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The product code(s) for this leaflet is: PL35533/0115.
Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg hard capsules
Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg 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 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 medicine works or is safe in these people.
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.
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. 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 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 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.
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.
It is not known if this medicine can affect an unborn baby or pass into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby or planning to breast-feed your baby, 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.
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.
Adults
Atomoxetine should be started at a total daily dose of 40mg for a minimum of 7 days. Your doctor may then decide to increase this to the usual maintenance dose of 80mg-100mg daily. The maximum daily dose your doctor will prescribe is 100mg.
If you have problems with your liver your doctor may prescribe a lower dose.
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.
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. 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)
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 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 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 (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.
The active substance is atomoxetine.
Active Substance: Each hard capsule contains 10mg atomoxetine as 11.43mg atomoxetine hydrochloride
Capsule Shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), Purified water
Active Substance: Each hard capsule contains 18mg atomoxetine as 20.57mg atomoxetine hydrochloride
Capsule Shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), iron oxide yellow (E172), Purified water
Active Substance: Each hard capsule contains 25mg atomoxetine as 28.57mg atomoxetine hydrochloride
Capsule Shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), indigo carmine (E132), Purified water
Active Substance: Each hard capsule contains 40mg atomoxetine as 45.71mg atomoxetine hydrochloride
Capsule Shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), indigo carmine (E132), Purified water
Active Substance: Each hard capsule contains 60mg atomoxetine as 68.57mg atomoxetine hydrochloride
Capsule Shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172), Purified water
Active Substance: Each hard capsule contains 80mg atomoxetine as 91.42mg atomoxetine hydrochloride
Capsule Shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), Purified water
Active Substance: Each hard capsule contains 100mg atomoxetine as 114.28mg atomoxetine hydrochloride
Capsule Shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), Purified water
Atomoxetine 10mg hard capsules: White powder in a 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’.
Atomoxetine 18mg hard capsules: White powder in a 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’.
Atomoxetine 25mg hard capsules: White powder in a 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’.
Atomoxetine 40mg hard capsules: White powder in a 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.’
Atomoxetine 60mg hard capsules: White powder in a 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’.
Atomoxetine 80mg hard capsules: White powder in a 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’.
Atomoxetine 100mg hard capsules: White powder in a 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’.
Atomoxetine is supplied in blisters in a cardboard box.
7, 14, 28 and 56 hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer(s)
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This leaflet was last revised in 12/2019
1010436 - P4.1