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The product code(s) for this leaflet is: PLGB 46918/0006.
Atomoxetine 4mg/ml Oral Solution
Atomoxetine 4 mg/ml oral solution
atomoxetine
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:
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 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.
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
Atomoxetine oral solution 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, 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.
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:
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 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.
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.
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.
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.
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.
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.
This oral solution can irritate the eye. If the oral solution comes 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 oral solution should also be washed as soon as possible.
This medicine contains 32.97 mg sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
This medicine contains 2.63 mg of sodium (main component of cooking/table salt) in each ml. This is equivalent to 3.3 % of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 0.8 mg of sodium benzoate in each ml.
This medicine contains 9.44 mg of propylene glycol in each ml.
This medicine contains 0.02 mg ethanol (alcohol) in each ml.
The amount of alcohol in 25 ml of this medicine (the maximum daily dose) is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
Atomoxetine oral solution is available in a bottle. This is part of a pack which also includes a dosing device containing a 10 ml oral syringe marked in 1 ml increments and a press-in-bottle adaptor. Read the instructions for use booklet, which is included in the carton for instructions on how to use the adaptor and the dosing syringe.
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 weight. He/she will normally start you on a lower dose before increasing the amount of Atomoxetine you need to take according to your body weight.
Adults
If you have problems with your liver your doctor may prescribe a lower dose.
If you take more Atomoxetine than you should contact your doctor or the nearest hospital casualty department immediately and tell them how much medicine you have taken. The most commonly reported symptoms accompanying overdoses are gastrointestinal symptoms, sleepiness, dizziness, tremor, and abnormal behaviour.
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 there are usually no side effects but your ADHD symptoms may return. You should talk to your doctor first before you stop treatment.
Your doctor will do some tests
They will also be done when the dose is changed. These tests will include:
Atomoxetine does not need to be taken for ever. 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.
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)
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)
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.
ADULTS
Common side effects (may affect up to 1 in 10 people)
CHILDREN and YOUNG PEOPLE over 6 years
ADULTS
Uncommon side effects (may affect up to 1 in 100 people)
CHILDREN and YOUNG PEOPLE over 6 years
ADULTS
Rare side effects (may affect up to 1 in 1,000 people)
CHILDREN and YOUNG PEOPLE over 6 years
ADULTS
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.
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 the Yellow Card Scheme at 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.
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 bottle after ‘Exp’. The expiry date refers to the last day of that month.
Do not use the oral solution more than 45 days after the first time you open the bottle.
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.
Oral solution, 4 mg/ml (clear colourless)
Atomoxetine oral solution is available in a bottle with a child resistant cap containing 100 ml of solution. The pack also includes a dosing device consisting of a 10 ml oral syringe marked in 1 ml increments and a press-in-bottle adaptor.
Atomoxetine oral solution is available in a pack containing one bottle and in a multipack of three bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
To request a copy of this leaflet in Braille, large print or audio please call 0800 198 5000 (UK only).
Please be ready to give the following information:
Product name: Atomoxetine 4 mg/ml oral solution
Reference number: PLGB 46918/0006
This leaflet was last revised in 09/2022.