Attentra 80 mg Capsules

ATTENTRA contains the active ingredient atomoxetine (as atomoxetine hydrochloride). ATTENTRA is used to treat attention-deficit and hyperactivity disorder (ADHD):

• in children over six years of age
• in young people
• in adults.

Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist.

Do not take ATTENTRA if you:

• Are hypersensitive (allergic) to atomoxetine (as atomoxetine hydrochloride), or to any of the other ingredients of ATTENTRA.
• Are taking a medicine known as a monoamine oxidase inhibitor (MAOI), for example phenelzine, in the last two weeks. A MAOI is sometimes used for depression and other mental health problems; taking ATTENTRA with a MAOI could cause serious side effects or be life-threatening. You also need to wait at least 14 days after you stop taking ATTENTRA before you take a 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 ATTENTRA.
• 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 (pheochromocytoma).
• Have impaired liver function.

Warnings and precautions:

Take special care with ATTENTRA if you:

• Develop thoughts about killing yourself or try to kill yourself.
• Have problems with your heart (including heart defects) or an increased heartbeat. ATTENTRA can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
• Have high blood pressure. ATTENTRA can increase blood pressure.
• Have low blood pressure. ATTENTRA can cause dizziness or fainting in people with low blood pressure.
• Have problems with sudden changes in your blood pressure or your heart rate.
• Have cardiovascular disease or past medical history of stroke.
• Have liver problems. You may need a lower dose.
• Have psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious.
• Have mania (feeling elated or over-excited, which causes unusual behaviour) and agitation.
• Have aggressive feelings.
• Have unfriendly and angry (hostile) feelings.
• Have a history of epilepsy or have had seizures for any other reason. ATTENTRA might lead to an increase in seizure frequency.
• Have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words.
• Have Raynaud’s phenomenon which is a discolouration of the fingers and/or the toes after exposure to changes in temperature (cold or hot) or emotional events.
• Have problems with your bladder such as difficulty passing urine while taking ATTENTRA, you should inform your doctor.

If you are a child or teenager your doctor will monitor your height and weight during your treatment with ATTENTRA. Please inform your doctor if you notice any weight loss or slowed growth while taking ATTENTRA.

Serotonin syndrome: Serotonin syndrome is a potentially life-threatening condition which may occur when taking ATTENTRA in combination with some other medicines (see section 2 - Other medicines and ATTENTRA). Signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, incoordination and rigidity, hallucinations, coma, fast heartbeat, 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 ATTENTRA 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.

Do not share medicines prescribed for you with any other person. Always take ATTENTRA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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.

If you are a child or teenager (6 years or older): Your doctor will tell you how much ATTENTRA you should take and will calculate this according to your weight. He/she will normally start you on a lower dose before increasing the amount of ATTENTRA 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.

ATTENTRA should not be used in children under 6 years of age. Adults: ATTENTRA 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 daily dose your doctor will prescribe is 80 mg.

If you have problems with your liver or end-stage renal disease your doctor may prescribe a lower dose. Taking ATTENTRA at the same time each day will have the best effect. It will also help you remember when to take it. Your doctor will tell you how long your treatment with ATTENTRA will last. Do not stop treatment early. If you have the impression that the effect of ATTENTRA is too strong or too weak, tell your doctor or pharmacist.

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

If you forget to take ATTENTRA: Do not take a double dose to make up for forgotten individual doses. If you miss a dose, you should take it as soon as possible; however, you should not take more than the prescribed total daily amount of ATTENTRA in any 24-hour period.

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

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

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting (dizziness).

These are all very serious side effects. If you have them, you may have had a serious reaction to ATTENTRA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Less frequent occurrence:

• 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)
• 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 young adults have an increased risk of side effects:

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

Tell your doctor if you notice any of the following:

Frequent occurrence:

• Children, young adults and adults:
• decreased appetite and loss of appetite
• difficulty falling asleep and/or staying asleep, irritability, anxiety, depression and depressed mood, tics (habitual spasmodic contraction of the muscles)
• headache, general feeling of unwellness, dizziness
• dilation of the pupil of the eye
• abdominal pain, vomiting, nausea, constipation, indigestion
• skin reactions - red, swollen and sore, sometimes with small blisters, rash
• fatigue, a lack of energy and enthusiasm
• blood pressure increase, heart rate increase, weight decrease.
• Adults only:
• decreased sexual desire
• distortion of the sense of taste; abnormal sensation (typically tingling or pricking); trembling
• feelings or sensations that your heart is pounding or racing
• flushing, hot flush
• dry mouth, constipation, farting
• painful or difficult urination; extraordinary daytime urinary frequency; trouble starting or maintaining a urine stream; inability to completely or partially empty the bladder
• painful menstruation, typically involving abdominal cramps
• disorder of the discharge of semen from the male reproductive tract; inability to get or keep an erection firm enough to have sexual intercourse; swelling and inflammation of the prostate gland; male genital pain
• abnormal physical weakness or lack of energy
• chills, feeling jittery, thirst.

Less frequent occurrence:

• Children, young adults and adults:
• temporary loss of consciousness, tremor, migraine, reduced sense of touch or sensation, seizures
• blurred vision, infection of the eye causing redness
• Raynaud’s phenomenon (medical condition in which spasm of arteries cause episodes of reduced blood flow)
• difficult or laboured breathing
• abnormal liver function tests, jaundice (a condition in which the skin, whites of the eyes and mucous membranes turn yellow), inflammatory condition of the liver, liver injury, acute liver failure
• excessive sweating
• prolonged erection of the penis.
• Adults only:
• a sudden, compelling urge to urinate
• ejaculation failure, menstruation irregular, orgasm abnormal
• feeling cold, chest pain.

The following may also occur; Children and young people over 6 years:

• involuntary teeth grinding (bruxism).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ATTENTRA.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Store in the original container until required for use. Do not use after the expiry date stated on the label/carton/bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).