Patient leaflet - ATOMOXETINE 18 MG CAPSULES HARD
Atomoxetine 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg Capsules, hard
Important things you need to know about your medicine
This medicine is used to treat ADHD:
- The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’.
- The medicine helps with your brain activity. It can help improve your attention, help you concentrate, and make you less impulsive.
- You need to have other help for ADHD as well as this medicine.
Read Section 1 for more information.
Before you take this medicine, talk to your doctor if you:
- have mental health problems
- have a problem with your heart or blood circulation
- have serious problems with the blood vessels in your brain such as a stroke
Read Section 2 for more information.
While taking this medicine:
- See your doctor regularly. This is because your doctor will want to check how the medicine is working.
- Do not stop taking the medicine without first talking to your doctor.
- Your doctor may stop your medicine to see if it is still needed, if you take it for more than a year.
- The most common side effects in children and young people are:
headache, stomach ache, not feeling hungry, feeling or being sick, feeling sleepy, increased blood pressure, increased heart rate (pulse).
- The most common side effects in adults are:
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:
- your mood and how you feel changes
- you feel any problems with your heart e.g. a fast or unusual heartbeat rhythm
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.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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
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1. What Atomoxetine is and what it is used for
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2. What you need to know before you take Atomoxetine
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3. How to take Atomoxetine
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4. Possible side effects
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5. How to store Atomoxetine
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6. Contents of the pack and other information
1. what atomoxetine is and what it is used for
- Atomoxetine capsules, hard contains the active substance atomoxetine, which is used to treat attentiondeficit and hyperactivity disorder (ADHD). It is used: in children over six years of age in adolescents in adults
Atomoxetine 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.
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.
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.
About ADHD
Children and adolescents 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 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: work relationships low self esteem education
2. what you need to know before you take atomoxetine
Do not take Atomoxetine if you:
- are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
- took a medicine known as a monoamine oxidase inhibitor (MAOI), for example phenelzine, in the last two weeks. A MAOI is sometimes used for depression and other mental health problems; taking atomoxetine with a MAOI could cause serious side effects or be life-threatening. You also need to wait at least 14 days after you stop taking Atomoxetine before you take a MAOI
- have an eye disease called narrow-angle glaucoma (increased pressure in your eye)
- have serious problems with your heart which may be affected by an increase in heart rate and/or blood pressure, as this may be an effect of Atomoxetine
- have serious problems with the blood vessels in your brain – such as a stroke, swelling and weakening of part of a blood vessel (aneurysm) or narrow or blocked blood vessels
- have or have ever had a tumour of your adrenal gland (phaeochromocytoma)
Do not take this medicine 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 adults and children should be aware of the following warnings and precautions. Talk to your doctor or pharmacist before taking Atomoxetine if you have:
- problems with your heart (including heart defects) or an increased heartbeat. Atomoxetine can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
- high blood pressure. Atomoxetine can increase blood pressure.
- low blood pressure. Atomoxetine can cause dizziness or fainting in people with low blood pressure.
- problems with sudden changes in your blood pressure or your heart rate.
- cardiovascular disease or past medical history of stroke.
- liver problems. You may need a lower dose.
- a history of epilepsy or have had seizures for any other reason. Atomoxetine might lead to an increase in seizure frequency.
- depression, anxiety or ‘tics’ (uncontrollable movements, twitches or speech) – see also ‘Behaviour changes’ below
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.
Behaviour changes
Atomoxetine can cause changes to your behaviour during treatment, or make some conditions worse.
If you have any of the following and notice they become worse, or if you notice them for the first time during treatment, tell your doctor straight away:
- thoughts about killing or harming yourself, or trying to kill yourself
- psychotic symptoms including hallucinations (hearing or seeing things which are not there), believing things that are not true or being suspicious
- mania (feeling elated or over-excited, which causes unusual behaviour) and agitation
- aggressive feelings
- unfriendly and angry feelings (hostility)
- different moods than usual (mood swings) or feeling very unhappy (depression) or worried (anxiety).
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 blood pressure and your heart rate (pulse) before and during the time you take Atomoxetine
- your height and weight if you are a child or teenager during the time you take Atomoxetine
Your doctor will talk to you about:
- any other medicines you are taking
- whether there is any family history of sudden unexplained death
- any other medical problems (such as heart problems) you or your family may have
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.
Children under 6 years of age
Atomoxetine should not be used in children under 6 years of age as it is not known if the medicine works or is safe in this age group.
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.
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:
- medicines that increase blood pressure or are used to control blood pressure
- medicines for depression such as imipramine, venlafaxine, mirtazapine, fluoxetine and paroxetine
- medicines used to treat other mental health conditions
- some cough and cold remedies which contain medicines that can affect blood pressure. It is important to check with your pharmacist when you get any of these products
- quinidine (a medicine to treat abnormal heart rhythm)
- terbinafine (a medicine for fungal infection)
- salbutamol (a medicine to treat asthma) when taken by mouth or injected may make you feel as if your heart is racing, but this will not make your asthma worse
- medicines used to control the rhythm of the heart
- medicines which change the concentration of salts in the blood
- mefloquine or chloroquine (medicines for the treatment and prevention of malaria)
- methadone (a medicine used to treat addiction to certain substances)
- some antibiotic medicines (such as erythromycin and moxifloxacin)
- cisapride (a medicine to treat digestive problems)
- tramadol (a strong painkiller)
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 and breast-feeding
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 stop breast-feeding.
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.
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.
Atomoxetine contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‚sodium-free‘.
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. This is usually one or two times each 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 (see section 2, “Important information about the content of the capsules”)
- Taking the medicine at the same time each day may help you remember to take it
Children and adolescents (6 years or older)
Your doctor will tell you how much medicine 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.
Information for children and young people
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:
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* run about too much
-
* not be able to pay attention
-
* act quickly without thinking about what will happen next (impulsive)
- It affects learning, making friends and how you think about yourself. It is not your fault.
While you are taking this medicine:
- As well as taking this medicine you will also get help with ways to cope with your ADHD such as talking to ADHD specialists.
- This medicine should help you. But it does not cure ADHD.
- You will need to go to your doctor several times a year for check-ups. This is to make sure the medicine is working and that you are growing and developing all right.
- Girls must tell their doctor straight away if they think they may be pregnant. We do not know how this medicine affects unborn babies. If you are having sex, please talk to your doctor about contraception.
Some people cannot have this medicine
You cannot have this medicine if you:
- took a medicine known as a monoamine oxidase inhibitor (MAOI), for example phenelzine, in
- the last two weeks
- have an eye disease called narrow-angle glaucoma (increased pressure in your eye)
- have a serious problem with your heart
- have serious problems with the blood vessels in your brain
- have a tumour of your adrenal gland
Some people need to talk to their doctor before they start taking this medicine
You need to talk to your doctor if you:
- are pregnant or breastfeeding
- are taking other medicines – your doctor needs to know about all the medicines you are taking
- have thoughts about hurting yourself or others
- have problems with your heart beating too fast or skipping beats while you are not exercising
- hear voices or see things that others do not
- have problems with getting angry easily
Body weight up to 70 kg
A starting total daily dose of 0.5 mg per kg of body weight for a minimum of 7 days. Your doctor may then decide to increase this to the usual maintenance dose of about 1.2 mg per kg of body weight daily.
Body weight over 70 kg
A starting 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 daily. The maximum daily dose your doctor will prescribe is 100 mg.
Adults
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 to 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.
Things your doctor will do when you are taking this medicine
Your doctor will do some tests:
- before you start – to make sure that atomoxetine is safe and will be of benefit.
- after you start – they will be done at least every 6 months, but possibly more often.
Some tests will also be performed when your dose is changed. These tests will include:
- measuring height and weight in children and adolescents
- measuring blood pressure and heart rate
- checking whether you have any problems or if side effects have got worse while taking atomoxetine
Long-term treatment
Atomoxetine does not need to be taken for ever. If you take this medicine for more than a year, your doctor will review your treatment, to see if the medicine is still needed.
If you take more Atomoxetine than you should
Contact your doctor or the nearest hospital emergency 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.
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):
- feeling or having a very fast heartbeat, abnormal rhythms of the heart
- thinking about or feeling like killing yourself
- feeling aggressive
- feeling unfriendly and angry (hostility)
- mood swings or mood changes
- serious allergic reaction with symptoms of swelling of the face and throat, difficulty breathing, hives (small raised, itchy patches of skin)
- seizures
- psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious
Rare (may affect up to 1 in 1,000 people):
- liver injury, causing yellowing of the skin and eyes, fever with abdominal pain, dark urine or pale stools
- prolonged and painful erection lasting longer than 4 hours
Children and adolescents aged under 18 have an increased risk of side effects such as:
- mood swings or mood changes (may affect up to 1 in 10 people)
Adults have a reduced risk (may affect up to 1 in 1,000 people) of side effects such as:
- seizures
- psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious
You should stop taking Atomoxetine and call your doctor immediately if you have any of the following:
- dark urine
- yellow skin or yellow eyes
- tummy pain which is sore when you press it (tenderness) on the right side just below your ribs
- a feeling of sickness (nausea) that is unexplained
- tiredness
- itching
- feeling that you are coming down with flu
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 | Adults |
These effects may disappear after a while in most patients. |
|
| 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 |
| |
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 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 at:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App.
5. how to store atomoxetine
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 blister or carton 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.
6. contents of the pack and other information
What Atomoxetine contains
The active substance is atomoxetine. Each capsules contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg atomoxetine.
The other ingredients are:
Capsule contents: maize starch, pregelatinised maize starch, dimeticone and sodium starch glycolate Capsule shell: gelatine, titanium dioxide (E171), iron oxide yellow (E172) (18 mg, 60 mg, 80 mg, 100 mg capsules only), iron oxide black (E172) (25 mg, 40 mg, 60 mg capsules only), iron oxide red (E172) (80 mg, 100 mg capsules only), Indigotine (E132) (25 mg, 40 mg, 60 mg capsules only)
Printing ink: shellac, propylene glycol, iron oxide black (E172), potassium hydroxide
See section 2, 'Atomoxetine contains sodium’
What Atomoxetine looks like and contents of the pack
Atomoxetine 10 mg Capsules, hard are hard gelatine capsules with white cap and body, printed with “A910” on the cap and body in black ink.
Atomoxetine 18 mg Capsules, hard are hard gelatine capsules with gold cap and white body, printed with “A918” on the cap and body in black ink.
Atomoxetine 25 mg Capsules, hard are hard gelatine capsules with blue cap and white body, printed with “A925” on the cap and body in black ink.
Atomoxetine 40 mg Capsules, hard are hard gelatine capsules with blue cap and body, printed with “A940” on the cap and body in black ink.
Atomoxetine 60 mg Capsules, hard are hard gelatine capsules with blue cap and gold body, printed with “A960” on the cap and body in black ink.
Atomoxetine 80 mg Capsules, hard are hard gelatine capsules with brown cap and white body, printed with “A980” on the cap and body in black ink.
Atomoxetine 100 mg Capsules, hard are hard gelatine capsules with brown cap and body, printed with “A900” on the cap and body in black ink.
This medicine comes in blisters containing 7, 28 or 56 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Station Close,
Potters Bar,
Herts EN6 1TL,
United Kingdom.
Manufacturer
Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland
Mylan Hungary Kft,
Mylan Utca 1,
H-2900 Komarom,
Hungary
Balkanpharma Dupnitsa AD,
3 Samokovsko Shosse Str.,
Dupnitsa 2600,
Bulgaria
Actavis UK Limited,
Whiddon Valley,
Barnstaple,
Devon,
EX32 8NS,
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark: Atomoxetin Mylan
Czech Republic: Atomoxetin Mylan
Ireland: Atomoxetine 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg hard capsules
Netherlands: Atomoxetine HCl Mylan 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg harde capsules
Romania: Aomoxetina Mylan 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg capsule
Sweden: Atomoxetin Mylan
Slovakia: Atomoxetin Mylan 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
United Kingdom: Atomoxetine 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg Capsules, hard
This leaflet was last revised in September 2020
2266024
How do I take my medicine (capsules)?
- Swallow your medicine with water either with or without food.
- The capsules should not be opened. If the capsule breaks and the contents inside the capsules come into contact with your skin or eyes, get help from an adult.
- Your doctor will tell you how many times a day you should take your medicine.
- Take your medicine at the same time each day may help you remember to take it.
- Do not stop taking the medicine without talking to your doctor first.
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:
- Your heart beating faster than usual
- Being very depressed and unhappy or wanting to hurt yourself
- Feeling aggressive
- Being very unhappy or having different moods than usual (mood swings)
- Showing signs of an allergic reaction such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
- Having fits (seizures)
- Seeing, feeling, or hearing things that other people do not
- Liver injury: tummy pain which is sore when you press it (tenderness) on the right side just below your ribs 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:
- Make sure you keep your medicine in a safe place, so that no one else takes it, especially younger brothers or sisters.
- The medicine is only for you – do not let anyone else have it. It may help you, but it could hurt someone else.
- If you forget to take your medicine don’t take two capsules the next time. Just take one capsule at the next normal time.
- If you do take too much medicine, tell your mum, dad or carer right away.
- It is important not to take too much medicine or you will get ill.
- Don’t stop taking your medicine until your doctor says it’s OK