Strattera 10, 18, 25, 40, 60, 80 and 100 mg hard capsules
Important things you need to know about your medicine
This medicine is used to treat ADHD
Read Section 1 for more information.
Before you take this medicine, talk to your doctor if you:
Read Section 2 for more information.
While taking this medicine:
headache, stomach ache, not feeling hungry, feeling or being sick, feeling sleepy, increased blood pressure, increased heart rate (pulse).
feeling sick, dry mouth, headache, not feeling hungry, not being able to sleep, increased blood pressure, increased heart rate (pulse).
Read Sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
Read Section 2 and 4 for more information.
The rest of this leaflet includes more detail and other important information on the safe and effective use of this medicine.
The leaflet has been written in sections:
Sections 1 to 6 are for parents and carers (sometimes called ‘your guardians’).
The last section is a special section for a child or young person to read.
However, all sections are written as though the child or young person taking the medicine is reading them.
What is in this leaflet:
1. What Strattera is and what it is used for
2. What you need to know before you take Strattera
3. How to take Strattera
4. Possible side effects
5. How to store Strattera
6. Contents of the pack and other information
What it is used for
Strattera contains atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD). It is used
It is used only as a part of the total treatment of the disease which also requires treatments which do not involve medicines, such as counselling and behavioural therapy.
It is not for use as a treatment for ADHD in children under 6 years of age as it is not known if the drug works or is safe in these people.
In adults, Strattera is used to treat ADHD when the symptoms are very troublesome and affect your work or social life and when you have had symptoms of the disease as a child.
How it works
Strattera increases the amount of noradrenaline in the brain. This is a chemical that is produced naturally, and increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. This medicine has been prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and is therefore not addictive.
It may take a few weeks after you start the medicine for your symptoms to fully improve.
Children and young people with ADHD find it:
It is not their fault that they cannot do these things. Many children and young people struggle to do these things. However, with ADHD this can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places. ADHD does not affect the intelligence of a child or young person.
Adults with ADHD find it difficult to do all the things that children find difficult; however this may mean they have problems with:
Do NOT take Strattera if you:
Do not take Strattera if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take Strattera. This is because Strattera can make these problems worse.
Warnings and precautions
Both adult and children should be aware of the following warnings and precautions. Talk to your doctor or pharmacist before taking Strattera if you have:
Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because Strattera can make these problems worse. Your doctor will want to monitor how the medicine affects you.
Checks that your doctor will make before you start to take Strattera
These checks are to decide if Strattera is the correct medicine for you.
Your doctor will measure your
Your doctor will talk to you about:
It is important that you provide as much information as you can. This will help your doctor decide if Strattera is the correct medicine for you. Your doctor may decide that other medical tests are needed before you start taking this medicine.
Other medicines and Strattera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes non-prescription medicines. Your doctor will decide if you can take Strattera with your other medicines and in some cases your doctor may need to adjust your dose or increase your dose much more slowly.
Do not take Strattera with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 “Do not take Strattera”.
If you are taking other medicines, Strattera may affect how well they work or may cause side effects. If you are taking any of the following medicines, check with your doctor or pharmacist before taking Strattera:
The medicines below may lead to an increased risk of an abnormal rhythm of the heart when taken with Strattera:
If you are not sure about whether any medicines you are taking are included in the list above, ask your doctor or pharmacist before taking Strattera.
Pregnancy and breast-feeding
It is not known if this medicine can affect an unborn baby or pass into breast milk.
If you are:
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may feel tired, sleepy or dizzy after taking Strattera. You should be careful if you are 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 content of the capsules
Do not open Strattera capsules because the contents of the capsule can irritate the eye. If the contents of the capsules come into contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any other part of the body that may have come into contact with the capsule contents should also be washed as soon as possible.
How much to take
If you are a child or teenager (6 years or older):
Your doctor will tell you how much Strattera you should take and will calculate this according to your weight. He/she will normally start you on a lower dose before increasing the amount of Strattera you need to take according to your body weight.
If you have problems with your liver your doctor may prescribe a lower dose.
If you take more Strattera than you should contact your doctor or the nearest hospital casualty department immediately and tell them how many capsules you have taken. The most commonly reported symptoms accompanying overdoses are gastrointestinal symptoms, sleepiness, dizziness, tremor, and abnormal behaviour.
If you forget to take Strattera
If you miss a dose, you should take it as soon as possible, but you should not take more than your total daily dose in any 24-hour period. Do not take a double dose to make up for a forgotten dose.
If you stop taking Strattera
If you stop taking Strattera there are usually no side effects but your ADHD symptoms may return. You should talk to your doctor first before you stop treatment.
Things your doctor will do when you are on treatment
Your doctor will do some tests
They will also be done when the dose is changed. These tests will include:
Strattera does not need to be taken for ever. If you take Strattera for more than a year, your doctor will review your treatment, to see if the medicine is still needed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Although some people get side effects most people find that Strattera helps them. Your doctor will talk to you about these sides effects.
Some side effects could be serious. If you have any of the side effects below, see a doctor straight away.
Uncommon (may affect up to 1 in 100 people)
Children and young adults aged under 18 have an increased risk of side effects such as:
Adults have a reduced risk (may affect up to 1 in 1,000 people) of side effects such as:
Rarely (may affect up to 1 in 1,000 people)
You should stop taking Strattera and call your doctor immediately if you have any of the following:
Other side effects reported include the following. If they get serious, tell your doctor or pharmacist.
Very common side effects (may affect more than 1 in 10 people)
CHILDREN and YOUNG PEOPLE over 6 years
These effects may disappear after a while in most patients.
Common side effects (may affect up to 1 in 10 people)
CHILDREN and YOUNG PEOPLE over 6 years
Uncommon side effects (may affect up to 1 in 100 people)
CHILDREN and YOUNG PEOPLE over 6 years
Rare side effects (may affect up to 1 in 1,000 people)
CHILDREN and YOUNG PEOPLE over 6 years
Effects on growth
Some children experience reduced growth (weight and height) when they start taking Strattera. However, with long-term treatment, children recover to the weight and height for their age range.
Your doctor will watch your child’s height and weight over time. If your child is not growing or gaining weight as expected, your doctor may change your child’s dose or decide to stop Strattera temporarily.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, website: www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.
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 that month.
This medicinal product does not require any special storage conditions.
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 to protect the environment.
What Strattera 10, 18, 25, 40, 60, 80 and 100 mg hard capsules contain
Yellow iron oxide E172 (18 mg, 60 mg, 80 mg and 100 mg)
Titanium dioxide E171 (10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg))
FD&C blue 2 (indigo carmine) E132 (25 mg, 40 mg and 60 mg)
Red iron oxide E172 (80 mg and 100mg)
Edible black ink (containing shellac and black iron oxide E172)
What Strattera looks like and contents of the pack
Capsule, hard, 10 mg (white, imprinted Lilly 3227/10 mg, approximately 15.5-16.1 mm length )
Capsule, hard, 18 mg (gold/white, imprinted Lilly 3238/18 mg, approximately 15.5-16.1 mm length)
Capsule, hard, 25 mg (blue/white, imprinted Lilly 3228/25 mg, approximately 15.5-16.1 mm length)
Capsule, hard, 40 mg (blue, imprinted Lilly 3229/40 mg, approximately 15.5-16.1 mm length)
Capsule, hard, 60 mg (blue/gold, imprinted Lilly 3239/60 mg, approximately 17.5-18.1 mm length)
Capsule, hard, 80 mg (brown/white, imprinted Lilly 3250/80 mg, approximately 17.5-18.1 mm length)
Capsule, hard, 100 mg (brown, imprinted Lilly 3251/100 mg, approximately 19.2-19.8 mm length)
Strattera capsules are available in packs of 7, 14, 28 or 56 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
The manufacturer is:
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Strattera is a trademark of Eli Lilly and Company Limited.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, the Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK: Strattera.
This leaflet was last revised in January 2021
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Eli Lilly and Company (Ireland) Limited, Tel: + 353-(0) 1 661 4377
Detailed information on this medicinal product is available on the website of: Ireland/HPRA
This information is to help you learn the main things about your medicine called Strattera.
If you don’t enjoy reading, someone like your mum, dad or carer (sometimes called ‘your guardian’) can read it to you and answer any questions.
It may help if you read small bits at a time.
Why have I been given this medicine?
This medicine can help children and young people with ‘ADHD’.
ADHD can make you:
While you are taking this medicine
Some people cannot have this medicine
You cannot have this medicine if you:
Some people need to talk to their doctor before they start taking this medicine
You need to talk to your doctor if you:
How do I take my medicine (capsules)?
Possible side effects
Side effects are the unwanted things that can happen when you take a medicine. If any of the following happen, tell an adult you trust straight away. They can then talk to your doctor. The main things that could affect you are:
As the medicine can make you feel sleepy, it is important not to do outdoor sports like riding a horse or bike, swimming or climbing trees. You could hurt yourself and others.
If you feel unwell in any way while you are taking your medicine please tell an adult you trust straight away.
Other things to remember
Who should I ask if there is anything I don’t understand?
Your mum, dad, carer, your doctor, nurse or pharmacist will be able to help you.