Kamaptin

Package leaflet: 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
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Kamaptin is and what it is used for

What Kamaptin is used for
Kamaptin contains atomoxetine and is used to treat attention deficit hyperactivity disorder (ADHD). It is used in:

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

Kamaptin is given only as part of a comprehensive treatment programme which may also include non-drug treatments such as psychological, educational and social therapies.
Kamaptin 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 this age group.
In adults, Kamaptin is used to treat ADHD when symptoms are particularly severe and interfere with work or social functioning, and when symptoms of the disorder were already present during childhood.

How Kamaptin works
Kamaptin increases the level of noradrenaline in the brain. Noradrenaline is a chemical naturally produced by the body, and helps improve concentration and reduce impulsiveness and hyperactivity 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 fully improve.

About ADHD
Children and adolescents with ADHD may:

• have difficulty sitting still and
• have difficulty concentrating.
  It is not their fault that they struggle with these issues. Many children and adolescents have such problems. However, in people with ADHD, these difficulties may interfere with everyday life. Children and adolescents with ADHD may have problems with 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 have difficulties similar to those experienced by children with ADHD, but in adults this may lead to problems:

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

2. Important information before using Kamaptin

When NOT to use 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) within the past 2 weeks, e.g. phenelzine. MAOIs are sometimes used in the treatment of depression and other psychiatric disorders; taking Kamaptin together with an MAOI may cause severe adverse reactions or pose a life-threatening risk. A minimum of 14 days should also elapse between stopping Kamaptin and starting an MAOI.
• if the patient has a condition of the eye called narrow-angle glaucoma (increased pressure in the eye)
• if the patient has severe heart disorders which may worsen due to an increased heart rate and/or increased blood pressure, which may occur during treatment with Kamaptin
• if the patient has severe cerebrovascular diseases such as stroke, cerebral edema, aneurysm (weakening of a blood vessel wall), stenosis or occlusion of a blood vessel
• if the patient has a tumor of the adrenal gland (pheochromocytoma)

Kamaptin must not be taken if any of the above conditions apply.
If the patient is unsure, they should consult a doctor or pharmacist before starting
treatment with Kamaptin, as the medicine may worsen these conditions.

Warnings and precautions
Serotonin syndrome
Serotonin syndrome is a potentially life-threatening condition and may occur when
Kamaptin is taken together 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, psychomotor agitation, lack of coordination and rigidity, hallucinations,
coma, increased heart rate, elevated body temperature, rapid changes in blood pressure,
sweating, sudden flushing of the skin, tremor, exaggerated reflexes, nausea, vomiting and diarrhea.
If serotonin syndrome is suspected, seek immediate medical attention or go to the nearest hospital emergency department.

Both adults and children should be informed about the following warnings and precautions. Before starting treatment with Kamaptin, discuss with a doctor or
pharmacist if the patient has:

• suicidal thoughts or behaviors.
• heart disease (including congenital heart defects) or rapid heart rate. Kamaptin may increase heart rate (pulse). Cases of sudden death have been reported in patients with heart defects.
• high blood pressure. Kamaptin may increase blood pressure.
• low blood pressure. Kamaptin may cause dizziness or fainting in individuals with low blood pressure.
• sudden changes in blood pressure or heart rhythm.
• cardiovascular disorders or history of stroke.
• liver disease. A dose reduction may be necessary.
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), false beliefs, or paranoia.
• manic state (excitement or excessive agitation leading to unusual behavior) or hypomania.
• feelings of aggression.
• hostile or antagonistic attitude.
• history of seizures or epilepsy due to any cause. Kamaptin may increase the frequency of seizures.
• unusual mood changes (mood swings) or feelings of profound sadness.
• uncontrollable, repetitive movements of any part of the body or repetitive sounds or words.

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

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

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

• the patient’s blood pressure and heart rate (pulse) before starting Kamaptin and during treatment
• the patient’s height and body weight during treatment with Kamaptin, if the patient is a child or adolescent. The doctor will discuss with the patient:
• any other medicines currently taken or recently used
• any family history of sudden unexplained death
• any other diseases (such as heart conditions) in the patient or family members.

It is important to provide the doctor with as much information as possible. This will help the doctor decide whether Kamaptin is appropriate for the patient. The doctor may also order additional medical tests before starting treatment with this medicine.

Kamaptin and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently used, or planned for use, including over-the-counter medicines. The doctor will decide whether Kamaptin can be taken together with other medicines. In some cases, the doctor may decide to modify the dose or increase it more gradually.

Kamaptin must not be used together with monoamine oxidase inhibitors (MAOIs) used in the treatment of depression. See section 2, “When not to use Kamaptin”.

If the patient is taking other medicines, Kamaptin may affect their action or may cause adverse effects. If taking any of the following medicines, speak with a doctor or pharmacist before starting Kamaptin:

• 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 such medicine
• certain medicines used in the treatment of psychiatric disorders
• medicines that increase the risk of seizures
• certain medicines that may prolong the presence of Kamaptin in the body (e.g. 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 Kamaptin:

• medicines used to control heart function,
• medicines that alter blood electrolyte levels,
• medicines used in the prevention and treatment of malaria,
• certain antibiotics (e.g. erythromycin and moxifloxacin).

If in doubt whether any of the medicines being taken are listed above, ask the doctor or pharmacist before starting 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 migraine medicines called triptans. These medicines may interact with Kamaptin and may lead to serotonin syndrome, a potentially life-threatening condition. (See section 2, “Warnings and precautions”, “Serotonin syndrome”).

Pregnancy and breastfeeding
It is not known whether this medicine may affect the unborn child or pass into human 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 become pregnant,
• plans to start breastfeeding, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
After taking Kamaptin, fatigue, drowsiness or dizziness may occur.
The patient should exercise caution when driving or operating machinery until they know how they react to Kamaptin. If fatigue, drowsiness or dizziness occurs, the patient should not drive or operate machinery.

Important information about capsule contents
Do not open Kamaptin capsules, as the capsule contents may irritate the eyes.
If the capsule contents come into contact with the eye, rinse immediately with water and seek medical advice. Hands and any other parts of the body that have come into contact with the capsule contents should also be washed immediately.

3. How to take Kamaptin

• This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Usually, the medicine is 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 nausea occurs while taking Kamaptin once daily, your doctor may recommend switching to twice-daily dosing.
• Capsules should be swallowed whole, with or without food.
• Do not open the capsules, sprinkle out the 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 years and older):
Your doctor will determine the appropriate dose of Kamaptin based on the patient's body weight.
Treatment will start with a lower dose of Kamaptin 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 0.5 mg per kg of body weight for at least 7 days. Then, your doctor may increase 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. Then, your doctor may increase the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose that a doctor may prescribe is 100 mg.

Adults:

• Treatment with Kamaptin should start with a total daily dose of 40 mg for at least 7 days. Then, your doctor may increase 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.
Taking more Kamaptin than recommended
If you take more Kamaptin than recommended, contact your doctor or nearest hospital immediately and inform them of the number of capsules taken. The most commonly reported symptoms after overdose include gastrointestinal symptoms, drowsiness, dizziness, tremor, and unusual behavior. Serotonin syndrome, a potentially life-threatening condition, has also been reported very rarely. (See section 2. "Warnings and precautions", "Serotonin syndrome").
Missing a dose of Kamaptin
If you miss a dose, 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 Kamaptin treatment
Usually, no adverse effects occur after stopping Kamaptin, but ADHD symptoms may return. Talk to your doctor before stopping the medicine.
During treatment, your doctor will perform the following
Your doctor will carry out examinations

• before starting treatment – to ensure that Kamaptin is safe and beneficial for the patient;
• after starting treatment – examinations will be performed at least every 6 months, although likely more frequently.

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

• monitoring of growth and body weight in children and adolescents
• measurement of blood pressure and pulse
• checking for any problems or whether any adverse effects have worsened during treatment with Kamaptin.

Long-term treatment
Kamaptin does not need to be taken for life. After one year of treatment with Kamaptin, your doctor will assess the treatment outcomes 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 experiences them.
Although some people may experience adverse reactions, most patients find that the medicine
Kamaptin has helped them. The doctor will inform the patient about possible adverse reactions.
Some adverse reactions may be serious. If the patient experiences any of the following adverse
reactions, seek medical advice immediately.
Uncommon (may affect up to 1 in 100 people):

• palpitations or actual rapid heartbeat, heart rhythm disturbances
• suicidal thoughts or tendencies
• feeling of aggression
• hostile attitude or anger (hostility)
• mood swings or changes in mood
• severe allergic reactions, with symptoms such as:
• swelling of the face and throat
• breathing difficulties
• urticaria (small itchy skin rash)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), belief in false things, or suspiciousness

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

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

In adults, there is a reduced risk (may affect up to 1 in 1,000 people)
of the following adverse reactions:

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), belief in false things, or suspiciousness

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

• liver damage

The patient should stop taking Kamaptin and contact a 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, occurring upon pressure (tenderness)
• unexplained nausea
• fatigue
• itching
• flu-like symptoms

Other reported adverse reactions are listed below. If symptoms worsen, the patient should
contact a doctor or pharmacist.

Frequency unknown (cannot be determined from available data)
CHILDREN and ADOLESCENTS aged over 6 years

• Involuntary teeth grinding (bruxism)

Effect on growth
In some children, growth (body weight and height) may slow down after starting Kamaptin treatment. However, during long-term treatment, children achieve body weight and height appropriate 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 Kamaptin treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 Kamaptin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Kamaptin contains

• The active substance is atomoxetine 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 pregelatinized starch and colloidal anhydrous silica.
• The capsule shell contains sodium lauryl sulfate and gelatin. Capsule shell colorants: iron oxide yellow (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), iron oxide red (E172) (80 mg and 100 mg).

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

What Kamaptin looks like and contents of the pack
10 mg: Opaque white cap / opaque white body of size "3" capsule containing powder from white to off-white, printed with "I 23" in black ink on the body.
18 mg: Golden cap / opaque white body of size "3" capsule containing powder from white to off-white, printed with "I 24" in black ink on the body.
25 mg: Opaque blue cap / opaque white body of size "3" capsule containing powder from white to off-white, printed with "I 25" in black ink on the body.
40 mg: Opaque blue cap / opaque blue body of size "3" capsule containing powder from white to off-white, printed with "I 26" in black ink on the body.
60 mg: Opaque blue cap / golden body of size "2" capsule containing powder from white to off-white, printed with "I 27" in black ink on the body.
80 mg: Opaque brown cap / opaque white body of size "2" capsule containing powder from white to off-white, printed with "I 28" in black ink on the body.
100 mg: Opaque brown cap / opaque brown body of size "1" capsule containing powder from white to off-white, printed with "I 29" in black ink on the body.

Capsules are packed in transparent PVC/PVDC/Aluminum blisters.
Pack sizes: 7, 28 or 56 capsules.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorized for marketing in the European Economic Area under the following names:
Spain: Atomoxetina Macleods 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg hard capsules EFG
Germany: Atomoxetin Fairmed Healthcare 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg hard capsules
Portugal: Atomoxetina Macleods 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg capsules
Romania: ZENMET