Advertisement
Advertisement

APO-Atomoxetine

Contains the active ingredient atomoxetine (as hydrochloride)
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about APO-Atomoxetine. It does not contain all the information that is known about APO-Atomoxetine. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is APO-ATOMOXETINE. It contains the active ingredient atomoxetine.
It is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years and older,adolescents and adults.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
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.

How it works

APO-ATOMOXETINE works by acting on brain chemicals called amines which are involved in controlling behaviour. Available evidence suggests that APO-ATOMOXETINE does not have a significant potential for abuse.

Use in children

Safety and effectiveness in children younger than 6 years have not been established. Therefore this medicine is not recommended for children below 6 years.

Before you take this medicine

When you must not take it

Do not take this medicine if:
You have or have had any of the following:
certain heart diseases such as moderate to severe hypertension, abnormal or dangerously fast heart beat, thickening and hardening of the walls of the arteries due to cholesterol deposits
an uncontrolled overactive thyroid gland which causes increased appetite, weight loss, intolerance to heat, increased sweating, tremors, and rapid heart rate
a tumour of the adrenal gland, which sits near the kidney. 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.
Do not take APO-ATOMOXETINE if 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 do take APO-ATOMOXETINE while you are taking a MAOI, you may experience shaking (tremor), shivering, muscle stiffness, fever, rapid pulse, rapid breathing or confusion.
high pressure in the eye (glaucoma), or have a family history of glaucoma.
You are hypersensitive to, or have had an allergic reaction to, atomoxetine or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
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.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1.You have allergies to:

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

2.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
you are using a group of medicines called stimulants
you 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.

3.You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

4.You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.

5.You are planning to have surgery or an anaesthetic.

6.You are currently receiving or are planning to receive dental treatment.

7.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.

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

Taking other medicines

Some medicines may interact with atomoxetine. 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.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

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 will tell you how much APO-ATOMOXETINE you need to take each day.
Your doctor may increase or decrease your dose depending on your condition and any other illness that you may have.

How to take it

Swallow the capsules whole with a full glass of water.

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 this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.

How long to take it for

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 to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
Do not take more than your total daily dose in a 24 hour period.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel:
13 11 26 in Australia) for advice.
Alternatively go to the Accident and 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 APO-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 taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breastfeeding or are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital. It may affect other medicines used during surgery
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.
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 your height and weight from time to time when on long term therapy.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking this medicine.

Things you must not do

Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor tells you to.
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Do not open 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 as soon as possible if you do not feel well while you are taking APO-ATOMOXETINE.
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, 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
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, 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 immediately or go to the Accident and Emergency Department of your nearest hospital if you notice any of the following in you/your child while taking APO-ATOMOXETINE:
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)
These are serious side effects, which may require medical attention.
Serious side effects are rare or very rare.
Other side effects not listed above may also occur in some people.

Allergic reactions

If you think you are having an allergic reaction to APO-ATOMOXETINE, do not take any more of this medicine and tell your doctor 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:
cough, shortness of breath, wheezing or difficulty breathing
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 medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine 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 it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Atomoxetine Capsules looks like

APO-ATOMOXETINE 10 mg - white capsule body and white cap with "10 mg" printed on the capsule body in black.
APO-ATOMOXETINE 18 mg - white capsule body and yellow cap with "18 mg" printed on the capsule body in black.
APO-ATOMOXETINE 25 mg - white capsule body and blue cap with "25 mg" printed on the capsule body in black.
APO-ATOMOXETINE 40 mg - blue capsule body and blue cap with "40 mg" printed on the capsule body in black.
APO-ATOMOXETINE 60 mg - yellow capsule body and light blue cap "60 mg" printed on the capsule body in black.
APO-ATOMOXETINE 80 mg - white capsule body and brown cap with "80 mg" printed on the capsule body in black.
APO-ATOMOXETINE 100 mg - Brown capsule body and brown cap with "100 mg" printed on the capsule body in black.
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

APO-ATOMOXETINE contains 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine (as hydrochloride) as the active ingredient.
It also contains the following inactive ingredients:
pregelatinised maize starch
croscarmellose sodium
colloidal anhydrous silica
magnesium stearate
The capsule body and cap contains:
gelatin
titanium dioxide
one or more of the following:
indigo carmine
iron oxide yellow
iron oxide red
iron oxide black
black printing ink (Opacode monogramming ink S-1-277002 Black, ARTG 107581).
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Australian Registration Numbers

APO-ATOMOXETINE 10 mg capsules - AUST R 234800
APO-ATOMOXETINE 18 mg capsules - AUST R 234806
APO-ATOMOXETINE 25 mg capsules - AUST R 234804
APO-ATOMOXETINE 40 mg capsules -AUST R 234810
APO-ATOMOXETINE 60 mg capsules -AUST R 234788
APO-ATOMOXETINE 80 mg capsules -AUST R 234807
APO-ATOMOXETINE 100 mg capsules - AUST R 234803

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.

Distributor

Generic Partners Pty Ltd
313 Burwood Road
Hawthorn, VIC 3122
This leaflet was last updated in:
October 2016