Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using METHYLPHENIDATE XR ARX?
METHYLPHENIDATE XR ARX contains the active ingredient Methylphenidate hydrochloride
and is used to treat Attention Deficit Hyperactivity Disorder (ADHD).
2. What should I know before I use METHYLPHENIDATE XR ARX?
Do not use if you have ever had an allergic reaction to METHYLPHENIDATE XR ARX or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with METHYLPHENIDATE XR ARX and affect how it works.
4. How do I use METHYLPHENIDATE XR ARX?
Your doctor will tell you how much METHYLPHENIDATE XR ARX to take and how long you
will need to take it.
5. What should I know while using METHYLPHENIDATE XR ARX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using METHYLPHENIDATE
XR ARX.
Take METHYLPHENIDATE XR ARX exactly as your doctor has prescribed. Like all stimulants,
METHYLPHENIDATE XR ARX 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
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Things you should not do
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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.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how METHYLPHENIDATE
XR ARX affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Store METHYLPHENIDATE XR ARX in a cool dry place where the temperature is below 30°C.
Keep the container tightly closed.
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6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking METHYLPHENIDATE XR ARX . Like all medicines, METHYLPHENIDATE XR ARX can
have side effects, although not everybody gets them. Sometimes they are serious, most
of the time they are not. You may need medical attention if you get some of the side
effects. For more information, including what to do if you have any side effects,
see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
methylphenidate hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using METHYLPHENIDATE XR ARX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using
METHYLPHENIDATE XR ARX.
Where to find information in this leaflet:
1. Why am I using METHYLPHENIDATE XR ARX?
METHYLPHENIDATE XR ARX contains the active ingredient methylphenidate hydrochloride. METHYLPHENIDATE XR ARX is a stimulant that increases attention and decreases impulsiveness
and hyperactivity in patients with Attention Deficit Hyperactivity Disorder (ADHD).
METHYLPHENIDATE XR ARX is used to treat ADHD. METHYLPHENIDATE XR ARX is part of a comprehensive treatment program which usually
includes psychological, educational and social therapy.
METHYLPHENIDATE XR ARX should be used as part of a total treatment program for ADHD
that may include counselling or other therapies.
2. What should I know before I use METHYLPHENIDATE XR ARX?
Warnings
Do not use METHYLPHENIDATE XR ARX if:
You are allergic to methylphenidate hydrochloride, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
The packaging is torn or shows signs of tampering.
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 METHYLPHENIDATE XR ARX if you/your child have any of the following medical
conditions:
glaucoma (increased pressure in the eye) which is poorly controlled
overactive thyroid gland
heart problems, including severe angina (chest pain), irregular heartbeat, heart muscle
disease, high blood pressure (untreated or not under control)
high blood pressure (untreated or not under control)
severe depression, anorexia nervosa, suicidal tendency or other mental illness
phaeochromocytoma (a tumour of the adrenal gland)
have a history of drug or alcohol abuse
currently taking or have taken a monoamine oxidase (MAO) inhibitor, medicines used
to treat major depression (eg. phenelzine, tranylcypromine) or medicines used in Parkinson's
disease (eg. selegiline) within the last 14 days
Check with your doctor if you:
have any other medical conditions
are/is or have/has been alcohol or drug dependent
have/has seizures or fits
have/has heart problems
Heart-related problems including sudden death in patients who have heart problems
or heart defects, stroke and heart attack in adults and increased blood pressure and
heart rate have been reported with the use of methylphenidate, the active ingredient
in METHYLPHENIDATE XR ARX.
have / had thoughts about suicide or attempted suicide
have/has high blood pressure
have/has aggressive behaviour or hostility
have/has a narrowing or blockage in your digestive tract (stomach, small or large
intestine)
have tics (movements or sounds you cannot control) or Tourette's syndrome, or a family
history of these conditions
have/has a problem with the blood vessels in your brain (such as an aneurysm)
have/has eye problems, such as increased pressure in the eye, a condition called "glaucoma"
or long-sightedness (difficulty seeing near objects)
have/has liver or kidney problems
have/has mental problems including psychosis, mania, bipolar illness, or depression
Mental (psychiatric) problems may develop or get worse, including behaviour and thought
problems, bipolar illness, aggressive behaviour or hostility.
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 METHYLPHENIDATE XR ARX.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in METHYLPHENIDATE XR ARX passes into breast milk and there
is a possibility that your baby may be affected. Your doctor can discuss with you
the risks and benefits involved.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your 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 (MAO) inhibitors such as phenelzine, selegiline
medicines that increase blood pressure
medicines used to treat depression or anxiety such as venlafaxine, sertraline, amitriptyline
and imipramine
medicines used to treat high blood pressure. METHYLPHENIDATE XR ARX may decrease the
effectiveness of these medicines and your doctor may check your blood pressure and
change your dose of antihypertensive medicine.
medicines used for anaesthesia. METHYLPHENIDATE XR ARX should not be taken with certain
anaesthetics on the day of the operation, as there is a chance of a sudden rise in
blood pressure and heart rate during the operation. Tell your doctor if you are going
to have an operation.
medicines used to prevent seizures such as phenytoin, phenobarbitone, primidone and
valproate.
antipsychotic medicines such as olanzapine, risperidone and quetiapine used to improve
the symptoms of certain types of mental illness, e.g. schizophrenia and bipolar disorder.
Some medicines may interfere with METHYLPHENIDATE XR ARX and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect METHYLPHENIDATE XR ARX.
4. How do I use METHYLPHENIDATE XR ARX?
How much to take / use
If you/your child are currently taking other formulations of methylphenidate, your
doctor will decide the best starting dose
Children and Adolescents
The starting dose is one METHYLPHENIDATE XR ARX 18 mg extended- release tablet in
the morning
The maximum dose is 54 mg a day taken as one dose.
Adults
The starting dose is one METHYLPHENIDATE XR ARX 18 mg or 36 mg extended-release tablet
in the morning
The maximum dose is 72 mg a day taken as one dose.
Follow your doctor's instructions carefully and do not change or stop your dosage
without consulting your doctor first. Your doctor may adjust the amount of METHYLPHENIDATE
XR ARX you take until it is right for you.
How to take / use METHYLPHENIDATE XR ARX
METHYLPHENIDATE XR ARX should be swallowed whole with a glass of liquid. It should
not be chewed, broken or crushed.
METHYLPHENIDATE XR ARX may be taken with or without food.
If you/your child forget to use METHYLPHENIDATE XR ARX
METHYLPHENIDATE XR ARX should be used regularly at the same time each day. If you
miss your dose at the usual time:
It may be best to wait until the following morning to take the next dose. Remember
the effects of METHYLPHENIDATE XR ARX 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 use too much METHYLPHENIDATE XR ARX
If you think that you have used too much METHYLPHENIDATE XR ARX, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you/your child take too much METHYLPHENIDATE XR ARX you/your child may experience
symptoms such as vomiting, agitation, muscle twitching, hallucination, dry mouth,
excessive sweating, fever, headache, irregular or fast heartbeat, dilated pupils,
convulsions/fits, breathing problems, confusion and seizures
5. What should I know while using METHYLPHENIDATE XR ARX?
Things you/ your child should do
Always follow your doctor's instructions carefully
Take METHYLPHENIDATE XR ARX exactly as your doctor has prescribed. Like all stimulants,
METHYLPHENIDATE XR ARX 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 pulse and do blood
test from time to time to prevent unwanted side effects
Tell your doctor if you/your child become pregnant while taking METHYLPHENIDATE XR
ARX
Tell your doctor if you or your child become aggressive, anxious or agitated, or feel
more aggressive, anxious or agitated than usual
Tell your doctor if you or your child develop severe headaches, weakness or paralysis
of any body part, or develop problems with coordination, vision, speaking, finding
words or with your memory
Children should have their height and weight checked regularly as METHYLPHENIDATE
XR ARX may slow children's rate of growth
Tell your doctor if you/your child experience numbness, tingling and a changing colour
of the fingers and toes when cold (‘Raynaud’s phenomenon’)
Tell your doctor if you/your child are about to start taking a new medicine, that
you/your child are taking METHYLPHENIDATE XR ARX
Call you/ your child's doctor straight away if:
Parents and/or caregivers should be alert for the development of thoughts or acts
of self-harm, hallucinations, abnormal thinking (psychosis) or new or worsening hostility.
These were uncommon symptoms seen in clinical studies with methylphenidate hydrochloride
and it is not known if they were caused by methylphenidate hydrochloride. Contact
your/your child's doctor or mental health professional straight away or seek urgent
medical attention if these occur
Parents and/or caregivers should contact their/their child's doctor or seek urgent
treatment if they/their child develops chest pain, tightness in the chest, shortness
of breath, irregular heartbeat, feeling faint or loss of consciousness while taking
METHYLPHENIDATE XR ARX
You or your child develop prolonged and painful erections
Remind any doctor, dentist or pharmacist you visit that you are using METHYLPHENIDATE
XR ARX.
Things you should not do
Do not stop using this medicine suddenly.
Do not use METHYLPHENIDATE XR ARX 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.
Driving or using machines
METHYLPHENIDATE XR ARX may impair your ability to operate potentially hazardous machinery
or vehicles. You should exercise caution until you are reasonably certain how you
react to METHYLPHENIDATE XR ARX before you drive a car, operate machinery, or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep the tablets in the bottle until it is time to take them.
Store METHYLPHENIDATE XR ARX in a cool dry place where the temperature is below 30°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.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you/ your child do experience any side effects,
most of them are minor and temporary. However, some side effects may need medical
attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Stomach or bowel problems such as:
loss of appetite
stomach pain
nausea
vomiting
dry mouth
indigestion
constipation
weight loss
diarrhoea
Difficulty thinking or working because of:
headache
trouble sleeping
dizziness
Throat or lung infections such as:
cold
cough
sore throat and hoarse/ loss of voice
feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes
with a throbbing ache, fever, stuffy nose and loss of the sense of smell
Joints or movement changes such as:
painful and/ or swollen joints
aching muscles, muscle tightness, spasm, tenderness or weakness, not caused by exercise
difficulty opening the mouth
clenching or grinding the teeth
Other changes such as:
decreased sex drive or difficulty getting and keeping an erection
feeling very tired or weak
excessive thirst
feeling sleepy
loss of bladder control
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Behavioural changes
aggression
confusion
disorientation
seeing, feeling or hearing things that are not there
mood swings, overexcitement over-activity and uninhibited behaviour
feeling depressed
feeling tense
nervousness or anxiety
brief periods of acute anxiety where symptoms suddenly and usually include difficulty
breathing, chest pains, fast heart rate, dizziness and lightheadedness, sweating,
trembling and faintness
restlessness
agitation and irritability
movements or sounds that you cannot control (tics)
Nervous system changes such as:
convulsions, fits or seizures
muscle twitching or tremor
numbness and tingling feeling in fingers and toes
Reproductive system changes such as:
prolonged and painful erections
enlarged breasts in boys or men
Changes in your sight, namely:
visual disturbance
blurred or double vision
dilated pupils
Changes to the skin or hair such as:
unusual hair loss or thinning of the hair
redness of the skin
excessive sweating
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
Body temperature changes such as:
fever
hot flushes
Heart or blood problems such as:
fast or abnormal heart beat
increased blood pressure
chest pain
chest discomfort
low white blood cell count
low platelet count
Other side effects such as:
shortness of breath
nose bleeds
slowing of growth (height and weight) in children
blockage of the oesophagus, stomach, small or large intestine in patients who already
have a narrowing in any of these organs
increased levels of the liver enzyme ALT
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What METHYLPHENIDATE XR ARX contains
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Active ingredient
(main ingredient)
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Methylphenidate hydrochloride
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Other ingredients
(inactive ingredients)
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Lactose monohydrate
Hypromellose
Colloidal anhydrous silica
Magnesium stearate
Methacrylic acid copolymer
Triethyl citrate
Purified talc
Fumaric acid
Opadry 85F220137 Yellow (ARTG PI No. 140409 – 18 mg tablets)
Opadry 85F275019 Grey (ARTG PI No. 140410 – 27 mg tablets)
Opadry 85F48105 White (ARTG PI No. 123056 – 36 mg tablets)
Opadry 85F15266 Red (ARTG PI No. 141465 – 54 mg tablets)
OPACODE monogramming ink S-1-17823 BLACK (PI 12108)
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What METHYLPHENIDATE XR ARX looks like
METHYLPHENIDATE XR ARX 18 mg are yellow capsule-shaped tablets, with "2392" printed
in black ink on one side [AUST R 344274].
METHYLPHENIDATE XR ARX 27 mg are grey capsule-shaped tablets, with "2393" printed
in black ink on one side [AUST R 344270].
METHYLPHENIDATE XR ARX 36 mg are white capsule-shaped tablets, with "2394" printed
in black ink on one side [AUST R 344277].
METHYLPHENIDATE XR ARX 54 mg are brownish- red capsule-shaped tablets, with "2395"
printed in black ink on one side [AUST R 344275].
Who distributes METHYLPHENIDATE XR ARX
Sponsored in Australia by:
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
AUSTRALIA
Distributed in Australia by:
Arrotex Pharmaceuticals
15 – 17 Chapel Street
Cremorne, Victoria, 3121
This leaflet was prepared in October 2023.