine. Each hard capsule of Kamaptin, 40 mg contains atomoxetine hydrochloride equivalent to 40 mg of atomoxetine. Each hard capsule of Kamaptin, 60 mg contains atomoxetine hydrochloride equivalent to 60 mg of atomoxetine. Each hard capsule of Kamaptin, 80 mg contains atomoxetine hydrochloride equivalent to 80 mg of atomoxetine. Each hard capsule of Kamaptin, 100 mg contains atomoxetine hydrochloride equivalent to 100 mg of atomoxetine.
• The other ingredients are cornstarch and colloidal anhydrous silica.
• The capsule shell contains sodium lauryl sulfate and gelatin. The capsule shell colorants are: yellow iron oxide (E172) (18 mg, 60 mg, 80 mg, and 100 mg), titanium dioxide (E171) (10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg), indigo carmine (25 mg, 40 mg, and 60 mg), and red iron oxide (E172) (80 mg and 100 mg)

Printing ink:
shellac (E904), anhydrous alcohol (E1510), isopropyl alcohol, butyl alcohol, propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), potassium hydroxide (E525).

What Kamaptin looks like and contents of the packaging

10 mg: White opaque cap / white opaque body of size "3" capsules containing white to off-white powder, with imprint "I 23" on the body in black ink.
18 mg: Gold cap / white opaque body of size "3" capsules containing white to off-white powder, with imprint "I 24" on the body in black ink
25 mg: Blue opaque cap / white opaque body of size "3" capsules containing white to off-white powder, with imprint "I 25" on the body in black ink
40 mg: Blue opaque cap / blue opaque body of size "3" capsules containing white to off-white powder, with imprint "I 26" on the body in black ink
60 mg: Blue opaque cap / gold body of size "2" capsules containing white to off-white powder, with imprint "I 27" on the body in black ink
80 mg: Brown opaque cap / white opaque body of size "2" capsules containing white to off-white powder, with imprint "I 28" on the body in black ink
100 mg: Brown opaque cap / brown opaque body of size "1" capsules containing white to off-white powder, with imprint "I 29" on the body in black ink.
The capsules are packaged in a transparent blister pack of PVC/PVDC/Aluminum.
Pack sizes: 7, 28, or 56 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.
Rabowicka 15
62-020 Swarzędz
Poland
Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain
Atomoxetina Macleods 10mg, 18mg, 25mg, 40mg, 60mg, 80mg ó 100mg cápsulas duras EFG
Germany
Atomoxetin Fairmed Healthcare 10mg, 18mg, 25mg, 40mg, 60mg, 80mg und 100mg Hartkapseln
Portugal
Atomoxetina Macleods 10mg, 18mg, 25mg, 40mg, 60mg, 80mg ou 100mg cápsulas
Romania
ZENMET

Date of last revision of the leaflet: 24.01.2025