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ATOMOXETINE SANDOZ 25 MG CAPSULES HARD

Active substance(s): ATOMOXETINE HYDROCHLORIDE

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Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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Package leaflet: Information for the user
[Invented name] 10 mg hard capsules
[Invented name] 18 mg hard capsules
[Invented name] 25 mg hard capsules
[Invented name] 40 mg hard capsules
[Invented name] 60 mg hard capsules
[Invented name] 80 mg hard capsules
[Invented name] 100 mg hard capsules
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 [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information

1.

What [Invented name] is and what it is used for

What it is used for
[Invented name] 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.

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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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 [Invented name]

Do not take [Invented name] 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 [Invented name] with an MAOI could cause serious side effects or be lifethreatening. 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 [Invented name].
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 [Invented name] 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 [Invented name] if you have:
thoughts about killing yourself or trying to kill yourself.
problems with your heart (including heart defects) or an increased heartbeat. [Invented name]
can increase your heart rate (pulse). Sudden death has been reported in patients with heart
defects.
high blood pressure. [Invented name] can increase blood pressure.
low blood pressure. [Invented name] can cause dizziness or fainting in people with low blood
pressure.

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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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. [Invented name] 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 [Invented name] 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 [Invented name]
These checks are to decide if [Invented name] 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 [Invented name]
your height and weight if you are a child or teenager during the time you take [Invented name]
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[Invented name] 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 [Invented name] 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 [Invented name]
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
[Invented name] 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 [Invented name] with medicines called MAOIs (monoamine oxidase inhibitors) used for
depression. See section 2 “Do not take [Invented name]”.
If you are taking other medicines, [Invented name] may affect how well they work or may cause side
effects.

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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If you are taking any of the following medicines, check with your doctor or pharmacist before taking
[Invented name]:
-

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 [Invented name] 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 [Invented name]:
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 [Invented name].
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, 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 [Invented name]. You should be careful if you are
driving a car or operating machinery until you know how [Invented name] affects you. If you feel
tired, sleepy or dizzy you should not drive or operate machinery.

3.

How to take [Invented name]

-

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 [Invented name] once a day and experience sleepiness or feel sick, your doctor
may change your treatment schedule to twice a day.

-

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

-

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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 [Invented name] 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
[Invented name] 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
[Invented name] 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 [Invented name] 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
[Invented name].
Long-term treatment
[Invented name] does not need to be taken for ever. If you take [Invented name] for more than a year,
your doctor will review your treatment, to see if the medicine is still needed.
If you take more [Invented name] 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 [Invented name]
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.

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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If you stop taking [Invented name]
If you stop taking [Invented name] 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 [Invented name] 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 [Invented name] 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

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

-

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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
ADULTS
6 years
headache
feeling sick
pain in the stomach
dry mouth
decreased appetite (not feeling hungry)
headache
feeling or being sick
decreased appetite (not feeling hungry)
sleepiness
problems getting to sleep, staying asleep
increased blood pressure
and waking early
increased heart rate (pulse)
increased blood pressure
increased heart rate (pulse)
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
ADULTS
6 years
being irritable or agitated
feeling agitated
problems sleeping including waking early
decreased interest in sex
depression
sleep disturbance
feeling sad or hopeless
depression
feeling anxious
feeling sad or hopeless
tics
feeling anxious
large pupils (the dark centre of the eye)
dizziness
dizziness
an abnormal taste or change in taste that
constipation
will not go away
loss of appetite
tremor
upset stomach, indigestion
tingling or numbness in the hands or feet
swollen, reddened and itchy skin
sleepiness, drowsy, feeling tired
rash
constipation
feeling lazy (lethargy)
stomach ache
chest pain
indigestion
tiredness
wind (flatulence)
weight loss
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

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

-

-

-

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(prostatitis)
genital pain in men
failure to obtain an erection
ejaculation disorder
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
ADULTS
6 years
fainting
restlessness
tremor
tics
migraine
fainting
blurred vision
migraine
abnormal skin sensation, such as burning,
blurred vision
prickling, itching, or tingling
heart rhythm abnormal (QT prolongation)
tingling or numbness in the hands or feet
feeling cold in fingers and toes
seizure (fits)
chest pain
feeling or having a very fast heartbeat (QT shortness of breath
prolongation)
raised red itchy rashes (hives)
shortness of breath
muscle spasms
increased sweating
an urge to urinate
itchy skin
abnormal or absence of orgasm
lack of strength or energy
irregular menstruation
ejaculation failure
Rare side effects (may affect up to 1 in 1,000 people)
CHILDREN and ADOLESCENTS over
ADULTS
6 years
poor blood circulation which makes toes
poor blood circulation which makes toes
and fingers numb and pale (Raynaud’s
and fingers numb and pale (Raynaud’s
disease)
disease)
problems going to the toilet such as
prolonged and painful erections
frequent or hesitant urinating, pain on
urinating
prolonged and painful erections
genital pain in males

Effects on growth
Some children experience reduced growth (weight and height) when they start taking [Invented
name]. 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

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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or gaining weight as expected, your doctor may change your child’s dose or decide to stop [Invented
name] 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 national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety
of this medicine.

5.

How to store [Invented name]

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 . 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 [Invented name] contains
The active substance is Atomoxetine.
-

-

-

-

[Invented name] 10 mg hard capsules
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
[Invented name] 18 mg hard capsules
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
[Invented name] 25 mg hard capsules
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
[Invented name] 40 mg hard capsules
Each hard capsule contains 40 mg atomoxetine as 45.71 mg atomoxetine hydrochloride.

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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-

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

-

[Invented name] 60 mg hard capsules
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

-

-

-

-

[Invented name] 80 mg hard capsules
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
[Invented name] 100 mg hard capsules
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 [Invented name] looks like and contents of the pack
- [Invented name] 10 mg 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’.
- [Invented name] 18 mg 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’.
- [Invented name] 25 mg 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’.
- [Invented name] 40 mg 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.’
- [Invented name] 60 mg 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’.

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

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- [Invented name] 80 mg 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’.
- [Invented name] 100 mg 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’.
[Invented name] is supplied in blisters in a cardboard box.
Pack sizes:
For DE/H/4592+3/001-007/DC
7, 14, 28, 56 and 84 hard capsules
For DE/H/4594/001-007/DC
7, 14, 28 and 56 hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
<[To be completed nationally]>
This medicinal product is authorised in the Member States of the EEA under the following
names:
DE/H/4592/001-007/DC
Germany
AtomoxeHEXAL 10 mg Hartkapseln
AtomoxeHEXAL 18 mg Hartkapseln
AtomoxeHEXAL 25 mg Hartkapseln
AtomoxeHEXAL 40 mg Hartkapseln
AtomoxeHEXAL 60 mg Hartkapseln
AtomoxeHEXAL 80 mg Hartkapseln
AtomoxeHEXAL 100 mg Hartkapseln
Austria
Atomoxetin Sandoz 10 mg – Hartkapseln
Atomoxetin Sandoz 18 mg – Hartkapseln
Atomoxetin Sandoz 25 mg – Hartkapseln
Atomoxetin Sandoz 40 mg – Hartkapseln
Atomoxetin Sandoz 60 mg – Hartkapseln
Atomoxetin Sandoz 80 mg – Hartkapseln
Atomoxetin Sandoz 100 mg – Hartkapseln
Belgium
Atomoxetin Sandoz 10 mg harde capsules
Atomoxetin Sandoz 18 mg harde capsules
Atomoxetin Sandoz 25 mg harde capsules
Atomoxetin Sandoz 40 mg harde capsules
Atomoxetin Sandoz 60 mg harde capsules
Atomoxetin Sandoz 80 mg harde capsules
Atomoxetin Sandoz 100 mg harde capsules
Cyprus
Atomoxetine Sandoz 10 mg

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

Czech Republic

Denmark

Estonia

Spain

Hungary

Iceland

Lithuania

Atomoxetine Sandoz 18 mg
Atomoxetine Sandoz 25 mg
Atomoxetine Sandoz 40 mg
Atomoxetine Sandoz 60 mg
Atomoxetin Sandoz 100 mg
Atomoxetin Sandoz 80 mg
Atomoxetin Sandoz 60 mg
Atomoxetin Sandoz 40 mg
Atomoxetin Sandoz 25 mg
Atomoxetin Sandoz 18 mg
Atomoxetin Sandoz 10 mg
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetina Sandoz 10 mg cápsulas duras EFG
Atomoxetina Sandoz 18 mg cápsulas duras EFG
Atomoxetina Sandoz 25 mg cápsulas duras EFG
Atomoxetina Sandoz 40 mg cápsulas duras EFG
Atomoxetina Sandoz 60 mg cápsulas duras EFG
Atomoxetina Sandoz 80 mg cápsulas duras EFG
Atomoxetina Sandoz 100 mg cápsulas duras EFG
Atomoxetin Sandoz 10 mg kemény kapszula
Atomoxetin Sandoz 18 mg kemény kapszula
Atomoxetin Sandoz 25 mg kemény kapszula
Atomoxetin Sandoz 40 mg kemény kapszula
Atomoxetin Sandoz 60 mg kemény kapszula
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz
Atomoxetine Sandoz 10 mg kietosios kapsulės
Atomoxetine Sandoz 18 mg kietosios kapsulės
Atomoxetine Sandoz 25 mg kietosios kapsulės
Atomoxetine Sandoz 40 mg kietosios kapsulės
Atomoxetine Sandoz 60 mg kietosios kapsulės
Atomoxetine Sandoz 80 mg kietosios kapsulės

Page 12 of 15
20170808
722-2627.00 722-2628.00
722-2629.00 722-2630.00
722-2631.00 722-2632.00
722-2633.00

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

Latvia

Netherlands

Norway
Romania

Atomoxetine Sandoz 100 mg kietosios kapsulės
Atomoxetine Sandoz 10 mg cietās kapsulas
Atomoxetine Sandoz 18 mg cietās kapsulas
Atomoxetine Sandoz 25 mg cietās kapsulas
Atomoxetine Sandoz 40 mg cietās kapsulas
Atomoxetine Sandoz 60 mg cietās kapsulas
Atomoxetine Sandoz 80 mg cietās kapsulas
Atomoxetine Sandoz 100 mg cietās kapsulas
Atomoxetine Sandoz 10 mg, harde capsules
Atomoxetine Sandoz 18 mg, harde capsules
Atomoxetine Sandoz 25 mg, harde capsules
Atomoxetine Sandoz 40 mg, harde capsules
Atomoxetine Sandoz 60 mg, harde capsules
Atomoxetine Sandoz 80 mg, harde capsules
Atomoxetine Sandoz 100 mg, harde capsules
Atomoxetine Sandoz
Atomoxetină Sandoz 10 mg capsule
Atomoxetină Sandoz 18 mg capsule
Atomoxetină Sandoz 25 mg capsule
Atomoxetină Sandoz 40 mg capsule
Atomoxetină Sandoz 60 mg capsule
Atomoxetină Sandoz 80 mg capsule

Sweden

Slovakia

United Kingdom

Atomoxetine Sandoz 10 mg kapslar, hårda
Atomoxetine Sandoz 18 mg kapslar, hårda
Atomoxetine Sandoz 25 mg kapslar, hårda
Atomoxetine Sandoz 40 mg kapslar, hårda
Atomoxetine Sandoz 60 mg kapslar, hårda
Atomoxetine Sandoz 80 mg kapslar, hårda
Atomoxetine Sandoz 100 mg kapslar, hårda
Atomoxetine Sandoz 10 mg
Atomoxetine Sandoz 18 mg
Atomoxetine Sandoz 25 mg
Atomoxetine Sandoz 40 mg
Atomoxetine Sandoz 60 mg
Atomoxetine Sandoz 10 mg Capsules, hard
Atomoxetine Sandoz 18 mg Capsules, hard
Atomoxetine Sandoz 25 mg Capsules, hard
Atomoxetine Sandoz 40 mg Capsules, hard
Atomoxetine Sandoz 60 mg Capsules, hard
Atomoxetine Sandoz 80 mg Capsules, hard
Atomoxetine Sandoz 100 mg Capsules, hard

DE/H/4593/001-007/DC
Germany

Atomoxetin - 1 A Pharma 10 mg Hartkapseln
Atomoxetin - 1 A Pharma 18 mg Hartkapseln
Atomoxetin - 1 A Pharma 25 mg Hartkapseln
Atomoxetin - 1 A Pharma 40 mg Hartkapseln
Atomoxetin - 1 A Pharma 60 mg Hartkapseln

Page 13 of 15
20170808
722-2627.00 722-2628.00
722-2629.00 722-2630.00
722-2631.00 722-2632.00
722-2633.00

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

Atomoxetin - 1 A Pharma 80 mg Hartkapseln
Atomoxetin - 1 A Pharma 100 mg Hartkapseln
DE/H/4594/001-007/DC
Austria
ATAMA 10 mg Hartkapseln
ATAMA 18 mg Hartkapseln
ATAMA 25 mg Hartkapseln
ATAMA 40 mg Hartkapseln
ATAMA 60 mg Hartkapseln
ATAMA 80 mg Hartkapseln
ATAMA 100 mg Hartkapseln
Czech Republic
Bitinex 10 mg
Bitinex 18 mg
Bitinex 25 mg
Bitinex 40 mg
Bitinex 60 mg
Bitinex 80 mg
Bitinex 100 mg
Denmark
Atomoxetin Medical Valley
Greece
ATAMA καψάκιο σκληρό 10 mg
ATAMA καψάκιο σκληρό 18 mg
ATAMA καψάκιο σκληρό 25 mg
ATAMA καψάκιο σκληρό 40 mg
ATAMA καψάκιο σκληρό 60 mg
ATAMA καψάκιο σκληρό 80 mg
ATAMA καψάκιο σκληρό 100 mg
Germany
ATAMA 10 mg Hartkapseln
ATAMA 18 mg Hartkapseln
ATAMA 25 mg Hartkapseln
ATAMA 40 mg Hartkapseln
ATAMA 60 mg Hartkapseln
ATAMA 80 mg Hartkapseln
ATAMA 100 mg Hartkapseln
Iceland
Atomoxetin Medical Valley 10 mg hylki hart
Atomoxetin Medical Valley 18 mg hylki hart
Atomoxetin Medical Valley 25 mg hylki hart
Atomoxetin Medical Valley 40 mg hylki hart
Atomoxetin Medical Valley 60 mg hylki hart
Atomoxetin Medical Valley 80 mg hylki hart
Atomoxetin Medical Valley 100 mg hylki hart
Spain
ATAMA 10 mg cápsulas duras EFG
ATAMA 18 mg cápsulas duras EFG
ATAMA 25 mg cápsulas duras EFG
ATAMA 40 mg cápsulas duras EFG
ATAMA 60 mg cápsulas duras EFG
ATAMA 80 mg cápsulas duras EFG
ATAMA 100 mg cápsulas duras EFG
Romania
Bitinex 10 mg capsule
Bitinex 18 mg capsule
Bitinex 25 mg capsule

Page 14 of 15
20170808
722-2627.00 722-2628.00
722-2629.00 722-2630.00
722-2631.00 722-2632.00
722-2633.00

Business use only
Sandoz
1.3.1 spc-label-pl - common-pl - 8,506
(DE/H/4592-4593/001-007)
ATOMOXETINE HYDROCHLORIDE 10 MG 100 MG 18 MG 25 MG
40 MG 60 MG 80 MG CAPSULE, HARD

Sweden

Slovakia

United Kingdom

Bitinex 40 mg capsule
Bitinex 60 mg capsule
Bitinex 80 mg capsule
Bitinex 100 mg capsule
Atomoxetin Medical Valley 10 mg kapslar, hårda
Atomoxetin Medical Valley 18 mg kapslar, hårda
Atomoxetin Medical Valley 25 mg kapslar, hårda
Atomoxetin Medical Valley 40 mg kapslar, hårda
Atomoxetin Medical Valley 60 mg kapslar, hårda
Atomoxetin Medical Valley 80 mg kapslar, hårda
Atomoxetin Medical Valley 100 mg kapslar, hårda
Bitinex 10 mg tvrdé kapsuly
Bitinex 18 mg tvrdé kapsuly
Bitinex 25 mg tvrdé kapsuly
Bitinex 40 mg tvrdé kapsuly
Bitinex 60 mg tvrdé kapsuly
Bitinex 80 mg tvrdé kapsuly
Bitinex 100 mg tvrdé kapsuly
ATAMA 10 mg hard capsules
ATAMA 18 mg hard capsules
ATAMA 25 mg hard capsules
ATAMA 40 mg hard capsules
ATAMA 60 mg hard capsules
ATAMA 80 mg hard capsules
ATAMA 100 mg hard capsules

This leaflet was last revised in

Page 15 of 15
20170808
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722-2629.00 722-2630.00
722-2631.00 722-2632.00
722-2633.00

+ Expand Transcript

Further information

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