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ATAMA 25 MG HARD CAPSULES

Active substance(s): ATOMOXETINE HYDROCHLORIDE / ATOMOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user

ATAMA 10, 18, 25, 40, 60, 80 and 100mg 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 ATAMA is and what it is used for
2. What you need to know before you take ATAMA
3. How to take ATAMA
4. Possible side effects
5. How to store ATAMA
6. Contents of the pack and other information

1. What ATAMA is and what it is used for
What it is used for
ATAMA 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 ATAMA
Do not take ATAMA 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 ATAMA 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 ATAMA.
- 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 ATAMA 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
ATAMA if you have:
- thoughts about killing yourself or trying to kill yourself.
- problems with your heart (including heart defects) or an increased heartbeat. ATAMA can increase your heart rate (pulse).
Sudden death has been reported in patients with heart defects.
- high blood pressure. ATAMA can increase blood pressure.
- low blood pressure. ATAMA 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. ATAMA 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 ATAMA 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 ATAMA:
These checks are to decide if ATAMA 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 ATAMA
- your height and weight if you are a child or teenager during the time you take ATAMA
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 ATAMA 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 ATAMA 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 ATAMA
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 ATAMA 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 ATAMA with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 ‘Do not take ATAMA’.
If you are taking other medicines, ATAMA 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 ATAMA:
- 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 ATAMA 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 ATAMA:
- 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 ATAMA.
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-feed 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 ATAMA. You should be careful if you are driving a car or operating machinery until you
know how ATAMA affects you. If you feel tired, sleepy or dizzy you should not drive or operate machinery.

3. How to take ATAMA

- 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 ATAMA 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 ATAMA 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 ATAMA 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
- ATAMA should be started at a total daily dose of 40mg for a minimum of 7 days. Your doctor may then decide to increase this to the
usual maintenance dose of 80mg-100mg daily. The maximum daily dose your doctor will prescribe is 100mg.
If you have problems with your liver your doctor may prescribe a lower dose.
Things your doctor will do when you are on treatment
Your doctor will do some tests
- before you start - to make sure that ATAMA 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 ATAMA.
Long-term treatment
ATAMA does not need to be taken for ever. If you take ATAMA for more than a year, your doctor will review your treatment, to see if the
medicine is still needed.
If you take more ATAMA 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 ATAMA
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 ATAMA
If you stop taking ATAMA 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 ATAMA 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 ATAMA 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
- 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
These effects may disappear after a while in most patients. - 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 ATAMA. 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 ATAMA 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 (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 ATAMA
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 ATAMA contains
The active substance is Atomoxetine.
Strength

Active Substance

Capsule Shell

ATAMA 10mg
hard capsules
ATAMA 18mg
hard capsules
ATAMA 25mg
hard capsules
ATAMA 40mg
hard capsules
ATAMA 60mg
hard capsules
ATAMA 80mg
hard capsules
ATAMA 100mg
hard capsules

Each hard capsule contains 10mg atomoxetine
as 11.43mg atomoxetine hydrochloride.
Each hard capsule contains 18mg atomoxetine
as 20.57mg atomoxetine hydrochloride.
Each hard capsule contains 25mg atomoxetine
as 28.57mg atomoxetine hydrochloride.
Each hard capsule contains 40mg atomoxetine
as 45.71mg atomoxetine hydrochloride.
Each hard capsule contains 60mg atomoxetine
as 68.57mg atomoxetine hydrochloride.
Each hard capsule contains 80mg atomoxetine
as 91.42mg atomoxetine hydrochloride
Each hard capsule contains 100mg atomoxetine
as 114.28mg atomoxetine hydrochloride.

Gelatin, Sodium Lauryl Sulfate (E487),
Titanium dioxide (E171), Purified water
Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171),
iron oxide yellow (E172), Purified water
Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171),
indigo carmine (E132), Purified water
Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171),
indigo carmine (E132), Purified water
Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171),
indigo carmine (E132), iron oxide yellow (E172), Purified water
Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171),
iron oxide red (E172), iron oxide yellow (E172), Purified water
Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171),
iron oxide red (E172) iron oxide yellow (E172), Purified water

The other ingredients for all strengths are:
• Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
• Printing ink (black) consisting of: Shellac Glaze-45% (20% Esterified) in Ethanol, Iron Oxide Black (E172), Propylene Glycol
What ATAMA looks like and contents of the pack
- ATAMA 10mg hard capsules White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque white cap
imprinted in black ink with ‘10’ and opaque white body imprinted in black ink with ‘mg’.
- ATAMA 18mg hard capsules White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque rich yellow
cap imprinted in black ink with ‘18’ and opaque white body imprinted in black ink with ‘mg’.
- ATAMA 25mg hard capsules White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque blue cap
imprinted in black ink with ‘25’ and opaque white body imprinted in black ink with ‘mg’.
- ATAMA 40mg hard capsules
White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque blue cap
imprinted in black ink with ‘40’ and opaque blue body imprinted in black ink with ‘mg.’
- ATAMA 60mg hard capsules White powder in a hard gelatin capsule of size No 2 (length of 17.6±0.4 mm), opaque blue cap
imprinted in black ink with ‘60’ and opaque rich yellow body imprinted in black ink with ‘mg’.
- ATAMA 80mg hard capsules White powder in a hard gelatin capsule of size No 2 (length of 17.6±0.4 mm), opaque brown cap
imprinted in black ink with ‘80’ and opaque white body imprinted in black ink with ‘mg’.
- ATAMA 100mg hard capsules White powder in a hard gelatin capsule of size No 1 (length of 19.1 ± 0.4 mm), opaque brown cap
imprinted in black ink with ‘100’ and opaque brown body imprinted in black ink with ‘mg’.
ATAMA is supplied in blisters in a cardboard box.
Pack sizes:
7, 14, 28 and 56 hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
Manufacturer(s)
Pharmathen SA, Dervenakion 6, Pallini 15351, Attiki, Greece
or Pharmathen International SA, Industrial Park Sapes, Rodopi Prefecture, Block no 5, Rodopi 69300, Greece
or Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola PLA 3000, Malta
This leaflet was last revised in 01/2017
XXXXXXX P2.1

Artwork for:
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BAC ref:

Aspire Pharma Limited
ATAMA All strengths
Black
Leaflet
600mm x 170mm
Yes
15 November 2016
Artwork in User Tested style: revision date change
2.1
26 January 2017
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8 on 9pt Myriad Pro
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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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