Patient Leaflet Updated 28-Dec-2020 | Zentiva
Atomoxetine 10mg 18mg 25mg 40mg 60mg 80mg & 100mg hard capsules
Package leaflet: Information for the patient
Atomoxetine 10 mg hard capsules
Atomoxetine 18 mg hard capsules
Atomoxetine 25 mg hard capsules
Atomoxetine 40 mg hard capsules
Atomoxetine 60 mg hard capsules
Atomoxetine 80 mg hard capsules
Atomoxetine 100 mg hard capsules
Read all of this leaflet carefully before you (or a child in your care) starts taking this medicine because it contains important information for you.
In the next sections, the word You means You or a child in your care.
What is in this leaflet:
1. What Atomoxetine is and what it is used for
2. What you need to know before you take Atomoxetine
3. How to take Atomoxetine
4. Possible side effects
5. How to store Atomoxetine
6. Contents of the pack and other information
1. WHAT ATOMOXETINE IS AND WHAT IT IS USED FOR
What it is used for
Atomoxetine hard capsules contain atomoxetine and are used to treat attention-deficit and hyperactivity disorder (ADHD). It is used in children over six years of age, in young people and in adults. 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, atomoxetine 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
Atomoxetine 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 hard to sit still and hard to concentrate. 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 work, relationships, low self-esteem and education.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATOMOXETINE
Do not take Atomoxetine
Do not take atomoxetine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take atomoxetine. This is because atomoxetine 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 atomoxetine if you have:
Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because atomoxetine 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 Atomoxetine
These checks are to decide if atomoxetine 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 atomoxetine 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 Atomoxetine
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 atomoxetine 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 atomoxetine with medicines called MAOIs (monoamine oxidase inhibitors) used for depression (see section 2 “Do not take Atomoxetine”).
If you are taking other medicines, atomoxetine 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 atomoxetine:
The medicines below may lead to an increased risk of an abnormal rhythm of the heart when taken with atomoxetine:
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 atomoxetine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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.
This medicine should not be used during pregnancy, unless your doctor has advised you to do so.
You should either avoid taking this medicine if you are breast-feeding or discontinue breast-feeding.
Driving and using machines
You may feel tired, sleepy or dizzy after taking atomoxetine.
You should be careful if you are driving a car or operating machinery until you know how atomoxetine 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 atomoxetine 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.
3. HOW TO TAKE ATOMOXETINE
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Atomoxetine is usually taken one or two times a day (morning and late afternoon or early evening).
Children should not take this medicine without help from an adult.
If you are taking atomoxetine once a day and experience sleepiness or feel sick, your doctor may change your treatment schedule to twice a day.
The capsules should be swallowed whole, either with or without food.
The capsules should not be opened and the contents inside the capsules should not be removed and taken in any other way. Taking the medicine at the same time each day may help you remember to take it.
How much to take
If you are a child or teenager (6 years or older)
Your doctor will tell you how much atomoxetine you should take and will calculate this according to your body weight. The doctor will normally start you on a lower dose before increasing the amount of atomoxetine you need to take, according to your body weight.
Atomoxetine should be started at a total daily dose of 40 mg for a minimum of 7 days. Your doctor may then decide to increase this to the usual maintenance dose of 80 mg -100 mg daily. The maximum daily dose your doctor will prescribe is 100 mg.
If you have problems with your liver your doctor may prescribe a lower dose.
If you take more Atomoxetine than you should
If you take more than the prescribed dose, 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 Atomoxetine
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 Atomoxetine
If you stop taking atomoxetine 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:
Atomoxtine does not need to be taken forever. If you take atomoxetine 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Although some people get side effects, most people find that atomoxetine helps them. Your doctor will talk to you about these side 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 1000 people) of side effects such as:
Rare (may affect up to 1 in 1,000 people)
You should stop taking atomoxetine 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
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 atomoxetine. 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 atomoxetine 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE ATOMOXETINE
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
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 contains
Atomoxetine 18, 80 and 100 mg: Yellow iron oxide.
Atomoxetine 25 and 40 mg: Indigo carmine.
Atomoxetine 60 mg: Yellow iron oxide, Indigo carmine.
What Atomoxetine looks like and contents of the pack
Atomoxetine 10 mg: White capsule of size 4 with black imprinting symbol '10' containing white to off-white powder.
Atomoxetine 18 mg: Light yellow-white, size 4 capsule of size 4 with black imprinting symbol '18' containing white to off-white powder.
Atomoxetine 25 mg: White-blue capsule of size 4 with black imprinting symbol '25' containing white to off-white powder.
Atomoxetine 40 mg: Blue capsule of size 3 with black imprinting symbol '40' containing white to off-white powder.
Atomoxetine 60 mg: Blue-light yellow capsule of size 1 with black imprinting symbol '60' containing white to off-white powder.
Atomoxetine 80 mg: Yellow-white capsule of size 1 with black imprinting symbol '80' containing white to off-white powder.
Atomoxetine 100 mg: Yellow capsule of size 0 with black imprinting symbol '100' containing white to off-white powder.
The capsules are packed in PVC/Aclar/PVC – Al blisters and enclosed in a paper folding box.
Atomoxetine capsules are available in packs of 7, 14, 28, 30, 56, 84, 60, 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in 11/2020.