CONCERTA®

extended-release tablets
Methylphenidate hydrochloride
Consumer Medicine Information

What is in this leaflet CONCERTA is not recommended

for use in children less than 6 years
This leaflet answers some common and elderly over 65 years because it
questions about CONCERTA has not been studied in these age Before you take
extended-release tablets. It does not groups. CONCERTA
contain all the available information. CONCERTA tablets are made in an
It does not take the place of talking to extended release form. This means When you must not take it
your doctor or pharmacist. that they release the active ingredient Do not take CONCERTA if
All medicines have risks and slowly. The outer layer of the you/your child have an allergy to:
benefits. Your doctor has weighed CONCERTA tablet dissolves right
after it is swallowed in the morning, • methylphenidate hydrochloride
the risks of you or your child taking (the active ingredient in
CONCERTA against the benefits this giving an initial dose of
methylphenidate hydrochloride. CONCERTA) or
medicine is expected to have for you
or your child. The tablets have a special shell that • any of the other ingredients in
allows the rest of the CONCERTA. See Product
If you have any concerns about Description at the end of this
taking CONCERTA ask your doctor methylphenidate hydrochloride to be
released from the tablet at a slow rate leaflet for a list of ingredients.
or pharmacist.
throughout the day. Symptoms of an allergic reaction
Keep this leaflet with your medicine. may include: rash, itching or hives on
You may need to read it again. The tablet shell does not dissolve
completely after all the drug has been the skin; shortness of breath,
released and sometimes the tablet wheezing or difficulty breathing;
shell may be seen in your stool. This swelling of the face, lips, tongue or
is normal. other parts of the body.
What is CONCERTA Do not take CONCERTA if
used for Your doctor may have prescribed
you/your child have any of the
CONCERTA for another reason.
Ask your doctor if you have any following medical conditions:
CONCERTA is used to treat
Attention Deficit Hyperactivity questions about why this medicine • overactive thyroid gland
Disorder (ADHD). CONCERTA is has been prescribed for you/your • heart problems, including angina
part of a comprehensive treatment child. (chest pain), irregular heart beat
program which usually includes CONCERTA can be abused or that is potentially life-threatening
psychological, educational and social lead to dependence. Keep and high blood pressure
therapy. CONCERTA in a safe place to (untreated or not under control)
CONCERTA is a stimulant that prevent misuse and abuse. • a problem with the blood vessels
increases attention and decreases in your brain (such as an
impulsiveness and hyperactivity in aneurysm or a stroke)
patients with ADHD.
• severe depression, anorexia
CONCERTA should be used as part nervosa, suicidal tendency,
of a total treatment program for bipolar disorder or other mental
ADHD that may include counselling illness
or other therapies.
• currently taking or have taken a
monoamine oxidase (MAO)

CONCERTA® (230516) ACMI 1

 inhibitor, medicines used to treat • have/has a narrowing or blockage and change your dose of
major depression (eg. in your digestive tract (stomach, antihypertensive medicine.
phenelzine, tranylcypromine) or small or large intestine) • medicines used for anaesthesia.
medicines used in Parkinson's • Tourette's syndrome (tics) or a CONCERTA should not be taken
disease (eg. selegiline) within the family history of this disorder with certain anaesthetics on the
last 14 days day of the operation, as there is a
• have a problem with the blood
• phaeochromocytoma (a tumour of vessels in your brain (such as an chance of a sudden rise in blood
the adrenal gland) aneurysm) pressure and heart rate during the
• have a history of drug or alcohol operation. Tell your doctor if you
• have/has eye problems, such as are going to have an operation.
abuse increased pressure in the eye, a
Do not use CONCERTA if the condition called "glaucoma" or • medicines used to treat
packaging is torn or shows signs of long-sightedness (difficulty depression or anxiety such as
tampering. seeing near objects) venlafaxine, sertraline,
amitriptyline and imipramine
Do not use CONCERTA beyond • have/has liver or kidney problems
the expiry date (month and year) • medicines used to prevent
• have/has mental problems seizures such as phenytoin,
printed on the pack. including psychosis, mania,
phenobarbitone, and primidone
If you/your child take CONCERTA bipolar illness, or depression.
and valproate.
after the expiry date it may not work. Mental (Psychiatric) problems
• Antipsychotic medicines such as
may develop or get worse, olanzapine, risperidone and
Before you/your child start including behaviour and thought
to take it quetiapine used to improve the
problems, bipolar illness,
symptoms of certain types of
You must tell your doctor if you/your aggressive behaviour or hostility.
mental illness, e.g. schizophrenia
child: Your doctor may need to adjust the and bipolar disorder.
• are/is pregnant or planning to dose or adapt your treatment if These medicines may be affected
become pregnant you/your child have any of these by CONCERTA or may affect
conditions.
• are/is breastfeeding or wish to how well CONCERTA works.
breastfeed. If you have not told your doctor or Your doctor or pharmacist can
pharmacist about any of the above, tell you what to do if you/your
The active ingredient in
tell them before you/your child child are taking any of these
CONCERTA passes into breast
start taking CONCERTA. medicines.
milk and there is a possibility that
your baby may be affected. Your
Taking other medicines:
doctor can discuss with you the
risks and benefits involved Tell your doctor or pharmacist if
you/your child are taking any other Taking CONCERTA
• are/is or have/has been alcohol or
drug dependent medicines, including medicines you
can buy without a prescription from a Follow the directions given to you
• have/has seizures or fits pharmacy, supermarket or health by your doctor and pharmacist.
• have/has heart problems food shop. These directions may differ from the
Heart-related problems including In particular, tell your doctor or information contained in this leaflet.
sudden death in patients who pharmacist if you/your child are
have heart problems or heart taking any of the following: How much to take:
defects, stroke and heart attack in • Monoamine oxidase (MAO) If you/your child are currently
adults and increased blood inhibitors such as phenelzine, taking other formulations of
pressure and heart rate have been selegiline methylphenidate, your doctor will
reported with the use of decide the best starting dose
methylphenidate, the active • medicines that increase blood
pressure Children and Adolescents
ingredient in CONCERTA.
• medicines used to treat high • The starting dose is one
• have / had thoughts about suicide
blood pressure. CONCERTA CONCERTA 18 mg extended-
or attempted suicide
may decrease the effectiveness of release tablet in the morning
• have/has high blood pressure these medicines and your doctor • The maximum dose is 54 mg a
• have/has aggressive behaviour or may check your blood pressure day taken as one dose for children
hostility aged between 6-12 years and 72

CONCERTA® (230516) ACMI 2

 mg a day taken as one dose for Poisons Information Centre CONCERTA. Contact your/your
adolescents aged between 13-18 telephone number:0800 POISON or child's doctor or mental health
years. 0800 764 766 professional straight away or seek
Adults Keep this telephone number handy. urgent medical attention if these
occur
• The starting dose is one If you/your child take too much
CONCERTA 18 mg or 36 mg CONCERTA you/your child may • Tell your doctor if you or your
extended-release tablet in the experience symptoms such as child become aggressive, anxious
morning vomiting, agitation, muscle or agitated, or feel more
twitching, hallucination, dry mouth, aggressive, anxious or agitated
• The maximum dose is 72 mg a than usual
day taken as one dose. excessive sweating, headache,
irregular heart beat, dilated pupils, • Parents and/or caregivers should
How to take it: convulsions/fits, breathing problems, contact their/their child's doctor
confusion and seizures. or seek urgent treatment if
• CONCERTA should be they/their child develops chest
swallowed whole with a glass of pain, tightness in the chest,
liquid. It should not be chewed, shortness of breath, irregular
broken or crushed While you are taking heart beat, feeling faint or loss of
• CONCERTA may be taken with CONCERTA consciousness while taking
or without food. CONCERTA
If you do not understand the Things you must do • Tell your doctor if you or your
instructions provided with this child develop severe headaches,
• Always follow your doctor's weakness or paralysis of any
medicine, ask your doctor or
instructions carefully body part, or develop problems
pharmacist for help.
• Take CONCERTA exactly as with coordination, vision,
If you/your child forget to your doctor has prescribed. Like speaking, finding words or with
take it all stimulants, CONCERTA may your memory
become habit-forming and can be • Children should have their height
• It may be best to wait until the abused by some people. If
following morning to take the and weight checked regularly as
you/your child take it correctly as CONCERTA may slow children's
next dose. Remember the effects instructed by your doctor, abuse
of CONCERTA are designed to rate of growth
or dependence should not be a
last approximately 12 hours from problem, either now or later in • Tell your doctor if you/your child
the time it is taken. life experience numbness, tingling
• Do not take or give your child a and a changing colour of the
• Be sure to keep all of your fingers and toes when cold
double dose to make up for the doctor's appointments so that
dose missed. (‘Raynaud’s phenomenon’)
your/your child's progress can be
If you/your child have missed more checked • Tell your doctor if you or your
than one dose, or are not sure what child develop prolonged and
• Your doctor will want to check painful erections, seek immediate
to do, check with your doctor or your/your child's blood pressure
pharmacist. medical attention
and pulse and do blood test from
If you have trouble remembering time to time to prevent unwanted • Tell your doctor if you/your child
when to take your medicine, ask your side effects from happening are about to start taking a new
pharmacist for some hints. medicine, tell your doctor and
• Tell your doctor if you become pharmacist that you/your child
pregnant while taking are taking CONCERTA
If you/your child have taken CONCERTA
too much (overdose) • Tell your doctor if you/your child
• Parents and/or caregivers should are about to have an operation as
Immediately telephone your doctor be alert for the development of CONCERTA should not be used
or the Poisons Information Centre for thoughts or acts of self-harm, on the day of the operation
advice, or go to Accident and hallucinations, abnormal thinking
Emergency at your nearest hospital. (psychosis) or new or worsening Things you must not do
Do this even if there are no signs of hostility. These were uncommon
discomfort or poisoning. You/your symptoms seen in clinical studies • Do not drink alcohol whilst you
with CONCERTA and it is not are being treated with
child may need urgent medical
attention. known if they were caused by

CONCERTA® (230516) ACMI 3

 CONCERTA as it may increase • vomiting • brief periods of acute anxiety
the risk of side effects • dry mouth where symptoms being suddenly
• Do not use CONCERTA to treat and usually include difficulty
• indigestion
any other complaint unless your breathing, chest pains, fast heart
• constipation rate, dizziness and
doctor says so.
• weight loss lightheadedness, sweating,
• Do not give this medicine to trembling and faintness
anyone else, even if their • diarrhoea
symptoms seem similar. • restlessness
difficulty thinking or working
• Do not stop treatment without because of: • agitation and irritability
first checking with your doctor. • headache • movements or sounds that you
If you/your child suddenly stop cannot control (tics)
• trouble sleeping
taking this medicine, you/your nervous system changes such as:
• dizziness
child's condition may reappear or • convulsions, fits or seizures
you/your child may get unwanted throat or lung infections such as:
effects such as depression. Your • muscle twitching
• cold
doctor may want to gradually • numbness and tingling feeling in
• cough
reduce the amount of medicine fingers and toes
taken each day before stopping it • sore throat and hoarse/ loss of
reproductive system changes such
completely. voice
as:
• feeling of tension or fullness in
• prolonged and painful erections
Things to be careful of the nose, cheeks and behind your
eyes, sometimes with a throbbing • difficulty getting and keeping an
• CONCERTA may impair your erection
ability to operate potentially ache, fever, stuffy nose and loss
of the sense of smell • enlarged breasts in boys or men
hazardous machinery or vehicles.
You should exercise caution until joints or movement changes such changes in your sight, namely:
you are reasonably certain how as:
• visual disturbance
you react to CONCERTA before • painful and/ or swollen joints
you drive a car, operate • blurred or double vision
• aching muscles, muscle tightness,
machinery, or do anything else • dilated pupils
spasm, tenderness or weakness,
that could be dangerous. changes to the skin or hair such as:
not caused by exercise
• clenching or grinding the teeth • unusual hair loss or thinning of
the hair
other changes such as:
Side Effects • redness of the skin
• decreased sex drive • excessive sweating
All medicines can have side effects. • feeling very tired or weak • signs of allergy such rash, itching
Sometimes they are serious, most of
or hives on the skin; shortness of
the time they are not. You/your child
Tell your doctor immediately if breath, wheezing or difficulty
may need medical treatment if you
you notice any of the following: breathing; swelling of the face,
get some side effects. Do not be
lips, tongue or other parts of the
alarmed by this list of possible side behavioural changes such as:
body
effects. You/your child may not • aggression
experience any of them. body temperature changes such as:
• confusion
Ask your doctor or pharmacist to • fever
• disorientation
answer any questions you may • hot flushes
have. Tell your doctor if you/your • seeing, feeling or hearing things
heart or blood problems such as:
child experience any of the that are not there
following and they worry you: • fast or abnormal heart beat
• mood swings, overexcitement
stomach or bowel problems such over-activity and uninhibited • increased blood pressure
as: behaviour • chest pain
• loss of appetite • feeling depressed • chest discomfort
• stomach pain • feeling tense • low white blood cell count
• nausea • nervousness or anxiety • low platelet count

CONCERTA® (230516) ACMI 4

other side effects such as: Product Description • 18 mg: OPADRY II complete
• shortness of breath film coating system YS-30-
12788-A YELLOW
• nose bleeds What it looks like
• 27 mg: OPADRY II complete
• slowing of growth (height and CONCERTA 18 mg are yellow film coating system Y-30-17528
weight) in children capsule-shaped tablets, with "alza GRAY
• blockage of the oesophagus, 18" printed in black ink on one side.
• 36 mg: Opadry II White Y-30-
stomach, small or large intestine CONCERTA 27 mg are grey 18037
in patients who already have a capsule-shaped tablets, with "alza
narrowing in any of these organs • 54 mg: OPADRY II complete
27" printed in black ink on one side.
film coating system Y-30-15567-
• increased levels of the liver CONCERTA 36 mg are white A RED
enzyme ALT capsule-shaped tablets, with "alza
(OPADRY II coating systems also
Other side effects not listed above 36" printed in black ink on one side. contain lactose monohydrate,
may also occur in some people. Tell CONCERTA 54 mg are brownish- titanium dioxide and triacetin)
your doctor if you notice any other red capsule-shaped tablets, with "alza
effects. 54" printed in black ink on one side. Sponsor
JANSSEN-CILAG Pty Ltd
Ingredients
1-5 Khartoum Road
Each CONCERTA extended-release
After using tablet contains 18 mg, 27 mg, 36 mg
Macquarie Park NSW 2113 Australia
CONCERTA or 54 mg of methylphenidate Telephone: 1800 226 334
hydrochloride as the active
Storage ingredient.
NZ Office: Auckland New Zealand
Keep the tablets in the bottle until it Each tablet also contains the
Telephone: 0800 800 806
is time to take them. following other ingredients:
Store CONCERTA in a cool dry Tablet core:
place where the temperature is below This leaflet was prepared in May
• butylated hydroxytoluene
25°C. Keep the container tightly 2023.
closed. • cellulose acetate
• hypromellose
Keep medicines where children
cannot reach them. • iron oxide black
OROS® formulation is a trademark
A locked cupboard at least one-and- • iron oxide yellow of ALZA Corporation.
a-half metres (1.5 m) above the • iron oxide red (27 mg & 54 mg
ground is a good place to store only)
medicines.
• phosphoric acid
Do not store CONCERTA, or any
• poloxamer
other medicine, in the bathroom or
near a sink. Do not leave medicines • polyethylene oxide
in the car or on windowsills. Heat • povidone
and dampness can destroy some
• sodium chloride
medicines.
• stearic acid
Disposal • succinic acid
If your doctor tells you/your child to Tablet coating
stop taking CONCERTA extended- • carnauba wax
release tablets or the medicine has
• OPACODE WB monogramming
passed its expiry date, ask your
ink NS-78-17715 BLACK (also
pharmacist what to do with any
contains propylene glycol)
medicine that may be left over.
• OPADRY complete film coating
system YS-1-19025-A – CLEAR
(also contains macrogol 400)

CONCERTA® (230516) ACMI 5