STRATTERA®

atomoxetine hydrochloride

What is in this leaflet

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

All medicines have risks and benefits. Your doctor has weighed the risks of
you taking STRATTERA against the benefits it may have for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine.

What STRATTERA is used for

STRATTERA is used to treat Attention Deficit Hyperactivity Disorder (ADHD)
in children 6 years and older and adolescents. 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.

STRATTERA 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 prescribed for you. Your doctor may have prescribed it for another
reason.

Available evidence suggests that STRATTERA does not have a significant
potential for abuse.

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

Before you take STRATTERA

When you must not take it

Do not take STRATTERA if you have an allergy to:

• any medicine containing atomoxetine hydrochloride (the active ingredient
  in STRATTERA)
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or difficulty breathing; swelling of the face, lips, tongue
or other parts of the body; rash, itching or hives on the skin.

Do not take STRATTERA if you have any of the following conditions:

• 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 STRATTERA 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 STRATTERA while you are taking a MAOI, you may experience
shaking (tremor), shivering, muscle stiffness, fever, rapid pulse, rapid
breathing or confusion.

Do not take STRATTERA if you have high pressure in the eye (glaucoma),
or have a family history of glaucoma.

Do not take this medicine after the expiry date printed on the pack or
if the packaging is torn or shows signs of tampering. If it has expired or
is damaged, return it to your pharmacist for disposal.

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

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods,
preservatives or dyes.

Tell your doctor if you have or have had any of the following medical
conditions:

• 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.

Tell your doctor if 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.

Tell your doctor if you

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

STRATTERA generally should not be used in children, adolescents or adults
with known structural heart abnormalities. If you have been diagnosed with
structural heart abnormalities, you should only take STRATTERA under the
supervision of a cardiologist.

Tell your doctor if you are pregnant or plan to become pregnant or are
breast-feeding. 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 STRATTERA.

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
STRATTERA 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 STRATTERA
• 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.

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

How to take STRATTERA

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 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, 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 STRATTERA 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.

STRATTERA can be taken with or without food.

When to take it

STRATTERA 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 take too much (overdose)

If you think that you or anyone else may have taken too much STRATTERA,
immediately telephone your doctor or the Poisons Information Centre (telephone
0800 POISON or 0800 764 766) 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 STRATTERA, 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 STRATTERA

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 STRATTERA is
started or its dose is changed. (See 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.

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

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. Your doctor may also monitor your height
and weight from time to time when on long term therapy.

Things you must not do

Do not take STRATTERA 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 STRATERRA 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 STRATTERA
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 STRATTERA, do not take
monoamine oxidase inhibitors (MAOIs) within the first two weeks after stopping
STRATTERA.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking STRATTERA.

All medicines can have side effects. Sometimes they are serious, most of
the time they are not. You may need medical attention if you get some of the
side effects.

Do not be alarmed by the following lists of side effects. You may not
experience any of them. Ask your doctor or pharmacist to answer any questions
you may have.

Tell your doctor or pharmacist if you notice any of the following:

• constipation
• decreased appetite, upset or sore stomach, nausea or vomiting
• decreased weight
• dizziness
• constant flu like symptoms such as chills, fever or sore throat
• conjunctivitis or swollen runny eyes
• dilated pupils
• early morning waking, tiredness, difficulty sleeping
• mood swings or irritability
• skin rash itching
• unusual weakness
• testicular or genital pain in males.

Tell your doctor immediately or go to the Emergency Department of your
nearest hospital if you notice any of the following in you/your child while
taking STRATTERA:

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

After taking STRATTERA

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 capsules in a cool dry place where the temperature stays below
25° C.

Do not store STRATTERA 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 it looks like

STRATTERA 10 mg capsules are coloured opaque white and are marked with
"Lilly", "3227" and "10 mg".

STRATTERA 18 mg capsules are coloured gold and opaque white and are marked
with "Lilly", "3238" and "18 mg".

STRATTERA 25 mg capsules are coloured opaque blue and opaque white and are
marked with "Lilly", "3228" and "25 mg".

STRATTERA 40 mg capsules are coloured opaque blue and are marked with
"Lilly", "3229" and "40 mg".

STRATTERA 60 mg capsules are coloured opaque blue and gold and are marked
with "Lilly", "3239" and "60 mg".

Ingredients

STRATTERA contains 10, 18, 25, 40, or 60 mg of atomoxetine hydrochloride
as the active ingredient. It also contains:

• starch (pregelatinised maize)
• dimethicone 350
• gelatin
• sodium lauryl sulfate
• edible black ink
• one or more of the following:
  • indigo carmine CI73015
  • iron oxide yellow CI77492
  • titanium dioxide

This medicine does not contain lactose, sucrose, gluten, tartrazine or any
other azo dyes.