Atomoxetine 25 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 or for your child 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.

In the next sections, the word You means You or a child in your care.

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 hard capsules contains atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD). It is used in children over six years of age, in young people and in adults. It is used only as a part of the total treatment of the disease which also requires treatments which do not involve medicines, such as counselling and behavioural therapy.

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

In adults, Atomoxetine 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.

Atomoxetine 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.

Children and young people with ADHD find it hard to sit still and hard to concentrate. It is not their fault that they cannot do these things. Many children and young people struggle to do these things. However, with ADHD this can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places. ADHD does not affect the intelligence of a child or young person.

Adults with ADHD find it difficult to do all the things that children find difficult however this may mean they have problems with work, relationships, low self-esteem and education.

• if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
• if you took a medicine known as a monoamine oxidase inhibitor (MAOI), for example phenelzine, in the last two weeks. An MAOI is sometimes used for depression and other mental-health problems; taking Atomoxetine with an MAOI could cause serious side effects or be life-threatening. (You also need to wait at least 14 days after you stop taking Atomoxetine before you take an MAOI).
• if you have an eye disease called narrow-angle glaucoma (increased pressure in your eye).
• if you have serious problems with your heart which may be affected by an increase in heart rate and/or blood pressure, as this may be an effect of Atomoxetine.
• if you have serious problems with the blood vessels in your brain – such as a stroke, swelling and weakening of part of a blood vessel (aneurysm) or narrow or blocked blood vessels.
• if you have a tumour of your adrenal gland (pheochromocytoma).

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 Atomoxetine. This is because Atomoxetine can make these problems worse.

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.

Serotonin syndrome is a potentially life-threatening condition which may occur when taking Atomoxetine in combination with some other medicines (see section 2 “Other medicines and Atomoxetine”). Signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, incoordination and rigidity, hallucinations, coma, fast heart beat, increased body temperature, fast changes in blood pressure, sweating, flushing, tremor, overactive reflexes, nausea, vomiting, and diarrhoea. Contact a doctor or go to your nearest emergency department immediately if you think serotonin syndrome is happening to you.

Treatment with Atomoxetine may make you feel aggressive, hostile or violent; or aggravate these symptoms if they were present before treatment. It may also cause you to have unusual changes in behaviour or mood (including physical assault, threatening behaviour and thoughts of harming others). If you or your family and/or friends notice any of these reactions, talk to your doctor or pharmacist right away.

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.

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 anti-depressants, opioids as tramadol, and medicines used to treat migraine called triptans. These medicines may interact with Atomoxetine and can lead to serotonin syndrome, a potentially life-threatening condition. (See section 2, Warnings and Precautions, Serotonin Syndrome).
• 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 or are planning to have a 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 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.

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.

If you are a child or teenager (6 years or older)

Your doctor will tell you how much Atomoxetine you should take and will calculate this according to your body weight. The 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.

If you take more than the prescribed dose, 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. Very rarely, serotonin syndrome has also been reported, a potentially life-threatening condition. (See section 2, Warnings and precautions, Serotonin Syndrome).

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.

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 young people,
• measuring blood pressure and heart rate,
• checking whether you have any problems or if side effects have got worse while taking Atomoxetine.

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.

• 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 1000 people) of side effects such as:

• seizures
• psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious

Rare (may affect up to 1 in 1,000 people)

• liver injury

• 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 YOUNG PEOPLE over 6 years

• headache
• pain in the stomach
• decreased appetite (not feeling hungry)
• feeling sick
• 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 YOUNG PEOPLE 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 YOUNG PEOPLE 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 YOUNG PEOPLE 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

Not known (frequency cannot be estimated from the available data)

CHILDREN and YOUNG PEOPLE over 6 years

Involuntary teeth grinding (bruxism)

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 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 at: 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.

• The active substance is atomoxetine hydrochloride. Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg of atomoxetine.
• The other ingredients are pregelatinized maize starch, magnesium stearate, titanium dioxide, gelatin, 10A1 Black ink (Shellac glaze 45% (20% esterified) in ethanol, iron oxide black, propylene glycol, ammonium hydroxide 28%).

Atomoxetine 18, 80 and 100 mg: Yellow iron oxide.

Atomoxetine 25 and 40 mg: Indigo carmine.

Atomoxetine 60 mg: Yellow iron oxide, Indigo carmine.

Atomoxetine 10 mg: White capsule of size 4 with black imprinting symbol ‘10’ containing white to off-white powder.

Atomoxetine 18 mg: Light yellow-white, size 4 capsule of size 4 with black imprinting symbol ‘18’ containing white to off‑white powder.

Atomoxetine 25 mg: White-blue capsule of size 4 with black imprinting symbol ‘25’ containing white to off-white powder.

Atomoxetine 40 mg: Blue capsule of size 3 with black imprinting symbol ‘40’ containing white to off-white powder.

Atomoxetine 60 mg: Blue-light yellow capsule of size 1 with black imprinting symbol ‘60’ containing white to off-white powder.

Atomoxetine 80 mg: Yellow-white capsule of size 1 with black imprinting symbol ‘80’ containing white to off-white powder.

Atomoxetine 100 mg: Yellow capsule of size 0 with black imprinting symbol ‘100’ containing white to off-white powder.

The capsules are packed in PVC/Aclar/PVC – Al blisters, PVC/ PVDC – Al blisters and enclosed in a paper folding box.

Atomoxetine capsules are available in packs of:

Atomoxetine 10 mg, 18 mg and 100 mg 7, 14, 28, 30, 56, 84, 60, 90 capsules.

Atomoxetine 25 mg, 40 mg, 60 mg and 80 mg 7, 14, 28, 30, 56, 84, 60, 90, 98 capsules.

Not all pack sizes may be marketed.

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