2. What should I know before I use GUANFACINE VIATRIS?
Do not use if you have ever had an allergic reaction to GUANFACINE VIATRIS 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 GUANFACINE VIATRIS and affect how it works.
4. How do I use GUANFACINE VIATRIS?
Your doctor will tell you what dose to take each day based on you/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 GUANFACINE VIATRIS? ("You" means either yourself or
your child)
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using GUANFACINE VIATRIS.
If you become pregnant while using this medicine, tell the doctor immediately.
|
|
Things you should not do
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Do not stop using this medicine or change dosage without checking with your doctor.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how GUANFACINE VIATRIS affects
you.
|
|
Drinking alcohol
|
Be careful when drinking alcohol while taking GUANFACINE VIATRIS because it could
make you sleepy and drowsy.
|
|
Looking after your medicine
|
Store GUANFACINE VIATRIS in a cool dry place where the temperature is below 25°C.
|
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, irregular heart rhythms.
Active ingredient(s):
guanfacine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using GUANFACINE VIATRIS. 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 GUANFACINE VIATRIS. 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.
Where to find information in this leaflet:
1. Why am I using GUANFACINE VIATRIS?
GUANFACINE VIATRIS contains the active ingredient guanfacine hydrochloride.
GUANFACINE VIATRIS 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. GUANFACINE
VIATRIS can help improve your attention, concentration and make you less impulsive
and hyperactive.
GUANFACINE VIATRIS 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 GUANFACINE VIATRIS?
Warnings
Do not use GUANFACINE VIATRIS if:
you are allergic to guanfacine 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.
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 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 GUANFACINE VIATRIS or may affect how well GUANFACINE
VIATRIS 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 GUANFACINE VIATRIS.
4. How do I use GUANFACINE VIATRIS?
How much to take
Your doctor will normally start you/your child on a low dose. Your doctor will increase
the dose based on you/your child's body weight and how GUANFACINE VIATRIS 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 GUANFACINE VIATRIS until your doctor tells
you to stop.
When to take GUANFACINE VIATRIS
Take GUANFACINE VIATRIS once a day either in the morning or evening.
How to take GUANFACINE VIATRIS
GUANFACINE VIATRIS 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 GUANFACINE VIATRIS with fatty foods
Do not eat or drink products and juices containing grapefruit while you/your child
are being treated with GUANFACINE VIATRIS. It may interact with GUANFACINE VIATRIS
and affect how GUANFACINE VIATRIS works in the body.
If you/your child forget(s) to use GUANFACINE VIATRIS
GUANFACINE VIATRIS 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 GUANFACINE VIATRIS
If you think that you/your child have/has used too much GUANFACINE VIATRIS, 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 GUANFACINE VIATRIS?
Things you should do
Make sure that all of your doctors, dentists, and pharmacists know you/your child
are taking GUANFACINE VIATRIS. 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 GUANFACINE VIATRIS 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 GUANFACINE VIATRIS to treat any other complaints unless your doctor tells
you to.
Do not give GUANFACINE VIATRIS 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 GUANFACINE
VIATRIS 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 GUANFACINE VIATRIS because it could
make you sleepy and drowsy.
Looking after your medicine
Keep GUANFACINE VIATRIS tablets in the pack until it is time to take them. Store GUANFACINE
VIATRIS 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
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/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 GUANFACINE VIATRIS contains
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Active ingredient
(main ingredient)
|
Guanfacine hydrochloride
|
|
Other ingredients
(inactive ingredients)
|
Methacrylic acid - ethyl acrylate copolymer (1:1)
hypromellose
lactose monohydrate
povidone
crospovidone
microcrystalline cellulose
glycerol dibehenate
macrogol 6000
silica colloidal anhydrous
magnesium stearate
indigo carmine aluminium lake & iron oxide yellow (in 3 mg and 4 mg tablets)
|
Do not take this medicine if you are allergic to any of these ingredients.
What GUANFACINE VIATRIS looks like
GUANFACINE VIATRIS 1 mg tablet: White to off white colour, round shaped, biconvex
tablet debossed with 'G1' on one side and plain on the other side.
GUANFACINE VIATRIS 2 mg tablet: White to off white colour, oval shaped, biconvex tablet
debossed with 'G2' on one side and plain on the other side.
GUANFACINE VIATRIS 3 mg tablet: Light green to green colour, round shaped, biconvex
tablet debossed with 'G3' on one side and plain on the other side.
GUANFACINE VIATRIS 4 mg tablet: Light green to green colour, oval shaped, biconvex
tablet debossed with 'G4' on one side and plain on the other side.
GUANFACINE VIATRIS is supplied as a 28 tablet blister pack and 28 tablet bottle pack
sizes.
Who distributes GUANFACINE VIATRIS
Sponsor
Maple Healthcare Pty Ltd
Level 8, 555 Bourke Street
Melbourne VIC 3000 Australia
Distributed by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in March-2026.