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ATOMOXETINE 60MG HARD CAPSULES

Active substance(s): ATOMOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user
Atomoxetine 10mg Hard Capsules
Atomoxetine 18mg Hard Capsules
Atomoxetine 25mg Hard Capsules
Atomoxetine 40mg Hard Capsules
Atomoxetine 60mg Hard Capsules
Atomoxetine 80mg Hard Capsules
Atomoxetine 100mg Hard Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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 full name of this medicine is Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, and
100mg hard capsules but within the leaflet it will be referred to as Atomoxetine Capsules.
What is in this leaflet
1.
What Atomoxetine Capsules are and what they are used for
2.
What you need to know before you take Atomoxetine Capsules
3.
How to take Atomoxetine Capsules
4.
Possible side effects
5.
How to store Atomoxetine Capsules
6.
Contents of the pack and other information

1.

What Atomoxetine Capsules are and what they are used for

What it is used for
Atomoxetine Capsules contain atomoxetine and is used to treat attention-deficit and hyperactivity
disorder (ADHD). It is used
in children over six years of age
in young people
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 this age group.
In adults, Atomoxetine Capsules are 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 Capsules 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
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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 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
education.

2.

What you need to know before you take Atomoxetine Capsules

Do not take Atomoxetine Capsules:
if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in
section 6).
if you took a medicine known as a monoamine oxidase inhibitor (MAOI), for example
phenelzine, in the last two weeks. An MAOI is sometimes used for depression and other
mental-health problems; taking Atomoxetine Capsules with an MAOI could cause serious side
effects or be life-threatening. You also need to wait at least 14 days after you stop taking
Atomoxetine Capsules before you take an MAOI
if you have an eye disease called narrow-angle glaucoma (increased pressure in your eye)
if you 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 Capsules
if you 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 a tumour of your adrenal gland (phaeochromocytoma).
Do not take Atomoxetine Capsules if any of the above applies to you. If you are not sure, talk to your
doctor or pharmacist before you take Atomoxetine Capsules. This is because Atomoxetine Capsules
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 Capsules if you have:
thoughts about killing yourself or trying to kill yourself.
problems with your heart (including heart defects) or an increased heartbeat. Atomoxetine
Capsules can increase your heart rate (pulse). Sudden death has been reported in patients with
heart defects.
high blood pressure. Atomoxetine Capsules can increase blood pressure.
low blood pressure. Atomoxetine Capsules can cause dizziness or fainting in people with low
blood pressure.
problems with sudden changes in your blood pressure or your heart rate.
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cardiovascular disease or past medical history of stroke.
liver problems. You may need a lower dose.
psychotic symptoms including hallucinations (hearing voices 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 (hostility) feelings.
a history of epilepsy or have had seizures for any other reason. Atomoxetine Capsules might
lead to an increase in seizure frequency.
different moods than usual (mood swings) or feel very unhappy.
hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words.

Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is
because Atomoxetine Capsules 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 Capsules
These checks are to decide if Atomoxetine Capsules 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
Capsules
your height and weight if you are a child or teenager during the time you take Atomoxetine
Capsules.
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 Capsules 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 Capsules
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
Capsules 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 Capsules with medicines called MAOIs (monoamine oxidase inhibitors)
used for depression. See section 2 “Do not take Atomoxetine Capsules”.
If you are taking other medicines, Atomoxetine Capsules 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 Capsules:
-

medicines that increase blood pressure or are used to control blood pressure
medicines such as antidepressants, for example imipramine, venlafaxine, mirtazapine,
fluoxetine and paroxetine
some cough and cold remedies which contain medicines that can affect blood pressure. It is
important to check with your pharmacist when you buy any of these products
some medicines used to treat mental health conditions
medicines that are known to increase the risk of seizures
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-

some medicines that cause Atomoxetine Capsules to stay in the body for longer than normal
(such as quinidine and terbinafine)
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.

The medicines below may lead to an increased risk of an abnormal rhythm of the heart when taken
with Atomoxetine Capsules:
medicines used to control the rhythm of the heart
medicines which change the concentration of salts in the blood
medicines for malaria prevention and treatment
some antibiotic medicines (such as erythromycin and moxifloxacin).
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 Capsules.
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 discontinue
breastfeeding.
If you are pregnant or breast-feeding, thinking 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 Capsules. You should be careful if you
are driving a car or operating heavy machinery until you know how Atomoxetine Capsules 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 Capsules

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 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 Capsules 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.
Use in children and adolescents
If you are a child or teenager (6 years or older):

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Your doctor will tell you how much Atomoxetine Capsules 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 Capsules you need to take according to your body weight.
-

Body weight up to 70kg: a starting total daily dose of 0.5mg 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 1.2mg per kg of body weight daily.

-

Body weight over 70kg: a starting 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 daily. The
maximum daily dose your doctor will prescribe is 100mg.

Adults
Atomoxetine Capsules 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 80-100mg
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.
If you take more Atomoxetine Capsules than you should
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 Capsules
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 Capsules
If you stop taking Atomoxetine Capsules 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
before you start - to make sure that Atomoxetine Capsules is safe and will be of benefit.
after you start - they will be done at least every 6 months, but possibly more often.
They will also be done when the dose is changed. These tests will include:
measuring height and weight in children and young people
measuring blood pressure and heart rate
checking whether you have any problems or if side effects have got worse while taking
Atomoxetine Capsules.
Long-term treatment
Atomoxetine Capsules does not need to be taken forever. If you take Atomoxetine Capsules 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 C apsules helps them.
Your doctor will talk to you about these side effects.
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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)
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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.

Children and adolescents aged under 18 have an increased risk of side effects such as:
thinking about or feeling like killing yourself (may affect up to 1 in 100 people)
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.
Rare (may affect up to 1 in 1,000 people)
liver injury.
You should stop taking Atomoxetine Capsules 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.
Children and adolescents over 6 years
Very Common (may affect more than 1 in 10 people)
headache
pain in the stomach
decreased appetite (not feeling hungry)
feeling or being sick
sleepiness
increased blood pressure
increased heart rate (pulse).
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These effects may disappear after a while in most patients.
Common (may affect up to 1 in 10 people)
being irritable or agitated
problems sleeping including waking early
depression
feeling sad or hopeless
feeling anxious
tics
large pupils (the dark centre of the eye)
dizziness
constipation
loss of appetite
upset stomach, indigestion
swollen, reddened and itchy skin
rash
feeling lazy (lethargy)
chest pain
tiredness
weight loss.
Uncommon side effects (may affect up to 1 in 100 people)
fainting
tremor
migraine
blurred vision
abnormal skin sensation, such as burning, prickling, itching, or tingling
tingling or numbness in the hands or feet
seizure (fits)
feeling or having a very fast heartbeat (QT prolongation)
shortness of breath
increased sweating
itchy skin
lack of strength or energy.
Rare (may affect up to 1 in 1,000 people)
poor blood circulation which makes toes and fingers numb and pale (Raynaud’s disease)
problems going to the toilet such as frequent or hesitant urinating, pain on urinating
prolonged and painful erections
groin pain in males.
Adults
Very Common (may affect more than 1 in 10 people)
feeling sick
dry mouth
headache
decreased appetite (not feeling hungry)
problems getting to sleep, staying asleep and waking early
increased blood pressure
increased heart rate (pulse).
Common (may affect up to 1 in 10 people)
feeling agitated
decreased interest in sex
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sleep disturbance
depression
feeling sad or hopeless
feeling anxious
dizziness
an abnormal taste or change in taste that will not go away
tremor
tingling or numbness in the hands or feet
sleepiness, drowsy, feeling tired
constipation
stomach ache
indigestion
wind (flatulence)
being sick
hot flush or flushing
feeling or having a very fast heartbeat
swollen, reddened and itchy skin
increased sweating
rash
problems going to the toilet such as not be able to urinate, frequent or hesitant urinating, pain
on urinating
inflammation of the prostate gland (prostatitis)
groin pain in men
failure to obtain an erection
retarded orgasm
difficulty maintaining an erection
menstrual cramps
lack of strength or energy
tiredness
feeling lazy (lethargy)
chills
feeling, irritable, jittery
feeling thirsty
weight loss.

Uncommon (may affect up to 1 in 100 people)
restlessness
tics
fainting
migraine
blurred vision
heart rhythm abnormal (QT prolongation)
feeling cold in fingers and toes
chest pain
shortness of breath
raised red itchy rashes (hives)
muscle spasms
an urge to urinate
abnormal or absence of orgasm
irregular menstruation
ejaculation failure.
Rare (may affect up to 1 in 1,000 people)
poor blood circulation which makes toes and fingers numb and pale (Raynaud’s disease)
prolonged and painful erections.
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Effects on growth
Some children experience reduced growth (weight and height) when they start taking Atomoxetine
Capsules. 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 Capsules temporarily.
Reporting of side effects
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
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Atomoxetine Capsules

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.

6.

Contents of the pack and other information

What Atomoxetine Capsules contain
-

The active substance is atomoxetine hydrochloride. Each hard capsule contains atomoxetine
hydrochloride equivalent to either 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg of
atomoxetine.
The other ingredients are co-processed corn starch (consisting of corn starch and pregelatinised
corn starch), dimethicone 350 cs, sodium starch glycolate, gelatin, titanium dioxide (E171),
black ink (which contains shellac, propylene glycol, ammonia solution, black iron oxide (E172)
and potassium hydroxide) and colourants*.
* The colourants are:
10mg: No additional colourant.
18mg: Yellow iron oxide (E172)
25mg: and 40mg: Indigotine – FD&C Blue 2 (E132) and black iron oxide (E172)
60mg: Indigotine – FD&C Blue 2 (E132), black iron oxide (E172) and yellow iron oxide (E172)
80mg and 100mg: Yellow iron oxide (E172) and red iron oxide (E172)
What Atomoxetine Capsules look like and contents of the pack
10mg: Opaque white hard capsules, size 4, imprinted with “A910” in black ink.
18mg: Opaque gold (cap) and opaque white (body) hard capsules, size 3, imprinted with “A918” in
black ink.
25mg: Opaque blue (cap) and opaque white (body) hard capsules, size 3, imprinted with “A925” in
black ink.
40mg: Opaque blue hard capsules, size 2, imprinted with “A940” in black ink.
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60mg: Opaque blue (cap) and opaque gold (body) hard capsules, size 2, imprinted with “A960” in
black ink.
80mg: Opaque brown (cap) and opaque white (body) hard capsules, size 1, imprinted with “A980” in
black ink.
100mg: Opaque brown hard capsules, size 0, imprinted with “A900” in black ink.
Atomoxetine 10mg, 18mg, 25mg and 40mg Hard Capsules are available in pack sizes of 7 and 28.
Atomoxetine 60mg, 80mg and 100mg Hard Capsules are available in a pack size of 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Caduceus Pharma Ltd.
6th floor
94 Wigmore Street
London
W1U 3RF
UK
Manufacturer
Balkanpharma-Dupnitsa AD3 Samokovsko Shosse Str.
Dupnitsa
2600
Bulgaria
Actavis, Barnstaple, EX32 8NS, UK

This leaflet was last revised in February 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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