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ATOMOXETINE SANDOZ 80 MG CAPSULES HARD

Active substance(s): ATOMOXETINE HYDROCHLORIDE / ATOMOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user

SZ00000LT000

Atomoxetine 10 mg Capsules, hard
Atomoxetine 18 mg Capsules, hard
Atomoxetine 25 mg Capsules, hard
Atomoxetine 40 mg Capsules, hard
Atomoxetine 60 mg Capsules, hard
Atomoxetine 80 mg Capsules, hard
Atomoxetine 100 mg Capsules, hard
Atomoxetine
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.
What is in this leaflet
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

1

What Atomoxetine is and what it is
used for

What it is used for
Atomoxetine contains atomoxetine and is used to treat
attention-deficit and hyperactivity disorder (ADHD). It is used:
• in children over six years of age
• in adolescents
• 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 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.
How it 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.
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. An MAOI is sometimes used for depression and
other mental-health problems; taking Atomoxetine 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 this medicine before you take an 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 a tumour of your adrenal gland (phaeochromocytoma).
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.
Warnings and precautions
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:
• thoughts about killing yourself or trying to kill yourself.
• 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.
• 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 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
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
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.
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 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 get any of these products.
• some medicines used to treat mental health conditions
• medicines that are known to increase the risk of seizures
• some medicines that cause Atomoxetine 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:
• 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.
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 breast-feeding.
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.
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.

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 a day (morning and late afternoon or early evening).
• Children should not take this medicine without the
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.
• Oral use.
• 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.
How much to take
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.
• 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-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 on treatment
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.
They will also be done when the 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
Atomoxetine 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 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
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
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
Rarely (may affect up to 1 in 1,000 people)
• liver injury
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
• headache
• pain in the stomach
• decreased appetite (not feeling hungry)
• feeling or being sick
• sleepiness
• increased blood pressure
• increased heart rate (pulse)
ADULTS
These effects may disappear after a while in most patients.
• 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 side effects (may affect up to 1 in 10 people)
CHILDREN and ADOLESCENTS over 6 years
• 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
ADULTS
• feeling agitated
• decreased interest in sex
• 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 side effects (may affect up to 1 in 100 people)
CHILDREN and ADOLESCENTS over 6 years
• 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
ADULTS
• 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 side effects (may affect up to 1 in 1,000 people)
CHILDREN and ADOLESCENTS over 6 years
• 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
• poor blood circulation which makes toes and fingers
numb and pale (Raynaud’s disease)
• prolonged and painful erections

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.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme (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

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 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.
• Atomoxetine 10 mg Capsules, hard
Each hard capsule contains 10 mg atomoxetine as
11.43 mg atomoxetine hydrochloride.
• The other ingredients are
Capsule content: Pregelatinized maize starch, silica
colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), Purified water
• Atomoxetine 18 mg Capsules, hard
Each hard capsule contains 18 mg atomoxetine as
20.57 mg atomoxetine hydrochloride.
• The other ingredients are
Capsule content: Pregelatinized maize starch, silica
colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), iron oxide yellow (E172),
Purified water
• Atomoxetine 25 mg Capsules, hard
Each hard capsule contains 25 mg atomoxetine as
28.57 mg atomoxetine hydrochloride.
• The other ingredients are
Capsule content: Pregelatinized maize starch, silica
colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), indigo carmine (E132),
Purified water
• Atomoxetine 40 mg Capsules, hard
Each hard capsule contains 40 mg atomoxetine as
45.71 mg atomoxetine hydrochloride.
• The other ingredients are
Capsule content: Pregelatinized maize starch, silica
colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), indigo carmine (E132),
Purified water
• Atomoxetine 60 mg Capsules, hard
Each hard capsule contains 60 mg atomoxetine as
68.57 mg atomoxetine hydrochloride.
• The other ingredients are
Capsule content: Pregelatinized maize starch, silica
colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), indigo carmine (E132), iron
oxide yellow (E172), Purified water
• Atomoxetine 80 mg Capsules, hard
Each hard capsule contains 80 mg atomoxetine as
91.42 mg atomoxetine hydrochloride.
• The other ingredients are
Capsule content: Pregelatinized maize starch, silica
colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), iron oxide red (E172), iron
oxide yellow (E172), Purified water
• Atomoxetine 100 mg Capsules, hard
Each hard capsule contains 100 mg atomoxetine as
114.28 mg atomoxetine hydrochloride.
• The other ingredients are
Capsule content: Pregelatinized maize starch, silica
colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), iron oxide red (E172), iron
oxide yellow (E172), Purified water
• Printing ink (black) consisting of: Shellac Glaze-45%
(20% Esterified) in Ethanol, Iron Oxide Black (E172),
Propylene Glycol
What Atomoxetine looks like and contents of the pack
• Atomoxetine 10 mg Capsules, hard
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 18 mg Capsules, hard
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 25 mg Capsules, hard
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 40 mg Capsules, hard
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 60 mg Capsules, hard
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 80 mg Capsules, hard
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 100 mg Capsules, hard
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.
Pack sizes:
7, 14, 28, 56 and 84 hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK
Manufacturer
LEK farmacevtska družba d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
or
Pharmathen S.A.
6, Dervenakion str., Pallini, 153 51, Greece
or
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA3000, Malta
or
Pharmathen International S.A.
Industrial Park Sapes, Block No.5
Rodopi Prefecture,
69300, Greece
This leaflet was last revised in 07/2017.

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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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