Attentus 10 mg/18 mg/25 mg/40 mg/60 mg Capsules

ATTENTUS belongs to a group of medicines psychoanaleptics and is used to treat Attention-Deficit/ Hyperactivity Disorder (ADHD) in children 6 years of age or older, adolescents and adults.

Do not take ATTENTUS or give to a child in your care:

• If you are hypersensitive (allergic) to Atomoxetine hydrochloride or any of the ingredients of ATTENTUS (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 ATTENTUS with an MAOI could cause serious side effects or even be life-threatening.
• have an eye disease called narrow-angle glaucoma (increased pressure in your eye).
• have or had liver problems.
• have a condition called pheochromocytoma (tumour of your adrenal gland).
• have uncontrolled high blood pressure.
• have serious problems with your heart which may be affected by an increase in heart rate and/or blood pressure.

Warnings and precautions

WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS ATTENTUS (atomoxetine) increased the risk of suicidal ideation in children or adolescents. Patients started on therapy should be closely monitored. Tell your doctor before taking or giving ATTENTUS to a child in your care if you or a child in your care:

• have possible allergic reactions including severe allergic reactions known as anaphylaxis;
• have thoughts about killing yourself or trying to kill yourself;
• have aggressive feelings;
• have unfriendly and angry (hostility) feelings;
• feel elated or over-excited which causes unusual behaviour;
• have false perceptions of reality;
• have or had liver problems;
• have different moods or feel very unhappy;
• start having seizures;
• if your child is not growing or gaining weight as expected;
• have high blood pressure. ATTENTUS can increase blood pressure;
• have problems with your heart or an irregular heartbeat. ATTENTUS can increase your heart rate (pulse);
• have low blood pressure. ATTENTUS can cause dizziness or fainting in people with low blood pressure;
• have poor circulation which makes fingers and toes numb and pale (Raynauds disease);
• have problems with sudden changes in your blood pressure or heart rate;
• have cardiovascular disease or past medical history of stroke;
• have problems passing urine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Children

ATTENTUS has not been studied in children under 6 years of age and therefore should not be used in this patient population.

Do not share medicines prescribed for you with any other person. Always take ATTENTUS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The capsules should be swallowed whole. The capsules should not be opened and the contents inside the capsules should not be removed and taken in any other way. You can take ATTENTUS with or without food. Taking ATTENTUS at the same time each day may help you remember to take it. Do not give ATTENTUS to children under 6 years of age.

How much to take

If you are a child or adolescent (6 years or older): Your doctor will tell you how much ATTENTUS 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 ATTENTUS 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 for adults is 80mg. Your doctor will tell you how long your treatment with ATTENTUS will last. Do not stop any treatment unless your doctor tells you to do so.

If you have the impression that the effect of ATTENTUS is too strong or too weak, tell your doctor or pharmacist.

If you take more ATTENTUS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. The most commonly reported symptoms accompanying overdoses are gastrointestinal symptoms, sleepiness, dizziness, tremor, and abnormal behaviour.

If you forget to take ATTENTUS

If you (or a child in your care) misses 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 forgotten individual doses.

If you stop taking ATTENTUS

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.

ATTENTUS can have side effects. Not all side effects reported for ATTENTUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ATTENTUS, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking ATTENTUS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• serious allergic reaction with symptoms of
  • swelling of the face, lips, tongue and throat
  • difficulty breathing
  • hives (small raised, itchy patches of skin)
• dark urine
• yellow skin or yellow eyes
• tummy pain which is sore when you press it (tenderness) on the right side just below the ribs
• a feeling of sickness (nausea) that is unexplained
• tiredness
• itching
• feeling that you are coming down with flu

These are all very serious side effects. If you have them, you may have had a serious reaction to ATTENTUS. You may need urgent medical attention or hospitalisation. If you or a child in your care have any of the side effects below, see a doctor straight away.

• 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

Treatment with ATTENTUS in children can cause headache, stomach pain and decreased appetite. Stomach pain and decreased appetite normally resolve after a while. Treatment with ATTENTUS in adults can cause decreased appetite, insomnia, headache, dry mouth and nausea.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache
• Pain in the stomach
• Decreased appetite (not feeling hungry)
• Feeling sick (nausea)
• Being sick (vomiting)
• Sleepiness

• Feeling sick (nausea)
• Dry mouth
• Headache
• Decreased appetite (not feeling hungry)
• Problems getting to sleep, staying asleep and waking early

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Keep the container in the outer carton in order to protect from light. Do not use after the expiry date stated on the packaging. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).