Consumer medicine information

APO-ATOMOXETINE Capsules

Contains the active ingredient atomoxetine (as hydrochloride)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

This leaflet answers some common questions about atomoxetine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet. You may want to read it again.

What this medicine is used for

The name of your medicine is APO-Atomoxetine capsules. It contains the active ingredient atomoxetine (as hydrochloride).

It is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years and older, adolescents and adults. ADHD is a behavioural disorder that causes lack of focus and/or hyperactivity that is much more frequent or severe than others who are close in age or development.

Atomoxetine works by acting on brain chemicals called amines which are involved in controlling behaviour.

Ask your doctor if you have any questions about why this medicine has been chosen for you. Your doctor may have given you this medicine for another reason.

There is no evidence that this medicine is addictive.

This medicine is available only with a doctor’s prescription.

Before you are given this medicine

When you must not be given it

You must not be given this medicine if:

You have or have had any of the following:
– You are hypersensitive to, or have had an allergic reaction to, atomoxetine hydrochloride or any of the ingredients listed at the end of this leaflet.
– You have certain heart diseases such as moderate to severe hypertension, abnormal or dangerously fast heartbeat, thickening and hardening of the walls of the arteries due to cholesterol deposits
– You have an uncontrolled overactive thyroid gland which causes increased appetite, weight loss, intolerance to heat, increased sweating, tremors, and rapid heart rate
– You have a tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma). The symptoms are bouts of anxiety and headaches, palpitations, dizziness, a feeling of weakness, nausea, vomiting, diarrhoea, dilated pupils and blurring vision, stomach pains, and raised blood pressure.
– You have high pressure in the eye (glaucoma), or have a family history of glaucoma.
You are taking medicine called a monoamine oxidase inhibitor (MAOI) for the treatment of depression or have been taking a MAOI within the last 14 days.
Check with your doctor or pharmacist if you are unsure as to whether or not you are taking a MAOI.
If you take APO-Atomoxetine while you are taking a MAOI, you may experience shaking (tremor), shivering, muscle stiffness, fever, rapid pulse, rapid breathing or confusion.
Check with your doctor or pharmacist if you ate unsure as to whether or not you are taking a MAOI.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you are given it

Your doctor must know about all the following before you are given this medicine.

You must tell your doctor if:

You have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

You have or have had any medical conditions, especially the following:

high blood pressure
low blood pressure
fast heart beat
heart disease
conditions affecting blood flow in the brain, such as stroke
liver disease
kidney disease
an overactive thyroid gland
enlargement or disease of the prostate
difficulty passing urine
seizures, fits or convulsions
any psychiatric disorder, including depression or bipolar disorder.

You or your child have or have had:

thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts at self-harm.

You may wish to see a paediatric psychiatrist for further assessment and supervision of your child.

You:

are involved in strenuous exercise or activities
are using a group of medicines called stimulants
have a family history of sudden/cardiac death.

APO-Atomoxetine generally should not be used in children, adolescents or adults with known structural heart abnormalities.

You are currently pregnant or you plan to become pregnant, or are breastfeeding.
You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Your doctor can discuss with you the risks and benefits involved.

Safety and effectiveness in elderly patients older than 65 years and children younger than 6 years have not been established.

If you have not told your doctor about any of the above, tell him/her before you start taking APO-Atomoxetine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by atomoxetine or may affect how it works. You may need different amounts of your medicines or you may need to take different medicines. These include:

monoamine oxidase inhibitors (MAOIs), medicines used to treat some types of depression.
You should stop taking MAOIs at least two weeks before starting APO-Atomoxetine
certain medicines used to treat depression such as fluoxetine, paroxetine, desipramine, imipramine, venlafaxine and mirtazapine
certain medicines used to treat irregular heart beat such as quinidine
medicines used to treat low blood pressure or to raise blood pressure (pressor agents)
medicines containing the decongestants pseudoephedrine or phenylephrine
asthma reliever medicines such as salbutamol, when taken orally as a syrup or as an injection
certain medicines taken for anxiety such as diazepam or to treat epilepsy such as phenytoin.

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with APO-Atomoxetine.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking atomoxetine.

How this medicine is given

Carefully follow all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much of this medicine is given

For children and adolescents up to 70 kg body weight, the usual starting dose is approximately 0.5 mg/kg once a day.

After a minimum of 3 days, if necessary, the dose may be increased to approximately 1.2 mg/kg once daily in the morning or as evenly divided doses in the morning and late afternoon/early evening. After 2 to 4 additional weeks, if necessary, the dose may be increased to a maximum of 1.4 mg/kg once daily or 100 mg.

For children and adolescents greater than 70 kg body weight and adults, the usual starting dose is 40 mg once a day.

After a minimum of 3 days, if necessary, the dose may be increased to approximately 80 mg once daily in the morning or as evenly divided doses in the morning and late afternoon/early evening.

After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg.

If therapy is interrupted for more than 1 week, treatment should be started at the lowest recommended dose.

Your doctor may increase or decrease your dose depending on your condition and any other illness that you may have.

How it is given

Swallow the capsules whole with a full glass of water.

APO-Atomoxetine can be taken with or without food.

When to take it

APO-Atomoxetine is usually taken one or two times a day (early morning and late afternoon/early evening).

If you find that you are sleepy during the day or have trouble sleeping at night, talk to your doctor about the best time to take your medicine.

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you take this medicine before or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take more than your total daily dose in a 24 hour period.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you receive too much (overdose)

If you think that you or anyone else may have taken too much APO-Atomoxetine, immediately telephone your doctor or the Poisons Information Centre (telephone
13 11 26) for advice, or go to Emergency Department at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you have taken too much atomoxetine, the most common signs are sleepiness, agitation, hyperactivity, unusual behaviour and an upset stomach. In some cases of overdose, seizures have been reported.

While you are using this medicine

Things you must do

Contact your doctor or a paediatric psychiatrist straight away or go to the nearest hospital for treatment if you notice any sudden change in your child’s behaviour, if your child is demonstrating any of the following warning signs, if you notice any of the following or if they seem worse.

Signs to watch for:

thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or restless
panic attacks
difficulty sleeping (insomnia)
new or worse irritability
acting on dangerous impulses
an extreme increase in activity and talking
other unusual changes in behaviour.

Preventing suicidal thoughts or action:

To try and prevent suicidal thoughts or actions in your child, talk with and listen to your child about his or her thoughts and feelings and pay close attention to changes in his or her moods or action, especially if the changes occur suddenly. Other important people in your child’s life can help by paying attention as well (e.g. brothers and sisters, teachers, caregivers and other important people). Pay close attention to your child whenever APO-Atomoxetine is started or its dose is changed (see ‘Possible side effects’).

If you notice an increase in aggression or hostility since taking this medication, you should call your doctor as soon as possible.

Tell your doctor if you experience a seizure, fit or convulsion. If you already suffer from seizures, fits or convulsions, tell your doctor if they seem to increase in frequency.

Tell your doctor if you notice changes in your sexual function while you are taking this medicine.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking APO-Atomoxetine.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests (blood pressure and heart rate) from time to time while on therapy. After starting APO-Atomoxetine children may have a reduced rate of growth so your doctor may also monitor height and weight from time to time when on long term therapy.

Things you must not do

Do not take APO-Atomoxetine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not open your APO-Atomoxetine capsules as the content is an eye irritant. In the event of capsule content coming in contact with the eye, flush the affected eye immediately with water and seek medical advice. Hands and any potentially contaminated surfaces should be washed as soon as possible.

Things to be careful of

Be careful driving or operating machinery until you know how APO-Atomoxetine affects you. This medicine may cause dizziness, tiredness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

If your doctor advises you to stop taking APO-Atomoxetine, do not take monoamine oxidase inhibitors (MAOIs) within the first two weeks after stopping APO-Atomoxetine.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after you have been given APO-Atomoxetine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

Children, adolescents and adults

constipation
upset or sore stomach, nausea, vomiting
diarrhoea
decreased appetite
decreased weight
headache
dizziness
constant flu like symptoms such as chills, fever, irritated watery eyes, sore throat
dilated pupils
mood swings, irritability
skin rash, redness, itching
early morning waking, tiredness, difficulty sleeping
unusual weakness
lacking energy, feeling tired

Adults

dry mouth
thirst
difficulty urinating, abnormal, painful and/or frequent urination
sexual problems
testicular or genital pain in males
painful or irregular menstrual periods
hot flushes
increased sweating
tickling, tingling, burning, pricking, or numbness of skin
feeling jittery, tremors
agitation
persistent abnormal taste

Tell your doctor as soon as possible if you notice any of the following in you/your child while taking APO-Atomoxetine:

These may be serious side effects and you may need medical attention:

fast or irregular heart beat
fainting
numbness, tingling and colour change (white, blue then red) in fingers and toes when exposed to cold
seizures, fits or convulsions
signs of liver injury such as dark urine, yellowing of the skin or eyes, severe cramps of the stomach, or unexplained nausea, fatigue, lethargy, itching or flu-like symptoms
episodes of overactivity, elation or irritability
confusion or hallucinations (seeing or feeling things that are not really there)
thoughts of suicide or attempts to harm yourself (also see Things You Must Do if you notice this behaviour in children or adolescents)

Serious side effects are rare or very rare. Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice any other side effects.

Allergic reactions

If you think you are having an allergic reaction to APO-Atomoxetine, contact your medical or nursing staff immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

shortness of breath, wheezing, difficulty breathing or tightness in chest
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
fainting
hay fever-like symptoms.

Storage and disposal

Storage

Keep your capsules in the pack until it is time to take them. If you take the capsules out of the pack they may not keep as well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store APO-Atomoxetine or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What APO-Atomoxetine looks like

APO-Atomoxetine 10 mg: hard gelatin capsule, white opaque body and white opaque cap, printed in black APO AM10.

APO-Atomoxetine 18 mg: hard gelatin capsule, white opaque body and gold opaque cap, printed in black APO AM18.

APO-Atomoxetine 25 mg: hard gelatin capsule, white opaque body and blue opaque cap, printed in black APO AM25.

APO-Atomoxetine 40 mg: hard gelatin capsule, blue opaque body and blue opaque cap, printed in black APO AM40.

APO-Atomoxetine 60 mg: hard gelatin capsule, gold opaque body and blue opaque cap, printed in black APO AM60.

APO-Atomoxetine 80 mg: hard gelatin capsule, white opaque body and orange opaque cap, printed in black APO AM80.

APO-Atomoxetine 100 mg: hard gelatin capsule, orange opaque body and orange opaque cap, printed in black APO AM100.

All capsules contain a white to off white powder.

* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

APO-Atomoxetine 10 mg, 18 mg capsules contain 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg contain atomoxetine (as hydrochloride) as the active ingredient.

The capsules also contain the following inactive ingredients:

gelatin (may contain trace amounts of sulfites and phenylalanine)
pregelatinized maize starch
titanium dioxide
iron oxide yellow (18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg)
iron oxide red (80 mg, 100 mg)
indigo carmine (25 mg, 40 mg, 60 mg).

The capsules are printed with edible black ink (TekPrint SW-9008 Black Ink/TekPrint SW-9009 black Ink).

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-ATOMOXETINE (blisters)

10 mg capsules – AUST R 290979

18 mg capsules – AUST R 290980

25 mg capsules – AUST R 290981

40 mg capsules – AUST R 290982

60 mg capsules – AUST R 290983

80 mg capsules – AUST R 290984

100 mg capsules – AUST R 290985

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel St,
Cremorne VIC 3121

http://arrotex.com.au/

This leaflet was last updated in:
February2023

Published by MIMS April 2023