Find similiar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 49718/0010.
Atomoxetine 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg hard capsules
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
Atomoxetine
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 contains the active substance 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.
In adults, this medicine 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 Atomoxetine works
This medicine 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.
Children and adolescents with ADHD find it:
It is not their fault that they cannot do these things. Many children and adolescents struggle to do these things. However, with ADHD this can cause problems with everyday life. Children and adolescents 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 adolescent.
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 you:
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 this medicine. This is because this medicine 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.
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:
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.
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.
If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby or planning to breast-feeding your 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.
You may feel tired, sleepy or dizzy after taking Atomoxetine. You should be careful if you are driving or operating machinery until you know how Atomoxetine affects you. If you feel tired, sleepy or dizzy you should not drive or operate machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
If you have problems with your liver your doctor may prescribe a lower dose.
If you are a child or adolescent (6 years or older):
Your doctor will tell you how much Atomoxetine you should take and will calculate this according to your weight. Your doctor will normally start you on a lower dose before increasing the amount of Atomoxetine you need to take according to your body weight.
Use in children under six years of age
Atomoxetine is not for use as a treatment for ADHD in children under 6 years of age as it is not known if the medicine works or is safe in these people.
It may take a few weeks after you start the medicine for your symptoms to fully improve.
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.
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 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.
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.
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)
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:
Very common side effects (may affect more than 1 in 10 people)
CHILDREN and ADOLESCENTS 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 ADOLESCENTS over 6 years
ADULTS
Uncommon side effects (may affect up to 1 in 100 people)
CHILDREN and ADOLESCENTS over 6 years
ADULTS
Rare side effects (may affect up to 1 in 1,000 people)
CHILDREN and ADOLESCENTS 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
This medicine 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 protect the environment.
What Atomoxetine contains
Atomoxetine 100 mg hard capsules
Each hard capsule contains 100 mg atomoxetine as 114.28 mg atomoxetine hydrochloride.
Atomoxetine 10 mg hard capsules
hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque white cap imprinted in black ink with ‘10’ and opaque white body imprinted in black ink with ‘mg’, containing white powder.
Atomoxetine 18 mg hard capsules
hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque rich yellow cap imprinted in black ink with ‘18’ and opaque white body imprinted in black ink with ‘mg’, containing white powder.
Atomoxetine 25 mg hard capsules
hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque blue cap imprinted in black ink with ‘25’ and opaque white body imprinted in black ink with ‘mg’, containing white powder.
Atomoxetine 40 mg hard capsules
hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque blue cap imprinted in black ink with ‘40’ and opaque blue body imprinted in black ink with ‘mg’, containing white powder.
Atomoxetine 60 mg hard capsules
hard gelatin capsule of size No 2 (length of 17.6±0.4 mm), opaque blue cap imprinted in black ink with ‘60’ and opaque rich yellow body imprinted in black ink with ‘mg’, containing white powder.
Atomoxetine 80 mg hard capsules
hard gelatin capsule of size No 2 (length of 17.6±0.4 mm), opaque brown cap imprinted in black ink with ‘80’ and opaque white body imprinted in black ink with ‘mg’, containing white powder.
Atomoxetine 100 mg hard capsules
hard gelatin capsule of size No 1 (length of 19.1 ± 0.4 mm), opaque brown cap imprinted in black ink with ‘100’ and opaque brown body imprinted in black ink with ‘mg’, containing white powder.
Atomoxetine is supplied in blisters in a cardboard box.
Pack sizes:
Atomoxetine neuraxpharm 10 mg, 18 mg, 100 mg: 7, 14, 28 and 56 hard capsules
Atomoxetine neuraxpharm 25 mg, 40 mg, 60 mg, 80 mg: 7, 14, 28, 56 and 98 hard capsules
Not all pack sizes may be marketed.
or
or
or
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Atomoxetin-neuraxpharm 10 mg Hartkapseln
Atomoxetin-neuraxpharm 18 mg Hartkapseln
Atomoxetin-neuraxpharm 25 mg Hartkapseln
Atomoxetin-neuraxpharm 40 mg Hartkapseln
Atomoxetin-neuraxpharm 60 mg Hartkapseln
Atomoxetin-neuraxpharm 80 mg Hartkapseln
Atomoxetin-neuraxpharm 100 mg Hartkapseln
Poland: Atomoxetine NeuroPharma
United Kingdom: Atomoxetine neuraxpharm 10 mg hard capsules
Atomoxetine neuraxpharm 18 mg hard capsules
Atomoxetine neuraxpharm 25 mg hard capsules
Atomoxetine neuraxpharm 40 mg hard capsules
Atomoxetine neuraxpharm 60 mg hard capsules
Atomoxetine neuraxpharm 80 mg hard capsules
Atomoxetine neuraxpharm 100 mg hard capsules
This leaflet was last revised in 01/2020
761G.1a
NP-0105-06