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 INTUNIV?
INTUNIV contains the active ingredient guanfacine hydrochloride. INTUNIV is used to
treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children
and adolescents.
2. What should I know before I use INTUNIV?
Do not use if you have ever had an allergic reaction to INTUNIV or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, have history or current
mental health problems, 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 INTUNIV and affect how it works.
4. How do I use INTUNIV?
Your doctor will tell you what dose to take each day based on your/your child's body
weight and the dose if it is used together with a stimulant medicine.
Swallow the tablet whole with a full glass of water. Do not break, crush or chew the
tablet. Follow all directions given to you by your doctor or pharmacist carefully.
5. What should I know while using INTUNIV? ('You' means either yourself or your child)
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Things you should do
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Remind any doctor or dentist whom you visit that you are using INTUNIV. If you become
pregnant while using this medicine, tell the doctor immediately.
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Things you should not do
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Do not stop using this medicine or change dosage without checking with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how INTUNIV affects you.
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Drinking alcohol
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Be careful when drinking alcohol while taking INTUNIV because it could make you sleepy
and drowsy.
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Looking after your medicine
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Store INTUNIV in a cool dry place where the temperature is below 25°C.
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6. Are there any side effects?
Common side effects include feeling drowsy, headache, restless, trouble sleeping,
weight gain, loss of appetite, dry mouth, diarrhoea, constipation. Serious side effects
include allergic reaction, chest pain, seizures, loss of strength, need to urinate
frequently, itchy skin, high blood pressure.
Active ingredient(s): guanfacine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using INTUNIV. It does not take
the place of talking to your doctor or pharmacist.
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 INTUNIV. The information in this leaflet was last updated on the date listed on the final
page. More recent information on the medicine may be available. You should ensure
that you speak to your pharmacist or doctor to obtain the most up to date information
on this medicine. You can also download the most up to date leaflet from
www.takeda.com/en-au . Those updates may contain important information about the medicine and its use of
which you should be aware.
Where to find information in this leaflet:
1. Why am I using INTUNIV?
INTUNIV contains the active ingredient guanfacine hydrochloride. INTUNIV is a medicine used to treat the symptoms of Attention Deficit Hyperactivity
Disorder (ADHD) in children and adolescents 6-17 years old. It can be used alone or
with another medicine called a psychostimulant. INTUNIV can help improve your attention,
concentration and make you less impulsive and hyperactive.
INTUNIV should be used as part of a comprehensive treatment program which usually
includes psychological, educational and social therapy.
This medicine is not addictive.
2. What should I know before I use INTUNIV?
Warnings
Do not use INTUNIV if:
1. you are allergic to guanfacine hydrochloride, or any of the ingredients listed at
the end of this leaflet.
2. Always check the ingredients to make sure you can use this medicine.
3. Do not give this medicine to a child under the age of 6 years. Do not use if you are
an adult or are elderly. Safety and effectiveness in children younger than 6 years,
and adults and the elderly have not been established.
Check with your doctor if you/your child:
have heart problems or a low heart rate
have fainted
have low blood pressure
have history or current suicidal thoughts or behaviour
have liver or kidney problems
have any other medical conditions or take any medicines for any other condition
During treatment, you/your child 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/your child are pregnant or intend to become pregnant.
Talk to your doctor if you/your child are breastfeeding or intend to breastfeed.
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.
Some medicines may be affected by INTUNIV or may affect how well INTUNIV works.
You/your child may need different amounts of your medicines, or you/your child may
need to take different medicines. These include:
• medicines that lower blood pressure (antihypertensives)
• medicines used to treat epilepsy such as valproic acid
• medicines that make you sleepy
• medicines for mental health problems such as sedatives, benzodiazepines, barbiturates
and antipsychotics
• medicines that can affect liver metabolism such as ketoconazole, rifampin
• medicines that can affect enzyme metabolism
• medicines that contain metformin (used for treatment of type 2 diabetes).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect INTUNIV.
4. How do I use INTUNIV?
How much to take
Your doctor will normally start you/your child on a low dose. Your doctor will increase
the dose based on your/your child's body weight and how INTUNIV is working for you/your
child. Your doctor will tell you what dose to take each day and will calculate the
dose based on your/your child's body weight. The daily dose will be between 1-7 mg,
but not more than 7 mg. When used together with a stimulant, the usual daily recommended
dose is not more than 4 mg.
Follow the instructions provided and use INTUNIV until your doctor tells you to stop.
When to take INTUNIV
Take INTUNIV once a day either in the morning or evening.
How to take INTUNIV
INTUNIV can be taken with or without food. Swallow the tablet whole with a full glass
of water. Do not break, crush or chew the tablet.
Do not take INTUNIV with fatty foods
Do not eat or drink products and juices containing grapefruit while you/your child
are being treated with INTUNIV. It may interact with INTUNIV and affect how INTUNIV
works in the body.
If you/your child forget(s) to use INTUNIV
INTUNIV should be used regularly at the same time each day. If you/your child miss(es)
a dose, wait until the next day and take the usual dose.
Do not take a double dose to make up for the dose you/your child missed.
If you use too much INTUNIV
If you think that you/your child have/has used too much INTUNIV, you/your child 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.
Some of the signs and symptoms of an overdose may include high blood pressure at the
beginning turning into low blood pressure, slow heart rate, lack of energy, difficulty
breathing.
5. What should I know while using INTUNIV?
Things you should do
Make sure that all of your doctors, dentists, and pharmacists know you/your child
are taking INTUNIV. Remind them if any new medicines are about to be started.
If you/your child become pregnant while taking this medicine, tell your doctor immediately.
If you/your child have a gastrointestinal illness that leads to vomiting, tell your
doctor. This can be like missing doses which could lead to an increase in blood pressure
or heart rate.
All thoughts of suicide must be taken seriously. Talk to your doctor or mental health
professional if you/your child have thoughts or talk about death or suicide; or thoughts
or talk about self-harm or doing harm to others.
Keep all of your/your child's doctor's appointments so that your/your child's progress
can be checked. Your doctor will want to check your/your child's height and weight,
and blood pressure and heart rate at least once a year or when your/your child's dose
is changed or stopped to make sure the medicine is working and to prevent unwanted
side effects.
Things you/your child should not do
Do not stop using this medicine suddenly or lower the dosage without checking with
your doctor. If INTUNIV is stopped suddenly, your/your child's condition may worsen
or your/your child's blood pressure and heart rate may increase.
Do not take INTUNIV to treat any other complaints unless your doctor tells you to.
Do not give INTUNIV to anyone else, even if they have the same condition as you/your
child.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how INTUNIV
affects you.
This medicine may cause dizziness, light-headedness, tiredness, drowsiness in some
people. If you/your child have any of these symptoms, do not drive, operate machinery
or do anything else that could be dangerous. Children should be careful when riding
bicycles or climbing trees.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while taking INTUNIV because it could make you sleepy
and drowsy.
Looking after your medicine
Keep INTUNIV tablets in the pack until it is time to take them. Store INTUNIV in a
cool dry place where the temperature stays below 25°C.
Do not store it in the bathroom or near a sink, or in the car or on windowsill.
Do not use this medicine after the expiry date.
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.
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
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Less serious side effects
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What to do
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feeling sleepy or very drowsy
feeling tired or weary
headache
stomach pain
feeling restless or irritable
trouble sleeping or broken sleep or nightmares
feeling depressed, worried or having mood swings
new or worse aggressive behaviour, hostility
weight gain
loss of appetite
have a dry mouth
wetting yourself
feeling or being sick
diarrhoea, indigestion (upset stomach) or constipation
slow heartbeat
asthma
rash
feeling dizzy or faint
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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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allergic reaction which may result in a rash or more rarely to a sharp drop in blood
pressure, difficulty breathing, and hives/itching (anaphylactic reaction)
chest pain
seizures (fits) or convulsions
fainting
trouble breathing
low blood pressure or feeling dizzy when standing up
pale skin colour
high blood pressure or an unusual heart rhythm
fast heartbeat
itchy skin
need to urinate frequently
feeling agitated
hallucinations
sleeping more than normal
changes in liver blood test results
loss of strength
suicidal thoughts or behaviour
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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/your child 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 INTUNIV contains
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Active ingredient
(main ingredient)
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Guanfacine hydrochloride
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Other ingredients
(inactive ingredients)
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Methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate
80, hypromellose, lactose, povidone, crospovidone, silicified microcrystalline cellulose,
fumaric acid, glycerol dibehenate, indigo carmine aluminium lake (in 3 mg and 4 mg
tablets) and iron oxide yellow (in 3 mg and 4 mg tablets)
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Do not take this medicine if you are allergic to any of these ingredients.
What INTUNIV looks like
INTUNIV 1 mg tablet (AUST R 275278): Round and white to off-white, hard tablets, debossed
with 1MG on one side and 503 on the other side.
INTUNIV 2 mg tablet (AUST R 275313): Oblong shaped and white to off-white, hard tablets,
debossed with 2MG on one side and 503 on the other side.
INTUNIV 3 mg tablet (AUST R 275314): Round and green, hard tablets, debossed with
3MG on one side and 503 on the other side.
INTUNIV 4 mg tablet (AUST R 275315): Oblong shaped and green, hard tablets, debossed
with 4MG on one side and 503 on the other side.
INTUNIV is supplied as a 28 tablets pack size.
Who distributes INTUNIV
Takeda Pharmaceuticals Australia Pty Ltd
Level 39, 225 George Street
Sydney NSW 2000
Australia
Phone: 1800 012 612
This leaflet was prepared in June 2023.
INTUNIV® is a registered trademark of Shire Pharmaceuticals Ireland Limited, a Takeda company.
TAKEDA® and the TAKEDA® Logo are registered trademarks of Takeda Pharmaceutical Company Limited.