Strattera

PATIENT INFORMATION LEAFLET

Leaflet attached to 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.
• Other help, besides taking this medicine, is needed to treat ADHD.

Further information is contained in section 1

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

• mental health problems
• heart or blood vessel problems
• serious blood vessel problems in the brain, such as stroke

Further information is contained in section 2

While taking this medicine:

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

Further information is contained in sections 3 and 4

You should see your doctor immediately if you experience:

• mood changes or changes in feelings
• 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 again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• The medicine may harm others, even if their symptoms are the same as yours.
• 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 for parents and carers.
The last section is 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, which 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 patients.
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 were present 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 after starting the medicine before the symptoms improve.

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, it can interfere with daily life. Children and young people with ADHD may have difficulty learning and doing homework. They may have difficulty behaving 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, it can mean problems:
  • at work
  • in relationships
  • with low self-esteem
  • with learning.

  2. Important information before taking Strattera

  When must you not take Strattera?

  You must not take Strattera if any of the above applies to you. If you are not sure, you should talk to your doctor or pharmacist before taking Strattera, as the medicine may make these conditions worse. Your doctor will check how the medicine affects you.

  Warnings and precautions

  Before taking Strattera, you should talk to your doctor or pharmacist if you have:

  • thoughts or behaviors of suicide;
  • heart problems (including heart defects) or rapid heartbeat. Strattera may increase your 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 things that are not true, or being suspicious;
  • a manic state (excitement or overactivity that causes unusual behavior) and agitation;
  • feeling aggressive;
  • hostile or unfriendly attitude;
  • a history of epilepsy or seizures for any reason. Strattera may increase the risk of seizures;
  • mood changes or feelings of great sadness;
  • difficulty controlling a part of the body or repeating sounds or words.

  If any of the above applies to you, you should talk to your doctor or pharmacist before taking Strattera. Strattera may make these conditions worse. Your doctor will check how the medicine affects you.

  Tests that your doctor will do before you start taking Strattera

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

  • your blood pressure and heart rate before you start taking 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 if they occur in your family.

  It is important to give your doctor as much information as possible. This will help your doctor decide if Strattera is suitable for you. Your doctor may also do other medical tests before you start taking this medicine.

  Strattera and other medicines

  You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, including those that are available 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 must not take Strattera with medicines called monoamine oxidase inhibitors (IMAO) used to treat depression. See section 2 "When must you not 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 medicines for cough or cold that contain substances that affect blood pressure. It is important 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 by mouth or 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 with Strattera:

  • medicines used to control heart rate,
  • 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 must 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 must 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 contents of the capsules.

  3. How to take Strattera

  • This medicine should always be taken exactly as your doctor has instructed. 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 suggest taking it twice a day.
  • The capsules should be swallowed whole, with or without food.
  • You must not open the capsules or take them in any other way.
  • 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 prescribe the right dose of Strattera, based on your weight.
  Your doctor will start with a lower dose and may increase it to the usual maintenance dose, based on your weight.

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

  At the start of treatment, your doctor may also check your blood pressure and heart rate.

  Adults

  • Treatment with Strattera should be started with a total daily dose of 40 mg for at least 7 days. Your doctor may then increase the dose to the usual maintenance dose of 80-100 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 tell them how many capsules you have taken. The most common symptoms after taking too much Strattera are gastrointestinal symptoms, sleepiness, dizziness, trembling, and unusual behavior.

  What to do if you forget to take a dose of Strattera

  If you forget to take 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 forgotten 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 do tests

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

  Tests will also be done 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 got worse 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 taking Strattera are helped by it.
  Your doctor will tell 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
  • thoughts or behaviors of suicide
  • feeling aggressive
  • hostile or unfriendly attitude
  • mood changes or changes in feelings
  • 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 young people under 18 years, there is an increased risk of

  side effects, such as:

  • thoughts or behaviors of suicide (may affect up to 1 in 100 people)
  • mood changes or changes in feelings (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 things that are not true, 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 part 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 get worse, you should talk to your doctor or pharmacist.

  Very common side effects (may affect more than 1 in 10 people)
  CHILDREN AND ADOLESCENTS over 6 years old	ADULTS
  headache abdominal pain loss of appetite nausea or vomiting drowsiness increased blood pressure rapid heartbeat	nausea dry mouth headache loss of appetite sleep problems, including difficulty sleeping, waking up, or waking up early increased blood pressure rapid heartbeat

  Common side effects (may affect up to 1 in 10 people)
  CHILDREN AND ADOLESCENTS over 6 years old	ADULTS
  irritability or restlessness sleep problems, including waking up early depression feeling sad or hopeless anxiety tics dilated pupils (the black center of the eye) dizziness constipation loss of appetite stomach problems, indigestion swollen, red, or itchy skin rash lethargy chest pain fatigue weight loss.	restlessness decreased interest in sex sleep problems depression feeling sad or hopeless anxiety dizziness taste problems or changes in taste that persist trembling tingling or numbness in hands or feet drowsiness, lethargy, feeling tired constipation abdominal pain indigestion bloating with gas vomiting hot flashes or sudden flushing feeling of rapid heartbeat swollen, red, or itchy skin increased sweating rash difficulty urinating, such as inability to urinate, frequent urination, or difficulty starting to urinate, pain while urinating prostate problems groin pain in men difficulty getting an erection delayed orgasm difficulty maintaining an erection menstrual cramps lack of energy or strength fatigue lethargy chills irritability or shakiness feeling thirsty weight loss

  Uncommon side effects (may affect up to 1 in 100 people)
  CHILDREN AND ADOLESCENTS over 6 years old	ADULTS
  fainting trembling migraine blurred vision abnormal skin sensations, such as burning, tingling, or itching tingling or numbness in hands or feet seizures feeling or real rapid heartbeat (prolonged QT interval) shortness of breath increased sweating itching of the skin lack of energy or strength	restlessness tics fainting migraine blurred vision heart rhythm problems (prolonged QT interval) feeling of cold hands and feet chest pain shortness of breath red, itchy rash on the skin (hives) muscle spasms sudden need to urinate abnormal orgasm or lack of orgasm irregular menstrual periods ejaculation problems

  Rare side effects (may affect up to 1 in 1,000 people)
  CHILDREN AND ADOLESCENTS over 6 years old	ADULTS
  poor blood circulation, which causes numbness and paleness of fingers and toes (Raynaud's phenomenon). difficulty urinating, such as frequent urination or difficulty starting to urinate, pain while urinating prolonged and painful erections groin pain in boys and adolescents	poor blood circulation, which causes numbness and paleness of fingers and toes (Raynaud's phenomenon) prolonged and painful erections

  Effect on growth

  In some children, after starting Strattera, growth (weight and height) may slow down. However, during long-term treatment, children will achieve normal weight and height for their age group.
  Your doctor will check your growth and weight. If your child is not growing or gaining weight as expected, your doctor may change the dose or stop Strattera for a while.

  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, tel.: +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 kept out of sight and reach of children.
  Do 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 storage precautions.

  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 is atomoxetine hydrochloride. Each hard capsule contains atomoxetine hydrochloride 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 indigo carmine (E132) (25 mg, 40 mg, and 60 mg), and edible black ink (containing shellac and iron oxide black (E172)).

  What Strattera looks like and contents of the pack

  10 mg hard capsule: 15.5-16.1 mm long, white, with "Lilly 3227/10 mg" printed on it
  18 mg hard capsule: 15.5-16.1 mm long, gold and white, with "Lilly 3238/18 mg" printed on it
  25 mg hard capsule: 15.5-16.1 mm long, blue and white, with "Lilly 3228/25 mg" printed on it
  40 mg hard capsule: 15.5-16.1 mm long, blue, with "Lilly 3229/40 mg" printed on it
  60 mg hard capsule: 17.5-18.1 mm long, blue and gold, with "Lilly 3239/60 mg" printed on it
  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.
  For further information, please contact your local representative of the marketing authorization holder:
  Eli Lilly Polska Sp. z o.o.,
  ul. Żwirki i Wigury 18A, 02-092 Warsaw, Poland
  tel. +48 22 440-33-00

  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 carer, 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 concentrating
  • you to act quickly without thinking (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, such as talking to a specialist in ADHD treatment.
  • The medicine should help you, but it will not cure ADHD.
  • You will need to see 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 may 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 avoid getting pregnant.

  Who must not take this medicine

  You must not take this medicine if:

  • you have taken a medicine called a monoamine oxidase inhibitor (IMAO), such as phenelzine, in the last 2 weeks
  • you have an eye problem called narrow-angle glaucoma (increased pressure in the eye)
  • you have serious heart problems
  • you have serious 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 medicines you are taking
  • you have thoughts of suicide or self-harm
  • you have a rapid or irregular heartbeat when you are not exercising
  • you hear voices or see things that are not there
  • you have a problem with getting angry easily.

  How to take the medicine (capsules)

  • Swallow the medicine with water, with or without food.
  • Do not open the capsules. If the capsule breaks and the 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.
  • Do not stop taking the medicine without talking to your doctor.

  What are the possible side effects

  Side effects are unwanted symptoms that you may experience while taking the 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 to look out for are:

  • rapid heartbeat
  • feeling sad or depressed or having thoughts of self-harm
  • feeling aggressive
  • mood changes
  • allergic reactions, such as rash, itching, 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 part of the abdomen, which worsens when pressed (tenderness to pressure)

  This medicine may cause drowsiness, so it is important not to engage in 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.

  What else 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 anyone else. The medicine may help you, but it may harm someone else.
  • If you forget to take a dose, do not take a double dose next time. Take the next dose at the usual time.
  • If you take too much medicine, tell your mom, dad, or carer immediately.
  • It is important not to take too much medicine, as it may cause illness.
  • Do not stop taking the medicine without talking to your doctor.

  Who to ask if you have any questions

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