Atoxtrin 10 mg Capsules

ATOXTRIN 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
• 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

Do not take ATOXTRIN if you:

• are allergic to atomoxetine or any of the other ingredients of this medicine.
• took a medicine known as a monoamine oxidase inhibitor (MAOI), for example phenelzine or linezolid (an antibiotic used to treat certain serious bacterial infections), in the last two weeks. An MAOI is sometimes used for depression and other mental-health problems; taking ATOXTRIN 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 ATOXTRIN.
• 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).
• have uncontrolled high blood pressure or impairment of your liver function.

Do not take ATOXTRIN 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 ATOXTRIN if you have:

• thoughts about killing yourself or trying to kill yourself, hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability (rapid, often exaggerated changes in mood, where strong emotions or feelings (uncontrollable laughing or crying, or heightened irritability or temper). There is evidence that the risk of psychiatric adverse events is increased in children with a personal history of mood disorders, or who have a family history of mood disorders.
• problems with your heart (including heart defects) or an increased heartbeat. ATOXTRIN can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
• high blood pressure. ATOXTRIN can increase blood pressure.
• low blood pressure. ATOXTRIN can cause dizziness or fainting in people with low blood pressure.
• problems with sudden changes in your blood pressure or your heart rate.
• Raynaud’s phenomenon (a problem that causes decreased blood flow to the fingers).
• cardiovascular disease or past medical history of stroke.
• liver problems. You may need a lower dose.

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 ATOXTRIN 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 ATOXTRIN 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 ATOXTRIN 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 recommended total daily dose is 80 mg.

Adults: ATOXTRIN 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 daily. The maximum recommended total daily dose is 80 mg. If you have problems with your liver your doctor may prescribe a lower dose.

Not all side effects reported for ATOXTRIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ATOXTRIN, please consult your health care provider for advice. This medicine can cause side effects, although not everybody gets 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.

Less Frequent

• 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

Children and adolescents aged under 18 have an increased risk of side effects such as:

• thinking about or feeling like killing yourself
• mood swings or mood changes

Adults have a reduced risk 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

Less Frequent

• liver injury

You should stop taking ATOXTRIN 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

• Store at or below 25 °C.

• Store all medicines out of reach of children.

• Do not store in a bathroom.

• Do not take after the expiry date stated on the label.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).