2. What should I know before I use Artige?
Do not use if you have ever had an allergic reaction to Artige 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.
For more information, see Section
2. What should I know before I use Artige? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Artige?
ADHD (children only): Take 5mg once or twice daily at breakfast or lunch as per your
doctor's instruction.
Narcolepsy (adults only): Take 20 to 30 mg a day, depending on your doctor's instructions.
Swallow whole or half tablet orally with water.
5. What should I know while using Artige?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Artige.
Take your medicine as directed by your doctor.
If you become pregnant while taking Artige, tell your doctor immediately
|
|
Things you should not do
|
Do not stop using this medicine suddenly.
Do not change your dose without speaking to your doctor first.
|
|
Driving or using machines
|
Artige may cause dizziness, drowsiness, blurred vision, or hallucinations (seeing
or hearing things that aren't there) in some people. Be careful before you drive or
use any machines or tools or ride a bike until you know how Artige affects you.
|
|
Drinking alcohol
|
Alcohol may make the side effects worse.
Check to make sure food and other medicines taken do not contain alcohol.
|
|
Looking after your medicine
|
Store tablets below 25°C. Keep your tablets out of the reach of children.
|
6. Are there any side effects?
Common side effects include headache, drowsiness, dizziness, sleepiness, shaking of
the body, vomiting, mood changes, restlessness.
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.
|
WARNING: DRUG DEPENDENCE: Artige should be given cautiously to patients with a history of drug
dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological
dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can
occur, especially with parenteral abuse. Careful supervision is required during withdrawal
from abusive use since severe depression may occur. Withdrawal following chronic therapeutic
use may unmask symptoms of the underlying disorder that may require follow up.
|
Active ingredient:
methylphenidate hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Artige. 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 Artige.
Where to find information in this leaflet:
1. Why am I taking Artige?
Artige contains the active ingredient methylphenidate hydrochloride. Artige is a class of medicine that increases the activity of the brain.
Artige is used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is also
used to treat narcolepsy, a sleep-attack disorder.
2. What should I know before I take Artige?
Warnings
Do not take Artige if:
you are allergic to methylphenidate hydrochloride, or any of the ingredients listed
at the end of this leaflet.
you have anxiety, tension or agitation
you have Tourette's Syndrome (uncontrolled speech, body movements or tics) or a family
history of Tourette's
you have Glaucoma (increased pressure in the eye)
you have an overactive thyroid or other thyroid problems
you have heart problems - heart attack, irregular heartbeat, chest pain (angina),
heart failure, heart disease or if you were born with a heart problem
you have very high blood pressure (hypertension) or narrowing of the blood vessels
(arterial occlusive disease, which can cause pain in the arms and legs)
you have severe depression, eating disorder (anorexia) or other mental illness
you have a tumour in the adrenal gland which can cause high blood pressure and headaches.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions such as depression, suicidal thoughts or behaviour,
seeing or feeling things that are not there (hallucinations), unusual active or depressed
mood (bipolar illness), aggressive behaviour
have abnormal thoughts or are over-excited, over-active or un-inhibited
have motor or verbal tics, uncontrolled speech or movements, repeated twitching or
make repeated sounds or words, or if a family member has any of these
have had fits/convulsions
experience all of these problems: restlessness, tremor, sudden muscle contractions,
abnormal high temperature, nausea, vomiting
have high blood pressure (headaches, blurred vision, chest pain)
have any other medical conditions such as current or previous heart problems or serious
heart rhythm problems.
have any other medical conditions such as weakening of the blood vessels in the brain,
inflammation of the blood vessels, have had a stroke
have a history of drug or alcohol abuse
have eye problems, including increased pressure in your eye, glaucoma or trouble seeing
close-up
take any medicines for any other condition
have painful or long-lasting erections
have serious heart problems. You should be examined by a Heart Specialist before you
take Artige.
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.
Artige should not be taken in the first 3 months of pregnancy.
Do not breast feed if you are taking Artige.
Children under 6 years
Do not use Artige in children under 6 years of age.
Children under 18 years of age
Your doctor needs to take a detailed history and evaluation before you take Artige.
Children may have slower growth if taking Artige for a long time.
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.
Do not take Artige if:
you are taking monoamine oxidase inhibitors (MAOI) or have taken this medicine in
the last 2 weeks.
Tell your doctor or pharmacist if you are taking any of the following medicines:
medicines that increase blood pressure;
tricyclic antidepressants (treats depression);
alpha 2 agonists (treat high blood pressure);
oral anticoagulants (prevent blood clots);
anticonvulsants (treat fits/seizures);
medicines that treat mental illnesses (antipsychotics)
phenylbutazone (treats pain or fever);
that influence dopamine levels e.g. disease which affects movement (Parkinson's disease);
that change the level of serotonin in the body such as sertraline or venlafaxine that
are used to treat depression.
Tell your doctor or pharmacist if you are having an operation. Artige cannot be taken
with anesthetics due to an increased risk of blood pressure.
Artige may give false positives in drug testing.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Artige.
4. How do I take Artige?
How much to take
ADHD (children only): Start with 5 mg once or twice daily with gradual increases of
5 mg or 10 mg weekly, depending on your doctor's instructions.
The highest recommended dose of Artige for children is 60 mg per day.
Narcolepsy (adults only): the average dose is 20 to 30 mg a day, depending on your
doctor's instructions.
The highest recommended dose of Artige for adults is 60 mg per day.
Follow the instructions provided and use Artige until your doctor tells you to stop.
When to take Artige
Artige should be taken once or twice a day (for example at breakfast or lunch) as
per your doctor's instructions.
Doses should be taken 1 to 2 hours before the maximum effect is needed.
Swallow tablet with water.
Artige should be taken before 6pm as it can cause trouble sleeping if the dose is
taken late.
In some cases, sleeplessness occurs as the medicine wears off. Talk to your doctor
about doses in the evenings.
If you forget to take Artige
Artige should be used regularly at the same time each day. If you miss your dose at
the usual time, take it as soon as possible.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
Do not take more medicine than your doctor tells you to; do not take it more often
and do not use it for longer than your doctor tells you - this medicine can be addictive.
If you use too much Artige
If you think that you have used too much Artige, you may need urgent medical attention.
You could experience vomiting, feeling uneasy or tense (agitation), headache, shaking
(tremor), muscle twitching, irregular heartbeat, flushing, fever, sweating, dilated
pupils, breathing problems, confusion, fits, muscle spasms, or red-brown urine (muscle
breakdown).
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.
5. What should I know while taking Artige?
Things you should do
Take your medicine as directed by your doctor.
Make sure you keep any doctor's or specialist appointments as your doctor needs to
assess your treatment periodically.
Call your doctor straight away if you:
Have any chest pain, fainting or other possible heart problems.
Have any abnormal thoughts, over-active/excited or uninhibited actions, aggressive
behaviour, are seeing things.
Have fits or tics
Have eye problems
Have slurred speech, confusion, loss of coordination, sudden numbness
Have painful or long-lasting erections
Remind any doctor, dentist or pharmacist you visit that you are taking Artige.
Things you should not do
Do not stop using this medicine suddenly.
Do not change your dose without speaking to your doctor first.
Keep all doctors and specialists' appointments.
Growth in children
Some children taking Artige for a long time can have a slower than normal growth.
Medicines that raise serotonin
For example sertraline, venlafaxine used to treat depression.
If you feel restless, have tremor, abnormal high temperature, nausea, vomiting - stop
using Artige.
Driving or using machines
Be careful before you drive or use any machines or tools or ride a bike until you
know how Artige affects you.
Artige may cause dizziness, drowsiness, blurred vision, or hallucinations (seeing
or hearing things that aren't there) in some people.
Drinking alcohol
Do not drink alcohol while taking Artige.
Alcohol can make the side effects worse. Check to make sure food and other medicines
taken do not contain alcohol.
Sudden withdrawal
Do not suddenly stop taking Artige.
Stopping Artige suddenly can cause withdrawal effects - patients can feel depressed
or long lasting over-activity.
Looking after your medicine
Store below 25°C.
Follow the instructions on 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 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
|
Less serious side effects
|
What to do
|
|
Problems of the brain, spinal cord and nerves:
Headache, dizziness
Drowsiness or sleepiness
Shaking of the body (tremor)
Emotional problems - excitement, restlessness
Rapid, extreme or unpredictable mood changes/mood swings
Nervousness
Being obsessed with one thing
Feeling aggressive
Feeling depressed
Trouble falling asleep, sleeping problems
Unusual active or depressed mood
Confusion, disoriented
Heart problems:
A problem with heart rate or heart rhythm
Changes in blood pressure and heart rate (usually an increase)
Infections:
Sore throat
Runny nose, nasal congestion
Cough
Sneezing
Fever
Eating problems:
Decreased appetite
Decreased weight
Reduced weight gain
Mental illness:
Grinding, gnashing, or clenching your teeth
Irritability
Feeling uneasy or worried - agitation
Nervousness
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Less serious side effects (continued)
|
Less serious side effects
|
What to do
|
|
Gut problems:
Nausea
Dry mouth
Stomach pain or upset
Feeling full soon after eating
Indigestion
Vomiting
Toothache
Diarrhoea
Constipation
Skin problems:
Rash
Skin blisters
Itchy skin
Pink or red itchy rashes
Hair loss
Uncontrollable sweating
General problems:
Feeling jittery
Bed wetting
Tiredness
Slow growth
Blood-related problems:
Fingers feel numb, having pins and needles or turn blue/purple
Extreme coldness of hands or feet
Temporary muscle weakness, loss of skin sensation
Bones, joint problems:
Joint stiffness or pain
Decreased ability to eat or speak
Locked jaw, trouble opening the mouth, tooth/neck/face pain
Muscle cramping
Muscle pain or twitch
Eye problems:
Blurred eyesight
Double vision
Dilated pupils
Trouble seeing
Lung problems:
Cough
Body system which fights disease:
Swelling of the ears
Reproductive problems:
Increased breast size in males
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
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 Artige contains
|
Active ingredient
(main ingredient)
|
Methylphenidate hydrochloride
|
|
Other ingredients
(inactive ingredients)
|
lactose, calcium phosphate, gelatin, magnesium stearate, purified talc and wheat starch
|
|
Potential allergens
|
Lactose, gluten, animal product
|
Do not take this medicine if you are allergic to any of these ingredients.
What Artige looks like
Artige tablets are immediate release white tablets that are scored and marked AB and
CG on the reverse; packs of 100 tablets.
Australian Registration Number:
Artige tablet: AUST R 117306
Who distributes Artige
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1 800 671 203
® = Registered Trademark
This leaflet was prepared in November 2025.
Internal document code:
(art300124c_v3 based on PI
art300124i)