Strattera

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Strattera 10 mg hard capsules

Strattera 18 mg hard capsules

Strattera 25 mg hard capsules

Strattera 40 mg hard capsules

Strattera 60 mg hard capsules

Atomoxetine

Important information about your medicine

This medicine is used to treat ADHD

• The full name of ADHD is "attention deficit hyperactivity disorder".
• The medicine helps the brain to work properly. It may help to improve attention, concentration, and reduce impulsiveness.
• ADHD treatment also requires other help besides taking this medicine.

Further information is contained in section 1

Before taking this medicine, you should talk to your doctor if you have:

• mental disorders
• heart or circulatory problems
• severe blood vessel problems in the brain, such as stroke

Further information is contained in section 2

While taking this medicine:

• You should regularly visit your doctor to check how the medicine is working.
• You should not stop taking the medicine without consulting your doctor.
• After one year of treatment, your doctor may recommend stopping the medicine to check if it is still needed.
• The most common side effects in children and adolescents are: headache, abdominal pain, loss of appetite, feeling unwell or nausea, drowsiness, increased blood pressure, and rapid heartbeat.
• The most common side effects in adults are: feeling unwell, dry mouth, headache, loss of appetite, insomnia, increased blood pressure, and rapid heartbeat.

Further information is contained in sections 3 and 4

You should contact your doctor immediately if you experience:

• mood or feeling changes
• any heart problems, such as rapid or irregular heartbeat

Further information is contained in sections 2 and 4

The rest of the leaflet contains more detailed and other important information about the safe and effective use of this medicine.

• You should keep this leaflet to read it again if you need to.
• If you have any doubts, you should consult your 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.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

The leaflet is written in sections:

Sections 1 to 6 are intended for parents and caregivers.
The last section is intended for children and young people to read.
However, all sections are written so that children and young people can understand them.

Table of contents of the leaflet:

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

1. What is Strattera and what is it used for

What is this medicine used for?

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

• in children over 6 years old
• in adolescents
• in adults. The medicine is used 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 old, as it is not known if the medicine is effective and safe in these individuals.
In adults, Strattera is used to treat ADHD if the symptoms are very troublesome and interfere with work or social life, and the symptoms of the disorder occurred in childhood.

How does this medicine work?

Strattera increases the level of noradrenaline in the brain. Noradrenaline is a chemical substance naturally produced by the body. It increases concentration and reduces impulsiveness and hyperactivity in patients with ADHD. The medicine is prescribed to help control the symptoms of ADHD. This medicine does not have a stimulating effect and therefore does not cause addiction.
It may take a few weeks from the start of treatment before the symptoms completely disappear.

About ADHD

Children and adolescents with ADHD have:

• difficulty sitting still and
• difficulty concentrating. It is not their fault that they cannot control it. Many children and young people struggle with these problems. However, in people with ADHD, this can disrupt 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.
Adults with ADHD have difficulty with all the things that children with ADHD have difficulty with, but for adults, this can mean problems:

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

2. Important information before taking Strattera

When not to take Strattera:

• 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 (IMAO), such as phenelzine, in the last 2 weeks. IMAO is sometimes used to treat depression and other mental health conditions. Taking Strattera with IMAO can cause serious side effects or be life-threatening. You should also wait at least 14 days after stopping Strattera before starting treatment with IMAO;
• if you have a eye problem called narrow-angle glaucoma (increased pressure in the eye);
• if you have severe heart problems that may worsen with increased heart rate and/or increased blood pressure (which may be caused by taking Strattera);
• if you have 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 you have a tumor of the adrenal gland (pheochromocytoma).

You should not take Strattera if any of the above conditions apply. If you are not sure, you should talk to your doctor or pharmacist before taking Strattera, as the medicine may worsen these conditions.

Warnings and precautions

Before taking Strattera, you should discuss with your doctor or pharmacist if you have:

• suicidal thoughts or behaviors;
• heart problems (including heart defects) or rapid heartbeat. Strattera may increase heart rate. There have been reports of sudden death in patients with heart defects;
• high blood pressure. Strattera may increase blood pressure;
• low blood pressure. Strattera may cause dizziness or fainting in people with low blood pressure;
• sudden changes in blood pressure or heart rate;
• heart or blood vessel problems or a history of stroke;
• liver problems. The dose of Strattera may need to be reduced;
• psychotic reactions, including hallucinations (hearing voices or seeing things that are not there), believing in untrue things, or being suspicious;
• manic mood (excitement or excessive restlessness that causes unusual behavior) and agitation;
• feeling aggressive;
• hostile or unfriendly attitude;
• a history of seizures or convulsions for any reason. Strattera may increase the risk of seizures.
• mood changes or feelings of great sadness;
• difficulty controlling repetitive movements of any part of the body or repeating sounds or words.

If any of the above conditions apply, you should talk to your doctor or pharmacist before taking Strattera. Strattera may worsen these conditions. Your doctor will monitor how the medicine affects you.

Tests your doctor will perform before starting Strattera

These tests are necessary to decide if Strattera is suitable for you.
Your doctor will measure

• your blood pressure and heart rate before starting Strattera and during treatment
• your height and weight during treatment if you are a child or adolescent.

You should talk to your doctor if you are

• taking any other medicines
• have a family history of sudden death for unknown reasons
• have any other medical conditions (such as heart problems) or a family history of them.

It is essential to give your doctor as much information as possible. This will help your doctor decide if Strattera is right for you. Your doctor may also order other medical tests before starting treatment with this medicine.

Strattera and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those bought without a prescription. Your doctor will decide if you can take Strattera with other medicines. In some cases, your doctor may decide to adjust the dose or increase it more slowly.
You should not take Strattera with medicines called monoamine oxidase inhibitors (IMAO) used in depression. See section 2 "When not to take Strattera".
If you are taking other medicines, Strattera may affect their action or cause side effects. If you are taking any of the following medicines, you should talk to your doctor or pharmacist before taking Strattera:

• medicines that increase blood pressure or are used to control blood pressure,
• antidepressant medicines, 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 buying 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 Strattera 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 rhythms if taken with Strattera:

• medicines used to control heart rhythm,
• medicines that change the level 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, you should ask your doctor or pharmacist before taking Strattera.

Pregnancy and breastfeeding

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

• You should not take this medicine during pregnancy, unless your doctor advises you to.
• You should avoid taking this medicine while breastfeeding or stop breastfeeding.

If you

• -are pregnant or breastfeeding,
• -think you may be pregnant or plan to have a baby,
• -plan to start breastfeeding, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

After taking Strattera, you may feel tired, sleepy, or dizzy. You should be careful when driving a car or operating machinery until you know how Strattera affects you. If you feel tired, sleepy, or dizzy, you should not drive or operate machinery.

Important information about the contents of the capsules

You should not open the capsules of Strattera, as the contents may irritate your eyes. If the contents of the capsule get into your eye, you should 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 capsule contents.

3. How to take Strattera

• This medicine should always be taken as directed by your doctor. It is usually taken once or twice a day (in the morning and late afternoon or early evening).
• If you experience drowsiness or feeling unwell while taking Strattera once a day, your doctor may recommend taking it twice a day.
• The capsules should be swallowed whole, with or without food.
• You should not open the capsules or spill their contents.
• Taking the medicine at the same time every day will help you remember to take it.

What dose to take

Children and adolescents (6 years and older)

Your doctor will recommend the appropriate dose of Strattera, calculated according to your body weight.
Your doctor will start with a lower dose and then increase it to the usual maintenance dose.

• Body weight up to 70 kg: the total initial daily dose is approximately 0.5 mg/kg body weight for at least 7 days. Your doctor may then 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. Your doctor may then recommend increasing the dose to the usual maintenance dose of approximately 80 mg per day. The maximum daily dose that your doctor can prescribe is 100 mg.

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

What to do if you take too much Strattera

You should contact your doctor or the nearest hospital immediately and inform them of the number of capsules you have taken. The most common symptoms reported after overdose are gastrointestinal symptoms, sleepiness, dizziness, tremor, and abnormal behavior.

What to do if you miss a dose of Strattera

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

What to do if you stop taking Strattera

After stopping Strattera, you may not experience any side effects, but your ADHD symptoms may return. You should talk to your doctor before stopping the medicine.

What your doctor will do while you are taking Strattera

Your doctor will perform tests

• before starting treatment - to make sure that Strattera is safe and suitable for you;
• during treatment - tests will be performed at least every 6 months, although probably more often.

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

• measuring your height and weight if you are a child or adolescent
• measuring your blood pressure and heart rate
• checking for any problems or if side effects have worsened while taking Strattera.

Long-term treatment

You will not need to take Strattera for the rest of your life. After one year of treatment with Strattera, your doctor will assess the results to decide if you still need to take the medicine.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Strattera can cause side effects, although not everybody gets them.
Although some people experience side effects, most people find that Strattera helps them.
Your doctor will inform you about the possible side effects.
Some side effects can be serious. If you experience any of the following side effects, you should contact your doctor immediately:
Uncommon(may affect up to 1 in 100 people)

• feeling or real rapid heartbeat, irregular heartbeat
• suicidal thoughts or behaviors
• feeling aggressive
• hostile or unfriendly attitude
• mood changes or mood swings
• severe allergic reactions, which can cause 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 untrue things, or being suspicious.

In children and young people under 18 years, there is an increased risk of

side effects, such as:

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

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

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

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

• -liver damage.

You should stop taking Strattera and contact your doctor immediately if you experience any of the following symptoms:

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

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

Effect on growth

In some children, Strattera may cause growth delay (weight and height). However, during long-term treatment, children 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 Strattera.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Strattera

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 and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 needed. This will help protect the environment.

6. Contents of the pack and other information

What Strattera contains

• The active substance of Strattera is atomoxetine in the form of hydrochloride. Each hard capsule contains hydrochloride atomoxetine equivalent to 10 mg, 18 mg, 25 mg, 40 mg, or 60 mg of atomoxetine.
• The other ingredients are maize starch and dimethicone.
• The capsule shell contains sodium lauryl sulfate and gelatin. The capsule shell colors are: yellow iron oxide E172 (18 mg and 60 mg), titanium dioxide E171 (10 mg, 18 mg, 25 mg, 40 mg, and 60 mg), and blue dye E132 (25 mg, 40 mg, and 60 mg), edible black ink (containing shellac and iron oxide E172).

What Strattera looks like and contents of the pack

Hard capsule 10 mg: 15.5-16.1 mm long, white, with the imprint Lilly 3227/10 mg
Hard capsule 18 mg: 15.5-16.1 mm long, gold and white, with the imprint Lilly 3238/18 mg
Hard capsule 25 mg: 15.5-16.1 mm long, blue and white, with the imprint Lilly 3228/25 mg
Hard capsule 40 mg: 15.5-16.1 mm long, blue, with the imprint Lilly 3229/40 mg
Hard capsule 60 mg: 17.5-18.1 mm long, blue and gold, with the imprint Lilly 3239/60 mg
Strattera is available in packs of 7, 14, 28, or 56 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands
Manufacturer:
Lilly S.A., Avda. Industria 30, 28108 Alcobendas, Madrid, Spain.
Strattera is a trademark of Eli Lilly and Company Limited.

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

Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and United Kingdom: Strattera.

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych http://www.urpl.gov.pl .
<----------------------------------------------------------------------------------------------------------->

Information for children and young people

The following text contains the most important information about Strattera. You should read it yourself or ask someone else, such as your mom, dad, or caregiver, to read it to you and answer your questions.
It may help to read the text in parts.

Why was I prescribed this medicine?

This medicine may help children and young people with 'ADHD'.

• ADHD may cause:
• you to be too restless
• you to have difficulty paying attention
• you to act quickly without thinking, which can cause problems (impulsively)
• ADHD can affect your learning, relationships, and self-esteem. Your restless behavior is not your fault.

While taking this medicine

• To help you with ADHD, you will also receive other help besides taking this medicine, such as talking to a specialist in ADHD treatment.
• The medicine should help you, but it will not cure ADHD.
• You will need to visit your doctor several times a year to make sure the medicine is working and that you are growing and developing properly.
• Girls should tell their doctor immediately if they think they might be pregnant. It is not known how the medicine affects an unborn baby. If you have started having sex, you should talk to your doctor about how to prevent pregnancy.

Who should not take this medicine

You should not take this medicineif:

• you have taken a medicine called a monoamine oxidase inhibitor (IMAO), such as phenelzine, in the last 2 weeks
• you have a eye problem called narrow-angle glaucoma (increased pressure in the eye)
• you have severe heart problems
• you have severe blood vessel problems in the brain
• you have a tumor of the adrenal gland

Who needs to talk to their doctor before taking this medicine

You should tell your doctor if:

• you are pregnant or breastfeeding
• you are taking other medicines - your doctor needs to know about all the medicines you are taking
• you have thoughts of harming yourself or others
• you have a rapid or irregular heartbeat when you are not exercising
• you hear voices or see things that other people do not see or hear
• you have a problem with getting angry too easily.

How to take the medicine (capsules)

• Swallow the medicine with water, with or without food.
• You should not open the capsules. If a capsule breaks and its contents get on your skin or in your eye, ask an adult for help.
• Your doctor will tell you how often to take the medicine during the day.
• Taking the medicine at the same time every day will help you remember to take it.
• You should not stop taking the medicine without talking to your doctor first.

Possible side effects

Side effects are unwanted symptoms that can occur when taking a medicine.
If you experience any of the following symptoms, you should tell a trusted adult immediately. They can then talk to your doctor. The main symptoms that may occur are:

• rapid heartbeat
• feeling sad or depressed or having thoughts of self-harm
• feeling aggressive
• mood changes
• allergic reaction symptoms, such as rash, itching, hives on the skin, swelling of the face, lips, tongue, or throat, difficulty breathing, or swallowing.
• seizures
• seeing, feeling, or hearing things that are not there
• liver damage: pain in the upper right side of the abdomen, which worsens when pressed (tenderness to pressure)

This medicine may cause drowsiness, so it is essential to be careful when doing sports, such as horse riding, cycling, swimming, or climbing trees. You may harm yourself or others.

If you feel unwell while taking this medicine, you should tell a trusted adult immediately.

Other things to remember

• You should keep the medicine in a safe place, where no one else can take it, especially younger brothers or sisters.
• This medicine is only for you - do not give it to others. The medicine may help you, but it may harm someone else.
• If you forget to take a dose, do not take a double dose the next time. Take the next dose at the usual time.
• If you take too much medicine, tell your mom, dad, or caregiver immediately.
• It is essential not to take too much medicine, as it can cause illness.
• You should not stop taking the medicine without talking to your doctor first.

Who to ask if you have any questions

You should ask your mom, dad, caregiver, doctor, nurse, or pharmacist for help.