Atomoxetine neuraxpharm 80 mg hard capsules

• 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.

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

Atomoxetine contains the active substance 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.

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 Atomoxetine 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.

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

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.

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.

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.

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.

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.

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.

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.

You may feel tired, sleepy or dizzy after taking Atomoxetine. You should be careful if you are driving or operating machinery until you know how Atomoxetine affects you. If you feel tired, sleepy or dizzy you should not drive or operate machinery.

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.

• The capsules are usually taken one or two times a day (morning and late afternoon or early evening). Taking the medicine at the same time each day may help you remember to take it.
• 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.

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.

Use in children under six years of age

Atomoxetine is not for use as a treatment for ADHD in children under 6 years of age as it is not known if the medicine works or is safe in these people.

• 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.
• Children should not take this medicine without the help from an adult.

It may take a few weeks after you start the medicine for your symptoms to fully improve.

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.

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 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 there are usually no side effects but your ADHD symptoms may return. You should talk to your doctor first before you stop treatment.

• thinking about or feeling like killing yourself (uncommon - may affect up to 1 in 100 people)
• mood swings or mood changes (common - may affect up to 1 in 10 people)

• 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 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

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)

These effects may disappear after a while in most patients.

ADULTS

• 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

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.

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, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Atomoxetine 10 mg hard capsules

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’, containing white powder.

Atomoxetine 18 mg hard capsules

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’, containing white powder.

Atomoxetine 25 mg hard capsules

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’, containing white powder.

Atomoxetine 40 mg hard capsules

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’, containing white powder.

Atomoxetine 60 mg hard capsules

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’, containing white powder.

Atomoxetine 80 mg hard capsules

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’, containing white powder.

Atomoxetine 100 mg hard capsules

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’, containing white powder.

Atomoxetine is supplied in blisters in a cardboard box.

Pack sizes:

Atomoxetine neuraxpharm 10 mg, 18 mg, 100 mg: 7, 14, 28 and 56 hard capsules

Atomoxetine neuraxpharm 25 mg, 40 mg, 60 mg, 80 mg: 7, 14, 28, 56 and 98 hard capsules

Not all pack sizes may be marketed.

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