Atomoxetine Neuropharma

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: information for the user

Atomoxetine NeuroPharma, 10 mg, hard capsules

Atomoxetine NeuroPharma, 18 mg, hard capsules

Atomoxetine NeuroPharma, 25 mg, hard capsules

Atomoxetine NeuroPharma, 40 mg, hard capsules

Atomoxetine NeuroPharma, 60 mg, hard capsules

Atomoxetine NeuroPharma, 80 mg, hard capsules

Atomoxetine NeuroPharma, 100 mg, hard capsules

Atomoxetine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• You should 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 only. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Atomoxetine NeuroPharma is and what it is used for
• 2. Before you take Atomoxetine NeuroPharma
• 3. How to take Atomoxetine NeuroPharma
• 4. Possible side effects
• 5. How to store Atomoxetine NeuroPharma
• 6. Contents of the pack and other information

1. What Atomoxetine NeuroPharma is and what it is used for

What Atomoxetine NeuroPharma is used for

Atomoxetine NeuroPharma contains the active substance atomoxetine and is used to treat attention deficit hyperactivity disorder (ADHD) in children over 6 years old, adolescents, and adults.

• in children over 6 years old
• in adolescents
• in adults

Atomoxetine NeuroPharma is used as part of a comprehensive treatment programme, which includes psychological, educational, and social measures. In adults, Atomoxetine NeuroPharma is used to treat ADHD, when symptoms are very troublesome and affect work or social life, and when symptoms have been present since childhood.

How Atomoxetine NeuroPharma works

This medicine increases the levels of noradrenaline in the brain. Noradrenaline is a chemical that is naturally produced by the body. It increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. This medicine is prescribed to help control the symptoms of ADHD.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and remaining in one place
• concentrating

It is not their fault that they cannot control their behaviour. Many children and adolescents have difficulty with these behaviours. However, in people with ADHD, this behaviour can interfere with their daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving at home, in school, and in other places. ADHD does not affect the intelligence of a child or adolescent.

Adults with ADHD have difficulty with all the things that children with ADHD have difficulty with, but for adults, this may mean:

• problems at work
• problems with relationships
• low self-esteem
• problems with learning

2. Before you take Atomoxetine NeuroPharma

When not to take Atomoxetine NeuroPharma

• if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6)
• if you have taken a medicine called a monoamine oxidase inhibitor (MAOI), such as phenelzine, within the last 2 weeks. MAOIs are sometimes used to treat depression and other mental health conditions. Taking Atomoxetine NeuroPharma with an MAOI can cause serious side effects or be life-threatening. You should also wait at least 14 days after stopping MAOI treatment before starting treatment with Atomoxetine NeuroPharma
• if you have an eye problem called narrow-angle glaucoma (increased pressure in the eye)
• if you have severe heart problems that may get worse if your heart rate or blood pressure increases, which may be caused by taking Atomoxetine NeuroPharma
• if you have severe blood vessel problems in the brain, such as stroke, swelling, or weakness of a blood vessel (aneurysm), narrowing, or blockage of blood vessels
• if you have a tumour of the adrenal gland (phaeochromocytoma)

Do not take Atomoxetine NeuroPharma if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine, as it may make these conditions worse.

Warnings and precautions

Both adults and children should be aware of the following warnings and precautions.

Before taking Atomoxetine NeuroPharma, talk to your doctor or pharmacist if you:

• have thoughts or feelings of suicide
• have heart problems (including heart defects) or an increased heart rate. Atomoxetine NeuroPharma can increase heart rate (pulse). There have been reports of sudden death in patients with heart defects
• have high blood pressure. Atomoxetine NeuroPharma can increase blood pressure

Atomoxetine NeuroPharma can cause:

• low blood pressure. Atomoxetine NeuroPharma can cause dizziness or fainting in people with low blood pressure
• sudden changes in blood pressure or heart rate
• heart or blood vessel problems, or if you have had a stroke
• liver problems. Your doctor may need to reduce your dose
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), believing in things that are not true, or being suspicious
• mania (excitement or overactivity that causes unusual behaviour)
• aggression
• hostility or anger
• a history of epilepsy or seizures, as Atomoxetine NeuroPharma can increase the risk of seizures
• mood changes or mood swings
• uncontrollable movements, such as twitching or repeating sounds or words

If any of the above applies to you, talk to your doctor or pharmacist before taking Atomoxetine NeuroPharma, as this medicine may make these conditions worse. Your doctor will monitor you.

Tests your doctor will perform before you start taking Atomoxetine NeuroPharma

These tests are necessary to decide if Atomoxetine NeuroPharma is suitable for you.

Your doctor will:

• measure your blood pressure and heart rate (pulse) before you start taking Atomoxetine NeuroPharma and during treatment
• measure your height and weight during treatment if you are a child or adolescent

Talk to your doctor if you:

• are taking any other medicines
• have a family history of sudden death for no known reason
• have any other medical conditions (such as heart problems) or if they have occurred in your family

It is important to tell your doctor as much as possible. This will help your doctor decide if Atomoxetine NeuroPharma is suitable for you. Your doctor may need to perform other medical tests before you start taking this medicine.

Your doctor's recommendations during treatment

Your doctor will:

• perform tests before you start treatment to make sure that taking Atomoxetine NeuroPharma will be safe and beneficial for you
• perform tests during treatment, at least every 6 months, although probably more often

Tests will also be performed if your dose is changed. These tests will include:

• measuring your height and weight if you are a child or adolescent
• measuring your blood pressure and pulse
• checking for any problems or if side effects have worsened while taking Atomoxetine NeuroPharma

Important information about the contents of the capsules

Do not open the capsules of Atomoxetine NeuroPharma, as the contents of the capsule may irritate your eyes. If the contents of the capsule get into your eye, rinse it immediately 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 capsule.

Atomoxetine NeuroPharma and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take, including those obtained without a prescription.

Your doctor will decide if you can take Atomoxetine NeuroPharma with other medicines.

Do not take Atomoxetine NeuroPharma with medicines called monoamine oxidase inhibitors (MAOIs) used to treat depression. See section 2 "When not to take Atomoxetine NeuroPharma".

If you are taking other medicines, Atomoxetine NeuroPharma may affect their action or cause side effects.

If you are taking any of the following medicines, talk to your doctor or pharmacist before taking Atomoxetine NeuroPharma:

• 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 essential to check with your pharmacist when purchasing any of these medicines
• certain medicines used to treat mental health conditions
• medicines that increase the risk of seizures
• certain medicines that may prolong the time Atomoxetine NeuroPharma stays in your 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 rhythms if taken with Atomoxetine NeuroPharma:

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

If you are unsure if the medicines you are taking are listed above, ask your doctor or pharmacist before taking Atomoxetine NeuroPharma

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if this medicine can affect an unborn baby or pass into breast milk.

• Do not take this medicine during pregnancy, unless your doctor advises you to.
• Do not take this medicine while breastfeeding or stop breastfeeding.

Driving and using machines

After taking Atomoxetine NeuroPharma, you may feel tired, sleepy, or dizzy. Be careful when driving a car or operating machinery until you know how Atomoxetine NeuroPharma affects you.

If you feel tired, sleepy, or dizzy, do not drive or operate machinery.

3. How to take Atomoxetine NeuroPharma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take

Adults

• Start with a total daily dose of 40 mg for at least 7 days. Your doctor may then increase your dose to the usual maintenance dose of 80-100 mg per day. The maximum daily dose your doctor can prescribe is 100 mg.

If you have liver problems, your doctor may prescribe a lower dose.

• Capsules are usually taken once or twice a day (in the morning and late afternoon or early evening). Taking your medicine at the same time every day can help you remember to take it.
• If you feel sleepy or nauseous after taking Atomoxetine NeuroPharma once a day, your doctor may change your treatment schedule to twice a day.

Children and adolescents (6 years and older)

Your doctor will prescribe the right dose of Atomoxetine NeuroPharma based on your weight. Your doctor will start with a lower dose and increase it to the right dose for your weight.

• Weight up to 70 kg: the initial total daily dose is approximately 0.5 mg per kg of body weight for at least 7 days. Your doctor may then increase your dose to the usual maintenance dose of approximately 1.2 mg per kg of body weight per day.
• Weight over 70 kg: the initial total daily dose is 40 mg for at least 7 days. Your doctor may then increase your dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose your doctor can prescribe is 100 mg.

Children under 6 years:

Do not give Atomoxetine NeuroPharma to children under 6 years old to treat attention deficit hyperactivity disorder (ADHD), as its effects and safety in this age group have not been established.

Method of administration

• Oral use.
• Swallow the capsules whole, with or without food.
• Do not open or remove the contents of the capsule in any way.
• Children should not take this medicine without adult supervision.

Duration of treatment

It may take a few weeks for all symptoms to improve after starting treatment with Atomoxetine NeuroPharma.

You do not need to take Atomoxetine NeuroPharma for the rest of your life. After one year of treatment with Atomoxetine NeuroPharma, your doctor will assess the results of your treatment to decide if you should continue taking the medicine.

Taking too much Atomoxetine NeuroPharma

Contact your doctor or the nearest hospital immediately and tell them how many capsules you have taken. The most common symptoms of overdose are gastrointestinal symptoms, sleepiness, dizziness, tremor, and abnormal behaviour.

Missing a dose of Atomoxetine NeuroPharma

If you miss a dose, take it as soon as possible. However, do not take more than the total daily dose in 24 hours. Do not take a double dose to make up for a missed dose.

Stopping treatment with Atomoxetine NeuroPharma

After stopping treatment with Atomoxetine NeuroPharma, there are usually no side effects, but ADHD symptoms may return. Talk to your doctor before stopping treatment with Atomoxetine NeuroPharma.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, contact your doctor immediately.

Uncommon(may affect up to 1 in 100 people)

• feeling or actual rapid heartbeat, irregular heartbeat
• thoughts or feelings of suicide
• aggression
• hostility or anger
• mood changes or mood swings
• severe allergic reactions, with symptoms such as:
• swelling of the face and throat
• difficulty breathing
• hives (small, itchy bumps on the skin)
• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in things that are not true, or being suspicious

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

thoughts or feelings of suicide (uncommon - may affect up to 1 in 100 people)

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

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

• seizures
• psychotic symptoms, including hallucinations (hearing voices or seeing things that are not there), believing in things that are not true, or being suspicious

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

• liver damage

If you experience any of the following symptoms, stop taking Atomoxetine NeuroPharma and contact your doctor immediately:

• dark urine
• yellowing of the skin or eyes
• pain in the upper right part of the abdomen, which worsens when pressed
• unexplained nausea
• fatigue
• itching
• flu-like symptoms

Other reported side effects are listed below. If your symptoms worsen, contact your doctor or pharmacist.

Effect on growth

In some children, growth (weight and height) may slow down after starting treatment with Atomoxetine NeuroPharma. However, during long-term treatment, children will achieve normal weight and height for their age group.

Your doctor will monitor your child's growth and weight. If your child is not growing or gaining weight as expected, your doctor may decide to change the dose or temporarily stop treatment with Atomoxetine NeuroPharma.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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

Reporting side effects will help to gather more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Atomoxetine NeuroPharma

Keep this medicine out of the 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 month stated.

There are no special storage instructions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Atomoxetine NeuroPharma contains

• The active substance is atomoxetine.
• Atomoxetine NeuroPharma, 10 mg, hard capsules

Each hard capsule contains 10 mg of atomoxetine in the form of 11.43 mg of atomoxetine hydrochloride.

• Other ingredients are: Capsule contents: maize starch, colloidal anhydrous silica, and dimethicone (350). Capsule shell: gelatin, sodium lauryl sulfate, and titanium dioxide (E 171)
• Atomoxetine NeuroPharma, 18 mg, hard capsules Each hard capsule contains 18 mg of atomoxetine in the form of 20.57 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: maize starch, colloidal anhydrous silica, and dimethicone (350). Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), and yellow iron oxide (E 172)
• Atomoxetine NeuroPharma, 25 mg, hard capsules Each hard capsule contains 25 mg of atomoxetine in the form of 28.57 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: maize starch, colloidal anhydrous silica, and dimethicone (350). Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), and indigo carmine (E 132)
• Atomoxetine NeuroPharma, 40 mg, hard capsules Each hard capsule contains 40 mg of atomoxetine in the form of 45.71 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: maize starch, colloidal anhydrous silica, and dimethicone (350). Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), and indigo carmine (E 132)
• Atomoxetine NeuroPharma, 60 mg, hard capsules Each hard capsule contains 60 mg of atomoxetine in the form of 68.57 mg of atomoxetine hydrochloride.
• 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), and yellow iron oxide (E 172)
• Atomoxetine NeuroPharma, 80 mg, hard capsules Each hard capsule contains 80 mg of atomoxetine in the form of 91.42 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: maize starch, colloidal anhydrous silica, and dimethicone (350). Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172)
• Atomoxetine NeuroPharma, 100 mg, hard capsules Each hard capsule contains 100 mg of atomoxetine in the form of 114.28 mg of atomoxetine hydrochloride.
• Other ingredients are: Capsule contents: maize starch, colloidal anhydrous silica, and dimethicone (350). Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172)
• Printing ink consisting of: shellac - 45% (20% esterified) in ethanol, iron oxide black (E 172), propylene glycol

What Atomoxetine NeuroPharma looks like and contents of the pack

Atomoxetine NeuroPharma, 10 mg, hard capsules

hard gelatin capsule, size 3 (length 15.7±0.4 mm), white opaque cap with black printing "10" and white opaque body with black printing "mg", containing white powder.

Atomoxetine NeuroPharma, 18 mg, hard capsules

hard gelatin capsule, size 3 (length 15.7±0.4 mm), intense yellow opaque cap with black printing "18" and white opaque body with black printing "mg", containing white powder.

Atomoxetine NeuroPharma, 25 mg, hard capsules

hard gelatin capsule, size 3 (length 15.7±0.4 mm), blue opaque cap with black printing "25" and white opaque body with black printing "mg", containing white powder.

Atomoxetine NeuroPharma, 40 mg, hard capsules

hard gelatin capsule, size 3 (length 15.7±0.4 mm), blue opaque cap with black printing "40" and blue opaque body with black printing "mg", containing white powder.

Atomoxetine NeuroPharma, 60 mg, hard capsules

hard gelatin capsule, size 2 (length 17.6±0.4 mm), blue opaque cap with black printing "60" and intense yellow opaque body with black printing "mg", containing white powder.

Atomoxetine NeuroPharma, 80 mg, hard capsules

hard gelatin capsule, size 2 (length 17.6±0.4 mm), brown opaque cap with black printing "80" and white opaque body with black printing "mg", containing white powder.

Atomoxetine NeuroPharma, 100 mg, hard capsules

hard gelatin capsule, size 1 (length 19.1±0.4 mm), brown opaque cap with black printing "100" and brown opaque body with black printing "mg", containing white powder.

Atomoxetine NeuroPharma is available in blisters in a carton.

Package sizes:

Atomoxetine NeuroPharma 10 mg, 18 mg, 100 mg: 7, 14, 28, and 56 hard capsules.

Atomoxetine NeuroPharma 25 mg, 40 mg, 60 mg, 80 mg: 7, 14, 28, 56, and 98 hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

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

Manufacturers

Pharmathen SA, Dervenakion 6, 15351 Pallini Attiki, Greece

Pharmathen International SA, Industrial Park Sapes, Rodopi Prefecture, Block no. 5, 69300 Rodopi, Greece

Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany:

Atomoxetin-neuraxpharm 10 mg Hartkapseln

Atomoxetin-neuraxpharm 18 mg Hartkapseln

Atomoxetin-neuraxpharm 25 mg Hartkapseln

Atomoxetin-neuraxpharm 40 mg Hartkapseln

Atomoxetin-neuraxpharm 60 mg Hartkapseln

Atomoxetin-neuraxpharm 80 mg Hartkapseln

Atomoxetin-neuraxpharm 100 mg Hartkapseln

Poland:

Atomoxetine NeuroPharma

United Kingdom:

Atomoxetine neuraxpharm 10 mg hard capsules

Atomoxetine neuraxpharm 18 mg hard capsules

Atomoxetine neuraxpharm 25 mg hard capsules

Atomoxetine neuraxpharm 40 mg hard capsules

Atomoxetine neuraxpharm 60 mg hard capsules

Atomoxetine neuraxpharm 80 mg hard capsules

Atomoxetine neuraxpharm 100 mg hard capsules

Date of last revision of the leaflet: May 2020