CONCERTA® extended-release tablets

ADHD

Methylphenidate hydrochloride 18 mg, 36 mg and 54 mg

What is in this leaflet

This leaflet answers some common questions about CONCERTA extended-release
tablets. 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 or your child taking CONCERTA against the benefits this medicine is expected
to have for you or your child.

If you have any concerns about taking CONCERTA ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What is CONCERTA used for

CONCERTA is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in
adolescents and children over 6 years of age.

CONCERTA is part of a comprehensive treatment program, which usually includes
psychological, educational and social therapy.

CONCERTA is a stimulant that increases attention and decreases impulsiveness
and hyperactivity in patients with ADHD.

CONCERTA tablets are made in an extended release form. This means that they
release the active ingredient slowly. The outer layer of the CONCERTA tablet
dissolves right after it is swallowed in the morning, giving an initial dose of
methylphenidate hydrochloride.

The tablets have a special shell that allows the rest of the methylphenidate
hydrochloride to be released from the tablet at a slow rate throughout the day.

The tablet shell does not dissolve completely after all the drug has been
released and sometimes the tablet shell may be seen in your stool. This is
normal.

Your doctor may have prescribed CONCERTA for another reason. Ask your
doctor if you have any questions about why this medicine has been prescribed for
you/your child.

Before you take CONCERTA

When you must not take it

Do not take CONCERTA if you/your child have an allergy to:

methylphenidate hydrochloride (the active ingredient in CONCERTA) or
any of the other ingredients in CONCERTA. See Product Description
at the end of this leaflet for a list of ingredients.

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

Do not take CONCERTA if you/your child have any of the following medical
conditions:

severe anxiety, tension or agitation because the use of this drug may make
these conditions worse
Tourette's syndrome (tics) or a family history of this disorder
glaucoma (increased pressure in the eye)
overactive thyroid gland
severe angina (chest pain)
irregular heartbeat
have/has heart disease
severe depression or other mental illness
currently taking or have taken a MOA inhibitor (eg phenelzine) within the
last 14 days.

Do not use CONCERTA if the packaging is torn or shows signs of tampering.

Do not use CONCERTA beyond the expiry date (month and year) printed on the
pack. If you/your child take CONCERTA after the expiry date it may not work.

Before you/your child start to take it

You must tell your doctor if you/your child:

are pregnant or planning to become pregnant
are breastfeeding or wish to breastfeed
are or have been alcohol or drug dependent
have/has seizures or fits
have/has high blood pressure
have/has a narrowing or blockage in your digestive tract (stomach, small
or large intestine)
have/has blurred vision.

Your doctor may need to adjust the dose or adapt your treatment if you/your
child have any of these conditions.

If you have not told your doctor or pharmacist about any of the above,
tell them before you/your child start taking CONCERTA.

Taking other medicines:

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

In particular, tell your doctor or pharmacist if you/your child are taking
any of the following:

Monoamine oxidase (MOA) inhibitors such as phenelzine
Clonidine a medicine used to treat high blood pressure
medicines that increase blood pressure
medicines used to treat depression such as fluuoxetine, amitriptyline and
imipramine
medicines used to prevent seizure such as phenytoin and phenobarbitone
medicines used to prevent blood clots such as warfarin.

These medicines may be affected by CONCERTA or may affect how well CONCERTA
works. Your doctor or pharmacist can tell you what to do if you/your child are
taking any of these medicines.

Taking CONCERTA

Follow the directions given to you by your doctor and pharmacist.
These directions may differ from the information contained in this leaflet.

How much to take:

Adolescents and Children over 6 years

The starting dose is one CONCERTA 18 mg extended-release tablet in the
morning
If you/your child are currently taking other formulations of
methylphenidate, your doctor will decide the best starting dose
The maximum dose for children aged from 6 to 12 years is 54 mg a day and
the maximum dose for adolescents aged from 13 to 18 years is 72 mg a day,
taken as one dose.

How to take it:

CONCERTA should be swallowed whole with a glass of liquid. It should not
be chewed, broken or crushed
CONCERTA may be taken with or without food.

If you do not understand the instructions provided with this medicine, ask
your doctor or pharmacist for help.

If you/your child forget to take it

It may be best to wait until the following morning to take the next dose.
Remember the effects of CONCERTA are designed to last approximately 12 hours
from the time it is taken.
Do not take or give your child a double dose to make up for the dose
missed.

If you/your child have missed more than one dose, or are not sure what to
do, check with your doctor or pharmacist.

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

If you/your child have taken too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre for
advice, or go to Accident and Emergency at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You/your child
may need urgent medical attention.

Poisons Information Centre telephone numbers:

Australia: 13 11 26
New Zealand: 0800 POISON or 0800 764 766

Keep these telephone numbers handy.

If you/your child take too much CONCERTA you/your child may experience
symptoms such as vomiting, headache, irregular heart beat, dilated pupils,
breathing problems, confusion and seizures.

While you are taking CONCERTA

Things you must do

Always follow your doctor's instructions carefully
Take CONCERTA exactly as your doctor has prescribed. Like all stimulants,
CONCERTA may become habit-forming and can be abused by some people. If
you/your child take it correctly as instructed by your doctor, abuse or
dependence should not be a problem, either now or later in life
Be sure to keep all of your doctor's appointments so that your/your
child's progress can be checked
Your doctor will want to check your/your child's blood pressure and do
blood test from time to time to prevent unwanted side effects from happening
Tell your doctor if you become pregnant while taking CONCERTA
If you/your child are about to start taking a new medicine, tell your
doctor and pharmacist that you/your child are taking CONCERTA.

Things you must not do

Do not use CONCERTA to treat any other complaint unless your doctor says
so.
Do not give this medicine to anyone else, even if their symptoms seem
similar.
Do not stop treatment without first checking with your doctor. If
you/your child suddenly stop taking this medicine, you/your child's condition
may reappear or you/your child may get unwanted effects such as depression.
Your doctor may want to gradually reduce the amount of medicine taken each day
before stopping it completely.

Side Effects

All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You/your child may need medical treatment if you get some
side effects. Do not be alarmed by this list of possible side effects. You/your
child may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you/your child experience any of the following and
they worry you:

headache
loss of appetite
trouble sleeping
stomach pain
dizziness

Tell your doctor immediately if you notice any of the following:

high fever and muscle stiffness
signs of allergy such rash, itching or hives on the skin; shortness of
breath, wheezing or difficulty breathing; swelling of the face, lips, tongue
or other parts of the body
fast or abnormal heart beat
increased blood pressure
confusion or hallucinations
nausea and/or vomiting
unusual tiredness or weakness
blurred or double vision
depression.

Other side effects not listed above may also occur in some people. Tell your
doctor if you notice any other effects.

After using CONCERTA

Storage

Keep the tablets in the bottle until it is time to take them.

Store CONCERTA in a cool dry place where the temperature is below 25°C. Keep
the container tightly closed.

Keep medicines where children cannot reach them. A locked cupboard at
least one-and-a-half metres (1.5 m) above the ground is a good place to store
medicines.

Do not store CONCERTA, or any other medicine, in the bathroom or near a sink.
Do not leave medicines in the car or on window sills. Heat and dampness can
destroy some medicines.

Disposal

If your doctor tells you/your child to stop taking CONCERTA extended-release
tablets or the medicine has passed its expiry date, ask your pharmacist what to
do with any medicine that may be left over.

Product Description

What it looks like

CONCERTA 18 mg are yellow capsule-shaped tablets, with "alza 18" printed in
black ink on one side [AUST R 93862].

CONCERTA 36 mg are white capsule-shaped tablets, with "alza 36" printed in
black ink on one side [AUST R 93863].

CONCERTA 54 mg are brownish-red capsule-shaped tablets, with "alza 54"
printed in black ink on one side [AUST R 93864].

Ingredients

Each CONCERTA extended-release tablet contains 18 mg, 36 mg or 54 mg of
methylphenidate hydrochloride as the active ingredient.

Each tablet also contains the following other ingredients: butylated
hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, Opacode black
NS-78-17715, Opadry clear YS-1-19025-A, phosphoric acid, poloxamer, polyethylene
oxide, povidone, sodium chloride, stearic acid, succinic acid and synthetic iron
oxides. The 18 mg tablet also contains Opradry II yellow YS-30-12788-A. The 36
mg tablet also contains Opradry II white Y-30-18037. The 54 mg tablet also
contains Opradry II red Y-30-15567-A.

CONCERTA extended-release tablets contain lactose.

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